Tabletop drug dispensing vial access adapter

[0001] This application is a continuation-in-part of U.S. application Ser. No. 11/245,595, filed Oct. 7, 2005, which is a continuation of application Ser. No. 10/958,805, filed Oct. 5, 2004, now U.S. Pat. No. 6,997,917, which is a continuation of application Ser. No. 09/994,543, filed Nov. 27, 2001, now U.S. Pat. No. 6,832,994, which is a continuation-in-part of application Ser. No. 09/668,815 filed Sep. 23, 2000, now U.S. Pat. No. 6,544,246, which is a continuation-in-part of application Ser. No. 09/489,619, filed Jan. 24, 2000, now U.S. Pat. No. 6,139,534, all of which are incorporated herein by reference in their entirety.

[0002] 1. Field of the Invention

[0003] This invention relates to a vial access adapter connected to a vial which contains a medical fluid therein and is closed by an elastomeric stopper. In particular, it relates to a vial access adapter for use with a vial which is enshrouded or contained in a protective cover which shields medical personnel from radiation. The vial access adapter allows withdrawal of a maximal amount of medical fluid (particularly a radioactive medical fluid) without inverting the vial.

[0004] 2. Reported Developments

[0005] Vials made of glass or polymeric materials, the walls of which are non-collapsible, require an air inlet when medical fluid is withdrawn therefrom to prevent the formation of vacuum therein. Typically, vials containing a medical fluid are closed by rubber stoppers which are pierced by a dual spike having a medical fluid passage and an air inlet passage therein. The air inlet passage contains a filter to prevent entry of particulate matter or bacteria into the vials during a medicament withdrawal process.

[0006] An improvement in the present invention over the prior art is the spatial configuration of the medical fluid access spike which, on positioning of the vial access over a vial having a rubber stopper, allows essentially complete withdrawal of the medical fluid contained in the vial.

[0007] The present invention comprises at least three embodiments. In a first embodiment the medical fluid access spike penetrates the rubber stopper and just clears the bottom surface of the rubber stopper. The vial, to which the vial access adapter is attached, is turned upside during the withdrawal process. In a second embodiment the medical fluid access spike penetrates the rubber stopper and extends to the bottom of the vial. The vial in this embodiment is held in an upright position during the withdrawal process. Both embodiments allow essentially complete withdrawal of the medical fluid contained in the vial.

[0008] A third embodiment of the present invention concerns handling large and/or heavy liquid drug containers and specifically containers for radioactive fluids (e.g. nuclear drugs such as diagnostic or therapeutic radiopharmaceuticals or other radioactive fluids).

[0009] Based on the safety guidelines issued by the Food and Drug Administration, including the 1991 Bloodborne Pathogens Standard (29 CFR 1910.1030) and the most recent revision to that standard (H.R. 5178), medical device manufacturers are instructed to strengthen safety requirements relating to the use of safety-engineered sharp devices. Typically, medicaments contained in vials are accessed using a steel needle or with a point-of-use needle less adapter.

[0010] When vials contain radioactive fluids such as radiopharmaceuticals it is required that shielding is in place in front of the technician or other operator who removes products from the vial for administration to patients. In addition, it is also required that the radioactive fluid itself is placed in a protective container, often referred to as PIG, that is generally constructed of lead, a lead-containing alloy. This latter requirement is difficult to meet considering, for example, that a lead PIG for a 30 ml vial could weigh up to seven pounds. Inverting the vial and inserting the steel needle to remove some or all of its contents is extremely difficult due to the weight of the PIG. Since the vial is held upside-down in the PIG cover, a means to hold the vial in the PIG is necessary so that it does not fall out by the affect of gravity. Attempts were made to hold the vial in the PIG by friction fit. However, this made the removal of the vial from the PIG unsafe and difficult due to the force required to remove the vial from the PIG. When a vial is nearly empty, the radio pharmacist or other operator has to manipulate the steel needle, whether the vial is right-side-up or upside-down, to ensure that as much of the nuclear drug as possible is removed from the vial to minimize waste.

[0011] The present invention addresses this requirement by providing a vial having a flat, concave, V-shaped bottom and a needle less access means which allow close to complete removal of the nuclear medicine contained in the vial standing right-side-up on a table top or a similar flat horizontal surface.

[0012] In accordance with a first embodiment of the present invention, there is provided a vial access adapter for use with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic or therapeutic agent, or nutritional formulation therein. The vial access adapter body comprises:

• • [0013] a horizontal top wall having a plurality of vent holes therein;
  • [0014] a horizontal second wall spaced parallel from the horizontal top wall;
  • [0015] a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber there between and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
  • [0016] a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward and terminating in a sharp point;
  • [0017] a fluid flow channel in the first spike designed for carrying the liquid;
  • [0018] a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point;
  • [0019] an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and
  • [0020] an elastomeric membrane within the luer connector for sealing the fluid flow channel.

[0021] Preferably, the elastomeric membrane reseals itself upon repeated penetration by the external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.

[0022] In accordance with a second embodiment of the present invention, there is provided a vial access adapter used in combination with a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic or therapeutic agent, or nutritional formulation therein. The vial comprises:

• • [0023] a cylindrical side wall;
  • [0024] a flat bottom portion; and
  • [0025] a constricted neck portion terminating in a rim. The constricted neck portion and the rim define an open area which is closed by an elastomeric stopper hermetically sealing the content of the vial. The elastomeric stopper comprises a cylindrical side wall and flat top and bottom surfaces.

[0026] The constricted neck portion and the rim define an open area which is closed by an elastomeric stopper hermetically sealing the content of the vial. The elastomeric stopper comprises a cylindrical side wall and flat top and bottom surfaces.

