MXPA97005521A - Filling and supply device of jeri - Google Patents

Abstract

The present invention relates to a fluid transfer device for accessing fluid from containers and tubes comprising: a cannula assembly including a cannula having a distant proximal end and a lumen therethrough, and a hub having a open proximal end with a recess therein having a frusto-conical shaped surface for removable connection with a fluid transfer device having a frusto-conical shaped tip, and a distal end attached to the proximal end of the cannula so that the lumen In fluid comonication with the open proximal end of the hub, a filling conduit having a proximal end, a distal end and a passage therethrough, the conduit includes a housing at the proximal end, a needle portion in the distant end and an arrow portion between them, the housing has a cavity at its proximal end in fluid commication with e The passageway, cutting edge at the distal end of the needle portion to penetrate a container retainer, and means for removably coupling the cannula assembly with the housing so that the open proximal end of the hub is in fluid communication with the passageway. of the filling conduit and the cannula assembly is removably coupled with the housing, and a protector having an open proximal end open, a distal end and a side wall therebetween defining a recess in the protector, the protector is remotely connected to the conduit so that the arrow portion and the needle portion are contained within the rece

Description

FILLING AND SUPPLY DEVICE FOR SYRINGE Cross Reference to Related Requests The invention in question is a continuation in part of Patent Application Serial No. 08 / 245,934 filed May 19, 1994.

Field of the Invention The present invention relates to a device mountable on a hypodermic syringe or other fluid delivery device that allows access to the medicament or injectable liquid either in glass ampules or in containers having elastomeric closures and the subsequent supply of the medicament or liquid injectable Background A typical hypodermic syringe includes a syringe barrel with a mounting collar for threadably coupling the hub of a cannula needle. The hub and cannula needle are connected to each other or held separately from the syringe barrel until shortly before use. In cases where the needle is held separately, the medical practitioner selects an appropriate needle assembly for the procedure that is being performed. The needle assembly is removed from its sterile package and the hub of the needle assembly is threadedly engaged with the mounting collar of the syringe barrel. Liquid pharmaceuticals and other injectable liquids are often stored in rigid containers that can be accessed using a hypodermic syringe. Some containers for liquid pharmaceutical products are plastic or glass containers with an elastomeric closure that can be penetrated by the needle of a hypodermic syringe. To access the liquid in a container, the medical practitioner moves the plunger of the hypodermic syringe in a proximal direction to draw within the syringe barrel a volume of air substantially equal to the volume of the desired medication. The open distal end of the syringe is then urged through the elastomeric closure of the container and the air in the syringe barrel is injected into the container. The distal tip of the needle and the container coupled thereto are gravitationally directed upwards. The medical practitioner ensures that the distant tip of the needle is covered by the medicament in the container by manipulating the needle and the container one with respect to the other. The plunger of the hypodermic syringe is then moved next to the medicament through the needle and into the chamber of the syringe barrel. After removing a desired dose of the medication from a container, the medical practitioner can inject the medication either into a patient, another container or into an injection site of an intravenous device or catheter. There is a trend towards I.V. no needles that do not require a sharp needle cannula to join the injection site of an I.V. There are many systems that have injection sites covered by a pre-divided septum that can be accessed through a blunt cannula. Therefore, after removing the medication from the bottle using a sharp needle, the user should remove the needle and install a blunt cannula if the medication will be used with IV equipment. The user risks accidental needle sticking when using the needle to remove the medication inside the syringe and in the act of removing the needle to replace it with a blunt cannula. Also, there is the potential for contamination of the components when they are installed and removed during the filling and supply process. Accordingly, there is a need for a device that will allow the syringe to be filled from a bottle having a penetrable stopper without the use of a very sharp needle and the subsequent supply of the medicament to IV equipment through a blunt cannula without having to handle or re-protect sharp needles. Plastic containers and elastomeric closures for containers are somewhat permeable to gas. Some pharmaceutical products will degrade rapidly in the presence of even small amounts of gas. So, those pharmaceutical products are typically stored in glass ampoules. The frangible end of a glass ampule can be split to allow access to the medication stored therein. The medical practitioner can remove the medication by inserting the tip of the needle into a hypodermic syringe inside the medication when stored in the ampule. The syringe of the hypodermic syringe is then moved proximally to draw the liquid medicament into the ampule through the needle and into the cylinder of the hypodermic syringe. The hypodermic syringe can then be removed from the ampule and used substantially in the manner described above. The ampule is typically held with the top open gravitationally upward while the hypodermic syringe is filling. This length of needle required for the filling of the ampule can substantially exceed the length of the needle required in a convenient manner for subsequent use for injections. Similarly, there are similar or similar problems when the medication obtained from an ampule will be injected subsequently into an injection site that has a pre-divided septum since the needle must be installed and removed from the syringe and the new blunt cannula installed. . Therefore, there are risks of accidental contamination and needle pricks before the combination of filled syringe and blunt cannula is adequately prepared.

