Title:
APPARATUS FOR TRANSFERRING LIQUID BETWEEN A CONTAINER AND A FLEXIBLE BAG
United States Patent 3788369
Abstract:
A resiliently flexible bag has a chamber with inlet and outlet passageways, the outlet passageway being connectible to a tube and the inlet passageway having perforable closure means. The chamber is normally filled with a liquid, such as a saline solution. A cannula is mounted upon a container for insertion through the closure member and communication between the chamber in the bag and the interior of the container. If the container holds a liquid, intermittent, manual compressing and releasing of the flexible bag causes the liquid within the bag to move into the container or the liquid in the container to move into the bag, depending upon their relative vertical positions. A special cannula and container therefor are provided to furnish filtered air to the bag prior to connection thereof with the container if such air is needed.
US Patent References:
A DISPENSER FOR POWDERED MEDICAMENTS
Meirhoefer - May 1972 - 3662930
ASEPTIC CONNECTOR AND CLOSURE
Anderson - July 1970 - 3519158
Parenteral solution equipment and method of using same
Richter et al. - May 1962 - 3033202
METHOD FOR FILLING A SYRINGE
Flynn - May 1971 - 3578037
A DISPENSER FOR POWDERED MEDICAMENTS
Meirhoefer - May 1972 - 3662930
ASEPTIC CONNECTOR AND CLOSURE
Anderson - July 1970 - 3519158
Parenteral solution equipment and method of using same
Richter et al. - May 1962 - 3033202
METHOD FOR FILLING A SYRINGE
Flynn - May 1971 - 3578037
Application Number:
05/149321
Publication Date:
01/29/1974
Filing Date:
06/02/1971
View Patent Images:
Export Citation:
Assignee:
The Upjohn Company (Kalamazoo, MI)
Primary Class:
Other Classes:
141/330, 604/414, 141/383, 604/408
International Classes:
A61J1/00; A61J1/05; B65B3/16
Field of Search:
141/329,382,330,383,311,384,313,317,10,18,17,68,19,21,23,24,114 128/272 222/212,215
Primary Examiner:
Bell Jr., Houston S.
Assistant Examiner:
Schmidt, Frederick R.
Attorney, Agent or Firm:
Woodhams, Blanchard & Flynn
Claims:
The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows
1. An apparatus for transferring and mixing liquids, comprising:
2. An apparatus according to claim 1, wherein said closure means associated with one of said outlet means includes a self-closing seal means adapted to be penetrated by the other end of said needle for permitting communication between said bag means and said vial means, said self-closing seal means being capable of automatically closing and sealing to prevent leakage therethrough when the needle is withdrawn therefrom so as to again close off said chamber.
3. An apparatus for transferring and mixing a liquid and a medicament, comprising:
4. An apparatus according to claim 3, wherein said inlet and outlet spouts are disposed adjacent and in substantially parallel relationship to one another and extend outwardly from one end of said bag means, and said bag means being provided with means associated with the other end thereof for permitting said bag means to be suspended from a suitable holding device.
1. An apparatus for transferring and mixing liquids, comprising:
2. An apparatus according to claim 1, wherein said closure means associated with one of said outlet means includes a self-closing seal means adapted to be penetrated by the other end of said needle for permitting communication between said bag means and said vial means, said self-closing seal means being capable of automatically closing and sealing to prevent leakage therethrough when the needle is withdrawn therefrom so as to again close off said chamber.
3. An apparatus for transferring and mixing a liquid and a medicament, comprising:
4. An apparatus according to claim 3, wherein said inlet and outlet spouts are disposed adjacent and in substantially parallel relationship to one another and extend outwardly from one end of said bag means, and said bag means being provided with means associated with the other end thereof for permitting said bag means to be suspended from a suitable holding device.
Description:
BACKGROUND OF THE INVENTION
This invention relates in general to an apparatus for transferring a liquid between a container and a flexible bag and/or mixing liquids and, more particularly, to types thereof adapted for placing additives in an infusion bag.
