JPH10295780A - Fluid transportation device accessing fluid from vial and ampul and method to transport fluid using the same device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a fluid transportation device to fill chemicals to a syringe from a vial with a pierceable stopper. SOLUTION: This fluid transportation device is provided with a cannula assembly 121 including a cannula 122 connected to a hub 128. A filling straw-like body 134 has a base end, terminal end, and communication path 138. The straw- like body 134 is also provided with a needle part and a shaft part. A blade part 145 is provided at the end of a needle part 141. A narrow shielding body composed of a base end, a terminal end, and a side wall between the base end and the terminal end (the side wall forms a dent part at the shielding body) is detachably connected to the filling straw-like body 134, and the shaft and needle of the filling straw-like body is stored in the dent part. A tight plug 756 has an end part which is projected outward from the end of the shielding body, parts from the terminal end to the base end are movable in a vest form, and a fluid is prevented from being communicated between the path and the outside of the shielding body at the base end without pressure.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention provides access to drugs or injectable liquids in either glass ampules or vials having an elastomeric lid,
Thereafter, it relates to a device attachable to a hypodermic syringe or other fluid administration device, which allows for the administration of the medicament or injectable liquid.

[0002]

BACKGROUND OF THE INVENTION A typical hypodermic syringe comprises a syringe barrel having a mounting collar that threadably engages a hub of a needle cannula. The hub and needle cannula are connected to each other or kept separate from the syringe barrel until just prior to use. When storing the needles separately, the physician will select the appropriate needle assembly for the procedure being performed. The needle assembly is removed from the sterile package and the hub of the needle assembly is threadedly engaged with the mounting collar of the syringe barrel.

[0003]

SUMMARY OF THE INVENTION Liquid medicaments and other injectable liquids are often stored in rigid containers that can be operated using a hypodermic syringe. The container for the liquid medicament is a plastic or glass vial with an elastomeric lid that can be pierced by the needle of a hypodermic syringe. To access the liquid in the vial, the physician moves the plunger of the hypodermic syringe proximally to introduce an amount of air approximately equal to the desired amount of drug into the syringe barrel. The open end of the needle is then pushed through the vial's elastomeric lid and the air in the syringe barrel is injected into the vial. The distal tip of the needle, and the vial engaged with the tip, are then turned up so that gravity can be utilized. The physician ensures that the distal tip of the needle is covered by the drug in the vial by manipulating the needle and the vial with each other. The plunger of the hypodermic syringe is then moved proximally to aspirate the drug through the needle and into the syringe barrel chamber.

[0004] Once the desired dose of drug has been aspirated from the vial, the physician can inject the drug into the patient's body, another vial or intravascular set, or the injection site of a catheter. I. V. A needleless I.D. that does not require a sharp needle cannula to puncture the injection site of the set V. Tend to use the system. There are many systems that have an injection site covered by a pre-cut septum that can be operated with an obtuse cannula. Thus, after aspirating the drug from the vial using a sharpened needle, the I.D. V. If a drug is to be used with the set, the user removes the needle and attaches an obtuse cannula. Since the user uses the needle to aspirate the drug into the syringe and replace it with an obtuse cannula, the user may accidentally pierce the needle when removing the needle. Also, during installation and removal of components during the filling and dosing process, the components can be contaminated. Thus, it is possible to fill the syringe from a vial with a pierceable stopper without using a very sharp needle, after which the drug is passed through an obtuse cannula without having to handle or reshield the sharp needle. To I. V. There is a need for a device that allows for administration to a set.

[0005] Plastic vials and elastomeric lids for the vials are somewhat gas permeable. Certain pharmaceutical products degrade quickly, even in the presence of small amounts of gas. Accordingly, such medicaments are typically stored in glass ampules. The weakened end of the glass ampoule can be snapped to allow access to the medicament stored therein. The physician can aspirate the drug by inserting the tip of the needle in the hypodermic syringe into the drug stored in the ampoule. next,
The hypodermic plunger is moved proximally to aspirate the liquid medicament in the ampoule through the needle and into the hypodermic syringe barrel. The hypodermic syringe can then be withdrawn from the ampoule and used in substantially the same manner as described above. The ampoule is typically held open with the top open so that gravity can be utilized while filling the hypodermic syringe. The length of the needle required to fill the ampoule may be substantially greater than the convenient length of the needle required for subsequent use for injection. Similarly, when the drug aspirated from the ampoule is subsequently injected into an injection site having a pre-cut septum, the needle must be attached to and removed from the syringe, and a new obtuse cannula must be attached, identical or similar. There is a problem of. Thus, prior to providing a properly filled syringe and obtuse cannula combination, there is a risk of accidental contamination and needle sticks.

[0006]

SUMMARY OF THE INVENTION The present invention is directed to an apparatus for safely and efficiently filling a hypodermic syringe. The device can include an obtuse cannula having exposed proximal and distal ends. The proximal end is configured to engage the distal end of a hypodermic syringe. For example, the proximal end of the obtuse cannula can include a protrusion for threaded engagement with a luer collar at the distal end of the syringe barrel. The distal end of the cannula may be obtuse and configured to selectively engage a prior art connector for an intravascular line.

The device further includes a vial access spike having exposed proximal and distal ends and a communication passage extending axially therethrough. The proximal end of the vial access spike is releasably mounted in fluid tight engagement with the distal end of the obtuse cannula. For example, the proximal end of the passage through this vial access spike
The fluid can be frictionally secured in a fluid tight engagement over the distal end of the obtuse cannula. The end of this vial access spike defines a beveled tip that is sharp enough to pierce the rubber stopper of the vial, but preferably not sharp enough to pierce the skin by accidental touch. . The vial access spike may further comprise a cap for selectively sealing engagement on the proximal end of the spike. This cap can be integrally connected to the vial access spike by a hinge or an anchor. The hinged connection can be formed by an over-center hinge, which is stable in the fully open or fully closed position of the cap. However, in the intermediate position, the over-center hinge will be biased to bias the cap either to a fully open position or a fully closed position.

[0008] The device may further comprise a protective shield mountable on at least the distal end of the vial access spike. The protective shield may have a hinge or a slot surrounding the anchor. This shield prevents the tip of the beveled end of the spike from becoming contaminated before insertion into the vial.

[0009] The assembled obtuse cannula, vial access spike, and shield can be packaged separately from the hypodermic syringe. Alternatively, the assembled obtuse cannula and vial access can be attached to and packaged with a hypodermic syringe.

The hypodermic syringe equipped with the filling device of the present invention can be filled by removing the shield from the vial access spike and pushing the beveled end of the vial access spike through the vial stopper. Thereafter, the hypodermic syringe and vial are inverted so that the liquid medicament in the vial covers the end of the vial access spike. The plunger of the hypodermic syringe is then pulled proximally to draw fluid into the syringe barrel. The user can then separate the connected hypodermic syringe and obtuse cannula from the vial access spike and use the connected hypodermic syringe and acute cannula in a conventional manner. The vial access spike can remain in the vial and seal the vial so that the cap can be engaged over the proximal end of the spike and subsequently manipulated.

[0011] A fluid transfer device of the present invention for removing fluid from a vial and an ampoule includes a cannula having a proximal end, a distal end, and a lumen therethrough; A hub having a distal end connected to the proximal end of the cannula such that the lumen is in fluid communication with the open proximal end of the hub. A filled straw having a proximal end, a distal end, and a passage therethrough includes a proximal housing, a distal needle portion,
A shaft portion between the proximal end and the needle portion. To limit the depth of penetration of the needle portion into the vial stopper, a ledge is provided between the needle portion and the shaft portion. The housing has a cavity at its proximal end in fluid communication with the passage. A blade portion is provided at the distal end of the needle portion for piercing the vial stopper. The open end of the hub is in fluid communication with the passage of the filling straw;
A structure is provided for releasably engaging the cannula assembly with the housing so that the cannula is within the cavity. A shield having an open proximal end, a distal end, and a sidewall between the proximal and distal ends, wherein the sidewall forms a recess in the shield, is removably connected to the filling straw; The shaft portion and the needle portion of the filling straw are accommodated in the recess.

