WO1998034582A1

WO1998034582A1 - Needle-less fluid transfer device and method

Info

Publication number: WO1998034582A1
Application number: PCT/US1998/002473
Authority: WO
Inventors: Thomas P. Castellano; Paul H. Kovelman
Original assignee: Visionary Medical Products, Inc.
Priority date: 1997-02-07
Filing date: 1998-02-04
Publication date: 1998-08-13
Also published as: AU6152298A

Abstract

A needle-less fluid transfer device for transferring fluid from a first receptacle to a second receptacle, the device includes a housing, a valve and a restoring member. The housing has a channel and is adapted to couple with the first receptacle and the second receptacle free of the use of needles. The channel in the housing facilitates fluid communication between the first receptacle and the second receptacle. The valve is movably disposed in the channel of the housing. The restoring member is coupled to the housing and the valve to generate a restoring force to maintain the valve in a closed position when the second receptacle is decoupled from the housing. The restoring force of the restoring member is overcome and the valve is moved to an open position when the second receptacle is coupled to the housing. The restoring force of the restoring member restores the valve to the closed position when the second receptacle is decoupled from the housing.

Description

TITLE

NEEDLE-LESS FLUID TRANSFER DEVICE AND METHOD

RELATED APPLICATIONS This application claims priority on U.S. Provisional Application Serial No.

60/039,316, filed February 7, 1997.

FIELD OF THE INVENTION

This invention relates to devices and methods of transferring fluids from one container to another, and, in particular embodiments, to a transfer device and method that is used to transfer medication to a syringe or other medication delivery device without the use of needles.

BACKGROUND OF THE INVENTION Traditionally, medications have been stored in small bottles that permit storage and transfer of the medication to the location where the medication will be administered. Upon receipt of the bottle, the user shakes the bottle and turns the bottle upside down or sideways to cover the septum with medication. Next the user utilizes a syringe and inserts a needle through the septum to cover the inserted end of the needle with medication. Then the user empties the syringe of air by injecting an amount of air into the bottle and follows this by withdrawing an equivalent amount of medication from the bottle.

The use of a septum and this procedure suffers from many drawbacks. First there is a safety problem. Since users must use needles, there is always the chance of being stuck or injured with a needle when changing needles, mixing medications or transferring medication. Injury can also include contamination with infected bodily fluids after an injection. Second, there is the possibility of contaminating the medication in the bottle during mixing or transfer due to accidental sticks or contact by the user with the needle that is inserted into the septum of the bottle. To overcome these drawbacks, other fluid transfer systems have attempted to use a plurality of needles or channels to transfer the fluid from one container to another. Although these devices may have reduced the chance of contamination, these devices still suffer from the drawback that a needle must be used to transfer the medication from the bottle to a syringe.

SUMMARY OF THE DISCLOSURE

It is an object of an embodiment of the present invention to provide an improved needle-less fluid transfer device and method that obviates for practical purposes the above- mentioned limitations. According to an embodiment of the invention, there is a needle-less fluid transfer device for transferring fluid from a first receptacle to a second receptacle, the device includes a housing, a valve and a restoring member. The housing has a channel and is adapted to couple with the first receptacle and the second receptacle without a needle. The channel in the housing facilitates fluid communication between the first receptacle and the second receptacle. The valve is movably disposed in the channel of the housing. The restoring member is coupled to the housing and the valve to generate a restoring force to maintain the valve in a closed position when the second receptacle is decoupled from the housing. The restoring force of the restoring member is overcome and the valve is moved to an open position when the second receptacle is coupled to the housing. The restoring force of the restoring member restores the valve to the closed position when the second receptacle is decoupled from the housing.

In further embodiments of the present invention, the first receptacle is a medication bottle or vial, and the second receptacle is a needle-less syringe or intravenous (IV) transfer device. The housing is adapted to be secured to the medication bottle or vial by friction, and the housing further includes male Luer type threads. The needle-less syringe includes female Luer threads adapted to mate with the male Luer threads of the housing, and the needle-less syringe is adapted to be coupled to the housing by threading the male Luer threads with the female Luer threads.