It is commonplace to feed or treat a medical patient by injecting nutrients and/or medicaments in liquid form into a vein. It has also been commonplace to use resiliently flexible containers, such as plastic bags, to hold the liquid, such as a saline solution, dextrose or glucose, to be injected into the vein of the patient. Furthermore, it is well known in practice to add medicaments to the liquid being injected into the patient's vein, thereby avoiding the inconvenience and discomfort of independent injections of these additives. However, it has been found necessary to package the additives in airtight glass vials for a number of reasons. In the first place, Federal regulations require the use of glass containers for the storage of parenterals. These containers must be air-tight for certain medicaments because of their relatively rapid deterioration in the presence of ambient air. Also, the containers must be capable of sterilization at temperatures which would damage some plastics. Furthermore, certain of these additives will, over a period of time, react with certain types of plastic containers, whereas, they will not react with glass containers.
Glass syringes can be used as storage containers for some additives, but not others because of air leakage, risk of contamination and the short shelf life of certain medicaments after they have been mixed with a diluent. Also, glass syringes are expensive, difficult to fill and inconvenient to store.
The most convenient method for moving additives from a glass vial to the flexible bag containing the liquid carrier is by means of a cannula or transfer needle which is mounted or mountable upon the additive vial. Usually the cannula must be moved relative to the additive vial in order to effect communication between the cannula and the interior of the vial. Otherwise, the airtight condition within the container would be disturbed prior to use of the additive therein.
Where the additive is a liquid, it has in the past been transferred from the vial to the bag either by relying upon gravity, which produces an exasperatingly slow flow, or by using a syringe to remove the liquid from the vial and then injecting it into the bag. However, where the additive is a dry material, it has heretofore been necessary to first put the dry material into solution within the vial and thereafter transfer the solution from the vial to the flexible bag either by the process of gravity flow or by using a syringe. Obviously, these procedures have produced inefficiency and have risked the chance of producing unsterile conditions in both the mixing and administration of the additives involved.
Accordingly, a primary object of this invention has been the provision of an apparatus for quickly mixing an additive with a liquid for intraveneous injection wherein the additive is contained in a relatively rigid glass vial and, sometimes, in a dry form.
A further object of this invention has been the provision of a method for transferring liquid between a resiliently flexible bag and a relatively rigid glass vial interconnected by a transfer needle wherein the vial, under some circumstances, contains a dry material which must be dissolved, said method being adapted to use some of the liquid within the flexible bag as the diluent after which the method moves the solution from the vial into the flexible bag.
A further object of the invention is the provision of a method and apparatus, as aforesaid, whereby sterile air can be added to the contents of the flexible bag prior to communication thereof with the interior of the additive vial in order to facilitate the transfer of liquid therebetween.
Other objects and purposes of this invention will become apparent to persons familiar with this type of equipment upon reading the following descriptive material and examining the accompanying drawings, in which:
FIG. 1 is a broken front elevational view of a liquid transfer apparatus embodying the invention.
FIG. 2 is a broken side elevational view of said apparatus.
FIG. 3 is a broken front elevational view of said apparatus showing the bag in a compressed condition.
FIG. 4 is a broken front elevational view illustrating the apparatus after the compressed bag is released.
FIG. 5 is a broken fragment of the front elevational view of said apparatus in the inverted position.
FIG. 6 is a sectional view taken along the line VI--VI in FIG. 1.
FIG. 7 is a broken fragment of a front elevational view of said apparatus illustrating a modified additive container.
FIG. 8 is a side elevational view of a transfer needle container.
FIG. 9 is a sectional view taken along the line IX--IX in FIG. 8.
FIG. 10 is an enlarged broken fragment of FIG. 9 showing a modified transfer needle and container.
For convenience in description, the terms "upper," "lower" and words of similar import shall have reference to the apparatus of the invention as appearing in FIGS. 1 and 2. The terms "inner," "outer" and derivatives thereof shall have reference to the geometric center of said apparatus and the component parts thereof.
SUMMARY OF THE INVENTION
The objects and purposes of the invention, including those set forth above, have been met by providing a resiliently flexible and liquid-tight bag having inlet and outlet spouts at the lower end thereof. The outlet spout is connectibe to a tube for the purpose of conducting liquid from the bag into a vein of a patient. The inlet spout has a closure means which can be penetrated by a transfer needle mounted upon a rigid glass vial holding a medicament which must be added to the liquid contents of the bag. The method concerns the movement of liquid from the rigid glass container into the flexible bag by alternately squeezing and releasing the bag in a pumping action, while holding the vial above the bag.