The fluid transfer device of the present invention includes a cannula assembly that includes a cannula having a proximal end, a distal end, and a lumen therethrough. A hub having an open proximal end and a distal end is connected to the proximal end of the cannula such that the lumen is in fluid communication with the open proximal end of the hub. The filling straw has a proximal end, a distal end, and a passage therethrough. The filling straw comprises a needle portion at its distal end and a shaft portion between the needle portion and the proximal end. A blade portion is provided at the distal end of the needle portion for piercing the vial stopper. The cannula assembly and the filling straw are releasably engaged such that the proximal end of the hub is in fluid communication with the passage of the filling straw. The shield has an open proximal end, an open distal end, and a sidewall between the proximal and distal ends, the sidewall forming a recess in the shield. A shield is removably connected to the filling straw so that substantially the entire needle portion and shaft portion are received in the recess. The sealing plug has a proximal end and a distal end. The sealing plug has a distal position in which the sealing plug projects distally outward from a distal end of the shield, and a non-pressurized fluid between the distal end and a proximal position (the passage and the exterior of the shield). The sealing plug can be telescopically moved to a position where the sealing plug seals the needle portion to prevent communication.

The present invention also relates to a method of transferring an injectable liquid, the method comprising: (a) an elongated cylinder defining a chamber for holding a fluid; an open proximal end, a distal end, and A distal end extending from a distal end and having a distal passage in fluid communication with the chamber; a stopper slidably engaging fluid tightly within the barrel of the syringe; and a stopper connected to the stopper and of the barrel of the syringe. Providing a syringe comprising a syringe barrel having an elongated plunger rod extending proximally through an open proximal end;
(B) a filling device for a syringe, the shield having a cannula assembly and an open proximal end, wherein the shield is between the open distal end and the proximal end and the distal end; And a shield removably connected to the filling straw so that the shaft portion and the needle portion are received in the recess. A cannula having a proximal end, an obtuse end, and a lumen therethrough, and a hub having an open proximal end, such that the lumen is in fluid communication with the open proximal end of the hub. A filled straw having a hub having a distal end connected to the proximal end of the cannula, a proximal end, a distal end, and a passage therethrough, the housing at the proximal end, and the needle at the distal end; Portion and between the proximal and distal ends And a filling straw having a blade portion provided at the distal end of the needle portion so as to pierce a vial stopper, the cannula assembly being disposed on the open base of the hub. A sealing plug having a proximal end and a distal end adapted to releasably engage with the filling straw such that the end is in fluid communication with the passage of the filling straw; Wherein the sealing plug has a distal position projecting distally outward from the distal end of the shield and is adapted to be telescopically movable from the distal end to the proximal position, wherein the sealing position is at the proximal position. A filling device for the syringe, wherein the plug seals the needle portion such that a plug may prevent communication of unpressurized fluid between the passage and the outside of the shield. Step and (c) above A distal end disposed within the open proximal end of the hub, the chamber connecting the syringe filling device to the syringe in fluid communication with the cannula; and (d) having a pierceable septum; Providing a vial holding an injectable liquid; (e) removing the shield from the filling straw; and (f) removing the pierceable septum of the vial from the filling straw. Piercing with a needle portion to provide fluid communication between the interior of the vial and the chamber of the syringe; and (g) moving the plunger rod proximally with respect to the syringe barrel to provide a desired volume of injection. Aspirating the liquid from the vial into the chamber; and (h) withdrawing the needle portion from the septum of the vial; A method for transferring an injectable liquid, comprising:

(I) Reconnecting the shield to the filling straw so that substantially the entire shaft portion and the needle portion of the filling straw are accommodated in the recess of the shield. And (j) moving the sealing plug from the distal position to the proximal position to seal the needle portion.

[0015]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS While the present invention may be embodied in many different forms of embodiments, this disclosure is only an example of the principles of the present invention and an implementation which describes the scope of the invention. Preferred embodiments of the present invention are shown in the drawings and will be described in detail with reference to the drawings, with the understanding that the present invention is not intended to be limited only to the embodiments. The scope of the invention should be determined by the appended claims and equivalents thereof.

A syringe filling device according to the present invention is shown generally at 10 in FIGS. The syringe filling device 10 includes an obtuse cannula 12, a vial access spike 14, and a shield 16. The syringe filling device 10 comprises a hypodermic syringe 1 of the prior art.
8 to be used together. The hypodermic syringe 18
Syringe barrel 2 having a distal end 22, a proximal end (not shown), and a fluid receiving chamber 24 between the distal and proximal ends.
0 is provided. The proximal end of the syringe barrel 20 is open and slidably receives the plunger 26 in fluid tight engagement with the cylindrical wall forming the chamber 24. The distal end 22 of the syringe barrel 20 has an elongated tip 28 that extends axially therethrough and has a passage 30 communicating with the chamber 24. The syringe preferably includes a luer collar 32 concentrically surrounding the tip 28 and a female thread 34.

The obtuse cannula 1 of the syringe filling device 10
2 is preferably integrally formed of a thermoplastic material and the cannula comprises a proximal end 36 and a distal end 3
8 and a lumen 40 extending axially therethrough.
The proximal end 36 of the obtuse cannula 12 is configured to be threadably engageable with the threaded portion 34 of the luer collar 32. The distal end 38 of the obtuse cannula 12 is cylindrical and has an outer diameter "a".
To form The distal end 38 is also configured to engage an intravenous connector having a pre-cut septum so that a fluid medicament can be administered to the patient from the chamber 24 of the syringe barrel 20.

Also, the vial access spike 14
Preferably, the vial access spike is formed integrally from a thermoplastic material and the vial access spike is
, A distal end 44 and a passage 46 extending axially therethrough. The portion of the passage 46 adjacent to the proximal end 42
As shown in FIG. 2, the distal end 3 of the obtuse cannula 12
8 is arranged in a releasable fluid tight engagement. Passageway 46 is cylindrical and defines an inner diameter “b” (approximately equal to the outer diameter of obtuse cannula 12 adjacent distal end 38) adjacent proximal end 42 of vial access spike 14. The distal end 44 of the vial access spike 14 has a beveled tip 48 that is sharp enough to be pushed through the rubber stopper of the vial, as described and illustrated further herein. However, it is preferred that the beveled tip 48 is not sharp enough to pierce the skin when accidentally touched.

The vial access spike 14 further comprises a cap 50, the cap 50
Hinge 5 connected to the spike 14 at a position near 2
2 is articulated. The dimensions of the cap 50 are such that it nests over the proximal end 42 of the vial access spike 14 to seal in a substantially fluid tight engagement. As shown in FIG. 1 to FIG.
Reference numeral 2 denotes an over-center hinge having a first hinge 54 forming the rotation axis of the cap 50. The over-center hinge 52 further comprises a second hinge element 56, wherein the second hinge element comprises a first hinge 54
Are formed parallel to, but spaced apart from, the rotation axis of. Second hinge 56
Is resiliently deflectable at the elbow 57 and the second hinge is in the fully open position with the cap 50 as shown in FIGS. 1-3, or as shown in FIG. It is configured to be non-biased when in a completely closed position. However, the second hinge element 5
6 is biased when in the middle position. Thus, the elasticity of this second hinge element 56 facilitates the opening or closing force applied by the user and urges the cap 50 toward a fully open or fully closed position.