In still further embodiments, the valve further includes a valve head and an axial stem connected to the valve head. The axial stem is disposed in and slidably moves back and forth along the channel of the housing. Also, the axial stem has one or more ports along the periphery of the axial stem leading to an axial fluid channel in the axial stem to provide fluid communication between the first receptacle and the second receptacle when the valve is in the open position and the first receptacle and the second receptacle are both coupled to the housing. In particular, the valve head closes off the axial channel of the housing when the second receptacle is decoupled from the housing, and the axial stem is moved axially, and the valve head is moved away from the second receptacle and the axial channel of the housing when the second receptacle is coupled to the housing to expose the one or more portals leading to the axial fluid channel to place the valve in the open position. In further embodiments, the restoring member is a spring surrounding an external periphery of the axial stem of the valve and within an interior periphery of the axial channel of the housing to bias the valve in the closed position. Alternatively, the restoring member is an elastic material surrounding an external periphery of the axial stem of the valve and within an interior periphery of the axial channel of the housing to bias the valve in the closed position.

In yet another embodiment, the valve and the restoring member form a poppet valve coupled to the housing. Also, the second receptacle includes means for generating a vacuum pressure when coupled to the housing to draw out the fluid from the first receptacle through the valve and housing and into the second receptacle. Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS A detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures.

Fig. 1 is a cross-sectional view of a needle-less transfer device in accordance with a first embodiment of the invention that is attached to a medication container. Fig. 2 is another cross-sectional view of the needle-less transfer device of Fig. 1 attached to a medication container and a needle-less syringe.

Fig. 3 is an enlarged cross-sectional view of the needle-less transfer device of Fig. 1 with the valve in a closed position.

Fig. 4 is an enlarged cross-sectional view of the needle-less transfer device of Figs. 1 and 3 with the valve in an open position.

Fig. 5 A shows the needle-less transfer device of Fig. 1 being used to transfer air from a connected needle-less syringe to a connected medication container.

Fig. 5B shows the needle-less transfer device of Fig. 1 being used to transfer fluid from a connected medication container to a connected needle-less syringe. Fig. 6 A shows a conventional septum being used to transfer air from a connected needled syringe to a connected medication container.

Fig. 6B shows a conventional septum being used to transfer fluid from a connected medication container to a syringe with a needle.

Fig. 7 is cross-sectional view of a valve in accordance with a second embodiment of the present invention.

Fig. 8 is a cross-sectional view of an elastic sleeve in accordance with third embodiment of the present invention for use with the valve shown in Fig. 7.

Fig. 9 is a cross-sectional view of a valve in accordance with a fourth embodiment of the present invention. Figs. 10(a) and 10(b) are cross-sectional views of a two piece valve in accordance with a fifth embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings for purposes of illustration, the present invention is embodied in a needle-less fluid transfer device for transferring fluids from a first container to a second container. In preferred embodiments of the present invention, the needle-less fluid transfer device utilizes conventional medication containers or bottles that are for use with septums to transfer medication from the medication container to a standard needle-less syringe having a Luer connector. However, it will be recognized that further embodiments of the invention may be used with other medication containers, such as IV bags, infusion pumps, medication supply sources or the like, and with other needle- less medication receiving devices, such as IV pumps, jet injectors or the like. In addition, it will be recognized that the needle-less fluid transfer device may be used to transfer other fluids, such as chemicals, food substances or the like, which would benefit from needle-less transfer techniques and a reduction in the chance of contamination.

Fig. 1 shows a needle-less fluid transfer device 100 in accordance with a first embodiment of the present invention. As shown in Fig. 1, a needle-less fluid transfer device 100 is attached and secured to a standard medication vial 3. Generally, the medication vials 3 are manufactured in various sizes from lOmL to 60mL. However, larger or smaller medication vials or bottles may be used with the needle-less fluid transfer device 100. Typically, the medication vials 3 are formed from glass or plastic. However, other suitable materials, such as metals, ceramics, composites or the like, may be used.

Preferably, the needle-less transfer device 100 is distributed as a complete unit 102, which includes the needle-less fluid transfer device 100, medication container 3 and a cap 12 to cover and protect the needle-less fluid transfer device 100. The cap 12 is used to seal the medication vial 3 and needle-less fluid transfer device 100 for shipping and during periods when the remaining medication in the partially used medication vial 3 is stored. A housing 6 of the needle-less fluid transfer device 100 includes male threads 14 at the end of the housing 6 (that are positioned at an opposite end from the female valve seat 1 IB) that are adapted to mate with corresponding female threads on the cap 12. The male threads 14 also correspond with the female threads generally used on Luer Lock syringes, such as a syringe 104, as shown in Figs. 2, 5 A and 5B. In alternative embodiments, the needle-less fluid transfer device 100 may be sold and shipped separately from the medication vial 3 to facilitate retrofitting of bottles previously fitted was traditional medical septums or the like.