[0027] The vial access adapter is designed to be placed on the constricted neck portion of the vial and to pierce the elastomeric stopper by a dual spike, one serving as a fluid flow channel and the other as an air flow channel. The vial access adapter, having a vial access adapter body comprises:

• • [0028] a horizontal top wall having a plurality of vent holes therein;
  • [0029] a horizontal second wall spaced parallel from the horizontal top wall;
  • [0030] a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber there between and extending downward from the horizontal second wall forming a skirt and terminating in a bottom rim;
  • [0031] a first spike centrally located in the vial access adapter body having a top portion extending above the horizontal wall and terminating in an externally threaded luer connector, and a bottom portion extending downward to the flat bottom portion of the vial and terminating in a sharp point;
  • [0032] a fluid flow channel in the first spike adapted to carry the liquid medicament from the vial;
  • [0033] a second spike positioned parallel to the first spike extending downward from the horizontal second wall and terminating in a sharp point, said second spike extending just below the bottom surface of the elastomeric stopper;
  • [0034] an air flow channel in the second spike designed for air flow from the chamber between the horizontal top wall and the horizontal second wall into the vial during withdrawal of the liquid medicament from the vial; and an elastomeric membrane with the luer connector for sealing the fluid flow channel.

[0035] Preferably, the elastomeric membrane reseals itself upon repeated penetration by an external luer connector and allows repeated withdrawal of the liquid medicament from the vial without risk of contamination from atmospheric environment.

[0036] The vial and vial access adapter combination provides a delivery system for a medical fluid from the vial wherein the vial is in an upright position during the withdrawal process by the use of a luer-equipped syringe allowing complete or close to complete withdrawal of the medical fluid from the vial. The combination requires matching the height of the vial with the length of the fluid flow channel for complete or close to complete withdrawal of the medical fluid from the vial: each vial access adapter is “dedicated” to the particular height of the vial. If the height of the vial is not precisely matched with the length of the fluid channel flow spike, less than complete withdrawal of the medical fluid from the vial is achieved.

[0037] In accordance with a third embodiment of the present invention, there is provided a glass vial or a rigid or semi-rigid polymeric vial containing a liquid medicament, diagnostic or therapeutic agent, or nutritional formulation, and preferably a nuclear formulation therein. In a preferred embodiment the nuclear formulation or nuclear medicine is a diagnostic or therapeutic radiopharmaceutical or other radioactive medical fluid. In this embodiment the vial is preferably enshrouded or contained in a protective cover to prevent radiation emission from the contents of the vial. The bottom of the interior of the vial may be flat or it may be V shaped.

[0038] In one embodiment, the vial comprises:

• • [0039] a cylindrical side wall;
  • [0040] a bottom portion having an outside wall and an inside wall wherein: said outside wall is flat, capable of being placed on a horizontal surface, such as a tabletop or a protective cylindrical container having a flat, horizontal bottom surface, and said inside wall comprises a generally V-shaped configuration having a side wall with an angle of more than 90° and less than 180° to the horizontal bottom surface and preferably an angle 25 of about 100° to about 170°; and
  • [0041] a constricted neck portion terminating in a rim.

[0042] The inside wall preferably terminates at the center bottom portion of the vial however, it may be spaced from the center portion of the vial forming a relatively small horizontal flat surface parallel to the flat, horizontal outside wall of the bottom portion.

[0043] In another embodiment, the vial comprises:

• • [0044] a cylindrical side wall;
  • [0045] a bottom portion having an outside wall and an inside wall wherein: said outside wall is flat, capable of being placed on a horizontal surface, such as a tabletop or a protective cylindrical container having a flat, horizontal bottom surface, and said inside wall is also flat; and
  • [0046] a constricted neck portion terminating in a rim.

[0047] The constricted neck portion and the rim define an open area which is closed by an elastomeric stopper hermetically sealing the content of the vial. The elastomeric stopper comprises a cylindrical side wall and flat top and bottom surfaces.

[0048] The vial of the present invention may be equipped with a non-vented vial access adapter which is placed on the constricted neck portion of the vial and pierces the elastomeric stopper by a fluid withdrawal spike having a flow channel therein. The fluid withdrawal spike extends from the vial access adapter to the bottom of the vial and is capable of delivering most of the content of the vial which is in a right-side-up position. The vial access adapter, having a vial access adapter body comprises:

• • [0049] a horizontal top wall;
  • [0050] a cylindrical side wall integral with the horizontal top wall extending downward from the horizontal top wall forming a skirt and terminating in a bottom rim, said skirt is adapted to tightly engage the rim portion of the vial;
  • [0051] a fluid withdrawal spike having a flow channel therein, centrally located in the vial access adapter body having a top portion extending above the horizontal top wall and terminating in an externally threaded female luer connector, and the bottom portion extending downward to the V-shaped bottom portion of the vial; and
  • [0052] a removable cap covering the externally threaded female luer connector to hermetically seal the content of the vial prior to use.

[0053] In another embodiment, the vial of the present invention is equipped with a vented vial access adapter which is placed on the constricted neck portion of the vial and pierces the elastomeric stopper by a fluid withdrawal spike having a flow channel therein. The fluid withdrawal spike extends from the vial access adapter to the bottom of the vial and is capable of delivering most of the content of the vial which is in a right-side-up position. The vented vial access adapter, having a vial access adapter body comprises:

• • [0054] a horizontal top wall having a plurality of vent holes therein;
  • [0055] a horizontal second wall spaced parallel from the horizontal top wall;
  • [0056] a cylindrical side wall integral with the horizontal top wall and the horizontal second wall enclosing a chamber there between and extending downward from the horizontal top wall forming a skirt and terminating in a bottom rim, said skirt is adapted to tightly engage the rim portion of the vial;
  • [0057] a fluid withdrawal spike having a flow channel therein centrally located in the vial access adapter body having a top portion extending above the horizontal top wall and terminating in an externally threaded female luer connector, and the bottom portion extending downward to the bottom portion of the vial; and
  • [0058] a removable cap covering the externally threaded female luer connector to hermetically seal the content of the vial prior to use.

