METHODS AND SYSTEMS FOR PERFORMING NEUROINTERVENTIONAL PROCEDURES

• US 20100204684A1
• Filed: 01/12/2010
• Published: 08/12/2010
• Est. Priority Date: 01/13/2009
• Status: Abandoned Application

• Current Assignee: Neurocorp., Inc
• Original Assignee: Neurocorp., Inc
• Inventors: Garrison, Michi E., Chou, Tony M.
• Application Number:
  US12/686,202
• Publication Number:
  US 20100204684A1
• Time in Patent Office: Days
• US Class Current: 606/1
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A system of devices for treating cerebral artery disease or the brain includes an arterial access sheath adapted to be introduced into a common carotid, internal carotid, or vertebral artery through a penetration in the artery and receive blood from the artery. The system further includes a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site, and a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt. A treatment device is adapted to be introduced into the artery through the arterial access sheath and is configured to treat the cerebral artery or brain.

Claims

1. A system of devices for treating cerebral artery disease or the brain, comprising:

an arterial access sheath adapted to be introduced into a common carotid, internal carotid, or vertebral artery through a penetration in the artery and receive blood from the artery;

a shunt fluidly connected to the arterial access sheath, wherein the shunt provides a pathway for blood to flow from the arterial access sheath to a return site;

a flow control assembly coupled to the shunt and adapted to regulate blood flow through the shunt; and

a treatment device adapted to be introduced into the artery through the arterial access sheath and configured to treat the cerebral artery or brain.

2. A system of devices as in claim 1, further comprising an aspiration source connected to the shunt and adapted to aspirate the artery.

3. A system of devices as in claim 1, wherein the arterial access sheath has a step or taper to a reduced diameter at a distal end of the arterial access sheath to allow insertion of the distal end into a common carotid or vertebral artery while maintaining a larger diameter in the section of sheath outside the artery.

4. A system of devices as in claim 3, wherein the reduced diameter section is between 3 and 5 cm in length.

5. A system of devices as in claim 1, wherein the arterial access sheath has a step or taper to a reduced diameter at the distal end to allow insertion of the distal end into an internal carotid artery, distal vertebral or basilar artery.

6. A system of devices as in claim 5, wherein the reduced diameter section is between 10 and 15 cm in length.

7. A system of devices as in claim 1, further comprising an occlusion element on the distal end of the arterial access sheath.

8. A system of devices as in claim 7, wherein the occlusion element is a balloon.

9. A system of devices as in claim 1, further comprising a closure device adapted to provide a closure force to the penetration.

10. A system of devices as in claim 9, wherein the closure device is a suture-based closure device.

11. A system of devices as in claim 9, wherein the closure device is a self-closing clip.

12. A system of devices as in claim 1, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

13. A system of devices as in claim 1, wherein the treatment device comprises a stent delivery catheter.

14. A system of devices as in claim 1, wherein the treatment device comprises balloon dilatation catheter.

15. A system of devices as in claim 1, wherein the treatment device comprises a balloon occlusion catheter.

16. A system of devices as in claim 1, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

17. A system of devices as in claim 16, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

18. A system of devices as in claim 1, wherein the treatment device comprises a thrombus removal system.

19. A system of devices as in claim 1, wherein the treatment device comprises a diagnostic angiography catheter.

20. A system of devices as in claim 1, wherein the treatment device comprises a brain tumor treatment device.

21. A system of devices for treating cerebral artery disease or the brain, comprising:

an arterial access sheath adapted to be introduced into a common carotid, internal carotid, or vertebral artery through a penetration in the artery and receive blood from the artery;

a treatment device adapted to be introduced into the artery through the arterial access sheath and configured to treat the cerebral artery or the brain; and

a closure device adapted to provide a closure force to the penetration.

22. A system of devices as in claim 21, wherein the closure device is a suture-based closure device.

23. A system of devices as in claim 21, wherein the closure device is a self-closing clip.

24. A system of devices as in claim 21, wherein the closure device is configured to be applied prior to insertion of the sheath.

