US3788524A

US3788524A - Additive container

Info

Publication number: US3788524A
Authority: US
Inventors: L Davis; W Kirkland
Original assignee: Cutter Laboratories Inc
Current assignee: Bayer Corp
Priority date: 1971-12-22
Filing date: 1971-12-22
Publication date: 1974-01-29
Anticipated expiration: 1991-01-29

Abstract

An additive container for supplying an additive material for mixing with a parenteral solution contained in a dispensing receptacle, characterized in that the additive container includes a hollow body member containing therein a chamber that defines at one end an end wall provided with a through opening, said body member including an integral tubular extension that communicates at one end with said opening and at the other end with conduit means having a pointed extremity. The open end of the body member is closed by closure means that are operable to effect flow of fluid through said tubular extension. According to a first embodiment, the closure means comprises a resilient closure member that is manually deformable to effect pumping of fluid through said tubular extension. In a second embodiment, the resilient closure member, in addition to being deformable to effect the aforementioned pumping operation, is also deformable to define a piston element that is longitudinally displaceable within the body member to force additive material through the opening. Finally, in a third embodiment, the closure member comprises the piston element of a syringe which may be adapted for operation by a sheath that normally protects the syringe needle element.

Description

limited States Patent [191 Davis et al.

ADDITIVE CONTAINER [75] Inventors: Loren Roger Davis, Rancho Cordova; Walter Dean Kirkland,

Walnut Creek, both of Calif.

[73] Assignee: Cutter Laboratories Inc., Berkeley,

Calif.

22 Filed: Dec. 22, 11971 21 'Appl. No.1 210,848

[52] US. Cl. 222/209 [51] Int. Cl B65d 37/00 [58] Field of Search. 222/209, 386, 386.5, 325-327;

128/218 N, 218 P, 221, 216, 272, 218 R, 215

[56] References Cited UNITED STATES PATENTS 3,256,894 6/1966 Sherman 222/209 X 2,978,722 4/1961 Kusakabe.... 222/386.5 X 3,659,749 5/1972 Schwartz 222/386 X 3,215,142 11/1965 Buono 1 222/209 X 2,761,598 9/1956 Darlington, Jr 222/541 3,212,685 10/1965 Swan et al. 222/386 2,831,615 4/1958 Sherbondy 222/541 X 3,297,207 l/1967 Ballin ZZZ/386.5 X 3,184,120 5/1965 Undi 222/209 3,073,319 l/1963 Sperber.... 222/209 X 2,281,738 5/1942 Wolcott. 222/209 1,987,146 l/1935 l-lein..... 128/218 R 2,834,346 5/1958 Adams 128/218 R' 2,812,763 11/1957 Ferguson 128/218 R 2,920,797 Sherbondy 222/327 [451 Jan. 29, 1974 Primary Examiner-Stanley H. Tollberg Assistant Examiner-Norman L. Stack, Jr. Attorney, Agent, or Firm-Daniel W. Sixbey et al.

[ 5 7] ABSTRACT An additive container for supplying an additive material for mixing with a parenteral solution contained in a dispensing receptacle, characterized in that the additive container includes a hollow body member containing therein a chamber that defines at one end an end wall provided with a through opening, said body member including an integral tubular extension that communicates at one end with said opening and at the other end with conduit means having a pointed extremity. The open end of the body member is closed by closure means that are operable to effect flow of fluid through said tubular extension. According to a first embodiment, the closure means comprises a resilient closure member that is manually deformable to effect pumping of fluid through said tubular extension.

- In a second embodiment, the resilient closure member, in addition to being deformable to effect the aforementioned pumping operation, is also deformable to define a pistonelement that is longitudinally displaceable within the body member to force additive material through the opening. Finally, in a third embodiment, the closure member comprises the piston element of a syringe which may be adapted for operation by a sheath that normally protects the syringe needle element.

15 Claims, 14 Drawing Figures PAIENIEDJANZS I974 SHEET 1 OF 4 & 4.

F /'g. In

PATENTED 3.788.524

saw u or 4 Fig. 9

. 1 ADDITIVE CONTAINER BACKGROUND OF THE INVENTION Parenteral solutions-are usually stored in containers under reduced pressures, which containers normally include rubber closure means designed for penetration by the hollow spike conduit of a drip chamber assembly leading to the patient. Airways for equalizing pressures in the system are provided either by a separate tube extending through the closure of the dispensing container or an airway'with a check valve integral with the spikedrip chamber assembly. If 'it is desired to incorporate a liquid additive into the'parenteral solution, this can be conveniently accomplished before the insertion of the spike-drip'chamber, while the dispensing container is still under vacuum, by using the type of additive container which consists merely of .a vial with a hollow spiked end. After inserting the spike through the closure on the dispensing container, the fluid additive will be drawn into the dispensing container. The additive container is then replaced with the spike-dripchamber and the mixture of parenteral solution and additive is ready for delivery.

