Infusion system with self-generating pressure assembly

• US 4,379,453 A
• Filed: 09/15/1980
• Issued: 04/12/1983
• Est. Priority Date: 12/28/1978
• Status: Expired due to Term

• Current Assignee: Howard C. Baron
• Original Assignee: Howard C. Baron
• Inventors: Baron, Howard C.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US06/186,955
• Time in Patent Office: 939 Days
• Field of Search: 128/214 F, 128/214.2, 128/DIG. 12, 128/225, 222/94, 222/95, 222/386.5, 222/399
• US Class Current: 604/145
• 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: B01J 7/02 by wet methods

Abstract

An infusion system with a self-generating pressure assembly includes a flexible infusion container which contains a fluid, such as blood and an expandible envelope which contains a pair of chemical agents which generate a gas when mixed. In use, the chemical agents are mixed by manual manipulation of the expandable envelope, creating a gas which expands causing the expandible envelope to bear against the flexible infusion container creating fluid pressure therein which causes the infusion fluid to flow out of the infusion container. The assembly may comprise a sleeve surrounding both the infusion container and expandible envelope, or a flexible panel secured to the side edges of the expandible envelope and forming a sleeve-like opening into which the infusion container is inserted.

Claims

1. For use with a flexible-walled infusion bag storing a supply of fluid to be fed intravenously and having an outlet, an infusion system for dispensing fluid under pressure from said infusion bag comprising:

an outer container having a substantially inextensible wall portion defining an interior cavity sized for removably receiving said infusion bag therein;

an expandable envelope disposed within said cavity adjacent said infusion bag, said expandible envelope being completely sealed and having a normal collapsed condition in which it occupies a minor portion of said cavity; and

manually operable inflation means within said expandible envelope including at least two separate frangible capsules, each of said capsules being independently rupturable only by manipulation through the wall of said expandible envelope to generate separate supplies of gas within said expandible envelope, when ruptured, to expand said envelope and squeeze said infusion bag against said inextensible wall portion, thereby dispensing said fluid from said infusion bag through said outlet.

2. An infusion system according to claim 1 wherein said expandible envelope contains a quantity of a first reagent, and each of said capsules contains a quantity of second reagent which reacts with said first reagent, when each of said capsules is ruptured, to generate an inflating gas.

3. An infusion system according to claim 2 wherein said first reagent is sodium bicarbonate solution, said second reagent is glacial acetic acid, and said inflating gas is carbon dioxide.

4. An infusion system according to claim 3 wherein said expandible envelope contains approximately 6 grams of sodium bicarbonate in 50 cc water, and each of said capsules contains approximately 2.5 cc glacial acetic acid.

5. An infusion system according to claim 2 wherein said expandible envelope and said outer container have transparent flexible walls to permit viewing of said inflation means.

6. An infusion system according to claim 5 wherein said first reagent contains an indicator dye which enters each ruptured capsule to indicate its ruptured condition.

7. An infusion system according to claim 1 wherein said capsules are fixedly positioned at discrete locations within said expandible envelope.

8. An infusion system according to claim 1 wherein each of said capsules comprises a frangible glass ampoule housed within an open-ended protective plastic tube, and porous wadding material retained in the ends of each tube.

9. For use with a flexible-walled infusion bag storing a supply of fluid to be fed intravenously and having an outlet, a disposable infusion system for dispensing fluid under pressure from said infusion bag comprising:

an outer container having a tubular sleeve with an open top and bottom end, an interior space sized for removably receiving said infusion bag therein, and a continuous, unbroken wall including an inextensible wall portion,

an expandible envelope disposed within said container at one side of said interior space and opposite to said inextensible wall portion of said container;

said infusion bag being receivable within said interior space between said expandible envelope and said wall portion;

said container wall having a height sufficient to extend over the major portion of said infusion bag when the latter is received within said container, with at least a portion of the expandible envelope projecting beyond said container wall;

said expandible envelope having flexible walls, the envelope being completely sealed, and having a normal collapsed condition in which said expandible envelope occupies a minor portion of the interior space of said container; and

means including a frangible member secured at a fixed position within the projecting portion of said expandible envelope for generating a supply of gas therein in sufficient volume to cause said expandible envelope to expand to an extended position in which it substantially fills the interior space of said container, the projecting portion of said expandible envelope comprising locating means for denoting the position of said frangible member so that said frangible member is readily accessible from the exterior of said container through the projecting portion of said flexible wall of said expandible envelope, whereby said frangible member may be quickly and easily located and manually ruptured to generate gas within said expandible envelope, thereby causing said expandible envelope to expand to press said infusion bag against said wall portion of said container to lock said infusion bag in position and create pressure within said infusion bag sufficient to cause a flow of said fluid from said infusion bag through the outlet thereof.

10. An infusion system according to claim 9 in which said expandible envelope is formed integrally with said tubular sleeve.

11. An infusion system according to claim 9 in which said expandible envelope is formed separately from said tubular sleeve and is sized for insertion therein.

12. An infusion system according to claim 11 in which said expandible envelope has a width substantially equal to the width of said tubuar sleeve.

13. An infusion system according to claim 11 in which said expandible envelope has a width greater than the width of said tubular sleeve, said envelope being insertible into said sleeve with its side portions folded inwardly and embracing said infusion bag, whereby when said envelope is inflated, said folded side portions apply pressure against the sides of said infusion bag.

14. An infusion system according to claim 9 in which said frangible member is a capsule containing a plurality of chemical ingredients capable of generating gas when mixed, said frangible member having at least one thin partition wall separating said chemical ingredients.

15. An infusion system according to claim 14 in which said sleeve and expandible envelope are made of flexible, transparent plastic sheet material.

16. An infusion system according to claim 15 in which the upper and lower portions of said expandible envelope project beyond the upper and lower edges of said tubular sleeve.

17. An infusion system according to claim 16 in which said expandible envelope is formed with an integral nipple projecting from the upper portion thereof and communicating with the interior of said envelope.

19. An infusion system according to claim 9 wherein said locating means comprises a transparent wall portion of said expandible envelope at the location of said frangible member which exposes said frangible member to view.

18. A method of administering an infusion fluid to a patient through an intravenous infusion tube from a flexible-walled infusion bag installed in an infusion system comprising an outer container having a substantially inextensible wall portion defining an interior cavity in which said infusion bag is received, an expandible envelope disposed within said cavity adjacent said infusion bag, said expandible envelope being completely sealed and having a normal collapsed condition in which it occupies a minor portion of said cavity, and inflation means within said expandible envelope including at least two separate frangible capsules, each of said capsules being independently rupturable only by manipulation through the wall of said expandible envelope to generate separate supplies of gas within said expandible envelope, when ruptured, to expand said envelope and squeeze said infusion bag against said inextensible wall portion, thereby dispensing said fluid from said infusion bag through said infusion tube to the patient, comprising the steps of:

manually rupturing only one of said capsules by manipulating it through the wall of said expandible envelope to generate a first gas pressure which expands said envelope and dispenses a portion of the fluid from said infusion bag; and

manually rupturing the second of said capsules by manipulating it through the wall of said expandible envelope when the flow of infusion fluid has slowed due to partial depletion of the fluid from said infusion bag and reduction in pressure within said expandible envelope, to generate a second gas pressure which further expands said envelope to complete dispensing of substantially all fluid remaining in said infusion bag.