An alternative hinge 52a as shown in FIG.
Form a mooring device. The anchor serves to retain the cap 50 near the proximal end 42 of the spike 14.
However, the anchor does not facilitate opening or closing the cap 50.

The shield 16 is preferably made of a thermoplastic material, and has an open proximal end 60 and a distal end 61 (preferably closed). A passage 62 extends into the proximal end 60 to form an inner diameter “c” (approximately equal to the outer diameter “d” of the vial access spike 14 adjacent its proximal end 42). In this manner, the proximal end 60 of the shield 16 releasably frictionally engages the vial access spike to prevent accidental touching of the vial access spike 14 or contamination of the spike. . The proximal end 60 of the shield 16 is
It is further characterized by having a slot 63. The slot 63 is sized to surround the hinge 52 and allow the shield 16 to fully seat on the outer periphery of the vial access spike 14.

The filling device 10 can be packaged and sold in a pre-assembled state as shown in FIG. More specifically, the proximal end 4 of the vial access spike 14
2 is frictionally engaged around the distal end 38 of the obtuse cannula 12, while the shield 16 is
4 can be frictionally engaged with at least a part of the outer periphery. Alternatively, the filling device 10 and obtuse cannula 12 may be packaged and sold pre-installed on a hypodermic syringe 18. In this latter embodiment, the shield 16 is preferably sized to releasably frictionally engage over the outer peripheral portion of the luer collar 32. Also, vial access spike 1
4 and shield 16 may be sold in an assembled state where the cap seals the proximal end of the spike.

The filling device 10 is used with the proximal end 36 of the obtuse cannula 12 threadedly engaged with the luer collar 32 of the syringe barrel 20. The shield 16 is removed immediately before use. The plunger 26 is then moved proximally to flush an amount of air approximately equal to the desired drug dose into the syringe barrel 24.
Suction into. Then, vial access spike 14
Can be pushed through the rubber stopper 64 of the vial assembly 66. Next, plunger 26 is moved distally to force air from syringe chamber 24 into vial 66.

The hypodermic syringe 18 and vial 66 are turned upside down as shown in FIG. 5 so that the liquid medication 68 covers the portion of the passage 46 of the vial access spike 14 adjacent its distal tip 48. Next, the plunger 26 is again moved in the proximal direction to aspirate the desired dose of the liquid drug 68 into the chamber 24. Next, the syringe 18 and the vial assembly 66 are again turned upside down so that the vial assembly 66 is below the syringe 18 so that gravity can be utilized. Next, the syringe 18 and obtuse cannula 12 are connected to the vial access spike 14 and vial 6.
Separated from 6. The syringe 18 and obtuse cannula 12 are then used in a standard manner as described above. The vial access spike 14 stays in the rubber stopper 64 of the vial 66 and allows access to the medication 68 thereafter. The medication 68 is sealed from the environment by rotating the cap 58 about the hinge 52 and sealingly engaging the proximal end 42 of the vial access spike 14. Thereafter, the drug 68 remaining in the vial 66 can be accessed by hingedly rotating the cap 50 from the proximal end 42 of the vial access spike 14. This subsequent access can be performed using a prior art hypodermic syringe with an obtuse cannula.

As best shown in FIG. 6, the obtuse cannula 12 and the vial access spike 14 are formed by the obtuse cannula outer diameter and vial access spike passage 4.
Preferably, they can be connected to each other by an interference fit with the inner diameter of 6. A suitable obtuse angled cannula is one-piece molded from a thermoplastic material.
However, the obtuse cannula can be provided with a plastic hub. In this case, a separate obtuse cannula made of a rigid material such as stainless steel is connected to the hub by glue or other suitable means. Also, the obtuse cannula lumen 40 may be a standard luer slip with frictional engagement, as shown in FIG. 7, or a frusto-conical proximal end suitable for a locking luer syringe, as shown in FIG. A portion 41 is also provided.

FIG. 7 shows a frusto-conical elongated tip 28A.
Shown is an obtuse cannula 12 aligned for assembling with a syringe 18A having a frustoconical portion 41 of the obtuse cannula lumen (which is adapted to frictionally and releasably engage). I have. Preferably, the obtuse cannula of the present invention can be used with locking luer type syringes, such as syringe 18, and luer slip type syringes, such as syringe 18A.

FIG. 8 illustrates another embodiment of the present invention wherein the syringe 70 includes an integrally molded obtuse cannula 12B having a lumen 40B extending therethrough. This lumen 40B is in fluid communication with the syringe barrel chamber 24B. This embodiment of the invention functions substantially identically to the embodiment of FIGS. 1-7, except that the cylindrical obtuse cannula cannot be separated from the syringe barrel.

Although the present invention has been described with respect to certain preferred embodiments, it will be apparent that various modifications can be made without departing from the scope of the invention as set forth in the appended claims. For example, the obtuse cannula of the syringe filling device can be permanently attached to the hypodermic syringe, or can be integrally molded as part of the syringe barrel. Further, the releasable engagement between the vial access spike and the obtuse cannula may be other than a frictional engagement as described above. Additionally, obtuse metal needle cannulas can be used with vial access spikes.

Referring to FIGS. 8-21, a liquid transfer device 120 for manipulating liquid from vials and ampoules.
Includes a cannula assembly 121 that includes a cannula 122 having a proximal end 123, a distal end 125, and a lumen 127 therethrough. A hub 128 having an open proximal end 129 and a distal end 131 is connected to the proximal end 123 of the cannula so that the lumen 127 is in fluid communication with the open proximal end of the hub. Hub 128 may be configured as described in more detail below.
Preferably, it has a radial projection 132 that engages a locking luer collar on a syringe barrel or other fluid administration device. In this preferred embodiment, the cannula distal end 125 has an obtuse tip 133 and the cannula and hub are integrally formed of a thermoplastic material. However, this cannula and hub are manufactured separately and
It can be attached by various manufacturing methods (preferably an adhesive such as epoxy).

The filled straw 134 has a base 135
, A distal end 137 and a passage 138 therethrough. The filling straw 134 has a housing 139 at a proximal end 135, a needle portion 141 at a distal end 137, and a shaft portion 143 between the proximal and distal ends. The housing has at its proximal end a cavity 144 in fluid communication with passage 138. The distal end of the needle portion 141 has a blade portion 145 for piercing the vial stopper.

The blade portion is preferably sharp enough to pierce the vial stopper, but not as sharp as the needle cannula used to inject humans. A tip or blade portion that is sharp enough to pierce the vial but not enough to inject into humans
Many I.D. such as spikes or cannulas used with vials having a pierceable stopper. V. Used in therapy equipment. In this embodiment, the needle portion 141 is made of a metal such as stainless steel and can be held on the shaft portion using various manufacturing methods (preferably an adhesive such as epoxy). The metal needle portion has the advantage of being high strength and of small diameter, reducing the penetration force when the needle portion enters the vial stopper. It is also within the scope of the present invention to have a needle portion and a shaft portion integrally formed of a single material such as a thermoplastic material. In each case, it is preferred to have a shoulder 147 between the shaft portion and the needle portion so as to limit the depth of penetration of the needle into the vial stopper. Also, the appearance of a short needle, a protruding shoulder, and a relatively obtuse blade indicates to the user that the straw is not intended to be injected, and Helps prevent the body from being accidentally used to inject into humans.