As shown in Figs. 1-4, the needle-less fluid transfer device 100 includes the housing 6 and a valve 1. The valve 1 includes a valve head 25 having a conical flange forming a 90° angle which mates with the valve seat 1 IB of the housing 6 which also has a corresponding 90° angled conical recess to match the valve head 25. In alternative embodiments, the valve head 25 and the valve seat 1 IB may be formed with flanges and recesses at different angles or shapes to match the requirements of fluid delivery or different delivery containers. A s,eal ring 2 is used to seal the contact point between the valve head 25 and the valve seat 1 IB. The seal ring 2 provides a fluid tight seal when the valve head 25 is held in tension against the valve seat 1 IB of the housing 6. In preferred embodiments of the present invention, the seal ring 2 is manufactured from various rubber or silicone based materials that are approved by the FDA for use in medication vials and syringe plungers. However, in alternative embodiments, the seal ring may be made from other materials or omitted if a sufficient seal can be obtained between the valve head 25 and the valve seat 1 IB.

As shown in figs. 1-4, the valve 1 has an integral (or axial) stem 13 which acts as a spring guide for a spring 9. The integral stem 13 is also fitted with a spring retainer 11A which performs as a first bearing surface to stabilize the axial linear movement of the valve 1 during opening and closing for fluid transfer. The integral retainer 11 A also prevents the valve 1 from falling out of the channel 27 passing through the valve seat 1 IB of the housing 6 by engaging with a back of the valve seat 1 IB. The valve seat 1 IB also performs as a second bearing surface to provide stability during axial linear movement and to provide alignment for proper seating of the valve head 25 against the valve seat 1 IB of the housing 6 when the valve 1 is in the closed position. The spring 9 surrounds the integral stem 13 and is secured between the spring retainer 11 A and the back of the valve seat 1 IB. The integral stem 13 is formed with a retainer recess 26 that is formed to receive a retainer clip 10 that is used to retain the tension spring 9 and spring retainer 11 A in position along the integral stem 13. The integral valve stem 13 and valve head 25 move axially along the channel 27 in the housing 6 to open and close the valve 1. The valve 1 is open when the valve head 25 is displaced from the valve seat 1 IB and closed when the valve head 25 is tensioned against the valve seat 1 IB by the tension spring 9. In alternative embodiments, the spring retainer 11A may be omitted and the retainer clip 10 will provide the same structural function as the spring retainer 11 A. This results in a reduction in the number of parts. If required, the size of the retainer recess 26 and the retainer clip 10 may be increased to accommodate omission of the spring retainer 11 A. As shown in Figs. 1-4, the valve 1 includes four fluid transfer portals 7, placed around the integral stem 13 just below the valve head 25, at 90 degree intervals that facilitate fluid transfer through the needle-less fluid transfer device 100. In alternative embodiments of the present invention, more or less transfer portals 7 can be used and may be placed at different separation angles (e.g., three holes would be placed equally at 120 degree increments). In addition, the fluid transfer ports may be formed in different shapes if required to facilitate fluid transfer at different fluid flow rates and at different fluid viscosities.

In preferred embodiments, the housing 6 and valve are made of plastic materials such as Acetal (Delrin). However, in alternative embodiments, different materials, such as other plastics, ceramics, glass, metals, composites or the like may be used, with the choice being dictated by the FDA and medication reaction requirements.

