US20020123719A1 - Drug delivery systems and methods - Google Patents
Drug delivery systems and methods Download PDFInfo
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- US20020123719A1 US20020123719A1 US10/071,784 US7178402A US2002123719A1 US 20020123719 A1 US20020123719 A1 US 20020123719A1 US 7178402 A US7178402 A US 7178402A US 2002123719 A1 US2002123719 A1 US 2002123719A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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Definitions
- the present invention relates to the preparation and administration of a product and, more particularly, to the injection of the same into a living organism, for example, a human body.
- lyophilized substances i.e., drugs or compounds
- Lyophilization is the rapid freezing of a material at a very low temperature followed by rapid dehydration by sublimation in a high vacuum.
- the resulting lyophilized compound is typically stored in a glass vial or cartridge which is closed by a cap, such as a rubber stopper or septum.
- the diluent and compound are in separate, sterilized containers, the manual withdrawal of diluent via a syringe and reinjection of the same into the container containing the solid material such as a powdered or lyophilized drug may compromise sterility, and safety due to the use of a syringe.
- the present invention relates to systems and methods for delivering liquid drugs to a user.
- the drug delivery system can include delivery of reconstituted powdered drugs such as, for example, lyophilized drugs, or more generally for the transfer and delivery of liquid drugs. Powdered or lyophilized drug delivery further includes a system to reconstitute the powdered drug.
- the drug delivery systems may further include a pressurization system which pressurizes the drug for transfer to a delivery system or for direct subcutaneous delivery.
- the drug delivery system in accordance with the present invention includes an injector system which contacts the tissue and delivers the drug to the patient or user.
- the drug delivery system in accordance with the present invention includes filling of detachable delivery devices, for example, a standard syringe, a needleless injector, an infusion device or different types of pumps.
- detachable delivery devices for example, a standard syringe, a needleless injector, an infusion device or different types of pumps.
- a pen injector which aspirates the liquid drug from the system and in turn delivers the drug subcutaneously.
- the methods for delivering a powdered drug such as a lyophilized drug include the steps of pressurizing a diluent solution in a diluent vial.
- the pressurizing systems may include, but are not limited to, a compressed air supply, a chemical gas generator, a collapsible volume supply, a bellow canister, a standard syringe or a cylinder, for example.
- the methods further include the step of delivering the pressurized diluent solution to the powdered drug vial.
- the next step in the method includes the reconstitution of the drug to form a liquid drug by mixing the powdered drug with the diluent solution.
- the methods further include the steps of providing the liquid drug to an injector system or transferring the liquid drug to detachable delivery devices.
- the following step includes the injection of the liquid drug into the tissue of the patient or user.
- the methods further include the steps of moving the injection needle from a delivery or injection position to a retracted or storage position once delivery is complete.
- the features of the drug delivery systems may vary.
- the pressurization level can vary depending upon the viscosity level of the medicament
- the needle type or length can vary depending upon subcutaneous injection or intermuscular injection.
- the needle length ranges from 5 to 12 mm while the needle length may vary up to about 3 cm for intermuscular injections.
- the methods for delivering a liquid medicament to a patient include the steps of pressurizing the liquid drug solution in the vial with a pressurizing system. The subsequent steps are similar to the steps described with respect to the methods for delivering a powdered medicament.
- a preferred embodiment of the present invention features an injector system having an angled or unshaped needle.
- Another preferred embodiment of the present invention features an injector system having a straight needle.
- Yet another preferred embodiment of the present invention employs a transfer system for transferring the drug to delivery devices such as, for example, a standard syringe with a needle or a needleless pen injector.
- the devices receive the liquid drug from a container, such as a vial containing the liquid drug.
- the delivery devices subsequently deliver the medication to the user's tissue as described herein.
- the reconstituted drug delivery system has a housing having a first opening or port that receives a first container that contains a solid substance, such as a powdered lyophilized drug, for injection.
- a first container that contains a solid substance, such as a powdered lyophilized drug, for injection.
- the container is a rigid container, such as, for example, a vial or a cartridge containing the powdered drug.
- the housing can also include a second opening or port that receives a second container that contains a fluid to be mixed with material in the first container, to form an injectable fluid.
- the drug delivery system may include a manifold having a first channel that provides fluid communication between the first and second containers.
- the manifold further includes a second channel between the first container and a delivery or transfer device.
- the manifold can also include a communication channel to a pressurization system which provides the driving pressure to deliver the liquid drug.
- the penetrating member is a needle, in fluid communication with the first container after the needle moves between a storage position in the housing to an injection position extending outside the housing and into the user.
- a preferred embodiment of the invention provides for concealment of the injection needle within the main housing of the drug delivery device except during the injection of the drug to the user.
- This embodiment can include a needle retraction device for withdrawing the needle into the housing after injection to minimize the risk of exposure to a contaminated needle.
- the length of the delivery path from the container with the injectable fluid to the injection needle is reduced to minimize loss of residual amount of liquid drug.
- the injection needle first pierces the skin of the person being injected and is concurrently placed in fluid communication with the first container that contains the injectable fluid.
- the container that contains the injectable fluid is substantially visible during reconstitution and injection such that the user can visually observe the process.
- a compressed fluid such as a gas in the container with the injectable fluid, is used to force the injectable liquid through the injection needle and into the tissue being injected.
- the device has a single port with a compression element such that a container with a liquid medication, such as a previously reconstituted material, can be inserted into the housing and simultaneously pressurized to the needed pressure to deliver the correct dose over a predetermined time period.
- the device is used with the injectable fluid container being vertically oriented during injection.
- a gas impermeable membrane such as a hydrophilic membrane is disposed in the fluid path, which in a wetted state minimizes or preferably prevents gas flow while allowing liquid to flow through the membrane.
- the rigid containers need to be in a vertical orientation during reconstitution for appropriate pressurization. In an embodiment including a cartridge having diluent and air, a vertical orientation is not required for reconstitution.
- the axis of the injection needle is perpendicular to the longitudinal axis of the container with the injectable fluid.
- the containers containing a powdered or lyophilized drug and diluent are inserted in the housing in the same direction along parallel axes.
- the containers are inserted along a common axis or parallel axes in the opposite direction.
- the system can have housing apertures, ports, or openings that have a size compatible with standard vial and cartridge sizes such that existing vials and/or cartridges can be used.
- the container contents do not have to be mixed until immediately prior to injection. Because the contents of the containers are only in contact with other sterile parts, sterility prior to and during the reconstitution process is maintained.
- a further improvement to reduce and preferably prevent the risk of injecting gas into the injection site includes the use of a drug which is gas impermeable once wetted. Further, since the gas impermeable membrane can sustain pressure, the delivery time for the liquid drugs is shortened as a higher driving force is generated using pressurization systems. By disposing such a membrane such as a hydrophilic membrane in the drug delivery path that is gas impermeable in a wetted state, gas needed to control injection pressure and duration can be added in the system as the membrane checks the delivery of gas to the user.
- the container containing the fluid can be a changeable volume container which contains a controllable volume of a gas, for example, air.
- the device includes a manifold system to minimize the drug delivery path and simplify assembly costs, and increase system reliability.
- the simplicity and flexibility of the manifold system facilitates the use of standard prefilled cartridges and syringes.
- the manifold is a two-piece polycarbonate molding in which the two molded elements are ultrasonically welded together. The gas impermeable membrane is attached or welded to one piece of the polycarbonate molding.
- a further improvement to deliver an accurate predicted volume of a drug includes adjustable height penetrating members, such as, for example, outlet spikes.
- delivery of an accurate predicted volume for example 50% or 80% etc., can be gauged from the residual drug volume or the use of detachable delivery devices, for example, a standard syringe or a pen-type pump injector.
- a further improvement to the drug delivery systems includes interlocks and indicators which ensure the safe and accurate delivery of the drugs.
- the interlocks include, but are not limited to latches which provide for a desired sequence of operation such as pressurization of containers to follow the step of insertion of the containers, or prevention of displacement of the needle to an injection position after a first injection use.
- the indicators include a vertical orientation indicator and end of delivery indicators.
- the housing of the drug delivery device is shaped and designed to function appropriately to enable single handed operation.
- the bottom surface of the housing is flat in shape to allow table top placement to accommodate single handed operation by the user.
- the device is sized to enable the insertion of vials and subsequent activation of the device using one hand.
- the system housing is lightweight and compact, having a weight of less than 30 grams and a volume of less than 100 cm 3 .
- This provides a portable disposable device that can be discarded or recycled after a single use and that is readily transported by the user.
- the present invention is self-contained and maintains sterility throughout the reconstitution and injection of a fluid such as a lyophilized drug.
- the weight and volume of the system housing can vary depending upon the different embodiments and the volume of drug being delivered to a user.
- FIGS. 1 A- 1 F illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS. 2A and 2B illustrate cutaway views of the drug delivery device shown in FIGS. 1 A- 1 F, along line 2 A, 2 B- 2 A, 2 B in FIG. 1F.
- FIGS. 3 A- 3 D illustrate the sectional views of the internal components of the drug delivery device of FIGS. 1 A- 1 E and FIG. 2 during administration of the reconstituted drug.
- FIGS. 4 A- 4 O illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIG. 5A- 5 C are perspective views of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS. 6 A- 6 C illustrate the operation of a drug delivery device substantially similar to the device shown in FIGS. 5 A- 5 C.
- FIGS. 7 A- 7 C are partial perspective views of the drug delivery device of FIGS. 5 A- 5 C and 6 A- 6 C illustrating the injection of the drug.
- FIGS. 8 A- 8 F illustrate the operation of a drug delivery device substantially similar to the device shown in FIGS. 5 A- 5 C.
- FIGS. 9 A- 9 F illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS. 10A and 10B are graphical illustrations of the pressure, weight, and delivery characteristics of a preferred embodiment of the invention.
- FIGS. 11 A- 11 D illustrate cutaway views of an alternative embodiment including a drug container subassembly of the drug delivery device in accordance with the present invention.
- FIGS. 12 A- 12 B illustrate perspective views of a preferred embodiment of the diluent container subassembly shown in FIGS. 11 A- 11 D.
- FIGS. 13A and 13B illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIG. 14 illustrates a cutaway view of another preferred embodiment of the drug delivery device in accordance with the present invention.
- FIGS. 15A and 15B illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIG. 16 illustrates a cutaway view of an injection device in accordance with the present invention.
- FIGS. 17 A- 17 C illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIGS. 18 A- 18 C illustrate cutaway views of an alternate embodiment of the injector system of the drug delivery system in accordance with the present invention.
- FIGS. 19 A- 19 F illustrate alternate embodiments of pressurization systems included in the drug transfer system in accordance with the present transfer invention.
- FIGS. 20 A- 20 C illustrate views of an alternate embodiment of the drug delivery system in accordance with the present invention which uses standard vials containing a liquid medicament.
- FIG. 21 illustrates a view of another preferred embodiment of the drug delivery system in accordance with the present invention which uses standard vials containing a liquid medicament.
- FIGS. 22 A- 22 E illustrate cutaway and perspective views of an alternate embodiment of the drug delivery system in accordance with the present invention.
- FIGS. 23A and 23B illustrate alternate preferred embodiments to control the dose of drugs in accordance with the present invention.
- FIGS. 24 A- 24 C illustrate cutaway views of an alternate embodiment of the drug delivery system in accordance with the present invention incorporating filling devices, for example a syringe, to inject the drug system.
- filling devices for example a syringe
- FIG. 25 illustrates a cutaway view of an alternate embodiment of the drug transfer system in accordance with the present invention incorporating filling devices, for example a pen type pump to inject the liquid medicament.
- FIGS. 26 A- 26 D illustrate perspective views of a preferred embodiment of a drug transfer system in accordance with the present invention.
- FIGS. 27 A- 27 C illustrate cutaway views of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS. 28 A- 28 C illustrate cutaway views of the operation of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIG. 28D illustrates an enlarged cutaway view of a preferred embodiment of the spike which brings the liquid drug in communication with the delivery system in FIGS. 28 A- 28 C.
- FIGS. 29A and 29B illustrate partial cutaway views of a preferred embodiment of the drug transfer delivery system in accordance with the present invention.
- FIGS. 30A and 30B are views showing the two piece construction of the manifold in accordance with the drug delivery system of the present invention.
- FIGS. 31 A- 31 G are perspective views of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS. 32 A- 32 E are perspective views of another preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS. 33 A- 33 I are cutaway views illustrating the interlocks built into the drug delivery system in accordance with the present invention.
- FIGS. 34 A- 34 D are views of a preferred embodiment illustrating an end of delivery indicator of the drug delivery system in accordance with the present invention.
- FIG. 35 is a graphical illustration of a delivery profile of a preferred embodiment of the drug delivery system with no additional volume of air in the liquid vial in accordance with the present invention.
- FIG. 36 is a graphical illustration of the delivery duration and delivery pressure of a preferred embodiment of the drug delivery system in accordance with the present invention.
- FIG. 37 is a graphical illustration of delivery parameters of injecting a drug with no additional volume of air in accordance with the present invention.
- FIG. 38 is a graphical illustration of the air pressure gradient on a hydrophilic membrane in the drug delivery system in accordance with the present invention.
- FIG. 39 is a graphical illustration of the delivery profile with respect to time for a vial system containing about 7.5 ml of air in accordance with the present invention.
- FIG. 40 is a flowchart describing the method of delivery of a reconstituted drug in accordance with the present invention.
- FIG. 41 is a flowchart describing the method of delivery of a liquid drug in accordance with the present invention.
- the present invention is directed to drug delivery systems and methods.
- the drug delivery system provides generally-for the delivery of a drug in solution under pressure, and more particularly to the injection of powdered or lyophilized drugs that require reconstitution.
- the drug delivery system includes a reconstitution system, a pressurization system to facilitate drug delivery, a transfer system and an injector system.
- Different embodiments of the present invention may use only one of the systems described and other embodiments can employ combination of these systems, depending on the requirements of different applications.
- a preferred embodiment can deliver a liquid drug and not require reconstitution. Therefore the drug delivery systems and methods are a combination of some or all of the systems or processes described below.
- drug delivery device 100 comprises a first member or housing 304 and a pivotally connected second member or handle 106 .
- the device 100 is used to mix, within a sterilized environment, a first liquid such as a diluent 166 (for example, a fluid such as sterilized water) with a second powdered drug such as a lyophilized drug or compound concentrate 164 , e.g., interferon, and to inject the resulting reconstituted lyophilized drug into a living organism, which in the preferred embodiment is a human being.
- a first liquid such as a diluent 166
- a second powdered drug such as a lyophilized drug or compound concentrate 164 , e.g., interferon
- the device 100 utilizes a standard vial or first storage container 102 , which contains the lyophilized drug or compound 164 , and a standard cartridge or second storage container 116 , which contains the diluent 166 .
- the device 100 may be formed from inexpensive materials, such as plastic or the like, such that it is economically feasible to dispose of the device after a single
- the user In preparation for the administration of the drug, the user removes protective packaging which envelops the device 100 . This packaging maintains sterility of the device 100 prior to use.
- cartridge 116 containing diluent 166 comes preassembled, being locked into the bottom of housing 304 by the arms 133 as shown in FIGS. 2A and 2B.
- the sterility protector of the vial 102 is removed and then locked into the top of housing 304 as shown in FIG. 2A with a needle 124 from the housing penetrating a stopper 112 of the vial.
- vial 102 is filled with air at ambient pressure.
- the cartridge 116 is pushed upward, i.e., toward vial 102 .
- the cartridge 116 is punctured and the diluent 166 is delivered to the vial 102 as shown in part in FIG. 1C.
- there is a fluid such as gas in vial 102 which is compressed by transfer of diluent 166 into vial 102 .
- the user swills the device 100 to ensure the lyophilized drug is appropriately reconstituted.
- the reconstituted lyophilized drug, or injectable fluid is identified as reference number 160 .
- the device 100 is pressed against the skin of the person to be injected with the vial 102 in a vertical orientation to ensure that the compressed gas, for example, air is used to inject the reconstituted drug and that the gas or air is not injected into the injection site.
- the user presses the handle 106 which causes the injection needle 130 to move between a first position, or storage position, within the housing 304 as shown in FIG. 3A, and a second position, or injection position, outside the housing as shown in FIG. 3C. It is preferred that the needle extend out of the housing 304 in the range of 5 to 12 millimeters.
- the second extended position of the injection needle 130 is also illustrated in FIG. 1D.
- the injection needle 130 is fluidly connected to vial 102 such that the reconstituted lyophilized drug 160 , under pressure from the compressed gas in vial 102 , is delivered to the injection site.
- the delivery of the reconstituted lyophilized drug 160 can be completed in a time period in the range of 10 -30 seconds.
- a biasing mechanism 108 Upon release of handle 106 , a biasing mechanism 108 (to be detailed below) returns the handle to the original position. Simultaneously, a needle retraction mechanism (also to be described below) locks the injection needle 130 within the housing 304 , thereby reducing and preferably preventing exposure of the contaminated needle. The final stage of operation is illustrated in FIG. 1E, wherein the device 100 may be safely discarded.
- FIG. 1F is a view taken along line 1 F- 1 F of FIG. 1E and illustrates the relative positions of vial 102 and cartridge 116 in housing 304 . As shown, the longitudinal axes of vial 102 and cartridge 116 are parallel but offset relative to the positioning within the housing 304 . This allows for both vial 102 and cartridge 116 to be inserted into the housing 304 without interfering with the internal components of the device 100 , for example, the needle retraction mechanism described below.
- FIGS. 2A and 2B illustrate cutaway views along lines 2 A, 2 B- 2 A, 2 B of Figure IF of the device 100 including vial 102 and cartridge 116 .
- vial 102 is preferably a standard vial, for example, a 2 milliliter vial, which typically comprises glass and includes a puncturable rubber stopper 112 held in place by an aluminum band or other sealing mechanism 114 .
- the upper end of housing 304 includes a grooved portion 132 which locks the vial 102 to the housing by passing the lip of the aluminum band 114 under a pair of spaced apart arms that hook up into the housing.
- a first needle 124 is mounted to the housing 304 and is configured to pierce the rubber stopper 112 of vial 102 upon insertion of the vial into the locking position provided by arms 133 .
- First needle 124 is fluidly connected to a first channel or tube 122 for receiving the diluent from cartridge 116 as illustrated in FIG. 2B.
- Cartridge 116 similar to vial 102 , preferably comprises a standard cartridge (for example, a 2 milliliter cartridge with about 1 milliliter diluent) and includes a rubber stopper 118 which is pierced by a second needle 126 , or other suitable means.
- Second needle 126 is fixedly mounted on an extending member or compression element 238 of housing 304 such that the cartridge is pierced upon insertion of the cartridge.
- First tube 122 is fluidly connected to the second needle 126 .
- extending member 238 or compression element of housing 304 contacts and pushes rubber stopper 118 toward the bottom of cartridge 116 .
- the diluent 166 is forced up tube 122 into vial 102 to mix with the drug 164 contained therein.
- cartridge 116 contains approximately 1 milliliter of diluent which is forced into vial 102 , resulting in a pressure inside vial 102 of approximately 2.25 bars. This pressure can be adjusted, for example, by decreasing the amount of diluent or air in cartridge 116 . A higher pressure inside vial 102 injects the reconstituted drug 160 more quickly.
- a sterilized solution is provided wherein the diluent 166 is mixed with the lyophilized drug 164 with minimal exposure to outside contaminants. It is preferable that vial 102 containing the reconstituted lyophilized drug 160 be visible during reconstitution and injection such that the user can properly visually verify that the lyophilized drug 160 is thoroughly mixed with diluent 166 and that the vial 102 is vertical during injection to ensure the compressed gas is not being injected into the injection site.
- Handle member 106 is pivotally connected to the housing 304 at a first end by a pivoting mechanism 110 which can include a rivet or other suitable means such that the handle member rotates in the direction of arrow 240 .
- Handle member 106 includes biasing mechanism 108 which resiliently biases handle member such that the end opposite the pivotally connected end is forced away from housing 304 .
- Biasing mechanism 108 includes an extending member from handle member 106 which contacts housing 304 , thereby providing a resilient biasing force away from the housing when the handle member is forced toward the housing.
- the biasing mechanism 108 can comprise a conventional spring, or other suitable means, interposed between housing 304 and handle, member 106 which provides the biasing force.
- a needle injection and retraction mechanism for injecting the reconstituted drug 160 into the person and retracting the injection needle 130 within the housing 304 .
- the mechanism includes a first bar member 140 , which is pivotally connected at a first end by member 136 , and guidably mounted at a second end to the handle member 106 by a first coupling device 142 , such as a pin, rivet, bolt, or other suitable means.
- Member 136 fixedly supports injection needle 130 and is guided by an opening 138 , or needle aperture, in the housing 304 .
- injection needle 130 is in the range of a 24-28 gauge needle.
- first coupling device 142 is controlled by a J-shaped slot 134 which can comprise a slot or groove in handle member 106 .
- a second bar member 148 is pivotally connected at a first end to first coupling device 142 and pivotally connected at a second end to a third bar member 152 by a third coupling device 150 .
- Third bar member 152 fixedly supports a third needle 128 and may be guided by internal bore in housing 304 .
- a second channel or tube 120 fluidly connects the third needle 128 and injection needle 130 . It is preferable to minimize the length of tube 120 such that the residual volume of drug remaining in the tube after injection is reduced to increase the accuracy of the dosage.
- FIGS. 3 A- 3 D The operation of drug delivery device 100 shown in FIGS. 2A and 2B is illustrated in FIGS. 3 A- 3 D.
- FIG. 3A illustrates the stage at which the cartridge 116 is inserted forcing diluent 166 up tube 122 into vial 102 .
- the rubber stopper of 118 of cartridge 116 is forced to the bottom of the cartridge by member 238 as shown in FIGS. 2A and 2B.
- This causes the diluent 166 to be forced up tube 122 which results in the reconstituted drug 160 being under pressure, which in the preferred embodiment is approximately 2.25 bars.
- the device 100 is preferably vigorously shaken to ensure the lyophilized drug is properly mixed with diluent 166 .
- the device 100 is placed against the skin of the person being injected.
- the user presses handle member 106 toward the housing 304 in a direction shown by arrow 240 A, thereby displacing injection needle 130 from the first position within the housing to a second position outside the housing such that the needle penetrates the skin of the body being injected.
- first bar member 140 rides up the J-shaped slot 134 .
- second bar member 148 which includes a linear slot 244 , is rotated such that first coupling device 142 rides up to the top of slot 244 .
- FIG. 3D illustrates the continued pressing motion of the handle member 106 toward the housing 304 .
- the second bar member 148 forces third bar member 152 and hence third needle 128 upward such that third needle penetrates the rubber stopper 112 of vial 102 .
- the reconstituted lyophilized drug 160 is under pressure, it is forced through tube 120 and thus into the person being injected.
- biasing mechanism 108 is compressed.
- biasing mechanism 108 forces the handle member away from the housing 304 as indicated by arrow 240 B and thus withdraws injection needle within the housing.
- J-shaped slot 134 is beneficially provided with an end locking portion 146 which catches coupling device 142 such that the injection needle 130 is “locked” within the housing 304 after a single injection. Now, the device 100 can be safely discarded.
- FIGS. 4 A- 4 K illustrate a drug delivery device 100 - 1 in accordance with a preferred embodiment of the present invention wherein the same reference numbers refer to the same or similar elements. More particularly, FIG. 4A illustrates the device 100 - 1 which includes a housing 304 - 1 having a first port or opening 176 for receiving a diluent cartridge 116 and a second port or opening 262 for receiving vial 102 . In this embodiment, it is preferred that cartridge 116 containing diluent 166 be preassembled such that the cartridge is partially penetrated by needle 126 - 1 and such that the device 100 - 1 (without vial 102 ) is wrapped by a packaging material to maintain sterility prior to use.
- vial 102 and cartridge 116 are packaged separately from the device 100 - 1 as shown in FIG. 4A.
- the user removes the sterility protector and presses the vial 102 firmly into the opening until needle 124 - 1 penetrates the rubber stopper 112 .
- the user then forces cartridge 116 into the housing 304 - 1 .
- the rubber stopper 118 is first penetrated by needle 126 - 1 such that the needle extends into the diluent 166 . This stage is illustrated in FIG. 4B.
- the first opening 176 of housing 304 - 1 is preferably circular, thereby allowing the walls of cartridge 116 to enter the housing and not the rubber stopper 118 .
- the resulting reconstituted lyophilized drug 160 in vial 102 is preferably under pressure of about 2.25 bars. A greater or lower pressure may be necessary depending on the volume to be injected.
- the device 100 - 1 is preferably vigorously shaken to ensure the reconstituted lyophilized drug 160 is properly mixed in preparation for injection.
- Interlocking mechanism comprises a bar member 266 pivotally connected to the housing 304 - 1 between the openings 176 and 262 .
- the bar member is configured to be moved in the direction of arrow 264 (FIG. 4A) upon insertion of vial 102 .
- bar member 266 prevents cartridge 116 from being inserted.
- vial 102 is inserted, it rotates bar member 266 in the direction of arrow 264 as shown in FIG. 4A such that cartridge 116 can subsequently be inserted.
- the device 100 - 1 is further provided with an actuator or pushing member 174 for displacing the injection needle 130 - 1 between a first position within the housing 304 - 1 and a second position outside the housing. It is preferred that the injection needle 130 - 1 extend out of the housing 304 - 1 in the range of 5-12 millimeters.
- the injection needle 430 - 1 is in the range of a 24-28 gauge needle and is preferably a “U” type needle having a second end 172 configured to puncture sealing member 170 .
- Sealing member 170 which can be any puncturable material such as butyl rubber, sealingly maintains the liquid in the upper part of housing 304 - 1 prior to use.
- the locking assembly 268 A comprises member 268 as shown in FIG. 4C having a first end configured to be moved by pushing member 174 and a second end configured to displace a ball 270 or other appropriate movable locking device.
- the pushing member 174 With the pushing member 174 in the first position such that injection needle 130 is within the housing, groove 272 of the pushing member 174 aligns with groove 274 such that ball 270 can freely travel around the groove 274 of the pushing member.
- vial 102 is vertically oriented with the compressed gas above the liquid, thus being properly positioned for injection as shown in FIGS. 4B and 4C, ball 270 rests in the bottom of groove 274 allowing the pushing member 174 to displace the injection needle 130 .
- the ball 270 is positioned within grooves 272 and 274 to prevent displacement of the pushing member 174 .
- FIGS. 4 G- 4 L illustrate this aspect of the invention. More particularly, FIG. 4G is similar to FIG. 4C except cartridge 116 is shown outside of the housing 304 - 1 .
- FIG. 4H is a sectional view taken along line 4 H- 4 H of FIG. 4G and shows member 276 of the locking mechanism having a slotted portion 278 therein. Member 276 is slidable within the housing 304 - 1 and configured to be moved by insertion of cartridge 116 . The lower end of member 276 is positioned within grooves 272 and 274 as shown in FIG. 41. Thus, with member 276 in the position shown in FIG. 4H, or before cartridge 116 is inserted into the housing 304 - 1 , the pushing member 174 , and hence injection needle 130 - 1 , is prevented from moving to the injection position.
- the user presses pushing member 174 such that the injection needle 130 - 1 first extends out of the housing 304 - 1 , thus penetrating the skin of the person being injected.
- pushing member 174 causes the second end 172 of injection needle 130 - 1 to puncture sealing member 170 , thereby allowing the pressurized reconstituted lyophilized drug 166 to travel from vial 102 into the person being injected. It may take in the range of 10-30 seconds to deliver the injection fluid.
- This pressing motion compresses spring 190 such that upon release of pushing member 174 , the member returns to the original position, i.e., the needle 130 - 1 is withdrawn within the housing 304 - 1 and locked therein. Insertion of the pushing member 174 into the housing 304 - 1 also moves in member 268 such that ball 270 is biased against the pushing member. This is shown in FIG. 4N. When the pushing member 174 is returned to the first position, the ball 270 is positioned and held within groove 272 by member 268 , thereby preventing displacement of the pushing member and hence the injection needle 130 - 1 after a single injection. This configuration is illustrated in FIG. 40. With the injection needle 130 - 1 locked within the housing 304 - 1 , the device 100 - 1 may be safely discarded.
- FIGS. 5 A- 5 C illustrate a drug delivery device 100 - 2 in accordance with a preferred embodiment of the present invention. More particularly, FIG. 5A illustrates the device 100 - 2 with the cartridge 116 installed but not inserted or penetrated by any needle, and the vial 102 in place ready to be inserted. FIG. 5B illustrates the inserted vial 102 , while FIG. 5C shows the subsequently inserted cartridge 116 . At this stage, the diluent from cartridge 116 has been transferred to vial 102 , resulting in a pressurized liquid in the vial. The device 100 - 2 is vigorously shaken to ensure proper mixing of the reconstituted lyophilized drug. The device 100 - 2 is now ready for injection.
- the housing 304 - 2 advantageously includes a cutaway portion 254 which allows the user to visually inspect vial 102 to verify that the lyophilized drug 160 is thoroughly mixed with diluent 166 and to verify that vial 102 is vertically oriented during injection to ensure air is not being injected into the injection site.
- FIGS. 6 A- 6 C are plan views of a similar device 100 - 3 corresponding to FIGS. 5 A- 5 C, respectively. Accordingly, FIG. 6A illustrates the cartridge 116 installed but not punctured by needle 126 - 3 . Vial 102 , containing the lyophilized drug 164 , is also shown ready to be inserted into housing 304 - 3 .
- FIG. 6B shows the inserted vial 102 which is punctured by needle 124 - 3 .
- Vial 102 pushes first against surface 178 - 3 of puncturing device 182 - 3 and pushes device downward before being pierced by needle 124 .
- Pushing puncturing device 182 downward sets a spring which (as will be explained in FIGS. 7 A- 7 C) moves puncturing device upward such that needle 128 - 3 penetrates vial 102 .
- the spring can be preloaded.
- needles 124 - 3 and 126 - 3 are fluidly connected by a manifold 127 comprising a channel 129 or tube.
- the rubber stopper Upon insertion of cartridge 116 , the rubber stopper is first pierced by needle 126 , and as cartridge 116 is further inserted into the circular opening 176 - 3 of housing 304 - 3 , the rubber stopper 118 is forced to the bottom of cartridge 118 , thereby forcing the diluent 166 through the manifold 127 into vial 102 . This also compresses the gas that was heretofore contained in the vial 102 to a pressure sufficient for injection. The resulting stage is shown in FIG. 6C.
- the device 100 - 3 is preferably vigorously shaken to ensure proper mixing of the lyophilized drug 164 . Now, the device 100 - 3 is ready to inject the reconstituted drug solution 160 contained in the vial 102 .
- FIGS. 7 A- 7 C illustrate partial perspective views of the device 100 - 2 , 100 - 3 shown in FIGS. 5 A- 5 C and 6 A- 6 C. More particularly, FIG. 7A shows the pushing member 174 - 3 including an internal bore with member 252 slidably contained therein. Member 252 fixedly supports injection needle 130 which is in fluid communication with needle 128 via tube or channel 120 . Needle 128 shown in FIG. 7A has yet to pierce the rubber stopper 112 of vial 102 . Needle 128 is fixedly supported by puncturing device 182 .
- a first spring 190 is compressed allowing the member 252 to move downward until contacting the housing.
- the spring 190 is set such that it creates both axial and rotational movement. Only upon complete insertion of the vial 102 is the rotational movement of the spring enabled which in turn enables the puncturing of the vial 102 .
- injection needle 130 - 3 extends in the range of 5-12 millimeters out of the housing through needle aperture 256 .
- the injection needle 130 partially extending out of the housing 304 - 3 is illustrated in FIG. 7B.
- FIGS. 8 A- 8 E illustrate a drug delivery system 100 - 4 in accordance with a preferred embodiment of the present invention wherein the same reference numbers refer to the same or similar elements. More particularly, FIG. 8A illustrates the device 100 - 4 which includes housing 304 - 4 having a first port or opening 176 - 4 for receiving cartridge 116 and a second port or opening 262 - 4 for receiving vial 102 .
- Vial 102 containing the reconstituted drug 164 is inserted into the housing 304 , followed by the insertion of cartridge 116 containing the diluent 166 . Again, a rubber stopper of the cartridge 116 is forced to the bottom of the cartridge which forces the diluent under pressure into vial 102 . This stage is shown in FIG. 8B.
- the housing 304 - 4 includes a cutaway portion 400 such that vial 102 is substantially visible during reconstitution and injection. This allows the user to visually verify that the drug is properly reconstituted and that the vial 102 is vertically oriented during injection with the compressed gas above the reconstituted drug.
- FIG. 8C is a rear view taken of FIG. 8B and illustrates the injection of the reconstituted drug. More particularly, the pushing member or actuator 174 - 4 is pressed into housing 304 - 4 which forces injection needle 130 - 4 out of the housing and into the person being injected. In the preferred embodiment, the injection needle extends out of the housing in the range of 5-12 millimeters.
- the reconstituted drug in fluid communication with the vial 102 , is transferred from the vial and into the person being injected.
- FIGS. 8 D- 8 F are isometric views of the device 100 - 4 in the stages shown in FIGS. 8 A- 8 C, respectively.
- FIGS. 10A and 10B graphically illustrate system characteristics of a preferred embodiment of the drug delivery device.
- the system requires a sufficient fluid pressure in the delivery vial that is manually actuated by the user within a short time period.
- FIG. 10A shows the pressure (millibars) and weight (grams) characteristics of the system during a delivery period of about 30 seconds for a delivery volume of about 1.6 milliliters.
- FIG. 10B illustrates test results of the delivery of 1.6 milliliters into different animals using a single drug deliver device for the same time period.
- FIGS. 11 A- 11 D cutaway views of a preferred embodiment of a diluent container subassembly and a manifold, which may be used with the drug delivery devices or with an ordinary syringe or other drug delivery devices, are illustrated.