[0085] The vial access adapter of the present invention is used in conjunction with a container, such as a vial, containing a fluid therein, such as parenteral solutions, diagnostic or therapeutic media. In one preferred embodiment, the fluid is a diagnostic or therapeutic radiopharmaceutical or other radioactive medical fluid. Referring to the drawing, FIG. 1 shows the cross-section of vial 10 in an upright position having: a cylindrical side wall 12, a flat bottom portion 14 so that it may be placed in normal upright position on any flat surface, and a constricted neck portion 16 terminating in a rim 18. The neck portion and rim define an open area 20 closed by stopper 22 hermetically sealing the content of the vial. Typically, the stopper is held in the vial by a metal band (not shown).

[0086] The present invention comprises at least three embodiments.

[0087] In a first embodiment, the vial access adapter, generally designated by the numeral 24 and shown in perspective views in FIGS. 2 and 3, comprises: a cylindrical side wall 26 terminating in a rim 27; a flat, horizontal top wall 28 having vent holes 30 therein; threaded luer connector means 32 projecting vertically above the horizontal top wall 28; and a dual spike 34 and 36, terminating in sharp points 38 and 40, extending parallel to each other, and having flow passages therein 42 and 44, one being designed for passage of fluid, and the other being designed for passage of air. Cylindrical side wall 26 of the vial access adapter 24 is preferably provided with a plurality of slots 46 to facilitate the positioning of the vial access adapter onto vial 10 by a snap-on motion. In order to securely hold the vial access adapter on the vial, rim 27 of cylindrical side wall 26 is provided with protuberance 29 projecting towards dual spike 34 and 36. Protuberance 29 engages the neck portion 16 just below rim portion 18 of vial 10.

[0088] Reference is now made to FIGS. 4 and 5. FIG. 4 shows a top plan view of the vial access adapter and FIG. 5 shows a cross-sectional view of the vial access adapter taken along the line 5-5 of FIG. 4. In FIG. 4 there are shown: eight vent holes 30 in the flat horizontal top wall 28, dual spike 34 and 36, and an elastomeric seal 48 positioned inside the threaded luer connector means.

[0089] As best seen in FIG. 5, the vial access adapter 24 further comprises an internal second wall 50 which is parallel to the flat, horizontal top wall 28 and is spaced therefrom. Flat, horizontal top wall 28, internal second wall 50, and cylindrical sidewall 26 enclose a chamber 51 there between designed to hold a filter 52. The filter is an anti-microbial filter known in the art, such as Whatman Grade HCO1, USP Class 6.

[0090] The anti-microbial filter is a circular mat of randomly oriented fibers bound together with a polymeric material, such as a polyester elastomeric, ethylene methacrylate, ethylene vinyl acetate, ethylene vinyl alcohol, polyethylene or polypropylene treated with an anti-bacterial agent. The randomly oriented fibers may be made of nylon, cellulose, rayon and polyester.

[0091] One of the dual spikes 34 is adapted to carry liquid from vial 10. This spike is integral with the threaded luer connector means 32 and passes through the flat, horizontal top wall 28, and internal second wall 50. When the vial access adapter is assembled with vial 10 and pierces stopper 22, sharp point 38 just clears the bottom surface of stopper 22 to reach the liquid medicament contained in the vial. In use, when the vial is turned upside-down and connected to the vial access adapter, this positioning of the sharp point 38 just below the bottom surface of the stopper allows for maximum amount of withdrawal of medicament from the vial.

[0092] The other of the dual spikes 36 runs parallel to spike 34, however it only runs from below chamber 51 and is connected to internal second wall 50 and terminates in sharp point 40. It extends into the vial somewhat below sharp point 38 of first spike 34 so that the atmospheric air can be introduced into the vial even when the content of the vial is at a minimum volume.

[0093] The vial access adapter can be used without a seal within the threaded luer connector means 32. Preferably, however, a seal is used to prevent entry of atmospheric air when the vial access adapter is placed on the vial containing a medicament. The seal can be a horizontal, flat elastomeric membrane, or an inverted U-shaped membrane 49 as shown in FIG. 5B, which can be ruptured by a luer connector. Most preferably, the seal is an M-shaped elastomeric seal or membrane capable of resealing itself after one or more puncture by a luer connector.

[0094] The M-shaped elastomeric seal or membrane 48 is of inert, gas-impermeable polymeric material capable of flexing under pressure. It preferably has a thickness of from about 0.001 mm to about 1.00 mm and a durometer of from about 25 to about 80 Shore A. It is capable of being ruptured by a twisting motion of a luer connector. The configuration of the elastomeric membrane is M-shaped having a vertical leg portions and a top surface resembling a cup shape. Suitable elastomeric materials for constructing the diaphragm include:

• • [0095] natural rubber;
  • [0096] acrylate-butadiene rubber;
  • [0097] cis-polybutadiene;
  • [0098] chlorobutyl rubber;
  • [0099] chlorinated polyethylene elastomers;
  • [0100] polyalkylene oxide polymers;
  • [0101] ethylene vinyl acetate;
  • [0102] fluorosilicone rubbers;
  • [0103] hexafluoropropylene-vinylidene fluoride-tetrafluoroethylene terpolymers such as sold under the tradenames Fluorel and Viton;
  • [0104] butyl rubbers;
  • [0105] polyisobutene, such as sold under the tradename Vistanex;
  • [0106] synthetic polyisoprene rubber;
  • [0107] silicone rubbers;
  • [0108] styrene-butadiene rubbers;
  • [0109] tetrafluoroethylene propylene copolymers; and thermoplastic-copolyesters.

