System and method of use for treating occluded vessels and diseased tissue

• US 6,830,577 B2
• Filed: 01/28/2002
• Issued: 12/14/2004
• Est. Priority Date: 07/26/1996
• Status: Expired due to Term

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Hoganson, David M., Evans, Douglas G., Nash, John E.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US10/058,556
• Publication Number:
  US 20020198550A1
• Time in Patent Office: 1,051 Days
• Field of Search: 606/159, 606/114, 606/113, 606/167, 606/180, 606/195, 606/192, 604/22
• US Class Current: 606/159
• 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 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22048 Balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2205/05 combined with other kinds of therapy
• CPC Class Codes: A61M 5/14232 Roller pumps

Abstract

A system and method for treating diseased target tissue of a living being. The system comprises a working head, e.g., a rotary impacting impeller, a stent delivery catheter, a flush catheter, or liquid jets, a debris extraction sub-system, and may have barrier means in certain embodiments. The working head is arranged to treat diseased tissue, e.g., at least partially occluded with atherosclerotic plaque, or surrounding tissue being compromised by a disease such as cancer, in vessels or lumens, whereupon some debris may be produced. The debris extraction sub-system introduces an infusate liquid at a first flow rate adjacent the working head and withdraws that liquid and some blood at a second and higher flow rate, to create a differential flow adjacent the working head. The introduction of the infusate liquid may also be used to deliver drugs and other therapies systemically or locally, between the working head and the distal protection barrier.

Claims

1. A system for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head engages said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.

2. The system of claim 1 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.

3. The system of claim 1 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

4. The system of claim 3 wherein said liquid jets cause penetration of said infusate into said diseased target tissue.

5. The system of claim 4 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

6. The system of claim 5 wherein said biologically active material comprises a growth factor.

7. The system of claim 5 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.

8. The system of claim 1 wherein said barrier means is offset relative to said working head, with said offset causing said working head to engage said vessel or lumen.

9. The system of claim 1 wherein said barrier means comprises a balloon, filter, or other expandable member.

10. The system of claim 1 wherein said working head and said barrier means are arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.

11. The system of claim 1 wherein said system additionally comprises a separate catheter.

12. The system of claim 11 wherein said separate catheter is arranged to deliver a stent.

13. The system of claim 11 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.

14. The system of claim 1 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.

15. A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head, a pump means, and barrier means, said working head being arranged to treat occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, whereupon some debris may be produced from the occlusive material by said treatment, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said barrier means being arranged for location downstream of said working head and activatable to restrict the flow of the debris downstream of said barrier means, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of the target tissue.

16. The system of claim 15 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

17. The system of claim 16 wherein said jets are arranged to cause turbulent flow.

18. The system of claim 17 wherein said turbulent flow facilitates diffusion of said infusate into said diseased target tissue.

19. The system of claim 18 wherein said introduction of infusate liquid is separated from withdrawing of said liquid by a dwell time.

20. The system of claim 19 wherein said dwell time facilitates the diffusion or penetration of said infusate into said diseased target tissue.

21. The system of claim 15 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.

22. The system of claim 15 wherein said introduction of infusate liquid is separated from withdrawing of said liquid by a dwell time.

23. The system of claim 22 wherein said dwell time is predetermined.

24. The system of claim 20 wherein said dwell time comprises a through-flow stage, wherein said through-flow stage comprises introduction of a second infusate at a third rate and withdrawing said second infusate at said third rate.

25. The system of claim 15 wherein said barrier means comprises an expandable member.

26. The system of claim 25 wherein said expandable member comprises a balloon.

27. The system of claim 15 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

28. The system of claim 27 wherein said biologically active material comprises a growth factor.

29. The system of claim 27 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.

30. The system of claim 15 wherein said system additionally comprises a flexible instrument and wherein said working head comprises a portion of said instrument, said instrument being arranged to be passed through the being'"'"'s body so that said working head is located adjacent the diseased target tissue.

31. The system of claim 15 wherein said working head and said barrier means are arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.

32. The system of claim 15 wherein said system additionally comprises a separate catheter.

33. The system of claim 32 wherein said separate catheter is arranged to deliver a stent.

34. The system of claim 32 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.

35. The system of claim 15 wherein said system comprises a working head locater member, wherein said working head locater member serves to position said working head in said vessel or lumen.

36. The system of claim 35 wherein said working head locator member comprises said barrier means.

37. The system of claim 35 wherein said position is approximately on the center-line of said vessel or lumen.

38. The system of claim 15 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.

39. A system for treating diseased target tissue in a living being, wherein the diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said system comprising a working head and pump means, said working head being arranged to treat the occlusive material or the interior of the lumen to open or maintain flow of fluid therethrough or to treat said diseased tissue, wherein said working head is arranged to eject infusate liquid toward said interior surface and wherein said working head does not engage said occlusive material or said interior surface during said treatment, said pump means introducing an infusate liquid at a first flow rate at said working head and withdrawing said liquid at a second flow rate higher than said first flow rate, thereby creating a differential flow, said infusate liquid comprising at least one material, whereupon at least a portion of any debris produced by the treatment is withdrawn with said liquid by said pump means for collection remote from the site of target tissue.