- the diluent container subassembly 300 includes a preassembled compression portion 310 which allows the user to hold the diluent container 312 , which can be in the form of a compressible sealed bag, and insert it into a needle 314 .
- the diluent container 312 contains about 1 milliliter diluent and a controlled volume of gas, such as air, for example, and upon insertion into housing 304 - 6 , is pierced by the needle 314 .
- a controlled volume of gas such as air
- the diluent container 312 is sized to allow for expansion of the container as a result of changes to the environment.
- the compression portion 310 is used to compress the exterior of the diluent container and apply pressure to the contents of container during delivery of the diluent for mixing.
- the diluent containers are formed from flexible, collapsible materials, for example, polyethylene, polypropylene and nylon.
- the compression portion 310 includes a slider element 316 and two longitudinally extending arms 318 , 320 extending therefrom. Two cylindrical drums 322 , 324 are spaced between the longitudinally extending arms 318 , 320 .
- FIG. 11A illustrates the diluent container subassembly 300 positioned in the housing 304 - 6 of the drug delivery system in accordance with the present invention.
- FIG. 11D further illustrates the fully compressed state of a preferred embodiment of the diluent container subassembly 300 .
- the slider element 316 of the compression portion 310 translates in at least one axis, for example, in the illustrated embodiment, it can move up or down.
- the downward movement of the slider element 316 causes the diluent container 312 to wrap around the cylindrical drum 324 which compresses the contents of the diluent container 312 , thus forcing the diluent from the container 312 and through the needle 314 and into the vial 102 .
- the movement of the slider element 316 is limited by an end of travel position. At this end of travel position, the slider element 316 may be locked by a locking mechanism which ensures that the diluent container is kept compressed.
- a manifold 330 includes two needles 314 , 332 fixedly mounted at the ends of an extending member 334 .
- the needles can also comprise a penetrating member that is formed from an injection molded material such as medical grade polycarbonate or acrylic with the required level of rigidity to penetrate the vial or container.
- a channel 331 provides for fluid communication between the needles 314 and 332 . Needle 314 pierces the diluent container 312 upon insertion of the container, while needle 332 pierces the vial 102 upon insertion of the vial containing the lyophilized drug 164 .
- container 312 contains approximately 1 milliliter of diluent and a controlled volume of air which is forced into vial 102 , resulting in a pressure inside vial 102 of approximately 2.25 bars.
- the pressure inside vial 102 results from forcing the controlled volume of air in the diluent container 312 into the rigid volume in the vial 102 .
- the diluent 166 is forced into vial 102 to mix with the lyophilized drug 164 contained therein.
- the entire assembly is preferably shaken to ensure the reconstituted drug 160 is properly mixed in preparation for injection.
- the vial 102 is vertically oriented during injection to ensure air is not being injected into the injection site.
- the injector needle 130 - 6 is shown in a first position within the housing 304 - 6 .
- the injection needle 130 - 6 is in the range of a 24-28 gauge needle and is preferably a “U” shaped needle having a second end 172 - 6 configured to puncture sealing member 170 - 6 .
- An area 171 is located adjacent to the sealing member 170 - 6 and is in communication with the channel 331 as shown in 11 B.
- buttons 305 When the user compresses the button 305 , it causes the needle 130 - 6 to penetrate the skin and the second end 172 to penetrate the sealing member 170 .
- the drug and diluent solution will flow from the needle 332 , through the channel 331 , and area 171 and to the user via the injector needle 130 - 6 .
- the button 305 As the user compresses the button 305 , which is spring loaded by spring 306 , a pair of mating pawls 307 , 308 fit together and prevent the button from being pulled out and the reuse of the device as shown in FIG. 11C.
- FIGS. 12 A- 12 B illustrate perspective views of a preferred embodiment of the diluent container subassembly 300 and provide further details of the components of the compression portion 310 .
- the cylindrical drum 324 is slotted such that the diluent container can be inserted therein.
- the cylindrical drum 322 serves as a backing drum.
- the diluent container 312 is typically inserted between the cylindrical drum 324 and the backing drum 322 .
- the drum apparatus 322 , 324 moves in a rack and pinion gear apparatus 340 .
- An end of travel position 342 in the rack and pinion gear apparatus 340 constrains the movement of the cylindrical drum 324 at its end of movement position.
- This end of travel position correlates with the end of the wrapping of the diluent container 312 around the cylindrical drum and maximum compression of the contents of the container.
- a flange 344 can be used to hold the diluent container 312 at the bottom of the subassembly 300 .
- the diluent container 312 can be sealed by means of heat welding techniques or ultra sonic techniques to the flange 344 after it has been filled with the diluent.
- the longitudinally extending arms 318 , 320 in the compression portion 310 each comprise two members 350 , 352 , as shown in FIG. 12B.
- a cylindrical drum is attached to each member.
- the two members 350 , 352 are spaced apart from each other to accommodate the wrapping of the diluent container on the cylindrical drum 324 .
- FIGS. 13 A- 13 B cutaway views illustrate an alternate embodiment of the invention similar to that shown in FIGS. 11 A- 11 D including a manifold 350 .
- the manifold 350 has two needles 352 , 354 for the purpose of piercing the vial 102 and diluent container 312 respectively. Once the diluent 166 and the controlled volume of air are forced to move into vial 102 , the diluent mixes with the lyophilized drug 164 and results in the reconstituted drug 160 which is under pressure.
- the reconstituted drug is under pressure due to the controlled volume of air, it is forced through the needle 352 and into the person being injected through a needle 351 that is actuated by movement of pushing member 353 .
- This embodiment of the device provides a user comfort as it does not have to be vigorously shaken to ensure the reconstituted lyophilized drug 160 is properly mixed in preparation for injection.
- the controlled volume of air facilitates the mixing of the diluent and the lyophilized drug.
- the pushing member 353 displaces the injection needle 351 between a first position within the housing 304 and a second position outside the housing, or in an injection state.
- a locking mechanism comprising member 268 as shown in FIG. 4B is provided to accomplish the foregoing.
- the member 268 has a first end configured to be moved by pushing member 353 and a second end configured to displace a movable locking device, substantially similar to the device shown in FIG. 4B.
- the pushing member 353 causes the second end 355 of injection needle 351 to puncture sealing member 357 , thereby allowing the pressurized reconstituted drug 166 to travel from vial 102 into the person being injected. It may take in the range of 10-30 seconds to deliver the injection fluid.
- FIG. 14 a cutaway view illustrates a manifold of another preferred embodiment of the drug delivery device 100 - 8 in accordance with the present invention.
- the manifold 350 has two needles 352 , 354 for the purpose of piercing vial 102 and diluent container 312 , respectively.
- a flange substantially similar to the flange 127 shown in FIG. 6B, holds the septum or stopper 313 in place in the container 312 .
- An extending member or communication chamber 356 which is in fluid communication with the needles 352 , 354 , has a membrane such as a hydrophilic membrane or barrier 360 disposed therein.
- the hydrophilic membrane needs to be wetted before it functions to minimize or preferably prevent the flow of gas into a user's tissue.
- the hydrophilic membrane allows gas, for example, air to pass freely till it comes in contact with liquid and gets wet. Thus, when wet, no air such as the controlled volume of air in the diluent container 312 can pass through the hydrophilic membrane, preventing air from entering the user's tissue.
- the presence of the hydrophilic membrane prevents risks caused by any wrong use of the device 100 - 8 by the user such as incorrect positioning of vials or containers.
- FIGS. 15 A- 15 B cutaway views illustrate another preferred embodiment of a manifold of the drug delivery device in accordance with the present invention
- the needle 352 pierces the vial 102 while needle 354 pierces the diluent container 312 .
- the needle 354 and channel 352 on spike 352 A are in fluid communication.
- Diluent 166 moves from the diluent container 312 into vial 102 , thus mixing with the lyophilized drug to result in a reconstituted drug.
- a channel 358 is in communication with an area 361 sealed by a stopper 313 .
- Channel 358 also includes a hydrophilic membrane. Thus, upon the introduction of air to the channel, the membrane expands in the presence of air and disallows the passage of air therethrough.
- the user presses the button 363 which first moves injector needle 130 into the users skin. Further movement of the button 363 causes piercing member 172 to penetrate the stopper 313 . This enables liquid drug/diluent solution to move, via the air pressure in the vial 102 through the injector needle 130 and the user's skin.
- FIGS. 15A and 15B being more position independent, is not subject to air blocking the flow of liquids through the gas impermeable membrane until all the drug solution has been transferred out of the vial 102 .
- FIG. 15A shows the position of channel 358 relative to channel 352 .
- the embodiment illustrated with respect to FIG. 14 and the absence of the lower channel 358 is more position dependent and thus subject to air blocking the flow of liquids through the gas impermeable membrane even while the drug solution is being transferred out of the vial 102 .
- the delivery times of the drugs is dependent on the volume of vial which maybe adjusted.
- the pressure is adjusted in part by adjusting the vial volume size. A large vial volume of air relative to the drug would result in greater air pressure and faster drug delivery.
- the drug vials and the diluent containers are shown as being inserted in the housing 304 and aligned in the same direction along parallel axes.
- the vials and containers may not be aligned in the same direction along parallel axes.
- the vials and containers may be inserted along two different axes that are oriented at oblique or orthogonal angles relative to each other.
- FIG. 16 a cutaway view illustrates an alternate preferred embodiment of an injection device 236 in accordance with the present invention.
- the device 236 facilitates the sterilized injection of a prefilled cartridge or vial containing an injectable liquid, for example, a vial containing a liquid drug 160 .
- the device 236 includes first opening 161 for receiving vial 102 and a manifold 370 including member 372 sealingly engaged with the first opening 161 .
- Member 372 fixedly supports needle 374 and is supported by a collapsible volume, such as bellows 378 , or any other device capable of injecting a fluid such as a gas upon being compressed.
- a check valve 380 ensures that the flow from the bellows is unidirectional, that is, the drug under pressure can not enter the bellows 378 .
- the check valve 380 comprises a tubular member 381 adapted to deliver gas, for example air, to the vial 102 . Air is moved out of the bellows and into the tubular member 332 by compressing, the bellows 378 .
- the check valve 380 allows the flow of air out of the bellows 378 and into the vial but disallows the reverse flow of air from the vial into the bellows. Air from the bellows 378 is forced up through needle 374 and into vial 102 applying pressure to the contents of the vial 102 .
- the liquid drug 160 is under pressure and is injected into the user directly from the vial 102 .
- the injection process is the same as discussed earlier with respect to embodiments in FIGS. 13 - 15 , in that the use of a U-shaped needle assembly is compressed into the skin to activate injection.
- a hydrophilic membrane 360 in the drug delivery path minimizes and preferably prevents gas from being injected into the user.
- FIGS. 17 A- 17 C cutaway views illustrate an alternate embodiment of the drug delivery device 100 in accordance with the present invention.
- the diluent container comprises a syringe 390 .
- the diluent 166 is forced out of the syringe 390 through the channel 398 and into the contents of vial 102 via the needles 394 , 396 which are in fluid communication with each other through the member 398 .
- the diluent 166 is provided to vial 102 under pressure and is mixed with the reconstituted drug to result in a reconstituted drug solution ready for injection or delivery under pressure to a patient.
- the drug solution is delivered to a user using a u-shaped needle assembly as disclosed with respect to FIGS. 13 A- 13 B, 14 , and 15 A and 15 B.
- This syringe embodiment facilitates the use of a standard prefilled container or cartridge containing only a diluent.
- the device is flexible and does not require special means or training.
- FIGS. 9 A- 9 F illustrate an injection device 236 which facilitates the sterilized injection of a prefilled cartridge or vial containing an injectable liquid, for example, a vial containing a reconstituted drug 160 . It is preferable to use a standard vial, for example, a 2 milliliter vial, with this device 236 .
- device 236 includes a first opening for receiving the vial 102 and a manifold including member 232 which is slidably and sealingly engaged with the first opening.
- Member 232 fixedly supports needle 224 and is supported by a collapsible volume, such as bellows 228 , or any other device capable of injecting air upon being compressed. Needle 224 is in sealed communication with the bellows 228 as shown in FIG. 9A. The vial 102 is pressed into the housing 304 - 5 such that needle 224 pierces the rubber stopper 112 . This arrangement is shown in FIG. 9B.
- the vial 102 is further pressed into the housing 304 - 5 which forces member 232 to compress bellows 228 , thus forcing the air contained in bellows 228 up through needle 224 and into cartridge 116 .
- the cartridge 116 is under pressure for forcing the drug 166 into the person being injected.
- the bellows or other compression device can also be actuated by member 174 - 5 .
- device 236 is further provided with a pushing member 226 for displacing the injection needle 130 - 5 between a first position within the housing 304 - 5 and a second position outside the housing, or in an injection state.
- a distal end of the injection needle 130 - 5 can extend out of the housing 304 - 5 in the range of 5-12 millimeters.
- the injection needle 130 is preferably a “U” type needle having a second end 250 configured to puncture sealing member 230 .
- Sealing member 230 which may comprise any puncturable material such as butyl rubber, maintains the liquid in the upper part of housing 304 .
- the first end of the injection needle 130 first penetrates the skin of the person being injected as shown in FIG. 9D.
- the second end 250 of injection needle 130 - 5 puncture sealing member 230 , thereby allowing the reconstituted drug 160 to travel from cartridge 116 into the person being injected.
- FIG. 9E The pressing of the pushing member 226 into the housing 304 - 5 compresses a spring such that upon release of pushing member 226 , the member returns to the original position, i.e., the injection needle 130 - 5 is in the first position within the housing 304 - 5 as shown in FIG. 9F.
- This embodiment may be further provided with a locking mechanism similar to that disclosed in FIGS. 4 A- 4 K. With the injection needle locked within the housing 304 - 5 , the device 236 may be safely discarded.
- FIGS. 18 A- 18 C illustrate an injection device in accordance with an alternate preferred embodiment of the present invention.
- the drug delivery device 400 includes a straight needle 402 having a lancet 404 disposed on a first end.
- a cavity 405 in the septum 406 contains a liquid drug under pressure.
- the straight needle 402 includes a side hole 407 disposed on the shaft. The second end 408 of the straight needle is blocked.
- the injection needle 402 is displaced from a first position in the housing 412 to a second position outside the housing such that the needle 402 penetrates the skin of the user.
- the lancet 404 penetrates the user's tissue
- continued pressing motion of the member 410 toward the housing causes the side hole 407 to be in fluid communication with the cavity 405 of the septum 406 creating a path for the drug under pressure to flow into the user's tissue.
- the straight needle punctures the septum 406 at two locations. As shown in FIG. 18C, as the member 410 is released, the injection needle is withdrawn within the housing 412 .
- a 3 part ring structure including member 414 , latch 416 , gap 418 and spring 419 as shown in FIG. 18A provide an interlocking system.
- This safety mechanism which includes the members 410 , 414 , latch 416 , gap 418 and spring 419 provides an interlock to ensure against reuse of the drug delivery device 300 and exposure of needle 402 after the first use.
- the mating ridges 413 A and 413 B come together.
- the ridges are angled on one side to allow ridge 413 B to pass under 413 A when member 410 is depressed against the housing 412 .
- the ridges are pressed together when the force of the spring 419 moves member 410 away from the housing 412 . Because the ridges interface at a right angle to the direction of movement of the member 410 they serve to prevent further movement by the member and the needle 402 . This mechanism ensures that the device 400 is not reused.
- FIGS. 19 A- 19 F illustrate cutaway views of alternate preferred embodiments of systems which allow reconstitution of drug and subsequent transfer into a drug delivery device in accordance with the present invention.
- the drug Once the drug is made into a solution it may be transferred into a user by means of direct injection as shown in FIG. 11, for example, or into a drug delivery device such as an infusion pump, needleless injector or the like.
- the systems include a vial 420 containing a predetermined volume of a drug and a vial 422 containing a volume of a diluent.
- the use of standard vials facilitate the use of the drug delivery device by different drug suppliers.
- An air source 424 maybe included for the delivery of drugs. With drugs of higher viscosity, the use of pressure becomes more important. As illustrated in FIG. 19A, the sources of pressurized air can vary and may include, but are not limited to, a compressed air delivery supply 426 , a chemical gas generator 428 , a standard syringe 430 and a collapsible volume container, such as a bellow container 432 .
- the air source supplies the driving force to the diluent volume which moves the diluent solution 434 into the standard lyophilized drug vial 420 . Once reconstituted, the liquid drug is transferred via the air separator, such as a hydrophilic membrane 436 , to a drug delivery system.
- spike 438 in the diluent vial 422 and spike 440 in the drug vial 420 each have two paths.
- the spike 438 has a first path for compressed air to enter the diluent vial 422 and a second path for the pressurized diluent 434 to be in fluid communication with the drug vial 420 .
- the spike 440 has a first path for the pressurized diluent to enter the drug vial 420 and a second path for the delivery of the drug solution into a drug delivery device.
- other drug delivery devices may be received into this system to receive the drug solution.
- the air source is a compressed air canister 426 .
- the compressed air canister typically is a standard addition for domestic drug delivery devices.
- the user attaches the compressed air canister 426 to the drug delivery system 450 and punctures a seal 452 located in the compressed air canister.
- the air canister is then in fluid communication with the diluent vial 422 by means of channel 453 . Air is released from the compressed air canister 426 and is introduced into the diluent vial 422 , which in turn forces the diluent solution 434 to move into the drug vial 420 via channel 455 . After reconstitution is completed, the liquid drug is ready to be transferred.
- the concentration of the reconstituted drug can be controlled in this and other embodiments by changing the quantity of diluent transferred to reconstitute the drug.
- a hydrophilic membrane 436 in the drug delivery path minimizes and preferably prevents gas from being transferred to the drug delivery device.
- FIG. 19C shows a chemical gas generator 428 as the air source used in this particular embodiment to deliver the diluent 434 under pressure to the lyophilized drug vial.
- the chemical gas generator 428 includes a chemical compartment 456 which typically contains two materials 458 , 460 .
- the two materials 458 , 460 can be two liquids or a liquid and a solid palette 460 that are separated during shelf life. It should be noted that the materials used in the chemical compartment 456 and the reaction that ensues during the mixing of the materials are safe and biocompatible. Pushing a member 462 , in the chemical compartment 456 results in tearing of a seal 464 , for example, aluminum foil, which separates the two materials 458 , 460 during shelf life.
- the two materials are then in fluid communication and react to produce a gas such as, for example, carbon dioxide.
- the chemical gas generator 428 also includes a gas compartment 466 which is typically an air reservoir having a flexible enclosure 468 .
- the carbon dioxide produced in the chemical compartment 456 due to the reactions enters the gas compartment 466 and is accommodated in the flexible layers 468 that form the gas compartment.
- the movement of the flexible layers 470 , 472 force the air or carbon dioxide into the diluent vial 422 through the air pathway 423 .
- the gas compartment 466 has a double layer 470 , 472 comprising the flexible containment area.
- the two layers 470 , 472 provide for safety as if the air or gas generated as a result of the reaction in the chemical compartment does leak, it can be accommodated between the flexible enclosure 468 of the gas compartment 466 . Further, the gas compartment 466 is vented using a gas leakage pathway or vent port 474 . The air that is released from the chemical gas generator 428 enters the diluent vial 422 via the channel 423 which in turn forces the diluent solution 434 to move into the drug vial 420 via the channel 425 . After reconstitution is completed, the drug is ready to be used, and is transferred to a drug delivery system such as one described with respect to FIG. 19B.
- the air source used in this particular embodiment to deliver the diluent under pressure is a standard syringe 430 or an air reservoir.
- the syringe 430 is locked at an end of travel position.
- pressure is applied to a plunger shaft 480 the air is forced out of the syringe 430 and into the contents of the diluent vial 422 through the needle 482 and needle 434 which are in fluid communication through the member 484 .
- the diluent 434 is then forced into the drug compartment or drug vial 420 via member 484 under pressure which provides for the mixing with the lyophilized drug to result in a reconstituted drug which is then ready for injection or delivery under pressure to a user.
- a lever can be included to reduce the force required for pushing the plunger member 480 .
- the lever will increase the displacement and thus delivery of pressurized air to the diluent container in this case, the drug solution may be injected as shown in FIG. 19D, the sectional of which is the same as shown and described in other needle assemblies, for example, shown in FIGS. 11, 13, 14 , 15 , 16 , and 32 or transferred into a drug delivery device.
- the air source used in this particular embodiment to deliver the diluent under pressure to the lyophilized drug is a collapsible volume container such as a bellow container 432 .
- a check valve 488 or a one-way valve insures that the flow from the bellow container 432 is unidirectional, that is, the drug or diluent can not enter the bellows.
- the check valve 488 comprises a tubular member 490 adapted to deliver gas, for example air, to the diluent vial 422 .
- the resilient nature of the bellows is checked by the check valve 480 which does not allow air to enter the bellows and thus reinflate the bellows once the bellows have been compressed and air has exited.
- air contained in the bellows 432 is forced through needle 438 and into the diluent vial 422 via channel 491 applying pressure to the contents of the diluent vial.
- the diluent solution 434 in turn, is delivered under pressure to the drug vial 420 where the drug is reconstituted and can be transferred either by injection as described above or into a drug delivery device, as also described and shown relating to the embodiment of FIG. 19A.
- the air source used in this particular embodiment to deliver the diluent under pressure Is cylinder 490 .
- This embodiment is similar to the embodiment containing a standard syringe as described with respect to FIG. 19D.
- the plunger 492 is depressed to compress the air in the cylinder 490 .
- the air is driven into the diluent vial 422 through channel 494 which brings the cylinder and the diluent vial in fluid communication.
- the pressurized diluent in diluent vial 422 then moves into the vial 420 and mixed with the drug.
- the pressurized drug solution is then ready to be delivered.
- This can either comprise delivery to a drug delivery device as described with respect to the embodiment of FIG. 19A or injected as shown in the present embodiment having a straight needle assembly as shown and described in FIG. 18.
- an alternate embodiment of the drug delivery system 498 in accordance with the present invention includes standard vial 500 containing a liquid drug 502 .
- a volume of gas, for example air, contained in an air chamber 504 is introduced in the standard liquid drug vial 500 , creating air pressure above the liquid drug which allows for delivery of a liquid drug under pressure.
- the usage is position dependent, that is the delivery of the liquid drug, is performed with the standard vial 500 in a vertical position.
- a hydrophilic membrane minimizes or preferably prevents the introduction of the extra volume of air into the user's tissue.
- the standard vial 500 containing the liquid medicament 502 is inserted into the drug delivery device 498 in accordance with the present invention.
- An air chamber 504 is provided which upon insertion of the drug vial 500 and the puncturing of the seal 506 of the vial, is in fluid communication with the drug vial.
- the lip 505 A of a standard vial 500 is locked into position by means of a pair of arms 505 having ridges 507 projecting inwardly therefrom.
- the injector system is the straight needle 402 embodiment as disclosed in FIGS. 18 A- 18 C.
- the liquid drug is pressurized and is ready to be injected using the injector system described with respect to FIGS. 118 A- 118 C. After injection into the user's tissue, the needle is retracted automatically. The drug delivery device 498 is then disposed.
- an alternate preferred embodiment of a drug delivery system 510 which uses standard vial 500 containing a medicament is disclosed.
- a plunger 512 is included in the drug delivery device 510 .
- the drug delivery system 510 can have a compact configuration without a plunger. Snaps 514 lock the standard vial 500 into position. Snaps 516 hold the end portion of the vial having the seal 506 in place to ensure that the spike 518 pierces the seal 506 of the vial 500 before the vial is moved in the downward direction.
- Air in the air chamber 520 is delivered to the vial 500 when the air is compressed and displaced by the downward movement of the vial 500 .
- the liquid drug under pressure is delivered to an injector using tubing 522 .
- a hydrophilic membrane 524 minimizes or preferably prevents gas from entering the user's tissue.
- the injector system used can be similar to one described with respect to FIGS. 18 A- 18 C.
- the member 410 is moved to displace the injection needle 402 .
- FIGS. 22 A- 22 E the views illustrate an alternate preferred embodiment of the drug delivery system 530 in accordance with the present invention.
- This particular embodiment may be used as a reconstituted system and a drug delivery system and includes two vials 532 , 534 a first containing a diluent 533 and a second containing the lyophilized drug 535 .
- an air delivery system for pressurizing system such as a built-in air cylinder 533 in fluid communication with the diluent vial 532 which is disposed between the lyophilized drug vial 534 and the diluent vial 532 .
- Air is pushed into the diluent vial 532 forcing the diluent 533 from its vial into the lyophilized drug compartment or vial 534 .
- the liquid drug is ready for injection.
- a hydrophilic membrane is used as an air separator to minimize or preferably prevent the entry of air into the user's tissue.
- This particular embodiment uses a straight needle 402 injector system as described with respect to FIGS. 18 A- 18 C. Additionally, a positioning interlock, such as the mechanism, described with respect to FIGS. 2 A- 2 B is used.
- the air cylinder can be replaced with a standard syringe to be the air source as shown in FIGS. 22D and 22E.
- a check valve (as shown in FIG.
- the drug delivery system of the present invention is used to deliver an accurate volume of a drug solution.
- the predetermined volume can be delivered using different methodologies.
- a first embodiment controls the dose by changing the height of the outlet spike 535 in the liquid drug vial 537 as shown in FIGS. 23A, i.e. the higher the spike, the lesser is the amount of drug transferred out of the vial 537 .
- the spike is adjusted by means of threads 539 upon which the spike rotates or upon which it sealably slides. This can be used for to transfer or to inject the drug solution.
- Another preferred embodiment which increases the accuracy of the volume of drug delivered uses the residual drug volume as a parameter to indicate the volume delivered.
- One way of controlling delivered drug solution volume is to use the assembly shown in FIG. 23B. After the drug is pushed in solution in vial 102 the solution may be pulled into cavity 541 by piston 555 . The cavity 541 has indications thereon to aid the user in determining the proper volume. At the desired level, the piston is stopped. The drug solution is then transferred from the cavity 541 either via a needle into a user or into a drug delivery device.
- FIGS. 24 A- 24 C and FIG. 25 Yet another embodiment to provide an accurate volume of drug is disclosed with respect to FIGS. 24 A- 24 C and FIG. 25.
- the reconstitution system drug delivery device The dialing process retracts a floating piston which moves upward and creates an internal pressure which provides for aspiration of the reconstituted drug.
- a trigger 564 releases a preloaded spring to push the floating piston.
- Injection and disposal of the pump is performed after disconnection with a process similar to the process described with respect to FIGS. 2 A- 24 C.
- FIGS. 26 A- 26 D are perspective views of a drug transfer system having a drug delivery device 510 in accordance with the present invention.
- a diluent vial is inserted in a cavity 572 and a lyophilized drug vial is inserted in cavity 574 .
- a cavity 576 accommodates an air pressurization system to deliver drugs having a low level of viscosity.
- the drug transfer system includes an access 578 to receive a drug delivery device. The drug is transferred thereto via a needle 580 .
- FIGS. 27 A- 27 C are cutaway views of a preferred embodiment of a transfer system 600 in accordance with the present invention.
- the liquid drug from vial 602 is transferred to a drug delivery device 604 via an extension 606 .
- the liquid drug flows out of the vial 602 through spike 608 and through the tubing 610 into the needle 616 which is received into the drug delivery device 604 .
- the drug delivery device 604 is attached to the transfer system 600 .
- the filling process continues until the entire drug level reaches the outlet 604 A (shown in phantom in FIG. 26B) of the device 604 . At this point the filling process is completed.
- the drug may drain into the cylinder 614 . This is prevented by getting the friction forces higher than the impedance of the tubing 610 to the drug flow.
- FIGS. 28 A- 28 C are cutaway views of the operation of another preferred embodiment of a drug delivery system 630 , in particular of a position independent injection system in accordance with the present invention.
- the injection system 630 is position independent, that is the injector is not required to be in a vertical position during the injection process.
- the drug delivery system 630 includes a vial 632 containing the liquid drug 634 .
- the liquid drug 634 flows through the spike 636 along a tube 644 A into a cavity 652 .
- the spike includes two paths, one path 642 for delivering pressurized air into vial 632 from chamber 641 and another path 644 to deliver the liquid drug to the user via a needle 664 .
- a one-way valve 638 insures the unidirectional flow of the liquid drug 634 into the cavity 652 A.
- Spring 640 holds piston 656 within the cavity 652 .
- a floating piston 650 moves in the cavity 652 .
- a seal 654 is included in the floating piston.
- Member 660 rests atop a needle assembly 664 A. Member 660 is hingedly connected to member 662 .
- Member 662 has a finger 662 A. Prior to use, the finger 662 A rests within an aperture 662 B of the housing 660 A.
- the notch 656 is the end of travel position for the piston 656 .
- the air chamber 641 is depleted of air when the vial is moved downward.
- a member 641 A sealably slides within the walls of the chamber and forces the air into the vial.
- the member 641 A is prevented from leaking air out of the chamber by the seal 641 B.
- member 660 As illustrated with respect to FIG. 28C, once the member 660 is depressed, it causes the needle 664 to move downwardly outside the housing 660 A and into the user's tissue.
- Member 662 is hingedly connected to member 660 . When 660 is depressed, it causes member 662 to move upwardly disengaging the finger 662 A from the aperture 662 B and enables the spring 640 to return to a less compressed state. As it does, the spring 640 forces the piston towards the opposing end of the cavity 652 . This causes the liquid drug therein to move via channel 652 A and needle 664 into the user's tissue, the piston 656 is released due to the movement of member 662 in the upward direction. The piston 656 moves to the left.
- the floating piston 650 is under pressure and moves the liquid drug in cavity 652 through the injector needle 664 and into the user. It should be noted that after delivery of the liquid drug, the position of the floating piston 650 depends on the load on the spring 640 . To prevent the flow of residual drug under pressure, the spring 640 continues to be in a preloaded state. The seal 654 is pushed to the left side of the cavity 652 under pressure of spring 640 to seal against the exit of the pressurized residual drug via the channel 652 A. Although disclosed as having a pushing spring 640 , other mechanisms may be included in the injector system to result in a position independent injector.
- FIG. 28D a cutaway view of a spike 636 which brings the liquid drug 634 in fluid communication with the injector system is illustrated.
- the spike 636 penetrates the septum 639 of the vial 632 when the vial is inserted into the cavity 640 .
- the spike functions as a piston 641 A and is sealably and slidably movable by means of the seal 641 B within the interior walls of the chamber 641 .
- the spike also consists of two paths, an air inlet 642 and a drug outlet 644 .
- pressurized air enters the vial 632 from an air chamber 641 and forces the liquid drug 634 via a flexible tube 644 A to the injector system.
- the filling process for the injector system in a preferred embodiment is preferably done under a maximum pressure gradient of 0.3 bar. This includes a margin for example, priming at an altitude of 5,500 feet and is the maximum expected back pressure.
- FIGS. 29A and 29B illustrate partial cutaway views of another preferred embodiment of the drug transfer system 670 in accordance with the present invention.
- the drug vial 672 containing the liquid drug 674 is inserted into a cavity 676 .
- a spike 678 provides air into the liquid drug vial 672 for pressurization of the drug 674 and additionally the spike provides for an outlet for the liquid drug to be delivered to a drug delivery system 680 .
- the drug transfer system 670 is in fluid communication with the liquid drug vial 672 through a flexible tubing 682 and a needle 684 .
- a hydrophobic membrane 686 is disposed in the flexible tubing 682 to prevent the transfer of air into the drug delivery system. This hydrophobic membrane 686 prevents back flow.
- the air to pressurize the liquid drug 674 is provided by air in the reservoir 675 .
- a latch mechanism 688 secures the vial 672 to the detachable delivery system 680 during a filling process.
- FIG. 29A- 1 an enlarged view of the interface between the drug transfer system 670 and the detachable drug delivery device 680 is illustrated.
- a hydrophobic membrane 692 is disposed at the interface for blocking the flow of the drug once the drug delivery device 680 is filled.
- An elastomeric cover 694 is disposed around the needle 684 for protection against the needle 684 .
- Tab 693 is pulled off to remove the hydrophobic membrane 692 prior to use of the device 680 .
- the liquid drug vial 672 is pressed into the cavity 676 which causes the air in the reservoir 675 to be compressed and enter the liquid drug vial 672 . Air is prevented from leaking out of the cavity 675 by means of seal 685 .
- the liquid drug 674 is pressurized and delivered through the spike outlet 690 . Residual air from the air reservoir 675 is vented from an opening in the latch mechanism 688 once the latch is disengaged from the drug delivery device at the end of travel of the vial and subsequent end of the transfer process.
- the manifold is a biocompatible material such as, for example, polycarbonate or acrylic or pvc molding having a gas impermeable membrane 698 welded in the part 696 .
- the two pieces 696 , 697 are ultrasonically welded together.
- FIGS. 31 A- 31 E perspective views illustrate an alternate preferred embodiment of a drug delivery system 700 in accordance with the present invention.
- This particular embodiment maybe used with the reconstituted drug delivery system and includes two vials 702 and 704 , a first containing a diluent and a second containing a drug that needs to be reconstituted.
- a pressurizing system such as a built-in cylinder 706 in fluid communication with the diluent vial 702 .
- the built-in pressurization system such as the cylinder 706 , is disposed between the lyophilized drug vial and the diluent vial.
- a plunger 708 is slidably received into the cylinder 706 to provide the necessary air pressure to effect drug transfer. Air is pushed into the diluent vial forcing the diluent from its vial into the lyophilized drug compartment or vial 704 . As discussed previously, a hydrophilic membrane is used as an air separator to minimize or preferably prevent the entry of air into the user's tissue.
- a diluent vial is inserted into the drug delivery system 700 followed by the insertion of a drug vial. The plunger 708 is pushed downwards to pressurize the air in the cylinder 706 and deliver it to the diluent vial 702 .
