Controlled release infusion device

• US 5,318,540 A
• Filed: 10/06/1992
• Issued: 06/07/1994
• Est. Priority Date: 04/02/1990
• Status: Expired due to Fees

• Current Assignee: Pharmetrix Corporation
• Original Assignee: Pharmetrix Corporation
• Inventors: Athayde, Amulya L., Faste, Rolf A.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US07/957,446
• Time in Patent Office: 609 Days
• Field of Search: 604/410, 604/416, 604/131, 604/141, 604/145, 604/146, 604/140, 604/147, 604/87, 604/153
• US Class Current: 604/141
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/1483 using flexible bags externally pressurised by fluid pressure

Abstract

A portable infusion device assembly, having two pouches in pressure transmitting relationship, the first containing infusate and the second, a driving medium. The driving medium is pressurized by activation of osmotic pump, electrochemical reaction, release of pressurized fluid or gas or mechanical means and the rate of infusion is controlled by a rate controlling means. The infusate pouch is separately manufactured and can be stored apart of the rest of the system.

Claims

1. A portable infusion device assembly comprising:

a. a first pouch containing infusate and having a dispensing nozzle,

b. a second pouch containing a driving medium in pressure transmitting relationship to the aforesaid first pouch,

c. an integral power source comprising;

a pressure generating means for generating pressure in aforesaid driving medium, an activating means for initiating the action of the aforesaid power generating means, a rate-controlling means for regulating the volume change of the aforesaid first pouch,

d. a connecting means for attaching the aforesaid dispensing nozzle to the object of treatment and,

e. a housing containing the aforesaid first pouch and said second pouch, and including restraining walls defining an interior chamber volume formed and dimensioned to receive both said first pouch and said second pouch in restraining relationship therewith, said first pouch and said second pouch having a combined volume substantially equal to said chamber volume both before and after activation of said pressure generating means, said activation causing transmitting movement of said second pouch against said first pouch.

2. The device according to claim 1 where:

a. the pressure generating means is comprised of;

a gas generating electrolytic cell,

b. the rate controlling means is a electrical circuit operated in such a manner as to control the rate of gas formation and,

c. the driving medium is gaseous.

3. The device according to claim 1 where:

a. the pressure generating means is comprised of;

a gas under pressure,

b. the rate controlling means is a valve operated in such a manner as to control the rate of gas flow and,

c. the driving medium is gaseous.

4. The device according to claim 1 where:

a. the pressure generating means is comprised of;

a mechanical means for increasing the pressure of the pressure-transmitting pouch,

b. the rate controlling means is obtained by operating the aforesaid mechanical means in such a manner so as to control the rate of pressure formation and,

c. the driving medium is liquid.

5. The device according to claim 1 where:

a. the pressure generating means is comprised of;

a mechanical means for increasing the pressure of the pressure-transmitting pouch,

b. the rate controlling means is obtained by operating the aforesaid mechanical means in such a manner so as to control the rate of pressure formation and,

c. the driving medium is gaseous.

6. The device according to claim 1 wherein,

an inner space of the first infusate pouch includes:

a. a drug in dry form;

b. a pharmaceutically acceptable solvent for said drug and,

c. a breakable seal in separating relationship to said drug and solvent.

7. The device according to claim 1 where the drug contained in the infusate pouch is heparin.

8. The device according to claim 1 where the drug contained in the infusate pouch is insulin.

9. A portable infusion device assembly comprising:

a. a first pouch including a dispensing nozzle, and containing therein a drug in dry form, a pharmaceutically acceptable solvent for said drug, and a breakable seal in separating relationship to said drug and said solvent,

b. a second pouch containing a driving medium in pressure transmitting relationship to the aforesaid first pouch,

c. a power source comprising;

a pressure generating means for generating pressure in aforesaid driving medium, an activating means for initiating the action of the aforesaid power generating means, a rate controlling means for regulating the volume change of the aforesaid first pouch,

d. a connecting means for attaching the aforesaid dispensing nozzle to the object of treatment and,

e. a housing containing the aforesaid first pouch, and said second pouch and power source and including restraining walls defining an interior chamber formed and dimensioned to receive both said first pouch and said second pouch therein, said walls being in restraining relationship with the aforesaid first and second pouches such that the combination of said first and said second pouches substantially fills said chamber at all times.

10. The device according to claim 9 where:

a. the pressure generating means is comprised of;

a gas generating electrolytic cell,

b. the rate controlling means is a electrical circuit operated in such a manner as to control the rate of gas formation and,

c. the driving medium is gaseous.