The present invention includes means for releasably engaging the cannula assembly with the housing, and
As best shown in FIG. 10, the open proximal end of the hub is in fluid communication with the passage of the filling straw and the cannula is within the cavity or passage. This connection must be relatively tight because fluid is drawn through the filling straw and cannula assembly into a syringe or other fluid administration device. The means for releasably engaging the cannula assembly with the housing may be embodied in various structures such as screws, complementary protrusions and recesses, etc., but the inner surface 149 of the housing and the outer surface of the needle hub. It is preferable that 150 and 150 be an interference fit. Thus, the housing and hub can be releasably engaged and disengaged by pulling or separating the housing and hub from each other in the axial direction. As described in more detail below, the rotational force imparted to the filling straw through the housing can be transmitted to the hub to engage or disengage the hub and the barrel of the syringe. Also, being able to transmit torque from the filling straw to the cannula assembly,
This can be achieved by an interference fit between the inner surface 149 of the housing and the outer surface 150 of the hub. However, additional structures may be provided to facilitate the transfer of torque from the filling straw to the cannula assembly. In this preferred embodiment, the axial ribs 151 provided on the hub correspond to the axial ribs 15 in the housing.
2 to transmit torque from the filling straw to the cannula assembly.

The shield 155 has an open base end 157,
It has a distal end 158 and a side wall 159, which forms a recess 161 in the shield. The shield 155 is
Removably connected to the filling straw 134,
The needle portion and preferably the shaft portion of the filling straw are in the recess.

A number of structures can be used to releasably connect the shield and the filling straw, such as screws, projections and recesses to allow a snap-fit structure or an interference fit. Can be used. In this preferred embodiment, the inner surface 162 of the proximal end of the shield
Is in frictional engagement with the outer surface 163 of the housing. Thus, an axial force can be used to remove the shield and reattach the shield to the filling straw. Inner surface 162 and outer surface 163 are preferably frusto-conical so as to provide a smooth frictional engagement. Also, the inner surface 162 at the proximal end of the shield releasably engages the outer surface 150 of the hub to shield the filling straw or to shield the cannula assembly when the filling straw is removed. One of the key features of this preferred embodiment is that the shield can be used in the preferred embodiment. This is an important feature in that it allows for a variety of different ways to use the fluid transfer device of the present invention, depending on user preferences.

The fluid transfer device of the present invention is suitable for use with a fluid administration device such as a syringe. For purposes of illustration, the fluid transfer device 120 is connected to a hypodermic syringe 170 comprising a syringe barrel 171 having a distal end 173, a proximal end 174, and a circular sidewall 175 forming a chamber 176 for holding fluid. Shall be A volumetric indicator 172 is provided on the syringe barrel to measure the dose of the liquid to be administered. The distal end of the syringe barrel is connected to a hub 128 so that the lumen of the cannula 122 is in fluid communication with the syringe barrel chamber 176. In this embodiment, the syringe barrel end 173
Has a frusto-conical tip 177 having a conduit therethrough, which provides a fluid path between the cannula and the chamber. The frusto-conical tip of this syringe barrel is
The hub preferably frictionally engages the preferably frusto-conical surface 130 of the open proximal end 129 of the hub. The end of the syringe barrel also has a locking luer-type collar 17 surrounding the tip 177 concentrically.
Although it is preferred to have 9, it is not absolutely necessary. The luer collar has an internal thread 180 that engages a radial projection 132 of the hub 128 to securely hold the hub to the syringe barrel. It is within the scope of the present invention to include various hub configurations that attach to various other medical fluid handling devices. The above-described hub configuration with a frusto-conical inner cavity is only one of many of these many possibilities. Multiple syringes and fluid handling devices, such as stopcocks and adapters,
As well as other fluid handling devices, there are luer slips and locking luer fittings (a hub with a frusto-conical inner cavity is properly engaged). It is also within the scope of the present invention to provide a fluid transfer device in which the cannula assembly is integrally formed with the syringe barrel.

A stop 182 is disposed within the chamber 176 in a fluid tight engagement with the circular side wall 175 in a slidable manner. A rigid elongate plunger rod 183 is connected to the stopper, which is connected to the syringe barrel 1
71 extends in the proximal direction through the open proximal end. The stopper and the plunger rod can be formed in a single, unitary structure. The force applied to the plunger rod causes the stopper to slide in the proximal direction,
Fluid is drawn into chamber 176 through conduit 178. Conversely, when stopper 182 slides distally, fluid is forced out of chamber 176 through conduit 178.

The fluid transfer device 120 of the present invention (which is coupled to a fluid administration device such as a hypodermic syringe 170) is used to access the fluid in a vial or ampoule and to provide the fluid to an I.V. V. It can be supplied to the injection site of a set or catheter. As shown in FIG. 14, the fluid transfer device 120 is used with a syringe 170 to access an injectable liquid or drug, such as a fluid 185, retained in a vial 186 having a pierceable stopper 187. be able to. This fluid is operated by piercing the stopper 187 with the needle portion 141 of the filling straw 134. A shoulder 147 between the needle portion 141 and the shaft portion 143 of the filling straw limits the depth of penetration of the needle portion into the vial. In a preferred embodiment, the needle portion is about 10 mm long and about 1.3 mm in diameter. First, an amount of air approximately equal to the desired dose is injected into the vial. Thereafter, as shown in FIG. 14, the vial is turned upside down and the plunger acts in the proximal direction to draw fluid into the syringe and fill the straw passage 138 with the fluid 18 through the lumen of the cannula.
5. Push 5 from vial 186 into chamber 176 of the syringe barrel. The user compares the axial position of the plunger with a volumetric indicator 172 provided on the cylindrical side wall to ensure that the desired dose is obtained. It will be appreciated that the level of fluid 185 in the vial will progressively decrease as the fluid is drawn into the chamber of the syringe barrel. The shoulder 147 keeps the distal end of the needle portion close to the stopper and facilitates aspiration of most of the liquid from the vial. Also, due to the short length of the needle portion associated with the shoulder and the large shaft portion, the physician may clearly know that this device is not intended for injection into a human body. .

As best shown in FIG. 15, the fluid transfer device of the present invention can also be used to aspirate fluid 185 from ampoule 191. As described above, in use, the neck portion of the ampoule is snapped or cut to form an open neck portion 192. Since the ampoule does not have an elastomeric seal, the ampoule does not turn upside down during the transfer of fluid from the ampoule to the hypodermic syringe. Therefore, there is a need for a long filled straw that can extend toward the bottom or both sides of the ampoule. For this purpose, a shaft portion 143 of the filling straw is provided. This long shaft portion, in combination with the needle portion, allows the fluid transfer device of the present invention to efficiently remove liquid from the ampoule. In a preferred embodiment, the length of the shaft portion is about 15 mm and its outer diameter is about 3 mm. As with the vials, the action of the plunger draws fluid from the ampoule into the chamber of the syringe such that the fluid is drawn into the chamber through the straw passageway, the lumen of the cannula assembly.

8 to 21, particularly FIGS. 16 to 21
With reference to I.I. V. It can be appreciated that there are two distinct methods that can be used to deliver medication from the syringe to the injection site through a set or other catheter device having an injection site. This first method is illustrated in FIGS. 16, 17 and 21. In this first method, after filling the syringe with fluid from a vial or ampoule or other source, the shield 155 rests on the filling straw 134 so that the shield can be removed from the filling straw. The needle portion 141 and the shaft portion 143 are connected and are received in the recess 161 of the shield. This assembly is identical to that present at the start of the filling process. In this preferred embodiment, the engagement between the shield and the filling straw is effected by an axial movement, whereby the structure at the open proximal end of the shield is filled. Engage with the housing on the straw. Next, the filled syringe is moved to the point of use. At point of use, the user removes the shield and filling straw assembly from the cannula assembly by grasping the filling straw, preferably the raised portion 136 of the filling straw, as shown in FIG. The shield and filler straw assembly is removed from the cannula assembly by applying an axial force to remove the filler straw from the cannula assembly as shown. Because the cannula assembly is attached to the syringe by a locking luer collar, the connection between the cannula assembly and the syringe barrel is less than the frictional engagement between the filling straw and the cannula assembly. Strong, so that the actual applied force does not cause the cannula assembly to come off the syringe. According to the structure of various parts,
The forces can be balanced to achieve the desired result with respect to removing the component. The syringe is ready to administer the drug in this state, as described in more detail below.

