USRE29656E - Additive transfer unit having a slidable piercing member - Google Patents

Abstract

An additive container and transfer unit for transferring a solution from the additive container to a container which is under a vacuum, the transfer unit including a closure having a transfer pin or piercing member which is axially movable from a first position to a second position within a supporting member or guide. The additive container and transfer unit is particularly applicable to the transfer of a medicament within the container to a vacuumized parenteral fluid container. In this application, the additive container is inverted and the point of the transfer pin projecting from the closure is positioned on the I.V. fluid bottle stopper. As downward thrust is applied to the additive container, the end of the transfer pin projecting from the closure will pierce the I.V. fluid bottle stopper. As further thrust is applied, the additive container closure will move along the transfer pin, the other end of the transfer pin thereby piercing the diaphragm portion of the stopper within the transfer unit thereby providing a pathway between the two containers through the passageway in the transfer pin. The vacuum within the vacuumized container will then draw the solution within the additive container into the vacuumized container.

Description

This is a continuation, of application Ser. No. 465,230 filed Mar. 29, 1974, now abandoned.

BACKGROUND OF THE INVENTION

In administrating intravenous fluid to a patient, it is oftentimes necessary to add a medicament, such as potassium chloride solution, to the intravenous fluid. Intravenous fluids are mostly packaged in glass bottles which are sealed under a vacuum with rubber stoppers. It is therefore necessary to introduce the medicament through the stopper. One method is by use of a syringe, withdrawing the desired medicament from an ampule or stoppered vial and then injecting the medicament into the I.V. fluid container by puncturing the stopper with the needle of the syringe. Some disadvantages are apparent with this method. For example, use of an ampule results in danger of cut fingers from glass and glass particulate matter, requires the use of an antiseptic swab, includes the possibility for touch contamination, and requires considerable time to effect the transfer since many steps are involved. Likewise with stoppered vials, there is a possibility for touch contamination, the rubber closure of the vial must be cleansed, and the like with the ampule, considerable time is needed to effect the transfer. Additive containers containing the medicament to be added together with a special closure including a piercing pin for piercing the I.V. bottle stopper, such as illustrated in U.S. Pat. No. 3,055,367, are also available. Such containers include a fixed piercing pin with a stopper having an opening therethrough for communicating with the inside of the container. With such units, once opened some fluid may leak out when the unit is positioned for transfer. Additionally, the metal retaining ring which retains the stopper and piercing pin in place is not sterile and comes into contact with the sterile top of the I.V. bottle. With such units it is not possible to effect a partial withdrawal of the contents with a needle and syringe or it can be achieved only with difficulty, using a syringe having a long needle which is then inserted through the piercing pin.

SUMMARY OF THE INVENTION

The additive container and transfer unit of the present invention includes a closure which has a transfer pin axially movable in a central opening in the vial stopper, or otherwise movable from a first position to a second position, the inside end of the stopper being sealed by a puncturable diaphragm portion. The double-ended transfer pin pierces both the I.V. bottle and additive vial stoppers so that transfer is made at that point while the system is completely closed off from the atmosphere. In one embodiment of the invention, after the protective hood is removed, the additive vial is inverted and the point of the transfer pin projecting from the stopper is positioned on the I.V. bottle stopper. When force is applied to the additive container, the end of the transfer pin projecting from the stopper will pierce the I.V. bottle stopper. As further force is applied, the additive vial stopper will move along the transfer pin, the other end of the transfer pin thereby piercing the diaphragm portion of the stopper providing a pathway between the two containers. The vacuum within the I.V. fluid container will then draw the medicament within the additive container into the I.V. fluid container. Accordingly, in a single motion, the additive container and transfer unit is activated and the medicament transferred to the I.V. bottle.

In one embodiment, prior to use, the double-ended transfer pin can be removed and a needle and syringe used to draw out the contents of the additive container. This may be necessary when there is a need for only a partial dose of medicament, where the contents are to be added to an intravenous fluid bottle with depleted vacuum or where the contents are to be added to a flexible I.V. fluid container.