11. The device according to claim 9 where:

a. the pressure generating means is comprised of;

a gas under pressure,

b. the rate controlling means is a valve operated in such a manner as to control the rate of gas flow and,

c. the driving medium is gaseous.

12. The device according to claim 9 where:

a. the pressure generating means is comprised of;

a mechanical means for increasing the pressure of the pressure-transmitting pouch,

b. the rate controlling means is obtained by operating the aforesaid mechanical means in such a manner so as to control the rate of pressure formation and,

c. the driving medium is liquid.

13. The device according to claim 9 where:

a. the pressure generating means is comprised of;

a mechanical means for increasing the pressure of the pressure-transmitting pouch,

b. the rate controlling means is obtained by operating the aforesaid mechanical means in such a manner so as to control the rate of pressure formation and,

c. the driving medium is gaseous.

14. The device according to claim 9 where the drug contained in the infusate pouch is heparin.

15. The device according to claim 9 where the drug contained in the infusate pouch is insulin.

16. A portable infusion device assembly comprising:

a. a first pouch containing infusate and having a dispensing nozzle;

b. a second pouch containing a driving medium in pressure transmitting relationship to said first pouch;

c. a power source for generating a controlled pressure in said driving medium; and

d. a housing containing said first pouch and said second pouch, and including restraining walls defining an interior chamber having a chamber volume and formed and dimensioned to receive both said first pouch and said second pouch in restraining relationship therewith, said first pouch and said second pouch having a combined volume substantially equal to said chamber volume to substantially fill said interior chamber both before and after activation of said pressure generating means, said activation causing transmitting movement of said second pouch against said first pouch.

17. The device according to claim 16 wherein,

an inner space of the first infusate pouch includes:

a. a drug in dry form;

b. a pharmaceutically acceptable solvent for said drug and,

c. a breakable seal in separating relationship to said drug and solvent.

18. A method for infusing a patient with an infusate from a portable infusion device, said device comprising:

a first pouch containing said infusate and having a dispensing nozzle;

a second pouch containing a driving medium having a transmitting surface in pressure transmitting relationship with a facing surface of said first pouch, an integral power source for generating a controlled pressure in said driving medium;

connecting means for attaching said dispensing nozzle to said patient; and

a housing containing said first pouch, said second pouch and said power source and including restraining walls defining an interior chamber formed and dimensioned to receive both said first pouch and said second pouch therein, and said walls being in restraining relationship with said first and said second pouches such that the combination of said first and said second pouches substantially fill said chamber, said method comprising the steps of;

activating said power source to generate said controlled pressure in said driving medium;

inflating said second pouch, in controlled pressure communication with said power source, against said first pouch so that said second pouch transmitting surface exerts pressure on said first pouch facing surface in proportion to said controlled pressure;

expelling said infusate contained in said first pouch through said dispensing nozzle at a rate proportional to said inflation expansion of said second pouch.

19. A method for infusing a patient with an infusate from a portable infusion device, said device comprising:

a first pouch containing said infusate and having a dispensing nozzle;

a second pouch containing a driving medium having a transmitting surface in pressure transmitting relationship with a facing surface of said first pouch, a power source for generating a controlled pressure in said driving medium;

connecting means for attaching said dispensing nozzle to said patient; and

a housing containing said first pouch and said second pouch, and including restraining walls defining an interior chamber volume formed and dimensioned to receive both said first pouch and said second pouch in restraining relationship therewith, and said first pouch and said second pouch having a combined volume substantially equal to said chamber volume, said method comprising the steps of;

activating said power source to generate said controlled pressure in said driving medium;

inflating said second pouch, in controlled pressure communication with said power source, against said first pouch so that said second pouch transmitting surface exerts pressure on said first pouch facing surface in proportion to said controlled pressure while maintaining said combined volume substantially equal to said chamber volume both before and after said activating step, said activating step causing transmitting movement of said second pouch against said first pouch;

expelling said infusate contained in said first pouch through said dispensing nozzle at a rate proportional to said inflation expansion of said second pouch.

20. The method as defined in claim 19 wherein,

an inner space of first infusate pouch includes a drug in dry form, a pharmaceutically acceptable solvent for said drug, and a breakable seal in separating relationship to said drug and solvent,

said method further including the step of breaking said seal to permit mixing of said drug and said solvent.