Thrombectomy catheter system with occluder and method of using same

• US 7,220,269 B1
• Filed: 11/06/2003
• Issued: 05/22/2007
• Est. Priority Date: 11/06/2003
• Status: Active Grant

• Current Assignee: Surmodics MD, LLC (Surmodics Incorporated)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Bonnette, Michael J., Ansel, Gary M., Le, Hieu V., Janse, Dan T.
• Primary Examiner(s): Nguyen; Anhtuan T.
• Assistant Examiner(s): Houston; Elizabeth
• Application Number:
  US10/702,815
• Time in Patent Office: 1,293 Days
• Field of Search: 606/200, 606/159, 606/114, 606/127, 606/128, 606/168, 604/101.04, 604/35, 604/22, 604/43
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/2215 having an open distal end

Abstract

A thrombectomy catheter system with occluder and method of using same for removal of tissue, such as thrombus and the like, from a vessel in the body. Multiple catheters and an occluder-bearing guidewire tube at a thrombus site provide for expandable deployment of a compliant occluder against the vasculature walls distal to the thrombus. The expanded occluder is maneuvered proximally to urge thrombus into close proximity with a retractable capture cone located distally on a capture catheter where the thrombus is dislodged, entrained, and broken into pieces by the action of a fluid jet emanator and then evacuated through the capture catheter.

Claims

1. A method for thrombectomy comprising the steps of:

a. providing a guide catheter, the guide catheter having a distal end and a proximally situated manifold with a hemostasis nut and a lumen, and providing an occluder guidewire tube having a proximal end and a distal end, with a guidewire coil and an occluder at the distal end, and providing a capture catheter, the capture catheter having a distal end with a retractable capture cone and a fluid jet emanator affixed thereto, the fluid jet emanator including at least one proximally directed jet orifice, and a proximally located manifold, the proximally located manifold having an exhaust branch, a high pressure connection branch, and a hemostasis valve adapted for passage of the occluder guidewire tube;

b. advancing the distal end of the guide catheter into a vessel to a position adjacent to and proximal to a thrombus buildup;

c. loading and advancing the distal end of the occluder guidewire tube through the hemostasis nut and into and through the manifold of the guide catheter and thence through the lumen of the guide catheter;

d. advancing the distal end of the occluder guidewire tube, including the guidewire coil and the occluder, beyond the distal end of the guide catheter and through and beyond the thrombus buildup;

e. loading the distal end of the capture catheter, including the retractable capture cone and the fluid jet emanator over the proximal end of the occluder guidewire tube;

f. expanding the occluder to occlude the vessel;

g. positioning the capture catheter to an appropriate position and expandingly deploying the retractable capture cone adjacent to and just beyond the distal end of the guide catheter, thereby isolating the thrombus in the vessel between the deployed retractable capture cone and the expanded occluder;

h. providing and activating a high pressure medium to the fluid jet emanator so as to form rearwardly directed fluid jets;

i. macerating, dislodging, reducing, and breaking up the thrombus with the fluid jets; and

,

j. evacuating the macerated, dislodged, reduced and broken-up thrombus.

2. The thrombectomy method of claim 1, further comprising the step of repositioning the expanded occluder proximally to impinge, impact, dislodge, reshape and redistribute thrombus and to urge and deliver such thrombus into the retractable capture cone.

3. The thrombectomy method of claim 2, wherein the step of repositioning includes manipulation of the manifold of the capture catheter.

4. The thrombectomy method of claim 2, wherein the step of repositioning is continued to near impingement of the occluder with the retractable capture cone.

5. The thrombectomy method of claim 1, wherein the vessel is a blood vessel.

6. The thrombectomy method of claim 5, wherein the blood vessel is a vein or an artery.

7. The thrombectomy method of claim 1, further comprising the step of monitoring the position of the guide catheter distal end with fluoroscopy.

8. The thrombectomy method of claim 1, further comprising the step of manipulating the manifold of the guide catheter while advancing the guide catheter.

