Puncture resistant balloon for use in carotid artery procedures and methods of use

• US 6,582,396 B1
• Filed: 03/20/2000
• Issued: 06/24/2003
• Est. Priority Date: 05/13/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc.
• Inventors: Parodi, Juan Carlos
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/528,958
• Time in Patent Office: 1,191 Days
• Field of Search: 600/585, 600/586, 600/587, 600/433, 600/434, 600/435, 128/898, 604/101.04, 604/104, 604/96.01, 606/191, 606/194, 606/195, 606/200
• US Class Current: 604/101.04
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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: A61F 2230/0006 circular

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery during carotid stenting, the apparatus further comprising a wedge or capsule configured to reduce the risk of potentially dangerous interaction with the stent during retrieval.

Claims

1. Apparatus for removing emboli during an angioplasty or stenting procedure, the apparatus comprising:

a guide wire having proximal and distal ends, and a lumen extending therebetween;

an inflation port coupled to the proximal end of the guide wire in communication with the guide wire lumen;

an inflatable member disposed on the distal end of the guide wire in communication with the guide wire lumen;

means for reducing the risk of puncturing the inflatable member disposed on the guide wire;

a catheter having proximal and distal ends, a lumen extending therethrough, and a blood outlet port in communication with the lumen, the catheter adapted to be disposed in a patient'"'"'s carotid artery, the guide wire and inflatable member configured to pass through the lumen;

an occlusion element disposed on the distal end of the catheter and having an opening that communicates with the lumen, the occlusion element having a contracted state suitable for transluminal insertion and an expanded state wherein the occlusion element occludes antegrade flow in the artery;

a venous return catheter having proximal and distal ends, a lumen extending therethrough, and a blood inlet port in communication with the lumen; and

tubing that couples the blood outlet port to the blood inlet port.

2. The apparatus of claim 1 wherein the means for reducing the risk of puncturing the inflatable member comprises a resilient wedge affixed to the guide wire proximal of the inflatable member.

3. The apparatus of claim 1 wherein the means for reducing the risk of puncturing the inflatable member comprises a capsule affixed to the distal end of the guide wire and to a proximal portion of the inflatable member.

4. The apparatus of claim 3 wherein the inflatable member has a deployed state and a retrieval state.

5. The apparatus of claim 4 wherein:

the member is inflated and extends distally of the capsule in the deployed state; and

the member is deflated and drawn into the capsule in the retrieval state.

6. The apparatus of claim 3 wherein the capsule comprises a radiopaque feature.

7. The apparatus of claim 1 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

8. The apparatus of claim 1 wherein the occlusion element is balloon.

9. The apparatus of claim 8 wherein the balloon has a pear-shape with a wall thickness that varies along the length of the balloon.

10. The apparatus of claim 9 wherein a portion of the pear-shaped balloon extends beyond the distal end of the catheter in the contracted position and forms an atraumatic bumper.

11. The apparatus of claim 1 wherein the catheter comprises:

a non-stick tubular member;

a layer of wire braid disposed surrounding the non-stick tubular member; and

a layer of thermoplastic polymer disposed on the layer of wire braid.

12. The apparatus of claim 1 further comprising a pump that removes blood through the catheter and reperfuses blood via the venous return catheter.

13. The apparatus of claim 1 wherein the inflatable member comprises a radiopaque feature.

14. Apparatus for removing emboli during an angioplasty or stenting procedure, the apparatus comprising:

a guide wire having proximal and distal ends, and a lumen extending therebetween;

an inflation port coupled to the proximal end of the guide wire in communication with the guide wire lumen;

an inflatable member disposed on the distal end of the guide wire in communication with the guide wire lumen; and

means for reducing the risk of puncturing the inflatable member disposed on the guide wire comprising a capsule affixed to the distal end of the guide wire and to a proximal portion of the inflatable member.

15. The apparatus of claim 14 wherein the inflatable member has a deployed state and a retrieval state.

16. The apparatus of claim 15 wherein:

the member is inflated and extends distally of the capsule in the deployed state; and

the member is deflated and drawn into the capsule in the retrieval state.

17. The apparatus of claim 14 further comprising:

a catheter having proximal and distal ends, a lumen extending therethrough, and a blood outlet port in communication with the lumen, the catheter adapted to be disposed in a patient'"'"'s carotid artery, the guide wire and inflatable member configured to pass through the lumen;

an occlusion element disposed on the distal end of the catheter and having an opening that communicates with the lumen, the occlusion element having a contracted state suitable for transluminal insertion and an expanded state wherein the occlusion element occludes antegrade flow in the artery;

a venous return catheter having proximal and distal ends, a lumen extending therethrough, and a blood inlet port in communication with the lumen; and

tubing that couples the blood outlet port to the blood inlet port.

18. The apparatus of claim 17 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

19. The apparatus of claim 17 wherein the catheter comprises:

a non-stick tubular member;

a layer of wire braid disposed surrounding the non-stick tubular member; and

a layer of thermoplastic polymer disposed on the layer of wire braid.

20. The apparatus of claim 17 further comprising a pump that removes blood through the catheter and reperfuses blood via the venous return catheter.

21. The apparatus of claim 17 wherein the occlusion element is balloon.

22. The apparatus of claim 21 wherein the balloon has a pear-shape with a wall thickness that varies along the length of the balloon.

23. The apparatus of claim 22 wherein a portion of the pear-shaped balloon extends beyond the distal end of the catheter in the contracted position and forms an atraumatic bumper.

24. The apparatus of claim 14 wherein,the inflatable member comprises a radiopaque feature.

25. The apparatus of claim 14 wherein the capsule comprises a radiopaque feature.