Apparatus and methods for multiple fluid infusion

• US 5,578,005 A
• Filed: 09/16/1994
• Issued: 11/26/1996
• Est. Priority Date: 08/06/1993
• Status: Expired due to Term

• Current Assignee: ALISANAE GROUP LIMITED
• Sponsoring Entity: RIVER MEDICAL, INC.
• Inventors: Sancoff, Gregory E., Doyle, Mark C., Field, Frederic P.
• Primary Examiner(s): YASKO JR, JOHN D
• Time in USPTO: 802 Days
• Field of Search: 604/82, 604/81, 604/65-67, 604/135-139, 604/132, 604/133, 604/140-143, 604/89-92, 222/386.5, 222/394, 222/395, 222/399, 128/DIG. 12, 128/DIG. 24
• US Class Current: 604/82
• CPC Class Codes: A61M 2005/1404 : Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2005/14204 : with gas-producing electrochemical cell
• CPC Class Codes: A61M 5/1409 : in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/14593 : the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/1483 : using flexible bags externally pressurised by fluid pressure
• CPC Class Codes: B01J 7/02 : by wet methods
• CPC Class Codes: B65D 83/625 : the propellant being generated by a chemical or electrochemical reaction for pressure gas in portable fire extinguishers A62C13/02
• CPC Class Codes: Y10S 128/12 : Pressure infusion

Abstract

We disclose apparatus and methods for delivering for patient infusion or other use two or more fluids either sequentially or simultaneously. The apparatus has a fluid delivery compartment containing a first infusion fluid, a flexible membrane, and an openable bag containing a second infusion fluid. An attached gas reaction compartment contains chemical reactants which, when combined, react to evolve gas. The gas expands a gas expansion chamber causing the membrane to move into the fluid delivery compartment, displacing the first infusion fluid. The membrane eventually contacts and compresses the openable bag. Pressure from the membrane causes the bag to open and discharge its contents out of the infusion device.

Claims

1. An apparatus for delivering two or more fluids, said apparatus comprising:

a fluid delivery compartment, containing a first fluid;

a fluid displacement system, which exerts a force on said fluid delivery compartment and displaces said first fluid from said fluid delivery compartment; and

a fluid container containing a second fluid, located within said fluid delivery compartment and responsive to said force exerted by said fluid displacement system, which discharges said second fluid when said fluid displacement system has displaced a predetermined amount of said first fluid from said fluid deliver compartment.

2. The apparatus of claim 1, wherein said fluid displacement system comprises a flexible membrane adjacent said first fluid.

3. The apparatus of claim 2, wherein said flexible membrane is driven by pressure from a source of gas.

4. The apparatus of claim 3, wherein said source of gas is a gas reaction compartment having two or more reactants which combine to evolve gas.

5. The apparatus of claim 1, wherein said fluid displacement system comprises a force selected from the group consisting of gravity, spring force and elastomeric force.

6. The apparatus of claim 1, wherein said fluid container is a bag.

7. The apparatus of claim 1, wherein said fluid container is comprised of one or more sheets of material, said sheets having edges and sealed at said edges to form a closed container.

8. The apparatus of claim 1, wherein said fluid container is comprised of a polyolefin or a modified polyolefin.

9. The apparatus of claim 1, wherein said fluid container has one or more weak spots at which it opens when said fluid displacement system has displaced a predetermined amount of said first infusion fluid from said fluid delivery compartment.

10. The apparatus of claim 1, wherein said apparatus further comprises a sharp surface which opens said fluid container when said fluid displacement system has displaced a predetermined amount of said first fluid from said fluid delivery compartment.

11. The apparatus of claim 1, wherein said fluid displacement system further comprises a sharp surface which opens said fluid container when said fluid displacement system has displaced a predetermined amount of said first fluid from said fluid delivery compartment.

12. The apparatus of claim 1, wherein said apparatus further comprises a flow restrictor located in operable relation to said fluid container, which regulates the discharge of said second fluid from said fluid container.

13. The apparatus of claim 1, wherein said fluid container further comprises a flow restrictor located in operable relation to said fluid container, which regulates the discharge of said second fluid from said fluid container.

14. The apparatus of claim 1, wherein said predetermined amount of said first fluid is substantially all of said first fluid.

15. The apparatus of claim 1, wherein said second fluid is selected from the group consisting of a sterile saline infusion solution and a sterile dextrose infusion solution.

16. The apparatus of claim 1, wherein said second fluid contains an anticoagulant.

17. A method for delivering for patient infusion two or more fluids, said method comprising the steps of:

providing a fluid delivery compartment containing a first infusion fluid and containing at least one fluid container containing a second infusion fluid therein;

displacing said first infusion fluid from said fluid delivery compartment through an exit port; and

discharging said second infusion fluid through said exit port when a predetermined amount of said first infusion fluid has been displaced from said fluid delivery compartment or simultaneously with discharge of at least a portion of said first infusion fluid.

18. The method of claim 17, wherein said displacing step is performed by acting on said first infusion fluid through a flexible membrane.

19. The method of claim 18, wherein said acting step is performed by an expanding gas.

20. The method of claim 17, wherein said displacing and discharging steps are performed by gravity, spring or elastomeric forces acting on said first and second infusion fluids.

21. The method of claim 17, wherein said discharging step is performed by opening said fluid container.

22. The method of claim 17, further comprising the step of restricting the discharge of said second infusion fluid.

23. The method of claim 17, wherein one portion of said second infusion fluid is discharged with at least a portion of said first infusion fluid, and another portion of said second infusion fluid is discharged after discharge of said first infusion fluid.