EP0091310A2
Expired / Lapsed
EP
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A closed system and a method for mixing two separately stored components
Assignee: Baxter International Inc
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Filing: 1983-04-05
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Granted: —
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Expires: 2003-04-05
Abstract
Abstract A closed system (20) for separately storing and selectively mixing two components (82, 74), such as a drug and a diluent, under sterile conditions. The closed system (20) can incorporate a drug vial (80) of standard construction. A unique junction (76) of the closed system permits a drug vial with a drug therein to be connected in a sterile manner with a compressible chamber (22) having a diluent therein, after the drug and diluent have been separately sterilized. The junction (76) encloses the end portions (78, 104) of access means (44, 90) to each of the receptacles (22, 80), maintaining the end portions in sterile, spaced relation and providing for the selective establishment of a sterile pathway between the drug and diluent for mixing in a closed environment. The compressible chamber (22) is of a unique design including gas-trapping and reservoir compartments (32, 30) in open communication. The compressible chamber (22) is utilized with the junction (76) to provide an efficient, sterile storage and mixing system.
Inventors
- 👤 Stephen Pearson
- 👤 Steffen A. Lyons
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-24 15:40
CPC Classifications
A; A61; A61J; A61J1/00; A61J1/14; A61J1/20; A61J1/2089; A61J1/05; A61J1/10; A61J1/2003; A61J1/2006; A61J1/201; A61J1/2017; A61J1/2068; A61J1/2072; A61J1/2093
Claims Analysis
Total Claims: 17
Claim 1
Independent Claim
173 words
A closed system for mixing two separately stored components under sterile conditions, comprising: (a) a compressible chamber including a selectively gas-trapping compartment and a reservoir compartment in open communication with said gas-trapping compartment, said compressible chamber containing the first component, which is a sterile liquid; (b) a container containing the second component, which is sterile, at least one of said container and said chamber also containing a sterile gas; (c) means to access said chamber, adjacent said gas-trapping compartment; (d) means to access said container; (e) a junction enclosing the end portions of each of said access means, so as to maintain said end portions sterile; (f) at least one of said access means including an element capable of selectively piercing said junction so as to connect said access means and establish a sterile pathway between said container and said chamber, through said access means; (g) whereupon after said sterile pathway is established, said gas-trapping and reservoir compartments may be selectively positioned to facilitate the proper mixing of the first and second components.
Claim 2
Dependent Claim
173 words
A closed system for mixing two separately stored components under sterile conditions, comprising: (a) a compressible chamber including a selectively gas-trapping compartment and a reservoir compartment in open communication with said gas-trapping compartment, said compressible chamber containing the first component, which is a sterile liquid; (b) a container containing the second component, which is sterile, at least one of said container and said chamber also containing a sterile gas; (c) means to access said chamber, adjacent said gas-trapping compartment; (d) means to access said container; (e) a junction enclosing the end portions of each of said access means, so as to maintain said end portions sterile; (f) at least one of said access means including an element capable of selectively piercing said junction so as to connect said access means and establish a sterile pathway between said container and said chamber, through said access means; (g) whereupon after said sterile pathway is established, said gas-trapping and reservoir compartments may be selectively positioned to facilitate the proper mixing of the first and second components.
Claim 3
Dependent Claim
194 words
A closed system for mixing two separately stored components under sterile conditions, comprising: (a) a compressible chamber including a selectively gas-trapping compartment and a reservoir compartment in open communication with said gas-trapping compartment, said compressible chamber containing a sterile liquid component and a sterile gas; (b) a container in the form of a drug vial containing a drug component such as a liquid or a particulate solid and sealed with a pierceable stopper; (c) means to access said compressible chamber adjacent to said gas-trapping compartment; (d) a junction enclosing an end portion of said chamber access means and at least the exposed portion of said pierceable stopper, said junction selectively maintaining said chamber access means end portion and said exposed portion of said pierceable stopper sterile; (e) said chamber access means including an element capable of selectively piercing said junction and said pierceable stopper so as to establish a sterile pathway between said compressible chamber and said drug vial through said element and said pierceable stopper; (f) whereupon after said sterile pathway is established, said gas-trapping and reservoir compartments may be selectively positioned to facilitate proper mixing of the sterile liquid and the drug.
Claim 4
Dependent Claim
194 words
A closed system for mixing two separately stored components under sterile conditions, comprising: (a) a compressible chamber including a selectively gas-trapping compartment and a reservoir compartment in open communication with said gas-trapping compartment, said compressible chamber containing a sterile liquid component and a sterile gas; (b) a container in the form of a drug vial containing a drug component such as a liquid or a particulate solid and sealed with a pierceable stopper; (c) means to access said compressible chamber adjacent to said gas-trapping compartment; (d) a junction enclosing an end portion of said chamber access means and at least the exposed portion of said pierceable stopper, said junction selectively maintaining said chamber access means end portion and said exposed portion of said pierceable stopper sterile; (e) said chamber access means including an element capable of selectively piercing said junction and said pierceable stopper so as to establish a sterile pathway between said compressible chamber and said drug vial through said element and said pierceable stopper; (f) whereupon after said sterile pathway is established, said gas-trapping and reservoir compartments may be selectively positioned to facilitate proper mixing of the sterile liquid and the drug.
