CN1190599A - Complete set of commodity, equipment and spare parts for external use of intestines and stomach - Google Patents

Complete set of commodity, equipment and spare parts for external use of intestines and stomach Download PDF

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Publication number
CN1190599A
CN1190599A CN97102415A CN97102415A CN1190599A CN 1190599 A CN1190599 A CN 1190599A CN 97102415 A CN97102415 A CN 97102415A CN 97102415 A CN97102415 A CN 97102415A CN 1190599 A CN1190599 A CN 1190599A
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CN
China
Prior art keywords
cylinder
container
intermediate store
dose
equipment
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Pending
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CN97102415A
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Chinese (zh)
Inventor
约尔格-克里斯提安·哈格
克特·格布哈特
赫尔穆特·洛尼奇
乌尔里希·巴斯特克
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Sanofi Aventis Deutschland GmbH
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Rhone Poulenc Rorer GmbH
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Priority to CN97102415A priority Critical patent/CN1190599A/en
Publication of CN1190599A publication Critical patent/CN1190599A/en
Pending legal-status Critical Current

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Abstract

The characteristic lies in that the complete set of commodity consists at least one syringe needle, a devices for delivering one dose of the specific liquid medicine, at least one container filled with said liquid medicine, the container can be put in the device and with the aid of device to evacuate one dosage of said liquid medicine. It provided also the facility for delivering the specific liquid volume of the specific medicinal product and the complete set of spare parts. By using said apparatus, the user can simply administrate the liquid medicine at the best subcutaneous potition.

Description

Complete commodity, equipment and complete spare unit that parenteral uses
The present invention relates to complete commodity, a kind of equipment of this parenteral use and complete spare unit of above-mentioned complete commodity or equipment implemented that a kind of parenteral uses the liquid medicine goods.
But the liquid medicine goods that parenteral uses refer to, and are used for hypodermic those goods by means of syringe, and the professional who is subjected to medical training today, especially doctor or nurse extensively adopt.Use traditional syringe, syringe is wanted the relevant liquid medicine goods of filling before parenteral uses for this reason.Or this liquid medicine goods have been housed in advance as disposable syringe.But this means that this user must be undertaken by doctor's operation, this for every day predetermined restricted in the time in order to treat the liquid medicine goods that diseases associated must the subcutaneous injection ormal weight, all too has bothered.
The objective of the invention is to provide a kind of probability, and this probability has been arranged, this user can be especially simply at the pharmaceutical preparation of parenteral and a kind of liquid of best subcutaneous use.
By the present invention for reaching this purpose, employing has the complete commodity of the described feature of claim 1, employing has the equipment of the described feature of claim 11, and, adopt and to replenish in case of necessity by the described complete commodity of claim 1 or by the complete spare unit with the described feature of claim 34 of the described equipment of claim 11.
In the treatment time of requirement, be used for the complete commodity that parenteral uses the liquid medicine goods by the present invention by user, based on following basic concept, promptly, during the treatment of doctor formula regulation, for user provides all necessary commodity, thereby make user have the ability do not having medical professional nation to help down, oneself is at parenteral and be preferably in the needed liquid medicine goods of subcutaneous use.Therefore, at least comprise a syringe needle by complete commodity of the present invention, an equipment that is used for by the pharmaceutical preparation amount of liquid of dose output regulation, and at least one is filled with the container of liquid medicine goods, but in the container load facility, and can press the dose emptying by means of equipment, and wherein, the pharmaceutical preparation amount of liquid that each dose is equivalent to stipulate.In other words, what user need be done is, being used in being included in complete commodity exported the equipment of the standard solution scale of construction, load onto the syringe needle that in complete commodity, has equally, and the container that in addition will be filled with the liquid medicine goods again inserts in this outut device, just can be at parenteral and the best subcutaneous use dose by the pharmaceutical preparation of doctor formula regulation so be right after after this user.
By complete commodity of the present invention series of advantages is arranged.The prerequisite of at first guaranteeing is, press complete commodity of the present invention in the unit of a unique sale, comprise that user needed all being used for use desired articles for use at parenteral, so these articles for use can be kept in these corresponding complete commodity by user oneself during the user treatment together on the one hand, and on the other hand for the doctor who prescribes work very simple, it can be split into prescription with this complete commodity integral body.Because be included in the outut device in the complete commodity, in view of its structure, forcibly determined pharmaceutical preparation amount of liquid for each dose defined, so can not cause the liquid medicine product dosage to surpass or not enough by complete commodity of the present invention, therefore the parenteral of the liquid medicine goods that undertaken by user uses as safe as a house.In addition, user has whole orders to place at one's fingertips and the open-and-shut parenteral that is used for uses required articles for use, has therefore significantly improved user to the examination by the complete commodity of the present invention.In addition, prevent to pollute the articles for use that include by complete commodity of the present invention, especially in the use of user, and shipping and depositing because it is designed to black box institute, this commercial be tangible especially advantage.
By first kind of form of implementation of the complete commodity of the present invention regulation, these complete commodity have and the quantity of the pharmaceutical preparation dose that will the use syringe needle as respective numbers.Therefore user can will be replaced with the corresponding syringe needle of an aseptic packaging at the syringe needle that this time uses after parenteral uses the liquid medicine goods, thus the danger of avoiding infection reliably especially.The syringe needle preferred design that is placed in the complete commodity becomes like this, and promptly the real pin of syringe needle is protected with a solid plastic cover, and this solid plastic cover guarantees the aseptic of syringe needle on the one hand, and it is injured to prevent that on the other hand user itself from bumping because of carelessness on syringe needle.Specifically include this syringe needle of being introduced above ten in this type of form of implementation of complete commodity, therefore be placed on container in these complete commodity and that be filled with the liquid medicine goods, ten doses that correspondingly can have parenteral to use.
In order to make user when parenteral uses the liquid medicine goods, can use more easily by complete commodity of the present invention, another kind of favourable design code, in complete commodity, also include its quantity and the corresponding pledget of syringe needle quantity, wherein these pledgets are impregnated with disinfectant solution, for example low ethanol, ethanol, propanol.For preventing the undesirable evaporation of disinfectant solution in pledget, so will flood the pledget of disinfectant solution is packaged individually in the suitable thin film preferably in plastic sheeting and the especially laminated film, user is before parenteral uses pharmaceutical preparation, at first from packing, take out pledget, then the injection site sterilization of selecting for user with it.
In by the another kind of form of implementation in the complete commodity of the present invention, also have a zone in these complete commodity, be used for depositing exhausted syringe needle and/or exhausted pledget.The zone that is used to deposit exhausted syringe needle and/or exhausted pledget is preferably designed as, when using these complete commodity these exhausted syringe needles and/or exhausted pledget not from then on the zone drop out, so this zone especially is designed to enclosed areas separately.If this zone design for example is designed to closed box for detachably being contained in the zone in the complete commodity, so, if wish or because laws and regulations requirement, just can with exhausted syringe needle and in case of necessity pledget for example carry out waste disposal individually by specialized department.
In by complete commodity of the present invention, a container can be arranged in principle, a plurality of doses of liquid medicine goods are housed in the container,, and can press the dose emptying by means of this equipment in this case as long as guarantee that with this Vessel Design be in the energy insertion equipment.Yet particularly advantageously be, will be by the liquid medicine goods of dose by the use of user parenteral, fill in the glass ampule (syringe of glass) of a column type or drum type brake, this glass ampule especially is equipped with the liquid medicine goods of about 1.5ml to about 8ml, is preferably in about 2ml between about 6ml.
The particularly advantageous improvement regulation of above-mentioned glass ampule, in by complete commodity of the present invention, be provided with such glass ampule, promptly, its end section has a kind of puncture thin film and top plug closes, wherein, stopper be designed to can be in glass ampule vertically along with the decline of the liquid levels direction towards the puncture thin film moves.This special design of glass ampule has outstanding advantage, the bottom of stopper be close near the liquid levels or even contact with it, therefore when liquid levels descends, above relevant liquid level, there is not any mattress owing to repeatedly export dose.The benefit of making like this, prevent to produce the oxidation reaction of undesirable relevant liquid medicine goods on the one hand, adopt this particular design of stopper on the other hand, prevent from effectively to form vacuum because of amount of liquid reduces in glass ampule, this vacuum can cause harmful effect for the accuracy by dose output liquid amount.
(the foregoing stopper that vertically can towards puncture thin film direction move wherein be housed) in the form of implementation for the glass ampule introduced in the above, guarantee the sealing that between stopper and glass inwall, requires, one by the complete commodity of the present invention is improved regulation, has one at least at the stopper outer surface, best 2 to 5 plate-like sections that radially outwards refer to.When inserting stopper in the glass ampule, they are pressed against the sealing surface of fluid-tight on the ampoule inner surface and air seal and can be out of shape in order to constitute one.Outwards the plate-like section of Zhiing is preferably designed as like this, that is, the end of plate-like section is because stopper moves in glass ampule, and inverse move direction strain is to constitute a corresponding larger-size sealing surface.The manufactured materials of relevant stopper is preferably selected elastic chemically stable plastics or elastomeric material for use, has confirmed already that specially suitable was butyl halide rubber.
