Catheter having a funnel-shaped occlusion balloon of uniform thickness and methods of manufacture

• US 20030023204A1
• Filed: 06/27/2002
• Published: 01/30/2003
• Est. Priority Date: 03/13/1998
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Betelia, Rainier, Vo, Hung Van
• Granted Patent: US 6,960,222 B2
• Time in Patent Office: Days
• US Class Current: 604/103.07
• 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 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• 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 2025/1031 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 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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
• CPC Class Codes: A61M 25/1034 : Joining of shaft and balloon
• 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 a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Claims

1. Apparatus for removing emboli from a vessel during an interventional procedure, the apparatus comprising:

a catheter having proximal and distal ends, a working lumen extending therethrough; and

an occlusion balloon having a distal end affixed to an interior surface of the working lumen and a proximal end everted to surround, and affixed to, a portion of the catheter proximal of the distal end of the catheter disposed on the distal end of the catheter, the occlusion balloon having a contracted state suitable for insertion into a vessel and a deployed state configured to occlude antegrade flow in the vessel,

wherein the occlusion balloon comprises a wall having a substantially uniform thickness along its length, and in the deployed state, provides a funnel-shaped transition into the working lumen.

2. The apparatus of claim 1 wherein the working lumen has an interior polymer cover.

3. The apparatus of claim 2 wherein the distal end of the occlusion balloon is fused to the interior polymer cover.

4. The apparatus of claim 3 wherein the distal end of the occlusion balloon is adhesively bonded to the interior polymer cover.

5. The apparatus of claim 3 wherein the occlusion balloon further comprises a distal section situated just proximal of the distal end, wherein the distal section of the occlusion balloon is fused to a distalmost end of the interior polymer cover.

6. The apparatus of claim 5 wherein an exterior surface of the catheter comprises an exterior polymer cover.

7. The apparatus of claim 5 wherein the proximal end of the occlusion balloon is fused to the exterior polymer cover.

8. The apparatus of claim 7 wherein the proximal end of the occlusion balloon is affixed to the exterior polymer cover at a distance between about 10-20 mm proximal of the distal end of the catheter.

9. The apparatus of claim 7 wherein the proximal end of the occlusion balloon is adhesively bonded to the exterior polymer cover.

10. The apparatus of claim 2 further comprising an inflation lumen disposed within the exterior polymer cover that is in fluid communication with the occlusion balloon.

11. The apparatus of claim 2 further comprising a radiopaque marker band disposed at the distal end of the catheter.

12. The apparatus of claim 11 wherein the catheter comprises a wire braid disposed between the interior polymer cover and the exterior polymer cover, the apparatus further comprising a radiopaque marker band disposed between the wire braid and exterior polymer cover.

13. The apparatus of claim 1 wherein the occlusion balloon further comprises a proximal taper in the deployed state.

14. The apparatus of claim 1 further comprising a blood outlet port coupled to the proximal end of the catheter.

15. A method of manufacturing an emboli catheter for use in an interventional procedure, the method comprising:

providing a catheter having an exterior surface, proximal and distal ends and a working lumen extending therethrough having an interior surface;

providing an occlusion balloon having first and second ends and a uniform thickness therebetween;

affixing a first end of the occlusion balloon to the interior surface of the working lumen;

everting the second end of the occlusion balloon over the distal end of the catheter so that the second end is disposed surrounding the catheter at a position proximal of the distal end; and

affixing the second end of the occlusion balloon to the exterior surface of the catheter at the location proximal of the distal end.

16. The method of claim 15 wherein the interior surface of the working lumen comprises an interior polymer cover, and affixing the first end of the occlusion balloon to the interior surface of the working lumen comprises fusing the first end to the interior polymer cover.

17. The method of claim 15 wherein the interior surface of the working lumen comprises an interior polymer cover, and affixing the first end of the occlusion balloon to the interior surface of the working lumen comprises adhesively bonding the first end to the interior polymer cover.

18. The method of claim 15 wherein the exterior surface of the catheter comprises an exterior polymer cover, and affixing the second end of the occlusion balloon to the exterior surface of the catheter comprises fusing the second end to the exterior polymer cover.

19. The method of claim 15 wherein the exterior surface of the catheter comprises an exterior polymer cover, and affixing the second end of the occlusion balloon to the exterior surface of the catheter comprises adhesively bonding the second end to the exterior polymer cover.

20. The method of claim 15 wherein providing a catheter further comprises providing a catheter having a radiopaque marker band disposed on the catheter adjacent to the distal end.