DEVICES AND SYSTEMS FOR THROMBUS TREATMENT

• US 20140052103A1
• Filed: 03/13/2013
• Published: 02/20/2014
• Est. Priority Date: 08/14/2012
• 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., Friedman, Nathan L., Zacharias, Eric H.
• Granted Patent: US 9,204,887 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A thrombus treatment device includes a support wire, a body frame portion that is disposed about an axis defined by the support wire, one or more tethers that each have a first end and a second end, and a filter element extending from the body frame portion. Each of the one or more tethers is attached at its first end to the body frame portion, and at its second end to a collar that couples the second end of each of the multiple tethers to the support wire. When the collar is positioned substantially within a region interior of the body frame portion, a rotational actuation of the support wire causes a swiveling motion of the one or more tethers.

Claims

1. A thrombus treatment device, comprising:

a support wire;

a body frame portion that is disposed about an axis defined by the support wire, wherein a longitudinal length of the body frame portion is at least two times as long as an outer diameter of the body frame portion;

a tether portion that includes one or more tethers that extend from the body frame portion to a collar that is coupled to the support wire; and

a filter portion that extends from the body frame portion.

2. The device of claim 1, wherein the longitudinal length of the body frame portion is at least three times as long as the outer diameter of the body frame portion.

3. The device of claim 1, wherein the longitudinal length of the body frame portion is at least four times as long as the outer diameter of the body frame portion.

4. The device of claim 1, wherein the longitudinal length of the body frame portion is at least five times as long as the outer diameter of the body frame portion.

5. The device of claim 1, wherein a longitudinal length of the filter portion is less than or equal to one-half of the longitudinal length of the body frame portion.

6. The device of claim 1, wherein the one or more tethers are adapted to evert to a configuration wherein the one or more tethers are substantially within an area defined by the body frame portion.

7. The device of claim 1, wherein the one or more tethers are comprised of nitinol.

8. The device of claim 1, wherein the one or more tethers are comprised of a polymeric material.

9. The device of claim 1, wherein the device includes multiple tethers that each extend from the body frame portion to the collar that is coupled to the support wire.

10. The device of claim 9, wherein each tether of the multiple tethers is adapted to evert to a configuration wherein each tether of the multiple tethers is substantially within an area defined by the body frame portion.

11. The device of claim 1, wherein the filter portion does not substantially overlap the body frame portion.

12. The device of claim 1, wherein the body frame portion defines a plurality of open-faced cells arranged in at least three rows along the longitudinal length of the body frame portion, and wherein the filter portion overlaps the body frame portion by up to one row of the at least three rows and does not overlap the remaining body frame portion.

13. The device of claim 12, wherein the body frame portion defines from three to ten rows of open-faced cells along the longitudinal length of the body frame portion.

14. The device of claim 1, wherein the filter portion overlaps 20% or less of the longitudinal length of the body frame portion.

15. The device of claim 1, wherein the one or more tethers extend from a proximal end of the body frame portion, and wherein the filter portion extends from a distal end of the body frame portion.

16. A method of treating a thrombus, comprising:

introducing a catheter to a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device through a lumen of the catheter, the thrombus treatment device comprising;

(a) a body frame portion, (b) a tether portion that includes one or more tethers that extend from the body frame portion to a collar that is coupled to a support wire, and (c) a filter portion that extends from the body frame portion, wherein a longitudinal length of the body frame portion is at least two times as long as an outer diameter of the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter,

wherein the body frame portion expands with a radial force sufficient to embed in the thrombus in response to the proximal withdrawal of the catheter.

17. The method of claim 16, wherein the body frame portion is adapted to open a flow channel through or around the thrombus when the body frame portion expands and contacts the thrombus.

18. The method of claim 16, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.

19. The method of claim 16, further comprising pretreating the filter portion with a thrombogenic material or autologous blood.

20. The method of claim 19, wherein the thrombus treatment device acts as an occluder while the thrombogenic material or autologous blood restricts blood flow through the filter portion.