Brief Description of the Invention The invention in question relates to a device for safely and efficiently filling a hypodermic syringe. The device may include a blunt cannula having opposite proximal and distant ends. The proximal end is configured with the distal end of the hypodermic syringe. For example, the proximal end of the blunt cannula may include projections for threadably coupling a "luer" neck at the distal end of the syringe barrel. The distal end of the cannula may be blunt and may be configured for selective engagement with a prior art accessory of an intravenous line. The device further comprises a container access tip having opposite proximal and distant ends and a communication passage extending axially therethrough. The proximal end of the container access tip is releasably mounted in fluid tight engagement with the distal end of the blunt cannula. For example, the proximal end of the passage through the container access tip can be frictionally secured in fluid tight engagement over the distal end of a blunt cannula. The distal end of the container access tip defines a bevelled tip that is sharp enough to penetrate the rubber seal of a container, though preferably not sharp enough to penetrate the skin through accidental contact. The container access tip may further include a cap for selective sealing engagement on the proximal end of the tip. The lid may be connected unitarily to the container access point by means of a hinge or a lock. A hinged connection can be defined by a hinge on the center that is stable in a completely open or completely closed position of the lid. However, the hinge on the center will be deflected in intermediate positions to push the lid either within the fully open or fully closed position. The device may further comprise a protective cover which may be mounted on at least the distal end of the container access point. The protective cover may have a groove to enclose the hinge or lock. The protector prevents contamination of the beveled distant point of the tip before insertion into the container. The assembled roman cannula, the container access acicle and the protector can be packaged separately from the hypodermic syringe. Alternatively, the assembled blunt cannula and the container access can be mounted on and packed with the hypodermic syringe. A hypodermic syringe having the filling device in question mounted thereon can be filled by removing the protector from the container access needle and urging the bevelled end of the container access needle through the container retainer. The hypodermic syringe and the container can be inverted, so that the liquid medicament in the package covers the distal end of the container access needle. The plunger of the hypodermic syringe can be pulled in a proximal direction to draw fluid into the syringe barrel. The user can then separate the connected hypodermic syringe and blunt cannula from the container access needle and the connected hypodermic syringe and blunt cannula can be conveniently used. The container access acicle will remain in the container and the lid may be coupled over the proximal end of the acicle to seal the container for subsequent access. A fluid transfer device for accessing the fluid from the containers and ampoules of the present invention comprises a cannula assembly that includes a cannula having a proximal end, a distal end and a lumen therethrough, and a hub having an open proximal end and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the open proximal end of the hub. A filling duct that has a proximal end, a distal end and a passage therethrough including a housing at the proximal end, a needle portion at the distal end and an arrow portion therebetween. A flange is provided between the needle portion and the arrow portion to limit the depth of penetration of the needle portion into the container retainer. The housing includes a cavity at its proximal end in fluid communication with the passage. A cutting edge at the distal end of the needle portion is provided to penetrate a container retainer. The structure is provided to removably couple the cannula assembly with the housing so that the open end of the hub is in fluid communication with the passageway of the filling conduit and the cannula is within the cavity. A protector having an open proximal end, a distal end and a side wall therebetween defining a recess in the guard is removably connected to the conduit so that the arrow portion and the channel portion of the conduit are contained within the recess. . Another embodiment of the present invention includes a method for transferring injectable liquid which includes the steps of: (a) providing a syringe including a syringe barrel having an elongated cylindrical body defining a chamber for holding fluid, an open proximal end , a distal end and a tip extending from the distal end having a tip passage therethrough in fluid communication with the chamber, a seal in fluid-tight slidable coupling within the cylinder and an elongated piston rod connected to the retainer and extending proximally through the open end of the cylinder; (b) providing a syringe filling device comprising a cannula assembly that includes a cannula having a proximal end, a blunt distant end and a lumen through the same, and a hub having an open proximal end and a distant end attached to the proximal end of the cannula so that the lumen is in fluid communication with the open proximal end of the hub; a filling conduit having a proximal end, a distal end and a passage therethrough, the conduit including a housing at the proximal end, a needle portion at the distal end and an arrow portion therebetween, the housing having a cavity at its proximal end in fluid communication with the passage, a cutting edge on the distal end of the needle portion for penetrating a container retainer, the cannula assembly being removably coupled with the housing such that the proximal end open of the hub is in fluid communication with the passage of the filling conduit and the cannula is inside the cavity; and a protector having an open proximal end, a distal end and a side wall therebetween defining a recess in the protector, the protector is removably connected to the conduit so that the arrow portion and the needle portion are contained within the recess, the open proximal end of the protector is configured to releasably engage the hub when the filling conduit is removed from the hub. (C) connecting the syringe filler device to the syringe so that the tip is positioned within the open proximal end of the hub and the chamber is in fluid communication with the cannula; (d) providing a package having a penetrable septum and containing an injectable liquid; (e) remove the conduit protector; (f) penetrating the penetrable septum of the container with the needle portion of the filling conduit to establish fluid communication between the interior of the container and the chamber of the syringe; (g) withdrawing the desired amount of the injectable liquid from the container into the chamber by moving the plunger rod in a direction close to the cylinder; and (h) removing the needle portion from the septum of the container.

Brief Description of the Drawings Fig. 1 is an exploded perspective view of the syringe filling device according to the present invention for accessing the medicament in the ampule. Fig. 2 is a side elevation view of a blunt cannula and a container access spout of the subject invention. Fig. 3 shows the filling device of Fig. 2 mounted to a hypodermic syringe and access to a fluid medication in a container with retainer. Fig. 4 is a side elevational view similar to FIG. 3, but showing the hypodermic syringe and the needle cannula separated from the container and the access needle to the container.

Fig. 5 is a side elevational view similar to FIG. 2, but showing an acic for access to alternative packaging. FIG. 6 is a cross-sectional view of the blunt cannula and the container access needle of FIG. 5 taken along the line 6-6. FIG. 7 is a perspective view of the blunt cannula of the present invention and a syringe aligned for assembly. Figure 8 is an alternative embodiment of the present invention wherein the blunt cannula and the syringe barrel are integrally molded of one piece construction. Figure 9 is a side elevational view of the fluid transfer device of the present invention attached to a syringe.

Fig. 10 is a partial cross-sectional view of a fluid transfer device and the syringe of Fig. 9 taken along lines 10-10. Fig. 1 1 is a side elevation view illustrating the assembly of the fluid transfer device of the present invention. Fig. 12 is a cross-sectional view of the fluid transfer device of Fig. 1 1 taken along lines 12-12. Fig. 13 is a side elevational view of the fluid transfer device attached to a syringe barrel illustrating the guard that is removed.