As best illustrated in FIGS. 18-21, a second method of using the fluid transfer device of the present invention is to fill a syringe with a fluid from a vial or ampoule immediately after filling the straw. The user removes the filling straw 134 by grasping (preferably the raised portion 136 of the filling straw) and applying an axial force to remove the filling straw from the cannula assembly. Need. Next, as shown in FIG. 19, a shield 155 is placed over the cannula assembly to protect the cannula until the point of use. Hub 128 of cannula assembly and housing 139 of filled straw
Has a similar profile, and the shield 155 can engage either the hub or the housing, so this second method is possible. In the preferred embodiment, the engagement is a frictional engagement, wherein engagement and disengagement is achieved by applying an axial force. In use, as shown in FIG. 20, by applying a force in the distal axial direction, the shield 15
5 is removed from the cannula assembly.

The preferred embodiment of the fluid transfer device of the present invention is described in I.S. V. Includes a cannula with an obtuse end used with the set or with other catheter devices with injection points with a pre-cut septum.
Specifically, as shown in FIG. V. Set 195 includes a hollow inner conduit 198 and a flexible tube 199.
(Typically connected to the patient's vasculature through a catheter). In addition, the housing 197 has an I.P. V. It also contains a flexible tube 196 connected to a source of fluid. The housing 197 also includes a port 200 having a conduit 201 communicating with the hollow interior. A septum 203 covers or is located within the end of the conduit. The most common ports are covered by a pierceable or pre-cut diaphragm and are known in the art and have the Latin meaning "P" which means "when need arises".
Sometimes referred to as an "RN" port. The septum is preferably made of rubber or other elastomeric material so that a sharp needle cannula can be inserted to inject fluid into or aspirate fluid from the catheter. It becomes possible. After withdrawing the needle cannula, the septum seals itself. As shown in FIG. 21, the diaphragm 203 is a pre-cut diaphragm having a slit 204. This septum 203 is
1 is effectively sealed from the outside of the housing. However, access to this conduit can be provided by pressing the obtuse tip 133 of the cannula 122 against the septum region having the slit 204. Light force on the syringe assembly in the axial direction causes the obtuse end of the cannula to enter the conduit through a slit (pushed open by the obtuse cannula). When the obtuse cannula is removed from the conduit, the slit portion of the septum seals naturally.
Because the housing 197 is connected to the patient's vasculature, the medicament can be administered to the patient through the PRN port without further puncturing the patient's blood vessels, ie, in this case, without using a sharp needle. .

The entire operation of filling a syringe from a vial or ampoule containing an injectable liquid or fluid such as a medicament and administering this fluid to the patient uses only the cannula assembly of the present invention, Without using a needle,
What can be done is one important feature of the present invention. The most common prior art method of aspirating medication from a vial having a pierceable septum is to attach the standard hypodermic needle assembly shown in FIG. 23 to a hypodermic syringe. This fluid is drawn into the syringe barrel and then
Discard the needle and attach the obtuse cannula to the syringe.
This additional step creates the potential for accidental needle stick accidents and requires some form of disposal system. The present invention, in its preferred embodiment, does not use a standard needle and does not require a disposal step. This is because all components of the fluid transfer device remain in the syringe until the point of use, and immediately after use, all components can be properly disposed of. The present invention also provides a fluid transfer device that allows the syringe to be filled and allows the administration of a medicament to a patient without using a sharp injection catheter.

FIG. 22 illustrates an alternative cannula assembly 221 having a metal cannula 222 (preferably made of stainless steel). The cannula 222 has a proximal end 223 and a distal end 2 through which the lumen passes.
25. The distal end 225 has an obtuse tip 233. Cannula assembly 221 functions in substantially the same manner as cannula assembly 121 except that the cannula is made of metal. Stainless steel cannulas have the advantage of being stronger than cannulas made of thermoplastic material, and while maintaining that high strength,
This stainless steel cannula is desirable because it is possible to manufacture the cannula with a smaller outer diameter and a larger lumen diameter.

FIG. 23 illustrates a prior art needle assembly 321. The needle assembly is used to administer the medicament to the patient, and also includes a medicament vial and an I.V. V. It is commonly used to transfer fluid through a pierceable septum, such as the septum found in a set. Needle assembly 321 includes a proximal end 3
23, a needle cannula 322 having a distal end 325 and a lumen therethrough. The distal end 325 further comprises a sharp tip 333 that can pierce the skin, a flexible stopper, and a septum.

The preferred embodiment of the fluid transfer device of the present invention comprises a cannula assembly having an obtuse cannula used. The obtuse cannula is filled into the syringe through a vial or ampoule and injected into the syringe. V.
It allows the use of a single device to dispense fluid from a vial or ampoule through a pre-cut septum of a set or other catheter device. Thus, this preferred embodiment fills and administers injectable fluid without the use of a sharp needle cannula or after filling the syringe and requiring the additional step of disposing of the cannula. It is a needleless device. However, it is also within the scope of the present invention to provide a fluid transfer device incorporating a needle assembly with a needle cannula having a sharp distal tip, such as needle assembly 321. The pre-slit septum is a catheter, or I.P.
V. If not available for the set, a sharp steel needle cannula must be used. However, even with a needle assembly having a sharp needle cannula, the fluid transfer device of the present invention has distinct advantages over the prior art.
That is, the needle assembly remains integral with the syringe from the time of filling through the time of injection, and thus, after filling the syringe,
The additional step of removing the sharp needle cannula from the syringe is not required, and in this intermediate step,
The cumbersome extra steps involved in disposing of sharp needle cannulas are not required. The needle cannula is also protected from damage during the filling process.

FIGS. 24 and 25 illustrate an alternative fluid transfer device of the present invention. The fluid transfer device of FIGS. 24 and 25 is similar to that of FIGS. 9 through 9 except that the structure is provided such that a rotational movement is required to remove the filling straw from the cannula assembly. It functions in much the same way as the twenty fluid transfer devices. Specifically, the alternative fluid transfer device 420 includes a cannula assembly 421 having a cannula 422 and a hub 428. The hub 428 further includes a locking luer collar 424 having an internal thread 426. Filled straw 434
Is a housing 439 having a radial projection 440 configured to engage the female thread 426 of the luer collar 424.
It has. Thus, the attachment of the filling straw to the cannula assembly is performed by a rotating operation. A shield 455 is removably attached to the filling straw. The filling straw and the shield are configured such that by moving the shield axially relative to the filling straw, the shield can be removed and reconnected to the filling straw. This alternative embodiment of the invention offers distinct advantages to the user. It is that the shield is removed from the filling straw by axial movement, and the filling straw is
This is because they can be removed from the cannula assembly through a rotating operation, and the user does not have a risk of accidentally removing another component when trying to remove one component.

FIG. 26 illustrates an alternative structure of the fluid transfer device of the present invention, in which a cannula,
Alternatively, the cannula assembly is formed integrally with the syringe barrel. Specifically, cannula 522 and hub 528
Is formed integrally with the syringe barrel 571, so that the cannula cannot be removed from the syringe barrel. Other than this feature,
The syringe and obtuse cannula function in substantially the same manner as in the embodiment shown in FIGS.

