INTERVENTIONAL CATHETER SYSTEM AND METHODS

• US 20090254166A1
• Filed: 02/05/2009
• Published: 10/08/2009
• Est. Priority Date: 02/05/2008
• Status: Active Grant

• Current Assignee: Silk Road Medical, Inc.
• Original Assignee: Silk Road Medical, Inc.
• Inventors: Garrison, Michi E., Hyde, Gregory M., Schaer, Alan, Renati, Richard, Chou, Tony M.
• Granted Patent: US 9,669,191 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/3653 Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• 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

Abstract

An interventional catheter is adapted for treating a blood vessel. In an embodiment, the catheter includes an elongate shaft sized for insertion in a blood vessel and a stent positioned on a distal region of the elongate shaft. An expandable dilation member is coupled to a distal region of the elongate shaft. The expandable dilation member is adapted to expand outward. A stent containment member is positioned over the elongate shaft and the stent to contain the stent in a collapsed state.

Claims

1. An interventional catheter for treating a blood vessel, comprising:

an elongate shaft sized for insertion in a blood vessel;

a stent positioned on a distal region of the elongate shaft;

an expandable dilation member coupled to a distal region of the elongate shaft, the expandable dilation member adapted to expand outward; and

a stent containment member positioned over the elongate shaft and the stent to contain the stent in a collapsed state.

2. A catheter as in claim 1, wherein the stent is positioned over the expandable dilation member.

3. A catheter as in claim 1, wherein the stent is positioned distal of the expandable dilation member.

4. A catheter as in claim 1, wherein the stent is positioned proximal of the expandable dilation member.

5. A catheter as in claim 1, wherein the catheter has a working length suitable for deployment through a transcervical access sheath into the common carotid artery.

6. A catheter as in claim 5, wherein the working length is within the range of approximately 40 cm to 60 cm.

7. A catheter as in claim 5, wherein the working length is within the range of approximately 40 cm to 75 cm.

8. A catheter as in claim 1, further comprising a tubing within the elongate shaft, wherein an annular lumen is formed between the tubing and the elongate shaft for inflation of the expandable dilation member.

9. A catheter as in claim 1, wherein the expandable dilatation member is slideably coupled to the elongate shaft

10. A catheter as in claim 1, wherein the expandable dilation member is an inflatable balloon.

11. A catheter as in claim 1, wherein stent containment member is a retractable sheath which can be retracted from the elongate shaft.

12. A catheter as in claim 11, wherein the sheath is completely removable from the elongate shaft.

13. A catheter as claim 1, wherein stent containment member is a sheath that can be peeled away from the shaft.

14. A catheter as in claim 13, wherein the sheath is pre-weakened along its length to facilitate peeling away from the shaft.

15. A catheter as in claim 1, wherein the stent containment member is a rip cord wound around the stent.

16. A catheter as claim 1, wherein stent containment member is a sheath with a side opening with at least one lace-up thread that pulls out to release the sheath from the elongate shaft.

17. A catheter as claim 1, wherein stent containment member is wire that is intertwined with the stent, wherein the wire can be pulled to release the stent from the elongate shaft.

18. A catheter as claim 1, wherein stent containment member is wire that is intertwined with elements on the elongate shaft, wherein the wire can be pulled to release the stent from the elongate shaft.

19. A catheter as in claim 1, further comprising a detection element coupled to the expandable dilation member, wherein the detection element detects when the expandable dilation member transitions from an expanded state to a collapsed state.

20. A catheter as in claim 1, further comprising a flush lumen coupled to the elongate shaft wherein at least one exit port is positioned at a distal region of the flush lumen so that fluid can flow out of the flush lumen through the exit port into the blood vessel.

21. A catheter system as in claim 20, further comprising a source of fluid coupled to the flush lumen and adapted to flow fluid into the flush lumen.

22. An interventional catheter system for treating a blood vessel, comprising:

an elongate shaft sized for insertion in a blood vessel;

an expandable dilation member coupled to a distal region of the elongate shaft, the expandable dilation member adapted to expand outward to dilate a stent; and

a flush lumen coupled to the elongate shaft wherein at least one exit port is positioned at a distal region of the flush lumen so that fluid can flow out of the flush lumen through the exit port into the blood vessel.

