CA2057015A1 - Device and method for avoiding contamination of multi-dose medicament vials - Google Patents
Device and method for avoiding contamination of multi-dose medicament vialsInfo
- Publication number
- CA2057015A1 CA2057015A1 CA 2057015 CA2057015A CA2057015A1 CA 2057015 A1 CA2057015 A1 CA 2057015A1 CA 2057015 CA2057015 CA 2057015 CA 2057015 A CA2057015 A CA 2057015A CA 2057015 A1 CA2057015 A1 CA 2057015A1
- Authority
- CA
- Canada
- Prior art keywords
- air
- syringe
- clean
- vial
- reservoir
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/2006—Piercing means
- A61J1/201—Piercing means having one piercing end
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The disclosure of this application is directed to a clean air tube (10), having a charge of purified air, which provides a constantly renewable source of purified air for loading into a medicament syringe prior to use of the syringe (14) for withdrawing liquid medicament from a multi-dose vial. The tube is fitted with a clean-filtering membrane (11), through which ambient air is filtered upon being drawn into the tube (10). The disclosure also describes the sequence of steps involved in loading the syringe with clean-filtered air.
Description
1 2~7`~
1DEVICE ~ND METHOD FOR AVOIDING CONTAMINATION OF
1DEVICE ~ND METHOD FOR AVOIDING CONTAMINATION OF
2~ULTI-DOSE MEDIC~MENT VIALS
The present invention relates generally to a 6 tube or reservoir which provides a source of clean air 7 for injection into a multi-dose medicament vial prior to 8 withdrawing medicament from the vial for injection into a 9 patient. The invention also relates to a method for loading clean-filtered air into the barrel of a syringe 11 prior to use of the syringe to withdraw medicament from a 12 multi-dose viaI.
13 Liquid medication which is to be injected by needle 14 is often sold in multi-dose containers. In some cases (e g., insulin), as many as 50 or 60 doses or shots are 16 contained in a single vial. The vials are fitted with a 17 rubber diaphragm, and when a dose is to be administered, 18 the needle of a syringe is pushed through the rubber 19 membrane and the proper amount of liquid medicament is withdrawn for injection into the patient.
21 Since the vial is airtight, withdrawal of liquid 22 medicament creates a partial vacuum inside the vial, and, 23 after a few doses have been withdrawn, the vacuum becomes 24 enough of a factor to make it difficult to withdraw any further doses. To compensate for this, the standard 26 practice, each time a dose is to be administered, is to 27 inject a quantity of air into the vial first, and then 28 withdraw jthe medication. As described by Sorensen et al 29 in Basic Nursing, page 949 et seq. (W. B. Saunders Company, Philadelphia, 1979), the standard procedure 31 includes the following steps:
32 1. Cleanse the stopper of the vial with alcohol or 33 Betadine.
34 2. Draw into the syringe an amount of atmospheric air about equal in volume to the dose to be 36 withdrawn from the vial.
205701~ 2 l 3. Push the syringe needle through the stopper of 2 the vial, and inject air into the vial. Then 3 withdraw the amount of medication needed.
The present invention relates generally to a 6 tube or reservoir which provides a source of clean air 7 for injection into a multi-dose medicament vial prior to 8 withdrawing medicament from the vial for injection into a 9 patient. The invention also relates to a method for loading clean-filtered air into the barrel of a syringe 11 prior to use of the syringe to withdraw medicament from a 12 multi-dose viaI.
13 Liquid medication which is to be injected by needle 14 is often sold in multi-dose containers. In some cases (e g., insulin), as many as 50 or 60 doses or shots are 16 contained in a single vial. The vials are fitted with a 17 rubber diaphragm, and when a dose is to be administered, 18 the needle of a syringe is pushed through the rubber 19 membrane and the proper amount of liquid medicament is withdrawn for injection into the patient.