[0110] As best seen in FIGS. 6 and 7, the M-shaped membrane 48 comprises: leg portion 54, and cup-shaped portion 56. Cup-shaped portion comprises: horizontal bottom portion 58; and side portion 60. Leg portion 54 and side portion 60 typically have a thickness of from about 3 to 6 mm while bottom portion 58 typically has a thickness of from about 5 to 20 mm.

[0111] The horizontal bottom portion 58 is provided with a slit 62 which extends from the top surface 64 of the horizontal bottom portion toward the bottom surface 66. However, the slit does not penetrate the bottom surface. The unpenetrated membrane, denoted by the numeral 68, has a thickness of from about 0.001 mm to about 2.0 mm. The unpenetrated membrane maintains the content of the container in sealed condition. In use, when this membrane is ruptured by an external access means, such as a luer connector or spike, fluid communication is established between the content of the container and the external access means. Upon disengaging the external access means, the cup-shaped portion of the diaphragm reseals itself for the reason that the membrane is resilient and springs back to its original configuration. As a result, the container is resealed until the fluid withdrawal process is repeated.

[0112] The M-shaped membrane is bounded to the fluid-carrying spike 34 at its opening thereof by conventional means known in the art.

[0113] FIG. 8 shows in cross-sectional view the vial access adapter 24 and the vial assembly. Dual spikes 34 and 36 have been inserted into the vial through stopper 22. Liquid passage 42 just clears the bottom portion of the stopper so that, when the assembly is turned upside-down, essentially all the liquid may be withdrawn from the vial.

[0114] Spike 36 having air-flow passage 44 therein is longer than spike 34 having liquid medicament flow passage 42 therein in order to prevent air from circulating back into the liquid medicament flow passage during withdrawal of the liquid medicament from the vial.

[0115] FIG. 9 shows in cross-sectional view a typical luer connector 70 attachable to the vial access adapter of the present invention. The luer connector comprises a cylindrical cap 72 and a tubing conduit 74. Cylindrical cap 72 comprises inside wall 76 having threads 78 therein extending towards tubing conduit 74. Upon attachment, luer connector 70 will engage thread means 32 of vial access adapter 24. Tubing conduit 74 has a bottom portion 80 which extends beyond the cylindrical cap and is adapted to rupture the elastomeric membrane 48 or 49 of the vial access adapter 24.

[0116] FIG. 10 shows in cross-sectional view a portion of the threaded luer connector means with the elastomeric membrane therein prior to penetration of the membrane by the luer connector of a syringe.

[0117] FIG. 11 shows in cross-sectional view a portion of the threaded luer connector means with the elastomeric membrane therein during penetration and break-through of the membrane by the luer connector of a syringe.

[0118] In use, the vial access adapter of the first embodiment is engaged with a vial containing a liquid therein by a snap-on motion. The dual spike penetrates the stopper establishing fluid communication between the vial and the vial access adapter. Next, an external connector or the luer connector of a syringe is engaged with the vial access adapter by a twisting motion, threading the luer connector into the luer connector mean of the vial access adapter. Upon sufficient twisting of the elastomeric membrane is ruptured and fluid communication is achieved between the luer connector and the vial access adapter. These steps of engagement are accomplished while the vial containing the liquid is positioned on a flat surface in a right-side-up position. Upon completing these steps, the vial is turned upside-down and the liquid is transferred from the vial into the external luer connector having, for example, tubing conduit therein from which the fluid is administered to a patient. When a syringe, having a plunger therein equipped with a luer connector is used, withdrawal of the liquid is accomplished by moving the plunger towards its open end and thereby drawing the liquid into the syringe barrel. The desired amount of liquid withdrawn can be seen in the syringe. Upon disconnecting the external luer connector from the vial access adapter, the M-shaped elastomeric membrane reseals itself thereby keeping the liquid in the vial in aseptic condition. The self-sealing membrane allows repeated access to the liquid contained in the vial.

[0119] A second embodiment of the present invention is shown in FIGS. 12, 13, 14, 15, 16, 17, and 18 wherein the numerals marked by prime (′) denote like elements described in the first embodiment.

[0120] FIG. 12 shows the cross-section of the vial 10′ in an upright position having a fluid 15′ therein comprising: a cylindrical side wall 12′, a flat bottom portion 14′, and a constricted neck portion 16′ terminating in a rim 18′. The neck portion and rim define an open area 20 closed by an elastomeric stopper 22′ hermetically sealing the medical fluid 15′ contained in the vial. The vial typically contains of from about 5 ml to about 150 ml or more of the medical fluid.

[0121] The vial access adapter, generally designated by the numeral 24′ and shown in perspective views in FIGS. 13 and 14, comprises:

• • [0122] a cylindrical side wall 26′ terminating in a rim 27′;
  • [0123] a flat horizontal top wall 28′ having vent holes 30′ therein;
  • [0124] threaded luer connector means 32′ projecting vertically above the horizontal top wall 28′; and
  • [0125] a dual spike 34′ and 36′, terminating in sharp points 38′ and 40′, extending parallel to each other, and having flow passages therein 42′ and 44′, one being designed for passage of a fluid, and the other being designed for passage of air.

[0126] Spike 34′ is elongated to reach bottom portion 14′ of vial 10′ as shown in FIG. 18. Spike 36′ is short and extends just below the bottom surface of elastomeric stopper 22′. Cylindrical side wall 26′ of the vial access adapter 24′ is preferably provided with a plurality of slots 46′ to facilitate the positioning of the vial access adapter onto vial 10′ by a snap-on motion. In order to securely hold the vial access adapter on the vial, rim 27′ of cylindrical side wall 26′ is equipped with protuberance 29′ projecting inward towards dual spike 24′ and 36′. Protuberance 29′ engages the neck portion 16′ just below the rim portion of 18′ of vial 10′.

[0127] Reference is now made to FIGS. 15, 16, 17 and 18. FIG. 15 shows a top plan view of the vial access adapter, and FIG. 16 shows a cross-sectional view of the vial access adapter taken along the line 16-16 of FIG. 15. In FIG. 15 there are shown: eight vent holes 30′ in the flat, horizontal top wall 28′, dual spike 34′ and 36′, and an elastomeric seal 48′ positioned inside the threaded luer connector means.