However, once a spike has entered the closure means, the vacuum is either lost or greatly reduced to the point where an additive cannot be introduced by the above procedure. Also, when thespike is removed, unsterilized or environmental air can pass through the hole in the closure.

Additive containers have been designed to permit the introduction of an additive when little or no vacuum exists. These are generally vials which have a flexible, hollow dome-shaped member attached to the open end of the vial with a hollow spike extending from the center of the dome-shaped member. The spike is designed to fit tightly in the hole of the closure means of the dispensing container. This type of container is frequently used where" the additive is" in the form of a desiccated solid. Afterinserting the spike through the closure of effect to draw parenteral solution into the additive container sufficient for dissolving the solid. The dispensing container is then placed in an upright position and the solution of additive can be pumped into the parenteral solution. If the additive is bottled in the form of a solution, the reconstitution step is, of course, unnecessary.

In the hands of the unskilled operator, unless the additive container is pumped in a direction quite coincidentally with the axis of the spike, the domed member will buckle to one side and the pumping action becomes ineffectual in delivering the solution. If the spike does not fit tightly in the closure or if the spike is replaced by a needle, then this style .of additive container is even moredifficult to operate. One hand must be used to hold the rigid support. for the needle or spike while the other hand is used to hold the body of the additive container for the pumping operation. The forearm as well as the hand is used to generate the force for the pumping action and such a force would tend to dislodge the spike or needle from the closure of the dispensing container or even break off the needle if one hand fails to maintain the support for the needle or spike.

Normally, once a dispensing container-drip chamber assembly is established for administering the parenteral solution (with or withoutv an additive) to a patient, the only means for supplying another additive is to disassemble the system and place another additive into the dispensing container as previously described. Alternatively, with the system employing a check-valve airway, a hypodermic syringe is used to draw the additive solution from a stoppered vial containing the additive, the needle is removed from the syringe, the luer stem of the syringe is placed in the airway conduit, and the additive is forced through. the airway into the dispensing container. Either procedureis not only time consuming but also permits the possibility for contamination of the parenteral solution.

A primary object of the present invention is to provide an improved additive container which overcomes the problem associated with previous containers. The novel container of this invention permits the transfer of an additive to a dispensing container either directly, regardless of the presence or absence of a vacuum, or in a system where the parenteral solution is already being administered. Furthermore, this additive container will permit the simultaneous transfer of other additives to the dispensing container without disrupting thp system, and in addition, all transfers of additive are accomplished under sterile conditions and without steps which could cause contamination. The container of this invention also permits the addition of additives packaged either in the liquid or solid form.

According to a more specific object of the invention, the additive container includes a hollow body member that contains a chamber having at one end an end wall provided with a through opening, said body member having an integral tubular extension that communicates at one end with said opening and extends longitudinally from said end wall, said tubular extension being connected with conduit means having at its free end a pointed extremity. Closure means are provided at the other end of the container that are operable to dispose fluid in a desired direction through said tubular extension. In one embodiment, the closure means comprises a resilient closure member adapted for repeated manualdeformation to pump fluid through said tubular ex tension. According to a second embodiment, the resilient closure member in addition to being repeatedly deformable to effect the aforementioned pumping operation is further deformable upon progressive insertion within said body member to define a piston element that is longitudinally displaceable in said chamber to force fluidfrom said chamber outwardly through said tubular extension. According to a third embodiment, the closure member comprises the piston element of a syringe which may be adapted for connection with a protective sheath that normally covers the conduit means, whereby said sheath functions alternatively as an operating handle for the closure member.

