SYSTEMS AND METHODS FOR PERCUTANEOUS OCCLUSION CROSSING

• US 20120095485A1
• Filed: 10/13/2011
• Published: 04/19/2012
• Est. Priority Date: 10/18/2010
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Cully, Edward H., Duncan, Jeffrey B.
• Granted Patent: US 8,932,315 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

The present invention provides methods and apparatuses for crossing or bypassing total or near total occlusions of vessels through the use of elongate members and specialized catheters that include a piercing catheter, a reentry catheter, a multi-lumen, reentry catheter, and combinations thereof. A piercing catheter comprises a distal tip used to pierce an occlusion in a crossing procedure and can be configured to microdissect the occlusion or provide support for an elongate member. A reentry catheter comprises a distal side port and ramp to facilitate the reentry or perforation of a vessel wall. A multi-lumen, reentry catheter comprises a tearable lumen divider and a distal side port and ramp.

Claims

1. A medical device comprising:

a catheter with proximal and distal ends;

a hollow chisel having a chisel passage therein, having a proximal and distal end, with a tip at the distal end, wherein the chisel'"'"'s proximal end is proximate to the catheter'"'"'s distal end; and

an elongate member axially movable along the longitudinal axis of the catheter and chisel,

wherein the tip is movable, in response to selective axial displacement of the elongate member, between a first position, in which the tip is disposed proximal to the axis, and a second position, in which the tip is spaced apart from the first position.

2. The medical device of claim 1, wherein the tip has at least two portions, at least one of which is moveable in response to selective axial displacement of the elongate member.

3. The medical device system of claim 2, wherein when the elongate member is withdrawn out of the chisel passage, a sharp tip forms.

4. The medical device system of claim 1, wherein the elongate member can be reciprocated in and out of the chisel'"'"'s distal end to actuate the chisel between a sharp tip and a blunt tip.

5. The medical device system of claim 1, wherein when the elongate member is pushed through and out of the distal end of the chisel, the tip opens to generally conform to the outer diameter of the wire.

6. The medical device system of claim 1, wherein when the elongate member is pushed out of the distal end of the chisel, the catheter and chisel together comprise a support catheter.

7. The medical device system of claim 1, wherein the chisel comprises a shape memory material.

8. The medical device system of claim 7, wherein the shape memory material is nitinol.

9. The medical device system of claim 1, wherein the elongate member is a guidewire, a catheter, or fiber.

10. A medical device comprising:

a piercing catheter;

an elongate member moveable along the longitudinal axis of the piercing catheter; and

a re-entry catheter, comprising a side port near the distal end, wherein the piercing catheter or elongate member can move through the side port.

11. The medical device of claim 10, wherein the re-entry catheter comprises a ramp near the distal end, wherein when the ramp is not actuated, the side port is closed and when the ramp is actuated the side port opens and the ramp is presented for directing the piercing catheter or elongate member through the side port.

12. The medical device system of claim 11, wherein

the ramp is not actuated when the distal ends of the elongate member and piercing catheter are distal to the side port, and

the ramp is actuated when the distal ends of the elongate member and piercing catheter are proximal to the side port.

13. The medical device system of claim 10, wherein when an elongate member is pushed through and out of the distal end of the piercing catheter, the piercing catheter becomes a support catheter.

14. The medical device of any claim 10, wherein the piercing catheter comprises

a catheter with proximal and distal ends;

and

a hollow chisel having a chisel passage therein, with proximal and distal ends, having a tip at the distal end, wherein the chisel'"'"'s proximal end is proximate to the catheter'"'"'s distal end,

wherein the tip is movable, in response to selective axial displacement of the elongate member, between a first position, in which the tip is disposed proximal to the axis, and a second position, in which the tip is spaced apart from the first position.

15. The medical device of claim 14, wherein the elongate member is removed from the chisel passage and the chisel is actuated to form a sharp tip.

16. The medical device system of claim 13, wherein the support catheter is of substantially rounded cross section along its length.

17. The medical device system of claim 10, wherein the ramp comprises a shape memory material.

18. The medical device system of claim 17, wherein the shape memory material is nitinol.

19. The medical device system of claim 10, wherein the elongate member is a guidewire, a catheter, or fiber.

20. A medical device comprising:

an elongate member; and

a re-entry catheter, comprising a side port and a ramp near the distal end, wherein when the ramp is not actuated, the side port is closed, and when the ramp is actuated, the side port opens and the ramp is presented for directing the elongate member through the side port.

