System and method of use for agent delivery and revascularizing of grafts and vessels

• US 20020138088A1
• Filed: 04/12/2002
• Published: 09/26/2002
• Est. Priority Date: 07/26/1996
• Status: Active Grant

• Current Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Nash, John E., Fisher, William T., Dodson, Charles W. Jr.
• Granted Patent: US 6,905,505 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 2017/22048 Balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• 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 opening a lumen in an occluded blood vessel, e.g., a coronary bypass graft, of a living being. The system comprises an atherectomy catheter having a working head, e.g., a rotary impacting impeller, and a debris extraction sub-system. The atherectomy catheter is located within a guide catheter. The working head is arranged to operate on, e.g., impact, the occlusive material in the occluded vessel to open a lumen therein, 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, through the guide catheter to create a differential flow adjacent the working head, whereupon the debris is withdrawn in the infusate liquid and blood for collection outside the being'"'"'s body. The introduction of the infusate liquid may also be used to establish an unbalanced flow adjacent the working head to enable the atherectomy catheter to be steered hydrodynamically. A guide wire having an inflatable balloon on its distal end may be used with the atherectomy catheter to block the flow of debris distally, while enabling distal tissues to be perfused with an oxygenating liquid. At least one flow control port may be provided in the guide catheter to prevent collapse of the vessel being revascularized. A cradle is provided to fix the guide catheter and guide wire in position within the body of the being while enabling the atherectomy catheter to be advanced along the guide wire and through the guide catheter.

Claims

1. An intravascular system for treating a living being via the being'"'"'s vascular system, said intravascular system comprising a catheter, an instrument having a working head, debris extraction means, an infusate liquid and at least one material to be carried by said infusate liquid into the being'"'"'s vascular system, said catheter comprising a distal end portion, said instrument being arranged to be extended through said catheter to form a passageway therebetween, said working head of said instrument being arranged to be located in a portion of a vessel to operate therein, whereupon some debris may be produced by the operation of said working head, said debris extraction means being arranged for introducing said infusate liquid and said at least one material into the being'"'"'s vascular system and creating a differential flow in said lumen, whereupon any debris produced by the operation of said working head is withdrawn by said differential flow through said passageway for collection remote from the vessel portion and is prevented from flowing into any upstream vessel or downstream vessel.

2. The intravascular system of claim 1 wherein said catheter comprises an introducer sheath or guide catheter.

3. The intravascular system of claim 1 wherein said at least one material comprises a drug, pharmaceutical, a biologically active material, or microspheres carrying chemicals.

4. The intravascular system of claim 3 wherein said biologically active material comprises a growth factor.

5. The intravascular system of claim 3 wherein said drug comprises heparin or urokinase.

6. The intravascular system of claim 1 additionally comprising hydrodynamic steering means for steering said instrument.

7. The intravascular system of claim 6 wherein said hydrodynamic steering means comprises a portion of said instrument and is located adjacent the working head, said instrument having a central longitudinal axis and being arranged to be rotated about its central longitudinal axis to bring said hydrodynamic steering means to a desired orientation with respect to the central longitudinal axis of the blood vessel in which said instrument is located.

8. The intravascular system of claim 7 wherein said hydrodynamic steering means produces an unbalance flow of fluid with respect to said instrument to propel said distal end of said instrument laterally of the central longitudinal axis of the blood vessel in which it is located.

9. The intravascular system of claim 1 additionally comprising a debris blocking member.

10. The intravascular system of claim 9 wherein said debris blocking member comprises a balloon.

11. The intravascular system of claim 10 additionally comprising at least one blood entrance port, said debris extraction system being operative to introduce said infusate liquid adjacent said working head and to cause debris and said infusate liquid to flow proximally through said passageway for extraction, said blood entrance port of said catheter being in communication with said passageway and with the patent blood vessel portion, whereupon blood from said patent blood vessel portion may enter for merger with said liquid and the debris.

12. The intravascular system of claim 11 wherein said blood entrance port comprises at least one opening in said catheter located proximally of said distal end portion.