These and other objects of the present invention will be readily apparent upon a consideration of the following specification and claims taken in conjunction with the accompanying drawings in which:

FIG. 1 is a longitudinal sectional view of-a first embodirnent of the additive container of the present invention;

FIG. 1a is a detailed cross-sectional view of a modification of the lower portion of the container of FIG. 1, the piercing member being illustrated as a spike;

FIG. lb is a longitudinal sectional view of a modified form of the closure means of FIG.'1;

FIG. 10 is a detailed sectional view illustrating the manner in which the pumping portion of the closure for the container of FIG. 1 is deformed;

FIG. 2 is a longitudinal section view of a second embodiment of the additive container of the present invention;

FIG. 3 is a detailed cross-sectional view showing how the pumping portion of the closure of the container of FIG. 2 is deformed;

FIG. 4 is a longitudinal sectional view of the container of FIG. 2 with the sealing ring removed and with the closure means operated as a piston;

FIG. 5 is a top plan view of the sealing ring of FIG.

FIG. 6 is a side elevational view of the sealing ring of FIG. 2;

FIG. 7 is a top plan view of a modified form of the closure means of the additive container of FIG. 2;

FIG. 8 is a detailed sectional view illustrating the closure means of FIG. 7 when functioning as a piston;

FIG. 9 is a view in elevation of the additive container of FIG. 2 in which the sealing ring and needle have been removed and the container is ready for insertion in the check-valve air way conduit of a spike-drip barrel assembly;

FIG. 10 is a longitudinal sectional view illustrating a third embodiment of the additive container of the present invention, including in phantom a showing of a handle; and

FIG. 11 is a view of a modification of the closure means of FIG. 10.

Basically, the additive container of this invention comprises a hollow rigid body, one end of which narrows to a small tubular extension. This tubular extension may be connected with a hollow needle or the extension may be elongated to form a hollow spike integral with the rest of the body. The needle or spike is normally scored a short distance from the place where the body narrows to form the extension, thereby to define a break-away portion. The body is made of a rigid material (preferably a transparent material, such as glass or plastic) which is essentially non-reactive with any additive which may be contained therein. The outer end of the needle or spike is shaped so as to cause a minimum of coring or tearing of any thin wall of a do sure through which it may be inserted.

The other end of the rigid body is closed by closure means preferably formed of rubber or a suitable polymeric material. There are three distinct types of closure means which, in combination with'the rigid body and scored needle or spike, provide an additive container which accomplishes one or more-of the desired objects. In effect, the additive container of this invention can be used either of two ways. The closure means are operable to permit the additive container to function either as a pump or as a syringe for transferring additive soludle 20 having an opening adjacent the pointed end thereof is secured to the tubular extension 16 in any well known manner, so that material contained within the tubular body 12 may be forced through the channel 18 and the hollow interior of the needle 20 out through the aperture at the pointed end of the needle.

The end of the body member 12 opposite the tubular extension 16 is open and is provided with an annular laterally projecting bead 22 having a flat end surface 24. This open end of the body member is closed by a resilient dome-shaped closure member 26 which has an annular beaded portion 28 molded into the lower portion thereof. This annular beaded portion is provided with a flat surface 30 which abuts the flat end surface 24 when the dome shaped closure is in place. Thus, the fiat surface 30 cooperates with an inner annular flange 32 which projects below the annular beaded portion 28 and seats against the inner surface of the tubular body 12 to form a seal between the dome-shaped closure member and the body 12 of the additive container 10.

The annular bead 28 is thickened so as to give added support for the closure member against the fiat end surface 24 of the body portion 12 as well as to provide support for a centrally projecting dome portion contiguous therewith. This centrally projecting dome portion includes a side wall 36 which angles upwardly from the annular bead 28 to a flat central crest surface 38. The side wall 36 includes a thin wall section 40 adjacent the annular beaded portion 28 and a thickened wall section 42 between thethin wall section and the flat central crest 38. The wall of the closure member 26 is quite thin at the flat central crest 38 so that the needle of a second additive container may be inserted therethrough. The thin and thick wall sections of the closure member cooperate with the projecting bead 28 to .cause the closure to rebound or return to its original shape after being manually deformed by pressure applied to the flat central crest 38.

A sealing ring 44 engages the underside of the annular laterally projecting bead 22 of the tubular body 12 and the upper surface of the annular beaded portion 28 of the closure member 26. The sealing ring is curved on the top. to conform with the curved surface of the beaded portion 28, and when the ring is crimped about the bead 22, a tight, leakproof sealis obtained between the abutting surfaces of the closure and body member.

The dome-shaped closure'member 26 is formed of resilient material such as rubber, synthetic plastic or the like, while the tubular body 12 is generally formed of glass or similar transparent material. The sealing ring 44 is made of any suitable material, such as metal, preferably aluminum or tin.