The method also pertains to a situation where a dry material is disposed within the vial and some of the liquid within the bag is moved by said pumping action into the vial to dissolve the dry material. The solution is then transferred from the vial into the bag by the pumping action. A transfer needle and container therefor including air filter means are used in the method for providing additional sterile air in the flexible bag if necessary.
DETAILED DESCRIPTION
The liquid transfer apparatus 10, one preferred embodiment of which is illustrated in FIG. 1, includes a resiliently flexible bag or receptacle 11 which, in this particular instance, is fabricated from two sheets 12 and 13 of plastic material, which sheets are firmly secured to each other along corresponding edges thereof to form a chamber 14 and flange 16 which extends completely around the bag. Cylindrical inlet and outlet spouts 17 and 18, respectively, are integral with the front and rear sheets 12 and 13 and communicate with the chamber at the lower end thereof. The outlet spout 18 is initially covered with a cap 19, and the bag is filled with a liquid 22 such a saline solution, glucose or the like. The cap 19 can be removed and replaced by a tube 23 (FIG. 4) for the purpose of transferring the liquid 22 from the bag 11 into the vein of a patient in a conventional manner.
The inlet spout 17 (FIG. 1) is closed by a membrane 24 (FIG. 6) spaced upwardly from the lower end thereof and by a removable closure member 26 which covers the lower end of the spout 17. Both the membrane 24 and the lower wall 27 of the closure member 26 are penetrable by a cannula or transfer needle 28 mounted upon the vial 29.
The bag 11 may be fabricated from a variety of plastic materials, such as polyethylene, polypropylene or polyvinyl-chloride, and the flange 16 thereon is provided with a plurality of openings 32 near the upper and lower ends thereof for suspending the apparatus 10 or the bag 11 by means of hooks 33, FIGS. 1 and 2.
The vial 29 (FIG. 1) is comprised of a glass bottle 34 (FIG. 6) with a perforable rubber seal or stopper 36, which may be made from natural or synthetic materials, inserted in or extending across the open upper end of the neck 37 on said bottle 34. The seal 36 is held in position by a metal collar 38 which is spun on or otherwise secured to the neck 37. The collar 38 has an upper wall 39 with a central opening 42 through which a cylindrical stem 43 extends. Said stem 43 has an integral outwardly projecting and annular flange 44 that is clamped between the wall 39 and the seal 36 (FIG. 6). These two parts can also be made in one piece.
The needle 28 may be of the substantially conventional transfer type having points at both ends and being rigidly engaged approximately midway between the ends thereof by a substantially cylindrical hub 46. A sleeve 47 is firmly secured at one end upon the hub 46 and extends downwardly therefrom concentrically with the needle 28. The lower end of the sleeve 47 has an outwardly extending, annular flange 48 which is spaced upwardly from the lower end of the needle. The sleeve 47 is slideably but snugly supported upon the stem 43 when the lower end of the needle 28 is disposed within the stem 43 but spaced upwardly from seal 36. When it is desired to effect communication between the needle 28 and the interior 49 of the bottle 34, said bottle and the sleeve 47 are relatively moved from their FIG. 1 positions to their FIG. 3 positions wherein the lower end of the needle 28 pierces the seal 36 and extends into the interior 49.
In this particular embodiment of the invention, the vial 29 contains a dry material, such as a freeze-dried medicament, which must be mixed with a diluent. The liquid solution is then added to the liquid in the chamber 14 for injection into the vein of the patient. However, it will be apparent that the apparatus and method of the invention can and will be used where the material within the vial 29 is initially a liquid.
FIG. 7 illustrates an alternate apparatus 60 including a bag 11 and vial 61 which are interconnectible by a transfer needle 62 having a hub 63. The vial 61, which may be similar to the vial disclosed in U.S. Pat. No. 3,464,414, has two compartments 68 and 72 separated by a constriction 66 in which a plug 67 is removably disposed. The plug 67 is forced out of the constriction and into the lower compartment 68 by pressure applied to the stopper 69 as it is moved from a raised position into its lowered position appearing in FIG. 7.
Normally, a dry material, such as a freeze-dried medicament, is disposed within the lower compartment 68 and, after the plug 67 is placed in the constriction 66, a diluent is placed in the upper compartment 72. Thereafter, the stopper 69 and collar 73 are mounted on the bottle 64.