21 Since the vial is airtight, withdrawal of liquid 22 medicament creates a partial vacuum inside the vial, and, 23 after a few doses have been withdrawn, the vacuum becomes 24 enough of a factor to make it difficult to withdraw any further doses. To compensate for this, the standard 26 practice, each time a dose is to be administered, is to 27 inject a quantity of air into the vial first, and then 28 withdraw jthe medication. As described by Sorensen et al 29 in Basic Nursing, page 949 et seq. (W. B. Saunders Company, Philadelphia, 1979), the standard procedure 31 includes the following steps:
32 1. Cleanse the stopper of the vial with alcohol or 33 Betadine.
34 2. Draw into the syringe an amount of atmospheric air about equal in volume to the dose to be 36 withdrawn from the vial.
205701~ 2 l 3. Push the syringe needle through the stopper of 2 the vial, and inject air into the vial. Then 3 withdraw the amount of medication needed.
4 4. Proceed with injection of the patient.
A source of potential problems in the above standard 6 procedure is that, if the atmospheric air should be 7 contaminated, the contamination is incorporated in the 8 dose of medication and is injected through the skin 9 (normally the body's first line of defense against infection). Pathogens in the atmospheric air are thus ll introduced directly into the body tissues or blood, where 12 they can cause serious infections. The problem is 13 aggravated if the liquid medication (e.g., NPH insulin) 14 contains suspended solids and must be shaken before the dose is withdrawn from the vial. In such case, the 16 shaking causes the contaminated air to be thoroughly 17 mixed with the medicament. The problem is especially 18 aggravated after 30 or 40 shots of contaminated air have l9 been injected into the vial.
It is an object of the present invention to provide 2l a device and a method for overcoming the above-mentioned 22 problems associated with the injection of atmospheric air 23 into medicament vials.
24 It is a further object of the invention to provide a specially designed clean air reservoir for furnishing the 26 air to be injected into medicament vials.
27 It is a still further object of the invention to 28 provide a sequence of method steps resulting in loading a 29 medical syringe with clean-filtered air and using such air to obtain a dose of medication for parenteral 3l administration to patients.
32 Other objects and advantages will become apparent as 33 the specification proceeds.
SUMMARY OF THE INVENTION
36 The present invention relates to a clean air 37 reservoir comprising a container having substantially 38 rigid, air impermeable walls and at least two apertures, WO90/14798 2 ~ ~ 7 o ~ ~ PCT/~S90/0l9l8 l one of said apertures being sealed by an air i~permeable 2 membrane capable of penetration by the needle of a 3 syringe, and the other aperture being sealed by a clean-4 filtering material.
The invention also relates to a method of 6 administering liquid medication to a patient by injection 7 through the skin, comprising the steps of loading air 8 from a purified air reservoir into the barrel of a 9 syringe, pushing the syringe needle distally through the septum of a medicament vial, expelling treated air from ll the barrel of the syringe into the interior of said vial, 12 moving the syringe plunger proximally to withdraw the 13 desired dosage of medicament from the vial, and injecting 14 said dosage through the skin of the patient.
A preferred embodiment of the invention relates to a 16 method of loading clean-filtered air into the barrel of a 17 syringe, comprising the steps of pushing the syringe 18 needle distally through a first septum of a vessel l9 containing clean-filtered air, and moving the syringe plunger proximally to withdraw clean-filtered air from 21 the vessel into the syringe, whereby the differential in 22 pressure thus created within the vessel causes 23 atmospheric air to be drawn into the vessel through a 24 second septum fitted with a clean-filtering membrane.
27 The objects, features and advantages of the 28 invention will be apparent to those skilled in the art 29 from the following detailed description, taken together with the accompanying drawings, in which:
3l FIG. l is a longitudinal section of the clean air 32 reservoir of the present invention, together with an 33 associated syringe, prior to withdrawal of clean-filtered 34 air from the reservoir.