A protective sheath 46 is normally employed to enclose a needle 20, the open end of-this sheath being insertable over the tubular extension 16. The sheath is made of somewhat flexible material, such as rubber or plastic, and serves to protect the needle as well as to maintain sterility prior to use for this portion of the additive container.

FIG. 1a shows a portion of the tubular body 12 in which the needle 20 is replaced by a hollow spiked member 48 which is integral with the tapered portion 14 of the tubular body. With this modification, the tubular body and spiked portions are preferably formed from a suitable synthetic plastic material, although glass is also suitable for use. The spike 48 (and/or the needle 20) may be provided with a score line 50 spaced between the point thereof and the tapered portion 14 of the tubular body 12, said score line extending around the periphery of the needle or spike. The pointed portions of both the needle 20 and the spike 48 are constructed so as to cause a minimum of coring or tearing of the thin portion of any resilient closure through which each may penetrate. Prior to use, the spike 48 may also be enclosed with a protective sheath 46. i

With an additive container having the spike 48 of FIG. 1a, the dome-shaped closure member 26a of FIG. 1b is employed in place of the closure member 26 of FIG. 1. In this modification, the closure member 26a is essentially the same as the closure 26 except that the thick wall portion 42a thereof is not as thick as the wall portion 42 of FIG. 1. This widens the space beneath the flat central crest 38a to provide clearance for the entry of a spike 48 therethrough.

To use the additive container 10, the sheath 46 is removed from the needle or spike 48, and the needle or spike is inserted through the closure of a dispensing container for parenteral solution. If there is sufficient vacuum in the latter container, all of the liquid additive from within the additive container 10 will automatically be drawn into the dispensing container. If there is insufficient vacuum in the dispensing container to remove all of the additive solution, or if there is no vacuum, the additive solution may be pumped from the additive container 10 into the dispensing container by intermittently pressing and releasing the flat central crest 38 of the dome-shaped closure 26 with a finger or thumb as illustrated in FIG. lc. It requires only one hand to operate this pump and hold the additive container 10, for the additive container may be held steadily with two or more fingers while the thumb or index finger is employed to operate the pump. Conseduently, the amount of force used is considerably less than that used to operate previous pump style containers, and there is little or no chance that the force of the pumping action will dislodge or break off the needle or spike.

If the additive is in the form of a desiccated solid, the additive can first be reconstituted by inserting the needle or spikeinto a stoppered vial containing'sterile' water or a reconstituting solution, operating the pump to bring fluid into the additive container, and the resultant solution of the additive is then transferred to the dispensing container.

In thesituation where the dispensing container is not under vacuum, then the needle or spike of the additive container 10 is inserted through the closure of the dispensing container in an inverted position. Then, by pumping the dome-shaped closure 26, a portion of the parenteral solution is caused to enter the additive container to reconstitute the solid therein. This solution is then pumped back into the dispensing container after first placing it in an upright position.

If two additives are to be simultaneously introduced into the dispensing container, the needle or spike of one additive container 10 may be inserted through the flat central crest 38 in the dome-shaped closure 26 of a second additive container 10. Then the needle or spike of the second additive container is inserted through the closure of the dispensing container, and if a vacuum exists in the dispensing container, the solution of both additive containers will be withdrawn. Thus, the additive container 10 besides being easily operated, has the distinctive capability which permits the transfer of two or more additives at the same time without having the closure of the dispensing container penetrated more than once. To accomplish the transfer of two or more additives using previous types of containers, the closure of the dispensing container had to be repeatedly punctured which resulted in a greater likelihood of coring of the closureas well as leakage with the concurrent loss of vacuum and the entrance of unsterile air or pieces of the closure into the parenteral solution.

FIGS. 2-6 illustrate a second embodiment of the additive container of the present invention illustrated generally at 50 which includes a tubular body 52 having an end wall 54 which extends substantially normal to the longitudinal axis of the tubular body inwardly toward the center thereof and then tapers downwardly to provide a tubular needle-supporting extension 56. This needle supporting extension is provided with an internal channel 58 which-communicates with the interior of a hollow needle 60 of the type described with respect to FIG. 1.

As in the case of the additive container 10 of FIG. 1, the needle 60 may be scored or may be replaced by a spike integral with the needle supporting projection 56.