21. The method of claim 20, further comprising delivering a thrombolytic agent to the thrombus.

22. A thrombus treatment device, comprising:

a support tube;

a body frame portion that is disposed about an axis defined by the support tube, the body frame portion including a proximal end and a distal end;

a filter portion that extends from the distal end of the body frame portion; and

multiple tethers each having a first end and a second end, wherein the first end of each of the multiple tethers extends out a proximal end of the support tube, the tethers extending through a lumen of the support tube and out a distal end of the support tube and engaging the body frame portion near the distal end of the body frame portion and extending to the proximal end of the body frame portion, the second end of each of the multiple tethers being attached to the body frame portion near the proximal end of the body frame portion.

23. The device of claim 22, wherein each tether of the multiple tethers forms a loop around the body frame portion near the proximal end of the body frame portion.

24. The device of claim 22, wherein a proximally directed force applied to the first end of each of the multiple tethers causes the distal end of the body frame portion and the proximal end of the body frame portion to collapse radially toward the axis defined by the support tube.

25. The device of claim 22, wherein the multiple tethers collectively form a loop around the body frame portion near the proximal end of the body frame portion.

26. The device of claim 25, wherein a proximally directed force applied to the first end of each of the multiple tethers causes the distal end of the body frame portion and the proximal end of the body frame portion to collapse radially toward the longitudinal axis defined by the support tube.

27. A method of treating a thrombus, comprising:

introducing a catheter to a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device through a lumen of the catheter, the thrombus treatment device comprising;

(a) a support tube, (b) a body frame portion that is disposed about an axis defined by the support tube, the body frame portion including a proximal end and a distal end, (c) a filter portion that extends from the distal end of the body frame portion, and (d) multiple tethers each having a first end and a second end, wherein the first end of each of the multiple tethers extends out a proximal end of the support tube, the tethers extending through a lumen of the support tube and out a distal end of the support tube and engaging the body frame portion near the distal end of the body frame portion and extending to the proximal end of the body frame portion, the second end of each of the multiple tethers being attached to the body frame portion near the proximal end of the body frame portion;

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter, wherein the body frame portion expands with a radial force sufficient to embed in the thrombus in response to the proximal withdrawal of the catheter.

28. The method of claim 27, wherein the body frame portion is adapted to open a flow channel through the thrombus when the body frame portion expands and contacts the thrombus.

29. The method of claim 27, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.

30. The method of claim 27, further comprising pretreating the filter portion with a thrombogenic material or autologous blood.

31. The method of claim 30, wherein the thrombus treatment device acts as an occluder while the thrombogenic material or autologous blood restricts blood flow through the filter portion.

32. The method of claim 31, further comprising delivering a thrombolytic agent to the thrombus.

33. A thrombus treatment device, comprising:

a support wire;

a body frame portion that is disposed about an axis defined by the support wire, wherein a longitudinal length of the body frame portion is at least two times as long as an outer diameter of the body frame portion;

one or more tethers that each extend from a proximal end of the body frame portion to a collar that is coupled to the support wire; and

a filter portion that extends from a distal end of the body frame portion;

wherein the body frame portion defines a plurality of open-faced cells arranged in at least three rows along the longitudinal length of the body frame portion, and wherein the filter portion overlaps up to one row of the at least three rows and does not overlap the remaining rows.

34. The device of claim 33, wherein the longitudinal length of the body frame portion is at least three times as long as the outer diameter of the body frame portion.

35. The device of claim 33, wherein the longitudinal length of the body frame portion is at least four times as long as the outer diameter of the body frame portion.

36. The device of claim 35, wherein the longitudinal length of the body frame portion is at least five times as long as the outer diameter of the body frame portion.

37. A method of treating a thrombus, comprising:

inserting a catheter into a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device through a lumen of the catheter, the thrombus treatment device comprising;

(a) a body frame portion that has a longitudinal length that is at least two times as long as an outer diameter of the body frame portion, (b) a tether portion that includes one or more tethers that each extend from the body frame portion to a collar that is coupled to a support wire, and (c) a filter portion that extends from the body frame portion, wherein the body frame portion defines a plurality of open-faced cells arranged in at least three rows along the longitudinal length of the body frame portion, and wherein the filter portion overlaps up to one row of the at least three rows and does not overlap the remaining rows of the at least three rows;

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter,

wherein the body frame portion expands with a radial force sufficient to embed in the thrombus in response to the proximal withdrawal of the catheter.