FIG. 2 is a longitudinal section of the reservoir 36 and the syringe, after clean-filtered air has been 37 withdrawn from the reservoir into the syringe.
, ~ ,, ,,, , . ~, - i . : -2~7~
l FIG. 3 is a longitudinal section of a multi-dose 2 medicament vial and a syringe, after clean-filtered air 3 has been injected from the syringe into the vial.
4 FIG. 4 is a longitudinal section of the vial and syringe, after a dose of medicament has been withdrawn 6 from the vial into the syringe.
9 Referring to the drawings, the device of the present l0 invention is shown as a reservoir l0, having an aperture ll at each end. The first aperture is fitted with an air 12 impermeable membrane or plug ll, and the second aperture 13 is fitted with a membrane or plug 12 made of a clean-14 filtering material. The reservoir l0 thus comprises a 15 container for clean air, with a septum ll capable of 16 beinq penetrated by the needle 13 of a syringe 14, and a 17 septum 12 capable of clean-filtering atmospheric air 18 which passes into the container when air is wi~hdrawn l9 from the container by the syringe.
The reservoir l0 may be in any suitable form or 21 shape, although its preferred form is that of a cylinder 22 or tube, with apertures at each end. The walls of the 23 reservoir are made of any suitable air impermeable 24 material, such as glass, acrylic resin, or the like. In 25 the preferred embodiment, the reservoir is an acrylic 26 tube approximately 4" in length, with an inside diameter 27 of l/2", and having a wall thickness of l/16".
28 At one end, the tube l0 is fitted with an air 29 impermeable closure ll. The preferred material for the 30 closure is the standard rubber stopper currently used on 31 multiple dose medicament vials. As in the case of the 32 medicament vials, the closure ll may comprise a rubber 33 stopper or diaphragm, covered by a soft metal cap (e.g., 34 aluminum), which is removed prior to use. In place of 35 rubber,-any other suitable material may be used if it is 36 penetrable by the needle of a syringe and is self-sealing 37 after the syringe has been removed.
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...
W090/14798 PCT/~S90/01918 ,~ a ~
l At the other end, the tube l0 is fitted with a 2 clean-filtering membrane 12. One purpose for the 3 membrane is to act as a seal between the interior of the 4 tube and the atmosphere when there is little or no pressure differential between the two. A further purpose 6 is to allow atmospheric air to pass into the tube l0 when 7 pressure is reduced in the tube and to clean-filter such 8 air as it enters. A preferred material for the membrane 9 is a polytetrafluoroethylene/fabric laminate sold under the trademark Gore-Tex by W. L. Gore & Associates, Inc., ll Newark, DE. Any suitable material comprising or 12 incorporating a porous plastic filtering membrane such as 13 polytetrafluoroethylene, also known as PTFE or Teflon, 14 may be used. The pores in the membrane should be small enough to filter out dust particles and the 16 microorganisms or pathogens associated with them, as 17 found in the ambient air. Pores having dia~eters in the 18 range from 0.1-40 um are generally suitable for the l9 present purpose, although membranes having pore diameters outside this range can be useful, depending on the 21 character of the particles and the microorganisms 22 involved. Other suitable PTFE-based materials include 23 filter membranes sold under the trademark Ghia, by Ghia 24 Corporation, Pleasanton, CA; and membranes sold under the mark Fluoropore, by Millipore Corporation, Bedford, MA.
26 The clean air tube l0 described above, when ready 27 for use, is initially filled with purified air. The 28 filling may be accomplished, at~-the manufacturing site, 29 by charging the tube with air which has been sterilized by chemical or heat treatment. As another option, the 31 purified air may be introduced at any time by repeatedly 32 withdrawing air from the tube through a syringe until the 33 air within the tube has been completely replaced by 34 atmospheric air which has been clean-filtered by passing through the membrane 12.
