METHODS AND SYSTEMS FOR TREATMENT OF ACUTE ISCHEMIC STROKE

• US 20100217276A1
• Filed: 12/22/2009
• Published: 08/26/2010
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Hyde, Gregory M., Chou, Tony M.
• Granted Patent: US 10,226,563 B2
• Time in Patent Office: Days
• US Class Current: 606/128
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• 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: 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 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0031 characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• 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 2205/7545 for solid matter, e.g. microaggregates
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 2007/0043 : intra-cavitary
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and devices are disclosed that enable safe, rapid and relatively short and straight access to the cerebral arteries for the introduction of interventional devices to treat acute ischemic stroke. In addition, the disclosed methods and devices provide means to securely close the access site to the cerebral arteries to avoid the potentially devastating consequences of a transcervical hematoma.

Claims

1. A system of devices for treating acute ischemic stroke, comprising:

an arterial access sheath adapted to be introduced into a common carotid, internal carotid, or vertebral 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 therapeutic device adapted to be introduced into the artery through the arterial access sheath and configured to treat a thrombotic blockage from a cerebral artery.

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

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 sub-selective sheath adapted to be inserted through the arterial access sheath into an artery, and wherein the shunt is fluidly connected to the sub-selective sheath rather than the arterial access sheath.

10. A system of devices as in claim 9, further comprising an occlusion element on the distal end of the sub-selective sheath.

11. A system of devices as in claim 10, wherein the occlusion element is a balloon.

12. A system of devices as in claim 1, further comprising a telescoping extension to the arterial access sheath, wherein the telescoping extension is adapted to be inserted through the arterial access sheath and positioned such that at least a portion of the telescoping extension overlaps with the arterial access sheath and a portion extends distal from the sheath into the artery, and wherein once positioned, the inner lumen of the telescoping extension is contiguous with the inner lumen of the arterial access sheath.

13. A system of devices as in claim 12, further comprising an occlusion element on the distal end of the telescoping element.

14. A system of devices as in claim 13, wherein the occlusion element is a balloon.

15. A system of devices as in claim 1, wherein the therapeutic device includes a device adapted to remove a thrombotic blockage.

16. A system of devices as in claim 15, wherein the device to adapted to remove a thrombotic blockage comprises at least one of a coil, a basket, a snare, or a grasper.

17. A system of devices as in claim 1, wherein the therapeutic device includes a device adapted to disrupt a thrombotic blockage.

18. A system of devices as in claim 17, wherein the device adapted to disrupt a thrombotic blockage comprises at least one of a mechanical, hydraulic or vortex, sonic, ultrasonic, or other energy source.

19. A system of devices as in claim 1, wherein the therapeutic device includes a device adapted to aspirate the thrombotic blockage or debris generated from the thrombotic blockage.

20. A system of devices as in claim 1, wherein the therapeutic device includes a device adapted to infuse thrombolytic agents into a thrombotic blockage.

21. A system of devices as in claim 1, wherein the therapeutic device is a device adapted to establish a lumen through the thrombotic blockage.

22. A system of devices as in claim 21, wherein the device adapted to establish a lumen through the thrombotic blockage comprises at least one of a balloon catheter, a temporary stent, or a permanent stent.

23. A system of devices for treating acute ischemic stroke, comprising:

an arterial access sheath adapted to be introduced into a common carotid or vertebral 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 perfusion catheter adapted to be introduced in into the artery through the arterial access sheath and positioned in a site adjacent to or through a thrombotic blockage in a cerebral artery, wherein the perfusion catheter has at least one perfusion lumen for perfusing fluid into the cerebral artery.

24. A system as in claim 23, wherein the perfusion catheter contains exit holes in a side wall and in a distal end of a distal region of the catheter.

25. A system as in claim 23, wherein the perfusion catheter further comprises an occlusion balloon near the distal end of the catheter, configured to occlude the cerebral artery.

26. A system as in claim 25, wherein the perfusion catheter contains exit holes distal to the occlusion balloon.

27. A system as in claim 25, wherein the perfusion catheter contains exit holes both distal to and proximal to the occlusion balloon.