The bag 11 may be closed, after it is initially filled with a liquid, so that there is insufficient air therein to be removed and replaced by the liquid solution 74 in vial 61. It will be noted that, in the alternate apparatus 60, no liquid is required from the bag to be mixed with the liquid in the vial 61. Accordingly, it may be desirable to increase the amount of air in the bag 11 in order to facilitate the pumping action by which such air is moved into the vial 61 in order to displace the liquid 74 therefrom. Nevertheless, it is also desirable that the air which is placed in the bag 11 should be sterile. This result is achieved by means of the structure disclosed in FIGS. 8 and 9 or the structure disclosed in FIG. 10.
Specifically, the transfer needle 62 (FIG. 9) is placed in a two part cylindrical container 76 having upper and lower cup-shaped parts 77 and 78, respectively, the open ends of which are telescopically engaged. The upper wall 79 of the upper cup 77 is comprised of a filter 82 through which ambient air can pass, but which blocks contaminants in said air. Thus, after removing the lower cup 78, the lower end 83 of the needle 62 (FIG. 9) is inserted through the closure member 26, as shown in FIG. 7, so that ambient air can pass through the filter 82 into the chamber 84 within the upper part 77 thence through the needle 62 and into the bag 11. Ordinarily, the bag 11 will be in its FIG. 5 position during this operation so that no liquid will escape from the bag.
After the desired amount of air has been released into the bag 11, the upper part 77 (FIG. 9) of the container 76 is removed from the needle and its upper end is inserted into and through the stopper 69 (FIG. 7) of the vial 61, for example. The transfer of liquid from the vial 61 into the bag 11 can then proceed as discussed above with respect to vial 29.
Under some circumstances, there may be insufficient room in the bag to add additional air. In such case the upper part 77 may be removed from the needle 62 and some of the liquid within the bag 11 urged out through the needle by squeezing the bag. Then, before releasing the pressure on the bag, the upper part 77 is returned to the needle so that the air, thereafter drawn into the bag to replace the discharged liquid, is filtered and sterile.
In another version of the invention, the transfer needle 62 is replaced by a transfer needle 90 (FIG. 10) in which the hub 91 thereof also comprises the filter element. That is, the hub 91 is provided with a plurality of small lengthwise bores 92 which act as filter passageways through which air can pass, but which block contaminants. Thus, after the lower part 93 of the container 94 is removed from the upper part 96 thereof, ambient air can pass upwardly through the bores 92 into the chamber 97 and thence downwardly through the needle 90 and into the bag 11.
OPERATION
The operation of the apparatus 10, as well as the manner in which the method is carried out by means of the disclosed apparatus, will be apparent to persons skilled in this art from the aforegoing description. However, for convenience, they are specifically discussed hereinafter.
In operation, where the additive in the vial 29 is initially in liquid form and there is sufficient air space in the bag 11 for such liquid, the needle 28 (FIG. 6) is inserted into and through the lower wall 27 of the closure member 26 with the bag 11 in its inverted position of FIG. 5. The bag is then manually squeezed and released intermittently with a pumping action whereby air is first forced upwardly into the vial 29 and liquid is thereafter urged downwardly into the bag until all of the liquid in the vial 29 has been transferred into the bag 11.
If there is insufficient air in the bag 11, the transfer needle 62 or the transfer needle 90, with its corresponding container upper part 77 and 96, respectively, is utilized to increase the amount of sterile air. Where a vial 29 is to be used, which has its own needle, the transfer needle 62 or 90 is then removed from the closure member 26 and the needle 28 is inserted through said closure member in its place.
Where the vial is furnished with a non-liquid additive which must be dissolved in the liquid contained in the bag, then the needle 28 is urged downwardly relative to the bottle 34 until the needle penetrates the seal 36 and communicates with the interior 49 of the bottle 34. The needle 28 of the vial 29 containing the dry material is then inserted upwardly, as shown in FIG. 1, through the lower wall 27 of the closure member 26 and through the membrane 24 so that it is in communication with the chamber 14. These penetrations by the needle 28 can be reversed, if desired. The bag 11 is then squeezed or compressed, as appearing in FIG. 3, so that some of the liquid therein moves downwardly through the needle 28 into the bottle 34. When the pressure on the bag is released, the air compressed within the bottle 34 bubbles up through the liquid in the bag 11, as appearing in FIG. 4. The bottle 34, containing the dry material plus some of the liquid from the bag 11, is now agitated, as by shaking, until the dry material is dissolved in the portion of the liquid which has been forced into the bottle 34 through the needle 28.