36 In the operation of the invention, the aluminum cap 37 is removed from the end of the clean air tube l0, 38 exposing the rubber diaphragm ll. The outside surface of 205701~ 6 ~
l the rubber diaphragm is cleansed with an alcohol pledget, 2 and then, as shown in FIG. 1, the needle 13 of the 3 syringe 14 is guided distally through the rubber 4 diaphragm ll to position the tip of the needle well within the interior of the clean air tube lO. The 6 relative positions of the tube lO and the syringe 14 will 7 then be as shown in FIG. 1, with the plunger 15 still 8 adjacent the distal end of the syringe barrel, ready to 9 be moved proximally to withdraw air from the clean air tube.
11 As the next step, the plunger 15 is moved proximally 12 to assume the position shown in FIG. 2. Such movement 13 causes purified air to be withdrawn from the tube lO and 14 loaded into the barrel of the syringe 14. The movement of the plunger 15 should be sufficient to withdraw a 16 volume of air substantially equal to the volume of the 17 medicament dose to be administered to the patient. As 18 purified air is drawn from the tube 10, the lowered l9 pressure within the tube causes ambient air to be ta~en into the tube through the filter 12, as shown by the 21 arrows in FIG. 2.
22 Next the outer surface of the rubber diaphragm 16 of 23 a medicament vial 17 is cleansed with an alcohol pledget, 24 and the needle 13 of the syringe 14 (which now contains only purified air within its barrel) is guided distally 26 through the rubber diaphragm 16 into the interior of vial 27 17. The plunger 15 of the syringe is then moved distally 28 to expel the charge of air into the interior of vial 17, 29 thus increasing the air pressure within the vial. At this stage, the syringe 14 and the medicament vial 17 are 31 positioned as shown in FIG. 3.
32 Finally, the plunger 15 of the syringe 14 is moved 33 proximally to the position shown in FIG. 4, and in the 34 course thereof a dose of liquid medicament is withdrawn from the vial 17 into the barrel of the syringe. The 36 syringe is thPn removed from the vial, and the medicament 37 is administered to the patient by injection through the 38 skin.
WO90/14798 2 ~ 5 7 ~1 ~ PCT/US90/01918 l The device and method of the present invention 2 provide the following features which are significantly 3 advantageous in terms of effectiveness, safety and 4 economics:
l. The necessary step of injecting air into a 6 multiple dose medicament vial prior to 7 withdrawing the medicament can now be carried 8 out without introducing contaminated air into 9 the medicament.
2. The clean air tube with which this is ll accomplished has a simple, uncomplicated, 12 inexpensive structure which can be mass-- 13 produced on conventional machinery.
14 3. Since the clean-filtered air which is withdrawn from the clean air tube is instantly 16 replenished with freshly filtered air, the tube 17 can be used again and again without 18 deterioration in the purity of the air l9 furnished.
4. The simple, light-weight structure of the clean 2l air tube allows it to be packaged as a 22 companion item with the medicament vial itself.
23 The resulting tandem package thus furnishes not 24 only the medicament but also the means for clean-filtering the air used for obtaining the 26 medicament dose.
27 It will be understood that use of the term 23 "purified" herein contemplates materials or conditions 29 which have been treated to remove substantial proportions of microorganisms or other contaminants. Such treatment 3l may be by means of clean-filtering or standard 32 sterilizing techniques using heat or chemical means. The 33 spirit of the invention would not be avoided by use of 34 materials or conditions which have been substantially improved from the standpoint of aseptic goals, even 36 though the theoretical goal of 100% asepsis may not have 37 been achieved.
2~701~ 8 ~
l Althou~h preferred embodiments of the invention have 2 been described herein in detail, it will be understood by 3 those skilled in the art that other variations may be 4 made thereto without departing from the spirit of the invention.