23. A catheter system as in claim 22, further comprising a source of fluid coupled to the flush lumen and adapted to flow fluid into the flush lumen.

24. A catheter system as in claim 22, wherein the exit port of the flush lumen is positioned proximal to the expandable dilation member.

25. A catheter system as in claim 22, further comprising a tubing positioned coaxially over the elongate shaft, and wherein the flush lumen is formed between the tubing and the elongate shaft.

26. A catheter system as in claim 25, wherein the exit port is an annular space located at a distal end of the flush lumen.

27. A catheter system as in claim 25, wherein a distal end of the tubing is bonded to the elongate shaft and wherein the exit port is a plurality of holes in the outer wall of the tubing.

28. A catheter system as in claim 25, wherein the tubing is slideable relative to the elongate shaft.

29. A catheter system as in claim 22, wherein the flush lumen comprises a separate elongate member positioned adjacent the elongate shaft.

30. A catheter system as in claim 22, wherein the elongate shaft includes a guide wire lumen and an inflation lumen for inflating the expandable dilation member.

31. A catheter system as in claim 22, wherein the exit port is distal to the expandable dilation member.

32. A catheter system as in claim 22, wherein the elongate shaft has a working length within the range of approximately 40 cm to 75 cm.

33. An interventional catheter for treating a blood vessel, comprising:

an elongate shaft sized for insertion in a blood vessel;

an expandable dilation member coupled to a distal region of the elongate shaft, the expandable dilation member adapted to expand outward to dilate a stent; and

an expandable occlusion member coupled to a distal region of the elongate shaft, the expandable dilation member adapted to expand outward to occlude a blood vessel at a location distal of the expandable dilation member.

34. A catheter as in claim 33, wherein the elongate shaft includes a first lumen for inflating the expandable dilation member and a second lumen for inflating the expandable occlusion member.

35. A catheter as in claim 33, wherein the expandable dilation member is movable along the axis of the elongate shaft relative to the expandable occlusion member.

36. A catheter as in claim 33, wherein the elongate shaft further includes a flush lumen with at least one exit port positioned between the expandable dilation member and the expandable occlusion member.

37. A catheter as in claim 33, wherein the expandable dilation member and the expandable occlusion member comprise a single balloon having a proximal portion that expands to a first size and a distal portion that expands to a second size.

38. An interventional catheter for treating a blood vessel, comprising:

an elongate shaft sized for insertion in a blood vessel;

an expandable occlusion member coupled to a distal region of the elongate shaft, the expandable occlusion member adapted to expand outward to occlude a blood vessel; and

a flush lumen coupled to the elongate shaft wherein at least one exit port is positioned at a distal region of the flush lumen so that fluid can flow out of the flush lumen through the exit port into the blood vessel.

39. An interventional catheter as in claim 38, further comprising a source of fluid coupled to the flush lumen and adapted to flow fluid into the flush lumen.

40. An interventional catheter as in claim 38, wherein the exit port is proximal of the expandable occlusion member.

41. An interventional catheter as in claim 38, wherein the exit port is distal of the expandable occlusion member.

42. A method for treating a carotid artery, comprising:

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

positioning an arterial access sheath through the penetration;

inserting a catheter through the sheath into a treatment site comprised of the internal carotid artery or the bifurcation between the internal and external carotid arteries, wherein the catheter includes an expandable stent, a stent containment member, and an expandable dilation member;

releasing the stent so that the stent expands and deploys at the treatment site;

repositioning the catheter so that the dilation member is positioned inside the deployed stent; and

expanding the dilation member to post-dilate the stent.

43. A method as in claim 42, wherein the stent is initially situated over the expandable dilation member on the catheter, such that repositioning the catheter so that the dilation member is positioned inside the deployed stent does not require moving the catheter in either a distal or proximal direction.

44. A method as in claim 42, wherein the stent is initially situated proximal of the expandable dilation member on the catheter, such that repositioning the catheter so that the dilation member is positioned inside the deployed stent requires moving the catheter in a distal direction.

45. A method as in claim 42, wherein the stent is initially situated distal of the expandable dilation member on the catheter such that repositioning the catheter so that the dilation member is positioned inside the deployed stent requires moving the catheter in a proximal direction.

