Fluid exchange system for controlled and localized irrigation and aspiration

• US 20040193099A1
• Filed: 04/06/2004
• Published: 09/30/2004
• Est. Priority Date: 07/17/2001
• Status: Active Grant

• Current Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Original Assignee: Brian K. Courtney, John M. MacMahon, Thomas G. Goff
• Inventors: Goff, Thomas G., Courtney, Brian K., MacMahon, John M.
• Granted Patent: US 6,878,128 B2
• Time in Patent Office: Days
• US Class Current: 604/30
• CPC Class Codes: A61M 1/67 Containers incorporating a piston-type member to create suction, e.g. syringes cupping glasses A61M1/08; with a flexible member creating suction A61M1/68
• CPC Class Codes: A61M 1/774 Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently
• CPC Class Codes: A61M 1/81 Piston pumps, e.g. syringes

Abstract

The control of fluid introduction into and out of body conduits such as vessels, is of great concern in medicine. As the development of more particular treatments to vessels and organs continues it is apparent that controlled introduction and removal of fluids is necessary. Fluid delivery and removal from such sites, usually referred to as irrigation and aspiration, using fluid exchange devices that control also need to be considerate of potential volume and/or pressure in the vessel or organ are described together with catheter and lumen configurations to achieve the fluid exchange. The devices include several electrically or mechanically controlled embodiments and produce both controlled and localized flow with defined volume exchange ratios for fluid management. The applications in medicine include diagnostic, therapeutic, imaging, and uses for the introduction or removal of concentrations of emboli within body cavities.

Claims

1. A system for irrigation and aspiration within a localized region of the body comprising:

a fluid exchange apparatus comprising an irrigation reservoir and irrigation lumen having means for controlled delivery of irrigant fluid from the irrigation reservoir through the irrigation lumen to a target site;

an aspiration lumen having means for controlled collection of aspirant fluid through an aspiration lumen; and

a catheter element comprised of the irrigation or aspiration lumen, wherein the irrigation lumen terminates with at least one irrigation port at a distal end of the catheter element and the aspiration lumen terminates with at least one aspiration lumen such that fluid volume exchange occurs between the at least one irrigation port and the at least one aspiration port.

2. The system of claim 1 wherein the means for controlled delivery of irrigant fluid is comprised of a cylinder with a dedicated piston for forcing fluid from the cylinder.

3. The system of claim 1 wherein the means for controlled collection of aspirant fluid from the target site is comprised of a cylinder with a dedicated piston for drawing fluid into the cylinder.

4. The system of claim 2 wherein the piston and cylinder are components of a replaceable syringe.

5. The system of claim 1 wherein the fluid volume exchange creates turbuelence.

6. The system of claim 1 further comprising an occluding element proximal of the at least one irrigation and the at least one aspiration port.

7. The system of claim 6 wherein the occluding element is a balloon.

8. The system of claim 1 wherein the fluid exchange apparatus is further comprised of an irrigation chamber having an inflow line in fluid communication with the irrigation reservoir and wherein the outflow line is in fluid communication with the irrigation lumen.

9. The system of claim 1 wherein the fluid exchange apparatus is further comprised of an aspiration chamber having an inflow line in fluid communication with the aspiration lumen and an outflow line in fluid communication with the aspiration reservoir.

10. The system of claim 1 wherein the fluid exchange apparatus is comprised of a trigger and handle adapted to be held by the hand and which are activated to deliver irrigant fluid to the target site.

11. The system of claim 1 wherein the fluid exchange device is comprised of an electronically controlled pump.

12. The system of claim 1 wherein the means for controlled collection of aspirant fluid is comprised of at least one one-way valve in fluid communication with the aspiration lumen.

13. The system of claim 1 wherein the means for controlled delivery of irrigant fluid is coupled to the means for controlled collection of aspirant fluid to produce a predetermined ratio of fluid volume exchange at the target site.

14. The system of claim 13 wherein the ratio is approximately 1:

1.

15. The system of claim 13 wherein a ratio of irrigant to aspirant volume is between approximately 1:

2 and 2;

1.

16. A fluid exchange device for fixed volume fluid exchange within a body lumen comprising:

means for producing a pulsatile flow within the body lumen comprising;

means for controlled delivery of a fixed volume of irrigant fluid from an irrigation reservoir through an irrigation lumen and an irrigation port located at the distal end of a catheter;

means for controlled collection of a fixed volume of aspirant fluid from an aspiration port located in the distal end of the catheter through an aspiration lumen and into aspiration reservoir, wherein the means for controlled delivery and means for controlled collection are linked and produce the fixed volume exchange of the irrigant fluid and the aspirant fluid by the pulsatile flow at a target fluid exchange site within the body lumen.

17. The device of claim 16 wherein the means for controlled delivery of a fixed volume of irrigant fluid is comprised of a member connected to a piston that propels irrigant fluid and that is linked to a second member connected to a piston that withdraws aspirant fluid.

18. The device of claim 17 wherein the means for controlled collection of a fixed volume aspirant fluid is comprised of a member connected to a piston that withdraws aspirant fluid and that is linked to the piston that propels irrigant fluid.

19. The device of claim 17 wherein the second member is connected to the body of a cylinder containing the piston that propels irrigant fluid.

20. The device of claim 16 wherein the means for controlled delivery of a fixed volume of irrigant fluid is a syringe in fluid communication with the irrigation lumen, and wherein the syringe is linked to the means for controlled collection of a fixed volume of aspirant fluid.

21. The device of claim 16 wherein the means for controlled collection of aspirant fluid is comprised of a syringe in fluid communication with the aspiration lumen, and wherein the syringe is linked to the means for controlled delivery of a fixed volume of irrigant fluid .

22. The device of claim 20 further comprising irrigation and aspiration lumens connected to the handball with one-way valves.

23. The device of claim 20 wherein the means for controlling delivery of irrigant fluid is comprised of an irrigation chamber and aspiration chamber each having inflow and outflow lines each having one-way valves.

24. The device of claim 20 wherein the means for controlling delivery of the irrigant fluid is a unitary housing segregated into irrigant and aspirant reservoirs and having a single piston disposed between the irrigant and aspirant reservoirs.

25. The device of claim 16 wherein the device comprises a trigger actuated to produce a predetermined volume of fluid exchange upon a single actuation of the trigger.

26. The device of claim 25 wherein the trigger is connected to a piston and actuation of the trigger applies force to the piston.

27. The device of claim 25 wherein the trigger is configured to be cyclically actuated to produce repeated and incremental fixed fluid exchanges through incremental movement of the piston.