- the diluent solution is pressurized it is delivered to the drug vial 704 to reconstitute the drug.
- Pressing the knob mechanism 710 displaces an injection needle which is used to inject the reconstituted drug into a user tissue.
- the depression of the knob mechanism and subsequent injection is similar to that described earlier with regard to either the straight needle assembly shown in FIG. 18 or the U-shaped needle shown in FIGS. 11, 13 through 17 .
- FIGS. 31F and 31G two preferred embodiments 711 , 713 which provide a visual indication of device orientation are illustrated.
- the vertical indicators 711 , 713 are shown as being disposed on the top of the plunger 708 , however their location can vary to provide appropriate visual indication.
- a metal ball 714 rests upon a curved surface having visual having the vial containing the reconstituted drug is essentially used as a filling station by a detachable delivery device, for example, a standard syringe or a pen type pump.
- FIGS. 24 A- 24 C a position independent injector system 540 is illustrated.
- the drug 545 is reconstituted similar to the description provided with respect to earlier systems such as illustrated in FIG. 19F. After the drug has been reconstituted it can be aspirated by a conventional standard syringe 542 for the exact dose required. The accuracy using this method is about +/ ⁇ 5%.
- the fluid level in the cavity 550 is controlled by adjusting the pressure and geometry of the device 540 .
- the needle is held in place by the elastomeric septum or stopper 552 .
- the syringe 542 is removed from the drug delivery device 540 .
- the accuracy of the volume of the liquid drug delivered is determined by the scale on the syringe.
- the user then injects the drug and disposes of the syringe by one of several potential ways.
- One of the ways of disposing the syringe is by attaching the syringe to the open cavity 550 left in the drug delivery device 540 .
- a second way is by securing the needle 547 prior to disposing the syringe by locking it with a piece of plastic tubing.
- the system 540 and procedure used is free of air inclusions and does not require an air separator.
- the syringe needle 547 is placed in a closed cavity penetrating a septum 544 and thus allows for fluid communication between the needle 547 and the reconstituted drug.
- the volume of the closed cavity is designed to ensure the availability of the liquid drug to the needle 547 under controlled pressurized conditions.
- the position of the syringe piston 548 is fixed under pressurized conditions and the dose is manually aspirated from the syringe.
- FIG. 25 an alternate preferred embodiment of the drug delivery system 540 as described in FIGS. 24 A- 24 C is illustrated.
- the reconstitution stage is similar to the one described with respect to FIGS. 24 A- 24 C.
- the injector system including an attachable delivery device is different.
- the user dials or tunes the required dose using a pen type pump 560 that includes a dial 562 that is inserted into the indicators or scale 712 thereon.
- the ball 714 is enclosed within a clear casing 712 A.
- the positioning of the ball 714 in the middle of the scale is an indication of vertical orientation.
- an air bubble 716 disposed in a liquid 718 enclosed within a clear housing 718 A is used as the visual, indicator of orientation with respect to the scale 719 .
- the positioning of the air bubble 716 in the middle of the scale is an indication of vertical orientation.
- FIGS. 32 A- 32 E perspective views illustrate a further alternate embodiment of the drug delivery system 720 in particular a reconstitution and injection system, in accordance with the present invention.
- the reconstitution of the drug occurs by the mixing of the diluent solution with the drug.
- a separate pressurization system for the diluent is not required for this particular embodiment and can only be used with low viscosity drugs.
- the knob 730 is moved in a counter clockwise direction to begin the reconstitution process of the drug which opens a pathway connecting the diluent with the drug.
- the knob 730 is turned from a non-use position (as indicated when notches A and B align) to a ready to use position as indicated with the alignment of notches B and C.
- the knob 730 may be depressed and the solution injected.
- the internal pressure of the diluent vial and gravity cause the diluent to transfer to the vial containing the drug.
- Further movement of the knob or dial 730 activates an injection needle which interfaces with the user's tissue to deliver the reconstituted drug.
- the injection assembly is similar to the embodiments shown in FIGS. 11 , 13 - 17 .
- FIGS. 33 A- 33 I cutaway views of preferred embodiments of the drug delivery system emphasizing the interlocks disposed to provide for a safe system are illustrated.
- FIG. 33A and 33B the interlocks as required during shelf life of the drug delivery device 750 are illustrated.
- the end of the cylinder 752 has a biasing lip 766 extending outward to matingly fit with wall 758 and the lip must be flexible enough to bend with the pressure of wall 758 when vials are inserted in the assembly.
- the cylinder 752 is secured by latch 754 and mating lip 756 . This mating fit prevents the movement of the movable cylinder 752 in the vertical direction prior to use.
- the cylinder 752 provides pressurized air to the drug delivery system 750 .
- the movement in the downward direction of the cylinder 752 is minimized or preferably prevented by holding the latches 754 and 756 on the wall 758 .
- An upward movement of the cylinder 752 is prevented by latch 754 .
- the next step includes the insertion of the vials 760 and 762 into the device 750 . Only after the insertion of both vials 760 , 762 is the cylinder 752 free to be pushed in the vertical direction. The insertion of the vials forces the lip 766 inward enabling it to clear the wall 758 and thus enable the cylinder 752 to move downward. In addition, the latches 754 secure the vials in the device 750 .
- the cylinder 752 is pushed downward until the end of travel position and is locked by the mating of lip 766 and interlock element 768 .
- the lip 766 moves downward and catches on element 768 and moves to a radially expanded position which prevents the cylinder from travelling upward again.
- a locking element 768 keeps the cylinder in the bottomed out position.
- the element 768 is formed as a part of the wall 758 .
- a pushing member that moves in a relative perpendicular fashion to the direction of travel by the cylinder.
- a ball 772 is positioned prior to use within the housing to prevent depression of the member 776 .
- the lip 766 pushes a member 770 which allows the ball 772 to drop into a groove 774 making the movement of the pushing member 776 possible only if the device is in a vertical orientation.
- FIGS. 33H and 33I the interlocks during the phase of disposing of the drug delivery device which follows the injection phase are illustrated.
- the pushing member 776 is released by the action of the spring 777 pushing the member 776 . Since the movement of the ball 772 was limited by the body of the member 776 , with the release of the member 776 , the ball 772 can now move back into the groove 774 as it is assisted by the pressure applied by the rear shell latch 780 . This locks the pushing member 776 into position thereby preventing further use of the drug delivery device 750 .
- the drug delivery system is activated by pressurized gas, for example, air.
- pressurized gas for example, air.
- the air forces the drug to the injection site by pressurizing the drug.
- a hydrophillic membrane minimizes and preferably prevents the passage of air into the user's body.
- the hydrophillic membrane is disposed in the drug path to the user's tissue. Once wetted, the hydrophillic membrane allows liquid drug to proceed into the user's tissue and stops the passage of air into the user's tissue. In order to insure the effectiveness of the membrane, the hydrophillic membrane has to become wetted.
- a Hydrophobic membrane is also positioned in the drug path.
- an inlet 800 which provides the liquid drug 802 into a cavity 803 has both a hydrophobic membrane 806 and a hydrophillic membrane 810 disposed therein.
- the hydrophobic membrane 806 allows air to pass, but stops liquids.
- the hydrophillic membrane 810 allows liquid drug to pass while stopping the flow of gas.
- a flexible elastomeric diaphragm is disposed that acts as an indicator once filled with gas, for example, air. The membrane being flexible, once filled with air gives an external indication for end of delivery.
- FIG. 34D illustrates a manifold structure utilizing the end of delivery indicator 804 built into the manifold.
- the septum 814 surrounds a cavity containing the liquid drug.
- the spikes 816 and 818 interface with the elastomeric stoppers of vials containing a diluent and a medicament.
- FIG. 35 graphically illustrates the delivery profile from a high volume vial having no additional air pressure in the vial.
- the profile illustrates pressure (in millibars) versus time (in seconds).
- the initial pressure in the vial is in the order of about 300 millibars which decreases during the delivery process to approximately 0 millibars at the end of delivery process. This is in contrast to the pressure in a vial that initially contained approximately 3 milliliters of air as illustrated with respect to FIG. 33.
- the delivery process spanned a time period of approximately 86.4 seconds.
- FIG. 36 graphically illustrates delivery duration and delivery pressure with respect to an air volume in a vial.
- Three different profiles are illustrated with a first one 830 which is indicative of the pressure (in millibars) before delivery, a second profile 832 indicative of the residual pressure of the delivery and a third profile 834 which is indicative of delivering 0.95 ml of a liquid drug over a time span of about 8 seconds.
- FIG. 37 is a graphical illustration of the delivery parameters for an injection of a liquid drug having no additional air in the vial. As delivery of the drug occurs, the pressurization within the liquid vial decreases over the approximately 17 seconds of delivery. These curves illustrate test results of the delivery process of approximately 1 gram of liquid drug using a single drug delivery device for the same time period.
- FIG. 38 illustrates test results showing the air pressure gradient on hydrophilic membranes used to minimize or preferably prevent the entry of gas for example, air into the user's tissue.
- the test results prove membrane safety to insure that the membrane can withstand the pressures in the order of 2,700 millibars for a time duration of about six minutes.
- FIG. 39 graphically illustrates the performance of a drug delivery device in accordance with the present invention.
- Three delivery profiles 840 , 842 , 844 (in ml) vs. time (in seconds) are illustrated for a reconstituted lyophilized drug delivery system.
- the system includes a 0.45 micron pore size hydrophilic membrane to minimize or preferably prevent the flow of gas into the user's tissue. This particular pore size of the membrane provides an adequate particle filter and also allows the shortest time to deliver the drug to the user's tissue.
- FIG. 40 is a flow chart that describes the methods for delivery of a lyophilized drug in accordance with the present invention.
- the methods include the step 899 of inserting the drug and diluent containers into the drug delivery device. Further per step 900 , the method includes activating a pressurized air source which in turn is followed by the step 902 of pressurizing a diluent solution in a diluent vial.
- the pressurizing can be provided by subsystems which include but are not limited to a compressed air supply, a chemical gas generator, a collapsible volume air supply, a standard syringe or cylinder.
- the methods further include the step 904 of delivering the pressurized diluent solution to the lyophilized drug vial.
- the lyophilized drug is reconstituted per step 906 as a result of the mixing of the diluent with the lyophilized drug.
- the methods further include the step 908 of providing the liquid drug to an injector system or transferring the liquid drug to a detachable delivery device.
- the liquid drug is then injected into a user's tissue per step 910 .
- the injection needle is then moved to a safe storage position per step 912 .
- FIG. 41 is a flow chart that describes the methods for delivering a liquid medicament in accordance with the present invention.
- the methods include the step 913 of inserting a drug container such as a vial into the drug delivery system. Further, per step 914 the method includes activating a pressurized air source for low viscosity drugs. It should be noted that for drugs with a high level of viscosity no pressurization may be required.
- the method then includes the step 916 of pressurizing the standard drug vial.
- the pressurized liquid drug is transferred to a drug delivery system such as an injector system, or detachable delivery devices per step 918 .
- the liquid drug is then injected into the tissue of a user per step 920 .
- the method further includes the step 922 of retracting the injector into a safe storage position.
- drug used herein includes but is not limited to peptides or proteins (and mimetic thereof), antigens, vaccines, hormones, analgesics, anti-migraine agents, anti-coagulant agents, medications directed to the treatment of diseases and conditions of the central nervous system, narcotic antagonists, immunosuppressants, agents used in the treatment of AIDS, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, prostaglandins, antidiuretic agents and DNA or DNA/RNA molecules to support gene therapy.
- Typical drugs include peptides, proteins or hormones (or any mimetic or analogues or any thereof) such as insulin, calcitonin, calcitonin gene regulating protein, atrial natriuretic protein, colony stimulating factor, betaseron, erythropoietin (EPO), interferons such as ⁇ , ⁇ or ⁇ interferon, somatropin, somatotropin, somastostatin, insulin-like growth factor (somatomedins), luteinizing hormone releasing hormone (LHRH), tissue plasminogen activator (TPA), growth hormone releasing hormone (GHRH), oxytocin, estradiol, growth hormones, leuprolide acetate, factor VIII, interleukins such as interleukin-2, and analogues or antagonists thereof, such as IL-1ra; analgesics such as fentanyl, sufentanil, butorphanol, buprenorphine, levothy
Abstract
The present invention related to a drug delivery device for mixing and delivering a drug by injection. The devices includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example, a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetrating membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is movable from a storage position in the housing to an injection position extending through the housing.
Description
- This application is a divisional of U.S. application Ser. No. 09/439,614, filed on Nov. 12, 1999, which claims priority to U.S. Provisional Application No. 60/108,382 filed Nov. 13, 1998 and U.S. Provisional Application No. 60/113,644 filed Apr. 29, 1999, the entire teachings of all of these applications being incorporated herein by reference.
- The present invention relates to the preparation and administration of a product and, more particularly, to the injection of the same into a living organism, for example, a human body.
- Previously, various devices have been developed for the percutaneous delivery of medications into living organisms including syringes in which a liquid is delivered from a chamber using pressure asserted by a manual plunger through a needle inserted under the skin.
- Additionally, it is well known in the art that the storage life of certain injectable substances such as glucagon, used to dissolve blood clots, is increased when the substance is stored in a powdered or lyophilized state, for example. These lyophilized substances (i.e., drugs or compounds) are presently used for injection of materials that would otherwise be unstable. Lyophilization, for example, is the rapid freezing of a material at a very low temperature followed by rapid dehydration by sublimation in a high vacuum. The resulting lyophilized compound is typically stored in a glass vial or cartridge which is closed by a cap, such as a rubber stopper or septum.
- It is necessary to reconstitute the powdered or solid material, such as a lyophilized compound, prior to administration. This is accomplished by mixing the solid compound with a suitable diluent or liquid. Reconstitution typically involves the use of a syringe with a needle to withdraw the diluent from a separate vial and inject it into the vial containing the compound. The compound is then thoroughly mixed, typically by shaking the vial by hand, and a separate syringe with a needle withdraws the desired amount to be injected into the patient. Because two separate containers are used, the person reconstituting the compound must be certain to mix the correct amounts such that a proper concentration of the mixture results. When a syringe is used to mix the diluent and drug, the exact volume of diluent to drug ratio is difficult to obtain. Thus, precise concentration levels of administered drug may be compromised.
- Moreover, because the diluent and compound are in separate, sterilized containers, the manual withdrawal of diluent via a syringe and reinjection of the same into the container containing the solid material such as a powdered or lyophilized drug may compromise sterility, and safety due to the use of a syringe.
- Because of increased use of powdered compounds or lyophilized drugs, for example, it is desirable to provide both professional and non-professional personnel with a reconstituted drug delivery system. It is desirable to have a simple, reliable system that facilitates preparation and safe delivery of an accurate dosage of a reconstituted compound. In addition, it is desirable to provide a system that reconstitutes a lyophilized drug while maintaining sterility throughout the process. Also, it is desirable to provide improvements in the percutaneous delivery of medication generally, which provide for safe, effective administration by the user.
- The present invention relates to systems and methods for delivering liquid drugs to a user. The drug delivery system can include delivery of reconstituted powdered drugs such as, for example, lyophilized drugs, or more generally for the transfer and delivery of liquid drugs. Powdered or lyophilized drug delivery further includes a system to reconstitute the powdered drug. The drug delivery systems may further include a pressurization system which pressurizes the drug for transfer to a delivery system or for direct subcutaneous delivery. Further, the drug delivery system in accordance with the present invention includes an injector system which contacts the tissue and delivers the drug to the patient or user. In the alternative, the drug delivery system in accordance with the present invention includes filling of detachable delivery devices, for example, a standard syringe, a needleless injector, an infusion device or different types of pumps. Another example uses a pen injector which aspirates the liquid drug from the system and in turn delivers the drug subcutaneously.
- The methods for delivering a powdered drug such as a lyophilized drug include the steps of pressurizing a diluent solution in a diluent vial. The pressurizing systems may include, but are not limited to, a compressed air supply, a chemical gas generator, a collapsible volume supply, a bellow canister, a standard syringe or a cylinder, for example. The methods further include the step of delivering the pressurized diluent solution to the powdered drug vial. The next step in the method includes the reconstitution of the drug to form a liquid drug by mixing the powdered drug with the diluent solution. The methods further include the steps of providing the liquid drug to an injector system or transferring the liquid drug to detachable delivery devices. The following step includes the injection of the liquid drug into the tissue of the patient or user. The methods further include the steps of moving the injection needle from a delivery or injection position to a retracted or storage position once delivery is complete. It should be noted that, depending on the application or delivery of different medicaments, the features of the drug delivery systems may vary. For example, the pressurization level can vary depending upon the viscosity level of the medicament, and the needle type or length can vary depending upon subcutaneous injection or intermuscular injection. For example, for subcutaneous injections, the needle length ranges from 5 to 12 mm while the needle length may vary up to about 3 cm for intermuscular injections.
- The methods for delivering a liquid medicament to a patient include the steps of pressurizing the liquid drug solution in the vial with a pressurizing system. The subsequent steps are similar to the steps described with respect to the methods for delivering a powdered medicament.
- A preferred embodiment of the present invention features an injector system having an angled or unshaped needle. Another preferred embodiment of the present invention features an injector system having a straight needle. Yet another preferred embodiment of the present invention employs a transfer system for transferring the drug to delivery devices such as, for example, a standard syringe with a needle or a needleless pen injector. The devices receive the liquid drug from a container, such as a vial containing the liquid drug. The delivery devices subsequently deliver the medication to the user's tissue as described herein.
- Another preferred embodiment of the present invention features a combination system having the ability to reconstitute drug into solution and subsequently inject it into a user. In accordance with this embodiment the reconstituted drug delivery system has a housing having a first opening or port that receives a first container that contains a solid substance, such as a powdered lyophilized drug, for injection. It should be noted that the container is a rigid container, such as, for example, a vial or a cartridge containing the powdered drug. The housing can also include a second opening or port that receives a second container that contains a fluid to be mixed with material in the first container, to form an injectable fluid. The drug delivery system may include a manifold having a first channel that provides fluid communication between the first and second containers. The manifold further includes a second channel between the first container and a delivery or transfer device. The manifold can also include a communication channel to a pressurization system which provides the driving pressure to deliver the liquid drug. In a preferred embodiment, the penetrating member is a needle, in fluid communication with the first container after the needle moves between a storage position in the housing to an injection position extending outside the housing and into the user.
- A preferred embodiment of the invention provides for concealment of the injection needle within the main housing of the drug delivery device except during the injection of the drug to the user. This embodiment can include a needle retraction device for withdrawing the needle into the housing after injection to minimize the risk of exposure to a contaminated needle.
- In accordance with other aspects of the present invention, the length of the delivery path from the container with the injectable fluid to the injection needle is reduced to minimize loss of residual amount of liquid drug. According to another aspect of the invention, the injection needle first pierces the skin of the person being injected and is concurrently placed in fluid communication with the first container that contains the injectable fluid. According to yet another aspect of the invention, the container that contains the injectable fluid is substantially visible during reconstitution and injection such that the user can visually observe the process. A compressed fluid, such as a gas in the container with the injectable fluid, is used to force the injectable liquid through the injection needle and into the tissue being injected. In an alternative embodiment, the device has a single port with a compression element such that a container with a liquid medication, such as a previously reconstituted material, can be inserted into the housing and simultaneously pressurized to the needed pressure to deliver the correct dose over a predetermined time period.
- In a preferred embodiment of the system, the device is used with the injectable fluid container being vertically oriented during injection. To reduce the risk of injecting any gas into the injection site, a gas impermeable membrane such as a hydrophilic membrane is disposed in the fluid path, which in a wetted state minimizes or preferably prevents gas flow while allowing liquid to flow through the membrane. The rigid containers need to be in a vertical orientation during reconstitution for appropriate pressurization. In an embodiment including a cartridge having diluent and air, a vertical orientation is not required for reconstitution. According to a further aspect of the present invention, the axis of the injection needle is perpendicular to the longitudinal axis of the container with the injectable fluid. In a preferred embodiment, the containers containing a powdered or lyophilized drug and diluent are inserted in the housing in the same direction along parallel axes. In another embodiment, the containers are inserted along a common axis or parallel axes in the opposite direction. The system can have housing apertures, ports, or openings that have a size compatible with standard vial and cartridge sizes such that existing vials and/or cartridges can be used. The container contents do not have to be mixed until immediately prior to injection. Because the contents of the containers are only in contact with other sterile parts, sterility prior to and during the reconstitution process is maintained.
- According to another aspect of the present invention a further improvement to reduce and preferably prevent the risk of injecting gas into the injection site, includes the use of a drug which is gas impermeable once wetted. Further, since the gas impermeable membrane can sustain pressure, the delivery time for the liquid drugs is shortened as a higher driving force is generated using pressurization systems. By disposing such a membrane such as a hydrophilic membrane in the drug delivery path that is gas impermeable in a wetted state, gas needed to control injection pressure and duration can be added in the system as the membrane checks the delivery of gas to the user. The container containing the fluid can be a changeable volume container which contains a controllable volume of a gas, for example, air. This controllable volume of air and/or fluid are forced into the drug container, resulting in a drug under pressure to deliver the correct dose over a selected time period. According to a further aspect of the -invention, the device includes a manifold system to minimize the drug delivery path and simplify assembly costs, and increase system reliability. The simplicity and flexibility of the manifold system facilitates the use of standard prefilled cartridges and syringes. In a preferred embodiment, the manifold is a two-piece polycarbonate molding in which the two molded elements are ultrasonically welded together. The gas impermeable membrane is attached or welded to one piece of the polycarbonate molding.
- According to another aspect of the present invention, a further improvement to deliver an accurate predicted volume of a drug includes adjustable height penetrating members, such as, for example, outlet spikes. In the alternative, delivery of an accurate predicted volume, for example 50% or 80% etc., can be gauged from the residual drug volume or the use of detachable delivery devices, for example, a standard syringe or a pen-type pump injector.
- According to another aspect of the present invention, a further improvement to the drug delivery systems includes interlocks and indicators which ensure the safe and accurate delivery of the drugs. The interlocks include, but are not limited to latches which provide for a desired sequence of operation such as pressurization of containers to follow the step of insertion of the containers, or prevention of displacement of the needle to an injection position after a first injection use. The indicators include a vertical orientation indicator and end of delivery indicators.
- According to another aspect of the present invention, the housing of the drug delivery device is shaped and designed to function appropriately to enable single handed operation. For example, the bottom surface of the housing is flat in shape to allow table top placement to accommodate single handed operation by the user. Further, the device is sized to enable the insertion of vials and subsequent activation of the device using one hand.
- In a preferred embodiment, the system housing is lightweight and compact, having a weight of less than 30 grams and a volume of less than 100 cm3. This provides a portable disposable device that can be discarded or recycled after a single use and that is readily transported by the user. In addition, the present invention is self-contained and maintains sterility throughout the reconstitution and injection of a fluid such as a lyophilized drug. It should be noted, the weight and volume of the system housing can vary depending upon the different embodiments and the volume of drug being delivered to a user.
- FIGS.1A-1F illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS. 2A and 2B illustrate cutaway views of the drug delivery device shown in FIGS.1A-1F, along
line - FIGS.3A-3D illustrate the sectional views of the internal components of the drug delivery device of FIGS. 1A-1E and FIG. 2 during administration of the reconstituted drug.
- FIGS.4A-4O illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIG. 5A-5C are perspective views of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS.6A-6C illustrate the operation of a drug delivery device substantially similar to the device shown in FIGS. 5A-5C.
- FIGS.7A-7C are partial perspective views of the drug delivery device of FIGS. 5A-5C and 6A-6C illustrating the injection of the drug.
- FIGS.8A-8F illustrate the operation of a drug delivery device substantially similar to the device shown in FIGS. 5A-5C.
- FIGS.9A-9F illustrate the operation of a preferred embodiment of a drug delivery device in accordance with the present invention.
- FIGS. 10A and 10B are graphical illustrations of the pressure, weight, and delivery characteristics of a preferred embodiment of the invention.
- FIGS.11A-11D illustrate cutaway views of an alternative embodiment including a drug container subassembly of the drug delivery device in accordance with the present invention.
- FIGS.12A-12B illustrate perspective views of a preferred embodiment of the diluent container subassembly shown in FIGS. 11A-11D.
- FIGS. 13A and 13B illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIG. 14 illustrates a cutaway view of another preferred embodiment of the drug delivery device in accordance with the present invention.
- FIGS. 15A and 15B illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIG. 16 illustrates a cutaway view of an injection device in accordance with the present invention.
- FIGS.17A-17C illustrate cutaway views of an alternate embodiment of the drug delivery device in accordance with the present invention.
- FIGS.18A-18C illustrate cutaway views of an alternate embodiment of the injector system of the drug delivery system in accordance with the present invention.
- FIGS.19A-19F illustrate alternate embodiments of pressurization systems included in the drug transfer system in accordance with the present transfer invention.
- FIGS.20A-20C illustrate views of an alternate embodiment of the drug delivery system in accordance with the present invention which uses standard vials containing a liquid medicament.
- FIG. 21 illustrates a view of another preferred embodiment of the drug delivery system in accordance with the present invention which uses standard vials containing a liquid medicament.
- FIGS.22A-22E illustrate cutaway and perspective views of an alternate embodiment of the drug delivery system in accordance with the present invention.
- FIGS. 23A and 23B illustrate alternate preferred embodiments to control the dose of drugs in accordance with the present invention.
- FIGS.24A-24C illustrate cutaway views of an alternate embodiment of the drug delivery system in accordance with the present invention incorporating filling devices, for example a syringe, to inject the drug system.
- FIG. 25 illustrates a cutaway view of an alternate embodiment of the drug transfer system in accordance with the present invention incorporating filling devices, for example a pen type pump to inject the liquid medicament.
- FIGS.26A-26D illustrate perspective views of a preferred embodiment of a drug transfer system in accordance with the present invention.
- FIGS.27A-27C illustrate cutaway views of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS.28A-28C illustrate cutaway views of the operation of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIG. 28D illustrates an enlarged cutaway view of a preferred embodiment of the spike which brings the liquid drug in communication with the delivery system in FIGS.28A-28C.
- FIGS. 29A and 29B illustrate partial cutaway views of a preferred embodiment of the drug transfer delivery system in accordance with the present invention.
- FIGS. 30A and 30B are views showing the two piece construction of the manifold in accordance with the drug delivery system of the present invention.
- FIGS.31A-31G are perspective views of a preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS.32A-32E are perspective views of another preferred embodiment of a drug delivery system in accordance with the present invention.
- FIGS.33A-33I are cutaway views illustrating the interlocks built into the drug delivery system in accordance with the present invention.
- FIGS.34A-34D are views of a preferred embodiment illustrating an end of delivery indicator of the drug delivery system in accordance with the present invention.
- FIG. 35 is a graphical illustration of a delivery profile of a preferred embodiment of the drug delivery system with no additional volume of air in the liquid vial in accordance with the present invention.
- FIG. 36 is a graphical illustration of the delivery duration and delivery pressure of a preferred embodiment of the drug delivery system in accordance with the present invention.
- FIG. 37 is a graphical illustration of delivery parameters of injecting a drug with no additional volume of air in accordance with the present invention.
- FIG. 38 is a graphical illustration of the air pressure gradient on a hydrophilic membrane in the drug delivery system in accordance with the present invention.
- FIG. 39 is a graphical illustration of the delivery profile with respect to time for a vial system containing about 7.5 ml of air in accordance with the present invention.
- FIG. 40 is a flowchart describing the method of delivery of a reconstituted drug in accordance with the present invention.
- FIG. 41 is a flowchart describing the method of delivery of a liquid drug in accordance with the present invention.
- The foregoing and other objects, features, and advantages of the drug delivery systems and methods will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
- The present invention is directed to drug delivery systems and methods. The drug delivery system provides generally-for the delivery of a drug in solution under pressure, and more particularly to the injection of powdered or lyophilized drugs that require reconstitution. The drug delivery system includes a reconstitution system, a pressurization system to facilitate drug delivery, a transfer system and an injector system. Different embodiments of the present invention may use only one of the systems described and other embodiments can employ combination of these systems, depending on the requirements of different applications. For example, a preferred embodiment can deliver a liquid drug and not require reconstitution. Therefore the drug delivery systems and methods are a combination of some or all of the systems or processes described below.
