Fluid mixing and delivery apparatus

• US 5,236,418 A
• Filed: 12/07/1992
• Issued: 08/17/1993
• Est. Priority Date: 12/07/1992
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Kriesel, Marshall S.
• Primary Examiner(s): Mancene, Gene
• Assistant Examiner(s): PRICE JR, RICHARD THOMAS
• Application Number:
  US07/986,375
• Time in Patent Office: 253 Days
• Field of Search: 604/416, 604/249, 604/131, 604/133, 604/246, 604/89, 604/87, 604/88, 604/82, 604/83
• US Class Current: 604/85
• CPC Class Codes: A47G 21/183 with means for changing the flavour of the liquid
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061

Abstract

An apparatus for controllably mixing separately packaged beneficial agents and parenteral fluids to form an infusible mixture and for expelling the mixture at a precisely controlled rate from a delivery subsystem which includes its own self-contained energy source and is of a compact, low profile, laminate construction. The energy source of the delivery subsystem is made up of one or more elastomeric thin film, distendable membranes each having a uniform modulus of elasticity. The membranes cooperate with a base to define a fluid chamber having a fluid outlet in communication with a dispensing port for dispensing fluid from the device. The mixing subsystem includes cooperating sterile containers, one containing a parenteral fluid, such as a diluent, and the other containing a beneficial agent such as a drug.

Claims

1. A mixing and fluid delivery apparatus comprising:

(a) fluid delivery subsystem comprising;

(i) a base having a fluid inlet and fluid outlet interconnected by a fluid flow path; and

(ii) a distendable membrane constructed of an elastic material which is fitted over said base to define an internal chamber in communication with said fluid inlet and said fluid outlet, said membrane being distendable by fluid introduced into said internal chamber under pressure through said fluid inlet, said membrane having a tendency to return to a substantially nondistended configuration whereby fluid within said internal chamber will be expelled through said fluid outlet; and

(b) a mixing subsystem interconnectable with said fluid delivery subsystem for introducing fluid into said internal chamber thereof under pressure, said mixing subsystem comprising;

(i) a first portion having an additive containing chamber for containing a first component comprising an additive, said first portion having first and second ends; and

(ii) a second portion having a reservoir containing a second component, said first and second portions being interconnectable to permit fluid flow between said reservoir containing said second component and said additive-containing chamber.

2. An apparatus as defined in claim 1 in which said second component comprises a liquid and in which said base includes first flow means for establishing fluid communication between said fluid inlet of said base and said additive-containing chamber of said cartridge.

3. An apparatus as defined in claim 1 in which said first portion includes second flow means for establishing fluid communication between said additive-containing chamber and said reservoir of said fluid container.

4. An apparatus as defined in claim 3 in which said first end of said first portion is sealed by a penetrable plug and in which said first flow means comprises a hollow needle adapted to penetrate said penetrable plug.

5. An apparatus as defined in claim 3 in which said reservoir of said second portion is closed by a piston movable within said second portion between first and second positions.

6. An apparatus as defined in claim 5 in which said second flow means comprises a hollow needle adapted to penetrate said piston.

7. An apparatus as defined in claim 5 in which said liquid component comprises a diluent.

8. An apparatus as defined in claim 5 further including a substrate receivable within said additive-containing chamber, said additive being removably affixed to said substrate.

9. An apparatus as defined in claim 8 in which said additive comprises a beneficial agent.

10. An apparatus as defined in claim 9 in which said beneficial agent comprises a drug.

11. A mixing and fluid delivery apparatus comprising:

(a) fluid delivery subsystem comprising;

(i) a base having a passageway provided with a first hollow needle, a fluid inlet in communication with said hollow needle and fluid outlet interconnected with said fluid inlet by a fluid flow path; and

(ii) a distendable membrane laminate assembly constructed of thin membranes of elastic material which is fitted over said base to define first chamber in communication with said fluid inlet and said fluid outlet, said membrane laminate assembly being distendable by fluid introduced into said first chamber under pressure through said fluid inlet, said membrane laminate assembly having a tendency to return to a substantially nondistended configuration whereby fluid within said first chamber will be expelled through said fluid outlet; and

(b) a mixing subsystem for introducing fluid into said chamber under pressure, said mixing subsystem comprising;

