Methods and low profile apparatus for reducing embolization during treatment of carotid artery disease

• US 6,540,712 B1
• Filed: 03/20/2000
• Issued: 04/01/2003
• Est. Priority Date: 03/13/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc. (W.L. Gore and Associates)
• Inventors: Ohki, Takao, Parodi, Juan Carlos
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/528,569
• Time in Patent Office: 1,107 Days
• Field of Search: 604/500, 604/509, 604/101.01, 604/103.09, 604/170, 604/104, 604/96.01, 604/103.07, 604/5.01, 604/6.09, 604/6.14, 604/27, 604/4.01, 606/127, 606/108, 606/159, 606/191, 606/192, 606/194, 606/195, 606/198, 606/200, 606/213
• US Class Current: 604/6.14
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• 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 2017/2215 having an open distal end
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• 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
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1065 having a balloon which is inversely attached to the shaft at the distal or proximal end
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 : Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. A blood filter and/or flow control valve may be included in-line with the tubing to filter emboli from blood reperfused into the patient and to control the degree of flow reversal.

Claims

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

a catheter having proximal and distal ends, an aspiration lumen and a guide wire lumen, each of the aspiration lumen and guide wire lumen extending from the proximal end to the distal end, and a blood outlet port in communication with the aspiration lumen, the catheter adapted to be disposed in a patient'"'"'s carotid artery;

an occlusion element disposed on the distal end of the catheter and having an opening that communicates with the aspiration 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;

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

a flow control valve coupled between the blood outlet port and blood inlet port; and

a wire having a distal end and a balloon disposed on the distal end, wherein the wire and balloon are sized to pass through the guide wire lumen of the catheter.

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

3. The apparatus of claim 1 wherein the occlusion element is an inflatable member.

4. The apparatus of claim 3 wherein the inflatable element has a pear-shape with a wall thickness that varies along the length of the inflatable member.

5. The apparatus of claim 3 wherein a portion of the pear-shaped inflatable member extends beyond the distal end of the catheter in the contracted position and forms an atraumatic bumper.

6. The apparatus of claim 3 wherein a portion of the pear-shaped inflatable member extends beyond the distal end of the catheter in the contracted position and forms an atraumatic bumper.

7. 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.

8. The apparatus of claim 7 wherein the layer of wire braid is omitted in a distal region of the catheter.

9. The apparatus of claim 1 wherein the apparatus has a substantially uniform cross sectional diameter when the occlusion element is in the contracted state.

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

11. The apparatus of claim 1 further comprising a resilient wedge affixed to the wire proximal of the balloon to reduce snagging of the balloon following a stenting procedure.

12. Apparatus for removing emboli during an angioplasty or stenting procedure and a balloon disposed on the distal end, the apparatus comprising:

a catheter having a proximal end and a distal end, an aspiration lumen and a guide wire lumen, each of the aspiration lumen and the guide wire lumen extending from the proximal to the distal end, and a blood outlet port in communication with the aspiration lumen, the catheter adapted to be disposed in a patient'"'"'s carotid artery;

an occlusion element disposed on the distal region of the catheter and having an opening that communicates with the aspiration 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;

tubing that couples the blood outlet port to the blood inlet port; and

a wire having a distal end and a balloon disposed on the distal end, wherein the wire and balloon are sized to pass through the guide wire lumen of the catheter.

13. The apparatus of claim 12 further comprising a flow control valve coupled between the blood outlet port and blood inlet port.

14. The apparatus of claim 12 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

15. The apparatus of claim 12 wherein the occlusion element is an inflatable member.

16. The apparatus of claim 15 wherein the inflatable element has a pear-shape with a wall thickness that varies along the length of the inflatable member.

17. The apparatus of claim 12 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.

18. The apparatus of claim 12 wherein the apparatus has a substantially uniform cross sectional diameter when the occlusion element is in the contracted state.

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