6 WHAT IS CLAIMED IS:
A source of potential problems in the above standard 6 procedure is that, if the atmospheric air should be 7 contaminated, the contamination is incorporated in the 8 dose of medication and is injected through the skin 9 (normally the body's first line of defense against infection). Pathogens in the atmospheric air are thus ll introduced directly into the body tissues or blood, where 12 they can cause serious infections. The problem is 13 aggravated if the liquid medication (e.g., NPH insulin) 14 contains suspended solids and must be shaken before the dose is withdrawn from the vial. In such case, the 16 shaking causes the contaminated air to be thoroughly 17 mixed with the medicament. The problem is especially 18 aggravated after 30 or 40 shots of contaminated air have l9 been injected into the vial.
It is an object of the present invention to provide 2l a device and a method for overcoming the above-mentioned 22 problems associated with the injection of atmospheric air 23 into medicament vials.
24 It is a further object of the invention to provide a specially designed clean air reservoir for furnishing the 26 air to be injected into medicament vials.
27 It is a still further object of the invention to 28 provide a sequence of method steps resulting in loading a 29 medical syringe with clean-filtered air and using such air to obtain a dose of medication for parenteral 3l administration to patients.
32 Other objects and advantages will become apparent as 33 the specification proceeds.
SUMMARY OF THE INVENTION
36 The present invention relates to a clean air 37 reservoir comprising a container having substantially 38 rigid, air impermeable walls and at least two apertures, WO90/14798 2 ~ ~ 7 o ~ ~ PCT/~S90/0l9l8 l one of said apertures being sealed by an air i~permeable 2 membrane capable of penetration by the needle of a 3 syringe, and the other aperture being sealed by a clean-4 filtering material.
The invention also relates to a method of 6 administering liquid medication to a patient by injection 7 through the skin, comprising the steps of loading air 8 from a purified air reservoir into the barrel of a 9 syringe, pushing the syringe needle distally through the septum of a medicament vial, expelling treated air from ll the barrel of the syringe into the interior of said vial, 12 moving the syringe plunger proximally to withdraw the 13 desired dosage of medicament from the vial, and injecting 14 said dosage through the skin of the patient.
A preferred embodiment of the invention relates to a 16 method of loading clean-filtered air into the barrel of a 17 syringe, comprising the steps of pushing the syringe 18 needle distally through a first septum of a vessel l9 containing clean-filtered air, and moving the syringe plunger proximally to withdraw clean-filtered air from 21 the vessel into the syringe, whereby the differential in 22 pressure thus created within the vessel causes 23 atmospheric air to be drawn into the vessel through a 24 second septum fitted with a clean-filtering membrane.
27 The objects, features and advantages of the 28 invention will be apparent to those skilled in the art 29 from the following detailed description, taken together with the accompanying drawings, in which:
3l FIG. l is a longitudinal section of the clean air 32 reservoir of the present invention, together with an 33 associated syringe, prior to withdrawal of clean-filtered 34 air from the reservoir.
FIG. 2 is a longitudinal section of the reservoir 36 and the syringe, after clean-filtered air has been 37 withdrawn from the reservoir into the syringe.
, ~ ,, ,,, , . ~, - i . : -2~7~
l FIG. 3 is a longitudinal section of a multi-dose 2 medicament vial and a syringe, after clean-filtered air 3 has been injected from the syringe into the vial.
4 FIG. 4 is a longitudinal section of the vial and syringe, after a dose of medicament has been withdrawn 6 from the vial into the syringe.
9 Referring to the drawings, the device of the present l0 invention is shown as a reservoir l0, having an aperture ll at each end. The first aperture is fitted with an air 12 impermeable membrane or plug ll, and the second aperture 13 is fitted with a membrane or plug 12 made of a clean-14 filtering material. The reservoir l0 thus comprises a 15 container for clean air, with a septum ll capable of 16 beinq penetrated by the needle 13 of a syringe 14, and a 17 septum 12 capable of clean-filtering atmospheric air 18 which passes into the container when air is wi~hdrawn l9 from the container by the syringe.