After the solution in the glass bottle 34 is completed, the apparatus 10 is inverted, as appearing in FIG. 5, and the alternate compression and release of the bag 11 is repeated until all of the liquid has been forced out of the bottle 34 and down through the needle 28 into the bag 11. This is accomplished by virtue of the fact that the air at the upper end of the bag is forced upwardly into the bottle 34 during the compression of the bag and the pressure of the air in the bottle is elevated somewhat. Thus, when the bag is released, the compressed air forces the liquid down through the needle into the bag.
The closure member 26 and the membrane 24 are designed so that they will automatically close, after the needle 28 is removed, and provide a leak proof seal to prevent accidental discharge of the liquid through the inlet spout under normal operating conditions. That is, the force of gravity will not be sufficient to produce a leak of the liquid 22 through the inlet spout 17.
The vial 61 (FIG. 7) requires some preparation before use in that the dry material must be mixed with the diluent to produce the liquid 74. This procedure is well known. Thereafter, the transfer needle 62 or the transfer needle 90 is caused to penetrate the closure member 26 and the membrane 24 and the operation of the vial 61 with the bag 11 will be substantially the same as discussed above with respect to a vial 29 containing a liquid additive. The apparatus disclosed herein is capable of performing the method claimed hereinafter. However, it will be readily recognized that other specific types of apparatus can be utilized to carry out the claimed method.
Accordingly, although particular preferred embodiments of the invention have been disclosed above in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed structures, including the rearrangement of parts, lie within the scope of the present invention.
This invention relates in general to an apparatus for transferring a liquid between a container and a flexible bag and/or mixing liquids and, more particularly, to types thereof adapted for placing additives in an infusion bag.
It is commonplace to feed or treat a medical patient by injecting nutrients and/or medicaments in liquid form into a vein. It has also been commonplace to use resiliently flexible containers, such as plastic bags, to hold the liquid, such as a saline solution, dextrose or glucose, to be injected into the vein of the patient. Furthermore, it is well known in practice to add medicaments to the liquid being injected into the patient's vein, thereby avoiding the inconvenience and discomfort of independent injections of these additives. However, it has been found necessary to package the additives in airtight glass vials for a number of reasons. In the first place, Federal regulations require the use of glass containers for the storage of parenterals. These containers must be air-tight for certain medicaments because of their relatively rapid deterioration in the presence of ambient air. Also, the containers must be capable of sterilization at temperatures which would damage some plastics. Furthermore, certain of these additives will, over a period of time, react with certain types of plastic containers, whereas, they will not react with glass containers.
Glass syringes can be used as storage containers for some additives, but not others because of air leakage, risk of contamination and the short shelf life of certain medicaments after they have been mixed with a diluent. Also, glass syringes are expensive, difficult to fill and inconvenient to store.
The most convenient method for moving additives from a glass vial to the flexible bag containing the liquid carrier is by means of a cannula or transfer needle which is mounted or mountable upon the additive vial. Usually the cannula must be moved relative to the additive vial in order to effect communication between the cannula and the interior of the vial. Otherwise, the airtight condition within the container would be disturbed prior to use of the additive therein.
Where the additive is a liquid, it has in the past been transferred from the vial to the bag either by relying upon gravity, which produces an exasperatingly slow flow, or by using a syringe to remove the liquid from the vial and then injecting it into the bag. However, where the additive is a dry material, it has heretofore been necessary to first put the dry material into solution within the vial and thereafter transfer the solution from the vial to the flexible bag either by the process of gravity flow or by using a syringe. Obviously, these procedures have produced inefficiency and have risked the chance of producing unsterile conditions in both the mixing and administration of the additives involved.
Accordingly, a primary object of this invention has been the provision of an apparatus for quickly mixing an additive with a liquid for intraveneous injection wherein the additive is contained in a relatively rigid glass vial and, sometimes, in a dry form.