If above-mentioned stopper in glass ampule available one move less than the power between the most handy 4N to 8N of power of 10N, can guarantee especially that then above-mentioned every advantage has fabulous repeatability.
By means of by complete commodity of the present invention, all liquid medicine goods with storage stability all can be used at parenteral by user in principle.Here, this term of liquid medicine goods comprises all such goods, that is, they itself are liquid as real product, or, can be processed into liquid harmless on the organic or inorganic physiology by their stable solution, stable dosage or stable Emulsion.In the glass ampule of said vesse or above-mentioned best applications, preferably adorn a kind of special Enoxaparin-Natrium aqueous solution.Complete commodity of this class thereby be applied to such user, that is, these user are in view of its disease, and the doctor thinks must be chronically but all need heparin dose by fixed dose every day.Even so that patient is allowed to leave the danger that also can for example prevent tampon after the hospital.Performing another can think by the best applications of the complete commodity of the present invention, use the growth hormone of regulation and fixed amount regularly at parenteral, for this application scenario, be filled with a kind of growth hormone solution in container and the especially above-mentioned glass ampule, preferably the growth hormone aqueous solution.In the application's scope, this term of water not only is interpreted as water deionized water or distillatory, and refers to all Aquo Systems, especially normal saline or neutral solution.
In addition, the invention still further relates to a kind of equipment that is used for by the pharmaceutical preparation amount of liquid of dose output regulation, in this case, have one to be located at the zone that enclosure is used to install the container that is filled with the liquid medicine goods by equipment of the present invention.In addition, be provided with the output area of a pharmaceutical preparation dose by equipment of the present invention, when the pharmaceutical preparation of user oneself at parenteral and especially subcutaneous this dose of use, this user is just pointed in the output area.In pressing equipment of the present invention, the container that includes a plurality of doses connects into by intermediate store and output area, under container inserts by the state in the equipment of the present invention, the standard solution scale of construction of each dose, at first can transfer to intermediate store from container, then can be to the output area from middle memory transfer.By in the equipment of the present invention,, can determine the amount of the liquid medicine goods of each dose output by the volume of intermediate store.In other words, in pressing equipment of the present invention, by changing the volume of intermediate store, can change the amount that adopts the spendable dose of equipment parenteral of the present invention, in this case, the volume of intermediate store is advantageously selected to like this, promptly, each dose of the liquid medicine goods that use especially between 0.2ml and 0.6ml, is preferably between 0.2ml and the 0.4ml between 0.1ml and 1ml.
By equipment of the present invention a series of advantage is arranged.At first, it has a kind of fairly simple and uncomplicated structure, and can operate especially easily, because in order to use by equipment of the present invention, only need user will include the container of the liquid medicine goods of a plurality of doses, laying in the set zone of container in the load facility, and container can be braked there in case of necessity, then, automatically finish being connected and the connection from middle memorizer to the output area again of container and intermediate store at device interior.In other words, the mode of being introduced with this paper preface of carrying out is different, there, the liquid medicine goods that use for parenteral will pass through doctor or medical professional, and when adopting by equipment of the present invention, the goods that this user need not will use are again transferred to the syringe from ampoule bottle, and read the dosage accurately that will inject at the syringe place, because this process is in pressing equipment of the present invention, so because its structure is to force to realize.This just means when using by equipment of the present invention light unexpectedly, even patient and/or elderly patients also have the ability, by means of by equipment of the present invention for oneself applying the desired dose of goods that parenteral uses, need not any foreign aid and given directions.
For in by equipment of the present invention with being connected between the container in insertion equipment once mentioned above the very simple method design and the intermediate store, improve regulation by one of the present invention, between the container that has inserted and intermediate store of a plurality of doses of interior dress liquid medicine goods, be shaped on an interface channel at least.Here, an end of this interface channel, preferably stretch into the enclosure that is located at by present device and be used to settle in the zone of this container that is filled with pharmaceutical preparation, so, when container inserts, can couple together with the container that has inserted easily by this end.If what do that the container of intermediate store uses is the glass ampule that the front had been introduced in by complete commodity of the present invention, this glass ampule especially bottom is provided with the puncture thin film of having mentioned the front, chance then is provided, this end of interface channel is designed to corresponding end of fining away, or be preferably designed as hollow needle, so, pierce through this thin film by the end of this sharpening or by this hollow needle, and thereby with easy especially method, that once mentioned above can setting up between the content of glass ampule and intermediate store gets in touch.Puncture thin film this pierces through also can become by the following stated and is more prone to, that is, for the end or the hollow needle of fining away sets the brake component that is used for glass ampule, by this brake component preferably with the ampoule cervical region and thereby whole ampoule be fixed on its position.If this braking district is designed to screw thread or bayonet coupling, wherein, this screw thread or bayonet coupling can have the part engagement of respective shapes with the ampoule cervical region, then when being screwed into or being fixed on this braking district, forcibly finished by ampoule the axially-movable of ampoule towards closure, so the puncture thin film has just been pierced through in the end that is designed to fine away or the end of hollow needle, and thereby provide the liquid medicine goods to enter the flow path of intermediate storage area from glass ampule.
In pressing an improvement of the above-mentioned form of implementation of present device, for interface channel is equipped with a valve, it prevents that liquid stream from returning container from middle memory stream.In other words, by this embodiment of present device such interface channel is arranged, promptly it is provided with a check valve, so the liquid that relevant parenteral uses only along single flow direction, that is from the container to the intermediate store, flows through interface channel.
Relevant for the design of above-mentioned valve, as introducing in the above, it prevents that the liquid medicine goods are back to the container from middle memorizer, exist multiple probability.For example, this check valve can be designed to traditional ball valve.But particularly suitable is to be diaphragm valve with this one-way valve designs, wherein, the valve block of handy rubber elastic material system, can between the primary importance and the second position, move, in primary importance, valve block covers the part channel section of interface channel towards container, and in the second position, and valve block moves and thereby allows that liquid flows into intermediate store from container towards the intermediate store direction.For prevent that circular valve block from sticking on the primary importance and thereby disturb the working method of check valve, probability here is provided, be provided with one and annularly decide square spare, valve block leans against in its primary importance to be decided on the square spare, so annular decide square spare and has been reduced sealing surface on the whole, also will be as the back by means of the embodiment detailed description.
For by filling the dose of liquid medicine goods from container to intermediate store in the equipment of the present invention, can realize as described below that this fills, that is, the content of container enters intermediate store and it is full of under action of gravity.But more appropriate is, a piston that can move towards the output area direction vertically is set in intermediate store inside, wherein, when the output area direction is done this type of and moved axially, make the dose of the liquid medicine goods that contain at intermediate store shift to the output area at piston.When doing reciprocal with it moving axially, then being connected between intermediate store and the output area sealed airtightly, in intermediate store, produce vacuum, so one be located at the interface channel that extends by piston between container and the intermediate store, make the liquid of intermediate store filling from the container that the liquid medicine goods are housed.Intermediate store is such to be filled with outstanding advantage, it can make calm device enter intermediate store is that the amount of liquid of accurately stipulating has repeatability, therefore, the dose of the spendable liquid medicine goods that obtained from middle memorizer by user can very accurately and have repeatability.
In order in by equipment of the present invention, to be reached for the required set prior airtight partition of passage between intermediate store and output area of filling, exist multiple probability.For example in this passage, establish a valve, especially check valve equally, it only allow liquid from memory stream to the output area, but do not allow air or liquid to flow to intermediate store from the output area.But appropriate is for passage sets one can be from the closure member of external control corresponding valve for example.
By the maneuverable especially form of implementation regulation of a kind of durable in use and user of present device, the closure member of the passage of having mentioned above that can seal connection output area and intermediate store airtightly, removable lid in passage is designed to attach troops to a unit.The seal area of lid covers the outer tunnel mouth that is located on the output area airtightly.This lid is preferably designed as one can be fixed on equipment output area and/or shell connection by screw thread or bayonet coupling.If now for this form of implementation by present device, intermediate store should be by the top mode of introducing when container charges into the dose of liquid medicine goods, this should prevent that with regard to meaning the passway of air from be located at the output area from flowing to intermediate store, and thereby in intermediate store, be produced as the required vacuum of filling intermediate store, so this lid should be contained on the respective area of output area or shell, its set seal area and passway on this closure member is in engagement.After intermediate store is full of, remove this lid on the output area of slave unit or the respective area of shell, the dose of the liquid medicine goods that therefore exist in intermediate store can be by piston towards the output area and the moving axially from by discharging the equipment of the present invention of opened channel direction this moment.