The reservoir l0 may be in any suitable form or 21 shape, although its preferred form is that of a cylinder 22 or tube, with apertures at each end. The walls of the 23 reservoir are made of any suitable air impermeable 24 material, such as glass, acrylic resin, or the like. In 25 the preferred embodiment, the reservoir is an acrylic 26 tube approximately 4" in length, with an inside diameter 27 of l/2", and having a wall thickness of l/16".
28 At one end, the tube l0 is fitted with an air 29 impermeable closure ll. The preferred material for the 30 closure is the standard rubber stopper currently used on 31 multiple dose medicament vials. As in the case of the 32 medicament vials, the closure ll may comprise a rubber 33 stopper or diaphragm, covered by a soft metal cap (e.g., 34 aluminum), which is removed prior to use. In place of 35 rubber,-any other suitable material may be used if it is 36 penetrable by the needle of a syringe and is self-sealing 37 after the syringe has been removed.
, ,, .. , . . , . . ... ,, .. , , , ., .. , ., .,, . . . . ., , , , . , ,, ,, , , . ~ ", . . . ... ..
...
W090/14798 PCT/~S90/01918 ,~ a ~
l At the other end, the tube l0 is fitted with a 2 clean-filtering membrane 12. One purpose for the 3 membrane is to act as a seal between the interior of the 4 tube and the atmosphere when there is little or no pressure differential between the two. A further purpose 6 is to allow atmospheric air to pass into the tube l0 when 7 pressure is reduced in the tube and to clean-filter such 8 air as it enters. A preferred material for the membrane 9 is a polytetrafluoroethylene/fabric laminate sold under the trademark Gore-Tex by W. L. Gore & Associates, Inc., ll Newark, DE. Any suitable material comprising or 12 incorporating a porous plastic filtering membrane such as 13 polytetrafluoroethylene, also known as PTFE or Teflon, 14 may be used. The pores in the membrane should be small enough to filter out dust particles and the 16 microorganisms or pathogens associated with them, as 17 found in the ambient air. Pores having dia~eters in the 18 range from 0.1-40 um are generally suitable for the l9 present purpose, although membranes having pore diameters outside this range can be useful, depending on the 21 character of the particles and the microorganisms 22 involved. Other suitable PTFE-based materials include 23 filter membranes sold under the trademark Ghia, by Ghia 24 Corporation, Pleasanton, CA; and membranes sold under the mark Fluoropore, by Millipore Corporation, Bedford, MA.
26 The clean air tube l0 described above, when ready 27 for use, is initially filled with purified air. The 28 filling may be accomplished, at~-the manufacturing site, 29 by charging the tube with air which has been sterilized by chemical or heat treatment. As another option, the 31 purified air may be introduced at any time by repeatedly 32 withdrawing air from the tube through a syringe until the 33 air within the tube has been completely replaced by 34 atmospheric air which has been clean-filtered by passing through the membrane 12.
36 In the operation of the invention, the aluminum cap 37 is removed from the end of the clean air tube l0, 38 exposing the rubber diaphragm ll. The outside surface of 205701~ 6 ~
l the rubber diaphragm is cleansed with an alcohol pledget, 2 and then, as shown in FIG. 1, the needle 13 of the 3 syringe 14 is guided distally through the rubber 4 diaphragm ll to position the tip of the needle well within the interior of the clean air tube lO. The 6 relative positions of the tube lO and the syringe 14 will 7 then be as shown in FIG. 1, with the plunger 15 still 8 adjacent the distal end of the syringe barrel, ready to 9 be moved proximally to withdraw air from the clean air tube.
11 As the next step, the plunger 15 is moved proximally 12 to assume the position shown in FIG. 2. Such movement 13 causes purified air to be withdrawn from the tube lO and 14 loaded into the barrel of the syringe 14. The movement of the plunger 15 should be sufficient to withdraw a 16 volume of air substantially equal to the volume of the 17 medicament dose to be administered to the patient. As 18 purified air is drawn from the tube 10, the lowered l9 pressure within the tube causes ambient air to be ta~en into the tube through the filter 12, as shown by the 21 arrows in FIG. 2.