Fig. 14 is a side elevation view illustrating the fluid transfer device and the syringe used to withdraw the injectable liquid from a container having a penetrable stopper. Fig. 15 is a side elevational view of the fluid transfer device and syringe used to withdraw the injectable fluid from an ampule. Figs. 16 and 17 illustrate steps in a method of using the present invention between filling and supplying an injectable liquid. Figs. 18-20 illustrate steps of another method of using the present invention between filling and supplying the injectable liquid. Figure 21 is a side elevational view of the injectable liquid that is being delivered to an injection site in an equipment I. V. using a cannula assembly of the present invention and the syringe. Fig. 22 illustrates an alternative cannula assembly. Fig. 23 illustrates a standard hypodermic syringe. Figures 24 and 25 are side elevation views illustrating an alternative embodiment of the present invention. Figure 26 illustrates another embodiment of the present invention wherein the cannula and the syringe barrel are formally integrated in one piece.

Fig. 27 illustrates another embodiment of the fluid transfer device of the present invention and a syringe. Fig. 28 is an exploded cross-sectional view of the fluid transfer device and the syringe of Fig. 27 taken along lines 28-28.

Detailed description Insofar as the invention is satisfactory by the modalities in many different forms, the preferred embodiments of the invention are described in the drawings and will be described in detail herein with the understanding that the present description is considered to be illustrative of the invention. The principles of the invention are not intended to limit the scope of the invention to those illustrated modalities. The scope of the invention will be measured by the appended claims and their equivalents. The syringe filling device according to the invention in question is generally identified by the number 10 in FIGS. 1 and 2. The filling device 1 0 includes a blunt cannula 12, an access needle to the package 1 4 and a protector 1 6. The device 1 is for use with a hypodermic syringe 18 of the prior art. The syringe 1 8 includes a syringe barrel 20 having a distal end 22, a proximal end (not shown) and a flow receiving chamber 24 therebetween. The proximal end of the syringe barrel 20 is open and slidably receives a plunger 26 in fluid-tight engagement with the cylindrical wall defining the chamber 24. The distal end 22 of the syringe barrel 20 includes an elongate tip 28 having a passage 30. which extends axially therethrough and communicates with the chamber 24. The syringe preferably includes a "luer" neck 32 concentrically surrounding the tip 28 and includes an internal thread 34. The cannula 12 of the syringe filling device 10 it is preferably unitary molded from a thermoplastic material and includes, a proximal end 36, a distal end 38 and a lumen 40 extending axially therethrough. The proximal end 36 of the blunt cannula 12 is configured for threaded engagement with the thread 34 of the neck "luer" 32. The distal end 38 of the blunt cannula 12 is cylindrical and defines an external diameter "a". Distal end 38 is also configured to attach an intravenous fitting having a pre-divided septum to allow delivery of fluid medication from chamber 24 of syringe barrel 20 to a patient. The access acicle to the container 14 is also preferably molded from a thermoplastic material and includes a proximal end 42, a distal end 44 and a passage 46 extending axially therethrough. Portions of the passageway 46 adjacent the proximal end 42 are placed in leak-tight fluid-tight engagement on the distal end 38 of the blunt cannula 12a, shown in Fig. 2. The passage 46 is cylindrical and defines an internal diameter "b" adjacent to the proximal end 42 of the container access acicle 14 including a beveled tip 48 that is sufficiently sharp to be imputed through the rubber seal of a container, as explained and illustrated herein. However, the bevel tip 48 is preferably not sharp enough to penetrate the skin at incidental or accidental contact. The container access acicle 14 further includes a lid 50 hinged to a hinge 52 which is attached to an acicle 14 at a location near the proximal end 42. The lid 50 is dimensioned to be telescoped onto the proximal end 42 of the acicula of access to the container 14 for sealing engagement substantially fluid-tight. As shown in Figs. 1-4, the hinge 52 is a hinge on the center with a first hinge 54 defining an axis of rotation of the lid 50. The hinge in the center 52 further includes a second hinge element 56 which defines an axis of rotation parallel to, although spaced apart from the axis of rotation of the first hinge 54. The second hinge 56 is elastically flexible in the shoulder 57 and is configured to be in an undeflected condition in the fully open position of the cover 50, as shown in FIG. Figs. 1 -3 or in the fully closed position as shown in Fig. 4. However, the second hinge element 56 is deviated in the intermediate positions. The elasticity of the second hinge element 56 will therefore assist any opening or closing forces exerted by a user and which will urge the lid 50 to the fully open or fully closed position. The alternate hinge 52a, as shown in Fig. 5, defines a lock. The latch performs the function of the latch cap 50 near the proximal end 42 of the needle 14. However, the latch does not assist in the opening or closing of the cap 50. The shield 16 is preferably formed from a thermoplastic material and includes an open proximal end 60 and a distal end 61 that is preferably closed. A passage 62 extends into the proximal end 60 and defines an internal diameter "c" that is substantially equal to the external diameter "d" of the access acicle to the container 14 adjacent the proximal end 42 thereof. Therefore, the proximal end 60 of the shield 16 can be removably and frictionally coupled over the entire access acicle to the container to avoid inadvertent contact with and contamination of the access acicle to the container 14. The proximal end 60 of the shield 16 it is further characterized by a groove 63 that is dimensioned to encircle the hinge 52 and thereby allow the complete seating of the shield 16 on the access acicle to the container 14. The filling device 10 can be packaged and sold in a precondition -assembled as shown in Fig. 2. More particularly, the proximal end 42 of the access acicular to the container 14 is frictionally coupled on the distal end 38 of the blunt cannula 12, while the shield 16 can be frictionally coupled on at least portions of the acicular of access to the container 14. Alternatively, the filling device 10 and the blunt cannula 12 can be packaged and sold in a preassembled condition on the hypodermic syringe 18. In this latter embodiment, the shield 16 is preferably sized for releasable frictional engagement on the outer circumferential portions of the "luer" neck 32. Likewise, the access acicle to the container 14 and the protector 16 can be sold assembled with the lid sealing the proximal end of the acicule. The filling device 10 is used with the proximal end 36 of the blunt cannula 12 threadedly attached to the "luer" neck 32 of the syringe barrel 20. The shield 16 is removed shortly before use. The plunger 26 can be moved proximally to draw within the syringe barrel 24 a volume of air approximately equal to the desired dose of medicament. The beveled tip 48 of the access needle to the package 14 can be driven through the rubber seal of the package assembly 66. The plunger 26 is then moved remotely to propel air from the chamber of the syringe 24 into the package 66 The hypodermic syringe 18 and the container 66 are inverted, as shown in Fig. 5, so that the liquid medicament 68 covers the portion of the passage 46 of the access acicle to the container 14 adjacent to the distal tip 8 of the same The plunger 26 is then moved back in a proximal direction to draw within the chamber 24 the required