- With reference to FIG. 1A-1E, the general operation of a preferred embodiment of a
drug delivery device 100 is illustrated. FIGS. 2A-2B, and 3A-3D provide sectional views of the same embodiment for clarity. As specifically illustrated in FIG. 1A,drug delivery device 100 comprises a first member orhousing 304 and a pivotally connected second member or handle 106. Thedevice 100 is used to mix, within a sterilized environment, a first liquid such as a diluent 166 (for example, a fluid such as sterilized water) with a second powdered drug such as a lyophilized drug orcompound concentrate 164, e.g., interferon, and to inject the resulting reconstituted lyophilized drug into a living organism, which in the preferred embodiment is a human being. Advantageously, thedevice 100 utilizes a standard vial orfirst storage container 102, which contains the lyophilized drug orcompound 164, and a standard cartridge orsecond storage container 116, which contains thediluent 166. Thedevice 100 may be formed from inexpensive materials, such as plastic or the like, such that it is economically feasible to dispose of the device after a single injection. - In preparation for the administration of the drug, the user removes protective packaging which envelops the
device 100. This packaging maintains sterility of thedevice 100 prior to use. In the preferred embodiment of the invention,cartridge 116 containingdiluent 166 comes preassembled, being locked into the bottom ofhousing 304 by thearms 133 as shown in FIGS. 2A and 2B. - The sterility protector of the
vial 102 is removed and then locked into the top ofhousing 304 as shown in FIG. 2A with aneedle 124 from the housing penetrating astopper 112 of the vial. At this stage,vial 102 is filled with air at ambient pressure. Thecartridge 116 is pushed upward, i.e., towardvial 102. Thecartridge 116 is punctured and the diluent 166 is delivered to thevial 102 as shown in part in FIG. 1C. At this stage, as will be explained below, there is a fluid such as gas invial 102 which is compressed by transfer ofdiluent 166 intovial 102. The user swills thedevice 100 to ensure the lyophilized drug is appropriately reconstituted. The reconstituted lyophilized drug, or injectable fluid, is identified asreference number 160. - Now, drug in solution with the diluent is ready for injection. The
device 100 is pressed against the skin of the person to be injected with thevial 102 in a vertical orientation to ensure that the compressed gas, for example, air is used to inject the reconstituted drug and that the gas or air is not injected into the injection site. The user presses thehandle 106 which causes theinjection needle 130 to move between a first position, or storage position, within thehousing 304 as shown in FIG. 3A, and a second position, or injection position, outside the housing as shown in FIG. 3C. It is preferred that the needle extend out of thehousing 304 in the range of 5 to 12 millimeters. The second extended position of theinjection needle 130 is also illustrated in FIG. 1D. At this point, theinjection needle 130 is fluidly connected tovial 102 such that the reconstitutedlyophilized drug 160, under pressure from the compressed gas invial 102, is delivered to the injection site. The delivery of the reconstitutedlyophilized drug 160 can be completed in a time period in the range of 10 -30 seconds. - Upon release of
handle 106, a biasing mechanism 108 (to be detailed below) returns the handle to the original position. Simultaneously, a needle retraction mechanism (also to be described below) locks theinjection needle 130 within thehousing 304, thereby reducing and preferably preventing exposure of the contaminated needle. The final stage of operation is illustrated in FIG. 1E, wherein thedevice 100 may be safely discarded. - FIG. 1F is a view taken along
line 1F-1F of FIG. 1E and illustrates the relative positions ofvial 102 andcartridge 116 inhousing 304. As shown, the longitudinal axes ofvial 102 andcartridge 116 are parallel but offset relative to the positioning within thehousing 304. This allows for bothvial 102 andcartridge 116 to be inserted into thehousing 304 without interfering with the internal components of thedevice 100, for example, the needle retraction mechanism described below. - FIGS. 2A and 2B illustrate cutaway views along
lines device 100 includingvial 102 andcartridge 116. More particularly,vial 102 is preferably a standard vial, for example, a 2 milliliter vial, which typically comprises glass and includes apuncturable rubber stopper 112 held in place by an aluminum band orother sealing mechanism 114. The upper end ofhousing 304 includes agrooved portion 132 which locks thevial 102 to the housing by passing the lip of thealuminum band 114 under a pair of spaced apart arms that hook up into the housing. Afirst needle 124, or other suitable means, is mounted to thehousing 304 and is configured to pierce therubber stopper 112 ofvial 102 upon insertion of the vial into the locking position provided byarms 133.First needle 124 is fluidly connected to a first channel ortube 122 for receiving the diluent fromcartridge 116 as illustrated in FIG. 2B.Cartridge 116, similar tovial 102, preferably comprises a standard cartridge (for example, a 2 milliliter cartridge with about 1 milliliter diluent) and includes arubber stopper 118 which is pierced by asecond needle 126, or other suitable means.Second needle 126 is fixedly mounted on an extending member orcompression element 238 ofhousing 304 such that the cartridge is pierced upon insertion of the cartridge.First tube 122 is fluidly connected to thesecond needle 126. Upon insertion of thecartridge 116, extendingmember 238 or compression element ofhousing 304 contacts and pushesrubber stopper 118 toward the bottom ofcartridge 116. In this manner, the diluent 166 is forced uptube 122 intovial 102 to mix with thedrug 164 contained therein. In the preferred embodiment of the present invention,cartridge 116 contains approximately 1 milliliter of diluent which is forced intovial 102, resulting in a pressure insidevial 102 of approximately 2.25 bars. This pressure can be adjusted, for example, by decreasing the amount of diluent or air incartridge 116. A higher pressure insidevial 102 injects the reconstituteddrug 160 more quickly. - Thus, a sterilized solution is provided wherein the diluent166 is mixed with the
lyophilized drug 164 with minimal exposure to outside contaminants. It is preferable thatvial 102 containing the reconstitutedlyophilized drug 160 be visible during reconstitution and injection such that the user can properly visually verify that thelyophilized drug 160 is thoroughly mixed withdiluent 166 and that thevial 102 is vertical during injection to ensure the compressed gas is not being injected into the injection site. -
Handle member 106 is pivotally connected to thehousing 304 at a first end by apivoting mechanism 110 which can include a rivet or other suitable means such that the handle member rotates in the direction ofarrow 240.Handle member 106 includesbiasing mechanism 108 which resiliently biases handle member such that the end opposite the pivotally connected end is forced away fromhousing 304.Biasing mechanism 108 includes an extending member fromhandle member 106 whichcontacts housing 304, thereby providing a resilient biasing force away from the housing when the handle member is forced toward the housing. Alternatively, or additionally thebiasing mechanism 108 can comprise a conventional spring, or other suitable means, interposed betweenhousing 304 and handle,member 106 which provides the biasing force. - Also shown in FIG. 2A is a needle injection and retraction mechanism for injecting the reconstituted
drug 160 into the person and retracting theinjection needle 130 within thehousing 304. The mechanism includes afirst bar member 140, which is pivotally connected at a first end bymember 136, and guidably mounted at a second end to thehandle member 106 by afirst coupling device 142, such as a pin, rivet, bolt, or other suitable means.Member 136 fixedly supportsinjection needle 130 and is guided by anopening 138, or needle aperture, in thehousing 304. In the preferred embodiment of the invention,injection needle 130 is in the range of a 24-28 gauge needle. The movement offirst coupling device 142 is controlled by a J-shapedslot 134 which can comprise a slot or groove inhandle member 106. Asecond bar member 148 is pivotally connected at a first end tofirst coupling device 142 and pivotally connected at a second end to athird bar member 152 by athird coupling device 150.Third bar member 152 fixedly supports athird needle 128 and may be guided by internal bore inhousing 304. A second channel ortube 120 fluidly connects thethird needle 128 andinjection needle 130. It is preferable to minimize the length oftube 120 such that the residual volume of drug remaining in the tube after injection is reduced to increase the accuracy of the dosage. - The operation of
drug delivery device 100 shown in FIGS. 2A and 2B is illustrated in FIGS. 3A-3D. FIG. 3A illustrates the stage at which thecartridge 116 is inserted forcing diluent 166 uptube 122 intovial 102. It will be recalled that the rubber stopper of 118 ofcartridge 116 is forced to the bottom of the cartridge bymember 238 as shown in FIGS. 2A and 2B. This causes the diluent 166 to be forced uptube 122 which results in the reconstituteddrug 160 being under pressure, which in the preferred embodiment is approximately 2.25 bars. Thedevice 100 is preferably vigorously shaken to ensure the lyophilized drug is properly mixed withdiluent 166. - In FIG. 3B, the
device 100 is placed against the skin of the person being injected. The user presseshandle member 106 toward thehousing 304 in a direction shown byarrow 240A, thereby displacinginjection needle 130 from the first position within the housing to a second position outside the housing such that the needle penetrates the skin of the body being injected. - As shown in FIG. 3C, continued pressure of the
handle 106 towards thehousing 304 causes thefirst bar member 140 to ride up the J-shapedslot 134. Simultaneously,second bar member 148, which includes alinear slot 244, is rotated such thatfirst coupling device 142 rides up to the top ofslot 244. - FIG. 3D illustrates the continued pressing motion of the
handle member 106 toward thehousing 304. As thehandle member 106 continues to pivot, thesecond bar member 148 forcesthird bar member 152 and hencethird needle 128 upward such that third needle penetrates therubber stopper 112 ofvial 102. Because the reconstitutedlyophilized drug 160 is under pressure, it is forced throughtube 120 and thus into the person being injected. At this point, biasingmechanism 108 is compressed. As thehandle member 106 is released,biasing mechanism 108 forces the handle member away from thehousing 304 as indicated byarrow 240B and thus withdraws injection needle within the housing. This is illustrated in FIG. 3D. J-shapedslot 134 is beneficially provided with anend locking portion 146 which catchescoupling device 142 such that theinjection needle 130 is “locked” within thehousing 304 after a single injection. Now, thedevice 100 can be safely discarded. - FIGS.4A-4K illustrate a drug delivery device 100-1 in accordance with a preferred embodiment of the present invention wherein the same reference numbers refer to the same or similar elements. More particularly, FIG. 4A illustrates the device 100-1 which includes a housing 304-1 having a first port or opening 176 for receiving a
diluent cartridge 116 and a second port or opening 262 for receivingvial 102. In this embodiment, it is preferred thatcartridge 116 containing diluent 166 be preassembled such that the cartridge is partially penetrated by needle 126-1 and such that the device 100-1 (without vial 102) is wrapped by a packaging material to maintain sterility prior to use. Again, it is preferable to use a standard 2 milliliter vial and cartridge that contains 1 milliliter of diluent. Thus, the user unwraps the packaging material and placesvial 102 containing thelyophilized drug 164 into theopening 262. Alternatively,vial 102 andcartridge 116 are packaged separately from the device 100-1 as shown in FIG. 4A. The user removes the sterility protector and presses thevial 102 firmly into the opening until needle 124-1 penetrates therubber stopper 112. The user then forcescartridge 116 into the housing 304-1. Ascartridge 116 is forced into the housing 304-1, therubber stopper 118 is first penetrated by needle 126-1 such that the needle extends into the diluent 166. This stage is illustrated in FIG. 4B. - Continuing to insert the
cartridge 116 into the housing 304-1 forces therubber stopper 118 to the bottom of the cartridge, as shown in FIG. 4C. That is to say, thefirst opening 176 of housing 304-1 is preferably circular, thereby allowing the walls ofcartridge 116 to enter the housing and not therubber stopper 118. This forces the diluent 166 through needle 126-1 to a manifold orcommunication passageway 168 and into thevial 102. Again, the resulting reconstitutedlyophilized drug 160 invial 102 is preferably under pressure of about 2.25 bars. A greater or lower pressure may be necessary depending on the volume to be injected. The device 100-1 is preferably vigorously shaken to ensure the reconstitutedlyophilized drug 160 is properly mixed in preparation for injection. - It is preferable to insert
vial 102 containing thelyophilized drug 102 before insertion ofcartridge 116 containing diluent 166 such that the diluent is not spilled intoopening 262. In order to ensure the proper insertion sequence ofvial 102 andcartridge 116, an interlocking mechanism is provided in accordance with another aspect of the present invention. Interlocking mechanism comprises abar member 266 pivotally connected to the housing 304-1 between theopenings vial 102. Thus, as shown in FIG. 4A,bar member 266 preventscartridge 116 from being inserted. Asvial 102 is inserted, it rotatesbar member 266 in the direction ofarrow 264 as shown in FIG. 4A such thatcartridge 116 can subsequently be inserted. - As shown in FIG. 4B, the device100-1 is further provided with an actuator or pushing
member 174 for displacing the injection needle 130-1 between a first position within the housing 304-1 and a second position outside the housing. It is preferred that the injection needle 130-1 extend out of the housing 304-1 in the range of 5-12 millimeters. The injection needle 430-1 is in the range of a 24-28 gauge needle and is preferably a “U” type needle having asecond end 172 configured to puncture sealingmember 170. Sealingmember 170, which can be any puncturable material such as butyl rubber, sealingly maintains the liquid in the upper part of housing 304-1 prior to use. - It is preferable to prevent displacement of the
injection needle 130 when the device 100-1 is not properly oriented, for, example, upside down, in order to prevent the compressed gas invial 102 from being injected. Also, it is preferable to lock the injection needle 130-1 within the housing 304-1 after a single injection to reduce exposure to the contaminated needle. Additionally, it is preferable to only allow displacement of needle 130-1 after insertion ofcartridge 116. Accordingly, a lockingassembly 268A is provided to accomplish the foregoing. - The locking
assembly 268A comprisesmember 268 as shown in FIG. 4C having a first end configured to be moved by pushingmember 174 and a second end configured to displace aball 270 or other appropriate movable locking device. With the pushingmember 174 in the first position such thatinjection needle 130 is within the housing, groove 272 of the pushingmember 174 aligns withgroove 274 such thatball 270 can freely travel around thegroove 274 of the pushing member. Whenvial 102 is vertically oriented with the compressed gas above the liquid, thus being properly positioned for injection as shown in FIGS. 4B and 4C,ball 270 rests in the bottom ofgroove 274 allowing the pushingmember 174 to displace theinjection needle 130. If thevial 102 is not properly positioned (for example, the assembly being upside down such that compressed gas would be injected, as shown in FIGS. 4E and 4F), theball 270 is positioned withingrooves member 174. - The locking
assembly 268A can be further configured to allow displacement of the pushingmember 174 only aftercartridge 116 is inserted. FIGS. 4G-4L illustrate this aspect of the invention. More particularly, FIG. 4G is similar to FIG. 4C exceptcartridge 116 is shown outside of the housing 304-1. FIG. 4H is a sectional view taken alongline 4H-4H of FIG. 4G and showsmember 276 of the locking mechanism having a slottedportion 278 therein.Member 276 is slidable within the housing 304-1 and configured to be moved by insertion ofcartridge 116. The lower end ofmember 276 is positioned withingrooves member 276 in the position shown in FIG. 4H, or beforecartridge 116 is inserted into the housing 304-1, the pushingmember 174, and hence injection needle 130-1, is prevented from moving to the injection position. - When the
cartridge 116 is fully inserted into housing 304-1 as shown in FIG. 4J,member 276 is moved downward as shown in FIG. 4K. As shown in FIG. 4L, this allows slottedportion 278 to align such that pushingmember 174 and hence injection needle 130-1 can be moved to the injection position. - With the device100-1 properly held by the user such that
vial 102 is vertically oriented as shown in FIG. 4M, the user presses pushingmember 174 such that the injection needle 130-1 first extends out of the housing 304-1, thus penetrating the skin of the person being injected. Continued pressing of pushingmember 174 causes thesecond end 172 of injection needle 130-1 to puncture sealingmember 170, thereby allowing the pressurized reconstitutedlyophilized drug 166 to travel fromvial 102 into the person being injected. It may take in the range of 10-30 seconds to deliver the injection fluid. This pressing motion compressesspring 190 such that upon release of pushingmember 174, the member returns to the original position, i.e., the needle 130-1 is withdrawn within the housing 304-1 and locked therein. Insertion of the pushingmember 174 into the housing 304-1 also moves inmember 268 such thatball 270 is biased against the pushing member. This is shown in FIG. 4N. When the pushingmember 174 is returned to the first position, theball 270 is positioned and held withingroove 272 bymember 268, thereby preventing displacement of the pushing member and hence the injection needle 130-1 after a single injection. This configuration is illustrated in FIG. 40. With the injection needle 130-1 locked within the housing 304-1, the device 100-1 may be safely discarded. - FIGS.5A-5C illustrate a drug delivery device 100-2 in accordance with a preferred embodiment of the present invention. More particularly, FIG. 5A illustrates the device 100-2 with the
cartridge 116 installed but not inserted or penetrated by any needle, and thevial 102 in place ready to be inserted. FIG. 5B illustrates the insertedvial 102, while FIG. 5C shows the subsequently insertedcartridge 116. At this stage, the diluent fromcartridge 116 has been transferred tovial 102, resulting in a pressurized liquid in the vial. The device 100-2 is vigorously shaken to ensure proper mixing of the reconstituted lyophilized drug. The device 100-2 is now ready for injection. It should be noted that the housing 304-2 advantageously includes a cutaway portion 254 which allows the user to visually inspectvial 102 to verify that thelyophilized drug 160 is thoroughly mixed withdiluent 166 and to verify thatvial 102 is vertically oriented during injection to ensure air is not being injected into the injection site. - FIGS.6A-6C are plan views of a similar device 100-3 corresponding to FIGS. 5A-5C, respectively. Accordingly, FIG. 6A illustrates the
cartridge 116 installed but not punctured by needle 126-3.Vial 102, containing thelyophilized drug 164, is also shown ready to be inserted into housing 304-3. - FIG. 6B shows the inserted
vial 102 which is punctured by needle 124-3.Vial 102 pushes first against surface 178-3 of puncturing device 182-3 and pushes device downward before being pierced byneedle 124. Pushingpuncturing device 182 downward sets a spring which (as will be explained in FIGS. 7A-7C) moves puncturing device upward such that needle 128-3 penetratesvial 102. Alternatively, the spring can be preloaded. As shown, needles 124-3 and 126-3 are fluidly connected by a manifold 127 comprising achannel 129 or tube. Upon insertion ofcartridge 116, the rubber stopper is first pierced byneedle 126, and ascartridge 116 is further inserted into the circular opening 176-3 of housing 304-3, therubber stopper 118 is forced to the bottom ofcartridge 118, thereby forcing the diluent 166 through the manifold 127 intovial 102. This also compresses the gas that was heretofore contained in thevial 102 to a pressure sufficient for injection. The resulting stage is shown in FIG. 6C. The device 100-3 is preferably vigorously shaken to ensure proper mixing of thelyophilized drug 164. Now, the device 100-3 is ready to inject the reconstituteddrug solution 160 contained in thevial 102. - FIGS.7A-7C illustrate partial perspective views of the device 100-2, 100-3 shown in FIGS. 5A-5C and 6A-6C. More particularly, FIG. 7A shows the pushing member 174-3 including an internal bore with
member 252 slidably contained therein.Member 252 fixedly supportsinjection needle 130 which is in fluid communication withneedle 128 via tube orchannel 120.Needle 128 shown in FIG. 7A has yet to pierce therubber stopper 112 ofvial 102.Needle 128 is fixedly supported by puncturingdevice 182. As the pushing member 174-3 is pressed toward the housing 304-3 (i.e., in the direction of arrow 180), afirst spring 190 is compressed allowing themember 252 to move downward until contacting the housing. This allows injection needle 130-3 to extend out ofneedle aperture 256 in housing 304-3 to penetrate the skin of the person being injected. Thespring 190 is set such that it creates both axial and rotational movement. Only upon complete insertion of thevial 102 is the rotational movement of the spring enabled which in turn enables the puncturing of thevial 102. In the preferred embodiment, injection needle 130-3 extends in the range of 5-12 millimeters out of the housing throughneedle aperture 256. Theinjection needle 130 partially extending out of the housing 304-3 is illustrated in FIG. 7B. - As the pushing
member 174 is further pressed toward housing 304-3,spring 200, which is stiffer thanspring 190, is compressed allowingridge 258 of pushing member 174-3 to contactpuncture device 182. This causes rotation of puncturingdevice 182 in the direction ofarrow 186 as shown in FIG. 7C, such thatsurface 178 no longer contacts thevial 102. Thespring 190 which, as described above, was loaded upon insertion ofvial 102, now causes thepuncturing device 182 to rotate in the direction ofarrow 184, thereby causingneedle 128 to penetrate therubber stopper 112 ofvial 102. This arrangement is illustrated in FIG. 7C. Thereconstituted drug 160 is forced by the compressed gas withinvial 102 throughinjection needle 130 into the person being injected in a time range of approximately 10-30 seconds. - FIGS.8A-8E illustrate a drug delivery system 100-4 in accordance with a preferred embodiment of the present invention wherein the same reference numbers refer to the same or similar elements. More particularly, FIG. 8A illustrates the device 100-4 which includes housing 304-4 having a first port or opening 176-4 for receiving
cartridge 116 and a second port or opening 262-4 for receivingvial 102. -
Vial 102 containing thereconstituted drug 164 is inserted into thehousing 304, followed by the insertion ofcartridge 116 containing the diluent 166. Again, a rubber stopper of thecartridge 116 is forced to the bottom of the cartridge which forces the diluent under pressure intovial 102. This stage is shown in FIG. 8B. Advantageously, the housing 304-4 includes acutaway portion 400 such thatvial 102 is substantially visible during reconstitution and injection. This allows the user to visually verify that the drug is properly reconstituted and that thevial 102 is vertically oriented during injection with the compressed gas above the reconstituted drug. - FIG. 8C is a rear view taken of FIG. 8B and illustrates the injection of the reconstituted drug. More particularly, the pushing member or actuator174-4 is pressed into housing 304-4 which forces injection needle 130-4 out of the housing and into the person being injected. In the preferred embodiment, the injection needle extends out of the housing in the range of 5-12 millimeters. The reconstituted drug, in fluid communication with the
vial 102, is transferred from the vial and into the person being injected. FIGS. 8D-8F are isometric views of the device 100-4 in the stages shown in FIGS. 8A-8C, respectively. - FIGS. 10A and 10B graphically illustrate system characteristics of a preferred embodiment of the drug delivery device. To provide effective delivery of a specified amount of fluid and minimize patient discomfort, the system requires a sufficient fluid pressure in the delivery vial that is manually actuated by the user within a short time period. FIG. 10A shows the pressure (millibars) and weight (grams) characteristics of the system during a delivery period of about 30 seconds for a delivery volume of about 1.6 milliliters. FIG. 10B illustrates test results of the delivery of 1.6 milliliters into different animals using a single drug deliver device for the same time period.
- Referring to FIGS.11A-11D, cutaway views of a preferred embodiment of a diluent container subassembly and a manifold, which may be used with the drug delivery devices or with an ordinary syringe or other drug delivery devices, are illustrated. The
diluent container subassembly 300 includes apreassembled compression portion 310 which allows the user to hold thediluent container 312, which can be in the form of a compressible sealed bag, and insert it into aneedle 314. Thediluent container 312 contains about 1 milliliter diluent and a controlled volume of gas, such as air, for example, and upon insertion into housing 304-6, is pierced by theneedle 314. During storage or shelf life, thediluent container 312 is sized to allow for expansion of the container as a result of changes to the environment. In addition, thecompression portion 310 is used to compress the exterior of the diluent container and apply pressure to the contents of container during delivery of the diluent for mixing. The diluent containers are formed from flexible, collapsible materials, for example, polyethylene, polypropylene and nylon. Thecompression portion 310 includes aslider element 316 and two longitudinally extendingarms cylindrical drums longitudinally extending arms - FIG. 11A illustrates the
diluent container subassembly 300 positioned in the housing 304-6 of the drug delivery system in accordance with the present invention. FIG. 11D further illustrates the fully compressed state of a preferred embodiment of thediluent container subassembly 300. Theslider element 316 of thecompression portion 310 translates in at least one axis, for example, in the illustrated embodiment, it can move up or down. The downward movement of theslider element 316 causes thediluent container 312 to wrap around thecylindrical drum 324 which compresses the contents of thediluent container 312, thus forcing the diluent from thecontainer 312 and through theneedle 314 and into thevial 102. The movement of theslider element 316 is limited by an end of travel position. At this end of travel position, theslider element 316 may be locked by a locking mechanism which ensures that the diluent container is kept compressed. - A
manifold 330 includes twoneedles member 334. The needles can also comprise a penetrating member that is formed from an injection molded material such as medical grade polycarbonate or acrylic with the required level of rigidity to penetrate the vial or container. Achannel 331 provides for fluid communication between theneedles Needle 314 pierces thediluent container 312 upon insertion of the container, whileneedle 332 pierces thevial 102 upon insertion of the vial containing thelyophilized drug 164. In a preferred embodiment of the present invention,container 312 contains approximately 1 milliliter of diluent and a controlled volume of air which is forced intovial 102, resulting in a pressure insidevial 102 of approximately 2.25 bars. The pressure insidevial 102 results from forcing the controlled volume of air in thediluent container 312 into the rigid volume in thevial 102. Thus, the diluent 166 is forced intovial 102 to mix with thelyophilized drug 164 contained therein. The entire assembly is preferably shaken to ensure the reconstituteddrug 160 is properly mixed in preparation for injection. Thevial 102 is vertically oriented during injection to ensure air is not being injected into the injection site. - Referring to FIG. 11C, the injector needle130-6 is shown in a first position within the housing 304-6. As described hereinbefore, the injection needle 130-6 is in the range of a 24-28 gauge needle and is preferably a “U” shaped needle having a second end 172-6 configured to puncture sealing member 170-6. An
area 171 is located adjacent to the sealing member 170-6 and is in communication with thechannel 331 as shown in 11B. - When the user compresses the
button 305, it causes the needle 130-6 to penetrate the skin and thesecond end 172 to penetrate the sealingmember 170. The drug and diluent solution will flow from theneedle 332, through thechannel 331, andarea 171 and to the user via the injector needle 130-6. As the user compresses thebutton 305, which is spring loaded byspring 306, a pair ofmating pawls - FIGS.12A-12B illustrate perspective views of a preferred embodiment of the
diluent container subassembly 300 and provide further details of the components of thecompression portion 310. Thecylindrical drum 324 is slotted such that the diluent container can be inserted therein. Thecylindrical drum 322 serves as a backing drum. Thus, thediluent container 312 is typically inserted between thecylindrical drum 324 and thebacking drum 322. Thedrum apparatus pinion gear apparatus 340. An end oftravel position 342 in the rack andpinion gear apparatus 340 constrains the movement of thecylindrical drum 324 at its end of movement position. This end of travel position correlates with the end of the wrapping of thediluent container 312 around the cylindrical drum and maximum compression of the contents of the container. Aflange 344 can be used to hold thediluent container 312 at the bottom of thesubassembly 300. Thediluent container 312 can be sealed by means of heat welding techniques or ultra sonic techniques to theflange 344 after it has been filled with the diluent. Thelongitudinally extending arms compression portion 310 each comprise twomembers members cylindrical drum 324. - Referring to FIGS.13A-13B, cutaway views illustrate an alternate embodiment of the invention similar to that shown in FIGS. 11A-11D including a
manifold 350. The manifold 350 has twoneedles vial 102 anddiluent container 312 respectively. Once the diluent 166 and the controlled volume of air are forced to move intovial 102, the diluent mixes with thelyophilized drug 164 and results in the reconstituteddrug 160 which is under pressure. Because the reconstituted drug is under pressure due to the controlled volume of air, it is forced through theneedle 352 and into the person being injected through aneedle 351 that is actuated by movement of pushingmember 353. This embodiment of the device provides a user comfort as it does not have to be vigorously shaken to ensure the reconstitutedlyophilized drug 160 is properly mixed in preparation for injection. The controlled volume of air facilitates the mixing of the diluent and the lyophilized drug. The pushingmember 353 displaces theinjection needle 351 between a first position within thehousing 304 and a second position outside the housing, or in an injection state. - It is preferable to prevent displacement of the
injection needle 351 when the device 100-7 is not properly oriented, for example, upside down, in order to prevent the compressed gas invial 102 from being injected. Also, it is preferable to lock theinjection needle 351 within the housing 304-7 after a single injection to reduce and preferably to prevent the exposure to the contaminated needle. Additionally, it is preferable to only allow displacement ofneedle 351 after insertion ofdiluent container 312. Accordingly, a lockingmechanism comprising member 268 as shown in FIG. 4B is provided to accomplish the foregoing. Themember 268 has a first end configured to be moved by pushingmember 353 and a second end configured to displace a movable locking device, substantially similar to the device shown in FIG. 4B. - With the device100-7 properly held by the user such that
vial 102 is vertically oriented, the user presses pushingmember 353 such that theinjection needle 351 first extends out of the housing 304-7, thus penetrating the skin of the person being injected. Continued pressing of the pushingmember 353 causes thesecond end 355 ofinjection needle 351 to puncture sealingmember 357, thereby allowing the pressurizedreconstituted drug 166 to travel fromvial 102 into the person being injected. It may take in the range of 10-30 seconds to deliver the injection fluid. The pressing motion compressesspring 359 such that upon release of pushingmember 353, the member returns to the original position, i.e., the needle is withdrawn within thehousing 304 and locked therein. - Referring to FIG. 14, a cutaway view illustrates a manifold of another preferred embodiment of the drug delivery device100-8 in accordance with the present invention. The manifold 350 has two
needles vial 102 anddiluent container 312, respectively. A flange, substantially similar to theflange 127 shown in FIG. 6B, holds the septum orstopper 313 in place in thecontainer 312. An extending member or communication chamber 356 which is in fluid communication with theneedles barrier 360 disposed therein. It should be noted that the hydrophilic membrane needs to be wetted before it functions to minimize or preferably prevent the flow of gas into a user's tissue. The hydrophilic membrane allows gas, for example, air to pass freely till it comes in contact with liquid and gets wet. Thus, when wet, no air such as the controlled volume of air in thediluent container 312 can pass through the hydrophilic membrane, preventing air from entering the user's tissue. The presence of the hydrophilic membrane prevents risks caused by any wrong use of the device 100-8 by the user such as incorrect positioning of vials or containers. - Referring to FIGS.15A-15B, cutaway views illustrate another preferred embodiment of a manifold of the drug delivery device in accordance with the present invention, The
needle 352 pierces thevial 102 whileneedle 354 pierces thediluent container 312. Theneedle 354 andchannel 352 onspike 352A are in fluid communication.Diluent 166 moves from thediluent container 312 intovial 102, thus mixing with the lyophilized drug to result in a reconstituted drug. Achannel 358 is in communication with anarea 361 sealed by astopper 313.Channel 358 also includes a hydrophilic membrane. Thus, upon the introduction of air to the channel, the membrane expands in the presence of air and disallows the passage of air therethrough. - In use, the user presses the
button 363 which first movesinjector needle 130 into the users skin. Further movement of thebutton 363causes piercing member 172 to penetrate thestopper 313. This enables liquid drug/diluent solution to move, via the air pressure in thevial 102 through theinjector needle 130 and the user's skin. - It should be noted that the embodiment illustrated with respect to FIGS. 15A and 15B being more position independent, is not subject to air blocking the flow of liquids through the gas impermeable membrane until all the drug solution has been transferred out of the
vial 102. FIG. 15A shows the position ofchannel 358 relative to channel 352. Thus, only if thevial 102 is completely filled with air would it pass intochannel 358. In contrast, the embodiment illustrated with respect to FIG. 14 and the absence of thelower channel 358 is more position dependent and thus subject to air blocking the flow of liquids through the gas impermeable membrane even while the drug solution is being transferred out of thevial 102. - Further, it should be noted that the delivery times of the drugs is dependent on the volume of vial which maybe adjusted. The pressure is adjusted in part by adjusting the vial volume size. A large vial volume of air relative to the drug would result in greater air pressure and faster drug delivery.