Referring to FIGS. 27 and 28, an alternative fluid transfer device 600 is shown. This fluid transfer device 600
Are intended for use where a separate cannula assembly is not required. The fluid transfer device 600
Has a proximal end 635, a distal end 637, and a passage 638 therethrough.
And a filling straw 634 having The filling straw comprises the proximal housing 639, the distal needle portion 641, and a shaft portion 643 between the proximal and distal ends. It is preferable that the needle portion and the shaft portion are integrally formed of a thermoplastic material. The housing preferably has a frusto-conical cavity 644 at its proximal end in fluid communication with passage 638. A blade portion 645 is provided at the distal end of the needle portion for piercing the vial stopper. Open base 657
And a distal end 658 and a sidewall 659 between the proximal and distal ends.
Is provided, the sidewall forming a recess 661 in the shield. Preferably, the shield is detachably connected to the filling straw and the shaft portion and the needle portion of the filling straw are accommodated in the recess. A fluid retaining chamber 676, an open proximal end, a distal end 673, and a frusto-conical tip 677 extending from the distal end and having a distal passage 678 extending therethrough in fluid communication with the chamber. Frusto-conical tip 6
Syringe 67 having an elongated cylinder 671 forming
70 are provided. The tip is located within cavity 644 of housing 639 such that chamber 676 is in fluid communication with passage 638 of the filling straw.
A cavity 644 in the housing includes a frusto-conical wall 646 configured to frictionally engage a frusto-conical tip on the syringe barrel. A needleless device with a valve and special fittings designed to accept the standard frusto-conical tip of a hypodermic syringe barrel is provided. In the case of the needleless device, a separate cannula assembly is not required since the tip of the syringe barrel functions as a cannula for the device. 27 and 28 in all other respects.
The embodiment of the present invention functions in substantially the same way as the embodiment of FIGS. 9 to 20, except that the fluid is passed through the tip of the syringe, a fluid receiving device (a pre-designed to accept a standard syringe tip). (It may be a diaphragm with a cut)
The difference is that they are supplied within.

In this embodiment, it is preferred that the syringe include a locking luer collar 679 having internal threads 680, but this is not absolutely necessary. The proximal end of housing 639 is provided with a radial projection 632 that engages screws 680 to further facilitate the connection between the housing and the syringe barrel. In this embodiment, when the filling straw is removed, the shield engages with the luer collar, and after filling the syringe, the filling straw is discarded and the syringe tip is shielded again by the shield 655. The shield 655 preferably has a radial projection 640 so that it can be moved to the point of use. In an alternative, the filled syringe with the shielded filling straw attached may be transferred to the point of use to remove the shield and the filling straw as described above for use with the embodiment of FIGS. 9-20. Both may be removed and discarded.

Referring to FIGS. 29 and 30, one alternative fluid transfer device 720 is shown. In some respects, the fluid transfer device 720 functions similarly to the fluid transfer devices of FIGS. 9-21. For purposes of explanation, components of the fluid transfer device 720 that are the same as those in the embodiment of FIGS. 9-21 are designated by the same reference numerals.
The fluid transfer device 720 includes a cannula 122 and a hub 1.
28 can be provided. Filling straw 134 includes a needle portion 141 having a blade portion 145 at its distal end. The cannula assembly and straw are releasably engaged. The fluid transfer device 720 is connected to a syringe 170 having an elongated cylinder 171 forming a chamber 176 for holding a fluid.

The shield 755 has an open base end 757,
Open distal end 758 and sidewall 75 between the proximal and distal ends
9 (the side walls forming a recess 761 in the shield). The shield is removably connected to the filling straw so that the shaft portion 143 and the needle portion 141 are substantially received in the recess 761. The sealing plug 756 has a proximal end 760 and a distal end 764. The sealing plug has the distal position shown in FIG. 29, at which point the sealing plug projects distally outwardly from the distal end 758 of the shield 755 and is shown in FIG. 30 from the distal position. It is adapted to be nestable to a proximal position. The sealing plug includes means for sealing the needle portion to prevent unpressurized fluid from communicating between the filling straw passage 138 and the outside of the shield when the sealing plug is in the proximal position. ing. In this embodiment, the sealing means has a retaining conduit 766 extending distally from the proximal end of the sealing plug. The retaining conduit has an inner surface 767 that sealingly engages the needle portion of the filling straw when the sealing plug is in the proximal position shown in FIG. It is preferred to have a tapered portion 768 at the proximal end of the sealing plug to guide the needle portion into the retention conduit when the sealing plug is moved from the distal position to the proximal sealing position.

For certain applications, a structure is provided that prevents the sealing plug 756 from moving from its proximal sealed position to its distal position during normal use of the fluid transfer device 720, or such. It is preferable to adopt the form of a simple component. In this embodiment, the means for preventing movement of the sealing plug from the proximal sealing position to the distal position is such that in the proximal sealing position, the plug is located substantially within the open distal end 758 of the shield 755. It is provided in the form of such a plug. Substantially or fully within the open distal end of the shield significantly or completely restricts finger access to the plug for proximal movement. Also, the interacting structure between the shield and the plug can provide a means of preventing the sealing plug from moving out of its proximal sealing position. Such a structure may have components inside or outside the shield, corresponding to the structure of the plug. Such a structure may include a shield-like projection and / or recess that engages a projection and / or recess on the sealing plug when the sealing plug is in the proximal position.

The sealing plug can be held in its distal position by a mechanical interaction between the shield and the sealing plug, such as an interference fit structure, friction, screw or the like. In this embodiment, the shield has an inwardly directed protrusion 769, while the sealing plug has a recess 78.
One. When the sealing plug is in its distal position, the projection 769 is located in the recess 781 to hold the sealing plug in its desired axial position with respect to the shield. The protrusions can be of any size, from discrete protrusions to full annular or segmented rings, depending on the shape of the structure and the choice of material for the plug and shield. Similarly, the recess formed in the sealing plug can be of various forms that can suitably engage with the projections of the shield. The structure can also be inverted so that the protrusion is on the sealing plug and the recess is on the shield.

To move the sealing plug to its proximal sealing position, the user can apply finger pressure to the finger contact surface 790 at the distal end 764 of the sealing plug. In this embodiment, as the sealing plug moves proximally, if necessary, the tapered portion 768 guides the distal end of the needle portion 141 into the sealing plug retention conduit 766. In this embodiment, the inner surface 767 of the retention conduit is configured to contact the outer surface of the needle cannula 141 for sealing engagement. This inner surface can be continuous as shown, or other sealing structure, such as one or more inwardly projecting rings, that provides a seal. The proximal movement of the sealing plug with respect to the shield is
It can be limited by additional structures or by the form of the components. For example, if the sealing plug is completely within the shield, proximal movement of the sealing plug due to finger pressure is stopped when the finger contact surface of the plug is aligned with the distal end of the shield. In this embodiment, an additional structure is provided to limit the proximal movement of the sealing plug with respect to the shield. The structure comprises a projection 784 provided on the sealing plug and a ledge 78 provided on the shield.
8 is provided. In its proximal sealing position, the projection 784 contacts the ledge 788 to provide additional resistance to proximal movement and also allows the user to ensure that the sealing plug is in the proximal sealing position. provide feedback.
Physical engagement of the sealing plug with respect to the needle portion alone is sufficient to hold the sealing plug in its proximal sealing position. Although not absolutely necessary, this embodiment preferably includes an additional structure that holds the sealing plug in its proximal sealing position. This structure is larger than the space provided by the outer surface 789 of the sealing plug at the projection 769 at the open end of the shield, and as a result, FIG.
As shown at 0, the sealing plug and the shield are in frictional engagement. All of the above-described structures that hold the sealing plug in its distal position are within the scope of the present invention that holds the sealing plug in its proximal sealing position.

