Fluid exchange system for controlled and localized irrigation and aspiration

• US 6,827,701 B2
• Filed: 07/17/2002
• Issued: 12/07/2004
• Est. Priority Date: 07/17/2001
• Status: Expired due to Fees

• Current Assignee: Foxhollow Technologies Incorporated (Medtronic Plc)
• Original Assignee: Kerberos Proximal Solutions (Medtronic Plc)
• Inventors: Goff, Thomas G., Courtney, Brian K., MacMahon, John M.
• Primary Examiner(s): Hayes, Michael J.
• Application Number:
  US10/198,718
• Publication Number:
  US 20030069549A1
• Time in Patent Office: 874 Days
• Field of Search: 604/6.11, 604/6.12, 604/19, 604/30, 604/36, 604/38, 604/43, 604/118, 604/121, 604/181, 604/236, 604/246, 417/341-343, 417/539, 606/167, 606/185
• US Class Current: 604/38
• 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 mechanical device for creating turbulent fluid exchange 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 and an aspiration lumen having means for controlled collection of aspirant fluid, wherein the means for controlled delivery of irrigant fluid and the means for controlled collection of aspirant fluid are mechanically linked to produce simultaneous delivery of irrigant fluid and removal of aspirant fluid, and wherein the fluid exchange apparatus is hand held and is comprised of a trigger actuated to simultaneously exert force on the means for controlled delivery of irrigant fluid and the means for controlled collection of aspiration fluid, and

a catheter element comprised of the irrigation or aspiration lumen a both, 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 port, wherein the at least one irrigation port and the at least one aspiration port are oriented to produce turbulent fluid exchange from the simultaneous delivery of irrigant fluid and removal of aspirant fluid.

2. The mechanical device 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 and is mechanically coupled to the means for controlled collection of aspirant fluid.

3. The mechanical device 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 and is mechanically coupled to the means for controlled delivery of irrigant fluid.

4. The mechanical device of claim 2 or 3 wherein the piston cylinder are components of a replaceable syringe.

5. The mechanical device of claim 3 wherein the trigger is coupled to a handle integrally attached to the cylinder and the dedicated piston of the means for controlled delivery of irrigant fluid.

6. The mechanical device of claim 5 wherein the trigger and the handle are integrally connected to the cylinder and the dedicated piston for forcing fluid from the cylinder

7. The mechanical device of claim 1 further comprising an occluding element proximal of the at least one irrigation port and the at least one aspiration port.

8. The mechanical device of claim 7 wherein the occluding element is a balloon.

9. The mechanical device 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.

10. The mechanical device 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.

11. The mechanical device 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.

12. The mechanical devices of claim 1 wherein a fluid volume of the irrigant reservoir and a volume of the aspirant reservoir are predetermined to produce a defined ratio of fluid volume exchange at the target site.

13. The mechanical device of claim 12 wherein the predetermined ratio is approximately 1:

1.

14. The mechanical device of claim 12 wherein the predetermined ratio is between approximately 1:

2 and 2;

1.

15. A mechanical device for creating turbulent fluid exchange 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, comprised of a cylinder with a dedicated piston for forcing fluid from a cylinder and an aspiration lumen having means for controlled collection of aspirant fluid, wherein the means for controlled delivery of irrrigant fluid the means for controlled collection of aspirant fluid are mechanically linked to produces simultaneous delivery of irrigant fluid and removal of aspirant fluid, wherein the fluid exchange apparatus is further comprised of a bigger coupled to a handle integrally attached to the cylinder and the dedicated piston; and

a catheter element comprised of the irrigation or aspiration lumen or both, 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 port, wherein the at least one irrigation port and the at least one aspiration port are oriented to produce turbulent fluid exchange from the simultaneous delivery of irrigant fluid and removal aspirant fluid.

16. The mechanical device of claim 15 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 and is mechanically coupled to the means for controlled delivery of irrigant fluid.

17. The mechanical device of claim 15 wherein the cylinder and the dedicated piston are components of a replaceable syringe.

18. The mechanical device of claim 15 wherein the device is hand held and the trigger is actuated to simultaneously exert force on the means for controlled delivery of irrigant fluid and the means for controlled collection of aspirant fluid.

19. The mechanical device of claim 15 further comprising an occluding element proximal of the at least one irrigation and the at least one aspiration port.

20. The mechanical device of claim 19 wherein the occluding element is a balloon.

21. The mechanical device of claim 15 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.

22. The mechanical device of claim 15 wherein the fluid exchange apparatus is further comprised of an aspiration chamber having an inflow line in fluid communication with the aspiration lumen and wherein the outflow line is in fluid communication with the aspiration reservoir.

23. The mechanical device of claim 15 wherein the trigger and the handle are integrally connected to the cylinder and the dedicated piston of the means for controlled delivery of irrigant fluid.

24. The mechanical device of claim 15 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.

25. The mechanical device of claim 15 wherein a fluid volume of the irrigant reservoir and a volume of the aspirant reservoir are predetermined to produce a defined ratio of fluid volume exchange at the target site.

26. The mechanical device of claim 25 wherein the predetermined ratio is approximately 1:

1.

27. The mechanical device of claim 25 wherein the predetermined ratio is between approximately 1:

2 and 2;

1.