Atherectomy device having trapping and excising means for removal of plaque from the aorta and other arteries

• US 6,309,399 B1
• Filed: 09/07/2000
• Issued: 10/30/2001
• Est. Priority Date: 07/17/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Barbut, Denise R., Root, Jonathan D., Pastrone, Giovanni
• Primary Examiner(s): Chaudhuri, Olik
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/656,775
• Time in Patent Office: 418 Days
• Field of Search: 606/200, 606/198, 606/108, 606/159, 606/170, 604/104, 604/22
• US Class Current: 606/159
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• 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 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• 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 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/00287 Bags for minimally invasive surgery
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/22069 Immobilising; Stabilising
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/32004 having a laterally movable cutting member at its most distal end which remains within the contours of said end
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 8/0808 for diagnosis of the brain
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• 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: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2210/127 : Aorta
• 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

An arterial catheter system for removing plaque from the aorta and other arteries is disclosed. The system typically includes an elongate catheter member, a filtration apparatus disposed within the distal region, and an atherectomy assembly which includes a mechanism for trapping and holding mobile or fixed plaque and an excising mechanism for removing the plaque. In use, the catheter is positioned so that the atherectomy assembly lies within a region of interest, the filtration apparatus is deployed downstream of the region of interest, the plaque is trapped and held by a snare, vacuum, or other trapping means, and then the excising mechanism is activated to remove the plaque. Methods are also disclosed for removing plaque from the aorta and other arteries.

Claims

1. A catheter for removing plaque from a blood vessel, comprising:

a flexible elongate member having an outer surface and a distal region;

expansion means disposed at the elongate member which is expandable between a contracted condition and an enlarged condition;

a filter mesh movable relative to the outer surface and having a first edge and a second edge;

the first edge attached to the expansion means;

the second edge closely associated with the outer surface of the flexible elongate member; and

an atherectomy assembly disposed within the distal region of the elongate member, the atherectomy assembly comprising means for plaque removal and trapping means, wherein during use plaque is trapped and held by the trapping means and excised from a blood vessel by the means for plaque removal.

2. The catheter in accordance with claim 1, wherein the flexible elongate member is equipped with steering capabilities.

3. The catheter in accordance with claim 1, wherein the flexible elongate member includes a housing having a cavity adapted to receive and store excised plaque material.

4. The catheter in accordance with claim 1, wherein the expansion means comprises an umbrella frame having a plurality of arms which, upon activation, bend outwardly to the enlarged condition.

5. The catheter in accordance with claim 1, wherein the filter mesh is disposed circumferentially about the elongate member.

6. The catheter in accordance with claim 1, wherein the filter mesh is disposed at a side of the elongate member.

7. The catheter in accordance with claim 1, wherein the filter mesh is disposed distally of a distal end of the elongate member.

8. The catheter in accordance with claim 1, wherein the filter mesh is movable longitudinally relative to the elongate member.

9. The catheter in accordance with claim 1, wherein the atherectomy assembly is disposed within the distal region of the elongate member and distal to the expansion means and the filter mesh.

10. The catheter in accordance with claim 1, wherein the atherectomy assembly is disposed within the distal region of the elongate member and proximal to the expansion means and the filter mesh.

11. The catheter in accordance with claim 1, wherein the elongate member extends through the filter mesh.

12. The catheter in accordance with claim 1, wherein the expansion means comprises an inflation seal.

13. The catheter in accordance with claim 12, wherein the elongate member further comprises an inflation system comprising a first lumen adapted to receive pressurized fluid and a second lumen adapted to evacuate gas, and wherein the inflation seal further includes an entry port in fluid communication with the first lumen of the flexible elongate member, so that when fluid is advanced through the first lumen, the fluid enters the inflation seal and forces gas from the inflation seal through the second lumen, thereby purging the system of gas.

14. The catheter in accordance with claim 13, wherein the inflation seal comprises a tubular balloon which encloses a chamber, and wherein the entry port and exit port are in close proximity, and wherein a septum is disposed between the entry and exit ports.