The upper open end of the tubular body 52 is provided with an annular laterally projecting bead 62 having a flat end surface 64. The open end of the tubular body 52 is closed by a dome-shaped resilient closure member 66.

The closure member 66 has an annular flange or skirt 68-Which projects laterally therefrom and includes a flat lower surface 70 which abuts the flat upper end surface 64 of the bead 62 when the closure member is in place on the tubular body 52. Additionally, the closure member 66 includes a thickened interior portion 72 which projects below the annular flange 68 and engages the inner wall of the tubular body 52. It will be noted with comparison to the additive container 10 of FIG. 1, that the thickened inner portion 72 of the dome-shaped closure member 66 is much thicker (i.e. over twice as thick) than the relatively thin annular flange or skirt 68, while in FIG. 1, the reverse is the case. This is to permit the flange 68 to fold back under pressure in a manner to be substantially described.

A side wall 74 of the closure member 66 angles upwardly from the annular flange 68 to a substantially flat central crest 76. Like the side wall 36, the side wall 74 includes a thick'wall section extending between a thin wall section 78 and a flat central crest 76. Thus the dome-shaped closure member may flex inwardly when pressure from a finger or thumb is applied to the flat central crest portion 76, as illustrated in FIG. 3, but will rebound to the original shape thereof when pressure is removed.

The closure member 66 is tightly sealed to the tubular body 52 by a sealing ring 82 which is crimped about the upper surface of the annular flange 68 and the lower surface of the bead 62. The sealing ring, which is preferably formed of metal, such as aluminum, has a tear-off tab 84 which is folded over the top and side surface of the ring and is joined to a portion of the inner rim 86 of ring 82. Ring 82 contains score lines '88 across the top and side surface at the area where the tab 84 overlaps these surfaces so that by tearing off this tab, the ring can be readily removed. With the ring 82 intact, this embodiment of the container is suitable for pumping operation of the closure member in the manner described above with reference to FIG. 1. However, with the ring 82 removed, upon the application of greater inwardly directed pressure upon the crest 76 of the closure member, the annular flange 68 folds backto permit the closure member 66 to be inserted in a piston-like manner within the tubular body 52 as shown in FIG. 4. This operation of the additive container is particularly advantageous when additive is to be transferred into a dispensing container which is already dispensing a parenteral solution to a patient. In this case, the needle 60, which is scored at 60a, is broken away and the conventional luer tip 56 of body 52 is inserted into the airway check valve conduit 90 of a spike-drip barrel unit attached to the dispensing container as shown in FIG. 9. The contents of the additive container can then be transferred at once by operating the closure member 66 as a piston.

If desired, the additive container of FIGS. 2 and 4 can be provided with an integral spike in place of the needle 60. When the spike is broken off at the score line, the remaining portion becomes a conventional Iuer tip which may fit within the airway check valve conduit as described above with reference to FIG. 9.

Referring now to the closure member modification of FIGS. 7 and 8, the closure member 92 is similar to the closure member 26 of FIG. 1, except that the annular beaded portion of the closure member is provided with a plurality of circumferentially spaced grooves 94 that define a number of external segments 96 which support the closure member against the end surface of the corresponding tubular body member. The closure member may be operated as a pump as discussed above, or, following tearing off of the sealing ring, the crest 98 may be subjected to sufficient inward force to permit the closure member 92 to act as a piston for forcing out the contents of the additive container.

Referring now to the embodiment of FIG. 10, the body and needle portions of the additive container are identical to those described for FIG. 1, but the closure member 100 is provided on its external surface with one or more axially spaced annular ribs 102 that provide sealing contact with the inner wall of the container. The closure need not have these ribs but may have an uninterrupted contacting surface. The central portion of the closure member 100 contains a bore 104 that defines the thin end wall 106. The closure member, which is preferably formed of rubber, but may be some other resilient polymer, contains a recess in which may be adhesively received a rigid, internally threaded tubular insert 108 that is preferably molded from a suitable plastic material and contains an opening 110 in alignment with the bore 104. At the lower end of the additive container, the needle is enclosed by a protective rubber sheath 112 that maintains the needle sterile. Mounted concentrically about the needle and the sheath is a rigid tubular operating member 114, the lower extremity 1 16 of which is externally threaded and dimensioned to correspond with the threaded bore 116 within the tubular insert. Consequently, in addition to serving as a protector for the needle, the operating member may be removed from the lower end of the additive container and threadably connected with the insert in the closure member at the upper end of the container, whereby the operating member 114 may be pushed or pulled to displace the closure member 100 downwardly and upwardly within the bore, member. As

an alternative to the illustrated threaded connection between the operating member and the insert, the elements may be connected by any other suitable type of rapid-fastening connection, such as a twist-lock or bayonnet type connection. No positive locking connection between the operating member and closure member is required if the closure member is only to be moved downwardly within the body member. For this purpose, the insert may be omitted and the operating member would be placedin the recess therefor in the closure member.