A further object of this invention has been the provision of a method for transferring liquid between a resiliently flexible bag and a relatively rigid glass vial interconnected by a transfer needle wherein the vial, under some circumstances, contains a dry material which must be dissolved, said method being adapted to use some of the liquid within the flexible bag as the diluent after which the method moves the solution from the vial into the flexible bag.
A further object of the invention is the provision of a method and apparatus, as aforesaid, whereby sterile air can be added to the contents of the flexible bag prior to communication thereof with the interior of the additive vial in order to facilitate the transfer of liquid therebetween.
Other objects and purposes of this invention will become apparent to persons familiar with this type of equipment upon reading the following descriptive material and examining the accompanying drawings, in which:
FIG. 1 is a broken front elevational view of a liquid transfer apparatus embodying the invention.
FIG. 2 is a broken side elevational view of said apparatus.
FIG. 3 is a broken front elevational view of said apparatus showing the bag in a compressed condition.
FIG. 4 is a broken front elevational view illustrating the apparatus after the compressed bag is released.
FIG. 5 is a broken fragment of the front elevational view of said apparatus in the inverted position.
FIG. 6 is a sectional view taken along the line VI--VI in FIG. 1.
FIG. 7 is a broken fragment of a front elevational view of said apparatus illustrating a modified additive container.
FIG. 8 is a side elevational view of a transfer needle container.
FIG. 9 is a sectional view taken along the line IX--IX in FIG. 8.
FIG. 10 is an enlarged broken fragment of FIG. 9 showing a modified transfer needle and container.
For convenience in description, the terms "upper," "lower" and words of similar import shall have reference to the apparatus of the invention as appearing in FIGS. 1 and 2. The terms "inner," "outer" and derivatives thereof shall have reference to the geometric center of said apparatus and the component parts thereof.
SUMMARY OF THE INVENTION
The objects and purposes of the invention, including those set forth above, have been met by providing a resiliently flexible and liquid-tight bag having inlet and outlet spouts at the lower end thereof. The outlet spout is connectibe to a tube for the purpose of conducting liquid from the bag into a vein of a patient. The inlet spout has a closure means which can be penetrated by a transfer needle mounted upon a rigid glass vial holding a medicament which must be added to the liquid contents of the bag. The method concerns the movement of liquid from the rigid glass container into the flexible bag by alternately squeezing and releasing the bag in a pumping action, while holding the vial above the bag.
The method also pertains to a situation where a dry material is disposed within the vial and some of the liquid within the bag is moved by said pumping action into the vial to dissolve the dry material. The solution is then transferred from the vial into the bag by the pumping action. A transfer needle and container therefor including air filter means are used in the method for providing additional sterile air in the flexible bag if necessary.
DETAILED DESCRIPTION
The liquid transfer apparatus 10, one preferred embodiment of which is illustrated in FIG. 1, includes a resiliently flexible bag or receptacle 11 which, in this particular instance, is fabricated from two sheets 12 and 13 of plastic material, which sheets are firmly secured to each other along corresponding edges thereof to form a chamber 14 and flange 16 which extends completely around the bag. Cylindrical inlet and outlet spouts 17 and 18, respectively, are integral with the front and rear sheets 12 and 13 and communicate with the chamber at the lower end thereof. The outlet spout 18 is initially covered with a cap 19, and the bag is filled with a liquid 22 such a saline solution, glucose or the like. The cap 19 can be removed and replaced by a tube 23 (FIG. 4) for the purpose of transferring the liquid 22 from the bag 11 into the vein of a patient in a conventional manner.
The inlet spout 17 (FIG. 1) is closed by a membrane 24 (FIG. 6) spaced upwardly from the lower end thereof and by a removable closure member 26 which covers the lower end of the spout 17. Both the membrane 24 and the lower wall 27 of the closure member 26 are penetrable by a cannula or transfer needle 28 mounted upon the vial 29.
The bag 11 may be fabricated from a variety of plastic materials, such as polyethylene, polypropylene or polyvinyl-chloride, and the flange 16 thereon is provided with a plurality of openings 32 near the upper and lower ends thereof for suspending the apparatus 10 or the bag 11 by means of hooks 33, FIGS. 1 and 2.