dose of the liquid medication 68. The syringe 18 and the container assembly 66 are inverted again so that the container assembly 66 is gravitationally below of the syringe. The syringe 18 and the blunt cannula 12 are separated after the access needle to the package 14 and the package 66. The syringe 18 and the blunt cannula 12 can then be used in the normal manner as explained above. The access canister to the package 14 can remain in the rubber retainer 64 of the package 66 to allow subsequent access to the medicament 68. The medicament 68 is sealed from the environment by rotating the cap 58 around the hinge 52 and inside the sealed coupling with the end next 42 of the container access acicle 14. The remaining medicament 68 can be accessed in the container 66 subsequently by hingedly rotating the lid 50 away from the proximal end 42 of the access acicle to the container 14. This subsequent access can be achieved with a conventional hypodermic syringe of the prior art having a blunt cannula. As best illustrated in FIG. 6, the blunt cannula 12 and the access needle to the package 14 are preferably connectable to each other by a frictional interference fit between the external diameter of the blunt cannula and the internal diameter of the passage 46 of the needle. of access to the container. The preferred blunt cannula is integrally molded from a piece of thermoplastic material. Nevertheless, the blunt cannula may be made with a plastic mallet and a separate blunt cannula made of rigid material such as stainless steel attached to the mallet by means of an adhesive or other suitable means. The lumen 40 of the blunt cannula also includes a proximal portion 41 of truncated conical shape suitable for frictionally coupling the standard "luer" slip, as illustrated in Fig. 7 or "luer" type lock syringes, as illustrated in Fig. 1. Fig. 7 illustrates a blunt cannula 12 aligned for assembly with syringe 18A having a trunco-conical elongated tip 28A which is adapted to frictionally and removably engage the truncated-conical portion 41 of the lumen of the blunt cannula. The blunt cannula of the present invention is preferably capable of being used with the "luer" type lock syringes, such as the syringe 18 and the luer-type syringes, such as a syringe 18A. FIG. 8 shows another embodiment of the present invention wherein the syringe 70 includes the integrally molded blunt cannula 12B having the lumen 40B extending therethrough in fluid communication with the chamber 24B of the syringe barrel. This embodiment of the invention works substantially identical to the embodiment of Figs. 1-7 except that the cylindrical blunt cannula can not be separated from the syringe barrel. While the invention has been described with respect to certain preferred embodiments, it is evident that various changes may be made without departing from the scope of the invention as defined by the appended claims. For example, the blunt cannula of the syringe filling device may be permanently mounted to a hypodermic syringe or integrally molded as part of the syringe barrel. Additionally, the releasable coupling between the container access needle and the blunt cannula may have different forms of the frictional coupling described and illustrated above. In addition, a metallic blunt needle cannula may be used with the access needle to the package. Referring to Figures 9-21, a fluid transfer device 120 for accessing the fluid from containers and ampules comprises a cannula assembly 121 that includes a cannula 122 having a proximal end 123, a distal end 125 and a lumen. 127 through it. A hub 128 having a proximal end 129 and a distal end 131 is attached 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. The hub 128 preferably includes the radial projection 132 for coupling the "luer" locking collar of a syringe barrel or other fluid delivery device, as will be explained in greater detail hereinafter. In this preferred embodiment, the distal end 125 of the cannula includes a blunt tip 133, and the cannula and hub are integrally formed of a thermoplastic material. However, the cannula and the hub can be formed separately and fixed through various manufacturing processes with adhesives such as epoxy which is preferred. A filling conduit 134 includes a proximal end 135, a distal end 137 and a passage 138 therethrough. The fill conduit 134 includes a housing 139 at the proximal end 134 and a needle portion 141 at the distal end 137 and an arrow portion 143 therebetween. The housing includes a cavity 144 in fluid communication with the passage 138. The distal end of the needle portion 141 includes a cutting edge 145 for penetrating a container retainer. The cutting edge is sharp enough to penetrate a container retainer but not as sharp as a needle cannula used for injection to humans. A point or cutting edge that is sharp enough to penetrate the container and not sharp enough for injection to humans is evidenced in many IV therapy devices such as needles or cannulas for use with containers having penetrable seals. . In this modality, the needle portion 141 is made of metal such as stainless steel and can be held in the arrow portion using various manufacturing methods with adhesives such as epoxy which is preferred. A metal needle portion offers the advantage of high strength and small diameter to reduce the penetration forces as the needle portion penetrates the container retainer. It is also within the scope of the present invention to have the needle portion and arrow portion integrally formed of a single material such as thermoplastic. In any case, it is preferred to have a shoulder 147 between the arrow portion and the needle portion to limit the depth of penetration of the needle into the container retainer. Also, the visual appearance of the short needle portion, the pronounced shoulder and the relatively blunt cutting edge communicate to the user that this conduit is not intended for injection and helps ensure that there will be no mistaken attempt to use it for injection to human beings. The present invention includes means for releasably coupling the cannula assembly with the housing so that the open proximal end of the hub is in fluid communication with the passageway of the filling conduit and the cannula is within the cavity or in the passageway. , as best illustrated in Figure 10. This connection should be relatively hermetic since the fluid will be drawn through the conduit and the cannula assembly into the syringe or other fluid delivery device. The means for removably coupling a cannula assembly to the housing can be obtained with various structures such as threads, complementary projections and recesses and the like, with a frictional interference fit being preferred between the inner surface 149 of the housing and the external surface 150 of the hub. needle Accordingly, the housing and the hub can be releasably coupled and uncoupled, or viewing the housing and the hub towards each other or separating them from one another in an axial movement. As will be explained in more detail below, it is preferred that the rotational force applied to the conduit through the housing can be transmitted to the hub to engage and disengage the hub and syringe barrel. This ability to transmit the torque from the conduit to the cannula assembly can also be achieved by the interference fit between the inner surface 149 and the housing and the outer surface 150 on the hub. However, the additional structure can be provided to facilitate the transfer of torque from the conduit to the cannula assembly. In this preferred embodiment, the axial ribs 151 on the hub may engage axial ribs 152 in the housing to transfer the torque from the conduit to the cannula assembly. A shield 155 includes an open proximal end 157, a distal end 158, and a side wall 159 therebetween defining a recess 161 and guard. The shield 155 is removably connected to the filling conduit 134 so that the needle portion and preferably the arrow portion of the conduit are within the recess.