About aspect the liquid medicine product amount height of each dose output repeatable, reach in this form of implementation by present device, that is, guarantee to be emptied completely intermediate store by being located at piston in the intermediate store when the output area direction moves axially.
In addition, by this emptying up hill and dale, prevent the unnecessary crystallization of remaining deposits yields or the deposition of the pharmaceutical preparation on intermediate store and/or piston wall, if this phenomenon is arranged, can influence the dosage accuracy to each dose on the one hand, entail dangers to is by the work of present device on the other hand.
A kind of particularly advantageous form of implementation by present device, can get rid of dose with having smoothly from middle memorizer repeatedly, wherein stipulate, intermediate store is designed to cylindrical, and there is one to be attached thereto and towards the petiolarea of the tapered design of output area direction, wherein, the passage introduced by the front of petiolarea is connected with follower.In addition, in this design, the shape of the intermediate store that the shape of piston and front are introduced is complementary, so piston has the petiolarea of a cylindrical piston district and a taper that links to each other with this district.If in pressing this form of implementation of present device, the interface channel that is located between container and the intermediate store is further extended, pass the cylindrical piston district in the piston top that extends to taper, then in pressing this design of present device, not only guaranteed thorough emptying, and guaranteed that highly intermediate store can have repeated filling.
There is multiple probability in the design that relates to the tapered piston petiolarea.For example the piston petiolarea of this taper is used with remainder piston commaterial and is made, but the sleeve pipe that the piston petiolarea of taper is extended by taper in a kind of particularly advantageous form of implementation constitutes, and it is in that end sealing in its counterpiston district.In the sleeve pipe of this conical design, it is located between container and the intermediate store almost along the interface channel of its whole axial lengths to be extended with one, and wherein, the sleeve pipe of conical design has some to be used as outlet opening from the liquid of container on its outer surface.Guarantee the dose of intermediate store filling successfully thus from the liquid medicine goods of container.
In equipment of the present invention, exist this probability in principle, promptly, be contained in the dose of the liquid medicine goods in the intermediate store, can directly use at parenteral by a high pressure that applies thereon by the output area that is connected with intermediate store via passage.But appropriate especially is, there is a construction section that is used for detachably fixing a syringe needle output area, and this construction section is designed to make passage to be connected with syringe needle fluid-tight ground.Therefore in pressing this form of implementation of present device, a removable syringe needle fixed thereon is housed on the construction section, syringe needle thrusts in the body part selected by user when using the liquid medicine goods then, and implements the parenteral use of these goods there.
Press the improvement regulation of this embodiment of present device, the lid of introducing above on construction section, can also additionally detachably installing, when the intermediate store filling, the effect of lid is to close passage set between intermediate store and output area.Relevant with the design of construction section and lid, or lid and syringe needle are fixed on the construction section simultaneously, or according to being chosen in fixed cap or fixed needle on the construction section, wherein, this probability of back is preferential the selection, is taking danger that Gai Houyou be subjected to still be fixed on the injury of syringe needle construction section on because avoided here.
By the another kind of embodiment regulation of present device, for construction section sets a sheath, in this case, this sheath covers a syringe needle that is fixed on the construction section at least partly or fully.Meanwhile, prevent that this sheath that this user injures by syringe needle because of carelessness can fixed cap, or can additionally assist to cover fixing on construction section, thus having formed a grip region, he can hold grip region when user is prepared to use by equipment of the present invention.
In the suitable especially form of implementation of the another kind of present device, comprise first cylinder of a cased portion and round one second cylinder of first cylinder, wherein, first cylinder and second cylinder can move with respect to shell vertically.In first cylinder, be provided with the zone that container is installed, in particular for the zone of above-mentioned ampoule is installed, and in second cylinder, be provided with the intermediate store that is connected with container.In pressing this embodiment form of present device, first and second cylinders can move between the primary importance and the second position vertically and can do reverse with it moving vertically, in primary importance, the syringe needle that may be locked on the construction section is protruding above the shell of above-mentioned sheath or equipment.And at this position intermediate store by passage and the syringe needle emptying that is attached thereto, and in the second position, the syringe needle that may be locked on the construction section is covered by sheath, and at this position intermediate store filling dose.
Above-mentioned form of implementation by present device allows to use the corresponding dose of liquid medicine goods in very simple mode at parenteral.For these needs from primary importance, be empty at person's one position intermediate store, first and second cylinders move with respect to shell vertically by these cylinders, are displaced to the second position.This axially movable result is, makes intermediate store be full of liquid from container.After being installed in a suitable syringe needle on the construction section, move axially by the direction of these two cylinders towards construction section, implement syringe needle thrusting in the user body part, the emptying intermediate store, and thereby the parenteral of having finished dose use.Yet these two cylinders are preferably designed as like this, promptly, they additionally can also move axially relatively each other, so, between the emptying of actual process of thrusting the user body part of syringe needle and intermediate store, also there is a time difference, and thereby can has a time delay ground to use the liquid medicine goods.
In order to make these two cylinders carry out above-mentioned moving axially from the primary importance to the second position and from the second position to the primary importance, can manually implement this moving axially along both direction.But this means, this by user carry out with two cylinders from the second position to the transfer process of primary importance, syringe needle thrusts body part must be undertaken by the own manual operating of user, this is bored to death for some user, and to some user even think the obstacle that can't go beyond.Therefore, a kind of particularly advantageous improvement of the above-mentioned form of implementation of present device regulation, first and second cylinders respectively set a spring, and are designed to, at these two springs of the second position of cylinder by tight, and in the primary importance release of cylinder.
On the second position for the corresponding spring compression of quilt that two cylinders is fixed on they, in by equipment of the present invention, respectively be provided with a brake component that is used for each cylinder.Attach troops to a unit in the brake component of second cylinder by release, second cylinder just can be under the spring force effect of the spring that is equipped on second cylinder, be displaced to primary importance from the second position, consequently, a syringe needle that is locked on the construction section is subjected to forcibly and not user is any to be thrust in the selected body part with influencing.Discharge then and attach troops to a unit in the brake component of first cylinder, therefore first cylinder is under the effect of the spring that is equipped on first cylinder, vertically towards output area direction motion, and thereby the emptying intermediate store, thereby applied the corresponding dose of liquid medicine goods at parenteral.
By a kind of appropriate especially of the above-mentioned form of implementation of present device and can be by this user convenient and do not have in the improvement of adopting difficultly, two cylinders can be locked in the second position with a unique brake component.This means that user need only discharge this single brake component,, implement the thrust process of syringe needle in body part and injection dose thus so that two cylinders that will be locked in the second position and receive spring force are displaced to primary importance together.
In order in above-mentioned form of implementation, to reach by present device, at first carry out syringe needle and thrust body part, implement the injection of dose then, some springs that had in a kind of appropriate especially improvement by this form of implementation that is equipped with invention equipment, they match each other with their spring characteristic curve.Wherein, the spring that is equipped on second cylinder has than the steeper spring characteristic curve of spring that is located on first cylinder, so by coordinating the spring characteristic curve of these two springs, that can adjust in a wide scope that the front mentioned thrusts and and then injects temporal delay between the two at syringe needle.
In pressing the another kind of favourable form of implementation of present device, one first cylinder and second cylinder round first cylinder are equipped with in portion in the enclosure, and wherein, first and second cylinders can move with respect to shell vertically.Be useful on the container of packing in the design of first cylinder interior, especially the zone of the glass ampule introduced of front and be provided with the intermediate store that is connected with container in second cylinder interior, they are designed to, first and second cylinders together, can shift to the second position and move with respect to shell vertically in contrast from primary importance, in primary importance, the syringe needle that may be locked on the construction section stretches out above sheath or shell, and be empty at this position intermediate store, in the second position, the syringe needle that may be locked on the construction section is covered by sheath.For the filling intermediate store, first cylinder can be with respect to the second position of second cylinder, further moves on to the 3rd position vertically towards the direction of container.
In other words, by this above-mentioned particularly advantageous design of present device, the form of implementation of some equipment of introducing with the front is different, and cylinder can only be taked first and second positions there, and one the 3rd position in addition in this design.
In order to utilize by equipment of the present invention, from the primary importance of two cylinders, two cylinders at first move on to the second position, and consequently, the syringe needle that is locked on the construction section is covered by sheath.At this constantly, intermediate store does not also fill the dose with the liquid medicine goods.And then, first cylinder moves on to the 3rd position towards the direction of container vertically with respect to second cylinder of still staying the second position, therefore, intermediate store by interface channel from the complete full of liquid pharmaceutical preparation of container.First cylinder from the second position to the process of this transfer of the 3rd position, connect the passage of syringe needle and intermediate store, the valve of having introduced by a front or seal airtightly by the lid of illustrating in front equally.Therefore, formed corresponding vacuum in intermediate store, this vacuum makes liquid import intermediate store from container, or causes from the liquid stream of container to intermediate store.