38. The method of claim 37, wherein the body frame portion is adapted to open a flow channel through the thrombus when the body frame portion expands and contacts the thrombus.

39. The method of claim 37, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.

40. The method of claim 37, further comprising pretreating the filter portion with a thrombogenic material or autologous blood.

41. The method of claim 40, wherein the thrombus treatment device acts as an occluder while the thrombogenic material or autologous blood restricts blood flow through the filter portion.

42. The method of claim 41, further comprising delivering a thrombolytic agent to the thrombus.

43. A thrombus treatment device, comprising:

a support tube;

a body frame portion that is disposed about an axis defined by the support tube, the body frame portion including a proximal end and a distal end;

a filter portion that extends from the distal end of the body frame portion;

one or more proximal tethers each having first and second ends, wherein the first end of each of the one or more proximal tethers is coupled to the support tube, and wherein the second end of each of the one or more proximal tethers is coupled to the body frame portion; and

one or more distal tethers each having first and second ends, wherein the first end of each of the one or more distal tethers is coupled to the support tube, and wherein the second end of each of the one or more distal tethers is coupled to the body frame portion.

44. The device of claim 43, wherein the one or more distal tethers are movably coupled to the support tube, and wherein the one or more proximal tethers are fixedly coupled to the support tube.

45. The device of claim 43, wherein the one or more distal tethers are fixedly coupled to the support tube, and wherein the one or more proximal tethers are movably coupled to the support tube.

46. The device of claim 43, wherein a distal end of the support tube is located distally of a location where the distal tethers are coupled to the support tube.

47. The device of claim 43, wherein a distal end of the support tube is located distally of the filter portion.

48. The device of claim 43, wherein the distal tethers are located substantially within an interior space defined by the filter portion.

49. The device of claim 43, wherein a longitudinal length of the body frame portion is at least two times as long as an outer diameter of the body frame portion.

50. The device of claim 43, wherein a longitudinal length of the body frame portion is at least three times as long as an outer diameter of the body frame portion.

51. The device of claim 43, wherein a longitudinal length of the body frame portion is at least four times as long as an outer diameter of the body frame portion.

52. The device of claim 43, wherein a longitudinal length of the filter portion is less than or equal to one-half of a longitudinal length of the body frame portion.

53. The device of claim 43, wherein the second end of each of the one or more proximal tethers is coupled to the proximal end of the body frame portion, and wherein the second end of each of the one or more distal tethers is coupled to the distal end of the body frame portion.

54. A method of treating a thrombus, comprising:

inserting a catheter into a patient and advancing a distal end of the catheter to a treatment site;

advancing a thrombus treatment device through a lumen of the catheter, the thrombus treatment device comprising;

a support tube;

a body frame portion that is disposed about an axis defined by the support tube, the body frame portion including a proximal end and a distal end;

a filter portion that extends from the distal end of the body frame portion;

one or more proximal tethers each having first and second ends, wherein the first end of each of the one or more proximal tethers is coupled to the support tube, and wherein the second end of each of the one or more proximal tethers is coupled to the body frame portion; and

one or more distal tethers each having first and second ends, wherein the first end of each of the one or more distal tethers is coupled to the support tube, and wherein the second end of each of the one or more distal tethers is coupled to the body frame portion,

positioning the thrombus treatment device within the lumen of the catheter at a position wherein the body frame portion is generally aligned with at least a portion of a thrombus at the treatment site; and

proximally withdrawing the catheter,

wherein the body frame portion expands with a radial force sufficient to embed in the thrombus in response to the proximal withdrawal of the catheter.

55. The method of claim 54, wherein the body frame portion is adapted to open a flow channel through the thrombus when the body frame portion expands and contacts the thrombus.

56. The method of claim 54, wherein the filter portion is adapted to capture thrombus particles displaced by the expansion of the body frame portion.