Claim 5
Dependent Claim
23 words
The closed system as in Claim 1 or 2, wherein only a single sterile pathway is established between said chamber and said container.
Claim 6
Dependent Claim
78 words
The closed system as in Claims 1, 2 or 3, wherein said chamber access means comprises a needle extending from said gas-trapping compartment, a flexible sleeve mounted about said needle and secured at a first end to said gas-trapping compartment, and a pierceable membrane secured to and closing said sleeve at a second end of said sleeve, wherein said needle serves as said piercing element and wherein said membrane includes said end portion of said chamber access means.
Claim 7
Dependent Claim
25 words
The closed system as in any preceding claim, wherein said junction is an in situ injection molding, preferably of a plastics material such as Kraton.
Claim 8
Dependent Claim
21 words
The closed system as in any preceding claim, wherein said junction does not exhibit coring upon piercing by said piercing element.
Claim 9
Dependent Claim
91 words
The closed system as in any preceding claim, including an internal wall in said compressible chamber, said internal wall having a closed end and an open end, defining said gas-trapping and reservoir compartments, segregating said gas-trapping and reservoir compartments along the length of said internal wall and at said closed end and defining an open flow path between said gas-trapping and reservoir compartments adjacent said open end; said internal wall enabling selective entrapment of at least a portion of said gas in said gas-trapping compartment adjacent said compressible chamber access means.
Claim 10
Dependent Claim
89 words
The closed system as in Claim 7, wherein said gas-trapping and reservoir compartments and said internal wall together define a generally "J" configuration for said compressible chamber, said reservoir compartment corresponding to the long leg of the "J" configuration, said gas-trapping compartment corresponding to the short leg of the "J" configuration and said internal wall separating the long and short legs of the "J" configuration, and further wherein said sterile pathway communicates with a top of said gas-trapping compartment, said top corresponding to the top' of the "J" configuration.
Claim 11
Dependent Claim
34 words
The closed system as in any preceding claim, wherein said compressible chamber comprises first and second flexible plastics sheets having an external seal, which may be a heat seal, such as a radio-frequency seal.
Claim 12
Dependent Claim
151 words
A method for mixing two separately stored components in a closed system according to Claim 1 under sterile conditions, the method comprising: (a) urging the element through the junction to connect the access means and establish a sterile pathway between the compressible chamber and the container; (b) transferring some of the liquid first component into the container through the pathway after some gas is in the container; (c) exchanging some of the liquid in the container with some of the liquid in the chamber by (i) manipulating the chamber until liquid in the gas-trapping compartment is adjacent the chamber access means annd the chamber access means is above the gas-trapping compartment, (ii) compressing the chamber, thereby urging some liquid from the chamber into the container, and (iii) stopping said compression, thereby urging some liquid from the container into the chamber; and (d) emptying the liquid in the container into the chamber.
Claim 13
Dependent Claim
62 words
The method as in Claim 10, wherein said liquid transfer includes steps comprising: (a) manipulating the chamber until the liquid first mixing component is adjacent the chamber access means; (b) compressing the chamber, thereby urging some liquid from the chamber into contact with the second mixing component in the container; and (c) stopping said compression before the container is filled with liquid.
Claim 14
Dependent Claim
123 words
The method as in Claim 10 or 11, wherein said liquid emptying step includes further steps comprising: (a) manipulating the chamber such that at least some of the gas in the reservoir compartment enters the gas-trapping compartment through the flow path; (b) manipulating the chamber until the gas in the gas-trapping compartment is adjacent the chamber access means and the chamber access means is above the gas-trapping compartment; (c) compressing the chamber, thereby urging at least some of the gas from the gas-trapping compartment into the container, thus pressurizing the air, above the liquid in the container; and (d) stopping said compression of the chamber, the pressurized gas in the container expelling the liquid in the container through the pathway into the chamber.
Claim 15
Dependent Claim
38 words
A method of forming a closed system according to Claim 1 wherein the junction is molded from heated molten material about said end portions so as to sterilize said end portions by heat transfer to said end portions.
Claim 16
Dependent Claim
58 words
A method of forming a closed system according to Claim 2 wherein the junction is molded from heated molten material about said end portion of said chamber access means and said exposed portion of said pierceable stopper, so as to sterilize said end portion and said exposed portion by heat transfer to said end portion and exposed portion.
Claim 17
Dependent Claim
23 words
The method as in Claim 13, or 14, wherein said junction is molded from molten material having a temperature of at least 500°F.
References Cited (Backward Citations)
No citation records indexed.
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