Perform therefrom and use the equipment of preparing then to contact with the body region of choosing, then, user is transferred to primary importance with second cylinder from the second position, so manual operating ground carries out the thrust process of syringe needle in this body region.Afterwards, user with first cylinder from the 3rd position transfer to primary importance, thereby cause in body, correspondingly injecting the dose of liquid medicine goods from middle memorizer.
As the front had been mentioned, such use was had any problem to some user, because they must thrust they self intravital process of thrusting with syringe needle by finishing themselves.For avoiding so doing, press an improvement regulation of the above-mentioned form of implementation of present device, be each cylinder (first cylinder, second cylinder) respectively sets a spring, wherein, preloading power when first spring is in the 3rd position in the position of first cylinder, preloading power when second spring is in the second position in the position of second cylinder.In addition, first cylinder can be fixed on the 3rd position with first brake component, and second cylinder can be fixed on the second position with second brake component, and they are designed to, and this fixing of adopting corresponding brake component to carry out preferably can discharge by a unique release-push.
In order to use this kind equipment, this user is transferred to the second position with the power that second cylinder overcomes corresponding second spring, and wherein, this of second cylinder moves axially preferably and undertaken by a moving member that is located at enclosure.When handling this moving member, the power that first cylinder overcomes first spring moves on to its second position, and in this case, second brake component is fixed on this second position with second cylinder.When further handling this moving member, first cylinder overcomes the power of corresponding first spring, moves on to the 3rd position with respect to second cylinder from the second position vertically, and is fixed on this 3rd position by first brake component.
By handling common release-push, under the resilient force of first and second springs, (first cylinder) or the second position (second cylinder) move to primary importance vertically from the 3rd position to make two cylinders, thereby thrust syringe needle in the body part forcibly under the influence that does not have user and finish from the injection of the dose of middle memorizer.
One of above-mentioned form of implementation is improved regulation, by handling common release-push, at first can discharge second brake component and lingeringly discharge first brake component then, and the former is fixed on the second position with second cylinder, and the latter is fixed on the 3rd position with first cylinder.
Especially, in the above-mentioned complete commodity of discussing when being applied to this paper and beginning, but also can sell in the shop under the situation of complete commodity not having by equipment of the present invention itself by equipment of the present invention.
In addition, the invention still further relates to complete spare unit, be used for that this paper begins to introduce by complete commodity of the present invention or top set forth by equipment of the present invention.
Comprise that by complete spare unit of the present invention at least one syringe needle and at least one are filled with the container of liquid medicine goods, container can insert above-mentioned by equipment of the present invention, and can press the dose emptying by means of this equipment.
By complete spare unit of the present invention outstanding advantage is arranged, aspect its construction features, both mated ideally in above-mentioned complete commodity, mate again with by equipment of the present invention, so, above-mentioned by complete commodity of the present invention or above-mentioned user by equipment of the present invention, just can be when following situation be arranged, use by complete spare unit of the present invention, promptly require for a long time to use the liquid medicine goods and will be included in the above-mentioned container that is filled with the liquid medicine goods in by complete commodity of the present invention when being drained through clocklike using at parenteral according to doctor's advice.
First kind of design code by the complete spare unit of the present invention is provided with an extracting tool in these complete spare unit, be used for splitting out by equipment of the present invention the container of emptying, and this equipment is used for the amount of liquid by dose output regulation.According to being located at the specific design that is used to install the zone of the container that is filled with the liquid medicine goods by the present device enclosure, also just determined the structure of extracting tool, extracting tool preferably have one by the user grasping means, and have one to be used for matching and/or the canned paragraph of emptying receptacles is caught in the effect of power by shape.
As like that pressing first kind of form of implementation of the complete spare unit of the present invention and stipulating by illustrate in the complete commodity of the present invention in front, these complete spare unit have and the quantity of the pharmaceutical preparation dose that will use is the syringe needle of respective numbers.Therefore user can will be replaced with the corresponding syringe needle of an aseptic packaging at the syringe needle that this time uses after parenteral uses the liquid medicine goods, thus the danger of avoiding infection especially reliably.The syringe needle preferred design that is placed in the complete spare unit becomes like this, and promptly the real pin of syringe needle is protected with a solid plastic cover, and this solid plastic cover guarantees the aseptic of syringe needle on the one hand, and it is injured to prevent that on the other hand user itself from bumping because of carelessness on syringe needle.Specifically include this syringe needle of being introduced above ten in this type of form of implementation of complete spare unit, therefore be placed on container in these complete commodity and that be filled with the liquid medicine goods, ten doses that correspondingly can have parenteral to use.
In order to make user when parenteral uses the liquid medicine goods, can use more easily by complete spare unit of the present invention, another kind of favourable design code, in complete spare unit, also include its quantity and the corresponding pledget of syringe needle quantity, wherein these pledgets are impregnated with disinfectant solution, for example low ethanol (ethanol, propanol).For preventing the undesirable evaporation of disinfectant solution in pledget, so will flood the pledget of disinfectant solution is packaged individually in the suitable thin film preferably in plastic sheeting and the especially laminated film, user is before parenteral uses pharmaceutical preparation, at first from packing, take out pledget, then the injection site sterilization of selecting for user with it.
In by the another kind of form of implementation in the complete spare unit of the present invention, also have a zone in these complete spare unit, be used for depositing exhausted syringe needle and/or exhausted pledget.The zone that is used to deposit exhausted syringe needle and/or exhausted pledget is preferably designed as, when using these complete spare unit these exhausted syringe needles and/or exhausted pledget not from then on the zone drop out, so this zone especially is designed to enclosed areas separately.If this zone design for example is designed to closed box for detachably being contained in the zone in the complete spare unit, so, if wish or because laws and regulations requirement, just can with exhausted syringe needle and in case of necessity pledget for example carry out waste disposal individually by specialized department.
In by complete spare unit of the present invention, a container can be arranged in principle, a plurality of doses of liquid medicine goods are housed in the container,, and can press the dose emptying by means of this equipment in this case as long as guarantee that with this Vessel Design be in the energy insertion equipment.Yet particularly advantageously be, will be by the liquid medicine goods of dose by the use of user parenteral, fill in the glass ampule of a column type or drum type brake, this glass ampule especially is equipped with the liquid medicine goods of about 1.5ml to about 8ml, is preferably in about 2ml between about 6ml.
The particularly advantageous improvement regulation of above-mentioned glass ampule, in by complete spare unit of the present invention, be provided with such glass ampule, promptly, its end section has a kind of puncture thin film and top plug closes, wherein, stopper be designed to can be in glass ampule vertically along with the decline of the liquid levels direction towards the puncture thin film moves.This special design of glass ampule has outstanding advantage, the bottom of stopper be close near the liquid levels or even contact with it, therefore when liquid levels descends, above relevant liquid level, there is not any mattress owing to repeatedly export dose.The benefit of making like this, prevent to produce the oxidation reaction of undesirable relevant liquid medicine goods on the one hand, adopt this particular design of stopper on the other hand, prevent from effectively to form vacuum because of amount of liquid reduces in glass ampule, this vacuum can cause harmful effect for the accuracy by dose output liquid amount.
(the foregoing stopper that vertically can towards puncture thin film direction move wherein be housed) in the form of implementation for the glass ampule introduced in the above, guarantee the sealing that between stopper and glass inwall, requires, one by the complete spare unit of the present invention is improved regulation, has one at least at the stopper outer surface, best 2 to 5 plate-like sections that radially outwards refer to.When inserting stopper in the glass ampule, they are pressed against the sealing surface of fluid-tight on the ampoule inner surface and air seal and can be out of shape in order to constitute one.Outwards the plate-like section of Zhiing is preferably designed as like this, that is, the end of plate-like section is because stopper moves in glass ampule, and inverse move direction strain is to constitute a corresponding larger-size sealing surface.The manufactured materials of relevant stopper is preferably selected elastic chemically stable plastics or elastomeric material for use, has confirmed already that specially suitable was butyl halide rubber.
If above-mentioned stopper in glass ampule available one move less than the power between the most handy 4N to 8N of power of 10N, can guarantee especially that then above-mentioned every advantage has fabulous repeatability.
By means of by complete spare unit of the present invention, again in conjunction with by equipment of the present invention or by complete commodity of the present invention, all liquid medicine goods with storage stability all can be used at parenteral by user in principle.Here, this term of liquid medicine goods comprises all such goods, that is, they itself are liquid as real product, or, can be processed into liquid harmless on the organic or inorganic physiology by their stable solution, stable dosage or stable Emulsion.In the glass ampule of said vesse or above-mentioned best applications, preferably adorn a kind of special Enoxaparin-Natrium aqueous solution.Complete commodity of this class thereby be applied to such user, that is, these user are in view of its disease, and the doctor thinks must be chronically but all need heparin dose by fixed dose every day.Even so that patient is allowed to leave the danger that also can for example prevent tampon after the hospital.Performing another can think by the best applications of the complete commodity of the present invention, use the growth hormone of regulation and fixed amount regularly at parenteral, for this application scenario, be filled with a kind of growth hormone solution in container and the especially above-mentioned glass ampule, preferably the growth hormone aqueous solution.