- In the preferred embodiments of the present invention the drug vials and the diluent containers are shown as being inserted in the
housing 304 and aligned in the same direction along parallel axes. In the alternative, it is contemplated that the vials and containers may not be aligned in the same direction along parallel axes. The vials and containers may be inserted along two different axes that are oriented at oblique or orthogonal angles relative to each other. - Referring to FIG. 16 a cutaway view illustrates an alternate preferred embodiment of an
injection device 236 in accordance with the present invention. Thedevice 236 facilitates the sterilized injection of a prefilled cartridge or vial containing an injectable liquid, for example, a vial containing aliquid drug 160. Thedevice 236 includesfirst opening 161 for receivingvial 102 and a manifold 370 includingmember 372 sealingly engaged with thefirst opening 161.Member 372 fixedly supportsneedle 374 and is supported by a collapsible volume, such asbellows 378, or any other device capable of injecting a fluid such as a gas upon being compressed. Acheck valve 380 ensures that the flow from the bellows is unidirectional, that is, the drug under pressure can not enter thebellows 378. Thecheck valve 380 comprises atubular member 381 adapted to deliver gas, for example air, to thevial 102. Air is moved out of the bellows and into thetubular member 332 by compressing, thebellows 378. Thecheck valve 380 allows the flow of air out of thebellows 378 and into the vial but disallows the reverse flow of air from the vial into the bellows. Air from thebellows 378 is forced up throughneedle 374 and intovial 102 applying pressure to the contents of thevial 102. Theliquid drug 160 is under pressure and is injected into the user directly from thevial 102. The injection process is the same as discussed earlier with respect to embodiments in FIGS. 13-15, in that the use of a U-shaped needle assembly is compressed into the skin to activate injection. As discussed earlier, due to the nature of the hydrophilic material, ahydrophilic membrane 360 in the drug delivery path minimizes and preferably prevents gas from being injected into the user. - Referring to FIGS.17A-17C, cutaway views illustrate an alternate embodiment of the
drug delivery device 100 in accordance with the present invention. The diluent container comprises asyringe 390. When pressure is applied to aplunger shaft 392, the diluent 166 is forced out of thesyringe 390 through thechannel 398 and into the contents ofvial 102 via theneedles member 398. Thus, the diluent 166 is provided tovial 102 under pressure and is mixed with the reconstituted drug to result in a reconstituted drug solution ready for injection or delivery under pressure to a patient. The drug solution is delivered to a user using a u-shaped needle assembly as disclosed with respect to FIGS. 13A-13B, 14, and 15A and 15B. This syringe embodiment facilitates the use of a standard prefilled container or cartridge containing only a diluent. The device is flexible and does not require special means or training. - The present invention includes alternate preferred embodiments of injection devices. FIGS.9A-9F illustrate an
injection device 236 which facilitates the sterilized injection of a prefilled cartridge or vial containing an injectable liquid, for example, a vial containing areconstituted drug 160. It is preferable to use a standard vial, for example, a 2 milliliter vial, with thisdevice 236. As shown in FIG. 9A,device 236 includes a first opening for receiving thevial 102 and amanifold including member 232 which is slidably and sealingly engaged with the first opening.Member 232 fixedly supportsneedle 224 and is supported by a collapsible volume, such asbellows 228, or any other device capable of injecting air upon being compressed.Needle 224 is in sealed communication with thebellows 228 as shown in FIG. 9A. Thevial 102 is pressed into the housing 304-5 such thatneedle 224 pierces therubber stopper 112. This arrangement is shown in FIG. 9B. - The
vial 102 is further pressed into the housing 304-5 which forcesmember 232 to compressbellows 228, thus forcing the air contained inbellows 228 up throughneedle 224 and intocartridge 116. Now, as illustrated in FIG. 9C, thecartridge 116 is under pressure for forcing thedrug 166 into the person being injected. The bellows or other compression device can also be actuated by member 174-5. - As shown in FIGS.9A-9F,
device 236 is further provided with a pushingmember 226 for displacing the injection needle 130-5 between a first position within the housing 304-5 and a second position outside the housing, or in an injection state. In the preferred embodiment a distal end of the injection needle 130-5 can extend out of the housing 304-5 in the range of 5-12 millimeters. In this particular embodiment, theinjection needle 130 is preferably a “U” type needle having asecond end 250 configured to puncture sealingmember 230. Sealingmember 230, which may comprise any puncturable material such as butyl rubber, maintains the liquid in the upper part ofhousing 304. As the user presses pushingmember 226 intohousing 304, the first end of theinjection needle 130 first penetrates the skin of the person being injected as shown in FIG. 9D. Continued pressing of pushingmember 226 into thehousing 304 causes thesecond end 250 of injection needle 130-5 to puncture sealingmember 230, thereby allowing the reconstituteddrug 160 to travel fromcartridge 116 into the person being injected. This is illustrated in FIG. 9E. The pressing of the pushingmember 226 into the housing 304-5 compresses a spring such that upon release of pushingmember 226, the member returns to the original position, i.e., the injection needle 130-5 is in the first position within the housing 304-5 as shown in FIG. 9F. This embodiment may be further provided with a locking mechanism similar to that disclosed in FIGS. 4A-4K. With the injection needle locked within the housing 304-5, thedevice 236 may be safely discarded. - Further, FIGS.18A-18C illustrate an injection device in accordance with an alternate preferred embodiment of the present invention. More particularly, the
drug delivery device 400 includes astraight needle 402 having alancet 404 disposed on a first end. Acavity 405 in theseptum 406 contains a liquid drug under pressure. Thestraight needle 402 includes aside hole 407 disposed on the shaft. Thesecond end 408 of the straight needle is blocked. In operation, as shown in FIGS. 18A, 18A-1, 18B and 18B-1, when themember 410 is moved forward toward thehousing 412, theinjection needle 402 is displaced from a first position in thehousing 412 to a second position outside the housing such that theneedle 402 penetrates the skin of the user. After thelancet 404 penetrates the user's tissue, continued pressing motion of themember 410 toward the housing causes theside hole 407 to be in fluid communication with thecavity 405 of theseptum 406 creating a path for the drug under pressure to flow into the user's tissue. The straight needle punctures theseptum 406 at two locations. As shown in FIG. 18C, as themember 410 is released, the injection needle is withdrawn within thehousing 412. - More particularly, referring to FIG. 18A-1, a 3 part ring
structure including member 414,latch 416,gap 418 andspring 419, as shown in FIG. 18A provide an interlocking system. This safety mechanism which includes themembers latch 416,gap 418 andspring 419 provides an interlock to ensure against reuse of thedrug delivery device 300 and exposure ofneedle 402 after the first use. Once themember 410 is compressed themating ridges ridge 413B to pass under 413A whenmember 410 is depressed against thehousing 412. The ridges are pressed together when the force of thespring 419 movesmember 410 away from thehousing 412. Because the ridges interface at a right angle to the direction of movement of themember 410 they serve to prevent further movement by the member and theneedle 402. This mechanism ensures that thedevice 400 is not reused. - FIGS.19A-19F illustrate cutaway views of alternate preferred embodiments of systems which allow reconstitution of drug and subsequent transfer into a drug delivery device in accordance with the present invention. Once the drug is made into a solution it may be transferred into a user by means of direct injection as shown in FIG. 11, for example, or into a drug delivery device such as an infusion pump, needleless injector or the like. The systems include a
vial 420 containing a predetermined volume of a drug and avial 422 containing a volume of a diluent. The use of standard vials facilitate the use of the drug delivery device by different drug suppliers. - An
air source 424 maybe included for the delivery of drugs. With drugs of higher viscosity, the use of pressure becomes more important. As illustrated in FIG. 19A, the sources of pressurized air can vary and may include, but are not limited to, a compressedair delivery supply 426, achemical gas generator 428, astandard syringe 430 and a collapsible volume container, such as abellow container 432. The air source supplies the driving force to the diluent volume which moves thediluent solution 434 into the standardlyophilized drug vial 420. Once reconstituted, the liquid drug is transferred via the air separator, such as ahydrophilic membrane 436, to a drug delivery system. It should be noted thatspike 438 in thediluent vial 422 and spike 440 in thedrug vial 420 each have two paths. Thespike 438 has a first path for compressed air to enter thediluent vial 422 and a second path for thepressurized diluent 434 to be in fluid communication with thedrug vial 420. Thespike 440 has a first path for the pressurized diluent to enter thedrug vial 420 and a second path for the delivery of the drug solution into a drug delivery device. As discussed earlier, it is contemplated that other drug delivery devices may be received into this system to receive the drug solution. - Referring to FIG. 19B, the air source is a
compressed air canister 426. The compressed air canister typically is a standard addition for domestic drug delivery devices. The user attaches thecompressed air canister 426 to thedrug delivery system 450 and punctures a seal 452 located in the compressed air canister. The air canister is then in fluid communication with thediluent vial 422 by means ofchannel 453. Air is released from thecompressed air canister 426 and is introduced into thediluent vial 422, which in turn forces thediluent solution 434 to move into thedrug vial 420 viachannel 455. After reconstitution is completed, the liquid drug is ready to be transferred. The concentration of the reconstituted drug can be controlled in this and other embodiments by changing the quantity of diluent transferred to reconstitute the drug. Ahydrophilic membrane 436 in the drug delivery path minimizes and preferably prevents gas from being transferred to the drug delivery device. - FIG. 19C shows a
chemical gas generator 428 as the air source used in this particular embodiment to deliver the diluent 434 under pressure to the lyophilized drug vial. Thechemical gas generator 428 includes achemical compartment 456 which typically contains twomaterials materials solid palette 460 that are separated during shelf life. It should be noted that the materials used in thechemical compartment 456 and the reaction that ensues during the mixing of the materials are safe and biocompatible. Pushing amember 462, in thechemical compartment 456 results in tearing of a seal 464, for example, aluminum foil, which separates the twomaterials chemical gas generator 428 also includes a gas compartment 466 which is typically an air reservoir having aflexible enclosure 468. The carbon dioxide produced in thechemical compartment 456 due to the reactions enters the gas compartment 466 and is accommodated in theflexible layers 468 that form the gas compartment. The movement of theflexible layers diluent vial 422 through theair pathway 423. It should be noted that the gas compartment 466 has adouble layer layers flexible enclosure 468 of the gas compartment 466. Further, the gas compartment 466 is vented using a gas leakage pathway or ventport 474. The air that is released from thechemical gas generator 428 enters thediluent vial 422 via thechannel 423 which in turn forces thediluent solution 434 to move into thedrug vial 420 via thechannel 425. After reconstitution is completed, the drug is ready to be used, and is transferred to a drug delivery system such as one described with respect to FIG. 19B. - Referring to FIG. 19D, the air source used in this particular embodiment to deliver the diluent under pressure is a
standard syringe 430 or an air reservoir. Thesyringe 430 is locked at an end of travel position. When pressure is applied to aplunger shaft 480 the air is forced out of thesyringe 430 and into the contents of thediluent vial 422 through theneedle 482 andneedle 434 which are in fluid communication through themember 484. The diluent 434 is then forced into the drug compartment ordrug vial 420 viamember 484 under pressure which provides for the mixing with the lyophilized drug to result in a reconstituted drug which is then ready for injection or delivery under pressure to a user. In an alternate embodiment, a lever can be included to reduce the force required for pushing theplunger member 480. The lever will increase the displacement and thus delivery of pressurized air to the diluent container in this case, the drug solution may be injected as shown in FIG. 19D, the sectional of which is the same as shown and described in other needle assemblies, for example, shown in FIGS. 11, 13, 14, 15, 16, and 32 or transferred into a drug delivery device. - Referring to FIG. 19E, the air source used in this particular embodiment to deliver the diluent under pressure to the lyophilized drug is a collapsible volume container such as a
bellow container 432. Acheck valve 488 or a one-way valve insures that the flow from thebellow container 432 is unidirectional, that is, the drug or diluent can not enter the bellows. Thecheck valve 488 comprises atubular member 490 adapted to deliver gas, for example air, to thediluent vial 422. The resilient nature of the bellows is checked by thecheck valve 480 which does not allow air to enter the bellows and thus reinflate the bellows once the bellows have been compressed and air has exited. Once compressed, air contained in thebellows 432 is forced throughneedle 438 and into thediluent vial 422 viachannel 491 applying pressure to the contents of the diluent vial. Thediluent solution 434 in turn, is delivered under pressure to thedrug vial 420 where the drug is reconstituted and can be transferred either by injection as described above or into a drug delivery device, as also described and shown relating to the embodiment of FIG. 19A. - Referring to FIG. 19F, the air source used in this particular embodiment to deliver the diluent under pressure Is
cylinder 490. This embodiment is similar to the embodiment containing a standard syringe as described with respect to FIG. 19D. Theplunger 492 is depressed to compress the air in thecylinder 490. The air is driven into thediluent vial 422 throughchannel 494 which brings the cylinder and the diluent vial in fluid communication. The pressurized diluent indiluent vial 422 then moves into thevial 420 and mixed with the drug. The pressurized drug solution is then ready to be delivered. This can either comprise delivery to a drug delivery device as described with respect to the embodiment of FIG. 19A or injected as shown in the present embodiment having a straight needle assembly as shown and described in FIG. 18. - Referring to FIGS.20A-20C, an alternate embodiment of the
drug delivery system 498 in accordance with the present invention includesstandard vial 500 containing aliquid drug 502. A volume of gas, for example air, contained in anair chamber 504 is introduced in the standardliquid drug vial 500, creating air pressure above the liquid drug which allows for delivery of a liquid drug under pressure. The usage is position dependent, that is the delivery of the liquid drug, is performed with thestandard vial 500 in a vertical position. In addition, a hydrophilic membrane minimizes or preferably prevents the introduction of the extra volume of air into the user's tissue. - In use, as shown in FIG. 20A, the
standard vial 500 containing theliquid medicament 502 is inserted into thedrug delivery device 498 in accordance with the present invention. Anair chamber 504 is provided which upon insertion of thedrug vial 500 and the puncturing of theseal 506 of the vial, is in fluid communication with the drug vial. Once inserted, thelip 505A of astandard vial 500 is locked into position by means of a pair ofarms 505 havingridges 507 projecting inwardly therefrom. The injector system is thestraight needle 402 embodiment as disclosed in FIGS. 18A-18C. Once the air from the air chamber is introduced into thestandard drug vial 500 the liquid drug is pressurized and is ready to be injected using the injector system described with respect to FIGS. 118A-118C. After injection into the user's tissue, the needle is retracted automatically. Thedrug delivery device 498 is then disposed. - Referring to FIG. 21, an alternate preferred embodiment of a
drug delivery system 510 which usesstandard vial 500 containing a medicament is disclosed. Aplunger 512 is included in thedrug delivery device 510. In order to reduce forces which are required to insert thestandard vial 500 in thedrug delivery device 510. In an alternate embodiment, thedrug delivery system 510 can have a compact configuration without a plunger.Snaps 514 lock thestandard vial 500 into position.Snaps 516 hold the end portion of the vial having theseal 506 in place to ensure that thespike 518 pierces theseal 506 of thevial 500 before the vial is moved in the downward direction. Air in theair chamber 520 is delivered to thevial 500 when the air is compressed and displaced by the downward movement of thevial 500. The liquid drug under pressure is delivered to aninjector using tubing 522. Ahydrophilic membrane 524 minimizes or preferably prevents gas from entering the user's tissue. The injector system used can be similar to one described with respect to FIGS. 18A-18C. Themember 410 is moved to displace theinjection needle 402. - Referring to FIGS.22A-22E, the views illustrate an alternate preferred embodiment of the
drug delivery system 530 in accordance with the present invention. This particular embodiment may be used as a reconstituted system and a drug delivery system and includes twovials 532, 534 a first containing a diluent 533 and a second containing thelyophilized drug 535. In addition, there is an air delivery system for pressurizing system, such as a built-inair cylinder 533 in fluid communication with thediluent vial 532 which is disposed between thelyophilized drug vial 534 and thediluent vial 532. Air is pushed into thediluent vial 532 forcing the diluent 533 from its vial into the lyophilized drug compartment orvial 534. After reconstitution is completed, the liquid drug is ready for injection. A hydrophilic membrane is used as an air separator to minimize or preferably prevent the entry of air into the user's tissue. This particular embodiment uses astraight needle 402 injector system as described with respect to FIGS. 18A-18C. Additionally, a positioning interlock, such as the mechanism, described with respect to FIGS. 2A-2B is used. Further, in an alternate embodiment, the air cylinder can be replaced with a standard syringe to be the air source as shown in FIGS. 22D and 22E. A check valve (as shown in FIG. 16) disposed in the air inlet between the syringe and manifold is included in the embodiment containing the syringe. The drug delivery system of the present invention is used to deliver an accurate volume of a drug solution. The predetermined volume can be delivered using different methodologies. A first embodiment controls the dose by changing the height of theoutlet spike 535 in theliquid drug vial 537 as shown in FIGS. 23A, i.e. the higher the spike, the lesser is the amount of drug transferred out of thevial 537. The spike is adjusted by means ofthreads 539 upon which the spike rotates or upon which it sealably slides. This can be used for to transfer or to inject the drug solution. Another preferred embodiment which increases the accuracy of the volume of drug delivered uses the residual drug volume as a parameter to indicate the volume delivered. One way of controlling delivered drug solution volume is to use the assembly shown in FIG. 23B. After the drug is pushed in solution invial 102 the solution may be pulled intocavity 541 bypiston 555. Thecavity 541 has indications thereon to aid the user in determining the proper volume. At the desired level, the piston is stopped. The drug solution is then transferred from thecavity 541 either via a needle into a user or into a drug delivery device. Yet another embodiment to provide an accurate volume of drug is disclosed with respect to FIGS. 24A-24C and FIG. 25. The reconstitution system drug delivery device. The dialing process retracts a floating piston which moves upward and creates an internal pressure which provides for aspiration of the reconstituted drug. Atrigger 564 releases a preloaded spring to push the floating piston. - Thus aspiration occurs by dialing the dose into the pen-type injector. Once the
pump 560 is filled as indicated by anindicator 566, it is disconnected from the filling device. - Injection and disposal of the pump is performed after disconnection with a process similar to the process described with respect to FIGS.2A-24C.
- FIGS.26A-26D are perspective views of a drug transfer system having a
drug delivery device 510 in accordance with the present invention. A diluent vial is inserted in acavity 572 and a lyophilized drug vial is inserted incavity 574. Acavity 576 accommodates an air pressurization system to deliver drugs having a low level of viscosity. Further, the drug transfer system includes anaccess 578 to receive a drug delivery device. The drug is transferred thereto via aneedle 580. - FIGS.27A-27C are cutaway views of a preferred embodiment of a
transfer system 600 in accordance with the present invention. Once pressurized by the air incavity 603, the liquid drug fromvial 602 is transferred to adrug delivery device 604 via anextension 606. The liquid drug flows out of thevial 602 throughspike 608 and through thetubing 610 into theneedle 616 which is received into thedrug delivery device 604. Referring to FIG. 27B, thedrug delivery device 604 is attached to thetransfer system 600. The filling process continues until the entire drug level reaches theoutlet 604A (shown in phantom in FIG. 26B) of thedevice 604. At this point the filling process is completed. It should be noted that during the filling process, if the user stops pushing thevial 602 into thetransfer system 600 the drug may drain into thecylinder 614. This is prevented by getting the friction forces higher than the impedance of thetubing 610 to the drug flow. In the alternative, it is also possible to dispose a one-way valve at the end of thetubing 610. Once thedrug delivery device 604 is filled with a liquid drug, it is disconnected from thetransfer system 600. Any residual drug in thesystem 600 can stay protected, and theneedle 616 is retracted and as described earlier with respect to the needle locking mechanisms is secured in thecover 606, and cannot be reexposed to cause harm or injury. - FIGS.28A-28C are cutaway views of the operation of another preferred embodiment of a
drug delivery system 630, in particular of a position independent injection system in accordance with the present invention. In this embodiment, theinjection system 630 is position independent, that is the injector is not required to be in a vertical position during the injection process. Referring to 28A, thedrug delivery system 630 includes avial 632 containing theliquid drug 634. Theliquid drug 634 flows through thespike 636 along atube 644A into acavity 652. The spike includes two paths, onepath 642 for delivering pressurized air intovial 632 fromchamber 641 and anotherpath 644 to deliver the liquid drug to the user via aneedle 664. The liquid drug exits from thepath 644 and travels alongtube 644A disposed at the bottom of the spike. A one-way valve 638 insures the unidirectional flow of theliquid drug 634 into thecavity 652A.Spring 640 holdspiston 656 within thecavity 652. A floatingpiston 650 moves in thecavity 652. Aseal 654 is included in the floating piston.Member 660 rests atop a needle assembly 664A.Member 660 is hingedly connected tomember 662.Member 662 has afinger 662A. Prior to use, thefinger 662A rests within anaperture 662B of thehousing 660A. Thenotch 656 is the end of travel position for thepiston 656. - The
path 642 from theair chamber 641 to thevial 102 pressurizes the vial by delivering air thereto. Theair chamber 641 is depleted of air when the vial is moved downward. As the vial moves downward, a member 641A sealably slides within the walls of the chamber and forces the air into the vial. The member 641A is prevented from leaking air out of the chamber by the seal 641B. - In use, when
vial 632 is pushed into thedevice 630, air from thecavity 641 enters into thevial 632 and pressurizes the liquid drug. Thisdrug 634 under pressure flows viapath 644 through the one-way valve 638 into the left side of thecavity 652. Pressurized air pushes the floatingpiston 650 to the right side of thecavity 652. The floatingpiston 650 moves until the position of thenotch 658, which is the end of travel position for thepiston 656 and thus for filling of thecavity 652. Thus, as illustrated in FIG. 28B, an accurate volume of liquid drug is filled incavity 652 and thedevice 630 is ready to be used. - As illustrated with respect to FIG. 28C, once the
member 660 is depressed, it causes theneedle 664 to move downwardly outside thehousing 660A and into the user's tissue.Member 662 is hingedly connected tomember 660. When 660 is depressed, it causesmember 662 to move upwardly disengaging thefinger 662A from theaperture 662B and enables thespring 640 to return to a less compressed state. As it does, thespring 640 forces the piston towards the opposing end of thecavity 652. This causes the liquid drug therein to move viachannel 652A andneedle 664 into the user's tissue, thepiston 656 is released due to the movement ofmember 662 in the upward direction. Thepiston 656 moves to the left. The floatingpiston 650 is under pressure and moves the liquid drug incavity 652 through theinjector needle 664 and into the user. It should be noted that after delivery of the liquid drug, the position of the floatingpiston 650 depends on the load on thespring 640. To prevent the flow of residual drug under pressure, thespring 640 continues to be in a preloaded state. Theseal 654 is pushed to the left side of thecavity 652 under pressure ofspring 640 to seal against the exit of the pressurized residual drug via thechannel 652A. Although disclosed as having a pushingspring 640, other mechanisms may be included in the injector system to result in a position independent injector. - Referring to FIG. 28D, a cutaway view of a
spike 636 which brings theliquid drug 634 in fluid communication with the injector system is illustrated. Thespike 636 penetrates theseptum 639 of thevial 632 when the vial is inserted into thecavity 640. The spike functions as a piston 641A and is sealably and slidably movable by means of the seal 641B within the interior walls of thechamber 641. As described hereinabove, the spike also consists of two paths, anair inlet 642 and adrug outlet 644. Once thevial 632 is inserted, pressurized air enters thevial 632 from anair chamber 641 and forces theliquid drug 634 via aflexible tube 644A to the injector system. The filling process for the injector system in a preferred embodiment is preferably done under a maximum pressure gradient of 0.3 bar. This includes a margin for example, priming at an altitude of 5,500 feet and is the maximum expected back pressure. - FIGS. 29A and 29B illustrate partial cutaway views of another preferred embodiment of the
drug transfer system 670 in accordance with the present invention. Thedrug vial 672 containing theliquid drug 674 is inserted into acavity 676. Aspike 678 provides air into theliquid drug vial 672 for pressurization of thedrug 674 and additionally the spike provides for an outlet for the liquid drug to be delivered to adrug delivery system 680. Thedrug transfer system 670 is in fluid communication with theliquid drug vial 672 through aflexible tubing 682 and aneedle 684. Ahydrophobic membrane 686 is disposed in theflexible tubing 682 to prevent the transfer of air into the drug delivery system. Thishydrophobic membrane 686 prevents back flow. The air to pressurize theliquid drug 674 is provided by air in thereservoir 675. Further, alatch mechanism 688 secures thevial 672 to thedetachable delivery system 680 during a filling process. - Referring to FIG. 29A-1, an enlarged view of the interface between the
drug transfer system 670 and the detachabledrug delivery device 680 is illustrated. Ahydrophobic membrane 692 is disposed at the interface for blocking the flow of the drug once thedrug delivery device 680 is filled. Anelastomeric cover 694 is disposed around theneedle 684 for protection against theneedle 684.Tab 693 is pulled off to remove thehydrophobic membrane 692 prior to use of thedevice 680. - In operation the
liquid drug vial 672 is pressed into thecavity 676 which causes the air in thereservoir 675 to be compressed and enter theliquid drug vial 672. Air is prevented from leaking out of thecavity 675 by means ofseal 685. Theliquid drug 674 is pressurized and delivered through thespike outlet 690. Residual air from theair reservoir 675 is vented from an opening in thelatch mechanism 688 once the latch is disengaged from the drug delivery device at the end of travel of the vial and subsequent end of the transfer process. - Referring to FIGS. 30A and 30B, the two
piece impermeable membrane 698 welded in thepart 696. The twopieces - Referring to FIGS.31A-31E, perspective views illustrate an alternate preferred embodiment of a
drug delivery system 700 in accordance with the present invention. This particular embodiment maybe used with the reconstituted drug delivery system and includes twovials cylinder 706 in fluid communication with thediluent vial 702. The built-in pressurization system such as thecylinder 706, is disposed between the lyophilized drug vial and the diluent vial. Aplunger 708 is slidably received into thecylinder 706 to provide the necessary air pressure to effect drug transfer. Air is pushed into the diluent vial forcing the diluent from its vial into the lyophilized drug compartment orvial 704. As discussed previously, a hydrophilic membrane is used as an air separator to minimize or preferably prevent the entry of air into the user's tissue. In use, a diluent vial is inserted into thedrug delivery system 700 followed by the insertion of a drug vial. Theplunger 708 is pushed downwards to pressurize the air in thecylinder 706 and deliver it to thediluent vial 702. Once the diluent solution is pressurized it is delivered to thedrug vial 704 to reconstitute the drug. Pressing theknob mechanism 710 displaces an injection needle which is used to inject the reconstituted drug into a user tissue. The depression of the knob mechanism and subsequent injection is similar to that described earlier with regard to either the straight needle assembly shown in FIG. 18 or the U-shaped needle shown in FIGS. 11, 13 through 17. - Referring to FIGS. 31F and 31G, two
preferred embodiments vertical indicators plunger 708, however their location can vary to provide appropriate visual indication. In the first embodiment of thevertical indicator 711, ametal ball 714 rests upon a curved surface having visual having the vial containing the reconstituted drug is essentially used as a filling station by a detachable delivery device, for example, a standard syringe or a pen type pump. - Referring to FIGS.24A-24C a position
independent injector system 540 is illustrated. Thedrug 545 is reconstituted similar to the description provided with respect to earlier systems such as illustrated in FIG. 19F. After the drug has been reconstituted it can be aspirated by a conventionalstandard syringe 542 for the exact dose required. The accuracy using this method is about +/− 5%. The fluid level in thecavity 550 is controlled by adjusting the pressure and geometry of thedevice 540. The needle is held in place by the elastomeric septum orstopper 552. In use, once the reconstituted drug is aspirated into thesyringe 542 by movingplunger 548 which moves thestopper 554 upwards allowing thesyringe 542 to be filled with the liquid drug, thesyringe 542 is removed from thedrug delivery device 540. The accuracy of the volume of the liquid drug delivered is determined by the scale on the syringe. The user then injects the drug and disposes of the syringe by one of several potential ways. One of the ways of disposing the syringe is by attaching the syringe to theopen cavity 550 left in thedrug delivery device 540. A second way is by securing theneedle 547 prior to disposing the syringe by locking it with a piece of plastic tubing. Thesystem 540 and procedure used is free of air inclusions and does not require an air separator. Thesyringe needle 547 is placed in a closed cavity penetrating aseptum 544 and thus allows for fluid communication between theneedle 547 and the reconstituted drug. The volume of the closed cavity is designed to ensure the availability of the liquid drug to theneedle 547 under controlled pressurized conditions. The position of thesyringe piston 548 is fixed under pressurized conditions and the dose is manually aspirated from the syringe. - Referring to FIG. 25 an alternate preferred embodiment of the
drug delivery system 540 as described in FIGS. 24A-24C is illustrated. The reconstitution stage is similar to the one described with respect to FIGS. 24A-24C. However, the injector system including an attachable delivery device is different. The user dials or tunes the required dose using apen type pump 560 that includes adial 562 that is inserted into the indicators orscale 712 thereon. Theball 714 is enclosed within a clear casing 712A. The positioning of theball 714 in the middle of the scale is an indication of vertical orientation. In thesecond embodiment 713 of the vertical indicator, anair bubble 716 disposed in a liquid 718 enclosed within a clear housing 718A is used as the visual, indicator of orientation with respect to thescale 719. The positioning of theair bubble 716 in the middle of the scale is an indication of vertical orientation. - Referring to FIGS.32A-32E, perspective views illustrate a further alternate embodiment of the
drug delivery system 720 in particular a reconstitution and injection system, in accordance with the present invention. In this embodiment the reconstitution of the drug occurs by the mixing of the diluent solution with the drug. A separate pressurization system for the diluent is not required for this particular embodiment and can only be used with low viscosity drugs. In use, theknob 730 is moved in a counter clockwise direction to begin the reconstitution process of the drug which opens a pathway connecting the diluent with the drug. Theknob 730 is turned from a non-use position (as indicated when notches A and B align) to a ready to use position as indicated with the alignment of notches B and C. At this point, theknob 730 may be depressed and the solution injected. The internal pressure of the diluent vial and gravity cause the diluent to transfer to the vial containing the drug. Further movement of the knob or dial 730 activates an injection needle which interfaces with the user's tissue to deliver the reconstituted drug. Again, the injection assembly is similar to the embodiments shown in FIGS. 11, 13-17. - Referring to FIGS.33A-33I, cutaway views of preferred embodiments of the drug delivery system emphasizing the interlocks disposed to provide for a safe system are illustrated. Referring in particular to FIG. 33A and 33B, the interlocks as required during shelf life of the
drug delivery device 750 are illustrated. The end of thecylinder 752 has a biasinglip 766 extending outward to matingly fit withwall 758 and the lip must be flexible enough to bend with the pressure ofwall 758 when vials are inserted in the assembly. During shelf life thecylinder 752 is secured bylatch 754 andmating lip 756. This mating fit prevents the movement of themovable cylinder 752 in the vertical direction prior to use. As previously described, thecylinder 752 provides pressurized air to thedrug delivery system 750. The movement in the downward direction of thecylinder 752 is minimized or preferably prevented by holding thelatches wall 758. An upward movement of thecylinder 752 is prevented bylatch 754. - Referring to FIG. 33C, the next step includes the insertion of the
vials device 750. Only after the insertion of bothvials cylinder 752 free to be pushed in the vertical direction. The insertion of the vials forces thelip 766 inward enabling it to clear thewall 758 and thus enable thecylinder 752 to move downward. In addition, thelatches 754 secure the vials in thedevice 750. - Referring to FIGS. 33D and 33E, the interlocks that play a role once the
cylinder 752 is pushed as illustrated. Thecylinder 752 is pushed downward until the end of travel position and is locked by the mating oflip 766 andinterlock element 768. Again, as described above with regard to pre-use, thelip 766 moves downward and catches onelement 768 and moves to a radially expanded position which prevents the cylinder from travelling upward again. A lockingelement 768 keeps the cylinder in the bottomed out position. Theelement 768 is formed as a part of thewall 758. - In the area where the drug solution is injected there is a pushing member that moves in a relative perpendicular fashion to the direction of travel by the cylinder. A
ball 772 is positioned prior to use within the housing to prevent depression of themember 776. When the cylinder is fully depressed, thelip 766, pushes amember 770 which allows theball 772 to drop into agroove 774 making the movement of the pushingmember 776 possible only if the device is in a vertical orientation. - Referring to FIGS. 33F and 33G, during the injection process different interlock elements insure the safe use of the drug delivery system. As the pushing
member 776 is depressed, which is only allowed if thedrug delivery system 750 is in a vertical orientation, thehorns 778 spread thelatch 780 which allows themember 770 to press theball 772 in the upward direction. Note the pushingmember 776 is already pushed to expose theneedle 782. - Referring to FIGS. 33H and 33I, the interlocks during the phase of disposing of the drug delivery device which follows the injection phase are illustrated. The pushing
member 776 is released by the action of thespring 777 pushing themember 776. Since the movement of theball 772 was limited by the body of themember 776, with the release of themember 776, theball 772 can now move back into thegroove 774 as it is assisted by the pressure applied by therear shell latch 780. This locks the pushingmember 776 into position thereby preventing further use of thedrug delivery device 750. - Referring to FIGS. 34A through 34D, a preferred embodiment of the drug delivery device having an end of delivery indicator is illustrated. As discussed previously with respect to preferred embodiments of the drug delivery system of the present invention, the drug delivery system is activated by pressurized gas, for example, air. The air forces the drug to the injection site by pressurizing the drug. A hydrophillic membrane minimizes and preferably prevents the passage of air into the user's body. The hydrophillic membrane is disposed in the drug path to the user's tissue. Once wetted, the hydrophillic membrane allows liquid drug to proceed into the user's tissue and stops the passage of air into the user's tissue. In order to insure the effectiveness of the membrane, the hydrophillic membrane has to become wetted. To enhance the effectivity of the drug delivery device, a Hydrophobic membrane is also positioned in the drug path. Referring to the FIGS. 34A and 34B, an
inlet 800 which provides theliquid drug 802 into acavity 803 has both ahydrophobic membrane 806 and ahydrophillic membrane 810 disposed therein. Thehydrophobic membrane 806 allows air to pass, but stops liquids. On the other side of thecavity 803 thehydrophillic membrane 810 allows liquid drug to pass while stopping the flow of gas. At one end of the hydrophobic membrane 806 a flexible elastomeric diaphragm is disposed that acts as an indicator once filled with gas, for example, air. The membrane being flexible, once filled with air gives an external indication for end of delivery. The presence of air occurs only once the liquid drug has been delivered. It should be noted that thehydrophillic membrane 810 is disposed close to the injection site as it allows liquid to go through to the injection site minimizing or preventing the flow of gas into the user's tissue. FIG. 34D illustrates a manifold structure utilizing the end ofdelivery indicator 804 built into the manifold. Theseptum 814 surrounds a cavity containing the liquid drug. Thespikes - FIG. 35 graphically illustrates the delivery profile from a high volume vial having no additional air pressure in the vial. The profile illustrates pressure (in millibars) versus time (in seconds). The initial pressure in the vial is in the order of about 300 millibars which decreases during the delivery process to approximately 0 millibars at the end of delivery process. This is in contrast to the pressure in a vial that initially contained approximately 3 milliliters of air as illustrated with respect to FIG. 33. As a result, there is no residual air pressure in the vial once delivery is complete. The delivery process spanned a time period of approximately 86.4 seconds.
- FIG. 36 graphically illustrates delivery duration and delivery pressure with respect to an air volume in a vial. Three different profiles are illustrated with a
first one 830 which is indicative of the pressure (in millibars) before delivery, asecond profile 832 indicative of the residual pressure of the delivery and athird profile 834 which is indicative of delivering 0.95 ml of a liquid drug over a time span of about 8 seconds. - FIG. 37 is a graphical illustration of the delivery parameters for an injection of a liquid drug having no additional air in the vial. As delivery of the drug occurs, the pressurization within the liquid vial decreases over the approximately 17 seconds of delivery. These curves illustrate test results of the delivery process of approximately 1 gram of liquid drug using a single drug delivery device for the same time period.
- FIG. 38 illustrates test results showing the air pressure gradient on hydrophilic membranes used to minimize or preferably prevent the entry of gas for example, air into the user's tissue. The test results prove membrane safety to insure that the membrane can withstand the pressures in the order of 2,700 millibars for a time duration of about six minutes.
- FIG. 39 graphically illustrates the performance of a drug delivery device in accordance with the present invention. Three
delivery profiles - FIG. 40 is a flow chart that describes the methods for delivery of a lyophilized drug in accordance with the present invention. The methods include the
step 899 of inserting the drug and diluent containers into the drug delivery device. Further perstep 900, the method includes activating a pressurized air source which in turn is followed by thestep 902 of pressurizing a diluent solution in a diluent vial. As discussed with respect to FIGS. 19A-19F, the pressurizing can be provided by subsystems which include but are not limited to a compressed air supply, a chemical gas generator, a collapsible volume air supply, a standard syringe or cylinder. - The methods further include the
step 904 of delivering the pressurized diluent solution to the lyophilized drug vial. The lyophilized drug is reconstituted perstep 906 as a result of the mixing of the diluent with the lyophilized drug. The methods further include thestep 908 of providing the liquid drug to an injector system or transferring the liquid drug to a detachable delivery device. The liquid drug is then injected into a user's tissue perstep 910. The injection needle is then moved to a safe storage position perstep 912. - FIG. 41 is a flow chart that describes the methods for delivering a liquid medicament in accordance with the present invention. The methods include the
step 913 of inserting a drug container such as a vial into the drug delivery system. Further, perstep 914 the method includes activating a pressurized air source for low viscosity drugs. It should be noted that for drugs with a high level of viscosity no pressurization may be required. The method then includes thestep 916 of pressurizing the standard drug vial. The pressurized liquid drug is transferred to a drug delivery system such as an injector system, or detachable delivery devices perstep 918. The liquid drug is then injected into the tissue of a user perstep 920. The method further includes thestep 922 of retracting the injector into a safe storage position. - It is further appreciated that the present invention may be used to deliver a number of drugs. The term “drug” used herein includes but is not limited to peptides or proteins (and mimetic thereof), antigens, vaccines, hormones, analgesics, anti-migraine agents, anti-coagulant agents, medications directed to the treatment of diseases and conditions of the central nervous system, narcotic antagonists, immunosuppressants, agents used in the treatment of AIDS, chelating agents, anti-anginal agents, chemotherapy agents, sedatives, anti-neoplastics, prostaglandins, antidiuretic agents and DNA or DNA/RNA molecules to support gene therapy.
- Typical drugs include peptides, proteins or hormones (or any mimetic or analogues or any thereof) such as insulin, calcitonin, calcitonin gene regulating protein, atrial natriuretic protein, colony stimulating factor, betaseron, erythropoietin (EPO), interferons such as α, β or γ interferon, somatropin, somatotropin, somastostatin, insulin-like growth factor (somatomedins), luteinizing hormone releasing hormone (LHRH), tissue plasminogen activator (TPA), growth hormone releasing hormone (GHRH), oxytocin, estradiol, growth hormones, leuprolide acetate, factor VIII, interleukins such as interleukin-2, and analogues or antagonists thereof, such as IL-1ra; analgesics such as fentanyl, sufentanil, butorphanol, buprenorphine, levorphanol, morphine, hydromorphone, hydrocodone, oxymorphone, methadone, lidocaine, bupivacaine, diclofenac, naproxen, paverin, and analogues thereof; anti-migraine agents such as sumatriptan, ergot alkaloids, and analogues thereof; anti-coagulant agents such as heparin, hirudin, and analogues thereof; anti-emetic agents such as scopolamine, ondansetron, domperidone, metoclopramide, and analogues thereof; cardiovacular agents, anti-hypertensive agents and vasodilators such as diltiazem, clonidine, nifedipine, verapamil, isosorbide-5-monotritate, organic nitrates, agents used in treatment of heart disorders, and analogues thereof; sedatives such as benzodiazepines, phenothiazines, and analogues thereof; chelating agents such as defroxanune, and analogues thereof; anti-diuretic agents such as desmopressin, vasopressin, and analogues thereof; anti-anginal agents such as fluorouracil, bleomycin, and analogues thereof; anti-neoplastics such as fluorouracil, bleomycin, and analogues thereof; prostaglandins and analogues thereof; and chemotherapy agents such as vincristine, and. analogues thereof, treatments for attention deficit disorder, methylphenidate, fluvoxamine, bisoprolol, tacrolimus, sacrolimus and cyclosporin.
- While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. For example, some of the features of the position independence can be used in connection with reconstitution combination systems, transfer systems or injection systems. Likewise interlock features may be used with any of the aforementioned systems.
Claims (40)
1. A material mixing device, said device comprising:
a housing;
a first port in said housing that receives a first container having first contents therein;
a second port in said housing that receives a second container that contains second contents to be mixed with said first contents to form a material;
a first passageway in said housing for placing said first port and said second port into fluid communication with each other, said passageway comprising a first end having a first needle and a second end having a second needle, said first needle penetrating said first container and said second container penetrating said second container; and
a movable seal in said second container that is displaced during insertion into said second port to expel said second contents under pressure through said passageway and into said second container.
2. The device of claim 1 wherein said first contents is a lyophilized drug and said second contents is a diluent.
3. The device of claim 2 wherein said housing comprises interlock means to prevent said second container from being engaged into said second port before said first container is inserted into said first port.