13. The intravascular system of claim 11 wherein said catheter includes an open distal end and wherein said open distal end forms said blood entrance port.

14. The intravascular system of claim 11 wherein said system is configured so that the pressure within the area contiguous with said working head is sufficient to prevent collapse of the vessel.

15. The intravascular system of claim 1 wherein said infusate liquid is introduced adjacent said working head.

16. The intravascular system of claim 1 wherein said infusate liquid exits said working head.

17. The intravascular system of claim 16 wherein said working head is rotatable.

18. The intravascular system of claim 17 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

19. The intravascular system of claim 18 wherein said working head does not engage occlusive material.

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

21. The intravascular system of claim 1 wherein said working head comprises a portion of an occlusion opening device.

22. The intravascular system of claim 21 wherein said occlusion opening device is selected from the group consisting of a balloon angioplasty catheter, an ultrasonic catheter, a stent delivery catheter, a device including a rotary abrasive head, and a device including a rotary cutting head.

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

24. The intravascular system of claim 23 wherein said separate catheter is arranged to deliver a stent.

25. The intravascular system of claim 23 wherein said separate catheter is arranged to deliver said infusate liquid or an irrigation liquid.

27. The intravascular system of claim 26 wherein said system additionally comprises a catheter and wherein said infusate liquid and the debris therein is withdrawn from the occluded blood vessel portion through said catheter.

28. The intravascular system of claim 26 wherein said at least one material comprises at least one drug, pharmaceutical, biologically active material, or microspheres carrying chemicals.

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

30. The intravascular system of claim 29 wherein said drug comprises heparin or urokinase.

31. The intravascular system of claim 26 wherein said working head comprises a movable impacting member.

32. The intravascular system of claim 26 wherein said working head is rotatable.

33. The intravascular system of claim 26 wherein said infusate liquid is introduced adjacent said working head.

34. The intravascular system of claim 26 wherein said infusate liquid exits said working head.

35. The intravascular system of claim 32 wherein said infusate liquid exits said working head.

36. The intravascular system of claim 35 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

37. The intravascular system of claim 36 wherein said working head does not engage occlusive material.

38. The intravascular system of claim 37, wherein said working head further comprises a thrombectomy device.

39. The intravascular system of claim 38, wherein said at least one material comprises urokinase.

40. The intravascular system of claim 26 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

41. The intravascular system of claim 26 wherein said working head comprises a portion of an occlusion opening device.

42. The intravascular system of claim 41 wherein said device comprises a balloon angioplasty catheter, an ultrasonic catheter, a laser catheter, a stent-delivery catheter, a thrombectomy device, a rotary abrasive head, or a rotary cutting head.

43. The intravascular system of claim 26 wherein said working head comprises an ultrasonic catheter.

44. The intravascular system of claim 26 wherein said system additionally comprises a second catheter.

45. The intravascular system of claim 44 wherein said second catheter is arranged to deliver a stent.

46. The intravascular system of claim 44 wherein said second catheter is arranged to deliver said infusate liquid or an irrigation liquid.

48. The intravascular system of claim 47 wherein said barrier means comprises an expandable member.

49. The intravascular system of claim 48 wherein said expandable member comprises a balloon.

50. The intravascular system of claim 47 wherein said at least one material comprises at least one drug, pharmaceutical, biologically active material, or microspheres carrying said at least one drug, pharmaceutical or biologically active material.

51. The intravascular system of claim 50 wherein said biologically active material comprises a growth factor.

52. The intravascular system of claim 40 wherein said drug comprises heparin or urokinase.

53. The intravascular system of claim 47 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 occluded vessel portion.

54. The intravascular system of claim 53 wherein said barrier means forms a portion of a guide wire, said guide wire extending through said instrument.

55. The intravascular system of claim 54 wherein said guide wire is arranged to provide a perfusion liquid downstream of said barrier means.

56. The intravascular system of claim 54 wherein said barrier means comprises an expandable member.

57. The intravascular system of claim 55 wherein said perfusion liquid comprises said infusate liquid, blood, or oxygenated liquid.