15. The catheter in accordance with claim 12, further comprising a plurality of holding strings which attach the inflation seal to the flexible elongate member.

16. The catheter in accordance with claim 12, wherein the trapping means comprises a suction device.

17. The catheter in accordance with claim 12, wherein the trapping means comprises a snare.

18. The catheter in accordance with claim 12, wherein the trapping means comprises a surface having an adjustable orifice.

19. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a cutting blade.

20. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a snare.

21. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a surface having an adjustable orifice.

22. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a basket having an adjustable opening adapted to close about the plaque and excise a portion of the plaque by pinching.

23. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a plurality of claws which are movable between an open and closed position.

24. The catheter in accordance with claim 12, wherein the means for plaque removal comprises first and second substantially semispherical surfaces pivotally connected to the elongate member and movable between an open and closed position.

25. The catheter in accordance with claim 12, wherein the means for plaque removal comprises a basket and a cutting wire having a first end anchored to the elongate member and a second end which is drawn in a proximal direction, wherein a segment of the cutting wire sweeps across the opening to the basket during operation.

26. The catheter in accordance with claim 1, further comprising one or more positioning fingers disposed within the distal region of the elongate member.

27. A catheter for removing plaque from a blood vessel, comprising:

a flexible elongate member having an outer surface and a distal region;

an inflation seal expandable between a contracted position and an enlarged condition;

an inflation system comprising a first lumen adapted to receive pressurized fluid and a second lumen adapted to evacuate gas, and wherein the inflation seal further includes an entry port in fluid communication with the first lumen of the flexible elongate member, so that When fluid is advanced through the first lumen, the fluid enters the inflation seal and forces gas from the inflation seal through the second lumen, thereby purging the system of gas;

a filter mesh movable relative to the outer surface and having a first edge and a second edge;

the first edge attached to the inflation seal;

the second edge being disposed circumferentially relative to the outer surface of the flexible elongate member; and

an atherectomy assembly disposed within the distal region of the elongate member, the atherectomy assembly comprising means for plaque removal and trapping means, wherein during use plaque is trapped and held by the trapping means and excised from a blood vessel by the means for plaque removal.

28. The catheter in accordance with claim 27, wherein the flexible elongate member is equipped with steering capabilities.

29. The catheter in accordance with claim 27, wherein the flexible elongate member includes a housing having a cavity adapted to receive and store excised plaque material.

30. The catheter in accordance with claim 27, wherein the inflation seal comprises an umbrella frame having a plurality of arms which, upon activation, bend outwardly to the enlarged condition.

31. The catheter in accordance with claim 27, wherein the atherectomy assembly is disposed within the distal region of the elongate member and distal to the inflation seal and the filter mesh.

32. The catheter in accordance with claim 27, wherein the atherectomy assembly is disposed within the distal region of the elongate member and proximal to the inflation seal and the filter mesh.

33. The catheter in accordance with claim 27, wherein the elongate member extends through the filter mesh.

34. The catheter in accordance with claim 27, wherein the inflation seal comprises a tubular balloon which encloses a chamber, and wherein the entry port and exit port are in close proximity, and wherein a septum is disposed between the entry and exit ports.

35. The catheter in accordance with claim 27, further comprising a plurality of holding strings which attach the inflation seal to the flexible elongate member.

36. The catheter in accordance with claim 27, wherein the trapping means comprises a suction device.

37. The catheter in accordance with claim 27, wherein the trapping means comprises a snare.

38. The catheter in accordance with claim 27, wherein the trapping means comprises a surface having an adjustable orifice.

39. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a cutting blade.

40. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a snare.

41. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a surface having an adjustable orifice.

42. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a basket having an adjustable opening adapted to close about the plaque and excise a portion of the plaque by pinching.

43. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a plurality of claws which are movable between an open and closed position.

44. The catheter in accordance with claim 27, wherein the means for plaque removal comprises first and second substantially semispherical surfaces pivotally connected to the elongate member and movable between an open and closed position.