A rubber or silicone O-shaped ring 5 in the small neck 4 of the medication vial 3 provides a seal between the housing 6 and the small neck 4 of the medication vial 3 to avoid fluid leakage between the medication vial 3 and the housing 6. A retainer band 8 is used to secure the housing 6 in the small neck 4 of the medication vial 3. In another embodiment, the O-shaped ring 5 is inserted in a recess in the housing 6, rather than the small neck 4 of the medication vial 3; or both the housing 6 and the small neck 4 of the medication vial 3 have recesses to hold the O-shaped ring 5. In alternative embodiments, the housing 6 may be adapted with threads, barbs or the like to mate with a similarly configured medication vial 3. In further alternatives, the housing 6 may be secured to the small neck 4 of the medication vial 3 by adhesives or the O-shaped ring may be omitted, if a sufficient seal can be obtained by tight tolerances between the housing 6 and the small neck 4 of the medication vial 3. As shown in Fig. 2, to use the needle-less fluid transfer device 100 that is already connected to a medication vial 3, a typical Luer Lock syringe 104 is mated and threaded onto the corresponding male threads 14 of the housing 6. Thus, the syringe body 20 does not have a needle attached. This eliminates the possibility of the user being pricked by a needle during the fluid transfer operation. The syringe body 20 is threaded onto the male threads 14 on the housing 6 of the needle-less fluid transfer device 100 until it stops (i.e., when the syringe body 20 is screwed all the way down). As the syringe body 20 is being screwed onto the housing 6, the integral nipple 16 of the syringe 104 mates with and presses against the integral stem 13 of the valve 1. This results in the integral stem 13 being axially displaced in the channel 27 of the housing 6, which also causes the valve head 25 to be displaced from the valve seat 1 IB of the housing 6 by an equal amount to open the valve 1. In preferred embodiments, the syringe 104 is screwed onto the housing 6 with the piston 17 displaced back in the syringe body 20 by the amount of medication that is desired to be withdrawn and transferred from the medication vial 3. Once the syringe 104 is screwed on the housing 6 and the valve 1 is in the open position, the user depresses the driver 18 of the syringe 104 to move the piston 17 forward and expel the air contained in the syringe body 20 into the medication vial 3. This creates a positive pressure that facilitates easy removal and transfer of the fluid from the medication vial 3. Next, the user pulls the driver 18 back which pulls the piston 17 back creating a vacuum pressure that withdraws and transfers the fluid from the medication vial 3 to the syringe 104 without the use of a needle. When the syringe 104 has been filled to the desired amount, the syringe body 20 is unscrewed from the threads 14 of the housing 6. As the syringe body is unscrewed, the pressure from the integral nipple 16 of the syringe 104 is reduced and the spring 9 bears against the spring retainer 11 A and retainer clip 10 to force the integral stem 13 and valve head 25 back along the channel 27 until the valve head 25 contacts and seals against the valve seat 1 IB. This closes the valve 1 to prevent fluid leakage. Finally, the user replaces the protective cap 12 on the male threads 14 of the housing 6 for storage of any medication left in the medication vial 3.

A needle-less medication fluid transfer device 100 in accordance with embodiments of the present invention addresses immediate concerns such as safety and contamination. The first concern is safety, for any health care workers who are mixing medications in an

IV, or trying to give an IV push, and mixing medications that need to be dissolved before given, such as antibiotics. The needle-less fluid transfer device 100 eliminates the need to use needles that could cause pricks or other injuries, since being accidentally stuck with a needle, even from a clean syringe when mixing medications to be given by IV, is a danger and concern. The needle-less fluid transfer device 100 also minimizes potential fear 3 by workers about pricks from needles that may have been contaminated with medications or bodily fluids. Thus, using a needle-less transfer fluid device 100 minimizes possible exposure to needles.

A needle-less fluid transfer device 100 allows for clean, safe transfer of mixed medications to an IV bag. Typical applications in which the needle-less fluid transfer device 100 would be used are in hospital pharmacies, where premixing occurs on an hourly basis, for medications, such as Heparin, Dopamine, Lidocaine, Dobutamine, Nipride or the like, for use on particular floors (with the exception of Heparin, most of the other drugs are critical care only). In addition, on various hospital floors, other health care professionals are mixing medications like potassium, Heparin boluses (in preparation for a drip to follow), IV antibiotics, and even pain medications like morphine, which is sometimes diluted in saline before administration. Currently, many of these steps use needles and rubber septums to transfer the needed mixtures of medication. Thus, the needle-less fluid transfer device 100 can replace a needle transfer. The second concern is the prevention of contamination of those medications needing to be mixed from powder to liquid, such as antibiotics. The use of a needle exposes the medication to contamination, since a prick could contaminate the medication to be mixed and transferred. A needle-less fluid transfer device 100 also substantially eliminates the need to check and recheck the secureness of a needle attached to a syringe (something many health care professionals fail to do). The needle-less fluid transfer device 100 substantially eliminates the chance of contamination, simply by eliminating or minimizing the number of in-between steps of drawing up a diluent, then transferring to the powdered med, such as an antibiotic using a needle. Antibiotics are just one of the medications that need reconstitution and which always involves several steps using syringes and needles. Use of the needle-less fluid transfer device 100 protects not only the staff, but the patient as well. Patients will receive all ordered medication, since the transfer is direct, and patients are at no risk for accidental needle injury as well while medications are being transferred.

