System and method for treating ischemic stroke

• US 20060058837A1
• Filed: 08/24/2005
• Published: 03/16/2006
• Est. Priority Date: 09/10/2004
• Status: Abandoned Application

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Gupta, Vikas, Hui, Delilah, Bose, Arani, Donahue, Sean
• Application Number:
  US11/210,635
• Publication Number:
  US 20060058837A1
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• 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. A system for removing thromboembolic material from a blood vessel in a patient, the system comprising:

a catheter proportioned for delivery into a blood vessel, the catheter including a catheter lumen;

a first elongate member, and a receiver on a distal portion of the first elongate member, the receiver formed of a plurality of structural members arranged to form a sleeve having a central lumen, a plurality of the structural members comprising engaging elements extending into the central lumen; and

a second elongate member extendable through the catheter lumen and having a separator element thereon, the separator element shaped such that movement of the separator element into contact with a body of thromboembolic material in a blood vessel separates pieces of thromboembolic material from the body.

2. The system of claim 1, further including an aspiration source fluidly coupled to the catheter lumen.

3. The system of claim 1, wherein the engaging elements including apex regions extending into the central lumen of the receiver.

4. The system of claim 3, wherein a plurality of the structural members comprise a plurality of generally v-shaped elements having longitudinally-oriented apexes, and wherein the engaging elements comprise a plurality of the v-shaped elements.

5. The system of claim 1, wherein the receiver is radially expandable from a compressed position in which the receiver is sized for movement within the catheter lumen, to an expanded position in which the receiver is sized for advancement over a body of thromboembolic material within the blood vessel to receive the body into the central lumen of the receiver, and wherein the engaging elements are oriented to engage the body within the central lumen.

6. The system of claim 4, wherein the structural members further comprise a plurality of spaced apart circumferential rings.

7. The system of claim 6, wherein the structural members further comprise a plurality of longitudinal struts extending between the circumferential rings.

8. The system of claim 7, wherein each engaging element is positioned between a corresponding pair of the longitudinal struts.

9. The system of claim 7, wherein each longitudinal strut includes at least one spring bend.

10. The system of claim 6, wherein the plurality of circumferential rings includes a proximal ring, a distal ring, and an intermediate ring, and wherein the v-shaped elements include a distal row of v-shaped elements positioned between the distal ring and the intermediate ring, and a proximal row of v-shaped elements positioned between the intermediate ring and the proximal ring.

11. The system of claim 10, wherein the engaging elements comprise a plurality of the v-shaped elements in the distal row.

12. The system of claim 2, wherein the separator element includes a proximal portion with a proximally-oriented surface and a tapered distal portion.

13. The system of claim 12, wherein the separator element has a generally conical profile extending from the proximally-oriented portion to the distal portion.

14. The system of claim 12, wherein the proximally-oriented surface is concave.

15. The system of claim 12, wherein the proximally-oriented surface is substantially planar.

16. The system of claim 12, wherein the proximally-oriented surface is convex.

17. The system of claim 12, wherein the elongate member includes a flexible distal tip and wherein the separator element is spaced proximally from the distal tip.

18. The system of claim 1, further including:

an elongate sheath having a sheath lumen proportioned to receive the catheter; and

an occlusion balloon on the sheath, the balloon inflatable to occlude flow of blood within a blood vessel.

19. The system of claim 18, further including instructions for use, the instructions setting forth a method of using the system, including the steps of:

determining the likely nature of a body of thromboembolic material;

positioning the sheath in a blood vessel of a patient to be treated;

occluding the blood vessel using the occlusion balloon;

if the likely nature of the thromboembolic material is determined to be hard;

positioning the receiver, in the compressed position, within the catheter;

passing the catheter through the sheath lumen into the blood vessel;

extending the receiver from the catheter;

advancing the receiver at least partially over the body of thromboembolic material, causing the body to be received into the central lumen of the receiver, and causing the engaging elements to engage the body; and

withdrawing the receiver into the sheath;

if the likely nature of the thromboembolic material is determined to be soft;

passing the catheter through the sheath lumen into the blood vessel and positioning the catheter proximally of the body of thromboembolic material;

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

advancing the separator element from the catheter 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 catheter lumen.

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

providing a catheter proportioned for delivery into a blood vessel, the catheter including a catheter lumen, further providing a first elongate member and a receiver on a distal portion of the first elongate member, the receiver formed of a plurality of structural members arranged to form a sleeve having a central lumen, a plurality of the structural members comprising engaging elements extending into the central lumen, and further providing a second elongate member extendable through the catheter lumen and having a separator element thereon;

positioning a sheath within a blood vessel of a patient to be treated, the sheath having an occlusion balloon thereon;

occluding the blood vessel using the occlusion balloon;

determining the likely nature of a body of thromboembolic material within the blood vessel;

if the likely nature of the thromboembolic material is determined to be hard;

positioning the receiver, in the compressed position, within the catheter;

passing the catheter through the sheath into the blood vessel;

extending the receiver from the catheter;

advancing the receiver at least partially over the body of thromboembolic material, causing the body to be received into the central lumen, and causing the engaging elements to engage the body; and

withdrawing the receiver into the sheath;

if the likely nature of the thromboembolic material is determined to be soft;

passing the catheter through the sheath the blood vessel and positioning the catheter proximally of the body of thromboembolic material;

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

advancing the separator element from the catheter 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 catheter lumen.

21. The method of claim 20, further comprising the step of, with the receiver disposed at least partially over the body of thromboembolic material, applying suction through the catheter lumen using the aspiration source, the suction facilitating retention of the thromboembolic material by the receiver.

22. The method of claim 20, further comprising the step of, with the receiver disposed at least partially over the body of thromboembolic material, sliding a distal portion of the catheter against a proximal portion of the receiver to cause the receiver to exert pressure against the thromboembolic body in a radially-inward direction.

23. The method of claim 20, wherein the step of withdrawing the separator element towards the catheter lumen prevents thromboembolic material entering the lumen from obstructing aspiration of additional material into the catheter lumen.

24. The method of claim 20, wherein the step of withdrawing the separator element towards the catheter lumen plunges thromboembolic material into the catheter lumen.

25. The method according to claim 20, wherein the method further includes repeating the steps of advancing and withdrawing the separator element one or more times.

26. The method of claim 20, wherein the step of advancing the separator element and/or the step of withdrawing the separator element breaks up thromboembolic material accumulating in the catheter lumen.

27. The method of claim 20, further including the steps of, if the likely nature of the thromboembolic material is determined in the determining step to be soft:

after the step of withdrawing the separator element towards the catheter lumen, removing the separator element from the catheter;

extending the receiver from the catheter;

advancing the receiver at least partially over a remaining body of thromboembolic material in the blood vessel;

causing the remaining body to be received into the central lumen and causing the engaging elements to engage the body; and

withdrawing the receiver into the sheath.

28. The method of claim 20, further including the steps of, if the likely nature of the thromboembolic material is determined in the determining step to be hard:

after at least the step of advancing the receiver, introducing the separator element into the blood vessel;

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

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

withdrawing the separator element towards the catheter lumen.

29. The method of claim 28, wherein the step of introducing the separator element into the blood vessel, includes extending the separator element through the receiver.

30. The method of claim 28, wherein the step of introducing the separator element into the blood vessel, is performed after the step of withdrawing the receiver into the sheath.

31. The method of claim 20, wherein the step of advancing the separator element and/or the step of withdrawing the separator element breaks up thromboembolic material in the blood vessel.

32-90. -90. (canceled)