58. The intravascular system of claim 57 wherein said infusate liquid is oxygenated.

59. The intravascular system of claim 55 wherein said perfusion liquid comprises said infusate liquid and said at least one material comprises at least one drug, pharmaceutical, biologically active material, or microspheres carrying chemicals.

60. The intravascular system of claim 59 wherein said biologically active material comprises a growth factor.

61. The intravascular system of claim 59 wherein said drug comprises heparin or urokinase.

62. The intravascular system of claim 56 wherein said expandable member comprises a balloon.

63. The intravascular system of claim 62 wherein said guide wire is arranged to provide a perfusion liquid downstream of said balloon.

64. The intravascular system of claim 63 wherein said guide wire is arranged so that said perfusion liquid inflates said balloon and is also provided downstream of said balloon.

65. The intravascular system of claim 47 wherein said infusate liquid is introduced adjacent said working head.

66. The intravascular system of claim 47 wherein said infusate liquid exits said working head.

67. The intravascular system of claim 66 wherein said working head is arranged to introduce said infusate liquid in the form of liquid jets.

68. The intravascular system of claim 67 wherein said working head does not engage occlusive material.

69. The intravascular system of claim 68 wherein said working head further comprises a thrombectomy device.

70. The intravascular system of claim 69 wherein said at least one material comprises urokinase.

71. The intravascular system of claim 47 wherein said working head comprises a balloon angioplasty catheter, an ultrasonic catheter, a laser catheter, a stent-delivery catheter, a thrombectomy device, a rotary abrasive head, or a rotary cutting head.

72. The intravascular system of claim 53 wherein said working head comprises an ultrasonic catheter.

26. An intravascular system for treating a lumen in a portion of vessel of a living being'"'"'s vascular system, the vessel being occluded by an occlusive material, said system comprising a lumen-opening member for introduction into the lumen of the vessel, debris blocking means, pump means, an infusate liquid and at least one material to be carried by said infusate liquid into the being'"'"'s vascular system, said lumen-opening member being arranged to act on the occlusive material in the interior of the occluded vessel to open the lumen for the freer flow of blood therethrough, said lumen opening member comprising a working head, whereupon some debris may be produced from the occlusive material by the action of said lumen-opening member, said debris blocking means being arranged to be located within the occluded vessel distally of said lumen opening member for preventing debris from flowing distally of said debris blocking means, said pump means being arranged for introducing said infusate liquid at a first flow rate and withdrawing said liquid at a second and higher flow rate to create a differential flow adjacent said working head, whereupon any debris produced by the action of said lumen-opening member is withdrawn with said infusate liquid by said differential flow for collection remote from the occluded vessel portion and is prevented from flowing into any upstream vessel or downstream vessel.

47. An intravascular system for treating a lumen in a blood vessel of a living being, the blood vessel being occluded by an occlusive material therein, said system comprising a working head, a pump means, barrier means, an infusate liquid and at least one material to be carried by said infusate liquid into the being'"'"'s vascular system, said working head being arranged to operate on the occlusive material in the interior of the occluded blood vessel to open a lumen therein for the freer flow of fluid therethrough, whereupon some debris may be produced from the occlusive material by the operation of said working head, 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, whereupon any debris produced by the operation of said working head is withdrawn with said liquid by said pump means for collection remote from the occluded vessel portion.

73. A method for treating a lumen in a portion of a blood vessel of a living being'"'"'s vascular system, the blood vessel portion being occluded by an occlusive material, the occluded blood vessel portion being located distally of a patent blood vessel portion, said method comprising:

(a) extending a first catheter through said patent blood vessel portion into said occluded blood vessel portion, said first catheter having a distal end portion and a port located proximally of said distal end portion;

(b) extending a second catheter through said first catheter so that a working portion of said second catheter is located in the occluded blood vessel portion;

(c) blocking the occluded blood vessel portion distally of said working portion of said second catheter;

(d) using said second catheter to open a lumen in the occluded portion of the blood vessel for the freer flow of blood therethrough;

(e) introducing an infusate liquid and at least one material to be carried by said infusate liquid into said occluded blood vessel portion and withdrawing said infusate liquid and any debris produced by the opening of the occluded portion of the blood vessel through a passageway in said first catheter; and

(f) providing a path for blood from the patent blood vessel portion to flow through said port into said passageway for merger with said infusate liquid and said debris.