Some medications commonly packaged in medication vials which are commonly used in IV drip, and push, and which would be adaptable to use in the needle-less fluid medication transfer device, are Lidocaine, Heparin, Dopamine, Dobutamine, insulin, potassium, multivitamins, ALL antibiotics, Inocor, tPa, Streptokinase, Nipirde, Verapmil, Inderal, Isuprel, Reglan, Tagamet, Rheopro, calcium, aminophylline, all the ingredients used in hyperalimentation, lipids, and the like. In addition to medication vials, embodiments of the present invention may also be used on IV bags and bottles. Also IV bags and bottles may be fitted with a modified needle-less fluid transfer device to directly connect with an IV drip system, or the like, to avoid the use of syringes and to facilitate easy connection of replacement IV bags. Also, not using needles minimizes the chance of contamination between IV bags. In further embodiments, the spring 9 may be replaced with an elastic material such as a foam tube or an accordion folded plastic material that can provide the restoring force needed to maintain the valve head 25 against the housing. Also, the valve head 25 may be replaced with an elastic cone shape that is very slightly larger than the opening in the valve seat 1 IB in the housing 6. The other end of the integral stem 13 would have a flange for retaining the spring or elastic restoring material. In other embodiments, the valve head 25 may be the same size as the opening in the valve seat 1 IB in the housing and overhangs the integral stem 13 to facilitate easy assembly of the needle-less fluid transfer device 100. An elastic grommet (not shown) would then slip over the valve head 25 to prevent the valve head 25 from passing through the opening in the valve seat 25 in the housing 6 and act as a seal. In these embodiments, the valve seat 1 IB and valve head 25 would be formed to provide a seal, but would not need to maintain the shape shown in Figs. 1-5B.

Fig. 7 shows a valve 200 having a valve head 25 and an integral stem 13 having a port 7 similar to the embodiment described above. The integral stem 13 also includes a retainer recess 26 that receives a retainer clip 10. However, the valve 200 in accordance with this embodiment, uses an elastic tensioning collar 202 formed from a foam material or collapsible material to replace of the spring 9 described above. In preferred embodiments, the elastic tensioning collar is formed from foamed plastic, such as neoprene, polystyrene or the like; however, alternative embodiments may use elastic tensioning collars formed from rubber, synthetic rubber or other suitable materials that can be compressed and which then elastically restore to their original shape. The use of an elastic tensioning collar 202, instead of the spring 9, simplifies construction of the needle-less fluid transfer device and reduces the number of moving parts. In addition, when the elastic tensioning collar is formed from a rubberized or plastic material, it is resistant to corrosion and tends to have a greater shelf life than the spring 9, which as described above, may be made of metal and thus be subject to corrosion problem.

In use, the elastic tensioning collar 202 functions as a spring when the syringe 104 is threaded onto the needle-less fluid transfer device and presses against the integral stem 13. As the integral stem 13 is moved forward, the retainer clip 10 attached to the integral stem 13 presses against the elastic tensioning collar 202 and compresses it against the valve seat 1 IB. As the syringe 104 continues to press against the integral stem 13, the elastic tensioning collar 202 compresses and allows the integral stem 13 to move along the channel 27 and the valve head 25 to move away from the valve seat 1 IB. This exposes the port 7 to allow fluid to pass into the syringe 104, in the same manner as described above. After the syringe 104 is filled with fluid, the syringe 104 is unscrewed from the needle-less fluid transfer device. This reduces the compressing forces on the elastic tensioning collar 202, which in turn permits the elastic tensioning collar 202 to expand and return to its original shape. As the elastic tensioning collar 202 expands, it presses the valve stem 13 back toward the syringe 104 and closes off the port 7 and reseats the valve head 25 against the valve seat 1 IB. This re-seals the medication vial 3 and permits storage when the medication vial 3 is not in use.

Fig. 8 shows an accordion-type elastic collar 210 in accordance with a third embodiment of the present invention. The accordion-type elastic collar 210 may be used instead of the elastic tensioning collar member 202 shown in Fig. 7. As shown in Fig. 8, the accordion-type elastic collar 210 includes a plurality of inward extending folds 212 and outward extending folds to 214 that permit the accordion-type elastic collar 210 to expand or compress in an accordion-type manner. Generally, the accordion-type structure allows the elastic collar 210 to be compressed more easily and uniformly than the elastic tensioning collar 202. The number of folds 212 and 214, and the angles of the folds 212 and 214 are determined based on the size of the syringe 104 that is used and the size of the valve contained in the needle-less fluid transfer device. As discussed above, the accordion-type elastic collar 210, shown in Fig. 8, can replace either the spring 9 or the elastic tensioning collar 202 in the needle-less fluid transfer device 100.