45. The catheter in accordance with claim 27, wherein the means for plaque removal comprises a basket and a cutting wire having a first end anchored to the elongate member and a second end which is drawn in a proximal direction, wherein a segment of the cutting wire sweeps across the opening to the basket during operation.

46. The catheter in accordance with claim 27, further comprising one or more positioning fingers disposed within the distal region of the elongate member.

47. A catheter for removing plaque from a blood vessel, comprising:

a flexible elongate member having an outer surface and a distal region;

expansion means disposed at the elongate member which is expandable between a contracted condition and an enlarged condition;

a filter mesh longitudinally movable relative to the outer surface and having a first edge and a second edge;

the first edge attached to the expansion means;

the second edge being disposed circumferentially relative to the outer surface of the flexible elongate member; and

an atherectomy assembly disposed within the distal region of the elongate member, the atherectomy assembly comprising means for plaque removal and a suction device, wherein during use plaque is trapped and held by the suction device and excised from a blood vessel by the means for plaque removal.

48. The catheter in accordance with claim 47, wherein the flexible elongate member is equipped with steering capabilities.

49. The catheter in accordance with claim 47, wherein the flexible elongate member includes a housing having a cavity adapted to receive and store excised plaque material.

50. The catheter in accordance with claim 47, wherein the expansion means comprises an umbrella frame having a plurality of arms which, upon activation, bend outwardly to the enlarged condition.

51. The catheter in accordance with claim 47, wherein the atherectomy assembly is disposed within the distal region of the elongate member and distal to the expansion means and the filter mesh.

52. The catheter in accordance with claim 47, wherein the atherectomy assembly is disposed within the distal region of the elongate member and proximal to the expansion means and the filter mesh.

53. The catheter in accordance with claim 47, wherein the elongate member extends through the filter mesh.

54. The catheter in accordance with claim 47, wherein the expansion means comprises an inflation seal.

55. The catheter in accordance with claim 54, wherein the elongate member further comprises an inflation system comprising a first lumen adapted to receive pressurized fluid and a second lumen adapted to evacuate gas, and wherein the inflation seal further includes an entry port in fluid communication with the first lumen of the flexible elongate member, so that when fluid is advanced through the first lumen, the fluid enters the inflation seal and forces gas from the inflation seal through the second lumen, thereby purging the system of gas.

56. The catheter in accordance with claim 55, wherein the inflation seal comprises a tubular balloon which encloses a chamber, and wherein the entry port and exit port are in close proximity, and wherein a septum is disposed between the entry and exit ports.

57. The catheter in accordance with claim 53, further comprising a plurality of holding strings which attach the inflation seal to the flexible elongate member.

58. The catheter in accordance with claim 53, wherein the trapping means comprises a snare.

59. The catheter in accordance with claim 53, wherein the trapping means comprises a surface having an adjustable orifice.

60. The catheter in accordance with claim 53, wherein the means for plaque removal comprises a cutting blade.

61. The catheter in accordance with claim 53, wherein the means for plaque removal comprises a snare.

62. The catheter in accordance with claim 53, wherein the means for plaque removal comprises a surface having an adjustable orifice.

63. The catheter in accordance with claim 54, wherein the means for plaque removal comprises a basket having an adjustable opening adapted to close about the plaque and excise a portion of the plaque by pinching.

64. The catheter in accordance with claim 54, wherein the means for plaque removal comprises a plurality of claws which are movable between an open and closed position.

65. The catheter in accordance with claim 54, wherein the means for plaque removal comprises first and second substantially semispherical surfaces pivotally connected to the elongate member and movable between an open and closed position.

66. The catheter in accordance with claim 54, wherein the means for plaque removal comprises a basket and a cutting wire having a first end anchored to the elongate member and a second end which is drawn in a proximal direction, wherein a segment of the cutting wire sweeps across the opening to the basket during operation.

67. The catheter in accordance with claim 48, further comprising one or more positioning fingers disposed within the distal region of the elongate member.