(i) a fluid container having a reservoir containing a liquid component and a penetrable piston movable within said reservoir between a first position and a second position; and

(ii) a cartridge assembly including a cartridge receivable within said passageway of said base and telescopically receivable within said fluid container for movement between first and second positions, said cartridge having a second chamber containing a beneficial agent and having first and second ends, said first end being closed by a penetrable plug penetrable by said first hollow needle and said second end having a second hollow needle adapted to penetrate said penetrable piston whereby, upon movement of said cartridge within said fluid container from said first position to said second position, fluid contained within said reservoir will flow into said second chamber of said cartridge and then outwardly of said second chamber into said fluid inlet of said base.

13. An apparatus as defined in claim 11 in which telescopic movement of said cartridge within said fluid container from said first position to said second position causes movement of said penetrable piston within said fluid container from said first position therewithin to said second position therewithin.

14. An apparatus as defined in claim 11 in which said cartridge assembly further includes flow control means for controlling fluid flow toward said fluid inlet of said base.

15. An apparatus as defined in claim 14 in which said flow control means comprises an interface plug disposed between said additive and said penetrable plug.

16. An apparatus as defined in claim 14 further including removable sealing means for closably sealing said cartridge assembly.

17. An apparatus as defined in claim 14 further including removable sealing means for closably sealing said fluid container.

18. An apparatus as defined in claim 14 further including a substrate receivable within said chamber of said cartridge, said additive being removably affixed to said substrate.

19. An apparatus as defined in claim 18 in which said substrate comprises a porous body.

20. An apparatus as defined in claim 18 in which said substrate comprises a gel, said additive being intermixed with said gel.

21. An apparatus as defined in claim 18 in which said substrate comprises an azlactone functional polymer.

22. An apparatus as defined in claim 18 in which said substrate comprises a functional polymer.

12. An apparatus as defined in claim in which said passageway of said base is provided with internal threads and said fluid container is provided with external threads mateable with said threads of said passageway of said base.

23. A mixing and fluid delivery apparatus comprising:

(a) fluid delivery subsystem comprising;

(i) a base having a passageway provided with a first hollow needle, a fluid inlet in communication with said hollow needle and fluid outlet interconnected with said fluid inlet by a fluid flow path; and

(ii) a distendable membrane constructed of elastic material which is fitted over said base to define first chamber in communication with said fluid inlet and said fluid outlet, said membrane being distendable by fluid introduced into said first chamber under pressure through said fluid inlet, said membrane having a tendency to return to a substantially nondistended configuration whereby fluid within said first chamber will be expelled through said fluid outlet; and

(b) a mixing subsystem interconnected with said fluid delivery subsystem for introducing fluid into said chamber under pressure, said mixing subsystem comprising an elongated housing having;

(i) a first portion including a reservoir containing a liquid component and first and second telescopically movable pistons, each movable between a first position and a second position; and

(ii) a second portion receivable within said passageway of said base, said second portion having a second chamber containing a beneficial agent and having first and second ends, said first end being closed by a penetrable plug penetrable by said first hollow needle upon interconnection of said mixing subsystem in the said delivery subsystem and said second end being in communication with said reservoir of said first portion upon movement of said first and second pistons from said first position to said second position, whereby fluid contained within said reservoir of said first portion will flow into said second chamber of said second portion and then outwardly of said second chamber into said fluid inlet of said base.

24. An apparatus as defined in claim 23 in which said passageway of said elongate housing is provided with an intermediate chamber disposed between said reservoir and said second chamber, said second piston being movable into said intermediate chamber upon movement of said first piston toward said second position.

25. An apparatus as defined in claim 24 in which said first portion of said housing includes a plunger means connected to said first piston for moving said first piston toward said second position.

26. An apparatus as defined in claim 25 in which said plunger means comprises a packing disposed at one end of said reservoir and a shaft sealably movable within said packing, said shaft being connected to said first piston.

27. An apparatus as defined in claim 26 further including sealing means for closably sealing both ends of said elongate housing assembly.

28. An apparatus as defined in claim 27 further including a substrate receivable within said second chamber of said second portion, said additive being removably affixed to said substrate.

29. An apparatus as defined in claim 26 in which said substrate comprises a porous body.