Fig. 9 shows a valve 300 in accordance with a fourth embodiment of the present invention. The valve 300 includes a valve head 25 and an integral stem 13 having a port 7, as described above. Rather than using a retaining recess 26 and a retainer clip 10, as described above, the valve 300 uses an elastic tensioning collar 302 that is coupled to the integral stem 13 by extension members 304. Thus, the valve 300 is formed from a single unitary piece of material. This configuration reduces the number of parts in the valve 300 from 4 parts to 1 part, since the valve head 25, integral stem 13 and the elastic tensioning collar 302 are all made from the same elastic material. The elastic material is chosen such that it exhibits sufficient structural integrity so that the valve head 25 and integral stem 13 resist major deformation that could cause leaks, and yet have sufficient elasticity to allow compression of the elastic tensioning collar 302. Such materials are neoprene foam, polystyrene foam or the like.

To assemble the needle-less fluid transfer device with the valve 300, the valve head 25 is bent away from the integral stem 13 and compressed together so that it will fit through the channel 27 through the valve seat 1 IB. After the valve head 25 passes though the valve seat 1 IB, the valve head 25 is released and springs back to its original shape due to the elastic nature of the material and then seals the medication vial 3 as shown in Fig. 1.

Figs. 10(a) and 10(b) show a valve assembly in accordance with a fifth embodiment of the present invention. The valve head piece 400 includes a valve head 25 and a integral sub-stem 404. The integral sub-stem 404 includes a plurality of protrusions 406 for engaging with the stem portion 402, shown in Fig. 10(b). The stem portion 402 includes an integral body 408 that has a slightly larger diameter than the integral sub-stem 404 on the valve head piece 400. This permits the integral sub-stem 404 to slide inside the integral body 408. The periphery of the integral body 408 includes a plurality of protrusion ports 410 for receiving the corresponding protrusions 406 on the integral sub- stem 404. The use of the protrusions 406 and the protrusion ports 410 permits the integral sub-stem 404 to be locked to the integral body 408 upon completion of assembly of the valve. As shown in Fig. 10(b), the integral body 408 is coupled to an accordion- type elastic collar 412 by extensions 414 so that the integral body 408, the accordion-type elastic collar 412 and the extensions are formed as a single piece. An advantage of this particular embodiment is that assembly is more easily facilitated, than the embodiment shown in Fig. 9, since the integral body 408 can be passed through the channel 27 between the valve seat 1 IB sufficiently so that the valve head piece 400 can be pushed into and locked within the integral body 408. Another advantage is that the valve head piece 400 may be made out of a different material than the stem portion 402. Thus, the valve head piece 400 may be made from a stiff er material, that provides a better seal at the valve seat 1 IB, than an elastic stem portion 402 formed from a material selected to have resiliency that will help close the combined valve head piece 400 and stem portion 402, when the needle-less fluid transfer device is not in use. Finally, this embodiment avoids some of the leakage problems that might arise from deforming the valve head 25 in the valve 300 shown in Fig. 9.

In the illustrated embodiment, the integral sub-stem 404 is shown as being relatively short and the integral body 408 is relatively long and includes the ports 7. However, in alternative embodiments, the integral sub-stem is longer and includes the ports 7, and the integral body 408 is correspondingly shortened. The lengths of the integral sub-stem 404 and integral body 408 are selected based on the structural requirements of the valve assembly in the needle-less fluid transfer device.

In further embodiments of the present invention, the housing 6 may be adapted with a small air release valve (such as those utilized on ink jet cartridges) to allow air to flow into the medication vial 3 through the housing 6 as the medication is withdrawn and transferred from the medication vial 3. Also, the medication vial 3 may be made of a collapsible material so that the medication vial 3 collapses as the medication is withdrawn to minimize contamination with the external air. Finally, the medication may be withdrawn from the medication vial 3 without positive pressure being created in the bottle before withdrawing fluid, and the valve 1 then opens to permit intake of air after the syringe 104 has been removed. This would be accomplished by the vacuum pressure in the medication vial 3 pulling the valve 1 open until the pressure is equalized.