22 Next the outer surface of the rubber diaphragm 16 of 23 a medicament vial 17 is cleansed with an alcohol pledget, 24 and the needle 13 of the syringe 14 (which now contains only purified air within its barrel) is guided distally 26 through the rubber diaphragm 16 into the interior of vial 27 17. The plunger 15 of the syringe is then moved distally 28 to expel the charge of air into the interior of vial 17, 29 thus increasing the air pressure within the vial. At this stage, the syringe 14 and the medicament vial 17 are 31 positioned as shown in FIG. 3.
32 Finally, the plunger 15 of the syringe 14 is moved 33 proximally to the position shown in FIG. 4, and in the 34 course thereof a dose of liquid medicament is withdrawn from the vial 17 into the barrel of the syringe. The 36 syringe is thPn removed from the vial, and the medicament 37 is administered to the patient by injection through the 38 skin.
WO90/14798 2 ~ 5 7 ~1 ~ PCT/US90/01918 l The device and method of the present invention 2 provide the following features which are significantly 3 advantageous in terms of effectiveness, safety and 4 economics:
l. The necessary step of injecting air into a 6 multiple dose medicament vial prior to 7 withdrawing the medicament can now be carried 8 out without introducing contaminated air into 9 the medicament.
2. The clean air tube with which this is ll accomplished has a simple, uncomplicated, 12 inexpensive structure which can be mass-- 13 produced on conventional machinery.
14 3. Since the clean-filtered air which is withdrawn from the clean air tube is instantly 16 replenished with freshly filtered air, the tube 17 can be used again and again without 18 deterioration in the purity of the air l9 furnished.
4. The simple, light-weight structure of the clean 2l air tube allows it to be packaged as a 22 companion item with the medicament vial itself.
23 The resulting tandem package thus furnishes not 24 only the medicament but also the means for clean-filtering the air used for obtaining the 26 medicament dose.
27 It will be understood that use of the term 23 "purified" herein contemplates materials or conditions 29 which have been treated to remove substantial proportions of microorganisms or other contaminants. Such treatment 3l may be by means of clean-filtering or standard 32 sterilizing techniques using heat or chemical means. The 33 spirit of the invention would not be avoided by use of 34 materials or conditions which have been substantially improved from the standpoint of aseptic goals, even 36 though the theoretical goal of 100% asepsis may not have 37 been achieved.
2~701~ 8 ~
l Althou~h preferred embodiments of the invention have 2 been described herein in detail, it will be understood by 3 those skilled in the art that other variations may be 4 made thereto without departing from the spirit of the invention.
6 WHAT IS CLAIMED IS:
Claims (10)
1. A clean air reservoir comprising: a container having substantially rigid, air impermeable walls and first and second apertures, said first aperture being sealed by an air impermeable membrane capable of penetration by the needle of a syringe, and said second aperture being sealed by an air permeable, clean-filtering material; and a charge of purified air in said container, said charge being accessible to the needle of a syringe which has penetrated said air impermeable membrane.
2. The clean air reservoir of claim 1 wherein said first aperture is sealed with a rubber membrane.
3. The clean air reservoir of claim 1 wherein said second aperture is sealed with a polytetrafluoroethylene membrane.
4. The clean air reservoir of claim 1 wherein the reservoir is in the form of a tube, with apertures at both ends.
5. The clean air reservoir of claim 1 wherein the walls of said reservoir are an acrylic resin.
6. The clean air reservoir of claim 1 wherein the walls of said reservoir are glass.
7. A method of administering liquid medication to a patient by injection through the skin, comprising the steps of loading air from a purified air reservoir into the barrel of a syringe, pushing the syringe needle distally through the septum of a partially full medicament vial, expelling treated air from the barrel of said syringe into the interior of said vial, moving the syringe plunger proximally to withdraw the desired dosage of medicament from said vial, and injecting said dosage through the skin of said patient.