In use, the fluid transfer device 720 is filled in the same manner as described with respect to the embodiment of FIGS. After filling, the shield is mounted again on the straw. Next, the user may select the finger contact surface 7 of the sealing plug.
Finger pressure is applied to 90 to move the sealing plug from the distal position shown in FIG. 29 to the proximal sealing position shown in FIG. At this point, the chamber 17 in the barrel 171 of the syringe
All fluid passages from 6 through the passages in the needle portion of the straw are sealed to protect their contents from the external environment and to prevent their contents from being lost to the external environment under pressure. Help to do. This feature allows for a longer inventory of drug transfer fluid transfer devices and syringes than unsealed devices such as the embodiment of FIGS. 9-21. This is one important feature of the embodiment of the present invention.

FIGS. 31 to 33 show FIGS. 27 and 28, respectively.
An alternative fluid transfer device 820 similar to the embodiment of FIG. 29 is shown, with a shield and sealing plug assembly similar to the embodiment of FIGS. 29 and 30, but not identical. ing. For purposes of explanation, the fluid transfer device 82
0 is connected to a syringe 670 having an elongated cylinder 671 forming a chamber 676 for holding a fluid.
The syringe 670 has an open proximal end, a distal end 673,
A frusto-conical tip 677 extending from the distal end,
A penetrating tip passage 678 in fluid communication with the chamber 676
And the frusto-conical tip 677 having Filling straw 634 has a proximal end 635, a distal end 637, and a passage 638 therethrough. The straw-like body is
A passage 638 is connected to the tip 677 of the syringe in fluid communication with the chamber 676.

The shield 855 has an open base end 857,
Open distal end 858 and sidewall 85 between the proximal and distal ends
9 (the side wall forms a recess 861 in the shield). The shield is removably connected to the filling straw so that the shaft portion and the needle portion are substantially received in the recess.

The sealing plug 856 has a proximal end 860 and a distal end 860.
64. The sealing plug has a distal position at which the sealing plug projects distally outwardly from the distal end of the shield to extend from the distal position illustrated in FIG. 31 to the base illustrated in FIG. It is adapted to be telescopically movable to an end position (where the sealing plug seals the needle portion to prevent unpressurized fluid from being in fluid communication between the passage and the outside of the shield). .

The sealing plug of the present invention can be manufactured using various materials such as natural rubber, synthetic rubber, thermoplastic elastomer, and thermoplastic resin. Are preferably softer materials such as natural rubber, synthetic rubber and thermoplastic elastomers. In this embodiment, these components are such that when the needle portion 641 is sufficiently long and the sealing plug 856 is in the proximal position shown in FIG. 32, the distal end of the needle portion 641 is within the proximal end 860 of the sealing plug. It is in a form to be embedded in. Depending on the shape of the blade portion 645 of the needle portion, the shape and material of the sealing plug, when the needle portion is embedded in the sealing plug, the sealing plug sealingly engages the outer surface of the needle portion, as shown in FIG. As described above, or to prevent fluid from communicating unpressurized between the passage and the outside of the shield. The fluid transfer device 820 is used in a manner similar to the embodiment of FIGS. 29 and 30.

FIG. 34 illustrates one alternative fluid transfer device 920 attached to a cannula assembly 521 that includes a syringe barrel 571.
And a hub 528 integrally formed with the cannula 522. Filled straw body 934 has a proximal end 935
, A distal end 937 and a passage 938 therethrough. The filling straw 934 includes a needle portion 941 at its distal end and a shaft portion 943 between the needle portion 941 and the proximal end 935. A blade portion 945 is provided at the end of the needle portion for piercing the vial stopper. The cannula assembly and the filling straw are releasably engaged. The shield 955 has an open proximal end 957.
And an open distal end 958 and a side wall 959 between the proximal and distal ends, the side wall forming a recess 961 in the shield. The shield is removably connected to the filling straw so that the needle portion and substantially all of the shaft portion are received in the recess.

The sealing plug 956 has a proximal end 960 and a distal end 964. The sealing plug has the distal position shown in FIG. 34, at which point the sealing plug projects distally outwardly from the distal end 958 of the shield 955, and from the distal position to the proximal position (the sealing plug). Seals the needle portion so that it can be telescopically moved between the passage and the outside of the shield to prevent fluid communication in an unpressurized state).

In use, the syringe is filled using the filling straw as described generally above, and the shield is replaced as shown in FIG. The user can then apply a proximal force to the finger contact surface 990 of the sealing plug to move the sealing plug to the proximal sealing position.

[Brief description of the drawings]

FIG. 1 is an exploded perspective view of a syringe filling device according to the present invention for accessing a drug in an ampoule.

FIG. 2 is a side view of an obtuse cannula and vial access spike of the present invention.

FIG. 3 is a view of the filling device of FIG. 2 attached to a hypodermic syringe and accessing a fluid medicament in a stoppered vial.

FIG. 4 is a side view similar to FIG. 3, showing the hypodermic syringe and obtuse cannula separated from the vial and the vial access spike.

FIG. 5 is a side view similar to FIG. 2, showing an alternative vial access spike.

FIG. 6 is a cross-sectional view of the obtuse cannula and vial access spike taken along line 6-6 of FIG.

FIG. 7 is a perspective view of the obtuse cannula and syringe of the present invention aligned for assembly.

FIG. 8 illustrates one alternative embodiment of the present invention in which the obtuse cannula and syringe barrel are integrally molded in a unitary structure.

FIG. 9 is a side view of the fluid transfer device of the present invention attached to a syringe.

FIG. 10 is a partial cross-sectional view of the fluid transfer device and syringe along line 10-10 of FIG. 9;

FIG. 11 is an exploded side view showing an assembled state of the fluid transfer device of the present invention.

FIG. 12 is a cross-sectional view of the fluid transfer device of FIG. 11 taken along line 12-12.

FIG. 13 is a side view of the fluid transfer device attached to the syringe barrel, with the shield removed.

FIG. 14 is a side view showing a fluid transfer device and a syringe used to aspirate injectable liquid from a vial having a pierceable stopper.

FIG. 15 is a side view of a fluid transfer device and syringe used to aspirate injectable liquid from an ampoule.

FIG. 16 is a side view showing one step of a method in which the present invention is used between filling and administration of an injectable liquid.

FIG. 17 is a side view showing one step of a method in which the present invention is used between filling and administration of an injectable liquid.

FIG. 18 is a side view showing one step of another method in which the present invention is used between filling and administration of an injectable liquid.

FIG. 19 is a side view showing one step of another method in which the present invention is used between filling and administration of an injectable liquid.

FIG. 20 is a side view showing one step of another method in which the present invention is used between filling and administration of an injectable liquid.

FIG. 21 shows a liquid injectable using the cannula assembly and syringe of the present invention. V. It is a side view which shows the state supplied to the injection | pouring point in a set.

FIG. 22 is a side view of one alternative cannula assembly.

FIG. 23 is a side view of a standard hypodermic injection needle.

FIG. 24 is a side view illustrating one alternative embodiment of the present invention.

FIG. 25 is yet another side view illustrating one alternative embodiment of the present invention.

FIG. 26 is a cross-sectional view of another embodiment of the present invention in which the cannula and syringe barrel are integrally formed as a single unit.

FIG. 27 is a cross-sectional view showing another embodiment of the fluid transfer device and the syringe of the present invention.

FIG. 28 is an exploded cross-sectional view of the fluid transfer device and syringe taken along line 28-28 of FIG. 27.