Press complete commodity of the present invention, press equipment of the present invention and press complete spare unit of the present invention by embodiment and accompanying drawings below, in the accompanying drawing:
Fig. 1 is the perspective view of a kind of form of implementation of complete commodity;
Fig. 2 is the equipment perspective illustration that is used for by the dose output standard solution scale of construction;
Fig. 3 is the exploded representation to Fig. 2;
Fig. 4 is the amplification schematic sectional view of lid;
Fig. 5 is can axially movable cylinder view sub-anatomy;
Fig. 6 is for first kind of form of implementation portion of the intermediate store after emptying view;
Fig. 7 is similar to Fig. 6, but has the intermediate store after being full of;
Fig. 8 is that check valve amplifies schematic sectional view;
Fig. 9 is the cutaway view of second kind of form of implementation of equipment of the intermediate store after band is full of: and
Figure 10 is the cutaway view of a kind of form of implementation of complete spare unit.
Part identical among Fig. 1 to 10 is represented with same label.
Totally represent that with label 1 also complete commodity shown in Figure 1 comprise an equipment 3 that is used to export by the dose pharmaceutical preparation standard solution scale of construction; Some syringe needles 2, syringe needle 2 are provided with corresponding needle guard 45 (Fig. 3), are used for the aseptic preservation of syringe needle 2; A glass ampule 8 is as the container that fills with the liquid medicine goods.In addition, also have the quantity of some quantity and syringe needle 2 to use the impregnated pledget 5 of disinfectant solution accordingly in the inside of complete commodity 1.These complete commodity 1 also have a zone 6 that is used to deposit exhausted syringe needle, wherein, in the represented form of implementation of Fig. 1, do not have the cap seal of expression to close among the available figure in this zone.If these zone 6 whole removable being contained in these complete commodity 1 then after putting into whole exhausted syringe needles, can be carried out waste disposal with this part 6 separately,, law does like this as long as having regulation or wish.Include 10 syringe needles 2 in the common complete commodity 1, therefore correspondingly in glass ampule, contain the amount of liquid that is useful on 10 doses therewith.Usually the amount of liquid by each dose output changes between 0.1ml and 1ml, therefore correspondingly contains the liquid medicine goods between the 1ml to 10ml therewith in glass ampule.For fear of pledget disinfectant solution volatilization, each pledget individually with fluid-tight be packaged in the corresponding plastic sheeting.Not shown cap seal of whole complete commodity 1 usefulness closes, or is contained in after putting said elements well in the traditional plastics package, in case of necessity or even aseptic plastics package.
The equipment 3 of having represented to be used for the amount of liquid of output liquid pharmaceutical preparation regulation in Fig. 2 in detail has a sheath 22, sheath 22 is made up of an outer cylinder 22a and the inner cylinder 22b with its concentric setting, they are with transparent plastics manufacturing, and available they cover a syringe needle 2 that is fixed on the equipment 3, syringe needle 2 is for example as seen from Figure 3.In addition, equipment 3 has a shell 4, is provided with up knob district 33 on shell 4; A visual windows 34; An enumerator 35; Second in command district 33a; The lid 36 that can dismantle from shell; A release-push 37; A moving member 38, it is fixed in the longitudinal joint 39 that a shape matches and by longitudinal joint 39 guiding; And a groove 40 arranged.
In this external equipment shown in Figure 23, fixed a lid 18 on the shell, also will describe this lid 18 in detail below in conjunction with Fig. 4.Therefore this equipment 3 can by user grip region 33 and 33a and at lid 18 places without any grip difficultly.The enumerator of having mentioned above 35 is used to calculate the number of times of the dose of the liquid medicine goods of being exported by equipment 3, and the window 34 that is located in the shell can be at the liquid level of glass ampule 8 load facilities, 3 back inspections in glass ampule 8, for will taking off, the glass ampule 8 of packing into covers 36, as shown in Figure 3.
In Fig. 3, schematically illustrated glass ampule 8 in equipment 3 insertion and cover 18 structure, and the structure of syringe needle 2.To take off earlier and cover 36 in order to insert glass ampule 8, so that open wide the zone 41 that the inside that is located at shell 4 is used to lay the container that is filled with the liquid medicine goods.After inserting glass ampule 8 in the zone 41, this opens wide salty newly closes with cap seal.The bottom of lid 36 has adding of extending vertically to have strong market potential 42, and its end is an end section 42a.Add have strong market potential 42 and end section 42a can move vertically with lid 36.This end section 42a can insert in the corresponding groove that is located in the stopper 10, therefore, in case ampoule 8 is packed in the zone 41, and will cover 36, just can have the masterpiece that is directed downwards vertically to be used on the ampoule 8 by screw thread or when being fixed on this opening by means of a kind of bayonet coupling.In the drawings in the another kind of best form of implementation of not representing, adding has strong market potential 42 can cover 36 relatively with an end section 42a and move axially along the direction of arrow 51, so will cover 36 be contained on the shell 4 after, can be undertaken this by the user manual operating and add and have strong market potential 42 and the moving axially of end section 42a, it is irrelevant that this moves axially and cover 36 fixed form.This point reaches by the following stated, promptly when user mounting cover 36,42 applies a power from covering 36 outwardly directed parts adding to have strong market potential.Be filled with the bottom of the glass ampule 8 of liquid medicine goods, pierce through thin film 9 with one and seal, pierce through thin film 9 and itself fix by crimping bonding strip 44 by traditional method.On construction section 21 (for example represented in Fig. 7), can fix a syringe needle 2 or fixed cap 18 by suitable screw thread according to selecting, these two kinds of probabilities are illustrated among Fig. 3.Needle guard of syringe needle 2 usefulness 45 surrounds, and user can be arrested syringe needle 2 by sheath 45, in order to avoid syringe needle 2 is stabbed user.Needle guard 45 can be clamped on the needle stand 2a of syringe needle 2, also can be fixed on the needle stand 2a by screw thread in case of necessity.
A sealing member 18a is arranged in the cylindrical cap 18 (Fig. 4), and it can combine with passway 19 (Fig. 5 and 6), is fixed on the construction section 21 by respective threads 18b in case cover 18, just can fluid by this sealing member 18a and air seal close passway 19.In addition, lid 18 also has one to open poor district 18c, is used to insert the wall of sheath 22 inner cylinder 22b.
In the signal decomposition view of Fig. 5, represented the inner body that equipment 3 is important.Finish with construction section 21 end comprising first inner cylinder, 23, the second outer cylinders, 24, the second cylinders 24, can be according to selecting fixed needle 2 or fixed cap 18 on this construction section 21.Sheath 22 detachably is fixed on this position of shell 4, has only represented the part of shell 4 in Fig. 5.Be that first cylinder 23 sets first spring 25, and be that second cylinder 24 sets second spring 26, wherein first spring 25 is at the top 23a of first cylinder 23 and be fixed between the ring 46 in second cylinder 24 and extend, and second spring 26 then is pressed against on the lower support 24a and the supporting 23b in the shell 4 of second cylinder 24.The moving member 38 and first cylinder 23 are designed to one.
In addition, first cylinder 23 has a base plate 23c, and its downside is provided with a protruding 23d.The bar 47 of piston 16 projection therewith connects, so piston 16 is fixed on this first cylinder and motion together therewith.Extending an interface channel 14 at bar 47 and piston 16 inside, this interface channel 14 also passes base plate 23c and passes protruding 23d and extend, and is communicated with hollow needle 48.
If be filled with now the glass ampule 8 of liquid medicine goods insert constitute in first cylinder 23 that container is laid the inner chamber in zone 41 and by means of stopper and add have strong market potential 42 or end section 42a on glass ampule, applied a pressure that points to construction section 21, hollow needle 48 just pierces through the puncture thin film 9 of glass ampule 8 so, thereby interface channel 14 is communicated with the content of glass ampule 8.In the bonding pad of bar 47 and protruding 23d, establish a check valve 15 for interface channel 14 here, in Fig. 8, amplify and represented this check valve 15.