[0128] The vial access adapter 24′ further comprises an internal second wall 50′ which is parallel to the flat, horizontal top wall 28′ and is spaced therefrom. Flat, horizontal top wall 28′, internal second wall 50′, and cylindrical side wall 26′ enclose a chamber 51′ there between designed to hold a filter 52′. The filter is an anti-microbial filter known in the art, such as Whatman Grade HCO1, USP Class 6.

[0129] In use, the vial access adapter of the second embodiment is engaged with the vial containing a liquid therein by a snap-on motion. The dual spike penetrates the stopper establishing fluid communication between the vial and vial access adapter.

[0130] Next, an external connector or the luer connector of, for example, a syringe is engaged with the vial access adapter by a twisting motion, threading the luer connector into the luer connector means of the vial access adapter. Upon sufficient twisting the elastomeric membrane is ruptured and fluid communication is achieved between the luer connector and the vial access adapter. These steps of engagement are accomplished while the vial containing the liquid is positioned on a flat surface in a right-side-up position. Upon completing these steps, the liquid is transferred from the vial into the external luer connector having, for example, tubing conduit therein from which the medicament is administered to a patient.

[0131] When a syringe, having a plunger therein equipped with a luer connector is used, withdrawal of the liquid is accomplished by moving the plunger towards its open end and thereby drawing the liquid into the syringe barrel. The desired amount of liquid withdrawn can be seen in the syringe. Upon disconnecting the external luer connector from the vial access adapter, the M-shaped elastomeric membrane reseals itself thereby keeping the liquid in the vial in aseptic condition. The self-sealing membrane allows repeated access to the liquid contained in the vial.

[0132] The vial access adapter body of both these embodiments is made of rigid or semi-rigid polymeric materials and can be used on bottles and vials made of for example, glass or rigid or semi-rigid polymeric materials. The liquid medicament contained in the bottles and vials can be, for example, a therapeutic, a diagnostic, or a nutritional preparation.

[0133] A third embodiment of the present invention is specifically directed to a vial enshrouded or contained in a protective cover to prevent radiation emission from a nuclear product such as a diagnostic or therapeutic radiopharmaceutical contained in the vial. In general, however, the configuration of the vial and the vial access adapter allows delivery of almost all of the contents of the vial which is in a right-side-up position on a horizontal surface.

[0134] Reference is now made to an embodiment of the present invention depicted in FIG. 19. FIG. 19 is a cross-sectional view of a vial in a protective container, often referred to as PIG, which shields the environment and any operator from radioactive emissions from the radiopharmaceutical or other radioactive fluid contained in the vial.

[0135] The vial and protective container are generally designated by the numeral 82. The vial 84 is in an upright position having a radioactive fluid 86 therein comprising: a cylindrical side wall 88; a constricted neck portion 90 terminating in a rim 92; open area 94 defined by a constricted neck portion and rim is closed by an elastomeric stopper 96, which hermetically seals the nuclear medicine 86 contained in the vial; an integral skirt and luer connector designated at 98; a fluid removal tube 100 extending towards the bottom of the vial; a luer cap 102 covering the opening in the luer connector; and a V-shaped bottom generally designed at 104 having a horizontal bottom portion 106, and side portions 108 and 108′ constituting the side portions thereof. The horizontal bottom portion may terminate in a sharp angle, or it may extend as a horizontal surface defining obtuse angles with side portions 108 and 108′ as illustrated in the drawing. The fluid removal tube 100 is precisely designed to reach horizontal bottom portion 106 in order to completely remove the liquid from the vial.

[0136] The protective container generally designated at 110, enshrouds or contains the vial and comprises:

• • [0137] a horizontal bottom wall 112;
  • [0138] vertical side walls 114 and 114′; and
  • [0139] a top wall or cover 116 which is openable with a hinge 118 or other means. The vial snuggly fits into the protective container the content of which may be reached by, for example, opening the top wall of the protective container. In one embodiment, the top wall or cover is hinged (118) to permit access to the vial. In another embodiment, instead of or in addition to the hinge 118, the top wall or cover 116 contains a covered or otherwise shielded opening to allow access to the vial. For example, the top wall or cover 116 may contain a hole covered by a disk (or other cover) that is rotated or pushed aside to allow access to the hole and thus the vial.

[0140] The protective cover is made of a material capable of blocking the transmission of radioactivity and particularly the transmission of α, β, or γ rays from the vial contents to the environment. For example, the protective cover may be constructed of a plastic (such as, for example, plexiglass), lead, tungsten or another metal or other material capable of blocking the transmission of radioactivity from α-, β-, or γ-ray emitting radiopharmaceuticals (or other radioactive fluids).

[0141] Note that a vial with a flat bottom may be used in place of the vial with the V shaped bottom in this embodiment.

[0142] FIG. 20 is a partial cross-sectional view on an enlarged scale of the male portion, generally designated at 120, of the luer connecting device wherein: the numeral 122 refers to the outside wall; the numeral 124 denotes threads on the inside wall; and the numeral 126 denotes the tube of the male portion with a longitudinal channel 127 therein. The male portion is to engage to female luer fitting which is shown in FIG. 21.

[0143] FIG. 21 is a partial cross-sectional view of the V-shaped vial 84 having: a constricted neck portion 90; a rim portion 92; and an elastomeric stopper 96 closing the open area of the vial. The rim and the elastomeric stopper held within the rim is further closed by a female luer connector, generally designated by the numeral 98 which comprises:

• • [0144] a skirt 128 having a robust fit with rim 92, which fit prevents the skirt from rotation when the male portion 120 of the luer connecting device is attached to the luer female fitting, generally designated at 130.

