Puncture resistant branch artery occlusion device and methods of use

• US 6,645,222 B1
• Filed: 10/17/2000
• Issued: 11/11/2003
• 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. (W.L. Gore and Associates)
• Inventors: Parodi, Juan Carlos, Horzewski, Michael J.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Sirmons, Kevin C.
• Application Number:
  US09/691,295
• Time in Patent Office: 1,120 Days
• Field of Search: 604/96.01, 604/103.05, 604/98.01, 604/99.01, 604/102.02, 604/171, 604/194, 604/97.01, 604/103.1, 606/200
• US Class Current: 606/200
• 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 2217/005 with suction drainage system
• 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: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Methods and apparatus are provided for removing emboli during an angioplasty, stenting, or surgical procedure comprising apparatus for occluding a branch artery to prevent reversal of flow during carotid artery stenting, the apparatus comprising a retrieval sheath 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:

an elongated tubular member having proximal and distal ends and a lumen extending therebetween, wherein the elongated tubular member comprises discrete proximal and distal sections connected at a junction;

an inflation port coupled to the proximal end of the tubular member in communication with the lumen;

a short tubular member;

an inflatable member having a proximal end coupled to the distal section and a distal end coupled to the short tubular member, the inflatable member in communication with the lumen;

a coil having a proximal end coupled to the distal end of the elongated tubular member and the short tubular member, the coil having a length that extends through the inflatable member and the short tubular member to form a floppy tip; and

a sheath slidably disposed on the tubular member, the sheath including a radially enlarged distal end adapted to selectably enclose the inflatable member during retrieval.

2. The apparatus of claim 1 further comprising a tube fixedly disposed within the lumen to support the junction.

3. The apparatus of claim 1 wherein at least a portion of the distal section is radiopaque.

4. The apparatus of claim 1 wherein at inflatable member has a deployed state and retrieval state.

5. The apparatus of claim 1 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 elongated tubular member 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.

6. The apparatus of claim 5 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

7. The apparatus of claim 5 wherein the occlusion element is a balloon.

8. The apparatus of claim 5 further comprising a pump that removes blood through the catheter and reperfuses blood via the venous return catheter.

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

an elongated tubular member having proximal and distal ends and a lumen extending therebetween;

an inflation port coupled to the proximal end of the tubular member in communication with the lumen;

an inflatable member disposed on the tubular member adjacent the distal end and in communication with the lumen;

a sheath slidably disposed on the tubular member to selectably enclose the inflatable member during retrieval;

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 elongated tubular member 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.

10. The apparatus of claim 9 wherein the elongated tubular member comprises discrete proximal and distal sections connected at a junction.

11. The apparatus of claim 10 further comprising a tube fixedly disposed within the lumen to support the junction.

12. The apparatus of claim 10 wherein at least a portion of the distal section is radiopaque.

13. The apparatus of claim 12 further comprising a coil fixedly disposed within the inflatable member, the coil extending beyond a distal end of the tubular member.

14. The apparatus of claim 9 wherein the inflatable member has a deployed state and a retrieval state.

15. The apparatus of claim 9 further comprising a blood filter coupled between the blood outlet port and the blood inlet port.

16. The apparatus of claim 9 wherein the occlusion element is a balloon.

17. The apparatus of claim 9 further comprising a pump that removes blood through the catheter and reperfuses blood via the venous return catheter.