The additive container and transfer unit of the present invention provides a completely closed system, permits rapid transfer of the medicament within the container, is easily adaptable to all I.V. fluid containers which are under a vacuum and have puncturable closures, and can be easily adapted to partial dose requirements and for making additions to flexible I.V. fluid containers.

The invention will be better understood with reference to the following description.

DRAWINGS

FIG. 1 is a side elevational view of one embodiment of the invention illustrating the transfer container and closure in an inverted position;

FIG. 2 is a partial side elevational view, partially in cross section illustrating the transfer container and closure of FIG. 1 prior to use;

FIG. 3 is a cross sectional view as seen along thelines 3--3 of FIG. 2;

FIG. 4 is a cross sectional view as seen along thelines 4--4 of FIG. 2;

FIG. 5 is a cross sectional view, partially in cross section illustrating use of the transfer container and closure with a parenteral solution container;

FIG. 6 is a plan view as seen along thelines 5--5 of FIG. 5;

FIG. 7 is a partial side elevational view, partially in cross section illustrating another embodiment of the invention;

FIG. 8 is a partial side elevational view in cross section of the transfer container and closure of FIG. 7;

FIG. 9 is a cross sectional view as viewed along the lines 9--9 of FIG. 8; and

Fig. 10 is a partial side elevational view, partially in cross section illustrating the transfer container and closure and used in conjunction with a parenteral solution container.

DETAILED DESCRIPTION

Referring to FIGS. 1 through 7 of the drawings, theadditive transfer container 10 comprises a closure portion 11 andcontainer 12. As best seen in FIG. 2, the closure 11 includes astopper 13 which is affixed to thefinish 22 of theneck 23 of thecontainer 12 by aninner ferrule 14. Thestopper 13 includes an annular shoulder 18 which abuts thefinish 22 of thecontainer neck 23 and is sealed thereto by theinner ferrule 14; the ferrule being crimped over the shoulder 18 and thebead 24 on theneck 23. Thestopper 13 includes acentral opening 19 which extends along the longitudinal axis of thestopper 13, theend 15 of thestopper 13 which projects into theneck 23 of thecontainer 12 being sealed by apuncturable diaphragm 16. Preferably, theend 17 of theopening 19 in thestopper 13 is of reduced diameter and tapers inwardly to guide thepiercing pin 28 as hereinafter described. Anannular undercut 20 is formed in thecentral opening 19 of thestopper 13, spaced away from theopen end 21 thereof and serves to retain thetransfer pin 28 in place as hereinafter described. The double endedtransfer pin 28 is disposed within thecentral opening 19 of thestopper 13. Thetransfer pin 28 is double ended, i.e., has a point at both ends, thepoint 29 on theproximal end 30 of thepin 28 being for the purpose of puncturing thestopper 45 in a parenteral solution container as hereinafter described, thepoint 31 on thedistal end 32 of thetransfer pin 28 being for the purpose of puncturing thediaphragm 16 of thestopper 13. Thetransfer pin 28 includes annularspaced projection 34 and barbs ornibs 33 extending outwardly from thebody 35 of thetransfer pin 28 as well as an annularly projecting shoulder or stop 36. Alongitudinal passageway 42 extends through thetransfer pin 28, thedistal end 32 being open. As illustrated, theproximal end 30 is closed and pointed but includesopposed expulsion ports 43 for release of the additive medicament into the I.V. bottle.

Prior to use, thetransfer pin 28 is positioned in thecentral opening 19 of thestopper 13 as illustrated in FIG. 2, theannular projection 34 in thetransfer pin 28 exerting pressure against thestopper 13 to prevent the leakage of air around thetransfer pin 28 and through thecentral opening 19 when entry is made as illustrated in FIG. 5. Ahood 40 is positioned on thestopper 13, theflange portion 41 of thehood 40 resting on theinner ferrule 14 which holds thestopper 13 on theneck 23 of thecontainer 12. Anannular ridge 48 formed in theflange portion 41 of thehood 40, projecting toward thestopper 13 provides an effective seal between the closure 11 andstopper 13. Anouter ferrule 37 is crimped in place over theflange 41 of thehood 40 and thebead 24 extending fromneck 23 of the bottle to hold the entire assembly 11 in place. To facilitate removal of theouter ferrule 37 or tamperproof seal, a tear-tab 38 can be formed thereon.