[0145] The skirt 128 is integral with the luer female fitting 130 which fitting comprises an inside wall 132 defining a channel 134 therein serving as a fluid pathway when male portion 120 of the luer connecting device is mated with the luer female fitting 130; groove in the bottom portion of the female luer connector; and an outside wall having the male portion 120 of the luer connecting device. Once the skirt has been mapped on the rim of the vial, the fluid removal tube 100 is inserted through the channel 134 through the top of the female luer connector. The fluid removal tube 100 comprises: a wide top portion 140 which slideably fits into grooves 136 without closing the channel 134 in tube 100 which extends to the V-shaped bottom portion 104 in vial 84. Note that a vial with a flat bottom can be used instead of one with a V-shaped bottom.

[0146] The action of mating the male luer connector 120 with the female luer connector 130 causes the fluid removal tube 100 to snap into groove 136 in the bottom portion of channel 134. This results in a fluid tight seal between the fluid removal tube and channel 134.

[0147] A syringe equipped with a luer connector may be used to withdraw the liquid from the shielded vial via the vial access adapter. Withdrawal is accomplished by moving the plunger to draw the contents into the syringe barrel. In a preferred embodiment, leaks of radioactive material are prevented when the syringe is used to withdraw liquid from the shielded vial. In one such embodiment, the syringe is equipped with a short needle; thus minimizing radioactive leaks when a syringe is used to remove the radioactive contents. In a more preferred embodiment, the syringe is equipped with a three way stopcock which may be used to minimize radioactive leaks. The three way stopcock is connected to the vial access adapter and to the syringe, allowing introduction of a saline flush or other fluid into the vial. A saline flush may be used to insure that substantially all of the contents of the vial are removed.

[0148] FIG. 22 is a partial cross-sectional view of the bottom of vial 84 and the medicinal fluid 86 contained in the bottom of the vial, wherein:

• • [0149] the numeral 100 denotes the fluid withdrawal tube having a fluid pathway 142 therein;
  • [0150] the numeral 86 denotes the medicinal fluid having a top surface 146 and a bottom surface 148;
  • [0151] the numeral 106 denotes the horizontal bottom portion of the vial; and
  • [0152] the numeral 144 denotes the terminating profile of the fluid withdrawal tube 100.
    The fluid removal tube must have a length to reach and have close contact with the bottom portion of the vial in order to remove most of the medicinal fluid therein. The tube is made of flexible polymeric material able to flex to the side as illustrated in FIG. 22. The configuration of the tube is cylindrical having a circular or oval cross-sectional configuration. Upon flexing, one portion of the terminating end rubs against the horizontal bottom portion 106 of the vial, and the bottom surface 148 of the medicinal fluid, while another portion of the terminating end at least reaches the top surface 146 of the medicinal fluid.

[0153] FIGS. 19-22 show a non-vented embodiment of the present invention while FIGS. 23-24 show a vented embodiment thereof. Note that while these embodiments are depicted with a vial having a V-shaped bottom a conventional vial with a flat bottom can also be used. FIG. 23 shows a top plan view of the table top dispensing vented vial access adapter, and FIG. 24 shows a partial cross-sectional view thereof taken along the line 24-24 of FIG. 23. In FIG. 23 there are shown eight vent holes 150 in the flat, horizontal top wall 152, and fluid removal tube 154. In this vented embodiment of the present invention, the tabletop dispensing vial access adapter further comprises: a horizontal top 152, being part of the integral skirt and female luer connector 98; a cylindrical side wall 156 of the skirt; an internal second wall 158 which is parallel to the horizontal top wall 152 and spaced therefrom: a filter 160 in the chamber 161 enclosed by horizontal top wall, cylindrical side wall and internal second wall; and filter cap 163 covering the top surface of the filter. The filter is an antimicrobial filter known in the art, such as Whatman Grade HCO1, USP Class. The remaining parts wherein the numerals marked by prime (′) denote elements described in FIG. 21.