As shown in FIG. 11, the use of an insert may be avoided by fonning the threaded bore 116a directly within the closure member a. The scored needle may also be replaced by a scored spike which is integral with the body member as previously described (FIG. la). In this case, the central aperture and bore 104 are made larger to allow the spike to penetrate through portion 106. The closure 100 is prevented from inadvertent separation from the body by means of a ring 118 much like the ring 44 in FIG. 1.

The embodiment of FIG. 10 may be used in a variety of ways similar to those described for the embodiments shown in FIGS. 2, 4, 7, 8, and 9, except that it is not operable as a pump in the manner previously described. For example, this embodiment may be used in tandem arrangement; or to expel the additive solution into a dispensing container, regardless of the existence or absence of vacuum, by pushing in on the closure 100; or the container, with the needle or spike broken off, can be inserted into a check-valve airway conduit. The handle 114 affords means for replacing the function of the pump action in the procedure for reconstituting an additive which is stored in the container in the form of a dessicated powder or solid. In this case, the handle 114 is removed along with the protective sheath 112 and the handle 114 is screwed or locked into closure 100. By pushing in on the handle 114 the sterile air in the container is expelled. The needle or spike is inserted into a dispensing container of parenteral solution or a vial containing sterile solution or water, and by pulling back on handle 114 the liquid is drawn into the additive container to dissolve the solid additive. The reconstituted additive is then expelled into the dispensing container by pushing in on handle 114.

To protect the exterior surfaces of the closures in each of the embodiments andkeep these surfaces sterile, a suitable covering or cap may be provided for enclosing this portion of the container. This covering is made so that it can easily be removed prior to using the container.

The additive container of this invention provides for the transferof additives under a variety of conditions while maintaining a maximum degree of sterility during the procedures, thereby resulting in safety for the patient. The design of the container permits easy filling with additive solutions, assembly of its components and final sterilization of the total package. As packaged, the contents and functioning surfaces remain sterile. The major portion of the container is made of material which is best suited for maintaining the integrity of the additive during storage and the amount of rubber surface in contact with the additive is kept at a minimum.

While in accordance with the provisions of the Patent Statutes, the preferred forms and embodiments have been illustrated and described, it is apparent that various changes and modifications may be made without deviating from the inventive concepts.

What is claimed is:

l. Additive container means for supplying an additive material to a closed container, comprising a hollow body member containing an additive material chamber that defines at one end an end wall containing a through opening, said body member including a tubular extension that communicates at one end with said opening and extends longitudinally from said end wall;

conduit means connected at one end with the other end of said tubular extension, said conduit means having at its free end. a pointed extremity; and

closure means connected with the other end of saidbodyImember for closing said chamber, said closure means being manually operable relative to said body member to effect the flow of fluid,

through said tubular extension, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to pump fluid through said tubular extension, said closure member being further deformable upon progressive insertion within the chamber of said body member to define a piston for forcing fluid from said chamber outwardly through said tubular extension.

2. Additive container means for supplying an additive material for mixing with a parenteral solution con- I tained in a dispensing container, comprising a hollow body member containing an additive material chamber that defines at one end an end wall containing a-through opening, said body member including a tubular extension that communicates at one end with said opening andextends longitudinally from said end wall;

conduit means connected atone end with the other end of said tubular extension, said conduit means having at its free end a pointed extremity; and

closure means connected with the other end of said body member for closing said chamber, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to effect the flow of fluid through said tubular extension, said closure member" beingfurther deformable upon progressive insertion within the chamber of said body member to define a piston for forcing fluid from said chamber outwardly through said tubular extension.

