MECHANICAL THROMBECTOMY WITH PROXIMAL OCCLUSION

• US 20150112376A1
• Filed: 10/17/2013
• Published: 04/23/2015
• Est. Priority Date: 10/17/2013
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: MOLAEI, Masoud, JOHNSON, Garrett, EPSTEIN, Evan David, SEMA, Ghislain
• Granted Patent: US 10,383,644 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 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 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2215 having an open distal end

Abstract

The medical device can comprise a manipulation member, a mechanical thrombectomy apparatus attached to a distal end of the manipulation member, and flow-restricting apparatus attached to the manipulation member to a location proximal to the mechanical thrombectomy apparatus. A method, for retrieving thrombus from a blood vessel, can comprise advancing a single elongate delivery member carrying a mechanical thrombectomy apparatus and a flow-restricting apparatus through a catheter to the blood vessel, expanding the thrombectomy apparatus and capturing the thrombus with the thrombectomy device, expanding the flow-restricting apparatus to at least partially occlude blood flow toward the thrombus, retracting at least a portion of the thrombectomy apparatus into the flow-restricting apparatus, and retracting the flow-restricting apparatus and the thrombectomy apparatus into the retrieval catheter.

Claims

1. A method for retrieving thrombus from a blood vessel, the method comprising:

advancing a distal end of a delivery catheter to the blood vessel;

advancing a single elongate delivery member carrying a mechanical thrombectomy device and an flow-restricting device through the delivery catheter to the blood vessel with the flow-restricting device proximal to the thrombectomy device;

expanding the thrombectomy device and capturing the thrombus with the thrombectomy device;

expanding the flow-restricting device to at least partially occlude blood flow toward the thrombus;

retracting at least a portion of the thrombectomy device into the flow-restricting device; and

retracting the flow-restricting device and the thrombectomy device into the retrieval catheter.

2. The method of claim 1, further comprising inserting a guide wire through the thrombus, and advancing the distal end of a delivery catheter over the guide wire to the blood vessel.

3. The method of claim 1, wherein advancing the distal end of a delivery catheter to the blood vessel comprises advancing the distal end of a delivery catheter to within 3 cm of the thrombus.

4. The method of claim 1, wherein advancing the distal end of a delivery catheter to the blood vessel comprises advancing the distal end of a delivery catheter to a location distal to a distal end of the thrombus.

5. The method of claim 1, wherein advancing the single elongate delivery member comprises positioning a distal end of the thrombectomy device distal to the thrombus and a proximal end of the thrombectomy device proximal to the thrombus.

6. The method of claim 5, wherein the thrombectomy device is expanded into the thrombus.

7. The method of claim 1, wherein the flow-restricting device is maintained within the delivery catheter while expanding the thrombectomy device.

8. The method of claim 1, further comprising waiting for a period of at least 30 seconds after expanding of the thrombectomy device before expanding of the flow-restricting device.

9. The method of claim 1, wherein the flow-restricting device is expanded after expanding the thrombectomy device.

10. The method of claim 1, further comprising retracting at least a portion of the thrombus into the flow-restricting device.

11. The method of claim 1, wherein retracting at least a portion of the thrombectomy device into the flow-restricting device comprises retracting the thrombectomy device until a stop member abuts a portion of the flow-restricting device.

12. The method of claim 1, further comprising inflating a balloon on the retrieval catheter.

13. The method of claim 12, further comprising inflating the balloon before retracting the flow-restricting device into the retrieval catheter,

14. The method of claim 12, further comprising, before inflating the balloon, retracting the flow-restricting device, with the thrombectomy device, toward the retrieval catheter until the flow-restricting device is within 1 cm of a distal end of the retrieval catheter.

15. The method of claim 1, further comprising aspirating through the retrieval catheter while retracting at least one of the thrombus, the flow-restricting device, or the thrombectomy device into the retrieval catheter.

16. The method of claim 1, further comprising containing at least a portion of at least one of the thrombus and thrombectomy device with the flow-restricting device while retracting the flow-restricting device and the thrombectomy device into the retrieval catheter.

17. A thrombectomy device, comprising:

an elongate delivery member;

a first expandable member attached to the elongate delivery member at a distal end of the elongate delivery member, and configured to capture a thrombus, the first expandable member having an expanded configuration and a collapsed configuration, the first expandable member having a maximum transverse outer dimension that is larger in the expanded configuration than in the collapsed configuration; and

a second expandable member slidably attached to the elongate delivery member at a location proximal to the first expandable member, and comprising a hub slidably surrounding the elongate delivery member, an expandable frame extending from the hub, and a membrane attached to the expandable frame, the hub having a static transverse inner dimension that is smaller than the maximum transverse outer dimension of the first expandable member in the collapsed configuration, the expandable frame having an expanded frame configuration and a collapsed frame configuration, the expandable frame having a maximum transverse outer frame dimension that is larger in the expanded frame configuration than in the collapsed frame configuration, the membrane extending from the hub to an outermost circumferential perimeter of the expandable frame in the expanded frame configuration.

18. The thrombectomy device of claim 17, wherein the first expandable member is configured to integrate with a thrombus upon expansion of the first expandable member.

19. The thrombectomy device of claim 17, wherein the first expandable member comprises a plurality of cells and, in the expanded configuration of the first expandable member, is generally tubular and has an open proximal end and an open distal end.

20. The thrombectomy device of claim 17, wherein the frame comprises a proximal portion and a distal portion, the distal portion being cylindrical in the expanded configuration, and the proximal portion flaring from the hub to the distal portion.

21. The thrombectomy device of claim 17, wherein the membrane extends from the hub along the entire longitudinal extent of the expandable frame.

22. The thrombectomy device of claim 17, further comprising a first stop member fixed to the elongate delivery member proximal to a proximal end of the second expandable member.

23. The thrombectomy device of claim 22, wherein the first stop member has a maximum transverse outer dimension that is larger than the transverse inner dimension of the hub.

24. The thrombectomy device of claim 22, further comprising a second stop member fixed to the elongate delivery member distal to the second expandable member.

25. The thrombectomy device of claim 24, wherein, in the collapsed frame configuration, a portion comprising a distal end of the frame has a minimum transverse inner dimension smaller than a maximum transverse outer dimension the second stop member.

26. The thrombectomy device of claim 24, wherein the second stop member has a maximum transverse outer dimension that is larger than the transverse inner dimension of the hub.

27. The thrombectomy device of claim 24, wherein the first stop member and the second stop member are separated by a distance greater than a length of the second expandable member when the frame is in the collapsed frame configuration.

28. The thrombectomy device of claim 17, wherein the second expandable member is self-expandable.

29. The thrombectomy device of claim 17, wherein the hub has a length less than 1 cm.

30. The thrombectomy device of claim 17, wherein the hub of the second expandable member comprises a circumferentially contiguous metallic tube having a length less than 1 cm.

31. The thrombectomy device of claim 17, wherein the membrane is attached on a radially outwardly facing surface of the frame.

32. The thrombectomy device of claim 17, wherein the frame comprises a first plurality of struts and a second plurality of struts, each strut of the first plurality has a proximal end connected to the hub and a distal end connected to at least two struts of the second plurality, each strut of the second plurality has a first and second ends connected to adjacent struts of the first plurality.

33. The thrombectomy device of claim 17, wherein the second expandable member comprises means for containing at least a portion of at least one of the thrombus and the first expandable member during retrieval of the thrombectomy device.