Various structures can be used to obtain the removable connection between the shield and the conduit such as the filaments, projections and recesses to achieve a press fit arrangement and interference settings. In this preferred embodiment, the inner proximal surface 162 in the shield frictionally engages the outer surface 163 in the housing. Accordingly, the axial force can be used to remove and reinstall the guard over the conduit. The inner surface 162 and the outer surface 163 are preferably truncated-conical in shape to provide smooth frictional engagement. It is an important feature of this preferred embodiment that the inner proximal surface 162 of the shield also releasably engage the outer surface 150 on the hub so that the shield can be used to protect the conduit or, when the conduit is removed, to protect the assembly from cannula This is an important feature since it allows different methods for using the fluid transfer device of the present invention, depending on the user's preference. The fluid transfer device of the present invention is suitable for use with fluid delivery devices such as syringes. For the purpose of illustration, the fluid transfer device 120 is connected to the hypodermic syringe 170 which comprises a syringe cylinder 171 having a distal end 173, a proximal end 174 and a circular side wall 175 defining a chamber 176 for retain the fluid. The volume measurement indications 172 are copper in the cylinder to measure the dose of liquid to be delivered. The distal end of the syringe barrel is connected to the hub 128 so that the lumen of the cannula 122 is in fluid communication with the chamber 176 of the syringe barrel. In this embodiment, the distal end 173 of the syringe barrel includes a trunco-conical shaped tip 177 having a conduit therethrough that provides a fluid path between the cannula and the chamber. The truncated-conical tip of the syringe barrel frictionally engages a preferably truncated-conical shaped surface 130 at the open proximal end 129 of the hub. The distal end of the syringe barrel preferably, but not necessarily, also includes a typical "luer" collar 179 that concentrically surrounds the tip 177. The "luer" neck has an internal threading 180 which engages the radial projection 132 on the hub 128 to hold it securely to the cylinder. It is within the scope of the present invention to include various hub configurations to join a variety of different medical fluid handling devices. The hub configuration described above, which has a truncoconical internal cavity, reflects one of those different possibilities. Many syringes and fluid handling devices, such as robinets and adapters and other fluid handling devices, contain "luer" tips and locking "luer" type fittings to which a hub having an internal cavity that has an internal cavity of truncated-conical shape. It is within the scope of the present invention to provide a fluid transfer device wherein the cannula assembly is molded with the syringe barrel. A detent 182 is placed in the chamber 176 in fluid-tight engagement with the circular side wall 175. A rigid elongated piston rod 183 is connected to the detent and extends proximally through the open proximal end of the cylinder 171. The retainer and the piston rod can be made of a one-piece unitary construction. The force applied to the plunger rod causing the sliding movement of the detent in a proximal direction draws the fluid through the conduit 178 into the chamber 176. In reverse, the sliding movement of the detent 182 in a distal direction that drives the fluid from the chamber 176 through the conduit 178. The fluid transfer device 120 of the present invention, coupled with a fluid delivery device, such as a syringe 170 hypodermic, can be used to access the fluid in a container or a vial and supply the fluid to the injection site of an IV device or catheter. As illustrated in Figure 14, the fluid transfer device 120 can be used with the syringe 170 to access the injectable liquid or medicament, such as fluid 185, contained within a container 186 having a penetrable retainer 187. It has access to the fluid when the retainer 187 penetrates with the needle portion 141 of the filling conduit. The shoulder 147 between the needle portion 141 and the arrow portion 143 on the fill passage will limit the penetration of the needle portion into the container. In the preferred embodiment the needle portion is approximately 10 mm long and has a diameter of approximately 1.3 mm. Initially, an air volume approximately equal to the desired dose is injected into the container. Then the container is inverted, as illustrated in Fig. 14, and the fluid is withdrawn into the syringe by the action of the plunger in a proximal direction to drive the fluid 185 from the container 186 through the passage 138 of the filling passage, the lumen of the cannula and into the chamber 176. of the syringe cylinder. The user will compare the axial position of the plunger with the volume measurement indicia 172 on the cylindrical side wall to ensure that the desired dose is obtained. It can be seen that the level of fluid 185 in the package will gradually decrease as the fluid is drawn into the chamber of the syringe barrel. The shoulder 147 maintains the distal end of the needle portion near the retainer to facilitate removal of almost all liquid from the container. Also, the short length of the needle portion coupled with the shoulder and the larger arrow portion give a clear message to the medical practitioner that the device is not intended for injection to humans. As best illustrated in FIG. 15, the fluid transfer device of the present invention can also be used to remove fluid 85 from the ampule 191. As noted below, at the time of use the neck portion of the ampule is split or cut leaving an open neck 192. Since the ampule does not have an elastomeric seal it does not reverse during the transfer of fluid from the ampule to a hypodermic syringe. Therefore, a long filling conduit is required, capable of reaching the bottom or sides of the ampule. For this purpose, the arrow portion 143 of the filling conduit is provided. The long arrow portion in conjunction with the needle portion allows the fluid transfer device of the present invention to effectively remove liquid from the ampule. In the preferred embodiment the arrow portion is approximately 1.5 m long and has an external diameter of approximately 3 mm. As with the container, fluid is withdrawn from the ampule inside the syringe chamber through the action of the plunger so that the fluid is withdrawn through the passageway in the duct, the lumen of the cannula assembly and inside. of the camera. Referring to Figures 8-21, with particular emphasis on Figs. 16-21, it can be seen that there