The vial 29 (FIG. 1) is comprised of a glass bottle 34 (FIG. 6) with a perforable rubber seal or stopper 36, which may be made from natural or synthetic materials, inserted in or extending across the open upper end of the neck 37 on said bottle 34. The seal 36 is held in position by a metal collar 38 which is spun on or otherwise secured to the neck 37. The collar 38 has an upper wall 39 with a central opening 42 through which a cylindrical stem 43 extends. Said stem 43 has an integral outwardly projecting and annular flange 44 that is clamped between the wall 39 and the seal 36 (FIG. 6). These two parts can also be made in one piece.
The needle 28 may be of the substantially conventional transfer type having points at both ends and being rigidly engaged approximately midway between the ends thereof by a substantially cylindrical hub 46. A sleeve 47 is firmly secured at one end upon the hub 46 and extends downwardly therefrom concentrically with the needle 28. The lower end of the sleeve 47 has an outwardly extending, annular flange 48 which is spaced upwardly from the lower end of the needle. The sleeve 47 is slideably but snugly supported upon the stem 43 when the lower end of the needle 28 is disposed within the stem 43 but spaced upwardly from seal 36. When it is desired to effect communication between the needle 28 and the interior 49 of the bottle 34, said bottle and the sleeve 47 are relatively moved from their FIG. 1 positions to their FIG. 3 positions wherein the lower end of the needle 28 pierces the seal 36 and extends into the interior 49.
In this particular embodiment of the invention, the vial 29 contains a dry material, such as a freeze-dried medicament, which must be mixed with a diluent. The liquid solution is then added to the liquid in the chamber 14 for injection into the vein of the patient. However, it will be apparent that the apparatus and method of the invention can and will be used where the material within the vial 29 is initially a liquid.
FIG. 7 illustrates an alternate apparatus 60 including a bag 11 and vial 61 which are interconnectible by a transfer needle 62 having a hub 63. The vial 61, which may be similar to the vial disclosed in U.S. Pat. No. 3,464,414, has two compartments 68 and 72 separated by a constriction 66 in which a plug 67 is removably disposed. The plug 67 is forced out of the constriction and into the lower compartment 68 by pressure applied to the stopper 69 as it is moved from a raised position into its lowered position appearing in FIG. 7.
Normally, a dry material, such as a freeze-dried medicament, is disposed within the lower compartment 68 and, after the plug 67 is placed in the constriction 66, a diluent is placed in the upper compartment 72. Thereafter, the stopper 69 and collar 73 are mounted on the bottle 64.
The bag 11 may be closed, after it is initially filled with a liquid, so that there is insufficient air therein to be removed and replaced by the liquid solution 74 in vial 61. It will be noted that, in the alternate apparatus 60, no liquid is required from the bag to be mixed with the liquid in the vial 61. Accordingly, it may be desirable to increase the amount of air in the bag 11 in order to facilitate the pumping action by which such air is moved into the vial 61 in order to displace the liquid 74 therefrom. Nevertheless, it is also desirable that the air which is placed in the bag 11 should be sterile. This result is achieved by means of the structure disclosed in FIGS. 8 and 9 or the structure disclosed in FIG. 10.
Specifically, the transfer needle 62 (FIG. 9) is placed in a two part cylindrical container 76 having upper and lower cup-shaped parts 77 and 78, respectively, the open ends of which are telescopically engaged. The upper wall 79 of the upper cup 77 is comprised of a filter 82 through which ambient air can pass, but which blocks contaminants in said air. Thus, after removing the lower cup 78, the lower end 83 of the needle 62 (FIG. 9) is inserted through the closure member 26, as shown in FIG. 7, so that ambient air can pass through the filter 82 into the chamber 84 within the upper part 77 thence through the needle 62 and into the bag 11. Ordinarily, the bag 11 will be in its FIG. 5 position during this operation so that no liquid will escape from the bag.
After the desired amount of air has been released into the bag 11, the upper part 77 (FIG. 9) of the container 76 is removed from the needle and its upper end is inserted into and through the stopper 69 (FIG. 7) of the vial 61, for example. The transfer of liquid from the vial 61 into the bag 11 can then proceed as discussed above with respect to vial 29.