21. The medical device of claim 20, wherein the elongate member is a guidewire, catheter, or fiber.

22. The medical device of claim 21, wherein the catheter is a piercing catheter.

23. The medical device of claim 20, wherein the reentry catheter has a semi-actuated ramp, which does not fully actuate upon removal of a guidewire.

24. The medical device of claim 23, wherein the ramp is fully actuated by an elongate member of larger diameter than a guidewire.

25. The medical device of claim 24, wherein the ramp is fully actuated by an elongate member sufficiently broad in diameter to tear a tearable sheath.

26. A method of crossing an occlusion comprising:

inserting an elongate member into an occluded vessel proximate an occlusion;

advancing a piercing catheter over the elongate member to a position proximate the distal end of the elongate member, wherein the piercing catheter comprises;

a hollow chisel having a chisel passage therein, with proximal and distal ends, wherein the distal end actuates between an open and closed position, wherein the distal end opens when the elongate member passes through the distal end, wherein the distal end closes to form a tip when the elongate member is removed from the distal end; and

a catheter with its distal end attached to the chisel'"'"'s proximate end such that the catheter and the chisel circumscribe the elongate member; and

applying a longitudinal force to advance at least one of the elongate member and piercing catheter into the occlusion.

27. The method of claim 26, wherein the elongate member is a guidewire, a catheter, or fiber.

28. The method of claim 26, wherein the chisel comprises a shape memory alloy.

29. The method of claim 28, wherein the shape memory alloy is nitinol.

30. The method of claim 26, wherein the tip has at least two portions, at least one of which is moveable in response to axial displacement of the elongate member.

31. The method of claim 26, wherein when the elongate member is withdrawn out of the chisel'"'"'s distal end, a sharp tip forms.

32. The method of claim 26, wherein the elongate member can be reciprocated in and out of the chisel lumen to actuate the chisel between a sharp tip and a blunt tip.

33. The method of claim 26, wherein when the elongate member is pushed through and out of the distal end of the chisel, the chisel tip opens to generally conform to the outer diameter of the wire.

34. A method of crossing an occlusion comprising:

inserting an elongate member into an occluded vessel proximate an occlusion;

advancing the elongate member into a sub-intimal space of the occluded vessel on a proximal side of the occlusion and to a distal side of the occlusion;

advancing a piercing catheter over the elongate member to a position proximate the distal end of the elongate member, wherein the piercing catheter comprises;

a hollow chisel having a chisel passage therein, with proximal and distal ends, wherein the distal end actuates between an open and closed position, wherein the distal end opens when the elongate member passes through the distal end, wherein the distal end closes to form a tip when the elongate member is removed from the distal end;

a catheter with its distal end attached to the chisel'"'"'s proximate end such that the catheter and the chisel circumscribe the elongate member;

advancing a side-port catheter over the piercing catheter,

wherein the side-port catheter has a side port and a ramp near the distal end;

wherein when the ramp is not actuated, the side port is closed and when the ramp is actuated the side port opens and the ramp is presented for directing the piercing catheter or elongate member through the side port; and

wherein the ramp is actuated when the distal end of the elongate member and piercing catheter is proximate the side port;

retracting the elongate member and piercing catheter to actuate the ramp; and

applying a longitudinal force to advance the piercing catheter up the ramp to re-enter the occluded vessel on a distal side of the occlusion.

35. The method of claim 34, wherein the elongate member is a guidewire, a catheter, or fiber.

36. The method of claim 34, wherein the tip has at least two portions, at least one of which is moveable in response to axial displacement of the elongate member.

37. The method of claim 34, wherein when the elongate member is withdrawn out of the chisel'"'"'s distal end, a sharp tip forms.

38. The method of claim 34, wherein the elongate member can be reciprocated in and out of the chisel passage to actuate the chisel between a sharp tip and a blunt tip.

39. The method of claim 34, wherein when the elongate member is pushed through and out of the distal end of the chisel, the chisel tip opens to generally conform to the outer diameter of the wire.

40. The method of claim 34, wherein the chisel comprises a shape memory alloy.

41. The method of claim 40, wherein the shape memory alloy is nitinol.

42. A method of forming an anatomical corridor comprising:

applying a longitudinal force to advance a piercing catheter through an anatomical feature, wherein the piercing catheter comprises;

an elongate member;

a hollow chisel having a passage therein, with proximal and distal ends, wherein the distal end actuates between an open and closed position, wherein the distal end opens when the elongate member passes through the distal end, wherein the distal end closes to form the tip when the elongate member is removed from the distal end; and

a catheter with its distal end attached to the chisel'"'"'s proximate end such that the catheter and the chisel circumscribe the elongate member.