are two separate methods that can be used to deliver medicament from the syringe to the injection site through an I-device. V. Or another catheter device having an injection site. The first method is illustrated in Figs. 16, 17 and 21. In the first method, after the syringe is filled with the fluid from a container or vial or other source, the protector 155 is placed on the filling conduit 134 so that the protector is removably connected to the duct and needle portion 141 and arrow portion 143 are contained within recess 161 of the guard. This is the same assembly that existed at the beginning of the filling process. In this preferred modality, the coupling between the protector and the conduit is achieved by axial movement which causes the structure on the proximal end of the protector to couple the housing on the filling conduit. The filled syringe is then supplied to the point of use. At the point of use, the user will remove the shield assembly and the conduit from the cannula assembly by holding the conduit, preferably in the raised portion 136 over the conduit and applying an axial force to remove the conduit from the cannula assembly, as is illustrated in Fig. 17. Since the cannula assembly is attached to the syringe through the locking "luer" neck, the connection between the cannula assembly and the syringe barrel is stronger than the frictional engagement between the barrel and the barrel. filling duct and cannula assembly, so that the actual force applied will not remove the cannula assembly from the syringe. Depending on the structures of the different parts, the forces can be balanced so that the desired result is obtained with respect to the removal components. The syringe is now ready to deliver the medicament, as will be described in more detail hereinafter. The second method for using the fluid transfer device of the present invention, as best illustrated in FIGS. 18-21, requires the user to remove the filling conduit 134 immediately after the syringe was filled with fluid from a container or vial by holding the filling conduit, preferably by the elongated portion 136 and applying an axial force to the conduit for remove it from the cannula assembly. The shield 155 is then placed over the cannula assembly, as illustrated in Fig. 19 to protect the cannula until the time of use. The second method is possible since the hub 128 of the cannula assembly and the housing 139 of the filling conduit have similar external shapes so that the shield 155 can couple either the hub or the housing. In this preferred embodiment the coupling is frictional and coupling and decoupling can be achieved by the application of axial forces. At the time of use, as illustrated in Fig. 20 the protector 1 55 is removed from the cannula assembly by the application of a distant axial force. The preferred embodiment of the fluid transfer device of the present invention includes a cannula having a blunt off end for use with I V. equipment or other catheter devices having injection sites with pre-divided septa. Specifically, as illustrated in Figure 21, a team I. V. 195 may include a housing 197 having a hollow internal conduit 198 and a flexible tube 199 connected to the vascular system of a patient, usually through a catheter. The housing 197 also contains the flexible tube 196 which is connected to a fluid source I .V. The housing 197 also includes the port 200 having a conduit 201 therethrough in communication with the hollow interior. A septum 203 covers the end of the conduit or how it is placed inside the conduit. The most common ports are covered by penetrable septa or pre-divided septa and are known in the art and sometimes referred to as "PRN" from the Latin pro re. cream that means "as the need arises". The septum is preferably made of rubber or other elastic material that allows the insertion of a sharp needle cannula in order to pour fluids into or withdraw fluids from the catheter. By removing the needle cannula, the septum seals itself. As illustrated in FIG. 21, the septum 203 is a pre-divided septum having a cut 204 therein. The septum 203 effectively seals the conduit 201 from the outside of the housing. However, access to the conduit can be achieved by pressing the blunt tip 133 of the cannula 122 against the area of the septum containing the cut 204. The light force applied to the syringe assembly in the axial direction will cause the blunt distant end of the can ula between the duct through the cut that is forced open by the blunt cannula. The removal of the blunt cannula from the duct, the cutting portion of the septum is automatically sealed. Since the housing 197 is connected to the medical vascular treatment of the patient, the patient can be delivered through the PRN port without further penetrating the patient's vein or, in this case, without the use of a sharp needle. It is an important feature of the present invention that the entire process of filling the syringe from a container or vial with a fluid, such as a liquid or injectable medicament, and delivery of this fluid to the patient can be accomplished using the assembly of The one of the present invention alone and without the use of any injection needle. The most common form of the prior art for delivering the medicament from a package with a penetrable septum is to attach a standard hypodermic needle assembly, illustrated in Figure 23, to a hypodermic syringe. The fluid is withdrawn into the syringe barrel and then the needle is discarded and a blunt cannula is attached to the syringe. This additional stage creates an opportunity for an accidental needle prick and requires the presence of some form of waste system. Wherein the present invention, in its preferred embodiment, does not use a standard needle and does not require a waste stage since all the components of the fluid transfer device can remain with the syringe until the time of use, at which time, all the components are properly placed. Also, the present invention provides a fluid transfer device that allows the filling of a syringe and the supply of the medicament to the patient without the use of a sharp injection cannula. Figure 22 illustrates an alternative cannula assembly 221 that includes a metal cannula 222, preferably made of stainless steel. Cannula 222 includes a proximal end 223, the distal end 225 having a lumen therethrough. The distal end 225 also includes the blunt tip 233. The cannula assembly 221 functions substantially as a cannula assembly 121 except that the cannula is made of metal. Stainless steel cannulas are desirable because of their strong resistance advantage over thermoplastic cannulas that allow the cannula to be made of smaller external diameters and a large lumen diameter while still having substantial strength.