3. Additive container means for supplying an additive material to a closed container, comprising a hollow body member containing an additive material chamber that defines at one end an endwall containing a through opening, said body member including a tubular extension that communicates at one end with said opening and extends longitudinally from said end wall;

conduit means connected at one end with the other end of said tubular extension, said conduit means having at its free end a pointed extremity; and

closure means connected with the other end of said 'body member for closing said chamber, said closure means being manually operable relative to said body member to effect the flow of fluid through said tubular extension, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to pump fluid through said tubular extension, said closure member having a dome-shaped central portion that extends outwardly from said body member, said closure member further including an annular beaded portion having adjacent said body member an annular surface in engagement with the end surface of said body member, said annular beaded portion including also an annular flange portion that extends inwardly within said body member chamber in sealed engagement with the sidewall of said body member.

4. Apparatus as defined in claim 3, wherein the sidewall portion of said closure member contains an annular portion of reduced thickness concentrically arranged within and spaced from said annular beaded portion, said portion of reduced thickness defining on adjacent sides thereof a relatively thick portion that insures uniform deformation of said closure member during the pumping operation thereof.

5. Apparatus as defined in claim 4, wherein the thickness of said annular beaded portion is relatively small with regard to that of said annular flange portion, whereby said closure member is deformable upon progressive insertion within said body member to define the piston portion of a syringe for forcing fluid from said chamber outwardly through said tubular extension.

6. Apparatus as defined in claim 4, wherein the thickness of said annular beaded portion is substantially greater than that of said annular flange portion.

7. Apparatus as defined in claim 6, wherein said annular beaded portion contains on its outer periphery a plurality of circumferentially spaced slots that define therebetween a plurality of radial projections adapted for engagement with the free extremity of the open end of said body member, whereby said closure member is deformable upon progressive insertion within said body member to define the piston portion of a syringe for forcing fluid from said chamber outwardly through said tubular extension.

8. An additive container for supplying an additive material to a closed container, comprising a body 'member containing an additive material chamber, said body member including an end wall containing an opening and discharge means for directing substances into and out of the chamber, said discharge means including a tubular extension connected at one end with said end wall, said extension communicating with the chamber through the end wall opening;

closure means for permitting substances to be manually pumped into and out of the additive material chamber, said closure means including an integral resilient dome-shaped closure member having a peripheral portion connected with the other end of said body member and a thickened central wall portion manually movable toward said end wall from a normally extended position to a first inserted position, said central wall portion including a central crest portion of reduced thickness adapted to be pierced by the discharge means of another additive container.

9. An additive container as defined in claim 8 further including sealing means for releasably connecting said closure member with said other end of said body member, whereby said closure member may be moved axially beyond said first inserted position within the chamber to form a piston for forcing substances out of said chamber.

10. An additive container as defined in claim 8 wherein said closure member further includes a flexible wall portion connecting said peripheral portion to said central wall portion, said flexible wall portion being thinner than both said peripheral portion and said central portion to insure uniform deformation of said closure member during the pumping operation.

11. An additive container for supplying an additive material to a parenteral solution container wherein the parenteral solution container is characterized by an opening sealed by a sealing member adapted to be pierced by a spike having an air inlet shaped to frictionally receive a luer shaped tip, comprising a body member containing an additive material chamber, said body member including an end wall connected with one end of said body, said end wall containing an opening;

closure means for forcing additive material out of said chamber through said end wall opening into said parenteral solution container, said closure means including an integral resilient closure member for closing the other end of said body member; and

discharge means for selectively directing additive material and parenteral solution into and out of the parenteral solution container by forming a passage between the chamber and parenteral solution container directly through the sealing member or through the air inlet of a spike inserted in the sealing member, said discharge means including a luer shaped portion connected at one end with said end wall, said luer shaped portion containing a through passage communicating with said end wall opening, said discharge means further including an extension portion frangibly connected with the other end of said luer shaped portion, said extension portion containing a discharge opening adjacent theouter end and a second through passage communicating with said first through passage and said discharge opening, said extension portion including a pointed outer tip for piercing the sealing member, whereby said extension portion may be used to directly pierce a sealing member or may be frangibly removed to permit said luer shaped portion to be inserted into the air inlet of a spike inserted into the sealing member.

12. An additive container as defined in claim 11 wherein said body member includes a cylindrical inner wall forming said chamber and said closure member is slidable axially into said chamber to form a piston for forcing substances out of said additive chamber.

13. An additive container as defined in claim 12 further including a rigid generally tubular protective sheath removably mounted concentrically about said luer shaped and extension portions, and a pair of cooperating fastener means one of which is connected with one end of said sheath and the other one of which is connected with the external central portion of said piston, whereby upon removal of said sheath from the luer portion end of said body member said sheath may be directly connected by said fastener means with said piston to define an operative handle therefor.