• [0154] Vial 10 & 10′
• [0155] Cylindrical side wall of vial 12 & 12′
• [0156] Flat bottom portion of vial 14 & 14′
• [0157] Liquid medicament in vial 15′
• [0158] Neck portion of vial 16 & 16′
• [0159] Rim portion of top of vial 18 & 18′
• [0160] Open area of top portion of vial 20 & 20′
• [0161] Stopper 22 & 22′
• [0162] Vial access adapter 24 & 24′
• [0163] Cylindrical side wall of vial access adapter 26 & 26′
• [0164] Rim of cylindrical side wall 27 & 27′
• [0165] Flat horizontal top wall of vial access adapter 28 & 28′
• [0166] Protuberance on rim portion 29 & 29′
• [0167] Vent holes in top wall of vial access adapter 30 & 30′
• [0168] Threaded luer connector means 32 & 32′
• [0169] Dual spikes 34, 34′, 36 & 36′
• [0170] Sharp points in dual spikes 38, 38′, 40 & 40′
• [0171] Flow passages in dual spikes 42, 42′ 44& 44′
• [0172] Slots in cylindrical side wall 46 & 46′
• [0173] Elastomeric seal/membrane, M-shaped diaphragm 48 & 48′
• [0174] U-shaped diaphragm 49 & 49′
• [0175] Internal second wall 50 & 50′
• [0176] Chamber 51 & 51′
• [0177] Filter 52
• [0178] Leg portion of M-shaped membrane 54
• [0179] Cup-shaped portion of M-shaped membrane 56
• [0180] Horizontal bottom portion of cup-shaped portion 58
• [0181] Side portion of cup-shaped portion 60
• [0182] Slit in bottom portion 62
• [0183] Top surface of cup-shaped portion 64
• [0184] Bottom surface of cup-shaped portion 66
• [0185] Unpenetrated portion of membrane 68
• [0186] Luer connector (external) 70
• [0187] Cylindrical cap of luer connector 72
• [0188] Tubing conduit of luer connector 74
• [0189] Inside wall of cylindrical cap 76
• [0190] Threads on inside wall of cylindrical cap 78
• [0191] Bottom end portion of tubing conduit 80
• [0192] Vial and protective container, generally designated 82
• [0193] Vial with V-shaped bottom 84
• [0194] Fluid, generally designated 86
• [0195] Cylindrical side wall of vial 88
• [0196] Constricted neck portion of vial 90
• [0197] Rim of vial 92
• [0198] Open area of rim 94
• [0199] Elastomeric stopper 96
• [0200] Integral skirt and female luer connector, generally designated 98
• [0201] Fluid removal tube 100
• [0202] Luer cap 102
• [0203] V-shaped bottom of vial, generally designated 104
• [0204] Horizontal bottom portion of V-shape 106
• [0205] Side portion of V-shape 108, 108′
• [0206] Protective container, generally designated 110
• [0207] Horizontal bottom wall of protective container 112
• [0208] Vertical side walls of protective container 114, 114′
• [0209] Top wall or cover of protective container 116
• [0210] Hinge means of top wall or cover of protective container 118
• [0211] Male portion of the luer connecting device, generally designated 120
• [0212] Outside wall of male portion 122
• [0213] Threads on the inside wall of male portion 124
• [0214] Tube of the male portion 126
• [0215] Channel in tube of male portion 127
• [0216] Skirt of female luer connector 128
• [0217] Female luer connector, generally designated 130
• [0218] Inside wall of female fitting 132
• [0219] Channel in female fitting 134
• [0220] Groove in the bottom portion of the female luer fitting 136
• [0221] Outside wall of female fitting with threads 138
• [0222] Wide top portion of fluid removal tube 140
• [0223] Tube fluid pathway 142
• [0224] Terminating profile of fluid removal tube 144
• [0225] Top surface of medicinal fluid 86 146
• [0226] Bottom surface of medicinal fluid 86 148
• [0227] Vent holes 150
• [0228] Horizontal top wall of skirt 152
• [0229] Fluid removal tube 154
• [0230] Cylindrical side wall of skirt 156
• [0231] Internal second wall 158
• [0232] Filter 160
• [0233] Chamber 161
• [0234] Filter cap 163

[0235] 1. A vial access adapter-vial assembly allowing for withdrawal of a medicinal fluid contained in the vial without inverting the vial, comprising:

• • [0236] (a) a vial having a medical fluid therein; and
  • [0237] (b) a vial access adapter body;
  • [0238] wherein said vial comprises:
  • [0239] a cylindrical side wall having a distal end and a proximal end, said distal end extending into a constricted neck portion terminating in a rim and defining an open fluid port, and said proximal end being closed by a flat outside bottom portion, and V-shaped inside bottom portion;
  • [0240] said fluid port being closed by an elastomeric stopper wherein said vial access adapter body comprises:
  • [0241] a cylindrical side wall having a distal end and a proximal end terminating in a rim;
  • [0242] a flat, horizontal top wall, closing the distal end of the cylindrical side wall;
  • [0243] an externally threaded female luer connector projecting vertically above the horizontal top wall for receiving an internally threaded male luer connector of a syringe or cartridge;
  • [0244] an elongated spike having a fluid flow channel therein, and being integral with said female luer connector, extending into said vial and reaching the V-shaped bottom portion thereof to allow withdrawal of essentially all the medical fluid from the vial when said vial is in the right-side-up position; and
  • [0245] a removable luer cap hermetically sealing the female luer connector.

[0246] 2. The vial access adapter-vial assembly of embodiment 1 wherein said vial is of glass or a polymeric material.

[0247] 3. The vial access adapter-vial assembly of embodiment 1 wherein said vial access adapter is made of a thermoplastic material.

[0248] 4. The vial access-adapter-vial assembly of embodiment 1 wherein said V-shaped inside bottom portion having a side wall with an angle of more than 90° and less than 180°.

[0249] 5. The vial access adapter-vial assembly of embodiment 4 wherein said V-shaped inside bottom portion having a side wall with an angle of more than 100° and less than 170°.

[0250] 6. The vial access adapter-vial assembly of embodiment 4 wherein the inside wall of the V-shaped bottom portion terminates at the center portion of said vial.

[0251] 7. A vial access adapter-vial assembly allowing withdrawal of a nuclear drug contained in the vial without inverting the vial, comprising:

• • [0252] (a) a vial having a nuclear drug therein; and
  • [0253] (b) a vial access adapter body;
  • [0254] wherein said vial comprises:
    • [0255] a cylindrical side wall having a distal end and a proximal end, said distal end extending into a constricted neck portion terminating in a rim and defining an open fluid port, and said 15 proximal end being closed by a flat outside bottom portion and a V-shaped inside bottom portion; said fluid port being closed by an elastomeric stopper;
  • [0256] wherein said vial access adapter body comprises:
    • [0257] a cylindrical wall having a distal end and a proximal end terminating in a rim;
    • [0258] a flat, horizontal top wall closing the distal end of the cylindrical side wall;
    • [0259] an externally threaded female luer connector projecting vertically above the horizontal top wall for receiving an internally threaded male luer connector of a syringe or cartridge;
    • [0260] an elongated spike having a fluid flow channel therein, and being integral with said female luer connector, extending into said vial and reaching the V-shaped bottom portion thereof to allow withdrawal of essentially all the nuclear drug from the vial when said vial is in the right-side-up position;
    • [0261] a removable luer cap hermetically sealing the female luer connector; wherein said the vial access adapter-vial assembly is enshrouded in a protective cover.

[0262] 8. The vial access adapter-vial assembly of embodiment 7 wherein said vial is of glass or a polymeric material.

[0263] 9. The vial access adapter-vial assembly of embodiment 7 wherein said vial access adapter is made of a thermoplastic material.