4. The device of claim 3 wherein first and second ports are adjacent each other in said housing and wherein said interlock means comprises a pivoting bar that blocks said first port whenever said second port is vacant and which pivots out of said second port whenever said first container is engaged with said first port.
5. The device of claim 1 wherein said first port and said second port are on opposite sides of said housing.
6. The device of claim 1 wherein said second container also comprises a controlled volume of gas.
7. The device of claim 6 wherein said gas is air.
8. The device of claim 6 wherein said device does not need to be shaken to thoroughly mix said first contents and said second contents to form said material.
9. The device of claim 6 further comprising:
a second passageway in said housing in fluid communication with said first passageway for conveying said material from said second container; and
a hydrophillic membrane in said second passageway, said hydrophillic membrane preventing the passage of said controlled volume of air into said second passageway while permitting said material to pass through.
10. The device of claim 6 further comprising:
a second passageway in said housing, parallel with said first passageway, for conveying said material from said second container; and
a hydrophillic membrane in said second passageway, said hydrophillic membrane preventing the passage of said controlled volume of air through said second passageway while permitting said material to pass through.
11. A material mixing device, said device comprising:
a housing;
a first port in said housing that receives a first container having first contents therein;
a second port in said housing for receiving a second compressible container having second contents therein;
a first passageway in said housing for placing said first port and said second port into fluid communication with each other; and
means for compressing said second compressible container to drive out said second contents into said first container to form said material.
12. The device of claim 11 wherein said passageway comprises a first end having a first needle and a second end having a second needle, said first needle penetrating said first container and said second needle penetrating said second compressible container.
13. The device of claim 11 wherein said second compressible container comprises a flexible bag and wherein said means for compressing comprises a pair of rotating drums between which said flexible bag passes.
14. The device of claim 11 wherein said first contents comprises a lyophilized drug and wherein said second contents comprises a diluent.
15. The device of claim 13 wherein said rotating drums are operated by a rack and pinion mechanism.
16. A container pressurization device, said device comprising:
a housing;
a port in said housing for receiving a container of a liquid; gas storage means;
a passageway for coupling said gas storage means in fluid communication with said container when said container is engaged with said port; and
activating said gas storage means to introduce a gas into said container through said passageway to pressurize the liquid contained therein.
17. The device of claim 16 wherein said gas storage means comprises a bellows that forces air into said container.
18. The device of claim 17 wherein movement of said container within said port compresses said bellows to force air into said container.
19. The device of claim 17 wherein said passageway comprises a needle.
20. The device of claim 18 wherein said passageway comprises a needle.
21. The device of claim 19 wherein said liquid comprises a reconstituted drug for injection.
22. The device of claim 20 wherein said liquid comprises a reconstituted drug for injection.
23. A material mixing device, said device comprising:
a housing;
a first port in said housing that receives a first container having first contents therein;
a second port in said housing that receives a second container that contains second contents to be mixed with said first contents to form a material;
a first passageway in said housing for placing said first port and said second port into fluid communication with each other, said passageway comprising a first end having a first needle and a second end having a second needle, said first needle penetrating said first container and said second needle penetrating said second container;
a second passageway for coupling a pressure source in fluid communication with said first contents; and
a third passageway for conveying said material out of said housing.
24. The device of claim 23 wherein said pressure source is a bellows.
25. The device of claim 23 wherein said pressure source is a syringe.
26. The device of claim 23 wherein said pressure source is a cylinder.
27. The device of claim 23 wherein said pressure source is a compressed air canister.
28. The device of claim 23 wherein said pressure source is a chemical gas generator.
29. The device of claim 23 further comprising a hydrophillic membrane in said third passageway, said hydrophillic membrane preventing the passage of said gas through said third passageway while permitting said material to pass through.
30. The device of claim 23 wherein said first contents is a diluent.
31. The device of claim 23 wherein said second content is a lyophilized drug.
32. The device of claim 23 wherein said second needle is vertically-positioned and is adjustable in height.
33. The device of claim 23 wherein said third passageway comprises a cavity and piston, said cavity including indicia thereon so that a user can operate said piston to withdraw a desired amount of said material.
34. The device of claim 26 wherein said housing comprises interlock means to prevent said cylinder from being activated until both said first container and said second container are engaged with said first and second ports, respectively.
35. The device of claim 34 wherein said interlock means comprises a lip at a piston end of said cylinder that is prevented from moving by an edge in a flexible wall that receives said cylinder, said flexible wall being deflected by the entry of said first and second containers into said respective first and second ports to disengage said lip from said edge.
36. The device of claim 26 wherein said housing comprises interlock means to prevent said cylinder from re-pressurizing once said gas is injected.
37. The device of claim 36 wherein said interlock means comprises a lip at a piston end of said cylinder that is trapped under a locking element at a completion end of the cylinder stroke which injects said gas.
38. A material mixing device, said device comprising:
a housing;
a first port in said housing that receives a first container having first contents therein;
a second port in said housing that receives a second container that contains second contents to be mixed with said first contents to form a material;
a third port in said housing that receives an air pressurization system;
a first passageway in said housing for placing said first port and said second port into fluid communication with each other, said first passageway comprising a first end having a first needle and a second end having a second needle, said first needle penetrating said first container and said second needle penetrating said second container; and
a second passageway for coupling said air pressurization in fluid communication with said first contents for forming said material under pressure.
39. The device of claim 38 wherein said material comprises a low viscosity drug.
40. A material mixing device, said device comprising:
a housing;
a first port in said housing that receives a first container having first contents therein;
a second port in said housing that receives a second container that contains second contents to be mixed with said first contents to form a material;
a passageway in said housing that can be manually switched for placing said first port and said second port into fluid communication with each other, said passageway comprising a first end having a first needle and a second end having a second needle, said first needle penetrating said first container and said second container penetrating said second container; and
a movable seal in said second container that is displaced during insertion into said second port to expel said second contents under pressure through said passageway and into said second container.
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Cited By (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20040006316A1 (en) * | 2002-07-02 | 2004-01-08 | Patton Catherine C. | Infusion device and method thereof |
WO2004047888A1 (en) * | 2002-11-26 | 2004-06-10 | Disetronic Licensing Ag | Insertion device for needle units |
US20040116847A1 (en) * | 2002-09-12 | 2004-06-17 | Children's Hospital Medical Center | Method and device for painless injection of medication |
EP1495775A1 (en) * | 2003-07-08 | 2005-01-12 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
WO2005002649A1 (en) * | 2003-07-08 | 2005-01-13 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
US20070270768A1 (en) * | 2006-05-17 | 2007-11-22 | Bruno Dacquay | Mechanical Linkage Mechanism For Ophthalmic Injection Device |
US20070276320A1 (en) * | 2004-02-17 | 2007-11-29 | Wall Eric J | Injection Device for Administering a Vaccine |
US20080269668A1 (en) * | 2006-10-27 | 2008-10-30 | Keenan James A | Medical Microbubble Generation |
US20080281292A1 (en) * | 2006-10-16 | 2008-11-13 | Hickingbotham Dyson W | Retractable Injection Port |
WO2008115566A3 (en) * | 2007-03-20 | 2009-12-23 | Peak Biosciences, Inc. | Guidance and implantation of catheters |
US20100233081A1 (en) * | 2007-05-10 | 2010-09-16 | Peak Bioscience, Inc. | Methods for administration of radiotherapeutic agents |
US20100280494A1 (en) * | 2006-08-08 | 2010-11-04 | Matsuura James E | Catheter and array for anticancer therapy |
US7985216B2 (en) | 2004-03-16 | 2011-07-26 | Dali Medical Devices Ltd. | Medicinal container engagement and automatic needle device |
US20120123346A1 (en) * | 2009-06-02 | 2012-05-17 | Sanofi-Aventis Deutschland Gmbh | Medicated module with needle guard |
US8226614B2 (en) | 2005-11-03 | 2012-07-24 | Patton Medical Devices, Lp | Fluid delivery devices, systems and methods |
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US9226875B2 (en) | 2009-06-02 | 2016-01-05 | Yukon Medical, Llc | Multi-container transfer and delivery device |
US20160367746A1 (en) * | 2015-06-19 | 2016-12-22 | Fresenius Medical Care Holdings, Inc. | Non-Vented Vial Drug Delivery |
US9636277B2 (en) | 2010-04-29 | 2017-05-02 | Yukon Medical, Llc | Multi-container fluid transfer and delivery device |
US9925333B2 (en) | 2013-06-18 | 2018-03-27 | Enable Injections, Inc. | Vial transfer and injection apparatus and method |
US10182969B2 (en) | 2015-03-10 | 2019-01-22 | Regeneron Pharmaceuticals, Inc. | Aseptic piercing system and method |
US10660823B2 (en) * | 2016-01-29 | 2020-05-26 | Credence Medsystems, Inc. | System and method for injection component preparation |
US10729842B2 (en) | 2012-09-24 | 2020-08-04 | Enable Injections, Inc. | Medical vial and injector assemblies and methods of use |
US10814062B2 (en) | 2017-08-31 | 2020-10-27 | Becton, Dickinson And Company | Reservoir with low volume sensor |
US11191895B2 (en) * | 2016-06-08 | 2021-12-07 | Shl Medical Ag | Device and system for dispensing a fluid under aseptic conditions |
US20220063847A1 (en) * | 2013-07-03 | 2022-03-03 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US11547801B2 (en) | 2017-05-05 | 2023-01-10 | Regeneron Pharmaceuticals, Inc. | Auto-injector |
US11642283B2 (en) * | 2007-12-31 | 2023-05-09 | Deka Products Limited Partnership | Method for fluid delivery |
US11654221B2 (en) | 2003-11-05 | 2023-05-23 | Baxter International Inc. | Dialysis system having inductive heating |
USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
Families Citing this family (494)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7192450B2 (en) | 2003-05-21 | 2007-03-20 | Dexcom, Inc. | Porous membranes for use with implantable devices |
US6001067A (en) | 1997-03-04 | 1999-12-14 | Shults; Mark C. | Device and method for determining analyte levels |
US20050033132A1 (en) | 1997-03-04 | 2005-02-10 | Shults Mark C. | Analyte measuring device |
US6610042B2 (en) | 1997-12-05 | 2003-08-26 | Felton Medical, Inc. | Disposable unit-dose jet-injection syringe for pre-filled and/or transfilled liquid injectable medical drug or vaccine products and method thereof |
US8346337B2 (en) | 1998-04-30 | 2013-01-01 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
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US8465425B2 (en) | 1998-04-30 | 2013-06-18 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US8480580B2 (en) | 1998-04-30 | 2013-07-09 | Abbott Diabetes Care Inc. | Analyte monitoring device and methods of use |
US6175752B1 (en) | 1998-04-30 | 2001-01-16 | Therasense, Inc. | Analyte monitoring device and methods of use |
US6949816B2 (en) | 2003-04-21 | 2005-09-27 | Motorola, Inc. | Semiconductor component having first surface area for electrically coupling to a semiconductor chip and second surface area for electrically coupling to a substrate, and method of manufacturing same |
US20080102121A1 (en) * | 1998-11-02 | 2008-05-01 | Elan Pharma International Limited | Compositions comprising nanoparticulate meloxicam and controlled release hydrocodone |
US20080113025A1 (en) * | 1998-11-02 | 2008-05-15 | Elan Pharma International Limited | Compositions comprising nanoparticulate naproxen and controlled release hydrocodone |
US7279001B2 (en) * | 1998-11-06 | 2007-10-09 | Neomend, Inc. | Systems, methods, and compositions for achieving closure of vascular puncture sites |
US6719719B2 (en) * | 1998-11-13 | 2004-04-13 | Elan Pharma International Limited | Spike for liquid transfer device, liquid transfer device including spike, and method of transferring liquids using the same |
EP1154691A4 (en) * | 1999-01-05 | 2004-07-07 | Massachusetts Eye & Ear Infirm | Targeted transscleral controlled release drug delivery to the retina and choroid |
US8226598B2 (en) * | 1999-09-24 | 2012-07-24 | Tolmar Therapeutics, Inc. | Coupling syringe system and methods for obtaining a mixed composition |
US20020055708A1 (en) * | 1999-09-24 | 2002-05-09 | Peterson Kenneth R. | Coupling syringe system and methods for obtaining a mixed composition |
US6626870B1 (en) * | 2000-03-27 | 2003-09-30 | Artix Laboratories, Inc. | Stoppering method to maintain sterility |
US6566144B1 (en) | 2000-03-27 | 2003-05-20 | Atrix Laboratories | Cover plate for use in lyophilization |
EP1267961A2 (en) | 2000-03-28 | 2003-01-02 | Elan Pharma International Limited | Device for measuring a volume of drug |
ES2287156T3 (en) | 2000-09-08 | 2007-12-16 | Insulet Corporation | DEVICES AND SYSTEMS FOR THE INFUSION OF A PATIENT. |
WO2002024259A2 (en) * | 2000-09-21 | 2002-03-28 | Elan Pharma International Limited | Reconstitution and injection system |
EP1702635B1 (en) * | 2000-11-09 | 2008-01-16 | Insulet Corporation | Transcutaneous delivery means |
EP2554196B1 (en) | 2000-11-30 | 2018-10-17 | Valeritas, Inc. | Fluid delivery and measurement systems |
US6560471B1 (en) | 2001-01-02 | 2003-05-06 | Therasense, Inc. | Analyte monitoring device and methods of use |
US6644309B2 (en) * | 2001-01-12 | 2003-11-11 | Becton, Dickinson And Company | Medicament respiratory delivery device and method |
US7850663B2 (en) | 2001-01-12 | 2010-12-14 | Becton, Dickinson And Company | Medicament microdevice delivery system, cartridge and method of use |
BR0208068A (en) | 2001-03-13 | 2005-04-19 | Mdc Invest Holdings Inc | Medical device and process for injecting medicine |
MXPA03007940A (en) * | 2001-03-13 | 2004-10-15 | Mdc Invest Holdings Inc | Pre-filled safety vial injector. |
US7041468B2 (en) | 2001-04-02 | 2006-05-09 | Therasense, Inc. | Blood glucose tracking apparatus and methods |
US8034026B2 (en) * | 2001-05-18 | 2011-10-11 | Deka Products Limited Partnership | Infusion pump assembly |
JP4681795B2 (en) | 2001-05-18 | 2011-05-11 | デカ・プロダクツ・リミテッド・パートナーシップ | Fluid pump infusion set |
CA2446882A1 (en) * | 2001-05-22 | 2002-11-28 | Udi Carmel | Mechanism for prevention of premature activation, in particular in drug administration |
US6702857B2 (en) | 2001-07-27 | 2004-03-09 | Dexcom, Inc. | Membrane for use with implantable devices |
US20030032874A1 (en) * | 2001-07-27 | 2003-02-13 | Dexcom, Inc. | Sensor head for use with implantable devices |
WO2003022330A2 (en) * | 2001-09-12 | 2003-03-20 | Becton, Dickinson And Company | Microneedle-based pen device for drug delivery and method for using same |
US8260393B2 (en) | 2003-07-25 | 2012-09-04 | Dexcom, Inc. | Systems and methods for replacing signal data artifacts in a glucose sensor data stream |
US9282925B2 (en) | 2002-02-12 | 2016-03-15 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
US9247901B2 (en) | 2003-08-22 | 2016-02-02 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
US8010174B2 (en) | 2003-08-22 | 2011-08-30 | Dexcom, Inc. | Systems and methods for replacing signal artifacts in a glucose sensor data stream |
WO2003092665A2 (en) * | 2002-05-02 | 2003-11-13 | Massachusetts Eye And Ear Infirmary | Ocular drug delivery systems and use thereof |
US7128727B2 (en) * | 2002-09-30 | 2006-10-31 | Flaherty J Christopher | Components and methods for patient infusion device |
US7544191B2 (en) * | 2002-10-22 | 2009-06-09 | Baxter International Inc. | Formed, filled, sealed solution container, port and method for establishing flow between the container and an administration set |
US7507226B2 (en) * | 2002-10-22 | 2009-03-24 | Baxter International Inc. | Access port with safety tab and fluid container employing same |
US7942861B2 (en) | 2002-10-22 | 2011-05-17 | Baxter International Inc. | Fluid container with access port and safety cap |
US20060264926A1 (en) * | 2002-11-08 | 2006-11-23 | Kochamba Gary S | Cutaneous stabilization by vacuum for delivery of micro-needle array |
US6896666B2 (en) * | 2002-11-08 | 2005-05-24 | Kochamba Family Trust | Cutaneous injection delivery under suction |
WO2004073551A2 (en) * | 2003-02-18 | 2004-09-02 | Massachusetts Eye And Ear Infirmary | Transscleral drug delivery device and related methods |
EP1614403B2 (en) | 2003-03-14 | 2014-06-18 | Depuy Spine, Inc. | Hydraulic device for the injection of bone cement in percutaneous vertebroplasty |
US8066713B2 (en) | 2003-03-31 | 2011-11-29 | Depuy Spine, Inc. | Remotely-activated vertebroplasty injection device |
JP4509100B2 (en) * | 2003-05-08 | 2010-07-21 | ノボ・ノルデイスク・エー/エス | Infusion device attachable to skin with removable needle insertion actuation |
WO2004098683A1 (en) * | 2003-05-08 | 2004-11-18 | Novo Nordisk A/S | Internal needle inserter |
EP1475113A1 (en) * | 2003-05-08 | 2004-11-10 | Novo Nordisk A/S | External needle inserter |
US7875293B2 (en) * | 2003-05-21 | 2011-01-25 | Dexcom, Inc. | Biointerface membranes incorporating bioactive agents |
US6948522B2 (en) | 2003-06-06 | 2005-09-27 | Baxter International Inc. | Reconstitution device and method of use |
DE10326306B4 (en) * | 2003-06-11 | 2010-09-23 | Henke-Sass Wolf Gmbh | Syringe, in particular for veterinary applications |
US8415407B2 (en) | 2004-03-21 | 2013-04-09 | Depuy Spine, Inc. | Methods, materials, and apparatus for treating bone and other tissue |
WO2006011152A2 (en) | 2004-06-17 | 2006-02-02 | Disc-O-Tech Medical Technologies, Ltd. | Methods for treating bone and other tissue |
US8282549B2 (en) | 2003-12-09 | 2012-10-09 | Dexcom, Inc. | Signal processing for continuous analyte sensor |
US7761130B2 (en) | 2003-07-25 | 2010-07-20 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
US8423113B2 (en) | 2003-07-25 | 2013-04-16 | Dexcom, Inc. | Systems and methods for processing sensor data |
US8761856B2 (en) | 2003-08-01 | 2014-06-24 | Dexcom, Inc. | System and methods for processing analyte sensor data |
US7591801B2 (en) | 2004-02-26 | 2009-09-22 | Dexcom, Inc. | Integrated delivery device for continuous glucose sensor |
US7925321B2 (en) | 2003-08-01 | 2011-04-12 | Dexcom, Inc. | System and methods for processing analyte sensor data |
US8060173B2 (en) | 2003-08-01 | 2011-11-15 | Dexcom, Inc. | System and methods for processing analyte sensor data |
US8886273B2 (en) | 2003-08-01 | 2014-11-11 | Dexcom, Inc. | Analyte sensor |
US8369919B2 (en) | 2003-08-01 | 2013-02-05 | Dexcom, Inc. | Systems and methods for processing sensor data |
US7774145B2 (en) | 2003-08-01 | 2010-08-10 | Dexcom, Inc. | Transcutaneous analyte sensor |
US20190357827A1 (en) | 2003-08-01 | 2019-11-28 | Dexcom, Inc. | Analyte sensor |
EP1502613A1 (en) * | 2003-08-01 | 2005-02-02 | Novo Nordisk A/S | Needle device with retraction means |
US8845536B2 (en) | 2003-08-01 | 2014-09-30 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8160669B2 (en) | 2003-08-01 | 2012-04-17 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8275437B2 (en) | 2003-08-01 | 2012-09-25 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8676287B2 (en) | 2003-08-01 | 2014-03-18 | Dexcom, Inc. | System and methods for processing analyte sensor data |
US9135402B2 (en) | 2007-12-17 | 2015-09-15 | Dexcom, Inc. | Systems and methods for processing sensor data |
US7920906B2 (en) | 2005-03-10 | 2011-04-05 | Dexcom, Inc. | System and methods for processing analyte sensor data for sensor calibration |
US8233959B2 (en) | 2003-08-22 | 2012-07-31 | Dexcom, Inc. | Systems and methods for processing analyte sensor data |
US20140121989A1 (en) | 2003-08-22 | 2014-05-01 | Dexcom, Inc. | Systems and methods for processing analyte sensor data |
IL157981A (en) | 2003-09-17 | 2014-01-30 | Elcam Medical Agricultural Cooperative Ass Ltd | Auto-injector |
IL157984A (en) | 2003-09-17 | 2015-02-26 | Dali Medical Devices Ltd | Autoneedle |
US8579908B2 (en) | 2003-09-26 | 2013-11-12 | DePuy Synthes Products, LLC. | Device for delivering viscous material |
KR20060099520A (en) * | 2003-10-21 | 2006-09-19 | 노보 노르디스크 에이/에스 | Medical skin mountable device |
EP1527792A1 (en) * | 2003-10-27 | 2005-05-04 | Novo Nordisk A/S | Medical injection device mountable to the skin |
ATE446111T1 (en) * | 2003-10-21 | 2009-11-15 | Novo Nordisk As | INTERNAL FLUID CONNECTOR FOR PRODUCING A FLUID CONNECTION |
PL1682203T3 (en) | 2003-10-23 | 2010-06-30 | Novo Nordisk As | Medical injection device mountable to the skin |
US20050090607A1 (en) * | 2003-10-28 | 2005-04-28 | Dexcom, Inc. | Silicone composition for biocompatible membrane |
US8158102B2 (en) * | 2003-10-30 | 2012-04-17 | Deka Products Limited Partnership | System, device, and method for mixing a substance with a liquid |
ES2739529T3 (en) * | 2003-11-06 | 2020-01-31 | Lifescan Inc | Drug administration pen with event notification means |
WO2005051170A2 (en) | 2003-11-19 | 2005-06-09 | Dexcom, Inc. | Integrated receiver for continuous analyte sensor |
US9247900B2 (en) | 2004-07-13 | 2016-02-02 | Dexcom, Inc. | Analyte sensor |
US11633133B2 (en) | 2003-12-05 | 2023-04-25 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
DE602004029092D1 (en) | 2003-12-05 | 2010-10-21 | Dexcom Inc | CALIBRATION METHODS FOR A CONTINUOUSLY WORKING ANALYTIC SENSOR |
US8423114B2 (en) | 2006-10-04 | 2013-04-16 | Dexcom, Inc. | Dual electrode system for a continuous analyte sensor |
US8364231B2 (en) | 2006-10-04 | 2013-01-29 | Dexcom, Inc. | Analyte sensor |
US8532730B2 (en) | 2006-10-04 | 2013-09-10 | Dexcom, Inc. | Analyte sensor |
US20050132466A1 (en) * | 2003-12-11 | 2005-06-23 | Kimberly-Clark Worldwide, Inc. | Elastomeric glove coating |
US20050127552A1 (en) | 2003-12-11 | 2005-06-16 | Kimberly-Clark Worldwide, Inc. | Method for forming an elastomeric article |
US8808228B2 (en) | 2004-02-26 | 2014-08-19 | Dexcom, Inc. | Integrated medicament delivery device for use with continuous analyte sensor |
EP1727577A1 (en) | 2004-03-26 | 2006-12-06 | Unomedical A/S | Injector device for infusion set |
WO2005094920A1 (en) * | 2004-03-30 | 2005-10-13 | Novo Nordisk A/S | Actuator system comprising lever mechanism |
CA2559750C (en) | 2004-03-31 | 2014-01-07 | Eli Lilly And Company | Injection apparatus having a needle cassette for delivering a pharmaceutical liquid |
US20050277883A1 (en) * | 2004-05-26 | 2005-12-15 | Kriesel Marshall S | Fluid delivery device |
GB2414400B (en) | 2004-05-28 | 2009-01-14 | Cilag Ag Int | Injection device |
GB2414409B (en) | 2004-05-28 | 2009-11-18 | Cilag Ag Int | Injection device |
GB2414402B (en) | 2004-05-28 | 2009-04-22 | Cilag Ag Int | Injection device |
GB2414405B (en) | 2004-05-28 | 2009-01-14 | Cilag Ag Int | Injection device |
GB2414401B (en) | 2004-05-28 | 2009-06-17 | Cilag Ag Int | Injection device |
GB2414399B (en) | 2004-05-28 | 2008-12-31 | Cilag Ag Int | Injection device |
GB2414406B (en) | 2004-05-28 | 2009-03-18 | Cilag Ag Int | Injection device |
GB2414775B (en) | 2004-05-28 | 2008-05-21 | Cilag Ag Int | Releasable coupling and injection device |
GB2414404B (en) | 2004-05-28 | 2009-06-03 | Cilag Ag Int | Injection device |
GB2414403B (en) | 2004-05-28 | 2009-01-07 | Cilag Ag Int | Injection device |
PL1750862T3 (en) | 2004-06-04 | 2011-06-30 | Teva Pharma | Pharmaceutical composition containing irbesartan |
US7294119B2 (en) * | 2004-06-10 | 2007-11-13 | Safety Syringes, Inc. | Passive delivery system diluents mixing and delivery |
GB0414054D0 (en) | 2004-06-23 | 2004-07-28 | Owen Mumford Ltd | Improvements relating to automatic injection devices |
US7783333B2 (en) | 2004-07-13 | 2010-08-24 | Dexcom, Inc. | Transcutaneous medical device with variable stiffness |
WO2006127694A2 (en) | 2004-07-13 | 2006-11-30 | Dexcom, Inc. | Analyte sensor |
US7946984B2 (en) * | 2004-07-13 | 2011-05-24 | Dexcom, Inc. | Transcutaneous analyte sensor |
US20060016700A1 (en) * | 2004-07-13 | 2006-01-26 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8565848B2 (en) | 2004-07-13 | 2013-10-22 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8452368B2 (en) | 2004-07-13 | 2013-05-28 | Dexcom, Inc. | Transcutaneous analyte sensor |
US8886272B2 (en) | 2004-07-13 | 2014-11-11 | Dexcom, Inc. | Analyte sensor |
KR100810158B1 (en) * | 2004-07-27 | 2008-03-07 | 일라이 릴리 앤드 캄파니 | A cartridge for use in a medication dispensing device |
US8062250B2 (en) | 2004-08-10 | 2011-11-22 | Unomedical A/S | Cannula device |
PL1838367T3 (en) * | 2004-09-02 | 2019-04-30 | Sanofi Aventis Deutschland | Method of assembly of drug delivery devices |
ES2906559T3 (en) | 2004-09-10 | 2022-04-19 | Becton Dickinson Co | Patch type infusion device |
WO2006032692A1 (en) | 2004-09-22 | 2006-03-30 | Novo Nordisk A/S | Medical device with cannula inserter |
WO2006032689A1 (en) * | 2004-09-22 | 2006-03-30 | Novo Nordisk A/S | Medical device with transcutaneous cannula device |
US20060106117A1 (en) * | 2004-11-12 | 2006-05-18 | Kimberly-Clark Worldwide, Inc. | Compound and method for prevention and/or treatment of vaginal infections |
US7619008B2 (en) * | 2004-11-12 | 2009-11-17 | Kimberly-Clark Worldwide, Inc. | Xylitol for treatment of vaginal infections |
JP4960252B2 (en) | 2004-11-22 | 2012-06-27 | インテリジェクト,インコーポレイテッド | Device, system and method for drug delivery |
US7648482B2 (en) | 2004-11-22 | 2010-01-19 | Intelliject, Inc. | Devices, systems, and methods for medicament delivery |
US10737028B2 (en) | 2004-11-22 | 2020-08-11 | Kaleo, Inc. | Devices, systems and methods for medicament delivery |
US7648483B2 (en) | 2004-11-22 | 2010-01-19 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US11590286B2 (en) | 2004-11-22 | 2023-02-28 | Kaleo, Inc. | Devices, systems and methods for medicament delivery |
US7947017B2 (en) | 2004-11-22 | 2011-05-24 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
EP1824536B1 (en) | 2004-12-06 | 2009-08-26 | Novo Nordisk A/S | Ventilated skin mountable device |
US20090076451A1 (en) | 2005-01-24 | 2009-03-19 | Nova Nordisk A/S | Medical Device with Protected Transcutaneous Device |
US7731686B2 (en) | 2005-02-01 | 2010-06-08 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
US8231573B2 (en) | 2005-02-01 | 2012-07-31 | Intelliject, Inc. | Medicament delivery device having an electronic circuit system |
US8361026B2 (en) | 2005-02-01 | 2013-01-29 | Intelliject, Inc. | Apparatus and methods for self-administration of vaccines and other medicaments |
US8206360B2 (en) | 2005-02-01 | 2012-06-26 | Intelliject, Inc. | Devices, systems and methods for medicament delivery |
ES2396745T3 (en) | 2005-02-01 | 2013-02-25 | Intelliject, Inc. | Devices for medication administration |
US9022980B2 (en) | 2005-02-01 | 2015-05-05 | Kaleo, Inc. | Medical injector simulation device |
US20060184103A1 (en) * | 2005-02-17 | 2006-08-17 | West Pharmaceutical Services, Inc. | Syringe safety device |
US7766900B2 (en) * | 2005-02-21 | 2010-08-03 | Biomet Manufacturing Corp. | Method and apparatus for application of a fluid |
US20080188810A1 (en) * | 2005-02-25 | 2008-08-07 | Novo Nordisk A/S | Pump Assembly With Safety Valve |
EP1855651A4 (en) * | 2005-03-03 | 2011-06-15 | Elan Pharma Int Ltd | Nanoparticulate compositions of heterocyclic amide derivatives |
US7985199B2 (en) | 2005-03-17 | 2011-07-26 | Unomedical A/S | Gateway system |
US20060223765A1 (en) * | 2005-03-30 | 2006-10-05 | Kimberly-Clark Worldwide, Inc. | Method for inhibiting and/or treating vaginal infection |
GB2425062B (en) | 2005-04-06 | 2010-07-21 | Cilag Ag Int | Injection device |
GB2424837B (en) * | 2005-04-06 | 2010-10-06 | Cilag Ag Int | Injection device |