8. The method of claim 7 wherein the volume of purified air expelled from the barrel of said syringe into the interior of said vial is approximately equal to the volume of medicament to be withdrawn from said vial.
9. A method of loading clean-filtered into the barrel of a syringe, comprising the steps of pushing the syringe needle distally through a first septum of a vessel containing clean-filtered air, and moving the syringe plunger proximally to withdraw said clean-filtered air from said vessel and into said syringe, whereby the differential in pressure thus created within said vessel causes atmospheric air to be drawn into said vessel through a second septum fitted with a clean-filtering membrane.
10. A method of administering liquid medication to a patient by injection through the skin, comprising the steps of pushing a syringe needle distally through a first septum of a container containing clean-filtered air, moving the syringe plunger proximally to withdraw clean-filtered air from said container and into said syringe, whereby the differential in pressure thus created within said container causes atmospheric air to be drawn into said container through a second septum fitted with an air permeable clean-filtering membrane, subsequently pushing said syringe needle distally through the septum of a partially full medicament vial, expelling clean-filtered air from the barrel of said syringe into the interior of said vial, moving the syringe plunger proximally to withdraw the desired dosage of medicament from said vial, and injecting said dosage through the skin of said patient.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US36029989A | 1989-06-02 | 1989-06-02 | |
| US07/360,299 | 1989-06-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2057015A1 true CA2057015A1 (en) | 1990-12-03 |
Family
ID=23417419
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2057015 Abandoned CA2057015A1 (en) | 1989-06-02 | 1990-04-02 | Device and method for avoiding contamination of multi-dose medicament vials |
Country Status (5)
| Country | Link |
|---|---|
| JP (1) | JPH04505403A (en) |
| AU (1) | AU5639290A (en) |
| CA (1) | CA2057015A1 (en) |
| GB (1) | GB2248782A (en) |
| WO (1) | WO1990014798A1 (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE517084C2 (en) * | 2000-08-10 | 2002-04-09 | Carmel Pharma Ab | Procedures and devices for aseptic preparation |
| EP1323403B1 (en) | 2001-12-17 | 2006-04-19 | Bristol-Myers Squibb Company | Transfer device and system comprising a cap assembly, a container and the transfer device |
| US20210318212A1 (en) * | 2018-08-13 | 2021-10-14 | Accroma Labtec Ag | Filter apparatus for use in an automated system for the preparation of a sample for a chemical or composition analysis |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US1967439A (en) * | 1927-09-26 | 1934-07-24 | Cook Lab Inc | Medicament package and process |
| US3157481A (en) * | 1961-12-11 | 1964-11-17 | Abbott Lab | Air filter assembly |
| US4227527A (en) * | 1978-10-23 | 1980-10-14 | Baxter Travenol Laboratories, Inc. | Sterile air vent |
| US4872872A (en) * | 1986-09-22 | 1989-10-10 | Polak Robert B | Medicament container/dispenser assembly |
-
1990
- 1990-04-02 CA CA 2057015 patent/CA2057015A1/en not_active Abandoned
- 1990-04-02 WO PCT/US1990/001918 patent/WO1990014798A1/en active Application Filing
- 1990-04-02 AU AU56392/90A patent/AU5639290A/en not_active Abandoned
- 1990-04-02 JP JP2507473A patent/JPH04505403A/en active Pending
-
1991
- 1991-11-29 GB GB9125483A patent/GB2248782A/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| GB9125483D0 (en) | 1992-01-29 |
| GB2248782A (en) | 1992-04-22 |
| WO1990014798A1 (en) | 1990-12-13 |
| JPH04505403A (en) | 1992-09-24 |
| AU5639290A (en) | 1991-01-07 |
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Legal Events
| Date | Code | Title | Description |
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| FZDE | Dead |