Press Fig. 8, this check valve 15 has a discoid seal membrane 49, and it is by 50 rests of a ring seat.Below seal membrane 49, form one and flow through expansion regions liquid and passway 14a passage 14.When the flow direction of liquid during along the direction of arrow 51, this as when the intermediate store filling in passage 14 desired flow direction, seal membrane 49 leaves ring seat 50, and does not hinder flowing of liquid.This motion of seal membrane is subjected to four restrictions that become the contact pin 51 of star arrangement, so prevent the passway 14a that seal membrane 49 shutoff have been expanded.When liquid flow direction and the direction of arrow 51 were opposite, seal membrane 49 was in it and is pressed against position on the ring seat 50 hermetically, and what therefore stop the contrary direction of arrow 51 of liquid flows the danger that does not exist seal membrane 49 to be stuck in this case.
Expression is same a kind of form of implementation of equipment among Fig. 6 and 7, but is in different duties.Fig. 6 indication equipment state that memorizer 13 is drained that mediates, the dose of liquid medicine goods uses at parenteral under this state, and this user places equipment the state of preparing for next dose.In Fig. 7, intermediate store 13 has been imported the dose of liquid medicine goods through passage 14 from ampoule 8.In addition, under duty shown in Figure 7, on construction section 21, fixed a syringe needle 2, thus Fig. 7 on the whole indication equipment be at once the duty of using at parenteral that can implement liquid medicine goods dose by user.
Comprised those parts that represent in Fig. 5 and that introduced in front in Fig. 6 and 7 equally, what adopt there is same symbol.
In first cylinder 23, in the zone 41 set, ampoule 8 is housed, and second cylinder 24 has constituted intermediate store 13 (also visible Fig. 5) in its underpart district 24c for ampoule 8.
From duty shown in Figure 6, under this state, lid 18 is fixed on the construction section 21, sealing member 18a has sealed the passway 19a of passage 19, passage 19 makes intermediate store be communicated with the passway, at this moment, first cylinder 23 and second cylinder 24 are together, move vertically by the contrary direction of arrow 51 of these two cylinders and with respect to shell 4, from scheming do not have the primary importance of expression to the represented second position of Fig. 6, in above-mentioned primary importance, spring 25 release basically, and second cylinder 24 leans against on the shell segments 53 by means of step 24b (Fig. 5).Therefore in this second position.The spring 25 of release is compacted when two cylinders are in primary importance, and wherein, fixing second brake component 27 that leans against on the step 24b by shelves of this second position is realized.
These two cylinders 23 and 24 move through the moving member 38 that manual control is located at enclosure vertically together to carry out, and at this moment, this of moving member 38 moves axially longitudinal joints 39 (Fig. 3) guiding that is subjected to be located in the shell 4.
For the intermediate store 13 that makes emptying in this second position from now on from the liquid medicine goods of the glass ampule 8 filling doses that are located at first cylinder, 23 inside, first cylinder 23 moves on to the 3rd position against the directions of arrow 51 and with respect to shell 4 and second cylinder 24 (it still stays the second position) by means of the power that moving member 38 overcomes spring 26, in this case, the result of this 3rd position for moving against the direction of arrow 51 vertically represented this 3rd position in Fig. 7.
Under this 3rd position of first cylinder, first cylinder 23 is by first brake component 28 fixing (Fig. 7).
Since lid 18 by it sealing member 18a and passway 19a fluid-tight combine, prevented that intermediate store 13 is through passage 19 gas leakage, so when the second position moves to the 3rd position vertically, in intermediate store 13, formed vacuum at first cylinder 23.Therefore therewith explicitly, when moving with first cylinder 23, the also contrary vertically direction of arrow 51 of piston 16 that is fixed on first cylinder 23 by piston rod 47 moves.The result that formed this vacuum is brought in intermediate store is, from ampoule 8 through interface channel 14 be located at first cylinder projection 23d and in Fig. 8, be expressed as the check valve of the intermediate store of opening, accurately intactly filling the dose of liquid medicine goods.
Why first cylinder can carry out if moving to the 3rd position with respect to shell and second cylinder vertically from the second position, be owing in the wall of second cylinder, be provided with the guider 39a of a seam shape, the part of moving member 38 is passed its extension, and the moving member 38 and first cylinder 23 are designed to one.
Replace with syringe needle 2 now and cover 18, this moment, syringe needle 2 was caught by needle guard 45 by user, and syringe needle 2 is tightened on the construction section 21.Afterwards, user removes needle guard 45, and equipment has been ready to use the dose of liquid medicine goods from now on.
For this purpose, this user chooses body part, and with the bottom of sheath 22 inner cylinder 22b by being placed on this body part.By handling release-push 27, make second brake component 27 overcome spring force 27a and move along the direction of arrow 54, so first cylinder 23 with second cylinder 24, opposite shell 4 moves along the direction of arrow 51 vertically under spring 26 effects.Consequently, the needle point of syringe needle 2 thrusts in the body region of the user that chooses.In two cylinders 23 and 24 axially movable together processes, be located at protruding 27b and a protruding 28a engagement that is located on first brake component 28 on second brake component 27, the spring force that consequently makes first brake component 28 overcome the spring 28b that is mounted in it equally also moves along the direction of arrow 54.Therefore with first cylinder 23 the 3rd position brake off from then on, so it axially moves under spring 25 effects along the direction of arrow 51 equally.Consequently make by bar 47 to move axially along the direction of arrow 51 with the piston that first cylinder 23 is connected, and thereby will be present in the dose of the liquid medicine goods in the intermediate store 13, be expelled in the body part through syringe needle 2.This axially-movable of first cylinder 23, by the step 24b termination of second cylinder 24, and the axially-movable of second cylinder 24 stops by shell segments 53.
After having finished the parenteral use, user is extracted syringe needle by means of this equipment from body part; Needle guard 45 is contained on the syringe needle 2; Syringe needle is screwed off from construction section 21, and will cover 18 and be screwed on the construction section 21.According to the size of the power that applies user this moment, or first and second cylinders still stay this primary importance, or two cylinders are transferred to position as shown in Figure 4.
Indication equipment is in such duty in second kind of form of implementation of equipment shown in Figure 9, and promptly this moment, intermediate store 13 was filled with the dose of liquid medicine goods.Therefore be in the state of the work of having got ready in the form of implementation shown in Fig. 9, that is can inject at once.Different with 7 forms of implementation of being introduced with the front by means of Fig. 6, these two cylinders 23 and 24 only move and can oppositely move axially with it along the direction of arrow 51 vertically between the primary importance (not expression among the figure) and the second position in the represented form of implementation of Fig. 9, lean on step 24b at primary importance first cylinder 23, step 24b then leans on shell segments 53, and be drained at primary importance intermediate store 13, and the second position is full of dose as shown in Figure 9 and at this second position intermediate store.In addition, only be provided with a unique brake component 29 in form of implementation shown in Figure 9, it is fixed on first cylinder 23 and second cylinder 24 on the second position, and can discharge this position by release-push 37.
For in equipment form of implementation shown in Figure 9, can syringe needle thrust in the body part process and this after this and then just emptying intermediate store 13 and thereby really use delaying on free between the dose of liquid medicine goods at parenteral, make spring 25 match each other like this with 26 spring characteristic curve, promptly the spring characteristic curve of spring 26 is steeper than the trend of the spring characteristic curve of spring 25.When handling release-push 37, the elastic force that brake component 29 overcomes spring 29a moves along the direction of arrow 54, so brake component 29 is released, and thereby first cylinder 23 and second cylinder 24 is moved axially together along the direction of arrow 51 opposite shell.Because so first cylinder that the spring characteristic curve of spring 26 has a more smooth spring characteristic curve with respect to its spring 25 vertically at second cylinder suddenly is when moving, walk front at first cylinder 23, so at first be that syringe needle 2 thrusts in the body part, be only cylinder 23 then and also thereby in addition pass through piston 16 displacements that bar 47 is connected with cylinder 23, the dose of liquid medicine goods is discharged from middle memorizer, be expelled in the body part of user.
In order to make by guaranteeing not have residue ground emptying intermediate store among top some embodiment that introduce of equipment of the present invention, intermediate store 13 has a cylindrical section 13b and the conical section 13a (Fig. 9) that is connected of cylindrical section therewith, wherein the port of export of conical section 13a imports passage 19, and this can be clear that in Fig. 9.Correspondingly, can in intermediate store 13, a cylindrical piston district and the piston region 16a towards passage 19 tapered contractions also be arranged axially movable piston 16, wherein the piston region of taper has the sleeve pipe of corresponding cone shape to constitute by one, and it comprises the port of export of interface channel 14.This telescopic bottom is sealed, and is provided with some outlet openings on its conical outer surface, so the liquid that infeeds through passage 14 enters in the intermediate store by these outlet openings.When this piston when the direction of arrow 51 axially moves down, the piston region 16a of this taper just squeezes the liquid that is present in the intermediate store 13, this is that piston region 16a by taper inserts conical section 13a and occupies this conical section 13a fully and realizes.