Fig. 23 illustrates a prior art needle assembly 321 that is commonly used to inject medicament into a patient and to transfer fluid through penetrable septa such as the septa found in drug packages and I .V equipment. The needle assembly 321 includes the needle cannula 322 having a proximal end 323, a distal end 325 and a lumen therethrough. The distal end 25 further includes a sharp tip 333 capable of easily penetrating the skin and the flexible seals. The preferred embodiment of the fluid transfer device of the present invention includes a cannula assembly having a blunt cannula for use that allows the use of a device for filling a syringe through a package or vial and supplying the fluid from the container or ampule through a pre-divided septum of a device I .V. or another catheter device. Accordingly, the preferred embodiment is a needleless system for filling and delivering the injectable fluid that does not require a sharp needle cannula or an additional step of disposing of the cannula after the syringe is filled. However, it is within the scope of the present invention to include a fluid transfer device that contains a needle assembly having a needle cannula with a sharp distant tip such as a needle assembly 321. In the uses where the pre-divided septum is not available in the catheter or I equipment. V., a sharp steel needle cannula should be used. However, even with a needle assembly having a sharp needle cannula, the fluid transfer device of the present invention offers a distinct advantage over the prior art in that the needle assembly remains with the syringe from the time of filling up to the time of injection and there is no additional step of removing a sharp needle cannula from the syringe after filling the syringe and without additional complications with respect to the disposal of the sharp needle cannula at this intermediate stage. Likewise, the needle cannula is protected from damage during the filling procedure. Figs. 24 and 25 illustrate an alternative fluid transfer device of the present invention. The fluid transfer device of Figs. 24 and 25 operates substantially the same as the fluid transfer device of Figs. 9-20 except that the structure is provided so that the removal of the filling conduit from the cannula assembly requires a rotational movement. 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" neck 424 having an internal thread 426. The filling conduit 434 it includes a housing 439 having a radial projection 440 configured to engage the internal thread 426 of the "luer" neck. Accordingly, the connection of the filling conduit to the cannula assembly is achieved by rotational movement. A shield 455 is removably connected to the conduit. The conduit and protector are configured so that the protector can be removed and reconnected to the conduit through the axial movement of the protector with respect to the conduit. This alternative embodiment of the present invention offers a distinct advantage to the user in that the protector is removable from the conduit through axial movement and the conduit is removable from the cannula assembly through rotational movement further ensuring that the user will not accidentally remove it. a component when the user intends to remove another. Fig. 26 illustrates an alternative structure of the fluid transfer device of the present invention wherein the cannula or cannula assembly is integrally formed with a syringe barrel. Specifically, the cannula assembly 521 including the cannula 522 and the hub 528 that is integrally molded with the syringe barrel 571 so that the cannula is not removable from the syringe barrel. Apart from this feature, the syringe and the blunt cannula function substantially the same as the embodiment illustrated in Figs. 9-21. Figs. 27-28 illustrate an alternative fluid transfer device 600. The fluid transfer device 600 is intended for use in applications where a separate cannula assembly is not required. The fluid transfer device 600 includes a fill conduit 634 having a proximal end 635, a remote end 637 and a passage 638 therethrough. The conduit includes a housing 639 at the proximal end, a needle portion 641 at the distal end, and an arrow portion 643 therebetween. The needle portion and the arrow portion are preferably integrally molded of thermoplastic material. The housing includes a cavity of preferably trunco-conical shape 644 at its proximal end in fluid communication with passage 638. A cutting edge 645 is provided at the distal end of the needle portion to penetrate a container retainer. A protector 655 has an open proximal end 657, a distal end 658 and a side wall 659 therebetween defining a recess 661 in the protector. The protector is removably connected to the conduit so that the arrow portion and the needle portion of the conduit are preferably contained within the recess. A syringe 670 having an elongated indium cylindrical body 671 defining a chamber 676 for retaining the fluid, a proximal end, or distal end 673 and a trunco-conical tip 677, extends from the distal end and has a passage of tip 678 through it in fluid communication with the camera. The tip is placed within the cavity 644 of the housing 639 so that the chamber 676 is in fluid communication with the passage 638 of the filling conduit. The cavity 64 in the housing includes a trunco-conical shaped wall 646 configured to frictionally engage the truncated-conical tip on the syringe barrel. There are needleless systems that include valves and special accessories that are designed to accept the standard truncated-conical tip of a hypodermic syringe barrel. With such systems, a separate cannula assembly is not necessary since the tip portion of the syringe barrel acts as the system cannula. In all other aspects the embodiment of Figures 27 and 28 functions substantially the same as the embodiment of Figures 9-20 with the exception that the fluid is delivered through the tip of the syringe into the device receiving the fluid which could be a pre-divided septum designed to accept a standard syringe tip. In this embodiment, it is preferred although it is not necessary for the syringe to include a locking luer neck 679 having an internal thread 680. The proximal end of the housing 639 includes the radial projection 632 which is adapted to engage the thread 680 to improve the connection between the housing and the syringe barrel. In this embodiment, it is preferable that the protector 655 includes a radial projection 640 so that the guard can engage the "luer" neck when the filling conduit is removed, so that after the filling of the syringe the conduit can be discarded and the tip of the syringe can be protected again with the protector 655 for delivery to the point of use. In the alternative, the syringe filled with the fixed protected conduit can be brought to the point of use where the protector and the conduit are removed together and discarded as described hereinabove using the embodiments of Figs. 9-20.