FIG. 29 is a side cross-sectional view of an alternative embodiment of the present invention having a shield provided with a removable sealing plug.

FIG. 30 is a side cross-sectional view of an alternative embodiment of the present invention having a shield provided with a removable sealing plug.

FIG. 31 is a side cross-sectional view of another alternative embodiment of the present invention having a shield provided with a removable sealing plug.

FIG. 32 is a side cross-sectional view of another alternative embodiment of the present invention having a shield provided with a removable sealing plug.

FIG. 33 is a cross-sectional view of the fluid transfer device of FIG. 32, taken along line 30-30.

FIG. 34 is a side cross-sectional view of yet another alternative embodiment of the present invention having a shield provided with a removable sealing plug.

[Explanation of symbols]

Reference Signs List 10 syringe filling device 12 cannula 14 vial access spike 16 shield 18 hypodermic syringe 20 syringe barrel 22 syringe end 24 chamber 26 plunger 28 syringe tip 30 passage 32 luer collar 34 luer collar thread 36 cannula proximal end 38 cannula end 40 Cannula lumen 42 Spike proximal end 44 Spike distal end 46 Passage 48 Spike end beveled tip 50 Spike cap 52 Hinge 54 First hinge element 56 Second hinge element 57 Elbow 58 Cap 60 Shield Proximal end 61 Shield end 62 Passage 63 Slot 64 Rubber stopper 66 Vial assembly 68 Drug

 ──────────────────────────────────────────────────続 き Continuation of the front page (71) Applicant 595117091 1 BECTON DRIVE, FRA NKLIN LAKES, NEW JE RSEY 07417-1880, UNITED STATES OF AMERICA (72) Inventor Gary Cohen 07422, New Jersey, United States of America, Highland Lakes, P.O. Box 734 (72) Inventor Alvin T. Olsen, Cleveland Road, Caldwell, New Jersey 07006, USA 30 (72) Inventor Mark C. Yale 07675, New Jersey, United States 07, Westwood, Lowell Street 67

Claims (10)

[Claims] 1. A fluid transfer device for accessing fluid from a vial and an ampoule, comprising: a cannula assembly having a cannula having a proximal end, a distal end, a lumen therethrough, an open proximal end; A cannula assembly comprising a hub having a distal end connected to the proximal end of the cannula, wherein the lumen comprises the hub in fluid communication with the open proximal end of the hub; A filling straw having a proximal end housing, a distal needle portion, and a shaft portion between the proximal end and the distal end; A filling straw having a cavity at a proximal end thereof in fluid communication with the passage, and a blade portion provided at a distal end of the needle portion so as to pierce a vial stopper; Cannula A shield having an open proximal end wherein the assembly and the filling straw are releasably engaged such that the open proximal end of the hub is in fluid communication with the passage of the filling straw. And having an open distal end and a side wall between the proximal end and the distal end forming a recess in the shield, wherein the shaft portion and the needle portion are substantially received in the recess. And a sealing plug releasably connected to the filling straw-like body, the sealing plug having a proximal end and a distal end, the sealing plug being distal to the distal end of the shielding body. A distal position protruding outwardly in the direction, and adapted to be telescopically movable from the distal position to the proximal position, wherein the sealing plug is configured to move the passageway and the passage when the sealing plug is in the proximal position. Unpressurized fluid between the outside of the shield And means for sealing said needle portion so as to prevent passing the fluid transfer device. 2. The fluid transfer device according to claim 1, wherein
The sealing means has a retaining conduit extending distally from the proximal end of the sealing plug, the retaining conduit sealingly engaging the needle portion when the sealing plug is in the proximal position. A fluid transfer device. 3. The fluid transfer device according to claim 2, wherein
A fluid plug having a tapered portion at the proximal end for guiding the needle portion into the retaining conduit when the plug is moved from the distal position to the proximal position. Transfer device. 4. The fluid transfer device according to claim 1,
The sealing means has the needle portion and the distal end of the needle portion is sufficient to be embedded within the proximal end of the sealing plug when the sealing plug is in the proximal position. A fluid transfer device, the length of the needle portion. 5. The fluid transfer device according to claim 1, wherein
The fluid transfer device further comprising means for preventing movement of the sealing plug from the proximal sealing position to the distal position. 6. The fluid transfer device according to claim 1, wherein
A fluid transfer device, wherein the open proximal end of the shield is configured to releasably engage the hub when the filling straw is removed from the hub. 7. The fluid transfer device according to claim 1, wherein
A fluid transfer device, wherein the distal end of the cannula has an obtuse distal tip. 8. The fluid transfer device according to claim 1, wherein
A syringe barrel having an elongated cylindrical body defining a chamber for holding a fluid, an open proximal end, a distal end, and a distal end extending from the distal end and having a distal passage formed in fluid communication with the chamber. A fluid transfer device, wherein the distal end is disposed within the open proximal end of the hub such that the chamber is in fluid communication with the lumen of the cannula. 9. The fluid transfer device according to claim 1, wherein
The cannula assembly is formed integrally with a syringe barrel having an elongated cylinder defining a fluid holding chamber, an open proximal end, and a distal end, the cannula extending from the distal end of the syringe barrel. A fluid transfer device that extends and is disposed such that the lumen of the cannula is in fluid communication with the chamber. 10. A method of transferring an injectable liquid, comprising: (a) an elongated cylinder forming a chamber for holding a fluid; an open proximal end; a distal end; A tip having a tip passage in fluid communication;
A syringe having a stopper fluid-tightly slidably engaged within the barrel of the syringe, and an elongated plunger rod connected to the stopper and extending proximally through the open proximal end of the syringe barrel. Providing a syringe comprising a barrel; and (b) a device for filling the syringe, comprising a cannula assembly, a shield having an open proximal end, an open distal end, and the proximal end and the distal end. And a side wall defining a recess in the shield, the shield being removably connected to the filling straw so that the shaft portion and the needle portion are received within the recess. A cannula assembly comprising: a cannula having a proximal end, an obtuse distal end, and a lumen therethrough; and a hub having an open proximal end, wherein the lumen is the hub of the hub. Open base and fluid A hub having a distal end connected to the proximal end of the cannula for passing therethrough, a filled straw having a proximal end, a distal end, and a passage therethrough, the housing at the proximal end; A filling straw having a distal needle portion and a shaft portion between the proximal end and the distal end and having a blade portion provided at the distal end of the needle portion so as to pierce a vial stopper; Wherein the cannula assembly is releasably engaged with the filling straw such that the open proximal end of the hub is in fluid communication with the passage of the filling straw. A sealing plug having a proximal end and a distal end, the sealing plug having a distal position where the sealing plug projects distally outward from the distal end of the shield, from the distal end to the proximal position. So that it can nest Wherein, in the proximal position, the sealing plug seals the needle portion so as to prevent communication of unpressurized fluid between the passage and the outside of the shield. Providing a filling device for the syringe; and (c) connecting the syringe filling device to the syringe such that the distal end is disposed within the open proximal end of the hub and the chamber is in fluid communication with the cannula. (D) providing a vial having a pierceable septum and holding an injectable liquid; (e) removing the shield from the filled straw; Piercing the pierceable septum of the vial with the needle portion of the filling straw to provide fluid communication between the interior of the vial and the chamber of the syringe; and (g) the plan. Aspirating a desired amount of injectable liquid from the vial into the chamber by moving the jarod proximally with respect to the syringe barrel; and (h) withdrawing the needle portion from the septum of the vial. A method for transferring an injectable liquid, comprising: (I) reconnecting the shield to the filling straw so that the shaft portion and the needle portion of the filling straw are accommodated within the recess of the shield; Moving the sealing plug from the distal position to the proximal position to seal the needle portion.