In use, the tamperproof metal seal orouter ferrule 37 is removed by grasping the tear-tab 38 and applying force to tear theseal 37. Removal of theseal 37 releases the rigidplastic hood 40 which protects the sterile integrity of thepiercing pin 28 prior to use. Thehood 40 is removed and discarded thereby exposing thetransfer pin 28. Theadditive container 10 is thereafter inverted and thetransfer pin 28 aligned with the diaphragm or opening 44 in thestopper 45 of aparenteral solution container 46. A single thrust of theadditive container 10 will activate the unit, theproximal end 30 of thetransfer pin 28 piercing thediaphragm 44 or passing through the opening in thestopper 45 in theparenteral solution bottle 46. As thetransfer container 10 is thrust downwardly, thestop 36 on thetransfer pin 28 will abut the surface of thestopper 45 on theparenteral solution container 46. Thereafter thetransfer pin 28 will remain stationary and with continued force, thedistal end 32 of thetransfer pin 28 will slide along thecentral opening 19 in thestopper 13 of theadditive container 10 with thepoint 31 thereof piercing thediaphragm 16 in thestopper 13. When entry is made through both stoppers, a pathway will be provided through thepassageway 42 in the double endedtransfer pin 28 and accordingly, the vacuum within theparenteral solution container 46 will draw the additive solution from theadditive container 12 through thetransfer pin 28 andexpulsion ports 43 into the I.V.container 46. With the embodiment as illustrated, 10 milliliters of additive solution can be transferred in two seconds or less. As force is applied, thetransfer pin 28 will move from a first position as illustrated in FIG. 2 to a second position as illustrated in FIG. 5, theprojection 33 on thetransfer pin 28 thereby fitting within the undercut 20 in thestopper 13. When thecontainer 10 is withdrawn, the cannula of an administration set (not shown) can be inserted into the stopper of the parenteral solution container for the purpose of administering the solution to a patient.

With thetransfer container 10 of the present invention, there is no possibility of leakage of fluid from theadditive container 12 when positioned for transfer to an I.V. bottle. In contrast, many such transfer containers have an open passage through the closure thereof so that when inverted, leakage of fluid can result. Further, with thetransfer container 10, thetransfer pin 28,stopper 13 area,hood 40 and seal 37 can be sterilized prior to putting the assembly in place. Consequently, since theseal 37, which comes in contact with the atmosphere, is removed prior to use; only sterile surfaces will come in contact. As can be seen in FIG. 5, thestop 36 of thesterile pin 28 comes into contact with the sterile top of the I.V.container 46stopper 45. Accordingly, any contamination of the I.V. solution within thecontainer 46 due to contact with unsterile surfaces is minimized.

If necessary, access to the additive solution within theadditive container 12 can be achieved by a syringe and needle. Theseal 37 andhood 40 is removed as previously described thereby exposing thetransfer pin 28. At this point, thetransfer pin 28 can be withdrawn from thestopper 13 and the needle of a syringe inserted through thediaphragm 16 in thestopper 13 of theadditive container 10. Additive solution within thecontainer 12 can then be withdrawn into the syringe. This technique can be useful if the vacuum within the parenteral solution bottle has been depleted, if transfer to a flexible plastic I.V. container is required, or if only a part of the contents of the additive container is desired.