Claims (10)

1 . A fluid transfer device for accessing a fluid from packages and ampules comprising: a cannula assembly including a cannula having a proximal end, a blunt distant end and a lumen through it, and a hub that has an open proximal end and a distal end attached to the proximal end of the cannula so that the lumen is in fluid communication with the open proximal end of the hub; a filling conduit having a proximal end, a distal end and a passage therethrough, the conduit including a housing at the proximal end, a needle portion at the distal end and an arrow portion therebetween, the housing having a cavity at its proximal end in fluid communication with the passage, a cutting edge at the distal end of the needle portion for penetrating a container retainer, and means for removably coupling the cannula assembly with the housing so that the open proximal end of the hub is in fluid communication with the lumen conduit passage and the cannula assembly removably coupled with the housing; and a protector having an open proximal end, a distal end and a side wall between them that defines a recess in the protector, the protector that is removably connected to the conduit so that the arrow portion and the needle portion are contained within of the recess.

2. The fluid transfer device of claim 1, further including a flange for limiting the depth of penetration of the needle portion into a container retainer.

3. The fluid transfer device of claim 1, wherein the open proximal end of the shield is configured to releasably engage the hub when the fill passage is withdrawn from the hub. The fluid transfer device of claim 1, wherein the means for releasably coupling the cannula assembly with the housing include a neck around the hub having an internal threading and a radial projection on the proximal end of the housing positioned to couple the threading to the rotational movement of the housing with respect to the hub. 5. The fluid transfer device of claim 1, wherein the cannula and the hub are integrally formed of thermoplastic material. 6. The fluid transfer device of the claim 1, wherein the needle portion and the arrow portion of the conduit are integrally formed of thermoplastic material. The fluid transfer device of claim 1, further including a syringe barrel having an elongated cylindrical body defining a chamber for holding fluid, an open proximal end, a distal end and a tip extending from the Distant end having a tip passage therethrough in fluid communication with the chamber, the tip being positioned within the open proximal end of the hub such that the chamber is in fluid communication with the lumen of the cannula. The fluid transfer device of claim 1, wherein the cannula assembly is integrally formed with the syringe barrel having an elongated cylindrical body defining a chamber for retaining fluid, an open proximal end and a distal end, the cannula extending from the distal end of the cylinder and positioned so that the lumen of the cannula is in fluid communication with the chamber. A method for transferring injectable liquid comprising the steps of: (a) providing a syringe including an elongated cylindrical body defining a chamber for holding the fluid, an open proximal end, a distal end and a tip extending from the distal end and having a tip passage therethrough in fluid communication with the chamber, a seal in fluid-tight slidable coupling within the cylinder and an elongated piston rod connected to the seal and extending in a manner close to through the open end of the cylinder; (b) providing a syringe filling device comprising a cannula assembly including a cannula having a proximal end, a blunt distant end and a lumen therethrough, and a sledge having an open proximal end and an end distant attached to the proximal end of the cannula so that the lumen is in fluid communication with the open proximal end of the hub; a filling conduit having a proximal end, a distal end and a passage therethrough, the conduit including a housing at the proximal end, a needle portion at the distal end and an arrow portion therebetween, the housing having a cavity at its proximal end in fluid communication with the passage, a cutting edge on the distal end of the needle portion for penetrating a container retainer, the cannula assembly being removably coupled with the housing so that the end the open close of the hub is in fluid communication with the passageway of the filling conduit and a protector having an open proximal end, a distal end, and a side wall between them that defines a recess in the protector, the protector being removably connected to the conduit so that the arrow portion and the needle portion are contained within the recess; (c) connecting the syringe filling device to the syringe so that the tip is positioned within the open proximal end of the hub and the chamber is in fluid communication with the cannula; (d) providing a package having a penetrable septum and containing an injectable liquid; (e) removing the conduit protector; (f) penetrating the penetrable septum of the container with the needle portion of the filling conduit to establish fluid communication between the interior of the container and the chamber of the syringe; (g) withdrawing the desired amount of the injectable liquid from the container into the chamber by moving the plunger rod in a direction close to the cylinder; and (h) removing the needle portion of the septum from said container. The method of claim 9, further comprising the steps of: (i) reconnecting the shield to the conduit so that the arrow portion and the needle portion of the conduit are contained within the recess of the shield; (j) moving the syringe to an I equipment. V. that has an injection site with a pre-divided septum; (k) removing the shield and conduit from the cannula assembly; and (I) advancing the syringe into the pre-divided septum so that the blunt tip of the cannula penetrates the septum and establishes fluid communication with the I equipment. V.; and (m) advancing the plunger so that the piston moves the fluid from the chamber through the lumen into the equipment I. V. 1 1. The method of claim 9, wherein the proximal end of the protector is configured to releasably couple the hub when the filling conduit is removed from the hub and further comprising the steps of: (n) removing the cannula conduit; (o) installing the protector on the cannula hub so that the cannula is within the recess of the protector; (p) moving the syringe towards an I equipment. V. that has an injection site with a pre-divided septum; (q) remove the protector from the cannula hub; (r) advancing the syringe into the pre-divided septum so that the blunt tip of the cannula penetrates the septum and establishes fluid communication with the I equipment. V.; and (s) advancing the plunger so that the piston moves the fluid from the chamber through the lumen into the I V equipment.