9. The thrombectomy method of claim 1, wherein the at least one jet orifice is one of a plurality of jet orifices.

10. The thrombectomy method of claim 1, further comprising the step of collapsing the occluder subsequent to removing the thrombus.

11. The thrombectomy method of claim 10, further comprising the step of withdrawing the collapsed occluder through the retractable capture cone.

12. The thrombectomy method of claim 11, further comprising the step of retracting the retractable capture cone proximally to retractably collapse the retractable capture cone to conform to the guide catheter.

13. The thrombectomy method of claim 12, further comprising the step of withdrawing the guide catheter, the capture catheter, and the occluder guidewire tube simultaneously.

14. The thrombectomy method of claim 12, further comprising the step repositioning the guide catheter, the capture catheter, and the occluder guidewire tube simultaneously and distally to adjacent to and proximal to another thrombus site, to prepare for additional thrombus removal.

15. A system for thrombectomy comprising:

a. a guide catheter, the guide catheter having a distal end and a proximally situated manifold with a hemostasis nut and a lumen;

b. an occluder guidewire tube having a proximal end and a distal end, with a guidewire coil and an occluder at the distal end; and

,

c. a capture catheter, the capture catheter having a distal end with a retractable capture cone and a fluid jet emanator affixed thereto, the fluid jet emanator including at least one proximally directed jet orifice, and the capture catheter having a proximally located manifold, the proximally located manifold having an exhaust branch, a high pressure connection branch, and a hemostasis valve adapted for passage of the occluder guidewire tube;

wherewith fluid and thrombus may be isolated in the vasculature between the retractable capture cone, when deployed, and the occluder, when expanded, then disrupted and macerated by action of fluid jets, for removal from the body by suction applied at the retractable capture cone, thereby avoiding undesired release of thrombus portions within the vasculature.

16. The system as defined in claim 15, wherein the occluder is an inflatable balloon.

17. The system as defined in claim 15, wherein the occluder is a controllable-shape mesh.

18. The system as defined in claim 15, wherein the occluder is a flexible shaped mesh.

19. The system as defined in claim 15, wherein the retractable capture cone comprises a position memory material.

20. The system as defined in claim 15, further comprising a plurality of expansion struts.

21. The system as defined in claim 20, wherein the plurality of expansion struts comprise a position memory material.

22. The system as defined in claim 15, wherein the fluid jet emanator is configured to entrain thrombus and thrombus debris.

23. The system as defined in claim 15, wherein the fluid jet emanator is configured so that the at least one proximally directed jet aids in carrying thrombus debris proximally for collection.

24. A system for thrombectomy comprising:

a. a guide catheter, the guide catheter having a distal end and a lumen;

b. an occluder guidewire tube having a proximal end and a distal end, with a guidewire coil and an occluder at the distal end;

c. a capture catheter, the capture catheter having a distal end with a retractable capture cone and a fluid jet emanator, the fluid jet emanator affixed to the capture catheter and including a plurality of proximally directed jet orifices, and the capture catheter further having a proximally located manifold, the manifold having an exhaust branch, a high pressure connection branch, and a hemostasis valve, and a lumen communicating between the distal end of the capture catheter and exhaust branch and a high pressure lumen communicating between the high pressure connection branch and the fluid jet emanator affixed to the capture catheter;

d. the capture catheter configured to pass through the lumen of the guide catheter, wherein the retractable capture cone is held in a retracted position when inside the lumen of the guide catheter;

e. the occluder guidewire tube configured to pass through the lumen of the capture catheter, so that the plurality of proximally directed jet orifices are disposed about the guidewire tube; and

,

f. wherewith fluid and thrombus may be isolated in the vasculature between the retractable capture cone, when deployed, and the occluder, when expanded, then disrupted and macerated by action of fluid jets, for removal from the body by suction applied at the retractable capture cone, thereby avoiding undesired release of thrombus portions within the vasculature.