[0264] 10. The vial access adapter-vial of embodiment 7 wherein said V-shaped inside bottom portion having a side wall with an angle of more than 90° and less than 180°.

[0265] 11. The vial access adapter-vial assembly of embodiment 10 wherein said V-shaped inside bottom portion having a side wall with an angle of from about 100° to about 170°.

[0266] 12. The vial access adapter-vial assembly of embodiment 10 wherein the inside wall of the V-shaped bottom portion terminates at the center portion of said vial.

[0267] 13. The vial access adapter-vial assembly of embodiment 7 wherein said protective cover is made of lead.

[0268] 14. The vial access adapter-vial assembly of embodiment 7 wherein said protective cover is made of an alloy comprising lead.

[0269] 15. The vial access adapter-vial assembly of embodiment 7 wherein said nuclear drug is a diagnostic agent.

[0270] 16. A vial access adapter-vial assembly allowing withdrawal of a medical fluid contained in the vial without inverting the vial comprising:

• • [0271] (a) a vial having a medical fluid therein; and
  • [0272] (b) a vial access adapter body;
  • [0273] wherein said vial comprises:
  • [0274] a cylindrical side wall having a distal end and a proximal end, said distal end extending into a constricted neck portion terminating in a rim and defining an open fluid port, and said proximal end being closed by a flat outside bottom portion and a V-shaped inside bottom portion; said fluid port being closed by an elastomeric stopper; wherein said vial access adapter body comprises:
  • [0275] a cylindrical wall having a distal end and a proximal end terminating in a rim;
  • [0276] a flat, horizontal top wall closing the distal end of the cylindrical side wall and having vent holes therein:
  • [0277] a horizontal second wall parallel to said horizontal top wall and spaced therefrom, said horizontal top wall, second wall and cylindrical side wall enclosing a chamber designed to hold a filter therein;
  • [0278] an antibacterial filter contained in said chamber;
  • [0279] an externally threaded female luer connector projecting vertically above the horizontal top wall for receiving an internally threaded male luer connector of a syringe or cartridge;
  • [0280] an elongated spike having a fluid flow channel therein, and being integral with said female luer connector, extending into said vial and reaching the V-shaped bottom portion thereof to allow withdrawal of essentially all the medical fluid from the vial when said vial is n the right-side-up position; and
  • [0281] a removable luer cap hermetically sealing the female luer connector.

[0282] 17. The vial access adapter-vial assembly of embodiment 16 wherein said vial is of glass or a polymeric material.

[0283] 18. The vial access adapter-vial assembly of embodiment 16 wherein said vial access adapter is made of thermoplastic material.

[0284] 19. The vial access adapter-vial assembly of embodiment 16 wherein said V-shaped inside bottom portion having a side wall with an angle of more than 90° and less than 180°.

[0285] 20. The vial access adapter-vial assembly of embodiment 19 wherein said V-shaped inside bottom portion having a side wall with an angle of from about 100° to about 170°.

[0286] 21. The vial access adapter-vial assembly of embodiment 19 wherein the inside wall of the V-shaped bottom portion terminates at the center portion of said vial.

[0287] 22. A vial access adapter-vial assembly allowing withdrawal of a nuclear drug contained in the vial without inverting the vial comprising:

• • [0288] (a) a vial having a nuclear drug therein; and
  • [0289] (b) a vial access adapter body;
  • [0290] wherein said vial comprises:
  • [0291] a cylindrical side wall having a distal end and a proximal end, said distal end extending into a constricted neck portion terminating in a rim and defining an open fluid port, and said proximal end being closed by a flat outside bottom portion and a V-shaped inside bottom portion; said fluid port being closed by an elastomeric stopper;
  • [0292] wherein said vial access adapter body comprises:
  • [0293] a cylindrical wall having a distal end and a proximal end terminating in a rim;
  • [0294] a flat, horizontal top wall closing the distal end of the cylindrical side wall and having vent holes therein:
  • [0295] a horizontal second wall parallel to said horizontal top wall and spaced therefrom, said horizontal top wall, second wall and cylindrical side wall enclosing a chamber designed to hold a filter therein;
  • [0296] an antibacterial filter contained in said chamber;
  • [0297] an externally threaded female luer connector projecting vertically above the horizontal top wall for receiving an internally threaded male luer connector of a syringe or cartridge;
  • [0298] an elongated spike having a fluid flow channel therein, and being integral with said female luer connector, extending into said vial and reaching the V-shaped bottom portion thereof to allow withdrawal of essentially all the medical fluid from the vial when said vial is in the right-side-up position; and
  • [0299] a removable luer cap hermetically sealing the female luer connector.

[0300] 23. The vial access adapter-vial assembly of embodiment 22 wherein said vial is of glass or a polymeric material.

[0301] 24. The vial access adapter-vial assembly of embodiment 22 wherein said vial access adapter is made of a thermoplastic material.

[0302] 25. The vial access adapter-vial assembly of embodiment 22 wherein said V-shaped inside bottom portion having a side wall with an angle of more than 90° and less than 180°.

[0303] 26. The vial access adapter-vial assembly of embodiment 25 wherein said V-shaped inside bottom portion having a side wall with an angle from about 100° to about 170°.

[0304] 27. The vial access adapter-vial assembly of embodiment 25 wherein said the inside wall of the V-shaped bottom portion terminates at the center portion of said vial.

[0305] 28. The vial access adapter-vial assembly of embodiment 22 wherein said protective cover is made of lead.

[0306] 29. The vial access adapter-vial assembly of embodiment 22 of wherein said protective cover is made of any alloy comprising lead.

[0307] 30. The vial access adapter-vial assembly of embodiment 22 wherein said nuclear drug is a diagnostic agent.

Various modifications of the present invention disclosed will become apparent to those skilled in the art. This invention is intended to include such modifications to be limited only by the scope of the claims.