System and method for treating ischemic stroke

• US 20060058836A1
• Filed: 08/24/2005
• Published: 03/16/2006
• Est. Priority Date: 09/10/2004
• Status: Active Grant

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Gupta, Vikas, Hui, Delilah, Bose, Arani, Donahue, Sean
• Granted Patent: US 8,366,735 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2217/005 with suction drainage system
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector

Abstract

A thromboembolic removal system for treating ischemic stroke, including a guide and occlusion catheter, a delivery and aspiration catheter, an aspiration pump, a thromboembolic receiver, and a thromboembolic separator.

Claims

1-31. -31. (canceled)

32. A method for removing thromboembolic material from a blood vessel in a patient, the method comprising the steps of:

providing a catheter having a lumen, the lumen including a distal end having a fixed inner diameter, and further providing an elongate member extendable through the lumen and having a separator element thereon, the separator element having a maximum diameter smaller than the diameter of the lumen distal end;

inserting the catheter into a blood vessel and positioning the catheter proximally of a body of thromboembolic material;

aspirating through the lumen to draw thromboembolic material into and through the lumen;

advancing the separator element from the lumen in a distal direction to cause the separator element to contact a portion of the body of thromboembolic material; and

withdrawing the separator element towards the lumen.

33. The method of claim 32, wherein the withdrawing step prevents thromboembolic material entering the lumen from obstructing aspiration of additional material into the lumen.

34. The method of claim 32, wherein the withdrawing step plunges thromboembolic material into the lumen.

35. The method according to claim 32, wherein the method further includes repeating the advancing and withdrawing steps one or more times.

36. The method of claim 32, wherein the advancing and/or withdrawing step breaks up thromboembolic material accumulating in the lumen.

37. The method of claim 32, wherein, during the advancing and/or withdrawing step, the elongate member breaks up bodies of thromboembolic material within the blood vessel.

38. The method according to claim 32, wherein the method further includes the step of occluding the blood vessel prior to the advancing step.

39. The method according to claim 38, wherein the occluding step includes the step of inflating an occlusion balloon within the blood vessel prior to the advancing step.

40. The method of claim 32, wherein the providing step provides the separator element to include a proximal portion with a proximally-oriented surface and a tapered distal portion.

41. The method according to claim 40, wherein during the withdrawing step the proximally-oriented surface carries thromboembolic material in a proximal direction.

42. The method according to claim 40, wherein the proximally-oriented surface includes a concave surface.

43. The method according to claim 40, wherein the providing step provides the proximally-oriented surface to include a substantially planar surface.

44. The method according to claim 40, wherein the providing step provides the proximally-oriented surface to include a convex surface.

45. The method according to claim 32, wherein the method includes the step of providing an elongate shaft and an expandable receiving element positioned on a distal portion of the shaft, and wherein the method includes the steps of expanding the receiving element, moving the expanded receiving element into contact with thromboembolic material, and engaging thromboembolic material with the receiving element.

46. The method according to claim 45, wherein the engaging step includes at least partially collapsing the receiving element onto thromboembolic material.

47. The method of claim 45, wherein the method includes the step of passing the receiving element through the catheter lumen prior to the step of advancing the separator element.

48. The method of claim 45, wherein the method includes the step of passing the receiving element through the catheter lumen after the step of advancing the separator element.

49. The method of claim 32, wherein the blood vessel is a cerebral artery.

50. The method of claim 32, wherein the method includes the step of passing a guidewire into the blood vessel, and wherein during the inserting step the catheter is advanced over the guidewire.

51. The method of claim 50, wherein the guidewire comprises the elongate member.

52. A system for removing thromboembolic material from a cerebral blood vessel, the system comprising:

an elongate catheter proportioned for insertion into a cerebral blood vessel, the catheter having a lumen extending therethrough, the lumen including a distal end having a fixed inner diameter;

an aspiration source fluidly coupled to the lumen; and

an elongate member extendable through the lumen and having a separator element thereon, the separator element having a maximum diameter smaller than the diameter of the lumen distal end.

53. The system of claim 52, wherein the separator element includes a proximal portion with a proximally-oriented surface and a tapered distal portion.

54. The system of claim 53, wherein the separator element has a generally conical profile extending from the proximally-oriented portion to the distal portion.

55. The system of claim 53, wherein the proximally-oriented surface is concave.

56. The system of claim 53, wherein the proximally-oriented surface is substantially planar.

57. The system of claim 53, wherein the proximally-oriented surface is convex.

58. The system of claim 52, wherein the elongate member includes a flexible distal tip and wherein the separator element is spaced proximally from the distal tip.

59. The system of claim 52, wherein the lumen comprises an inner diameter and wherein the maximum diameter of the separator element is in the range of 0.003-0.008 inches smaller than the inner diameter of the lumen distal end.

60. The system of claim 52, further including an occlusion balloon expandable within the cerebral blood vessel to occlude the vessel in a region of the catheter.

61. The system of claim 52, further including an expandable receiving element on an elongate shaft extendable through the lumen, the receiving element advanceable within the blood vessel into contact with thromboembolic material, and at least partially collapsible to engage thromboembolic material.

62. The system of claim 52, further including instructions for use, the instructions setting forth a method of using the system, including the steps of:

inserting the catheter into a blood vessel and positioning the catheter proximally of a body of thromboembolic material;

using the aspiration source, aspirating through the lumen to draw thromboembolic material into and through the lumen;

advancing the separator element from the lumen in a distal direction to cause the separator element to contact a portion of the body of thromboembolic material; and

withdrawing the separator element towards the lumen.

63. The system of claim 52, wherein the catheter has an outer diameter in the range of approximately 0.032 inch to 0.065 inch.

64-90. -90. (canceled)