Equally also can design such intermediate store 13, it does not have fully or have on a limited axial length just that the front introduces and especially be illustrated in conical section 13a among Fig. 9.In other words, here the cylindrical section 13b of intermediate store 13 directly imports in the passage 19, or cylindrical section 13b by a corresponding conical section 13a who has shortened therewith passage connect.Therewith correspondingly, the shape that is contained in piston 16 and such intermediate store 13 in the intermediate store 13 is complementary, sealing device that sets for outer surface of piston especially wherein, preferably the O RunddichtringO of rubber elastic material has guaranteed the faultless working method of equipment 3.
Introduced in the above with figure in all forms of implementation of expression, along with the emptying gradually of glass ampule 8, be contained in the ampoule 8 stopper 10 since in glass ampule liquid levels descend and move axially along the direction of arrow 51 equally.Thereby prevent from glass ampule, to form vacuum or above liquid levels, form air cushion.In addition, in order to guarantee emptying glass ampule to the drains, the end face 10a (Fig. 9) of stopper 10 dwindles gradually, so this end face 10a abuts on the cervical region 8a (Fig. 9) of glass ampule 8 after liquid level thoroughly descends.
At this state, the glass ampule that is emptied completely can be by means of taking out in extracting tool 10 slave units of representing in Figure 10.For this purpose, this extracting tool have for grasping extracting tool 101 means 102 and a canned paragraph, canned paragraph can be in the groove 10b (Fig. 9) in being located at stopper 10 by the frictional force combination when splitting out stopper 36.
In addition, represented complete spare unit 100 also comprise some syringe needles 2 in Figure 10, and syringe needle 2 is provided with the corresponding needle guard 45 (Fig. 3) that is used for aseptic preservation, and a glass ampule of representing with label 8 is arranged, and it is as the container of full of liquid pharmaceutical preparation.In addition, also have the quantity of a kind of its quantity and syringe needle 2 to be impregnated with the pledget 5 of disinfectant solution accordingly in complete spare unit 100 inside.These complete spare unit 100 also have a zone 6, are used to deposit exhausted syringe needle, in the form of implementation that Figure 10 represents, do not have the cap seal of expression to close among the available figure in this zone.If these zone 6 whole detachably being contained in the complete spare unit 100 as long as law has regulation or hope, can be carried out waste disposal separately with this part 6 so after having deposited whole used syringe needles.In complete spare unit 100,10 syringe needles 2 are arranged usually, the amount of liquid that in glass ampule 8, contains 10 doses correspondingly.Usually, the amount of liquid of exporting by each dose changes between 0.1ml and 1ml, so the liquid medicine goods between the 1ml to 10ml are housed in glass ampule.For fear of the volatilization of the disinfectant solution of pledget 5, each pledget 5 individually with liquid seal be packaged in the corresponding plastic sheeting.Whole complete spare unit 100 usefulness lid (not expression among the figure) sealing, or after having put element recited above well, be contained in the traditional plastics package, in case of necessity or even aseptic plastics package.In addition, the extracting tool of having mentioned above in these complete spare unit 100, also being provided with 101.
The term " puncture thin film " that uses repeatedly mainly is interpreted as a sealing disc with rubber elastic material system here above, and it can pass through a crimping cover, and preferably metal crimping cover is fixed on the ampoule, as being clear that from accompanying drawing.

Claims (42)

1. one kind is used for by the complete commodity of user at parenteral use liquid medicine goods, it is characterized by: in complete commodity (1), comprise a syringe needle (2) at least, an equipment (3) that is used for by the pharmaceutical preparation amount of liquid of dose output regulation, and at least one is filled with the container (8) of liquid medicine goods, container (8) but in the load facility (3), and can press the dose emptying by means of equipment (3), and wherein, the pharmaceutical preparation amount of liquid that each dose is equivalent to stipulate.
2. by the described complete commodity of claim 1, it is characterized by: complete commodity (1) have and the quantity of the pharmaceutical preparation dose that will the use syringe needle (2) as respective numbers.
3. according to claim 1 or 2 described complete commodity, it is characterized by: also include the pledget (5) that its quantity and syringe needle (2) quantity are flooded disinfectant solution accordingly in the complete commodity (1).
4. according to the described complete commodity of one of front claim, it is characterized by: also have a zone (6) in the complete commodity (1), be used for depositing exhausted syringe needle.
5. according to the described complete commodity of one of front claim, it is characterized by: the container (8) that is filled with the liquid medicine goods is in the glass ampule (8) of a column type or drum type brake.
6. according to the described complete commodity of claim 5, it is characterized by: the end section of glass ampule (8) is sealed with stopper (10) with puncture thin film (9) and top, wherein, stopper (10) be designed to can be in glass ampule (8) vertically along with the decline of the liquid levels direction towards puncture thin film (9) moves.
7. by claim 5 or 6 described complete commodity, it is characterized by: stopper (10) has one at least at its outer surface, best 2 to 5 plate-like sections that radially outwards refer to, when stopper (10) being inserted in the glass ampule (8), they are pressed against the sealing surface of fluid-tight on ampoule (8) inner surface and air seal and can be out of shape in order to constitute one.
8. by the described complete commodity of one of claim 5 to 7, it is characterized by: stopper (10) glass ampule (8) in available one less than the mechanical axis between the most handy 4N to 8N of power of 10N to mobile.
9. according to the described complete commodity of one of front claim, it is characterized by: be filled with a kind of aqueous solution of heparin in the container (8), preferably the aqueous solution of a kind of aqueous solution of low molecular weight heparin and especially Enoxaparin-Natrium.
10. according to the described complete commodity of one of front claim, it is characterized by: container is filled with a kind of growth hormone solution in (8), preferably the growth hormone aqueous solution.
11. equipment that is used to export the pharmaceutical preparation of the standard solution scale of construction, it is characterized by: in order to export the standard solution scale of construction by dose, equipment (3) has one to be located at the zone (41) that shell (4) inside is used to install the container (8) that is filled with the liquid medicine goods, and the output area that a pharmaceutical preparation dose is arranged; And, container (8) can be connected with the output area and is designed to by intermediate store (13), under the insertion state of container (8), the standard solution scale of construction of each dose, at first can transfer in the intermediate store (13), can transfer to the output area, in this case from middle memorizer (13) then from container (8), by the volume of intermediate store (13), can determine the amount of the liquid of each dose output.
12., it is characterized by: between container (8) that inserts and intermediate store (13), be provided with interface channel (14) according to the described equipment of claim 11.
13. according to the described equipment of claim 12, it is characterized by: for interface channel (14) is equipped with a valve, it prevents that liquid stream from flowing back to container (8) from middle memorizer (13).
14. according to the described equipment of one of claim 11 to 13, it is characterized by: be contained in the piston (16) that intermediate store is inner and can move towards the output area direction vertically for intermediate store (13) sets one, piston (16) is used for the liquid medicine goods are carried to the output area direction by dose at every turn.
15., it is characterized by: move axially by the direction of piston (16), can in intermediate store (13), fill pharmaceutical preparation with dose towards container (8) according to the described equipment of one of claim 11 to 14.
16. according to the described equipment of claim 15, it is characterized by: in intermediate store (13), move axially by piston (16), can in intermediate store (13), set up vacuum, be used for the dose of liquid pharmaceutical preparation being transferred in the intermediate store (13) from container (8).
17. according to the described equipment of claim 16, it is characterized by: intermediate store (13) is communicated with the output area via passage (19); And the available lid of passage (19) (18) seals airtightly.
18. according to claim 16 or 17 described equipment, it is characterized by: lid (18) is designed to one attaches troops to a unit in the removable closure member (18) of passage (19), and it is designed to, and makes the sealing member (18a) of lid (18) can cover passway (19a) airtightly.
19., it is characterized by: move axially towards the output area direction in intermediate store (13) by piston (16), intermediate store can be emptied completely according to the described equipment of one of claim 14 to 17.
20. according to the described equipment of one of claim 11 to 19, it is characterized by: intermediate store (13) be designed to columniform with have one to link to each other therewith and be designed to and be shrunk to the petiolarea (13a) of taper towards the output area direction, wherein, petiolarea (13a) is communicated with the output area by passage (19) '; And piston (16) has the shape that the shape of an intermediate store (13) matches.
21. according to the described equipment of one of claim 11 to 20, it is characterized by: there is a construction section (21) that is used for detachably fixing a syringe needle (2) output area, and this construction section (21) is designed to make passage (19) to be connected with syringe needle (2) fluid-tight ground.
22. according to claim 17,18 or 21 described equipment, it is characterized by: lid (18) can be fixed on the construction section, and be fixed into by lid (18) but fluid-tight close the channel section (19a) of outside finger.
23. according to the described equipment of one of claim 11 to 22, it is characterized by: for construction section (21) sets a sheath (22), sheath (22) covers a syringe needle (2) that may be locked on the construction section (21) at least partly.
