Controlled release portable pump

• US 5,492,534 A
• Filed: 05/20/1994
• Issued: 02/20/1996
• Est. Priority Date: 04/02/1990
• Status: Expired due to Fees

• Current Assignee: Flora Incorporated (Flora Manufacturing & Distributing Limited)
• Original Assignee: Pharmetrix Corporation
• Inventors: Horres, Charles R. Jr., Faste, Rolf A., Athayde, Amulya L.
• Primary Examiner(s): Hirsch, Paul J.
• Application Number:
  US08/246,641
• Time in Patent Office: 641 Days
• Field of Search: 604/131, 604/141, 604/145, 604/146, 604/410, 604/406
• 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
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

A portable pump, useful for medical and non-medical uses, has two pouches (3, 4) in pressure transmitting relationship, the first (4) containing an infusate (5) and the second (3), a driving medium (2). The driving medium is pressurized in any of a variety of ways, including activation of osmotic pump, electrochemical reaction (19), release of pressurized fluid or gas (21, 23) or mechanical means (24). The rate of infusion is controlled by a rate controller (18). The infusate pouch is separately manufactured and can be stored apart of the rest of the system. Pulses of pumped fluid can also be delivered according to one aspect of the invention (18, 40).

Claims

1. A portable pump comprising:

a first pouch containing a fluid to be pumped and having an outlet;

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

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

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 said power source generates said controlled pressure causing transmitting movement of said second pouch against said first pouch; and

means separate from said power source for delivering a pulse to increase the pressure in said second pouch to produce movement thereof against said first pouch and delivery of a pulse of fluid from said first pouch outlet.

2. The pump of claim 1 wherein the outlet is adapted for connection to a hollow needle assembly.

3. The pump of claim 1 wherein said power source for generating a controlled pressure is comprised of:

a gas generating electrolytic cell; and

a rate controlling means including an electrical circuit operated to control the rate of gas formation; and

the driving medium is gaseous.

4. The pump of claim 1 wherein the means for delivering a pulse of fluid pumped from the outlet comprises means for delivering a pulse of the driving medium to said second pouch.

5. The pump of claim 4 wherein the means for delivering the pulse of driving medium comprises a source of the driving medium and a one-way pump between said source and said second pouch.

6. The device according to claim 1 wherein the fluid pumped from said first pouch is insulin.

7. The pump of claim 1 wherein an inner space of said first pouch includes:

a drug in dry form in a first section of said first pouch;

a pharmaceutically acceptable solvent for said drug in a second section of said first pouch; and

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

8. A portable pump comprising:

a first pouch containing fluid to be pumped and having an outlet;

a second pouch containing a driving medium in pressure transmitting relationship to the first pouch;

an integral power source comprising a pressure generating means for generating pressure in said driving medium, an activating means for initiating the action of the power generating means, and a rate-controlling means for regulating the volume change of the first pouch;

a housing containing the first pouch and the second pouch, the housing 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; and

means separate from said power source for delivering a pulse of driving medium to said second pouch to increase the pressure in said second pouch to produce movement thereof against said first pouch and delivery of a pulse of fluid from said first pouch outlet.

9. A pharmaceutical delivery system comprising:

a first pouch including an outlet, 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 which upon breakage forms a fluid to be pumped from the first pouch outlet;

a second pouch containing a driving medium in pressure transmitting relationship to the first pouch;

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

a housing containing the first pouch, and 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, 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; and

means separate from said power source for delivering a pulse of driving medium to said second pouch to increase the pressure in said second pouch to produce movement thereof against said first pouch and delivery of a pulse of fluid from said first pouch outlet.

10. A method for pumping a fluid from a portable pump, said pump comprising a first pouch containing fluid to be pumped and having an outlet;

a second pouch containing a driving medium having a transmitting surface in pressure transmitting relationship with said first pouch;

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

to expel said fluid contained in said first pouch through said outlet at a rate proportional to said inflation expansion of said second pouch; and

further increasing the pressure in said second pouch in a pulsatile manner to deliver pulse of fluid pumped from the outlet of said first pouch.

11. A method for pumping a fluid from a portable pump, said pump comprising a first pouch containing said fluid to be pumped and having an outlet;

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; 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;

to cause compression of said first pouch and expelling of said fluid contained in said first pouch through said outlet at a rate proportional to said inflation expansion of said second pouch; and

supplying a pulse of pressure to said first pouch to cause a pulse expulsion of fluid from said first pulse outlet.

12. The method as defined in claim 11 wherein,

an inner space of said 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.

13. The method of claim 12 wherein the step of supplying a pulse of pressure comprises supplying an additional pulse of pressure to said second pulse to transmit to said first pulse.

14. The method of claim 13 wherein the step of supplying the additional pulse of pressure to the second pouch comprises injecting an additional quantity of the driving medium into said second pouch.

15. The method of claim 11 wherein the step of supplying a pulse of pressure comprises supplying and additional pulse of pressure to said second pouch to transmit to said first pouch.

16. The method of claim 15 wherein the step of supplying the additional pulse of pressure to the second pouch comprises injecting an additional quantity of the driving medium into said second pouch.

17. The method of claim 11 wherein the supplying step is effected from a source external to said housing containing said first and second pouches.