14. An additive container as defined in claim 11 wherein said extension portion includes a needle mounted within said luer shaped portion, said needle including a circumferential score line adjacent the outer extremity of said luer shaped portion.

15. An additive container as defined in claim 11 wherein said extension portion is formed of the same material as said luer shaped portion and includes a circumferential score line adjacent the outer extremity of said luer shaped portion.

Claims

1. Additive container means for supplying an additive material to a closed container, comprising a hollow body member containing an additive material chamber that defines at one end an end wall containing a through opening, said body member including a tubular extension that communicates at one end with said opening and extends longitudinally from said end wall; conduit means connected at one end with the other end of said tubular extension, said conduit means having at its free end a pointed extremity; and closure means connected with the other end of saidbody member for closing said chamber, said closure means being manually operable relative to said body member to effect the flow of fluid through said tubular extension, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to pump fluid through said tubular extension, said closure member being further deformable upon progressive insertion within the chamber of said body member to define a piston for forcing fluid from said chamber outwardly through said tubular extension.

2. Additive container means for supplying an additive material for mixing with a parenteral solution contained in a dispensing container, comprising a hollow body member containing an additive material chamber that defines at one end an end wall containing a through opening, said body member including a tubular extension that communicates at one end with said opening and extends longitudinally from said end wall; conduit means connected at one end with the other end of said tubular extension, said conduit means having at its free end a pointed extremity; and closure means connected with the other end of said body member for closing said chamber, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to effect the flow of fluid through said tubular extension, said closure member being further deformable upon progressive insertion within the chamber of said body member to define a piston for forcing fluid from said chamber outwardly through said tubular extension.

3. Additive container means for supplying an additive material to a closed container, comprising a hollow body member containing an additive material chamber that defines at one end an end wall containing a through opening, said body member including a tubular extension that communicates at one end with said opening and extends longitudinally from said end wall; conduit means connected at one end with the other end of said tubular extension, said conduit means having at its free end a pointed extremity; and closure means connected with the other end of said body member for closing said chamber, said closure means being manually operable relative to said body member to effect the flow of fluid through said tubular extension, said closure means including a resilient dome-shaped closure member adapted for repeated manual deformation and release to pump fluid through said tubular extension, said closure member having a dome-shaped central portion that extends outwardly from said body member, said closure member further including an annular beaded portion having adjacent said body member an annular surface in engagement with the end surface of said body member, said annular beaded portion including also an annular flange portion that extends inwardly within said body member chamber in sealed engagement with the sidewall of said body member.

8. An additive container for supplying an additive material to a closed container, comprising a body member containing an additive material chamber, said body member including an end wall containing an opening and discharge means for directing substances into and out of the chamber, said discharge means including a tubular extension connected at one end with said end wall, said extension communicating with the chamber through the end wall opening; closure means for permitting substances to be manually pumped into and out of the additive material chamber, said closure means including an integral resilient dome-shaped closure member having a peripheral portion connected with the other end of said body member and a thickened central wall portion manually movable toward said end wall From a normally extended position to a first inserted position, said central wall portion including a central crest portion of reduced thickness adapted to be pierced by the discharge means of another additive container.

11. An additive container for supplying an additive material to a parenteral solution container wherein the parenteral solution container is characterized by an opening sealed by a sealing member adapted to be pierced by a spike having an air inlet shaped to frictionally receive a luer shaped tip, comprising a body member containing an additive material chamber, said body member including an end wall connected with one end of said body, said end wall containing an opening; closure means for forcing additive material out of said chamber through said end wall opening into said parenteral solution container, said closure means including an integral resilient closure member for closing the other end of said body member; and discharge means for selectively directing additive material and parenteral solution into and out of the parenteral solution container by forming a passage between the chamber and parenteral solution container directly through the sealing member or through the air inlet of a spike inserted in the sealing member, said discharge means including a luer shaped portion connected at one end with said end wall, said luer shaped portion containing a through passage communicating with said end wall opening, said discharge means further including an extension portion frangibly connected with the other end of said luer shaped portion, said extension portion containing a discharge opening adjacent the outer end and a second through passage communicating with said first through passage and said discharge opening, said extension portion including a pointed outer tip for piercing the sealing member, whereby said extension portion may be used to directly pierce a sealing member or may be frangibly removed to permit said luer shaped portion to be inserted into the air inlet of a spike inserted into the sealing member.