While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

Claims

WHAT IS CLAIMED IS:

1. A needle-less fluid transfer device for transferring fluid from a first receptacle to a second receptacle, the device comprising: a housing having a channel and adapted to couple with the first receptacle and the second receptacle free of needles, wherein the channel facilitates fluid communication between the first receptacle and the second receptacle; a valve movably disposed in the channel of the housing; and a restoring member coupled to the housing and the valve to generate a restoring force to maintain the valve in a closed position when the second receptacle is decoupled from the housing, wherein the restoring force of the restoring member is overcome and the valve is moved to an open position when the second receptacle is coupled to the housing, and wherein the restoring force of the restoring member restores the valve to the closed position when the second receptacle is decoupled from the housing.

2. A needle-less fluid transfer device according to claim 1, wherein the first receptacle is a medication bottle, and wherein the second receptacle is a needle-less syringe.

3. A needle-less fluid transfer device according to claim 2, wherein the housing is adapted to be secured to the medication bottle by friction, and wherein the housing further includes male luer threads, wherein the needle-less syringe includes female luer threads adapted to mate with the male luer threads of the housing, and wherein the needle-less syringe is adapted to be coupled to the housing by threading the male luer threads with the female luer threads.

4. A needle-less fluid transfer device according to claim 1 , wherein the valve further includes a valve head and an axial stem connected to the valve head, wherein the axial stem is disposed in and slidably moves back and forth along the channel of the housing, wherein the axial stem has one or more ports along the periphery of the axial stem leading to an axial fluid channel in the axial stem to provide fluid communication between the first receptacle and the second receptacle when the valve is in the open position and the first receptacle and the second receptacle are both coupled to the housing.

5. A needle-less fluid transfer device according to claim 4, wherein the valve head closes off the channel of the housing when the second receptacle is decoupled from the housing, and wherein the axial stem is moved axially and the valve head is moved away from the second receptacle and the axial channel of the housing when the second receptacle is coupled to the housing to expose the one or more portals leading to the axial fluid channel to place the valve in the open position.

6. A needle-less fluid transfer device according to claim 4, wherein the restoring member is a spring surrounding an external periphery of the axial stem of the valve and within an interior periperphy of the channel of housing to bias the valve in the closed position.

7. A needle-less fluid transfer device according to claim 4, wherein the restoring member is an elastic material surrounding an external periphery of the axial stem of the valve and within an interior periperphy of the channel of housing to bias the valve in the closed position.

8. A needle-less fluid transfer device according to claim 1, wherein the valve and the restoring member form a poppet valve coupled to the housing.

9. A needle-less fluid transfer device according to claim 1 , wherein the second receptacle includes means for generating a vacuum pressure when coupled to the housing to draw out the fluid from the first receptacle through the valve and housing and into the second receptacle.

10. A needle-less medication transfer apparatus for transferring medication to a needle-less medication delivery device, the apparatus comprising: a medication container for holding the medication; a housing having a channel and being coupled to the medication container, wherein the housing is adapted to be coupled to the needle-less medication delivery device, wherein the channel facilitates fluid communication between the medication container and the needle-less medication delivery device; a valve movably disposed in the channel of the housing; and a restoring member coupled to the housing and the valve to generate a restoring force to maintain the valve in a closed position to substantially prevent leakage of medication from the medication container when the needle-less medication delivery device is decoupled from the housing, wherein the restoring force of the restoring member is overcome and the valve is moved to an open position to permit a flow of medication from the medication container to the needle-less medication delivery device when the needle- less medication delivery device is coupled to the housing, and wherein the restoring force of the restoring member restores the valve to the closed position when the needle-less medication delivery device is decoupled from the housing.

11. A needle-less medication transfer apparatus according to claim 10, wherein the medication container is a medication bottle, and wherein the needle-less medication delivery device is a needle-less syringe.

12. A needle-less medication transfer apparatus according to claim 11, wherein the housing is secured to the medication bottle by friction and a retainer, and wherein the housing further includes male luer threads, wherein the needle-less syringe includes female luer threads adapted to mate with the male luer threads of the housing, and wherein the needle-less syringe is adapted to be coupled to the housing by threading the male luer threads with the female luer threads.

