CLOT RETRIEVAL DEVICE FOR REMOVING OCCLUSIVE CLOT FROM A BLOOD VESSEL

• US 20160143653A1
• Filed: 11/25/2015
• Published: 05/26/2016
• Est. Priority Date: 11/26/2014
• Status: Active Grant

• Current Assignee: Neuravi Limited (Johnson & Johnson)
• Original Assignee: Neuravi Limited (Johnson & Johnson)
• Inventors: Vale, David, Casey, Brendan, Gilvarry, Michael, O'Gorman, Jacqueline, McArdle, Kevin
• Granted Patent: US 10,363,054 B2
• Time in Patent Office: Days
• 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 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/2217 single wire changing shape to a gripping configuration
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A clot retrieval device for removal of occlusive clot from a blood vessel comprises a clot engaging element 700 having a constrained delivery configuration and an expanded deployed configuration. In the expanded configuration peripheral portions are laterally spaced-apart and the clot engaging section 700 extends between the peripheral portions. The device 700 may have two superimposed wave patterns provided by a large amplitude curve 723 and shorter pitch sinusoidal patterns 721, 722. A wave shape varies the contact pressure between a clot and the device along the length of the device, reducing the compression of the clot by the device at some locations. The device can elongate when placed under tension which aids elongation of the clot during dislodgement.

Claims

1. A clot retrieval device for removing occlusive clot from a blood vessel comprising a clot engaging element having a constrained delivery configuration and an expanded deployed configuration, the clot engaging element having a first peripheral portion, a second peripheral portion and a clot engaging section extending between the first and second peripheral portions wherein, in the expanded configuration, the peripheral portions are laterally spaced-apart, the clot engaging section extends between the peripheral portions, and wherein at least a portion of the device has a longitudinally extending undulating edge.

2. A clot retrieval device as claimed in claim 1 wherein the undulating edge has a wave-like form.

3. A clot retrieval device as claimed in claim 1 wherein the undulating edge has a sinusoidal wave form.

4. A clot retrieval device as claimed in claim 1 wherein the device has at least two wave patterns.

5. A clot retrieval device as claimed in claim 4 wherein the wave patterns are superimposed on one another.

6. A clot retrieval device as claimed in claim 4 wherein a first pattern has a wavelength and an amplitude and the second pattern has a wavelength and an amplitude which are larger than those of the first pattern.

7. A clot retrieval device as claimed in claim 2 comprising an activator for modifying the wave shape.

8. A clot retrieval device as claimed in claim 7 wherein the activator comprises at least one push wire and/or at least one pull wire.

9. A clot retrieval device as claimed in claim 1 wherein the clot engagement element comprises one or more clot gripping features.

10. A clot retrieval device as claimed in claim 1 wherein, in the constrained configuration, the clot engaging section is substantially flat.

11. A clot retrieval device as claimed in claim 10 wherein in the expanded configuration the clot engaging section is curvilinear.

12. A clot retrieval device as claimed in claim 10 wherein in the expanded configuration the clot engaging section is substantially flat.

13. A clot retrieval device as claimed in claim 1 wherein in the constrained and expanded configurations the clot engaging section is substantially curvilinear.

14. A clot retrieval device as claimed in claim 11 wherein in the expanded configuration, the clot engaging section is of helical or spiral form.

15. A clot retrieval device as claimed in claim 11 wherein in the expanded configuration, the clot engaging section is of generally s-shape.

16. A clot retrieval device as claimed in claim 1 wherein the clot engaging element has two surfaces which face in generally opposite directions and one or both surfaces is engagable with clot in the expanded deployed configuration.

17. A clot retrieval device as claimed in claim 1 wherein the device comprises a portion defining a flow channel for flow of blood when the device is in the expanded deployed configuration.

18. A clot retrieval device as claimed in claim 1 wherein the device comprises a proximal section, a distal section and a clot engaging section between the proximal section and the distal section wherein the proximal section is slidably movable relative to the clot engaging section.

19. A clot retrieval device as claimed in claim 18 wherein the proximal section comprises a collar and proximal struts extending from the collar and the clot engaging section comprises a proximal shaft and the collar is slidably movable relative to the proximal shaft.

20. A clot retrieval device as claimed in claim 19 wherein at least some of the struts of the proximal section extend in a distal direction for at least partial capture of clot between the clot engaging section and the proximal struts on proximal movement of the collar relative to the proximal shaft.

21. A clot retrieval device as claimed in claim 2 wherein the wave pattern has an amplitude of from 2.0 mm to 6.0 mm.

22. A clot retrieval device as claimed in claim 2 wherein the wave pattern has a pitch of from 3.0 mm to 8.0 mm.

23. A clot retrieval device as claimed in claim 2 wherein the clot engaging section comprises a plurality of cells defined by struts and crowns and wherein at least some of the struts and/or crowns are aligned with the wave-like form to enhance embedding of clot.

24. A clot retrieval device as claimed in claim 1 wherein the clot engaging section of the device has a transverse cross section having both flat and curved sections.

25. A clot retrieval device as claimed in claim 1 wherein, in the expanded configuration, at least a portion of the clot engaging section of the device is a generally spiral or helical configuration relative to a longitudinal axis.

26. A clot retrieval device as claimed in claim 25 wherein the clot engaging section further comprises a distal tubular section.

27. A clot retrieval device as claimed in claim 26 having a clot fragment portion at the distal end of the tubular section.

28. A clot retrieval device as claimed in claim 1 wherein the clot engaging section comprises a pair of side rails formed from cell elements to which a plurality of clot engaging strut elements are connected, the cell elements protruding from opposite sides of a plane defined by the side rails.

29. A clot retrieval device as claimed in claim 1 wherein the clot engaging section comprises a plurality of segments, adjacent segments being aligned at approximately 90°

to each other.

30. A clot retrieval device as claimed in claim 29 wherein at least some of the segments are of flat shape in transverse cross section.

31. A clot retrieval device as claimed in claim 1 comprising a distal clot fragment protection section.

32. A method from removing occlusive clot from a blood vessel comprising the steps of:

providing a clot retrieval device having a clot engaging section with a longitudinally extending undulating form, the device having a constrained delivery configuration and an expanded deployed configuration;

advancing a microcatheter towards and across an occlusive clot;

loading the device into the microcatheter and advancing it to a distal portion of the microcatheter;

deploying the device to embed the clot; and

retrieving at least a portion of the device and the captured clot into a retrieval catheter.

33. A method as claimed in claim 32 comprising deploying the device within the clot.

34. A method as claimed in claim 32 comprising deploying a portion of the device between the clot and a portion of the vessel wall surrounding the clot.

35. A method as claimed in claim 33 comprising pulling the device proximally after deployment of the device within the clot.

36. A method as claimed in claim 35 comprising delaying pulling of the device proximally after deployment to further embed in the clot prior to pulling of the device and the clot proximally.

37. A method as claimed in claim 35 comprising pulling the device proximally into a larger vessel before retrieval into a retrieval catheter.

38. A method as claimed in claim 32 comprising twisting the device to embed the device into the clot.