Under some circumstances, there may be insufficient room in the bag to add additional air. In such case the upper part 77 may be removed from the needle 62 and some of the liquid within the bag 11 urged out through the needle by squeezing the bag. Then, before releasing the pressure on the bag, the upper part 77 is returned to the needle so that the air, thereafter drawn into the bag to replace the discharged liquid, is filtered and sterile.
In another version of the invention, the transfer needle 62 is replaced by a transfer needle 90 (FIG. 10) in which the hub 91 thereof also comprises the filter element. That is, the hub 91 is provided with a plurality of small lengthwise bores 92 which act as filter passageways through which air can pass, but which block contaminants. Thus, after the lower part 93 of the container 94 is removed from the upper part 96 thereof, ambient air can pass upwardly through the bores 92 into the chamber 97 and thence downwardly through the needle 90 and into the bag 11.
OPERATION
The operation of the apparatus 10, as well as the manner in which the method is carried out by means of the disclosed apparatus, will be apparent to persons skilled in this art from the aforegoing description. However, for convenience, they are specifically discussed hereinafter.
In operation, where the additive in the vial 29 is initially in liquid form and there is sufficient air space in the bag 11 for such liquid, the needle 28 (FIG. 6) is inserted into and through the lower wall 27 of the closure member 26 with the bag 11 in its inverted position of FIG. 5. The bag is then manually squeezed and released intermittently with a pumping action whereby air is first forced upwardly into the vial 29 and liquid is thereafter urged downwardly into the bag until all of the liquid in the vial 29 has been transferred into the bag 11.
If there is insufficient air in the bag 11, the transfer needle 62 or the transfer needle 90, with its corresponding container upper part 77 and 96, respectively, is utilized to increase the amount of sterile air. Where a vial 29 is to be used, which has its own needle, the transfer needle 62 or 90 is then removed from the closure member 26 and the needle 28 is inserted through said closure member in its place.
Where the vial is furnished with a non-liquid additive which must be dissolved in the liquid contained in the bag, then the needle 28 is urged downwardly relative to the bottle 34 until the needle penetrates the seal 36 and communicates with the interior 49 of the bottle 34. The needle 28 of the vial 29 containing the dry material is then inserted upwardly, as shown in FIG. 1, through the lower wall 27 of the closure member 26 and through the membrane 24 so that it is in communication with the chamber 14. These penetrations by the needle 28 can be reversed, if desired. The bag 11 is then squeezed or compressed, as appearing in FIG. 3, so that some of the liquid therein moves downwardly through the needle 28 into the bottle 34. When the pressure on the bag is released, the air compressed within the bottle 34 bubbles up through the liquid in the bag 11, as appearing in FIG. 4. The bottle 34, containing the dry material plus some of the liquid from the bag 11, is now agitated, as by shaking, until the dry material is dissolved in the portion of the liquid which has been forced into the bottle 34 through the needle 28.
After the solution in the glass bottle 34 is completed, the apparatus 10 is inverted, as appearing in FIG. 5, and the alternate compression and release of the bag 11 is repeated until all of the liquid has been forced out of the bottle 34 and down through the needle 28 into the bag 11. This is accomplished by virtue of the fact that the air at the upper end of the bag is forced upwardly into the bottle 34 during the compression of the bag and the pressure of the air in the bottle is elevated somewhat. Thus, when the bag is released, the compressed air forces the liquid down through the needle into the bag.
The closure member 26 and the membrane 24 are designed so that they will automatically close, after the needle 28 is removed, and provide a leak proof seal to prevent accidental discharge of the liquid through the inlet spout under normal operating conditions. That is, the force of gravity will not be sufficient to produce a leak of the liquid 22 through the inlet spout 17.
The vial 61 (FIG. 7) requires some preparation before use in that the dry material must be mixed with the diluent to produce the liquid 74. This procedure is well known. Thereafter, the transfer needle 62 or the transfer needle 90 is caused to penetrate the closure member 26 and the membrane 24 and the operation of the vial 61 with the bag 11 will be substantially the same as discussed above with respect to a vial 29 containing a liquid additive. The apparatus disclosed herein is capable of performing the method claimed hereinafter. However, it will be readily recognized that other specific types of apparatus can be utilized to carry out the claimed method.
Accordingly, although particular preferred embodiments of the invention have been disclosed above in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed structures, including the rearrangement of parts, lie within the scope of the present invention.