GB2424838B (en) | 2005-04-06 | 2011-02-23 | Cilag Ag Int | Injection device (adaptable drive) |
GB2424835B (en) | 2005-04-06 | 2010-06-09 | Cilag Ag Int | Injection device (modified trigger) |
GB2427826B (en) | 2005-04-06 | 2010-08-25 | Cilag Ag Int | Injection device comprising a locking mechanism associated with integrally formed biasing means |
GB2424836B (en) | 2005-04-06 | 2010-09-22 | Cilag Ag Int | Injection device (bayonet cap removal) |
US7645264B2 (en) | 2005-04-11 | 2010-01-12 | Becton, Dickinson And Company | Injection device with secondary reservoir |
EP1877116A1 (en) | 2005-04-13 | 2008-01-16 | Novo Nordisk A/S | Medical skin mountable device and system |
EP1874238A2 (en) * | 2005-04-29 | 2008-01-09 | Wyeth | Drug delivery devices and related components, systems and methods |
US7905868B2 (en) | 2006-08-23 | 2011-03-15 | Medtronic Minimed, Inc. | Infusion medium delivery device and method with drive device for driving plunger in reservoir |
US8137314B2 (en) * | 2006-08-23 | 2012-03-20 | Medtronic Minimed, Inc. | Infusion medium delivery device and method with compressible or curved reservoir or conduit |
US8512288B2 (en) | 2006-08-23 | 2013-08-20 | Medtronic Minimed, Inc. | Infusion medium delivery device and method with drive device for driving plunger in reservoir |
US20080097291A1 (en) * | 2006-08-23 | 2008-04-24 | Hanson Ian B | Infusion pumps and methods and delivery devices and methods with same |
US8840586B2 (en) | 2006-08-23 | 2014-09-23 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir filling and infusion medium delivery |
US9233203B2 (en) | 2005-05-06 | 2016-01-12 | Medtronic Minimed, Inc. | Medical needles for damping motion |
US8277415B2 (en) * | 2006-08-23 | 2012-10-02 | Medtronic Minimed, Inc. | Infusion medium delivery device and method with drive device for driving plunger in reservoir |
WO2006132752A1 (en) * | 2005-05-10 | 2006-12-14 | Elan Pharma International Limited | Nanoparticulate and controlled release compositions comprising vitamin k2 |
JP2008540546A (en) * | 2005-05-10 | 2008-11-20 | エラン ファーマ インターナショナル リミテッド | Nanoparticulate clopidogrel formulation |
WO2006120253A2 (en) * | 2005-05-13 | 2006-11-16 | Novo Nordisk A/S | Medical device adapted to detect disengagement of a transcutaneous device |
US20100028439A1 (en) * | 2005-05-23 | 2010-02-04 | Elan Pharma International Limited | Nanoparticulate stabilized anti-hypertensive compositions |
US20060275372A1 (en) * | 2005-06-03 | 2006-12-07 | Elan Pharma International Limited | Nanoparticulate imatinib mesylate formulations |
US20070042049A1 (en) * | 2005-06-03 | 2007-02-22 | Elan Pharma International, Limited | Nanoparticulate benidipine compositions |
WO2007053197A2 (en) * | 2005-06-03 | 2007-05-10 | Elan Pharma International, Limited | Nanoparticulate acetaminophen formulations |
DE112006001606T5 (en) | 2005-06-08 | 2009-07-09 | Elan Pharma International Ltd., Athlone | Nanoparticulate and controlled release composition comprising cefditoren |
ATE446742T1 (en) * | 2005-06-09 | 2009-11-15 | Elan Pharma Int Ltd | NANOPARTICULAR EBASTIN FORMULATIONS |
KR20080016952A (en) * | 2005-06-13 | 2008-02-22 | 엘란 파마 인터내셔널 리미티드 | Nanoparticulate clopidogrel and aspirin combination formulations |
CA2612384A1 (en) * | 2005-06-15 | 2006-12-28 | Elan Pharma International, Limited | Nanoparticulate azelnidipine formulations |
EP1904041A2 (en) * | 2005-07-07 | 2008-04-02 | Elan Pharma International Limited | Nanoparticulate clarithromycin formulations |
US7786176B2 (en) | 2005-07-29 | 2010-08-31 | Kimberly-Clark Worldwide, Inc. | Vaginal treatment composition containing xylitol |
US9381024B2 (en) | 2005-07-31 | 2016-07-05 | DePuy Synthes Products, Inc. | Marked tools |
US9918767B2 (en) | 2005-08-01 | 2018-03-20 | DePuy Synthes Products, Inc. | Temperature control system |
US20070060887A1 (en) * | 2005-08-22 | 2007-03-15 | Marsh David A | Ophthalmic injector |
DE602005018480D1 (en) | 2005-08-30 | 2010-02-04 | Cilag Gmbh Int | Needle device for a prefilled syringe |
DE602005023458D1 (en) | 2005-09-12 | 2010-10-21 | Unomedical As | A delivery system for an infusion set having first and second spring units |
WO2007033239A2 (en) * | 2005-09-13 | 2007-03-22 | Elan Pharma International, Limited | Nanoparticulate tadalafil formulations |
CN101262897A (en) * | 2005-09-13 | 2008-09-10 | 诺沃-诺迪斯克有限公司 | Reservoir device with inspection aid for detection of drug condition |
EP2279727A3 (en) | 2005-09-15 | 2011-10-05 | Elan Pharma International Limited | Nanoparticulate aripiprazole formulations |
US20110098656A1 (en) * | 2005-09-27 | 2011-04-28 | Burnell Rosie L | Auto-injection device with needle protecting cap having outer and inner sleeves |
ITMI20051826A1 (en) * | 2005-09-29 | 2007-03-30 | Novachem S A | KIT FOR THE PARENTERAL ADMINISTRATION OF MEDICATIONS |
WO2007045644A1 (en) | 2005-10-17 | 2007-04-26 | Novo Nordisk A/S | Vented drug reservoir unit |
US8360629B2 (en) | 2005-11-22 | 2013-01-29 | Depuy Spine, Inc. | Mixing apparatus having central and planetary mixing elements |
EP1954336A4 (en) * | 2005-11-29 | 2012-05-09 | Biodesign Res & Dev | Electrostatic transcutaneous hypodermic spray (electrostatic hypospray) |
EP1960018A1 (en) * | 2005-12-08 | 2008-08-27 | Novo Nordisk A/S | Medical system comprising a sensor device |
WO2007075839A2 (en) * | 2005-12-19 | 2007-07-05 | Diobex, Inc. | Glucagon injector for emergency treatment of hypoglycemia |
WO2007075677A2 (en) * | 2005-12-20 | 2007-07-05 | Antares Pharma, Inc. | Needle-free injection device |
RU2419459C2 (en) | 2005-12-23 | 2011-05-27 | Уномедикал А/С | Drug introduction device |
US9839743B2 (en) * | 2006-02-09 | 2017-12-12 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
DE602007013723D1 (en) | 2006-02-09 | 2011-05-19 | Deka Products Lp | SYSTEMS FOR DISPENSING FLUIDS IN PATCH SIZE |
US11364335B2 (en) | 2006-02-09 | 2022-06-21 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
KR20080104342A (en) | 2006-02-28 | 2008-12-02 | 우노메디컬 에이/에스 | Inserter for infusion part and infusion part provided with needle protector |
WO2007101798A2 (en) * | 2006-03-07 | 2007-09-13 | Novo Nordisk A/S | A drug storage and delivery device |
CN101401313B (en) | 2006-03-13 | 2014-06-11 | 诺沃—诺迪斯克有限公司 | Secure pairing of electronic devices using dual means of communication |
US20090292239A1 (en) * | 2006-04-06 | 2009-11-26 | Novo Nordisk A/S | Injector System for Needleless, High Pressure Delivery of a Medicament |
US8399012B2 (en) | 2006-04-17 | 2013-03-19 | Kimberly-Clark Worldwide, Inc. | Degradable therapeutic delivery device |
JP5062639B2 (en) | 2006-04-24 | 2012-10-31 | ノボ ノルディスク ヘルス ケア アーゲー | Transfer system for forming a drug solution from a lyophilized drug |
US20090275895A1 (en) * | 2006-04-24 | 2009-11-05 | Novo Nordisk A/S | Drug Delivery Device for Infusion of Several Portions of Drug |
EP2012852A1 (en) * | 2006-04-26 | 2009-01-14 | Novo Nordisk A/S | Skin-mountable device in packaging comprising coated seal member |
CN101437559B (en) * | 2006-05-04 | 2011-12-14 | 皇家飞利浦电子股份有限公司 | Medical injector |
US8703179B2 (en) * | 2006-05-11 | 2014-04-22 | Kimberly-Clark Worldwide, Inc. | Mucosal formulation |
US20070270744A1 (en) * | 2006-05-17 | 2007-11-22 | Bruno Dacquay | Limited Reuse Assembly For Ophthalmic Injection Device |
US7887521B2 (en) * | 2006-05-17 | 2011-02-15 | Alcon Research, Ltd. | Ophthalmic injection system |
US7811252B2 (en) * | 2006-05-17 | 2010-10-12 | Alcon Research, Ltd. | Dosage control device |
US20070268340A1 (en) * | 2006-05-17 | 2007-11-22 | Bruno Dacquay | Ophthalmic Injection System and Method Using Piezoelectric Array |
US20070270750A1 (en) * | 2006-05-17 | 2007-11-22 | Alcon, Inc. | Drug delivery device |
US7674243B2 (en) * | 2006-05-17 | 2010-03-09 | Alcon Inc. | Ophthalmic injection device using piezoelectric array |
US7862540B2 (en) * | 2006-05-17 | 2011-01-04 | Alcon Research, Ltd. | Ophthalmic injection device using shape memory alloy |
CA2834152C (en) | 2006-05-25 | 2016-07-05 | Bayer Healthcare Llc | Reconstitution device |
BRPI0712130A2 (en) * | 2006-05-30 | 2012-01-17 | Elan Pharma Int Ltd | nanoparticulate posaconazole formulations |
GB2438591B (en) | 2006-06-01 | 2011-07-13 | Cilag Gmbh Int | Injection device |
GB2438593B (en) | 2006-06-01 | 2011-03-30 | Cilag Gmbh Int | Injection device (cap removal feature) |
GB2438590B (en) | 2006-06-01 | 2011-02-09 | Cilag Gmbh Int | Injection device |
CN101460207B (en) * | 2006-06-06 | 2012-03-21 | 诺沃-诺迪斯克有限公司 | Assembly comprising skin-mountable device and packaging therefore |
US8439838B2 (en) | 2006-06-07 | 2013-05-14 | Unomedical A/S | Inserter for transcutaneous sensor |
WO2007143225A2 (en) | 2006-06-07 | 2007-12-13 | Abbott Diabetes Care, Inc. | Analyte monitoring system and method |
CA2653764A1 (en) | 2006-06-09 | 2007-12-13 | Unomedical A/S | Mounting pad |
US7909842B2 (en) * | 2006-06-15 | 2011-03-22 | Abbott Diabetes Care Inc. | Lancing devices having depth adjustment assembly |
US20080045925A1 (en) * | 2006-06-19 | 2008-02-21 | Stepovich Matthew J | Drug delivery system |
WO2007147741A1 (en) * | 2006-06-21 | 2007-12-27 | Novo Nordisk A/S | A one-hand operated drug mixing and expelling device |
CA2651992A1 (en) | 2006-06-30 | 2008-01-10 | Abbott Biotechnology Ltd. | Automatic injection device |
TW200820991A (en) * | 2006-07-10 | 2008-05-16 | Elan Pharma Int Ltd | Nanoparticulate sorafenib formulations |
US7806265B2 (en) * | 2006-07-12 | 2010-10-05 | Mobius Therapeutics, Llc | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
KR20090031618A (en) * | 2006-07-12 | 2009-03-26 | 엘란 코포레이션, 피엘씨 | Nanoparticulate formulations of modafinil |
FR2903685B1 (en) * | 2006-07-13 | 2008-09-05 | Arkema France | PROCESS FOR OBTAINING 1,2-DICHLOROETHANE BY DIRECT CHLORINATION WITH DIRECT EVAPORATION CATALYST SEPARATION STEP AND INSTALLATION FOR CARRYING OUT SAID METHOD |
DE102006035545B4 (en) * | 2006-07-27 | 2008-04-30 | Csl Behring Gmbh | Device for bringing components together by means of negative pressure under sterile conditions |
US8292848B2 (en) * | 2006-07-31 | 2012-10-23 | Bio Quiddity, Inc. | Fluid dispensing device with additive |
RU2452520C2 (en) * | 2006-08-02 | 2012-06-10 | Уномедикал А/С | Device for introduction |
KR20090037492A (en) * | 2006-08-02 | 2009-04-15 | 우노메디컬 에이/에스 | Cannula and delivery device |
US7618396B2 (en) * | 2006-08-09 | 2009-11-17 | Avant Medical Corp. | Injection system with hidden needles |
US7794434B2 (en) | 2006-08-23 | 2010-09-14 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir filling and infusion medium delivery |
US7682338B2 (en) | 2006-08-23 | 2010-03-23 | Medtronic Minimed, Inc. | Infusion medium delivery system, device and method with needle inserter and needle inserter device and method |
US20080051765A1 (en) * | 2006-08-23 | 2008-02-28 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir filling and infusion medium delivery |
US7828764B2 (en) * | 2006-08-23 | 2010-11-09 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir filling and infusion medium delivery |
US7811262B2 (en) | 2006-08-23 | 2010-10-12 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir filling and infusion medium delivery |
MX2009002455A (en) * | 2006-09-07 | 2009-03-20 | Wyeth Corp | Bone cement mixing systems and related methods. |
CN101516412B (en) | 2006-09-14 | 2014-02-12 | 德普伊斯派尔公司 | Bone cement and use method thereof |
US20080125712A1 (en) * | 2006-09-26 | 2008-05-29 | Alcon Manufacturing, Ltd. | Ophthalmic injection system |
US20080097390A1 (en) * | 2006-09-27 | 2008-04-24 | Alcon Manufacturing, Ltd. | Spring actuated delivery system |
KR101412296B1 (en) * | 2006-09-29 | 2014-06-25 | 인파 에스. 에이. | Packaging system for pharmaceutical compositions and kit for intravenous administration |
US20080086108A1 (en) * | 2006-10-05 | 2008-04-10 | Falkel Michael I | Method and apparatus for delivering a drug |
EP2063829B1 (en) * | 2006-10-16 | 2010-12-08 | Alcon Research, Ltd. | Universal rechargeable limited reuse assembly for ophthalmic hand piece |
US20080234625A1 (en) * | 2006-10-16 | 2008-09-25 | Bruno Dacquay | Fuse Assembly For Single Use Medical Device |
CN102014987A (en) * | 2006-10-16 | 2011-04-13 | 爱尔康研究有限公司 | Method of operating ophthalmic hand piece with disposable end |
US9022970B2 (en) * | 2006-10-16 | 2015-05-05 | Alcon Research, Ltd. | Ophthalmic injection device including dosage control device |
WO2008047372A2 (en) * | 2006-10-19 | 2008-04-24 | Elcam Medical Agricultural Cooperative Association Ltd. | Automatic injection device |
AU2007311451A1 (en) * | 2006-10-19 | 2008-04-24 | Depuy Spine, Inc. | Fluid delivery system |
EP1917990A1 (en) | 2006-10-31 | 2008-05-07 | Unomedical A/S | Infusion set |
ITPD20060419A1 (en) | 2006-11-13 | 2008-05-14 | Federico Nalesso | DEVICE FOR THE MAINTENANCE TREATMENT OF CENTRAL VENOUS CATHETERS |
US7637889B2 (en) * | 2006-11-15 | 2009-12-29 | Glynntech, Inc. | Drug delivery device with sliding valve and methodology |
US7938801B2 (en) * | 2006-11-22 | 2011-05-10 | Calibra Medical, Inc. | Disposable infusion device filling apparatus and method |
WO2008091838A2 (en) | 2007-01-22 | 2008-07-31 | Intelliject, Inc. | Medical injector with compliance tracking and monitoring |
GB2446778A (en) * | 2007-02-01 | 2008-08-27 | Pa Knowledge Ltd | Syringe adaptor |
KR20090117749A (en) * | 2007-02-02 | 2009-11-12 | 우노메디컬 에이/에스 | Injection site for injecting medication |
MX2009007755A (en) * | 2007-02-02 | 2009-07-27 | Unomedical As | Injection site for injecting medication. |
EP2114492A1 (en) * | 2007-03-06 | 2009-11-11 | Novo Nordisk A/S | Pump assembly comprising actuator system |
US7525344B2 (en) * | 2007-03-20 | 2009-04-28 | Tabula, Inc. | Configurable IC having a routing fabric with storage elements |
WO2008134570A2 (en) | 2007-04-27 | 2008-11-06 | Amylin Pharmaceuticals, Inc. | Mixing tool |
US8434528B2 (en) * | 2007-04-30 | 2013-05-07 | Medtronic Minimed, Inc. | Systems and methods for reservoir filling |
CA2685808C (en) * | 2007-04-30 | 2013-06-11 | Medtronic Minimed, Inc. | Needle inserting and fluid flow connection for infusion medium delivery system |
EP2146760B1 (en) | 2007-04-30 | 2018-10-10 | Medtronic MiniMed, Inc. | Reservoir filling, bubble management, and infusion medium delivery systems and methods with same |
US8597243B2 (en) | 2007-04-30 | 2013-12-03 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir air bubble management |
US7959715B2 (en) | 2007-04-30 | 2011-06-14 | Medtronic Minimed, Inc. | Systems and methods allowing for reservoir air bubble management |
US8613725B2 (en) | 2007-04-30 | 2013-12-24 | Medtronic Minimed, Inc. | Reservoir systems and methods |
US8323250B2 (en) | 2007-04-30 | 2012-12-04 | Medtronic Minimed, Inc. | Adhesive patch systems and methods |
US7963954B2 (en) | 2007-04-30 | 2011-06-21 | Medtronic Minimed, Inc. | Automated filling systems and methods |
US7751907B2 (en) | 2007-05-24 | 2010-07-06 | Smiths Medical Asd, Inc. | Expert system for insulin pump therapy |
EP2162169A1 (en) * | 2007-05-30 | 2010-03-17 | Eli Lilly & Company | Cartridge with multiple injection needles for a medication injection device |
US9044378B2 (en) | 2007-05-31 | 2015-06-02 | Safety Syringes, Inc. | Anti-needle stick safety device or system for use with drugs requiring reconstitution |
WO2008154312A1 (en) | 2007-06-08 | 2008-12-18 | Dexcom, Inc. | Integrated medicament delivery device for use with continuous analyte sensor |
US8657803B2 (en) * | 2007-06-13 | 2014-02-25 | Carmel Pharma Ab | Device for providing fluid to a receptacle |
EP2185224A1 (en) * | 2007-07-03 | 2010-05-19 | Unomedical A/S | Inserter having bistable equilibrium states |
DE602008005153D1 (en) | 2007-07-10 | 2011-04-07 | Unomedical As | INSERT WITH TWO SPRINGS |
RU2470679C2 (en) * | 2007-07-18 | 2012-12-27 | Уномедикал А/С | Controlled speed-up introduction apparatus |
US7740619B2 (en) * | 2007-08-01 | 2010-06-22 | Alcon Research, Ltd. | Spring driven ophthalmic injection device with safety actuator lockout feature |
US20090036842A1 (en) * | 2007-08-03 | 2009-02-05 | Raffi Pinedjian | Consumable Activation Lever For Injection Device |
EP2188004A4 (en) | 2007-08-21 | 2015-06-17 | Yukon Medical Llc | Vial access and injection system |
US7967795B1 (en) | 2010-01-19 | 2011-06-28 | Lamodel Ltd. | Cartridge interface assembly with driving plunger |
US9345836B2 (en) | 2007-10-02 | 2016-05-24 | Medimop Medical Projects Ltd. | Disengagement resistant telescoping assembly and unidirectional method of assembly for such |
CN101868273B (en) | 2007-10-02 | 2014-10-15 | 莱蒙德尔有限公司 | External drug pump |
US10420880B2 (en) | 2007-10-02 | 2019-09-24 | West Pharma. Services IL, Ltd. | Key for securing components of a drug delivery system during assembly and/or transport and methods of using same |
US9656019B2 (en) | 2007-10-02 | 2017-05-23 | Medimop Medical Projects Ltd. | Apparatuses for securing components of a drug delivery system during transport and methods of using same |
US9452258B2 (en) | 2007-10-09 | 2016-09-27 | Dexcom, Inc. | Integrated insulin delivery system with continuous glucose sensor |
US20090105684A1 (en) * | 2007-10-23 | 2009-04-23 | Baxter International Inc. | Medication port for medical fluid container |
US8417312B2 (en) | 2007-10-25 | 2013-04-09 | Dexcom, Inc. | Systems and methods for processing sensor data |
US8557179B2 (en) * | 2007-10-31 | 2013-10-15 | Novo Nordisk A/S | Non-porous material as sterilization barrier |
WO2009060419A2 (en) * | 2007-11-08 | 2009-05-14 | Elcam Medical A.C.A..L. Ltd | Vial adaptor and manufacturing method therfor |
WO2009065932A1 (en) * | 2007-11-22 | 2009-05-28 | Novo Nordisk Health Care Ag | Medical mixing device |
US8290559B2 (en) | 2007-12-17 | 2012-10-16 | Dexcom, Inc. | Systems and methods for processing sensor data |
MX364408B (en) * | 2007-12-20 | 2019-04-25 | Univ Southern California | APPARATUS and METHODS FOR DELIVERING THERAPEUTIC AGENTS. |
WO2009086182A1 (en) | 2007-12-21 | 2009-07-09 | Carticept Medical, Inc. | Articular injection system |
US8545440B2 (en) | 2007-12-21 | 2013-10-01 | Carticept Medical, Inc. | Injection system for delivering multiple fluids within the anatomy |
US9044542B2 (en) | 2007-12-21 | 2015-06-02 | Carticept Medical, Inc. | Imaging-guided anesthesia injection systems and methods |
US9456955B2 (en) | 2007-12-31 | 2016-10-04 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US10188787B2 (en) * | 2007-12-31 | 2019-01-29 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US10080704B2 (en) | 2007-12-31 | 2018-09-25 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US8986253B2 (en) | 2008-01-25 | 2015-03-24 | Tandem Diabetes Care, Inc. | Two chamber pumps and related methods |
EP2244662B1 (en) * | 2008-01-28 | 2021-09-29 | Implantica Patent Ltd. | Blood clot removal device and system |
US20090204077A1 (en) * | 2008-02-13 | 2009-08-13 | Hasted Soren B | Moulded Connection Between Cannula and Delivery Part |
EP2257324B1 (en) | 2008-02-11 | 2016-07-27 | Safety Syringes, Inc. | Syringe with safety needle guard and clip to prevent release of guard during reconstitution process |
CA2713485A1 (en) | 2008-02-13 | 2009-08-20 | Unomedical A/S | Sealing between a cannula part and a fluid path |
US20110098652A1 (en) * | 2008-02-13 | 2011-04-28 | Unomedical A/S | Moulded Connection between Cannula and Delivery Part |
CA2715667A1 (en) | 2008-02-20 | 2009-08-27 | Unomedical A/S | Insertion device with horizontally moving part |
US20110009822A1 (en) * | 2008-02-21 | 2011-01-13 | Poul Torben Nielsen | Dispenser for local anaesthetics and other liquids |
WO2009105709A1 (en) | 2008-02-21 | 2009-08-27 | Dexcom, Inc. | Systems and methods for processing, transmitting and displaying sensor data |
JP2011520779A (en) * | 2008-03-21 | 2011-07-21 | エラン・ファルマ・インターナショナル・リミテッド | Compositions and methods of use for site-specific delivery of imatinib |
US9107668B2 (en) * | 2008-03-25 | 2015-08-18 | Cook Medical Technologies Llc | Embolic particle mixing syringe |
WO2009146088A1 (en) * | 2008-04-01 | 2009-12-03 | Yukon Medical, Llc | Dual container fluid transfer device |
US8241616B2 (en) * | 2008-04-03 | 2012-08-14 | Rohm And Haas Company | Hair styling composition |
US8182769B2 (en) | 2008-04-04 | 2012-05-22 | Biomet Biologics, Llc | Clean transportation system |
US8518272B2 (en) | 2008-04-04 | 2013-08-27 | Biomet Biologics, Llc | Sterile blood separating system |
US8034044B2 (en) * | 2008-04-04 | 2011-10-11 | B. Braun Melsungen Ag | Systems and methods for combining materials |
US8021344B2 (en) | 2008-07-28 | 2011-09-20 | Intelliject, Inc. | Medicament delivery device configured to produce an audible output |
USD994111S1 (en) | 2008-05-12 | 2023-08-01 | Kaleo, Inc. | Medicament delivery device cover |
US20110005958A1 (en) * | 2009-07-09 | 2011-01-13 | Onpharma, Inc. | METHODS AND SYSTEMS FOR ADJUSTING THE pH OF MEDICAL BUFFERING SOLUTIONS |
GB2461086B (en) | 2008-06-19 | 2012-12-05 | Cilag Gmbh Int | Injection device |
GB2461088B (en) * | 2008-06-19 | 2012-09-26 | Cilag Gmbh Int | Injection device |
GB2461089B (en) | 2008-06-19 | 2012-09-19 | Cilag Gmbh Int | Injection device |
GB2461084B (en) | 2008-06-19 | 2012-09-26 | Cilag Gmbh Int | Fluid transfer assembly |
GB2461085B (en) | 2008-06-19 | 2012-08-29 | Cilag Gmbh Int | Injection device |
GB2461087B (en) | 2008-06-19 | 2012-09-26 | Cilag Gmbh Int | Injection device |
US9022987B2 (en) * | 2008-07-07 | 2015-05-05 | Gabriel Institute, Inc. | Delivery system for injection through zone of body |
US9808578B2 (en) | 2008-07-07 | 2017-11-07 | Gabriel Institute, Inc. | Delivery system for injections throughout zone of body |
US9393369B2 (en) | 2008-09-15 | 2016-07-19 | Medimop Medical Projects Ltd. | Stabilized pen injector |
US8408421B2 (en) | 2008-09-16 | 2013-04-02 | Tandem Diabetes Care, Inc. | Flow regulating stopcocks and related methods |
EP2334234A4 (en) | 2008-09-19 | 2013-03-20 | Tandem Diabetes Care Inc | Solute concentration measurement device and related methods |
US8141601B2 (en) | 2008-10-02 | 2012-03-27 | Roche Diagnostics Operations, Inc. | Manual filling aid with push button fill |
US8223028B2 (en) | 2008-10-10 | 2012-07-17 | Deka Products Limited Partnership | Occlusion detection system and method |
US9180245B2 (en) * | 2008-10-10 | 2015-11-10 | Deka Products Limited Partnership | System and method for administering an infusible fluid |
US8016789B2 (en) | 2008-10-10 | 2011-09-13 | Deka Products Limited Partnership | Pump assembly with a removable cover assembly |
US8708376B2 (en) | 2008-10-10 | 2014-04-29 | Deka Products Limited Partnership | Medium connector |
US8262616B2 (en) | 2008-10-10 | 2012-09-11 | Deka Products Limited Partnership | Infusion pump assembly |
US8267892B2 (en) * | 2008-10-10 | 2012-09-18 | Deka Products Limited Partnership | Multi-language / multi-processor infusion pump assembly |
US8066672B2 (en) | 2008-10-10 | 2011-11-29 | Deka Products Limited Partnership | Infusion pump assembly with a backup power supply |
EP2337543B1 (en) | 2008-10-15 | 2014-12-24 | Novo Nordisk Health Care AG | System for reconstitution of a powdered drug |
US7913475B2 (en) * | 2008-10-30 | 2011-03-29 | Fht, Inc. | Multi-stage end-to-end cytotoxin handling system |
US20100145305A1 (en) * | 2008-11-10 | 2010-06-10 | Ruth Alon | Low volume accurate injector |
EP2355944A1 (en) * | 2008-11-11 | 2011-08-17 | Novo Nordisk A/S | A bended injection needle |
JP5432176B2 (en) * | 2008-11-21 | 2014-03-05 | テルモ株式会社 | Connector |
CA2746164C (en) * | 2008-12-09 | 2019-08-13 | Becton, Dickinson And Company | Open and closed valve medication delivery system for high pressure injections |
MX2011005735A (en) | 2008-12-22 | 2011-06-21 | Unomedical As | Medical device comprising adhesive pad. |
US8152779B2 (en) * | 2008-12-30 | 2012-04-10 | Medimop Medical Projects Ltd. | Needle assembly for drug pump |
WO2010078207A1 (en) * | 2008-12-31 | 2010-07-08 | Deka Products Limited Partnership | Split ring resonator antenna adapted for use in wirelessly controlled medical device |
JP2012519016A (en) * | 2009-02-26 | 2012-08-23 | ジー−センス エルテーデー. | Pressure vessel system for storing / releasing fluid |
AU2010217760B2 (en) | 2009-02-27 | 2015-04-09 | Tandem Diabetes Care, Inc. | Methods and devices for determination of flow reservoir volume |
US9250106B2 (en) | 2009-02-27 | 2016-02-02 | Tandem Diabetes Care, Inc. | Methods and devices for determination of flow reservoir volume |
EP3593844A1 (en) | 2009-02-27 | 2020-01-15 | Lifescan, Inc. | Medical module for drug delivery pen |
US8303566B2 (en) * | 2009-07-09 | 2012-11-06 | Onpharma, Inc. | Methods and apparatus for buffering parenteral solutions |
JP5685579B2 (en) | 2009-04-14 | 2015-03-18 | ユーコン・メディカル,リミテッド・ライアビリティ・カンパニー | Fluid transfer device |
BRPI1012162A2 (en) | 2009-04-29 | 2016-01-12 | Abbott Biotech Ltd | automatic injection device |
ES2656488T3 (en) * | 2009-05-04 | 2018-02-27 | Valeritas, Inc. | Fluid transfer device |
US8632511B2 (en) * | 2009-05-06 | 2014-01-21 | Alcon Research, Ltd. | Multiple thermal sensors in a multiple processor environment for temperature control in a drug delivery device |
CN101884593B (en) * | 2009-05-14 | 2013-09-18 | 许清萍 | Method for preparing liquid preparation from high-dose lyophilized preparation |
EP2432523B1 (en) * | 2009-05-20 | 2020-01-15 | Sanofi-Aventis Deutschland GmbH | Assembly for use in a drug delivery device |
JP6072539B2 (en) | 2009-05-27 | 2017-02-01 | アルカーメス ファーマ アイルランド リミテッド | Reduction of flaky aggregation in nanoparticulate active agent compositions |
WO2011014704A2 (en) | 2009-07-30 | 2011-02-03 | Tandem Diabetes Care, Inc. | Infusion pump system with disposable cartridge having pressure venting and pressure feedback |
EP2459252B1 (en) | 2009-07-30 | 2013-08-21 | Unomedical A/S | Inserter device with horizontal moving part |
BR112012002804A2 (en) | 2009-08-07 | 2016-05-31 | Unomedical As | sensor device and one or more cannulas |
US10071198B2 (en) | 2012-11-02 | 2018-09-11 | West Pharma. Servicees IL, Ltd. | Adhesive structure for medical device |
US10071196B2 (en) | 2012-05-15 | 2018-09-11 | West Pharma. Services IL, Ltd. | Method for selectively powering a battery-operated drug-delivery device and device therefor |
US8157769B2 (en) | 2009-09-15 | 2012-04-17 | Medimop Medical Projects Ltd. | Cartridge insertion assembly for drug delivery system |
TWI619521B (en) * | 2009-12-15 | 2018-04-01 | 艾伯維生物技術有限責任公司 | Automatic injection device, automatic injection method and method for preventing misfiring |
JP5650242B2 (en) | 2009-12-16 | 2015-01-07 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | Self injection device |
DK2512559T3 (en) | 2009-12-16 | 2019-03-25 | Becton Dickinson Co | SELF-INJECTIVE DEVICE |
ES2565405T3 (en) | 2009-12-16 | 2016-04-04 | Becton Dickinson And Company | Auto injection device |
EP2512551B1 (en) | 2009-12-16 | 2019-03-20 | Becton, Dickinson and Company | Self-injection device |
JP5894082B2 (en) | 2009-12-16 | 2016-03-23 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | Self-injection device |
ES2617145T3 (en) | 2009-12-16 | 2017-06-15 | Becton, Dickinson And Company | Automatic injection device |
US8177747B2 (en) * | 2009-12-22 | 2012-05-15 | Alcon Research, Ltd. | Method and apparatus for drug delivery |
US8348898B2 (en) | 2010-01-19 | 2013-01-08 | Medimop Medical Projects Ltd. | Automatic needle for drug pump |
CA2792138A1 (en) | 2010-03-30 | 2011-10-06 | Unomedical A/S | Medical device |
KR101850687B1 (en) * | 2010-04-21 | 2018-04-20 | 애브비 바이오테크놀로지 리미티드 | Wearable automatic injection device for controlled delivery of therapeutic agents |
WO2011141907A1 (en) | 2010-05-10 | 2011-11-17 | Medimop Medical Projects Ltd. | Low volume accurate injector |
WO2011146583A2 (en) | 2010-05-19 | 2011-11-24 | Elan Pharma International Limited | Nanoparticulate cinacalcet formulations |
USD655017S1 (en) | 2010-06-17 | 2012-02-28 | Yukon Medical, Llc | Shroud |
WO2012013587A1 (en) * | 2010-07-26 | 2012-02-02 | Sanofi-Aventis Deutschland Gmbh | Multiple needle assembly for an injection device |
CN103079606A (en) * | 2010-08-10 | 2013-05-01 | 弗·哈夫曼-拉罗切有限公司 | Drug reconstitution and delivery device |
CN103153360B (en) | 2010-09-02 | 2016-04-06 | 贝克顿·迪金森公司 | Have band activate interceptor pin lid from injection device |
DE102010046058B4 (en) * | 2010-09-22 | 2015-01-08 | Heraeus Medical Gmbh | Discharge device for expressing a content of a container and method for activating the discharge device |
EP2433663A1 (en) | 2010-09-27 | 2012-03-28 | Unomedical A/S | Insertion system |
EP2436412A1 (en) | 2010-10-04 | 2012-04-04 | Unomedical A/S | A sprinkler cannula |
AU2011329876B2 (en) * | 2010-11-19 | 2014-09-18 | Eli Lilly And Company | Needle magazine for medication injection device |
CA2818982A1 (en) * | 2010-11-29 | 2012-06-07 | Sanofi-Aventis Deutschland Gmbh | Dispense interface component for a drug delivery device |
EP3473283B1 (en) | 2011-01-24 | 2020-12-09 | AbbVie Biotechnology Ltd. | Removal of needle shields from syringes and automatic injection devices |
AU2012210170B2 (en) | 2011-01-24 | 2016-09-29 | Elcam Medical Agricultural Cooperative Association Ltd. | Injector |
EP3187216B1 (en) | 2011-01-24 | 2019-08-21 | AbbVie Biotechnology Ltd. | Automatic injection devices having overmolded gripping surfaces |
US8939943B2 (en) | 2011-01-26 | 2015-01-27 | Kaleo, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
US8627816B2 (en) | 2011-02-28 | 2014-01-14 | Intelliject, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
US9084849B2 (en) | 2011-01-26 | 2015-07-21 | Kaleo, Inc. | Medicament delivery devices for administration of a medicament within a prefilled syringe |