13. A needle-less medication transfer apparatus according to claim 10, wherein the valve further includes a valve head and an axial stem connected to the valve head, wherein the axial stem is disposed in and slidably moves back and forth along the channel of the housing, wherein the axial stem has one or more ports along the periphery of the axial stem leading to an axial fluid channel in the axial stem to provide fluid communication between the first receptacle and the second receptacle when the valve is in the open position and the medication container and the needle-less medication delivery device are both coupled to the housing.

14. A needle-less medication transfer apparatus according to claim 13, wherein the valve head closes off the channel of the housing when the needle-less medication delivery device is decoupled from the housing, and wherein the axial stem is moved axially and the valve head is moved away from the needle-less medication delivery device and the channel of the housing when the needle-less medication delivery device is coupled to the housing to expose the one or more portals leading to the axial fluid channel to place the valve in the open position.

15. A needle-less medication transfer apparatus according to claim 13, wherein the restoring member is a spring surrounding an external periphery of the axial stem of the valve and within an interior periphery of the channel of the housing to bias the valve in the closed position.

16. A needle-less medication transfer apparatus according to claim 13, wherein the restoring member is an elastic material surrounding an external periphery of the axial stem of the valve and within an interior periphery of the channel of the housing to bias the valve in the closed position.

17. A needle-less medication transfer apparatus according to claim 10, wherein the valve and the restoring member form a poppet valve coupled to the housing.

18. A needle-less medication transfer apparatus according to claim 10, wherein the medication container contains medication prior to the housing being coupled to the medication container.

19. A needle-less fluid transfer device according to claim 10, wherein the needle-less medication delivery device includes means for generating a vacuum pressure when coupled to the housing to draw out the fluid from the medication container through the valve and housing and into the needle-less medication delivery device.

20. A needle-less medication transfer device for transferring medication from a medication container to a needle-less medication delivery device, the device comprising: a housing having an axial channel and adapted to couple with the medication container and the needle-less medication delivery device free of needles, wherein the axial channel facilitates fluid communication between the medication container and the needle-less medication delivery device; a valve movably disposed in the axial channel of the housing to seal off the fluid in the medication container when coupled to the medication container, wherein the valve further includes a valve head and an axial stem connected to the valve head, wherein the axial stem is disposed in and slidably moves back and forth along the axial channel of the housing, wherein the axial stem has one or more ports along the periphery of the axial stem leading to an axial fluid channel in the axial stem to provide fluid communication between the medication container and the needle-less medication delivery device when the valve is in an open position and the medication container and the needle-less medication delivery device are both coupled to the housing, wherein the valve head closes off the axial channel of the housing when the needle-less medication delivery device is decoupled from the housing, and wherein the axial stem is moved axially and the valve head is moved away from the needle-less medication delivery device and the axial channel of the housing when the needle-less medication delivery device is coupled to the housing to expose the one or more portals leading to the axial fluid channel to place the valve in the open position; and a restoring member coupled to the housing and the valve to generate a restoring force to maintain the valve in a closed position to prevent leakage of the fluid from the medication container when the medication container is decoupled from the housing and the needle-less medication delivery device is decoupled from the housing, wherein the restoring force of the restoring member is overcome and the valve is moved to an open position when the second receptacle is coupled to the housing to permit transfer of the fluid from the medication container to the needle-less medication delivery device when both the medication container and the needle-less medication delivery device are coupled to the housing, wherein the restoring force of the restoring member restores the valve to the closed position when the needle-less medication delivery device is decoupled from the housing, wherein the restoring member surrounds an external periphery of the axial stem of the valve and is within an interior periphery of the axial channel of the housing to bias the valve in the closed position, and wherein the needle-less medication delivery device includes means for generating a vacuum pressure when coupled to the housing to draw out the fluid from the medication container through the valve and the housing and into the needle-less medication delivery device.

21. A needle-less fluid transfer device according to claim 20, wherein the first receptacle is a medication bottle, and wherein the second receptacle is a needle-less syringe.

22. A needle-less fluid transfer device according to claim 21 , wherein the housing is adapted to be secured to the medication bottle by friction, and wherein the housing further includes male luer threads, wherein the needle-less syringe includes female luer threads adapted to mate with the male luer threads of the housing, and wherein the needle-less syringe is adapted to be coupled to the housing by threading the male luer threads with the female luer threads.

23 A needle-less medication transfer device according to claim 20, wherein the restoring member is a spring.

24. A needle-less medication transfer device according to claim 20, wherein the restoring member is an elastic material.