40. The system of claim 39 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging device, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.

41. The system of claim 39 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

42. The system of claim 41 wherein said jets are arranged to cause turbulent flow.

43. The system of claim 42 wherein said turbulent flow facilitates diffusion of said infusate into said diseased target tissue.

44. The system of claim 39 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

45. The system of claim 44 wherein said biologically active material comprises a growth factor.

46. The system of claim 44 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.

47. The system of claim 39 wherein said system additionally comprises a flexible instrument and wherein said working head comprises a portion of said instrument, said instrument being arranged to be passed through the being'"'"'s body so that said working head is located adjacent the diseased target tissue.

48. The system of claim 39 wherein said working head is arranged to be inserted or retracted through a deployed stent or other intraluminal prosthesis.

49. The system of claim 39 wherein said system additionally comprises a separate catheter.

50. The system of claim 49 wherein said separate catheter is arranged to deliver a stent.

51. The system of claim 49 wherein said separate catheter is arranged to deliver said infusate or irrigation liquid.

52. The system of claim 39 wherein said system comprises a working head locater member, wherein said working head locater member serves to position said working head in said vessel or lumen.

53. The system of claim 52 wherein said working head locator member comprises a barrier means.

54. The system of claim 52 wherein said position is approximately on the center-line of said vessel or lumen.

55. The system of claim 53 wherein said diseased target tissue is located near a branched portion of said vessel or lumen, said system further comprising a second barrier means arranged to be disposed in said branched portion.

56. A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located within a portion of a patent vessel or lumen portion, said method comprising, in no certain order:

(a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue;

(b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue;

(c) providing a barrier means to be arranged distally of said working head, and positioning said barrier means distally of said diseased target tissue to block the flow of infusate, blood, and/or any debris created; and

(d) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon at least a portion of any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.

57. The method of claim 56 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

58. The method of claim 57 wherein said biologically active material comprises a growth factor.

59. The method of claim 57 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.

60. The method of claim 56 wherein said working head is selected from the list consisting of a balloon angioplasty catheter, a diagnostic instrument, an imaging catheter, an ultrasonic catheter, a laser catheter, an irrigation catheter, a stent-delivery catheter, a rotary abrasive head, or a rotary cutting head.

61. The method of claim 56 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

62. The method of claim 61 wherein said liquid jets cause penetration of said infusate into said diseased target tissue.

63. The method of claim 56 wherein said guiding catheter comprises an insertion sheath.

64. The method of claim 56 wherein said barrier means is offset relative to said working head, with said offset causing said working head to engage said vessel or lumen.

65. The method of claim 56 wherein said method additionally comprises:

(e) supplying a separate catheter, wherein said separate catheter is located in the vessel or lumen proximate with said diseased target tissue and said separate catheter being arranged to deliver a stent.

66. The method of claim 56 wherein said method additionally comprises:

(e) supplying a separate catheter, wherein said separate catheter is located in said vessel or lumen proximate with said diseased target tissue with said separate catheter being arranged to deliver a stent;

(f) said working head being arranged to be inserted through a delivered stent; and

(g) employing said second catheter to deliver said stent.

67. The method of claim 66 wherein said working head comprises an irrigation catheter.

68. The method of claim 67 wherein said stent is delivered prior to the operation of said working head.

69. The method of claim 68 wherein said method further comprises:

(h) moving said working head such that it traverses at least the length of said stent during its operation.

70. The method of claim 56 wherein said diseased target is located near a branched portion of said vessel or lumen, said method further comprising:

(e) supplying a second barrier means arranged to be disposed in said branched portion;

(f) expanding said second barrier means in said branched portion prior to the operation of said working head, thereby blocking the flow of infusate, blood, and/or any debris created by the operation of said working head downstream through said branched portion.

71. A method for treating diseased target tissue in a living being, wherein said diseased target tissue comprises vessels or lumens at least partially occluded by an occlusive material therein or vessels or lumens with surrounding tissue disease, said vessel or lumen comprising an interior surface and surrounding tissue, said diseased target tissue being located distally of a patent vessel or lumen portion, said method comprising:

(a) extending a guiding catheter into said patent vessel or lumen portion into a position proximal to said diseased target tissue;

(b) extending a flexible member having a working head through said guiding catheter so that said working head is located in the vessel or lumen proximate with said diseased target tissue; and

(c) operating said working head to treat said vessel or lumen comprising said diseased target tissue, wherein said operation comprises introducing an infusate at a first flow rate at said working head and withdrawing said infusate at a second and higher flow rate to create a differential flow at said working head, whereupon any debris produced is withdrawn with said infusate, wherein said infusate comprises at least one material.

72. The method of claim 71 wherein said guiding catheter comprises an insertion sheath.

73. The method of claim 71 wherein said at least one material comprises saline, contrast, a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

74. The method of claim 73 wherein said biologically active material comprises a growth factor.

75. The method of claim 73 wherein said drug comprises anti-restenosis agents, anti-thrombogenic agents, anti-spasm agents, anti-proliferation agents, and anti-inflammatory agents.