25. A system of devices as in claim 21, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

26. A system of devices as in claim 21, wherein the treatment device comprises a stent delivery catheter.

27. A system of devices as in claim 21, wherein the treatment device comprises balloon dilatation catheter.

28. A system of devices as in claim 21, wherein the treatment device comprises a balloon occlusion catheter.

29. A system of devices as in claim 21, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

30. A system of devices as in claim 29, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

31. A system of devices as in claim 21, wherein the treatment device comprises a thrombus removal system.

32. A system of devices as in claim 21, wherein the treatment device comprises a diagnostic angiography catheter.

33. A system of devices as in claim 21, wherein the treatment device comprises a brain tumor treatment device.

34. A method for treatment of cerebral artery disease or the brain, comprising:

forming a penetration in a wall of a common carotid, internal carotid, or vertebral artery;

positioning an arterial access sheath through the penetration into the artery;

occluding at least one of the common or internal carotid artery or vertebral or basilar artery; and

treating the cerebral artery or the brain using a treatment device.

35. A method as in claim 34, further comprising establishing retrograde blood flow through the artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath.

36. A method as in claim 35, further comprising causing blood to flow from the shunt to venous sheath and into a venous return site.

37. A method as in claim 34, further comprising causing blood to flow from the shunt to an external receptacle.

38. A method as in claim 34, further comprising regulating the retrograde blood flow.

39. A method as in claim 34, further comprising controlling a state of the retrograde blood flow.

40. A method as in claim 34, further comprising monitoring the retrograde blood flow.

41. A method as in claim 34, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

42. A method as in claim 34, wherein the treatment device comprises a stent delivery catheter.

43. A method as in claim 34, wherein the treatment device comprises balloon dilatation catheter.

44. A method as in claim 34, wherein the treatment device comprises a balloon occlusion catheter.

45. A method as in claim 34, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

46. A method as in claim 45, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

47. A method as in claim 34, wherein the treatment device comprises a thrombus removal system.

48. A method as in claim 34, wherein the treatment device comprises a diagnostic angiography catheter.

49. A method as in claim 34, wherein the treatment device comprises a brain tumor treatment device.

50. A method as in claim 34, wherein the means for occlusion is an occlusion element attached to the arterial access sheath.

51. A method as in claim 50, wherein the occlusion element is a balloon

52. A method as in claim 50, wherein the occlusion element is a mechanical occlusion.

53. A method as in claim 34, further comprising actively aspirating through the arterial access device.

54. A method as in claim 53, wherein the aspiration means comprises a syringe.

55. A method as in claim 53, wherein the aspiration means comprises a suction pump and collection reservoir.

56. A method for treatment of cerebral artery disease or the brain, comprising:

forming a percutaneous penetration in a wall of a common carotid, internal carotid, or vertebral artery;

applying a closure device at a site of penetration before placement of an arterial access sheath;

positioning an arterial access sheath through the penetration into the artery;

treating the cerebral artery or the brain using a treatment device; and

closing the access site with the closure device.

57. A method as in claim 56, wherein the closure device comprises a suture-based closure device.

58. A method as in claim 56, wherein the closure device is a self-closing clip.

59. A method as in claim 56, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

60. A method as in claim 56, wherein the treatment device comprises a stent delivery catheter.

61. A method as in claim 56, wherein the treatment device comprises balloon dilatation catheter.

62. A method as in claim 56, wherein the treatment device comprises a balloon occlusion catheter.

63. A method as in claim 56, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

64. A method as in claim 63, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

65. A method as in claim 56, wherein the treatment device comprises a thrombus removal system.

66. A method as in claim 56, wherein the treatment device comprises a diagnostic angiography catheter.

67. A method as in claim 56, wherein the treatment device comprises a brain tumor treatment device.

68. A method as in claim 56, further comprising occluding at least one of the common or internal carotid artery or vertebral or basilar artery after positioning the arterial access site through the arterial penetration.