43. The method of claim 42, further comprising reciprocating the elongate member in and out of the chisel'"'"'s distal end to actuate the chisel between a sharp tip and blunt tip as the catheter is advanced through the anatomical feature.

44. The method of claim 42, wherein the elongate member is a guidewire, a catheter, or fiber.

45. The method of claim 42, wherein the chisel comprises a shape memory alloy.

46. The method of claim 45, wherein the shape memory alloy is nitinol.

47. The method of claim 42, wherein the tip has at least two portions, at least one of which is moveable in response to axial displacement of the elongate member.

48. The method of claim 42, wherein when the elongate member is withdrawn out of the chisel'"'"'s distal end, a sharp tip forms.

49. The method of claim 42, wherein the elongate member can be reciprocated in and out of the chisel passage to actuate the chisel between a sharp tip and a blunt tip.

50. The method of claim 42, wherein when the elongate member is pushed through and out of the distal end of the chisel, the chisel tip opens to generally conform to the outer diameter of the wire.

51. The method of claim 42, wherein when the elongate member is pushed through and out of the distal end of the chisel, the chisel tip opens to generally conform to the outer diameter of the wire.

52. A method of sub-intimal dissection of a vessel comprising:

inserting a guidewire into an occluded vessel proximate an occlusion;

advancing the guidewire into the sub-intimal space of the occluded vessel so the distal end of the elongate member has bypassed the occlusion;

advancing a reentry catheter with a tearable sheath over the elongate member so that the reentry catheter'"'"'s distal end is proximate the distal end of the elongate member;

withdrawing the guidewire;

advancing a larger elongate member distal the side-port and thereby tearing the tearable sheath;

withdrawing the larger elongate member proximal the side-port and thereby actuating the ramp; and

applying a longitudinal force to advance the larger elongate member up the ramp.

54. The method of claim 52, wherein the larger elongate member is a piercing catheter.

53. A method of perforating a vessel comprising:

inserting a guidewire into a vessel proximate a perforation site;

advancing a reentry catheter with a tearable sheath over the elongate member so that the reentry catheter'"'"'s distal end is proximate the distal end of the elongate member;

withdrawing the guidewire;

advancing a larger elongate member distal the side-port and thereby tearing the tearable sheath;

withdrawing the larger elongate member proximal the side-port and thereby actuating the ramp; and

applying a longitudinal force to advance the larger elongate member up the ramp to the perforation site.

55. A method of percutaneous treatment of an occlusion comprising:

inserting an elongate member into an occluded vessel proximate an occlusion;

advancing a piercing catheter over the elongate member to a position beyond the distal end of the elongate member such that a tip is formed at the distal end of the piercing catheter, wherein the piercing catheter comprises;

a hollow chisel having a passage therein, with proximal and distal ends, wherein the distal end actuates between an open and closed position, wherein the distal end opens when the elongate member passes through the distal end, wherein the distal end closes to form the tip when the elongate member is removed from the distal end; and

a catheter with its distal end attached to the chisel'"'"'s proximate end such that the catheter and the chisel circumscribe the elongate member;

applying a longitudinal force to advance the piercing catheter into the occlusion;

withdrawing the piercing catheter proximal the distal end of the elongate member;

advancing the elongate member into a sub-intimal space of the occluded vessel on a proximal side of the occlusion and to a distal side of the occlusion;

advancing a piercing catheter over the elongate member to a position proximate the distal end of the elongate member;

advancing a reentry catheter over the piercing catheter,

wherein the reentry catheter has a side port and a ramp near the distal end;

wherein when the ramp is not actuated, the side port is closed and when the ramp is actuated the side port opens and the ramp is presented for directing the piercing catheter or elongate member through the side port; and

wherein the ramp is actuated when the distal end of elongate member and piercing catheter is proximate the side port;

retracting the elongate member and piercing catheter to actuate the ramp; and

applying a longitudinal force to advance the piercing catheter up the ramp to re-enter the occluded vessel on a distal side of the occlusion.

56. A method of perforating a vessel comprising:

inserting a guidewire into a vessel proximate a perforation site;

advancing a reentry catheter comprising a distal end side-port and ramp over the elongate member so that the reentry catheter'"'"'s distal end is proximate the distal end of the elongate member;

advancing an elongate member distal the side-port;

withdrawing the elongate member and guidewire proximal the side-port and thereby actuating the ramp; and

applying a longitudinal force to advance the elongate member up the ramp to the perforation site.

57. The method of claim 56, wherein the elongate member is a piercing catheter.