24., it is characterized by: one first cylinder (23) is housed and in shell (4) inside round one second cylinder (24) of first cylinder (23) according to the described equipment of one of claim 11 to 23; Wherein, first cylinder and second cylinder (23,24) can move with respect to shell (4) vertically; In first cylinder (23), be provided with the zone (41) that container is installed, and in second cylinder (24), be provided with the intermediate store (13) that is connected with container (8), they are designed so that first and second cylinders (23,24) can between the primary importance and the second position, move and can do reverse with it moving vertically, in primary importance, may be locked in syringe needle (2) on the construction section (21), to surpass sheath (22) protruding, and at this position intermediate store (13) by passage (19) and syringe needle (2) emptying that is attached thereto; And in the second position, the syringe needle (2) that may be locked on the construction section (21) is covered by sheath (22), and at this position intermediate store (13) filling dose.
25., it is characterized by according to the described equipment of claim 24: by first and second cylinders (23,24) relatively and shell (4) do axially-movable from primary importance to the second position, can make intermediate store (13) fill liquid medicine goods with dose.
26. according to the described equipment of claim 25, it is characterized by: be that first cylinder (23) and second cylinder (24) respectively set a spring (25,26), and be designed to, these two springs (25,26) of the second position at cylinder (23,24) are compacted, and in the primary importance spring release of cylinder (23,24).
27. according to the described equipment of one of claim 24 to 26, it is characterized by: the available unique brake component (29) of two cylinders (23,24) is fixed on the second position.
28., it is characterized by: be that the spring (26) that second cylinder (24) sets has than being the steeper spring characteristic curve of spring (25) that first cylinder (23) sets according to claim 26 or 27 described equipment.
29., it is characterized by: one first cylinder (23) and second cylinder (24) round first cylinder (23) are housed in shell (4) inside according to the described equipment of one of claim 11 to 23; First and second cylinders (23,24) can move with respect to shell (4) vertically; Be useful on the zone (41) of the container of packing into (8) in first cylinder (23) indoor design, and be provided with the intermediate store (13) that is connected with container (8) at second cylinder (24), they are designed to, make first and second cylinders (23,24) together, can shift to the second position and mobile with respect to shell (4) vertically in contrast from primary importance, in primary importance, the syringe needle (2) that may be locked on the construction section (21) stretches out above sheath (22), and be empty at this position intermediate store (13), and in the second position, the syringe needle (2) that may be locked on the construction section (21) is covered by sheath (22); For filling intermediate store (13), first cylinder (23) can be with respect to the second position of second cylinder (24), further moves on to the 3rd position vertically towards the direction of container (8).
30. according to the described equipment of claim 29, it is characterized by: be each cylinder (23,24) respectively set a spring (25,26), wherein, first spring (25) is in the 3rd position preloading power in the position of first cylinder (23), preloading power when second spring (26) is in the second position in the position of second cylinder (24), in addition, available first brake component of first cylinder (23) (28) is fixed on the 3rd position, and available second brake component of second cylinder (24) (27) is fixed on the second position.
31., it is characterized by according to claim 29 or 30 described equipment: by handling a common release-push (37), at first can discharge second brake component (27), and than postponing can to discharge first brake component (28) after a period of time.
32. be used for by the described complete commodity (1) of one of claim 1 to 10 according to the described equipment of one of claim 11 to 31.
33. be used for according to the described complete commodity of one of front claim or the complete spare unit of equipment, it is characterized by: complete spare unit (100) comprise at least one syringe needle (2), and at least one is filled with the container (8) of liquid medicine goods, container (8) can insert in the equipment (3), and can press the dose emptying by means of this equipment (3).
34. according to the described complete spare unit of claim 33, it is characterized by: an extracting tool (101) is housed in complete spare unit (100), be used for the container (8) that slave unit (3) splits out emptying, equipment (3) is used for the amount of liquid by dose output regulation.
35., it is characterized by: contain the pledget (5) of counting the syringe needle (2) of respective numbers with dose and/or being impregnated with disinfectant solution in the complete spare unit (100) according to claim 33 or 34 described complete spare unit.
36. according to one of 35 described complete spare unit of claim 33, it is characterized by: complete spare unit (100) have a zone (6) that is used to deposit exhausted syringe needle (2).
37. according to the described complete spare unit of one of claim 33 to 36, it is characterized by: the container (8) that fills with the liquid medicine goods is cylindrical and glass ampule (8) drum type brake.
38. according to the described complete spare unit of claim 37, it is characterized by: glass ampule (8) bottom is sealed with stopper (10) with piercing through thin film (9) and top, wherein, stopper (10) is designed to can be in glass ampule (8) move towards the direction of puncture thin film (9) along with the liquid level of liquid descends.
39. according to claim 37 or 38 described complete spare unit, it is characterized by: stopper (10) has one at least at its outer surface, best 2 to 5 plate-like sealing lip sections that radially outwards refer to, when stopper (10) being inserted in the glass ampule (8), they are pressed against the sealing surface of the fluid-tight on ampoule (8) inner surface and can be out of shape in order to constitute one.
40., it is characterized by according to the described complete spare unit of one of claim 37 to 39: stopper (10) glass ampule (8) available one less than the mechanical axis of 10N to moving the power between the most handy 4N and the 8N.
41. according to the described complete spare unit of one of claim 33 to 40, it is characterized by: be filled with a kind of aqueous solution of heparin in the container (8), preferably the aqueous solution of a kind of aqueous solution of low molecular weight heparin and especially Enoxaparin-Natrium.
42. according to the described complete spare unit of one of claim 33 to 40, it is characterized by: container (8) is filled with a kind of growth hormone solution, preferably the growth hormone aqueous solution.
CN97102415A 1997-02-12 1997-02-12 Complete set of commodity, equipment and spare parts for external use of intestines and stomach Pending CN1190599A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN97102415A CN1190599A (en) 1997-02-12 1997-02-12 Complete set of commodity, equipment and spare parts for external use of intestines and stomach

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN97102415A CN1190599A (en) 1997-02-12 1997-02-12 Complete set of commodity, equipment and spare parts for external use of intestines and stomach

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CN1190599A true CN1190599A (en) 1998-08-19

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CN101454037B (en) * 2006-06-01 2012-03-28 西拉格国际有限公司 Injection device with syringe carrier engagement with cap
US8277414B2 (en) 2004-05-28 2012-10-02 Cilag Gmbh International Injection device
US8313464B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
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US8313465B2 (en) 2004-05-28 2012-11-20 Cilag Gmbh International Injection device
US8317751B2 (en) 2005-04-06 2012-11-27 Cilag Gmbh International Injection device
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US8834419B2 (en) 2008-06-19 2014-09-16 Cilag Gmbh International Reusable auto-injector
US8845594B2 (en) 2008-06-19 2014-09-30 Cilag Gmbh International Auto-injector with filling means
US8939958B2 (en) 2008-06-19 2015-01-27 Cilag Gmbh International Fluid transfer assembly for a syringe
US8968236B2 (en) 2005-04-06 2015-03-03 Cilag Gmbh International Injection device
US9028453B2 (en) 2008-06-19 2015-05-12 Cilag Gmbh International Reusable auto-injector
US9028451B2 (en) 2006-06-01 2015-05-12 Cilag Gmbh International Injection device
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US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9675758B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
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US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
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US9895493B2 (en) 2004-05-28 2018-02-20 Cilag Gmbh International Injection device
US10709849B2 (en) 2013-06-11 2020-07-14 Cilag Gmbh International Guide for an injection device
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US9895493B2 (en) 2004-05-28 2018-02-20 Cilag Gmbh International Injection device
US8343110B2 (en) 2004-05-28 2013-01-01 Cilag Gmbh International Injection device
US9675757B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
US8317751B2 (en) 2005-04-06 2012-11-27 Cilag Gmbh International Injection device
US8366669B2 (en) 2005-04-06 2013-02-05 Cilag Gmbh International Injection device
US8968236B2 (en) 2005-04-06 2015-03-03 Cilag Gmbh International Injection device
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
US9770558B2 (en) 2005-09-27 2017-09-26 Cilag Gmbh International Auto-injection device with needle protecting cap having outer and inner sleeves
CN101454037B (en) * 2006-06-01 2012-03-28 西拉格国际有限公司 Injection device with syringe carrier engagement with cap
US9072833B2 (en) 2006-06-01 2015-07-07 Cilag Gmbh International Injection device
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US8939958B2 (en) 2008-06-19 2015-01-27 Cilag Gmbh International Fluid transfer assembly for a syringe
US8834419B2 (en) 2008-06-19 2014-09-16 Cilag Gmbh International Reusable auto-injector
US8845594B2 (en) 2008-06-19 2014-09-30 Cilag Gmbh International Auto-injector with filling means
US10709849B2 (en) 2013-06-11 2020-07-14 Cilag Gmbh International Guide for an injection device
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