FIGS. 7 through 10 illustrate another embodiment of the present invention utilizing a metal needle insert molded in a plastic hub. Referring to FIG. 7, theadditive transfer unit 50 of this embodiment comprises acontainer 51 for storing the additive medicament and aclosure portion 52 including aprotective hood 53. As best seen in FIG. 8 which illustrates theunit 50 with thehood 53 removed and ready to use, theunit 50 comprises acontainer 51 or bottle having a projectingbead 54 on the neck thereof. Theclosure portion 52 comprises apuncturable stopper 55 including anannular shoulder 56 for abutment with thefinish 57 of thecontainer 51 and adiaphragm portion 58. Atubular member 60 for retaining the piercingmember 61 is positioned on thestopper 55 and ametal ferrule 62 is crimped over thebead 54 of thebottle 51 and theannular flange 63 extending from thetubular member 60 to retain theclosure 52 in place. Theflange 63 of thetubular member 60 may include anannular ridge 64 on both sides thereof to provide a more effective seal between thestopper 55 and thetubular member 60 and to provide a better crimping surface for theferrule 62. Thecylindrical portion 65 of thetubular member 60 includes acentral opening 66 therethrough in which is positioned the piercingmember 61. If desired, an undercut 67 can be formed in the cylindrical portion for retaining an 0ring 68 and provide a more effective seal when theprotective hood 53 is positioned in place as illustrated in FIG. 7.

The piercingmember 61 comprises ametal cannula 70 or needle insert molded in a plastic hub 71, the diameter of the hub 71 being coextensive with the diameter of theopening 66 through thetubular member 60 to prevent leakage of fluid while at the same time permitting the hub 71 to reciprocate or slide with in theopening 66. The length of the double endedneedle 70 is longer than the length of the hub 71 so that the pointed ends thereof project from either end of the hub 71. To provide a more effective seal, aportion 72 of the hub which extends from thetubular member 60 prior to use of theunit 50 can be formed of a smaller diameter than the remainingportion 73, with theopening 74 on the end of thetubular member 60 being of such diameter as to mate with thesmaller portion 72 of the hub 71. Such a construction will also prevent accidental release of the piercingmember 61 from theclosure 52.

As with the previously described embodiment, theunit 50 is put in use by removing theprotective hood 53 which is retained on thetubular member 60 by means of a spot weld to protect the sterile integrity of the piercingmember 61 and other exposed portions of theclosure 52. Theunit 50 is then put in place on thestopper 80 of aparenteral solution container 81 and pushed downwardly whereby theproximal end 75 of theneedle 70 will puncture thestopper 80 in theparenteral solution container 81. Further pressure will cause thetubular member 60 of theclosure 52 to slide along the hub 71 whereby thedistal end 76 of theneedle 70 will puncture thestopper 55 on theadditive container 51 thereby providing a fluid flow path from theadditive container 51 to theparenteral solution container 81. The additive medicament will thereby be drawn into theparenteral solution container 81. Theadditive unit 50 can then be withdrawn and theparenteral solution container 81 containing the medicament arranged for infusion of the solution to the patient.

Claims (6)

What is claimed is:

1. An additive transfer unit for storing and transferring of a medicament to a .Iadd.solution .Iaddend.container having an exposed closure .[.and a vacuum therein.].;

said transfer unit comprising .[.a.]. .Iadd.an additive .Iaddend.container for storing the medicament to be transferred, said .Iadd.additive .Iaddend.container having a rigid neck portion defining a finish, the opening in said .Iadd.additive .Iaddend.container being sealed by a closure affixed thereto;

said closure having a shoulder for resting against said finish of the rigid container neck, said closure including a puncturable stopper with a pierceable diaphragm portion positioned in sealing engagement with the opening in the .Iadd.additive .Iaddend.container and in a substantially stationary manner;

a tubular member having a cylindrical portion, the cylindrical portion including a central opening therein for slidably receiving a piercing member;

said tubular member including an undercut in the outside surface of the cylindrical portion thereof, sealing means positioned in said undercut;

a hood engageable with the cylindrical portion of the tubular member and the sealing means to cover the piercing member and tubular member prior to use of the unit;

said tubular member being positioned and arranged so that the opening therein overlies the diaphragm portion of said stopper;

crimping means to affix the closure and tubular member to the .Iadd.additive .Iaddend.container;

said piercing member being positioned within said central opening in said member and having a passageway therethrough for the flow of said medicament and a point on both ends thereof;

said piercing member having an integral stop and being movable from the first position for entry through the closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container with said integral stop constructed and arranged to contact said exposed closure of .[.vacuumized.]. .Iadd.said solution .Iaddend.container to a second position for puncturing of the stopper in the additive container to thereby provide a pathway between the containers and permit the medicament within the additive container to transfer into the .[.vacuumized.]. .Iadd.solution .Iaddend.container.