28. A system as in claim 27, wherein the distal and proximal exit holes are connected to a single perfusion lumen.

29. A system as in claim 27, wherein the distal exit holes are connected to one perfusion lumen, and the proximal exit holes are connected to a second, independent perfusion lumen.

30. A method for accessing a cerebral artery to treat acute ischemic stroke, 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 a thrombotic blockage in the cerebral artery.

31. A method as in claim 30, 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.

32. A method as in claim 31, further comprising causing blood to flow from the shunt to venous sheath and into a venous return site.

33. A method as in claim 31, further comprising causing blood to flow from the shunt to an external receptacle.

34. A method as in claim 31, further comprising regulating the retrograde blood flow.

35. A method as in claim 31, further comprising controlling a state of the retrograde blood flow.

36. A method as in claim 31, further comprising monitoring the retrograde blood flow.

37. A method as in claim 31, wherein treating a thrombotic blockage comprises inserting a treatment device through the arterial access sheath and positioning at least a portion of the treatment device in the cerebral artery for the purpose of at least removing or disrupting the thrombotic blockage.

38. A method as in claim 37, wherein removing the thrombotic blockage further comprises aspirating the thrombotic blockage or debris generated from the thrombotic blockage

39. A method as in claim 31, wherein treating a thrombotic blockage comprises establishing a lumen through the thrombotic blockage

40. A method as in claim 39, wherein establishing a lumen comprises implanting a temporary or permanent stent in the thrombotic blockage.

41. A method as in claim 39, wherein establishing a lumen comprising inflating a balloon in the thrombotic blockage.

42. A method as in claim 31, wherein treating a thrombotic blockage comprises infusing a bolus of thrombolytic drug through the arterial access sheath to the thrombotic blockage in the cerebral artery.

43. A method as in claim 42, further comprising positioning a micro catheter through the arterial access sheath to a site adjacent to the thrombotic blockage, and wherein infusing the bolus of thrombolytic drug comprises infusing through the micro catheter.

44. A method as in claim 30, wherein the means for occlusion is an occlusion element attached to the arterial access sheath.

45. A method as in claim 44, wherein the occlusion element is a balloon

46. A method as in claim 44, wherein the occlusion element is a mechanical occlusion.

47. A method as in claim 30, further comprising actively aspirating through the arterial access device.

48. A method as in claim 47, wherein aspiration means comprises a syringe.

49. A method as in claim 47, wherein aspiration means comprises a suction pump and collection reservoir.

50. A method for accessing a cerebral artery to treat acute ischemic stroke, 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 a thrombotic blockage in the cerebral artery; and

closing the access site with the closure device.

51. A method as in claim 50, wherein the closure device comprises a suture-based closure device.

52. A method as in claim 50, wherein the closure device is a self-closing clip.

53. A method as in claim 50, wherein treating a thrombotic blockage comprises inserting a treatment device through the arterial access sheath and positioning at least a portion of the treatment device in the cerebral artery for at least the purpose of removing or disrupting the thrombotic blockage.

54. A method as in claim 53, wherein removing the thrombotic blockage further comprises aspirating the thrombotic blockage or debris generated from the thrombotic blockage

55. A method as in claim 50, wherein treating a thrombotic blockage comprises establishing a lumen through the thrombotic blockage

56. A method as in claim 55, wherein establishing a lumen comprises implanting a temporary or permanent stent in the thrombotic blockage.

57. A method as in claim 55, wherein establishing a lumen comprises inflating a balloon in the thrombotic blockage.

58. A method as in claim 50, wherein treating a thrombotic blockage comprises infusing a bolus of thrombolytic drug through the arterial access sheath to the thrombotic blockage in the cerebral artery.

59. A method as in claim 58, further comprising positioning a micro catheter through the arterial access sheath to a site adjacent to the thrombotic blockage, and wherein infusing the bolus of thrombolytic drug comprises infusing through the micro catheter.

60. A method as in claim 50, 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.

61. A method as in claim 60, 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

62. A method as in claim 61, wherein treating a thrombotic blockage comprises inserting a treatment device through the arterial access sheath and positioning at least a portion of the treatment device in the cerebral artery for the purpose of removing or disrupting the thrombotic blockage.