69. A method as in claim 68, further comprising establishing retrograde blood flow through the artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath

70. A method as in claim 69, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

71. A method as in claim 69, wherein the treatment device comprises a stent delivery catheter.

72. A method as in claim 69, wherein the treatment device comprises balloon dilatation catheter.

73. A method as in claim 69, wherein the treatment device comprises a balloon occlusion catheter.

74. A method as in claim 69, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

75. A method as in claim 74, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

76. A method as in claim 69, wherein the treatment device comprises a thrombus removal system.

77. A method as in claim 69, wherein the treatment device comprises a diagnostic angiography catheter.

78. A method as in claim 69, wherein the treatment device comprises a brain tumor treatment device.

79. A method for treatment of cerebral artery disease or the brain, comprising:

forming a penetration in a wall of a common carotid, internal carotid or vertebral artery;

positioning an arterial access sheath through the penetration;

inserting a treatment device through the arterial access sheath into the common carotid or vertebral artery;

positioning at least a portion of the treatment device in the cerebral artery;

treating the cerebral artery or the brain using the treatment device.

80. A method as in claim 79, further comprising establishing an embolic protection condition.

81. A method as in claim 80, wherein establishing an embolic protection condition comprises deploying an occlusion element in the common or internal carotid artery or vertebral artery to block the artery.

82. A method as in claim 81, wherein the occlusion element is a balloon.

83. A method as in claim 81, wherein the occlusion element is a mechanical occlusion.

84. A method as in claim 81, wherein the occlusion element is attached to the arterial access sheath.

85. A method as in claim 81, wherein establishing an embolic protection condition further comprises actively aspirating the artery through the arterial access sheath.

86. A method as in claim 81, wherein the arterial access sheath includes a connection to a shunt and establishing an embolic protection condition further comprises establishing retrograde blood flow through the common carotid or vertebral artery such that blood flows into a lumen of the arterial access sheath and into the shunt.

87. A method as in claim 86, further comprising causing blood to flow from the shunt to venous sheath and into a venous return site.

88. A method as in claim 86, further comprising causing blood to flow from the shunt to an external receptacle.

89. A method as in claim 86, further comprising regulating the retrograde blood flow.

90. A method as in claim 86, further comprising controlling a state of the retrograde blood flow.

91. A method as in claim 86, further comprising monitoring the retrograde blood flow.

92. A method as in claim 79, wherein the penetration is formed percutaneously.

93. A method as in claim 92, further comprising applying a closure device to the penetration in the common carotid or vertebral artery to close the penetration.

94. A method as in claim 93, wherein the closure device comprises a suture-based device.

95. A method as in claim 93, wherein the closure device is applied prior to positioning an arterial access sheath through the penetration.

96. A method as in claim 93, wherein the closure device is a self-closing clip.

97. A method as in claim 79, further comprising identifying an indication associated with cerebral artery or cerebral disease.

98. A method as in claim 79, wherein the treatment device comprises an embolic system which delivers an embolic coil, material or fluid composition.

99. A method as in claim 79, wherein the treatment device comprises a stent delivery catheter.

100. A method as in claim 79, wherein the treatment device comprises balloon dilatation catheter.

101. A method as in claim 79, wherein the treatment device comprises a balloon occlusion catheter.

102. A method as in claim 79, wherein the treatment device comprises a microcatheter that delivers a therapeutic agent.

103. A method as in claim 102, wherein the therapeutic agent comprises at least one of a cerebral protective agent, a chemotherapeutic agent, a stem cell, a regenerative agents, a neurochemical agent, or neuropsychopharmacologic agent.

104. A method as in claim 79, wherein the treatment device comprises a thrombus removal system.

105. A method as in claim 79, wherein the treatment device comprises a diagnostic angiography catheter.

106. A method as in claim 79, wherein the treatment device comprises a brain tumor treatment device.