Thrombus treatment with emboli management

• US 20030199917A1
• Filed: 04/22/2002
• Published: 10/23/2003
• Est. Priority Date: 04/22/2002
• Status: Abandoned Application

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: ReShape LifeSciences, Inc.
• Inventors: Knudson, Mark B., Conrad, Timothy R.
• Application Number:
  US10/128,120
• Publication Number:
  US 20030199917A1
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• 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 17/320758 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 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A method for treating a body lumen having a natural occlusion at least partially occluding a flow of body fluid in the lumen includes obstructing the lumen with an artificial occlusion distal to the natural occlusion. The natural occlusion is ablated in a process which may create a plurality of emboli of the natural occlusion on a proximal side of the artificial occlusion. The emboli are removed from the lumen and, subsequently, the artificial occlusion is removed.

Claims

1. A method of treating a body lumen having a natural occlusion at least partially occluding flow of body fluid from flowing proximally from said natural occlusion to locations distal to said natural occlusion, comprising:

obstructing said lumen with a conformal artificial occlusion distal to said natural occlusion;

ablating said natural occlusion to create a plurality of emboli of said natural occlusion on a proximal side of said artificial occlusion;

removing said emboli from said lumen; and

removing said artificial occlusion.

2. A method according to claim 1 wherein said obstructing is achieved by forming said artificial occlusion with said lumen.

11. A method according to claim 2 wherein said artificial occlusion is laden with a therapeutic agent, said method further comprising releasing said agent into said lumen.

12. A method according to claim 2 wherein said artificial occlusion is radiopaque.

13. A method according to claim 11 wherein said agent is released during said removing of said artificial occlusion.

14. A method according to claim 1 wherein said lumen is a lumen of a blood vessel.

15. A method according to claim 14 wherein said blood vessel is a cerebral artery.

16. A method according to claim 14 wherein said blood vessel is a coronary artery.

3. A method according to claim 3 wherein said artificial occlusion is removed without substantial creation of permanent emboli.

4. A method according to claim 3 wherein said removing of said artificial occlusion is achieved by dissolving said artificial occlusion within said body fluid.

5. A method according to claim 3 wherein said removing of said artificial occlusion is achieved by dissolving said artificial occlusion by application of energy to said artificial occlusion.

6. A method according to claim 3 wherein said removing of said artificial occlusion is achieved by dissolving said artificial occlusion by application of chemical solvents to said artificial occlusion.

7. A method according to claim 6 wherein said solvents are contained within said artificial occlusion and selectively activated therein.

8. A method according to claim 3 wherein said removing of said artificial occlusion is achieved by mechanically ablating said artificial occlusion with said artificial occlusion formed from a material selected to form emboli dissolvable in said body fluid.

9. A method according to claims 3 wherein said artificial occlusion is formed from a hydrogel.

10. A method according to claim 9 wherein said hydrogel is delivered to said lumen distal to said natural occlusion in an unswelled state and swells to seal said lumen distal to said natural occlusion.

17. An apparatus for treating a body lumen having a natural occlusion at least partially occluding flow of body fluid from flowing proximally from said natural occlusion to locations distal to said natural occlusion, comprising:

a delivery member sized to be passed through said body lumen proximal to said natural occlusion and having a distal end adapted to be passed through said natural occlusion to a position distal to said natural occlusion; and

said delivery member including a delivery port adjacent said distal end for delivery of an artificial occlusion into said lumen distal to said natural occlusion.

18. An apparatus according to claim 17 wherein said delivery member includes an internal cavity in communication with said delivery port and containing a material selected to form said artificial occlusion upon ejection of said material through said delivery port.

19. An apparatus according to claim 18 wherein said cavity is sized to contain a complete bolus of said material adjacent said delivery port.

20. An apparatus according to claim 18 wherein said cavity is a lumen through said delivery member connected to a source of said material at a proximal end of said delivery member.

21. An apparatus according to claim 18 further comprising an actuator for delivering said material from said delivery port.

22. An apparatus according to claim 18 wherein said material is susceptible to swelling within said lumen and said material is contained within said cavity in an unswelled state.

23. An apparatus according to claim 18 wherein said material is a hydrogel.

24. An apparatus according to claim 17 wherein said distal end includes a sensor for sensing when said distal end has passed through a distal side of said natural occlusion.

25. An apparatus according to claim 24 wherein said sensor includes a member for sensing a resistance of said natural occlusion to movement of said distal end through said natural occlusion.

26. An apparatus according to claim 24 wherein said sensor includes a member for sensing a change in a characteristic parameter between said natural occlusion and said body fluid.