46. A method as in claim 42, wherein the expandable dilation member comprises an independently positionable balloon catheter shaft in a central lumen of the stent delivery catheter.

47. A method as in claim 42, further comprising causing retrograde blood flow from the carotid artery into the sheath.

48. A method as in claim 47, further comprising causing blood to flow from the sheath to a venous sheath and into a venous return site.

49. A method as in claim 47, further comprising causing blood to flow from the sheath to an external receptacle.

50. A method as in claim 47, further comprising regulating the retrograde blood flow.

51. A method as in claim 47, further comprising controlling a state of the retrograde blood flow.

52. A method as in claim 47, further comprising monitoring the retrograde blood flow.

53. A method as in claim 47, wherein the retrograde blood flow is achieved passively through the use of arterial perfusion stump pressure to drive retrograde blood flow.

54. A method as in claim 47, wherein the retrograde blood flow is achieved using active aspiration via a suction pump or a syringe to drive retrograde blood flow.

55. A method as in claim 42, wherein the penetration is formed percutaneously.

56. A method as in claim 42, wherein the expandable dilation member is an inflatable balloon.

57. A method as in claim 42, wherein the stent delivery catheter includes a stent containment member that contains the stent in a collapsed state and wherein releasing the stent comprises removing the stent containment member from the stent.

58. A method as in claim 57, wherein the stent containment member is a sheath and removing the stent containment member comprises retracting the sheath from the stent.

59. A method as in claim 57, wherein the stent containment member is a sheath that can be peeled away from the catheter and removing the stent containment member comprises peeling the stent containment member away from the catheter.

60. A method for treating a carotid artery, comprising:

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

positioning an arterial access sheath through the penetration;

inserting a catheter through the sheath into a treatment site comprised of the internal carotid artery or the bifurcation between the internal and external carotid arteries, wherein the catheter includes an expandable stent, a stent containment member, an expandable dilation member that dilates a stent and also includes a lumen through which flush fluid flows and an exit port through which flush lumen exits the catheter;

releasing the stent so that the stent expands and deploys at the treatment site;

positioning the catheter so that the dilation member is positioned inside the deployed stent;

expanding the dilation member to post-dilate the stent; and

passing flush fluid through the flush lumen and out of the exit port or aspirating blood into the flush lumen via the exit port.

61. A method as in claim 60, wherein the flush fluid exits the exit port at a location distal of the stent.

62. A method as in claim 60, wherein the flush fluid exits the exit port at a location proximal of the stent.

63. A method as in claim 60, further comprising causing retrograde blood flow from the carotid artery into the sheath while the flush fluid passes out of the exit port.

64. A method as in claim 63, wherein the retrograde blood flow is achieved passively through the use of arterial perfusion stump pressure to drive retrograde blood flow.

65. A method as in claim 63, wherein the retrograde blood flow is achieved using active aspiration via a suction pump or a syringe to drive retrograde blood flow.

66. A method for treating a carotid artery, comprising:

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

positioning an arterial access sheath through the penetration;

inserting a first catheter through the access sheath and using the first catheter to deploy a stent into a treatment site comprised of the internal carotid artery or the bifurcation between the internal and external carotid arteries;

positioning a second catheter through the sheath into the treatment site, wherein the second catheter includes an expandable dilation member that expands outward to dilate a stent and an expandable occlusion member that expands outward to occlude the internal carotid artery at a location distal of the expandable dilation member;

positioning the second catheter so that the dilation member is positioned inside the deployed stent and the occlusion member is positioned in the distal internal carotid artery;

expanding the dilation member to post-dilate the stent; and

expanding the occlusion member to occlude the internal carotid artery.

67. A method as in claim 66, wherein the occlusion member is expanded after the dilation member is expanded and further comprising permitting antegrade blood flow to flush the common carotid artery and a proximal region of the internal carotid artery into the external carotid artery.

68. A method as in claim 66, wherein the occlusion member is expanded after the dilation member is expanded and further comprising causing retrograde blood flow from the carotid artery into the sheath.

69. A method as in claim 68, wherein the retrograde blood flow is achieved passively through the use of arterial perfusion stump pressure to drive retrograde blood flow.