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

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

76. The method of claim 75 wherein said drug comprises heparin or urokinase.

77. The method of claim 73 additionally comprising the step of:

(g) introducing a third catheter through said first catheter, said third catheter being arranged to carry a stent into the lumen formed in the occluded blood vessel to hold said lumen open.

78. The method of claim 73 additionally comprising the steps of:

(g) extending a third catheter through said first catheter, said third catheter being arranged for introducing said infusate liquid into said occluded blood vessel portion.

79. The method of claim 73 wherein said second catheter is arranged to carry a stent into the occluded blood vessel to open a lumen in the material forming the restriction.

80. The method of claim 79 additionally comprising the step of

(g) introducing a third catheter through said first catheter, said third catheter being arranged to carry a stent into the lumen formed in the occluded blood vessel to hold said lumen open.

81. A method for treating a lumen in a portion of a blood vessel of a living being'"'"'s vascular system, the blood vessel being occluded by an occlusive material, the blood vessel being located distally of a patent blood vessel, said method comprising:

(a) extending a first catheter through said patent blood vessel portion into said occluded blood vessel portion, said first catheter having a distal end portion and a port located proximally of said distal end portion;

(b) blocking the flow of blood and debris distally of a working head;

(c) providing a vessel-opening catheter having said working head and extending said vessel-opening catheter through said first catheter so that said working head is located in the occluded blood vessel portion, said first catheter and said vessel-opening catheter defining a passageway therebetween;

(d) operating said working head to open the occluded blood vessel portion for the freer flow of blood therethrough;

(e) introducing an infusate liquid and at least one material to be carried by said infusate liquid into said occluded blood vessel portion at a first flow rate adjacent said working head and withdrawing said infusate liquid at a second and higher flow rate to create a differential flow adjacent said working head, whereupon blocked debris is withdrawn with said infusate liquid for passage proximally through said passageway; and

(f) providing a path for blood within said patent blood vessel portion to flow into said passageway for merger with said infusate and debris.

82. The method of claim 81 wherein said at least one material comprises at least one drug, pharmaceutical, biologically active material, or microspheres carrying chemicals.

83. The method of claim 82 wherein said biologically active material comprises a growth factor.

84. The method of claim 83 wherein said drug comprises heparin or urokinase.

85. A method for treating a lumen in a portion of a blood vessel of a living being'"'"'s vascular system, the blood vessel being occluded by an occlusive material, the occluded blood vessel being located distally of a patent blood vessel portion, said method comprising:

(a) extending a guide catheter through said patent blood vessel portion into said occluded blood vessel portion;

(b) extending a lumen-opening catheter having a working head through said guide catheter so that said working head is located in the lumen in the occluded blood vessel portion, said guide catheter and said lumen-opening catheter defining a fluid-flow passageway therebetween;

(c) blocking the flow of blood and any debris created distally of said working head;

(d) operating said working head to open the lumen for the freer flow of blood therethrough, wherein said operation comprises introducing an infusate liquid and at least one material to be carried by said infusate liquid into said occluded blood vessel portion at a first flow rate at said working head and withdrawing said infusate liquid at a second and higher flow rate to create a differential flow at said working head, whereupon debris is withdrawn with said infusate liquid for passage proximally through said fluid-flow passageway; and

(e) providing a path for blood within the patent blood vessel portion to flow into said fluid-flow passageway for merger with said infusate liquid and the debris.

86. The method of claim 85 wherein said at least one material comprises at least one drug, pharmaceutical, biologically active material, or microspheres carrying chemicals.

87. The method of claim 86 wherein said biologically active material comprises a growth factor.

88. The method of claim 87 wherein said drug comprises heparin or urokinase.

89. The method of claim 85 wherein said working head comprises liquid jets.