US9168202B2 (en) * | 2011-01-26 | 2015-10-27 | Gary L. Sharpe | Device and method for docking a vial with a container |
WO2012110057A1 (en) * | 2011-02-15 | 2012-08-23 | Chemisches Institut Schaefer Ag | Cefuroxime safety kit |
USD702834S1 (en) | 2011-03-22 | 2014-04-15 | Medimop Medical Projects Ltd. | Cartridge for use in injection device |
DK3575796T3 (en) | 2011-04-15 | 2021-01-18 | Dexcom Inc | ADVANCED ANALYZE SENSOR CALIBRATION AND ERROR DETECTION |
US9149580B2 (en) | 2011-07-19 | 2015-10-06 | Sanofi-Aventis Deutschland Gmbh | Cartridge holder for a drug delivery device |
PT2731642T (en) | 2011-09-02 | 2018-12-19 | Unl Holdings Llc | Insertion mechanism for a drug delivery pump |
USD681230S1 (en) | 2011-09-08 | 2013-04-30 | Yukon Medical, Llc | Shroud |
US11197689B2 (en) | 2011-10-05 | 2021-12-14 | Unomedical A/S | Inserter for simultaneous insertion of multiple transcutaneous parts |
EP2583715A1 (en) | 2011-10-19 | 2013-04-24 | Unomedical A/S | Infusion tube system and method for manufacture |
US9440051B2 (en) | 2011-10-27 | 2016-09-13 | Unomedical A/S | Inserter for a multiplicity of subcutaneous parts |
US9750396B2 (en) * | 2011-12-12 | 2017-09-05 | Smiths Medical Asd, Inc. | Variable length portal access device |
EP2809375B1 (en) | 2012-01-31 | 2021-08-11 | Medimop Medical Projects Ltd. | Time dependent drug delivery apparatus |
ES2576294T3 (en) * | 2012-02-22 | 2016-07-06 | Baxalta GmbH | Packaged package to prevent premature activation |
US9463280B2 (en) | 2012-03-26 | 2016-10-11 | Medimop Medical Projects Ltd. | Motion activated septum puncturing drug delivery device |
US10668213B2 (en) | 2012-03-26 | 2020-06-02 | West Pharma. Services IL, Ltd. | Motion activated mechanisms for a drug delivery device |
US9072827B2 (en) | 2012-03-26 | 2015-07-07 | Medimop Medical Projects Ltd. | Fail safe point protector for needle safety flap |
WO2013149186A1 (en) | 2012-03-30 | 2013-10-03 | Insulet Corporation | Fluid delivery device with transcutaneous access tool, insertion mechansim and blood glucose monitoring for use therewith |
EP2836257B1 (en) | 2012-04-09 | 2020-05-27 | Becton, Dickinson and Company | Injection mechanism utilizing a vial |
US9180242B2 (en) | 2012-05-17 | 2015-11-10 | Tandem Diabetes Care, Inc. | Methods and devices for multiple fluid transfer |
US9522235B2 (en) | 2012-05-22 | 2016-12-20 | Kaleo, Inc. | Devices and methods for delivering medicaments from a multi-chamber container |
USD769444S1 (en) | 2012-06-28 | 2016-10-18 | Yukon Medical, Llc | Adapter device |
CN104470566B (en) * | 2012-07-11 | 2018-02-09 | 尤尼特拉克特注射器控股有限公司 | The interposer with exhaust fluid passage for medicine transportation pump |
US9398913B2 (en) * | 2012-08-24 | 2016-07-26 | St. Jude Medical Puerto Rico Llc | Sealant storage, preparation, and delivery systems and related methods |
WO2014106096A1 (en) | 2012-12-27 | 2014-07-03 | Kaleo, Inc. | Devices, systems and methods for locating and interacting with medicament delivery systems |
US9421323B2 (en) | 2013-01-03 | 2016-08-23 | Medimop Medical Projects Ltd. | Door and doorstop for portable one use drug delivery apparatus |
US9173998B2 (en) | 2013-03-14 | 2015-11-03 | Tandem Diabetes Care, Inc. | System and method for detecting occlusions in an infusion pump |
US9011164B2 (en) | 2013-04-30 | 2015-04-21 | Medimop Medical Projects Ltd. | Clip contact for easy installation of printed circuit board PCB |
US9889256B2 (en) | 2013-05-03 | 2018-02-13 | Medimop Medical Projects Ltd. | Sensing a status of an infuser based on sensing motor control and power input |
GB2515038A (en) | 2013-06-11 | 2014-12-17 | Cilag Gmbh Int | Injection device |
GB2515032A (en) | 2013-06-11 | 2014-12-17 | Cilag Gmbh Int | Guide for an injection device |
GB2517896B (en) | 2013-06-11 | 2015-07-08 | Cilag Gmbh Int | Injection device |
GB2515039B (en) | 2013-06-11 | 2015-05-27 | Cilag Gmbh Int | Injection Device |
US9579257B2 (en) | 2013-08-20 | 2017-02-28 | Anutra Medical, Inc. | Haptic feedback and audible output syringe |
USD774182S1 (en) | 2014-06-06 | 2016-12-13 | Anutra Medical, Inc. | Anesthetic delivery device |
USD763433S1 (en) | 2014-06-06 | 2016-08-09 | Anutra Medical, Inc. | Delivery system cassette |
US9517307B2 (en) | 2014-07-18 | 2016-12-13 | Kaleo, Inc. | Devices and methods for delivering opioid antagonists including formulations for naloxone |
WO2016053954A1 (en) | 2014-09-29 | 2016-04-07 | Unitract Syringe Pty Ltd | Rigid needle insertion mechanism for a drug delivery pump |
WO2016073496A2 (en) * | 2014-11-03 | 2016-05-12 | Infield Medical, Llc | Medicament dispenser |
US9937292B2 (en) * | 2014-12-09 | 2018-04-10 | Medtronic Minimed, Inc. | Systems for filling a fluid infusion device reservoir |
US10251813B2 (en) | 2015-03-04 | 2019-04-09 | West Pharma. Services IL, Ltd. | Flexibly mounted cartridge alignment collar for drug delivery device |
US9795534B2 (en) * | 2015-03-04 | 2017-10-24 | Medimop Medical Projects Ltd. | Compliant coupling assembly for cartridge coupling of a drug delivery device |
US10695495B2 (en) | 2015-03-24 | 2020-06-30 | Kaleo, Inc. | Devices and methods for delivering a lyophilized medicament |
AU2016235138B2 (en) * | 2015-03-26 | 2018-07-26 | Enable Injections, Inc | Pressurized gas powered medicament transfer and re-suspension apparatus and method |
WO2016162755A2 (en) * | 2015-04-08 | 2016-10-13 | Cequr Sa | Combined medicament fill and cannula insertion device |
US9744297B2 (en) | 2015-04-10 | 2017-08-29 | Medimop Medical Projects Ltd. | Needle cannula position as an input to operational control of an injection device |
US10293120B2 (en) | 2015-04-10 | 2019-05-21 | West Pharma. Services IL, Ltd. | Redundant injection device status indication |
US10149943B2 (en) | 2015-05-29 | 2018-12-11 | West Pharma. Services IL, Ltd. | Linear rotation stabilizer for a telescoping syringe stopper driverdriving assembly |
EP3302652B1 (en) | 2015-06-04 | 2023-09-06 | Medimop Medical Projects Ltd. | Cartridge insertion for drug delivery device |
PT3310321T (en) | 2015-06-19 | 2019-07-17 | Baxalta Inc | Pooling device for single or multiple containers |
WO2017004345A1 (en) | 2015-06-30 | 2017-01-05 | Kaleo, Inc. | Auto-injectors for administration of a medicament within a prefilled syringe |
US9987432B2 (en) | 2015-09-22 | 2018-06-05 | West Pharma. Services IL, Ltd. | Rotation resistant friction adapter for plunger driver of drug delivery device |
US10576207B2 (en) | 2015-10-09 | 2020-03-03 | West Pharma. Services IL, Ltd. | Angled syringe patch injector |
CN108472438B (en) | 2015-10-09 | 2022-01-28 | 西医药服务以色列分公司 | Tortuous fluid path attachment to pre-filled fluid reservoirs |
EP3380061A4 (en) | 2015-11-24 | 2019-07-24 | Insulet Corporation | Wearable automated medication delivery system |
WO2017091584A1 (en) | 2015-11-25 | 2017-06-01 | Insulet Corporation | Wearable medication delivery device |
US10426699B2 (en) | 2015-11-30 | 2019-10-01 | Gary L. Sharp | Device and method for docking a vial with a container |
CN108495611B (en) | 2015-12-04 | 2021-02-19 | 康尔福盛303公司 | Manifold for an automatic drug dispenser |
EP3383345B1 (en) * | 2015-12-04 | 2020-03-11 | CareFusion 303, Inc. | Tube management structures for automatic drug compounder |
US10646643B2 (en) | 2016-01-21 | 2020-05-12 | West Pharma. Services IL, Ltd. | Needle insertion and retraction mechanism |
JP6513297B2 (en) | 2016-01-21 | 2019-05-22 | ウェスト ファーマ サービシーズ イスラエル リミテッド | Automatic injector, receiving frame and method of connecting cartridge in automatic injector |
JP6885960B2 (en) | 2016-01-21 | 2021-06-16 | ウェスト ファーマ サービシーズ イスラエル リミテッド | Drug delivery device with visual indicators |
WO2017161076A1 (en) | 2016-03-16 | 2017-09-21 | Medimop Medical Projects Ltd. | Staged telescopic screw assembly having different visual indicators |
CN109310831B (en) | 2016-06-02 | 2021-11-23 | 西医药服务以色列有限公司 | Three position needle retraction |
EP3490643B1 (en) | 2016-08-01 | 2021-10-27 | West Pharma. Services Il, Ltd. | Anti-rotation cartridge pin |
US11730892B2 (en) | 2016-08-01 | 2023-08-22 | West Pharma. Services IL, Ltd. | Partial door closure prevention spring |
US20180055738A1 (en) * | 2016-08-26 | 2018-03-01 | Changhai Chen | Dispenser system and methods for medication compliance |
US10722431B2 (en) | 2016-08-26 | 2020-07-28 | Changhai Chen | Dispenser system and methods for medication compliance |
US11246805B2 (en) | 2016-08-26 | 2022-02-15 | Changhai Chen | Dispenser system and methods for medication compliance |
WO2018039579A1 (en) * | 2016-08-26 | 2018-03-01 | Chen Changhai | Dispenser system and methods for medication compliance |
CN109414717A (en) * | 2016-12-05 | 2019-03-01 | 微邦科技股份有限公司 | Aerosol generating device with replaceable part |
JP7014797B2 (en) | 2016-12-23 | 2022-02-01 | カレオ,インコーポレイテッド | Drug delivery devices and methods for delivering drugs to babies and children |
US10835881B2 (en) * | 2017-01-11 | 2020-11-17 | Roy C. Putrino | Mixing device and methods thereof |
WO2018136413A2 (en) | 2017-01-17 | 2018-07-26 | Kaleo, Inc. | Medicament delivery devices with wireless connectivity and event detection |
WO2018156548A1 (en) | 2017-02-22 | 2018-08-30 | Insulet Corporation | Needle insertion mechanisms for drug containers |
JP7000443B2 (en) * | 2017-03-10 | 2022-02-10 | イネイブル インジェクションズ、インコーポレイテッド | Reconstructor, system and method |
JP7069206B2 (en) | 2017-03-24 | 2022-05-17 | ケアフュージョン 303、インコーポレイテッド | Vial connection features for automatic drug formulators |
CN110869072B (en) | 2017-05-30 | 2021-12-10 | 西部制药服务有限公司(以色列) | Modular drive mechanism for a wearable injector |
EP3654912B1 (en) * | 2017-07-20 | 2021-02-17 | Janssen Biotech, Inc. | Drug mixing device |
WO2019067367A1 (en) | 2017-09-26 | 2019-04-04 | Insulet Corporation | Needle mechanism module for drug delivery device |
US11331022B2 (en) | 2017-10-24 | 2022-05-17 | Dexcom, Inc. | Pre-connected analyte sensors |
US20190120785A1 (en) | 2017-10-24 | 2019-04-25 | Dexcom, Inc. | Pre-connected analyte sensors |
US11147931B2 (en) | 2017-11-17 | 2021-10-19 | Insulet Corporation | Drug delivery device with air and backflow elimination |
US11752070B2 (en) * | 2017-11-21 | 2023-09-12 | Sanofi | Mixing and/or reconstitution system |
US11083845B2 (en) * | 2017-12-20 | 2021-08-10 | Device And Apparatus Llc | Apparatus and method for neutralizing local anesthetic |
CN114470420A (en) | 2017-12-22 | 2022-05-13 | 西氏医药包装(以色列)有限公司 | Syringe adapted for cartridges of different sizes |
US20190275236A1 (en) * | 2018-03-08 | 2019-09-12 | Eyal BARMAIMON | Full path rigid needle |
WO2019182745A1 (en) | 2018-03-19 | 2019-09-26 | Bryn Pharma, LLC | Epinephrine spray formulations |
WO2020018433A1 (en) | 2018-07-16 | 2020-01-23 | Kaleo, Inc. | Medicament delivery devices with wireless connectivity and compliance detection |
KR20210068500A (en) | 2018-10-03 | 2021-06-09 | 다케다 야쿠힌 고교 가부시키가이샤 | Packaging for multiple containers |
KR102251644B1 (en) * | 2019-05-08 | 2021-05-13 | 김용현 | Drug mixing device, drug mixing kit comprising the same and method for manufacturing the same |
EP4009936A4 (en) | 2019-08-09 | 2023-08-09 | Kaleo, Inc. | Devices and methods for delivery of substances within a prefilled syringe |
EP4045109A1 (en) * | 2019-10-18 | 2022-08-24 | Amgen Inc. | Systems and approaches for drug delivery device reconstitution |
EP4161627A1 (en) * | 2020-06-04 | 2023-04-12 | Aquavit Pharmaceuticals, Inc. | Methods for delivering bioactive compositions and formulations to the skin using microchannel delivery device |
EP4255995A1 (en) | 2020-12-07 | 2023-10-11 | O&M Halyard, Inc. | Damp hand donning and moisturizing glove |
US11738140B2 (en) * | 2021-01-15 | 2023-08-29 | Medtronic Minimed, Inc. | Insertion device with linkage assembly |
Family Cites Families (67)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3542023A (en) | 1968-03-06 | 1970-11-24 | Min I Mix Corp | Minimix |
US3605744A (en) * | 1969-04-22 | 1971-09-20 | Edward M Dwyer | Injection apparatus and method of injecting |
AT303250B (en) * | 1970-02-19 | 1972-11-10 | Walter Stein Dr | Injection syringe equipped with a drug depot |
GB2126093A (en) | 1982-08-23 | 1984-03-21 | Vineland Lab Inc | Improved pneumatic vaccinator |
US4583971A (en) | 1984-02-10 | 1986-04-22 | Travenol European Research And Development Centre (Teradec) | Closed drug delivery system |
US4606734A (en) | 1984-02-22 | 1986-08-19 | Abbott Laboratories | Container mixing system with externally mounted drug container |
US4915689A (en) | 1984-06-13 | 1990-04-10 | Alza Corporation | Parenteral delivery system comprising a vial containing a beneficial agent |
US4689042A (en) | 1985-05-20 | 1987-08-25 | Survival Technology, Inc. | Automatic medicament ingredient mixing and injecting apparatus |
AT382783B (en) | 1985-06-20 | 1987-04-10 | Immuno Ag | DEVICE FOR APPLICATING A TISSUE ADHESIVE |
US4861335A (en) | 1985-07-26 | 1989-08-29 | Duoject Medical Systems Inc. | Syringe |
SE461765B (en) | 1986-07-10 | 1990-03-26 | Haessle Ab | DEVICE FOR RELEASE OF SUBSTANCE |
US4747829A (en) | 1987-01-21 | 1988-05-31 | E. R. Squibb & Sons, Inc. | Pre-filled syringe |
US4886495A (en) | 1987-07-08 | 1989-12-12 | Duoject Medical Systems Inc. | Vial-based prefilled syringe system for one or two component medicaments |
AT388503B (en) | 1987-05-21 | 1989-07-25 | Immuno Ag | SET FOR PROVIDING AND APPLICATION OF A TISSUE ADHESIVE |
US5364369A (en) * | 1987-07-08 | 1994-11-15 | Reynolds David L | Syringe |
US5554125A (en) | 1987-07-08 | 1996-09-10 | Reynolds; David L. | Prefilled vial syringe |
US4787891A (en) * | 1987-07-13 | 1988-11-29 | Paul Levin | Syringe holder and applicator |
US4850978A (en) | 1987-10-29 | 1989-07-25 | Baxter International Inc. | Drug delivery cartridge with protective cover |
US4915688A (en) | 1987-12-03 | 1990-04-10 | Baxter International Inc. | Apparatus for administering solution to a patient |
US5147323A (en) * | 1991-03-08 | 1992-09-15 | Habley Medical Technology Corporation | Multiple cartridge syringe |
US5360410A (en) * | 1991-01-16 | 1994-11-01 | Senetek Plc | Safety syringe for mixing two-component medicaments |
US5298023A (en) * | 1991-03-08 | 1994-03-29 | Habley Medical Technology Corporation | Multiple pharmaceutical dispenser with accumulator |
IT223172Z2 (en) | 1991-04-09 | 1995-06-13 | Tecnomedica Ricerche Srl | DEVICE FOR THE ADMINISTRATION OF DRUGS, PARTICULARLY TWO-COMPONENT PHARMA-CI |
GB9107647D0 (en) | 1991-04-11 | 1991-05-29 | Jeffrey Peter | Syringe construction providing needle point protection |
GB9111600D0 (en) | 1991-05-30 | 1991-07-24 | Owen Mumford Ltd | Improvements relating to injection devices |
US5207647A (en) | 1991-11-05 | 1993-05-04 | Phelps David Y | Needle device |
US5329976A (en) | 1991-12-09 | 1994-07-19 | Habley Medical Technology Corporation | Syringe-filling and medication mixing dispenser |
US5281198A (en) | 1992-05-04 | 1994-01-25 | Habley Medical Technology Corporation | Pharmaceutical component-mixing delivery assembly |
US5180370A (en) | 1992-05-18 | 1993-01-19 | Gillespie Elgene R | Safety hypodermic syringe with retractable needle |
US5531683A (en) | 1992-08-13 | 1996-07-02 | Science Incorporated | Mixing and delivery syringe assembly |
US5378233A (en) * | 1992-11-18 | 1995-01-03 | Habley Medical Technology Corporation | Selected dose pharmaceutical dispenser |
US5484406A (en) | 1992-11-19 | 1996-01-16 | Baxter International Inc. | In-line drug delivery device for use with a standard IV administration set and a method for delivery |
US5334162A (en) | 1993-03-15 | 1994-08-02 | Eli Lilly And Company | Cartridge assembly for a lyophilized compound forming a disposable portion of an injector pen and method for same |
US5540664A (en) * | 1993-05-27 | 1996-07-30 | Washington Biotech Corporation | Reloadable automatic or manual emergency injection system |
US5429611A (en) | 1993-06-10 | 1995-07-04 | Rait; Joseph M. | Syringe with automatically actuated shield |
CA2160540A1 (en) * | 1994-02-14 | 1995-08-17 | Gabriel Meyer | Injector module for a syringe, and pre-filled syringe provided therewith |
FR2716801B1 (en) | 1994-03-04 | 1996-09-06 | Pasteur Merieux Serums Vacc | Set for the distribution of a pharmaceutical solution in cartridges or the like, in particular after taking up a lyophilized product. |
US5466220A (en) | 1994-03-08 | 1995-11-14 | Bioject, Inc. | Drug vial mixing and transfer device |
US5389076A (en) * | 1994-04-05 | 1995-02-14 | Shaw; Thomas J. | Single use medical device with retraction mechanism |
GB9419566D0 (en) | 1994-09-27 | 1994-11-16 | El Refaey Hazem | Oral prostagladins for the routine management of the third stage of labour |
GB9425642D0 (en) | 1994-12-20 | 1995-02-22 | Weston Medical Ltd | Filling device |
US5595566A (en) * | 1995-01-31 | 1997-01-21 | Unique Management Enterprises, Inc. | Apparatus for shielding a syringe needle |
CA2168615A1 (en) * | 1995-03-07 | 1996-09-08 | Timothy J. Erskine | Catheter-advancement actuated needle retraction system |
IL114960A0 (en) | 1995-03-20 | 1995-12-08 | Medimop Medical Projects Ltd | Flow control device |
US5785682A (en) | 1995-03-22 | 1998-07-28 | Abbott Laboratories | Pre-filled syringe drug delivery system |
WO1998013088A1 (en) | 1996-09-27 | 1998-04-02 | Abbott Laboratories | Syringe system accommodating separate prefilled barrels for two constituents |
US5779668A (en) | 1995-03-29 | 1998-07-14 | Abbott Laboratories | Syringe barrel for lyophilization, reconstitution and administration |
US5566729A (en) | 1995-04-06 | 1996-10-22 | Abbott Laboratories | Drug reconstitution and administration system |
FR2733155B1 (en) * | 1995-04-18 | 1997-09-19 | Tebro | RECHARGEABLE SELF-INJECTOR |
SE9502285D0 (en) * | 1995-06-22 | 1995-06-22 | Pharmacia Ab | Improvements related to injections |
IE77523B1 (en) * | 1995-09-11 | 1997-12-17 | Elan Med Tech | Medicament delivery device |
EP0850076B1 (en) | 1995-09-11 | 2005-04-06 | Elan Corporation Plc | Medicament delivery device |
US5658259A (en) | 1995-10-19 | 1997-08-19 | Meridian Medical Technologies, Inc. | Dental cartridge assembly auto-injector with protective needle cover |
ZA9610374B (en) | 1995-12-11 | 1997-06-23 | Elan Med Tech | Cartridge-based drug delivery device |
PT928182E (en) | 1996-01-11 | 2002-10-31 | Duoject Inc | DISTRIBUTION SYSTEM FOR PHARMACEUTICAL PRODUCTS PACKED IN PHARMACEUTICAL BOTTLES |
GB9611562D0 (en) | 1996-06-03 | 1996-08-07 | Applied Research Systems | Device |
US5707365A (en) | 1996-08-06 | 1998-01-13 | Eli Lilly And Company | Insulin dispenser |
US5681292A (en) | 1996-10-29 | 1997-10-28 | Retrax Safety Systems, Inc. | Retractable needle and syringe combination |
US5882342A (en) | 1997-04-11 | 1999-03-16 | Safety Medical Manufacturing, Inc | Safety medical syringe with retractable needle |
US6186982B1 (en) * | 1998-05-05 | 2001-02-13 | Elan Corporation, Plc | Subcutaneous drug delivery device with improved filling system |
US6019750A (en) | 1997-12-04 | 2000-02-01 | Baxter International Inc. | Sliding reconstitution device with seal |
JP2002508225A (en) * | 1997-12-16 | 2002-03-19 | メリディアン メディカル テクノロジーズ,インコーポレイテッド | Automatic syringe |
DE19835749C1 (en) | 1998-08-07 | 2000-02-03 | Dieter Perthes | Ready-to-use syringe for unstable drugs |
US5935104A (en) | 1998-08-21 | 1999-08-10 | Safety Medical Manufacturing, Incorporated | Safety medical syringe with retractable needle |
US6113583A (en) | 1998-09-15 | 2000-09-05 | Baxter International Inc. | Vial connecting device for a sliding reconstitution device for a diluent container |
JP2002537321A (en) | 1999-02-22 | 2002-11-05 | エラン コーポレイション ピーエルスィー | Solid oral dosage form containing enhancer |
US6224346B1 (en) | 1999-08-09 | 2001-05-01 | Medimop Medical Projects, Ltd. | Fluid pump |
-
1999
- 1999-11-12 US US09/439,614 patent/US6364865B1/en not_active Expired - Fee Related
- 1999-11-12 AU AU17198/00A patent/AU1719800A/en not_active Abandoned
- 1999-11-12 IL IL14308799A patent/IL143087A0/en unknown
- 1999-11-12 CA CA002350706A patent/CA2350706A1/en not_active Abandoned
- 1999-11-12 US US09/439,879 patent/US6645181B1/en not_active Expired - Fee Related
- 1999-11-12 WO PCT/US1999/026751 patent/WO2000029049A1/en not_active Application Discontinuation
- 1999-11-12 EP EP19990960296 patent/EP1128858A1/en not_active Withdrawn
- 1999-11-12 US US09/439,963 patent/US6478771B1/en not_active Expired - Fee Related
- 1999-11-12 JP JP2000582094A patent/JP2002529204A/en active Pending
- 1999-11-12 US US09/439,725 patent/US6641565B1/en not_active Expired - Fee Related
-
2002
- 2002-02-07 US US10/071,784 patent/US20020123719A1/en not_active Abandoned
- 2002-09-23 US US10/252,336 patent/US6723068B2/en not_active Expired - Fee Related
-
2003
- 2003-07-14 US US10/618,894 patent/US20040015134A1/en not_active Abandoned
- 2003-08-07 US US10/636,068 patent/US20040030285A1/en not_active Abandoned
Cited By (73)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8221362B2 (en) | 2002-07-02 | 2012-07-17 | Patton Medical Devices, Lp | Infusion device |
US7524300B2 (en) | 2002-07-02 | 2009-04-28 | Patton Medical Devices, Lp | Infusion device |
US8221361B2 (en) | 2002-07-02 | 2012-07-17 | Patton Medical Devices, Lp | Infusion devices |
US8262627B2 (en) | 2002-07-02 | 2012-09-11 | Patton Medical Devices, Lp | Infusion device |
US8777925B2 (en) | 2002-07-02 | 2014-07-15 | Medtronic Minimed, Inc. | Methods relating to infusion device |
US20040006316A1 (en) * | 2002-07-02 | 2004-01-08 | Patton Catherine C. | Infusion device and method thereof |
US20060217659A1 (en) * | 2002-07-02 | 2006-09-28 | Patton Catherine C | Infusion devices |
US20060264818A1 (en) * | 2002-07-02 | 2006-11-23 | Patton Catherine C | Infusion device |
US20060264900A1 (en) * | 2002-07-02 | 2006-11-23 | Patton Catherine C | Method relating to infusion device |
US20070049874A1 (en) * | 2002-07-02 | 2007-03-01 | Patton Catherine C | Infusion Device |
US20070049876A1 (en) * | 2002-07-02 | 2007-03-01 | Patton Catherine C | Infusion Device |
US20070049877A1 (en) * | 2002-07-02 | 2007-03-01 | Patton Catherine C | Infusion Device |
US20070049875A1 (en) * | 2002-07-02 | 2007-03-01 | Patton Catherine C | Infusion Device |
US20070093757A1 (en) * | 2002-07-02 | 2007-04-26 | Patton Catherine C | Infusion Device |
US8216208B2 (en) | 2002-07-02 | 2012-07-10 | Patton Medical Devices, Lp | Method relating to infusion device |
US9486575B2 (en) | 2002-07-02 | 2016-11-08 | Medtronic Minimed, Inc. | Infusion device |
US7935090B2 (en) | 2002-07-02 | 2011-05-03 | Patton Medical Devices, Lp | Infusion device |
US7338465B2 (en) | 2002-07-02 | 2008-03-04 | Patton Medical Devices, Lp | Infusion device and method thereof |
US20080172034A1 (en) * | 2002-07-02 | 2008-07-17 | Patton Catherine C | Methods Relating To Infusion Device |
US7731680B2 (en) | 2002-07-02 | 2010-06-08 | Patton Medical Devices, Lp | Infusion device |
US7704228B2 (en) | 2002-07-02 | 2010-04-27 | Patton Medical Devices, Lp | Infusion device |
US8366683B2 (en) | 2002-07-02 | 2013-02-05 | Patton Medical Devices, Lp | Infusion devices |
US8221386B2 (en) | 2002-07-02 | 2012-07-17 | Patton Medical Devices, Lp | Method relating to infusion device |
US20040116847A1 (en) * | 2002-09-12 | 2004-06-17 | Children's Hospital Medical Center | Method and device for painless injection of medication |
US20050245956A1 (en) * | 2002-11-26 | 2005-11-03 | Urs Steinemann | Insertion device for needle units |
WO2004047888A1 (en) * | 2002-11-26 | 2004-06-10 | Disetronic Licensing Ag | Insertion device for needle units |
US7780636B2 (en) | 2003-07-08 | 2010-08-24 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
EP1495775A1 (en) * | 2003-07-08 | 2005-01-12 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
WO2005002649A1 (en) * | 2003-07-08 | 2005-01-13 | Novo Nordisk A/S | Portable drug delivery device having an encapsulated needle |
US11654221B2 (en) | 2003-11-05 | 2023-05-23 | Baxter International Inc. | Dialysis system having inductive heating |
US20070293826A1 (en) * | 2004-02-17 | 2007-12-20 | Wall Eric J | Injection Device for Administering a Vaccine |
US7670314B2 (en) | 2004-02-17 | 2010-03-02 | Children's Hospital Medical Center | Injection device for administering a vaccine |
US20070276320A1 (en) * | 2004-02-17 | 2007-11-29 | Wall Eric J | Injection Device for Administering a Vaccine |
US7896841B2 (en) | 2004-02-17 | 2011-03-01 | Children's Hospital Medical Center | Injection device for administering a vaccine |
US7985216B2 (en) | 2004-03-16 | 2011-07-26 | Dali Medical Devices Ltd. | Medicinal container engagement and automatic needle device |
US8551047B2 (en) | 2005-08-22 | 2013-10-08 | Patton Medical Devices, Lp | Fluid delivery devices, systems and methods |
US9039660B2 (en) | 2005-11-03 | 2015-05-26 | Medtronic Minimed, Inc. | Fluid delivery devices, systems and methods |
US10342919B2 (en) | 2005-11-03 | 2019-07-09 | Medtronic Minimed, Inc. | Fluid delivery devices, systems and methods |
US8226614B2 (en) | 2005-11-03 | 2012-07-24 | Patton Medical Devices, Lp | Fluid delivery devices, systems and methods |
US11771823B2 (en) | 2005-11-03 | 2023-10-03 | Medtronic Minimed, Inc. | Fluid delivery devices, systems and methods |
US20070270768A1 (en) * | 2006-05-17 | 2007-11-22 | Bruno Dacquay | Mechanical Linkage Mechanism For Ophthalmic Injection Device |
US20100280494A1 (en) * | 2006-08-08 | 2010-11-04 | Matsuura James E | Catheter and array for anticancer therapy |
US20080281292A1 (en) * | 2006-10-16 | 2008-11-13 | Hickingbotham Dyson W | Retractable Injection Port |
US20080269668A1 (en) * | 2006-10-27 | 2008-10-30 | Keenan James A | Medical Microbubble Generation |
US8257338B2 (en) * | 2006-10-27 | 2012-09-04 | Artenga, Inc. | Medical microbubble generation |
US8600479B2 (en) | 2007-03-20 | 2013-12-03 | Peak Biosciences, Inc. | Guidance and implantation of catheters |
US20100222668A1 (en) * | 2007-03-20 | 2010-09-02 | Dalke William D | Guidance and implantation of catheters |
US20110135569A1 (en) * | 2007-03-20 | 2011-06-09 | Peak Biosciences Inc. | Method for therapeutic administration of radionucleosides |
WO2008115566A3 (en) * | 2007-03-20 | 2009-12-23 | Peak Biosciences, Inc. | Guidance and implantation of catheters |
US8470295B2 (en) | 2007-05-10 | 2013-06-25 | Peak Biosciences, Inc. | Methods of treatment of androgenic steroidal hormone dependent cancer with auger electron-emitting nucleoside analogs |
US20100233081A1 (en) * | 2007-05-10 | 2010-09-16 | Peak Bioscience, Inc. | Methods for administration of radiotherapeutic agents |
US20230277416A1 (en) * | 2007-12-31 | 2023-09-07 | Deka Products Limited Partnership | Method for fluid delivery |
US11642283B2 (en) * | 2007-12-31 | 2023-05-09 | Deka Products Limited Partnership | Method for fluid delivery |
US20120123346A1 (en) * | 2009-06-02 | 2012-05-17 | Sanofi-Aventis Deutschland Gmbh | Medicated module with needle guard |
US9226875B2 (en) | 2009-06-02 | 2016-01-05 | Yukon Medical, Llc | Multi-container transfer and delivery device |
US8979791B2 (en) * | 2009-06-02 | 2015-03-17 | Sanofi-Aventis Deutschland Gmbh | Medicated module with needle guard |
US9636277B2 (en) | 2010-04-29 | 2017-05-02 | Yukon Medical, Llc | Multi-container fluid transfer and delivery device |
US10729842B2 (en) | 2012-09-24 | 2020-08-04 | Enable Injections, Inc. | Medical vial and injector assemblies and methods of use |
US9925333B2 (en) | 2013-06-18 | 2018-03-27 | Enable Injections, Inc. | Vial transfer and injection apparatus and method |
US11040138B2 (en) | 2013-06-18 | 2021-06-22 | Enable Injections, Inc. | Vial transfer and injection apparatus and method |
US20230312147A1 (en) * | 2013-07-03 | 2023-10-05 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US20220063847A1 (en) * | 2013-07-03 | 2022-03-03 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US11597541B2 (en) * | 2013-07-03 | 2023-03-07 | Deka Products Limited Partnership | Apparatus, system and method for fluid delivery |
US11406565B2 (en) | 2015-03-10 | 2022-08-09 | Regeneran Pharmaceuticals, Inc. | Aseptic piercing system and method |
US10182969B2 (en) | 2015-03-10 | 2019-01-22 | Regeneron Pharmaceuticals, Inc. | Aseptic piercing system and method |
US10434299B2 (en) | 2015-06-19 | 2019-10-08 | Fresenius Medical Care Holdings, Inc. | Non-vented vial drug delivery |
US9974942B2 (en) * | 2015-06-19 | 2018-05-22 | Fresenius Medical Care Holdings, Inc. | Non-vented vial drug delivery |
US20160367746A1 (en) * | 2015-06-19 | 2016-12-22 | Fresenius Medical Care Holdings, Inc. | Non-Vented Vial Drug Delivery |
US10660823B2 (en) * | 2016-01-29 | 2020-05-26 | Credence Medsystems, Inc. | System and method for injection component preparation |
US11191895B2 (en) * | 2016-06-08 | 2021-12-07 | Shl Medical Ag | Device and system for dispensing a fluid under aseptic conditions |
US11547801B2 (en) | 2017-05-05 | 2023-01-10 | Regeneron Pharmaceuticals, Inc. | Auto-injector |
US10814062B2 (en) | 2017-08-31 | 2020-10-27 | Becton, Dickinson And Company | Reservoir with low volume sensor |
USD1007676S1 (en) | 2021-11-16 | 2023-12-12 | Regeneron Pharmaceuticals, Inc. | Wearable autoinjector |
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US6478771B1 (en) | 2002-11-12 |
US6645181B1 (en) | 2003-11-11 |
US6641565B1 (en) | 2003-11-04 |
IL143087A0 (en) | 2002-04-21 |
US20040015134A1 (en) | 2004-01-22 |
WO2000029049A1 (en) | 2000-05-25 |
US20040030285A1 (en) | 2004-02-12 |
AU1719800A (en) | 2000-06-05 |
US6364865B1 (en) | 2002-04-02 |
WO2000029049A8 (en) | 2000-08-24 |
CA2350706A1 (en) | 2000-05-25 |
US6723068B2 (en) | 2004-04-20 |
JP2002529204A (en) | 2002-09-10 |
EP1128858A1 (en) | 2001-09-05 |
US20030023203A1 (en) | 2003-01-30 |
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