70. A method as in claim 68, wherein the retrograde blood flow is achieved using active aspiration via a suction pump or a syringe to drive retrograde blood flow.

71. A method as in claim 66, wherein the second catheter further includes a flush port between the expandable dilation member and the expandable occlusion member and further comprising flushing fluid to a location near the stent while the occlusion member occludes the internal carotid artery.

72. A method as in claim 66, wherein the expandable dilation member and the expandable occlusion member comprise a single balloon having a proximal portion that expands to a first size and a distal portion that expands to a second size and wherein post-dilating the stent and occluding the internal carotid artery comprises inflating the single balloon.

73. A method for treating a carotid artery, comprising:

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

positioning an arterial access sheath through the penetration;

inserting a catheter through the sheath into a treatment site comprised of the internal carotid artery or the bifurcation between the internal and external carotid arteries, wherein the catheter includes an expandable occlusion member that expands to occlude an artery and also includes a lumen through which fluid may be flushed or aspirated and an exit port through which flush lumen exits the catheter;

positioning the catheter so that the occlusion member is positioned in the internal carotid artery;

expanding the occlusion member to occlude the internal carotid artery; and

flushing fluid through the flush lumen and out of the exit port.

74. A method as in claim 73, wherein the flush exit port is located proximal of the occlusion member, and wherein the occlusion member is positioned in the internal carotid artery distal to the treatment site and the fluid is flushed into or aspirated from the treatment site.

75. A method as in claim 73, wherein the flush exit port is located distal of the occlusion member and wherein the occlusion member is positioned in the internal carotid artery proximal to the treatment site and the fluid is flushed into or aspirated from the treatment site.

76. A method as in claim 73, further comprising causing retrograde blood flow from the carotid artery into the sheath.

77. A method as in claim 76, wherein the retrograde blood flow is achieved passively through the use of arterial perfusion stump pressure to drive retrograde blood flow.

78. A method as in claim 76, wherein the retrograde blood flow is achieved actively by using a suction pump or a syringe to drive retrograde blood flow.

79. A method for treating a carotid artery, comprising:

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

positioning an arterial access sheath through the penetration;

causing retrograde blood flow from the carotid artery into the sheath;

inserting a stent delivery catheter through the sheath into a treatment site comprised of the internal carotid artery or the bifurcation between the internal and external carotid arteries;

releasing the stent so that the stent expands and deploys at the treatment site.

80. A method as in claim 79, further comprising causing blood to flow from the sheath to a venous sheath and into a venous return site.

81. A method as in claim 79, further comprising causing blood to flow from the sheath to an external receptacle.

82. A method as in claim 79, further comprising regulating the retrograde blood flow.

83. A method as in claim 79, further comprising controlling a state of the retrograde blood flow.

84. A method as in claim 79, further comprising monitoring the retrograde blood flow.

85. A method as in claim 79, wherein the retrograde blood flow is achieved passively through the use of arterial perfusion stump pressure to drive retrograde blood flow.

86. A method as in claim 79, wherein the retrograde blood flow is achieved using active aspiration via a suction pump or a syringe to drive retrograde blood flow.

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

88. A method as in claim 79, wherein the stent delivery catheter includes a stent containment member that contains the stent in a collapsed state and wherein releasing the stent comprises removing the stent containment member from the stent.

89. A method as in claim 88, wherein the stent containment member is a sheath and removing the stent containment member comprises retracting the sheath from the stent.

90. A method as in claim 88, wherein the stent containment member is a sheath that can be peeled away from the catheter and removing the stent containment member comprises peeling the stent containment member away from the catheter.

91. A method as in claim 88, wherein the stent containment member is completely removable and wherein releasing the stent comprises completely removing the stent containment member from the stent delivery catheter

92. A method as in claim 79, wherein the stent delivery catheter has a working length suitable for deployment through a transcervical access sheath into the common carotid artery.

93. A method as in claim 92, wherein the wherein the stent delivery catheter working length is within the range of approximately 40 cm to 60 cm.

94. A method as in claim 92, wherein the wherein the stent delivery catheter working length is within the range of approximately 40 cm to 75 cm.