2. The additive transfer unit of claim 1 wherein said tubular member includes an annular flange extending from one end thereof, the flange being positioned on the stopper so that the opening within the cylindrical portion overlies said stopper, and said crimping means for affixing said closure and tubular member to said .Iadd.additive .Iaddend.container includes a ferrule crimped about the flange and container to affix said member and stopper to the .Iadd.additive .Iaddend.container.

3. The additive transfer unit of claim 2 wherein the piercing member comprises a needle having a hub, the diameter of the hub being coextensive with the central opening through the tubular member to thereby prevent leakage of fluid while at the same time permitting the hub to slide within the central opening, the length of the needle being longer than the length of the hub so that the pointed ends thereof project from either end of the hub.

4. An additive transfer unit for storing and transferring of a medicament to a .Iadd.solution .Iaddend.container having an exposed closure .[.and a vacuum therein.].;

said transfer unit comprising .[.a.]. .Iadd.an additive .Iaddend.container for storing the medicament to be transferred, said .Iadd.additive .Iaddend.container having a rigid neck portion defining a finish, the opening in said container being sealed by a closure affixed thereto;

said closure having a shoulder for resting against said finish of the rigid container neck, said closure including a puncturable stopper positioned in sealing engagement with the opening in the .Iadd.additive .Iaddend.container and in a substantially stationary manner, and means for affixing the stopper to the .Iadd.additive .Iaddend.container;

said stopper including a central opening extending along the longitudinal axis thereof for slidably receiving a piercing member, the end of the stopper projecting into the container being sealed by a puncturable diaphragm;

a piercing member having a passageway therethrough for the flow of said medicament and a point on both ends thereof and disposed within the central opening in said stopper, one end of the piercing member extending from said opening;

said piercing member having an integral stop and being movable from a first position for entry through the closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container with said integral stop contacting said exposed closure of the .[.vacuumized.]. .Iadd.solution .Iaddend.container to a second position for puncturing of the diaphragm of the stopper in the additive container to thereby provide a pathway between the containers and permit the said medicament within the additive container to transfer into the .[.vacuumized.]. .Iadd.solution .Iaddend.container;

said integral stop of the piercing member including an annular shoulder extending from the body thereof at a point in the portion of the piercing member which extends from the central opening in the stopper, said shoulder preventing excessive movement of the piercing member in the central opening in the stopper when the piercing member is inserted in the closure of .[.a vacuumized.]. .Iadd.said solution .Iaddend.container;

said piercing member including an elongated body with said point on either end thereof and a projection extending from the body intermediate the ends thereof;

the central opening within the stopper including an undercut to receive the projection on the piercing member when the piercing member is moved from the first position to the second position within the central opening in the stopper for puncturing of the diagram of the stopper whereby the projection on the piercing member will engage the undercut in the opening in the stopper to thereby retain the piercing member within the opening in the stopper when the transfer unit is withdrawn from the .[.vacuumized.]. .Iadd.solution .Iaddend.container.

5. The additive transfer unit of claim 4 including a hood for protecting the piercing member and stopper prior to use, said hood having a flange extending from the open end thereof, the flange of the hood overlying said stopper, and means for affixing the hood to the .Iadd.additive .Iaddend.container.

6. The additive transfer unit of claim 5 wherein the means for affixing the hood to the .Iadd.additive .Iaddend.container comprises a tamperproof, removable seal fastened to the .Iadd.additive .Iaddend.container and hood so that upon removal of the seal, the hood can be removed to expose the piercing member. .Iadd. 7. The additive transfer unit as defined in claim 4 wherein said solution container is vacuumized. .Iaddend.

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