63. A method as in claim 62, wherein removing the thrombotic blockage further comprises aspirating the thrombotic blockage or debris generated from the thrombotic blockage

64. A method as in claim 61, wherein treating a thrombotic blockage comprises establishing a lumen through the thrombotic blockage

65. A method as in claim 64, wherein establishing a lumen comprises implanting a temporary or permanent stent in the thrombotic blockage.

66. A method as in claim 64, wherein establishing a lumen comprises inflating a balloon in the thrombotic blockage.

67. A method as in claim 61, wherein treating a thrombotic blockage comprises infusing a bolus of thrombolytic drug through the arterial access sheath to the thrombotic blockage in the cerebral artery.

68. A method as in claim 67, further comprising positioning a micro catheter through the arterial access sheath to a site adjacent to the thrombotic blockage, and wherein infusing the bolus of thrombolytic drug comprises infusing through the micro catheter.

69. A method as in claim 50, further comprising identifying an indication associated with acute ischemic stroke.

70. A method as in claim 50, further comprising establishing a cerebral perfusion condition.

71. A method as in claim 70, wherein establishing a cerebral perfusion condition comprises placing at least a portion of a perfusion catheter through the arterial access sheath and positioning a distal tip of the perfusion catheter distal to a thrombotic blockage and perfusing fluid into one or more cerebral arteries.

72. A method as in claim 71, wherein the perfusion fluid is selected from the group consisting of arterial blood, oxygenated solution, or neuroprotective agent.

73. A method as in claim 71, wherein the perfusion fluid is cooled to a temperature in the range 4 to 20°

C.

74. A method as in claim 71, wherein the perfusion catheter includes an occlusion balloon and the perfusion catheter perfuses both distal and proximal to the occlusion balloon.

75. A method as in claim 70, wherein establishing a cerebral perfusion condition comprises placing at least a portion of a perfusion catheter into a cerebral vein and perfusing fluid retrograde into brain tissue.

76. A method for accessing a cerebral artery to treat acute ischemic stroke, 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 artery;

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

removing thrombotic blockage in the cerebral artery using the treatment device.

77. A method as in claim 76, further comprising establishing an embolic protection condition.

78. A method as in claim 77, 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.

79. A method as in claim 78, wherein the occlusion element is a balloon.

80. A method as in claim 78, wherein the occlusion element is a mechanical occlusion.

81. A method as in claim 78, wherein the occlusion element is attached to the arterial access sheath.

82. A method as in claim 78, wherein establishing an embolic protection condition further comprises actively aspirating the artery through the arterial access device.

83. A method as in claim 78, wherein establishing an embolic protection condition further comprises establishing retrograde blood flow through the common carotid artery such that blood flows into a lumen of the arterial access sheath and into a shunt connected to the access sheath.

84. A method as in claim 83, further comprising causing blood to flow from the shunt to venous sheath and into a venous return site.

85. A method as in claim 83, further comprising causing blood to flow from the shunt to an external receptacle.

86. A method as in claim 83, further comprising regulating the retrograde blood flow.

87. A method as in claim 83, further comprising controlling a state of the retrograde blood flow.

88. A method as in claim 83, further comprising monitoring the retrograde blood flow.

89. A method as in claim 76, wherein the penetration is formed percutaneously.

90. A method as in claim 89, further comprising applying a closure device to the penetration in the common carotid artery to close the penetration.

91. A method as in claim 90, wherein the closure device comprises a suture-based device.

92. A method as in claim 90, wherein the closure device is applied prior to positioning an arterial access sheath through the penetration.

93. A method as in claim 90, wherein the closure device is a self-closing clip.

94. A method as in claim 76, further comprising identifying an indication associated with acute ischemic stroke.

95. A method for accessing a cerebral artery to treat acute ischemic stroke, comprising:

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

positioning an arterial access sheath through the penetration;

infusing a thrombolytic drug through the arterial access sheath to a thrombotic blockage in the cerebral artery;

removing thrombotic blockage in the cerebral artery using the thrombolytic drug.

96. A method as in claim 95, further comprising positioning at least a portion of the arterial access sheath in the cerebral artery.

97. A method as in claim 95, further comprising positioning a micro catheter through the arterial access sheath, and wherein the thrombolytic drug is infused through the micro catheter.