27. An apparatus according to claim 18 wherein said material is dissolvable within said body fluid.

28. An apparatus according to claim 18 wherein said material is dissolvable by application of energy to said artificial occlusion.

29. An apparatus according to claim 18 wherein said material is dissolvable by application of chemical solvents to said artificial occlusion.

31. An apparatus according to claim 18 wherein said material is removably by mechanically ablating said artificial occlusion with said material selected to form emboli dissolvable in said body fluid.

32. An apparatus according to claim 18 wherein said material is laden with a therapeutic agent.

33. An apparatus according to claim 18 wherein said material is radiopaque.

34. An apparatus according to claim 17 wherein said lumen is a lumen of a blood vessel.

35. An apparatus according to claim 34 wherein said blood vessel is a cerebral artery.

36. An apparatus according to claim 34 wherein said blood vessel is a coronary artery.

30. An apparatus according to claim 30 wherein said solvents are contained within said material and selectively activated therein.

37. A kit for treating a body lumen having a natural occlusion at least partially occluding flow of body fluid from flowing proximally from said natural occlusion to locations distal to said natural occlusion, comprising:

an occlusion-creating member for obstructing said lumen with a material creating a conformal artificial occlusion distal to said natural occlusion;

an ablator for ablating said natural occlusion to create a plurality of emboli of said natural occlusion on a proximal side of said artificial occlusion; and

an emboli-removing member for removing said emboli from said lumen.

38. A kit according to claim 37 wherein said obstruction-creating member includes:

a delivery member sized to be passed through said body lumen proximal to said natural occlusion and having a distal end adapted to be passed through said natural occlusion to a position distal to said natural occlusion; and

said delivery member including a delivery port adjacent said distal end for delivery of a artificial occlusion into said lumen distal to said natural occlusion.

39. A kit according to claim 38 wherein said delivery member includes an internal cavity in communication with said delivery port and containing said material selected to form said artificial occlusion upon ejection of said material through said delivery port.

40. A kit according to claim 38 wherein said cavity is sized to contain a complete bolus of said material adjacent said delivery port.

41. A kit according to claim 38 wherein said cavity is a lumen through said delivery member connected to a source of said material at a proximal end of said delivery member.

42. A kit according to claim 38 further comprising an actuator for delivering said material from said delivery port.

43. A kit according to claim 38 wherein said material is susceptible to swelling within said lumen and said material is contained within said cavity in an unswelled state.

44. A kit according to claim 37 wherein said material is a hydrogel.

45. A kit according to claim 38 wherein said distal end includes a sensor for sensing when said distal end has passed through a distal side of said natural occlusion.

46. A kit according to claim 45 wherein said sensor includes a member for sensing a resistance of said natural occlusion to movement of said distal end through said natural occlusion.

47. A kit according to claim 45 wherein said sensor includes a member for sensing a change in a characteristic parameter between said natural occlusion and said body fluid.

48. A kit according to claim 37 wherein said material is dissolvable within said body fluid.

49. A kit according to claim 37 wherein said material is dissolvable by application of energy to said artificial occlusion.

50. A kit according to claim 37 wherein said material is dissolvable by application of chemical solvents to said artificial occlusion.

51. A kit according to claim 50 wherein said solvents are contained within said material and selectively activated therein.

52. A kit according to claim 37 wherein said material is removably by mechanically ablating said artificial occlusion with said material selected to form emboli dissolvable in said body fluid.

53. A kit according to claim 37 wherein said material is laden with a therapeutic agent.

54. A kit according to claim 37 wherein said material is radiopaque.

55. A kit according to claim 37 wherein said lumen is a lumen of a blood vessel.

56. A kit according to claim 55 wherein said blood vessel is a cerebral artery.

57. A kit according to claim 55 wherein said blood vessel is a coronary artery.

58. A method of treating a first blood vessel defining a first lumen having a natural occlusion at least partially occluding flow of blood from flowing proximally from said natural occlusion to locations distal to said natural occlusion and wherein a second blood vessel having a second lumen resides adjacent said first blood vessel distal to said natural occlusion, comprising:

advancing a first member through said second lumen to a position adjacent said first vessel distal to said natural occlusion;

urging said member against a wall of the second vessel to impinge upon the first vessel urging said first vessel to form an artificial occlusion distal to said natural occlusion;

ablating said natural occlusion to create a plurality of emboli of said natural occlusion on a proximal side of said artificial occlusion;

removing said emboli from said lumen; and

removing said artificial occlusion.