Low-profile single-lumen dual-balloon catheter with integrated guide wire for embolectomy dilatation/occlusion and delivery of treatment fluid

• US 5,320,604 A
• Filed: 06/03/1993
• Issued: 06/14/1994
• Est. Priority Date: 04/24/1991
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Baxter International Inc.
• Inventors: Walker, Blair D., Higgins, Sheryl W.
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/071,731
• Time in Patent Office: 376 Days
• Field of Search: 604/96, 604/95, 604/101, 604/49-54, 604/264, 604/280, 604/169, 604/170, 604/164, 606/191-195
• US Class Current: 604/99.04
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/091 having a lumen for drug delivery or suction
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1063 having only one lumen used for guide wire and inflation, e.g. to minimise the diameter
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/09 Guide wires
• 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 25/104 used for angioplasty

Abstract

A fully exchangeable low-profile single-lumen dual-balloon catheter for embolectomy, dilatation, occlusion, and infusion of treatment fluid, and having an integrated guide wire, includes a flexible small diameter guide wire provided with an distal end valving portion of comparatively enlarged diameter and a flexible elongated tubular shaft with a pair of expandable balloons spaced apart on opposite sides of a waist portion which waist portion includes an infusion section with a perforation in fluid communication with the lumen. The fluid conducting lumen is adapted to perform multiple functions in conjunction with movements of the guide wire converting the catheter to one of several modes of operation by sealing cooperation of the guide wire valving portion with seal portions of the catheter shaft.

Claims

1. A single-lumen dual-balloon catheter and guide wire combination for dilatation, occlusion, and infusion of treatment fluid, said catheter comprising:

a flexible small diameter guide wire having a valving portion adjacent to a distal end thereof;

a flexible elongated tubular shaft having a proximal end and a distal end portion terminating in a distal end, said distal end portion including an expandable proximal balloon and an expandable distal balloon spaced axially from said proximal balloon by a waist portion therebetween, a single axially extending fluid conducting lumen adapted to receive said guide wire extending through said shaft in fluid communication with each balloon, said waist portion defining at least one perforation opening from said lumen outwardly thereon, and both said proximal balloon and said distal balloon having a respective distal orifice coaxially aligned with said lumen and adapted to receive said guide wire, each of said distal orifices being provided with means for releasably engaging in sealing relationship with said valving portion of said guide wire.

2. The catheter of claim 1 wherein said means for releasably engaging in sealing relationship comprises:

a resilient sleeve-like seal portion extending from said distal orifice and dimensioned to slidingly engage said valving portion of said guide wire, which valving portion is of relatively enlarged diameter.

3. The catheter of claim 1 wherein said enlarged diameter distal end valving portion of said guide wire comprises:

a cylindrical sleeve-like collar member sealingly coupled to said guide wire.

4. The catheter of claim 3 wherein said collar member is relatively rotatably captured upon said guide wire with a selected relative axial movement permitted therebetween.

5. The catheter of claim 4 wherein said selected relative axial movement between said collar member and said guide wire is limited to substantially no axial movement therebetween.

6. The catheter of claim 3 wherein said cylindrical collar is formed of a polymeric material.

7. The catheter of claim 4 wherein said polymeric material is selected from the group comprising:

polyvinylchloride, polyamide, polyimide and fluoropolymer.

8. The catheter of claim 3 wherein said cylindrical collar is formed of metal.

9. The catheter of claim 3 wherein said valving portion includes a pair of said collar members spaced axially apart on said guide wire.

10. The catheter of claim 1 further comprising at least one radiopaque marker disposed adjacent to said enlarged diameter distal end portion of said guide wire.

11. The catheter of claim 10 wherein said radiopaque marker comprises a flexible metallic coil extending beyond said enlarged diameter distal end portion of said guide wire.

12. The catheter of claim 1 further comprising at least one radiopaque marker fixed adjacent to the proximal end of said proximal balloon.

13. A low-profile single-lumen dual-balloon catheter for use in conjunction with a flexible, small diameter guide wire having a distal end valving portion of comparatively enlarged diameter, said catheter comprising:

a flexible elongate tubular shaft having a proximal end and a distal end portion terminating at a distal end, and at least one axially extending fluid conducting lumen adapted to receive said guide wire extending therethrough; and

an axially spaced apart pair of expandable balloons relatively located proximally and distally of one another in said distal portion adjacent said distal end of said tubular shaft in fluid communication with said lumen and each balloon having a respective distal orifice coaxially aligned with said lumen and adapted to receive said guide wire, said distal orifice of each balloon being provided with means for releasably engaging in sealing relationship said enlarged diameter distal end valving portion of said guide wire.

14. The catheter of claim 13 wherein said means for releasably engaging in sealing relationship comprises:

a resilient sleeve-like seal section extending from said distal orifice and dimensioned to slidingly engage said enlarged diameter distal end valving portion of said guide wire.

15. The catheter of claim 13 wherein said elongated tubular shaft and at least one of said expandable balloons are formed of resilient polymeric material.

16. The catheter of claim 15 wherein said polymeric material is selected from the group consisting of homopolymers and copolymers of:

polyvinylchoride, polyethylene, polyolefin, fluoropolymer, polyamide, polyester, polyimide, and polypropylene.

17. A low-profile single-lumen dual-balloon catheter and guide wire combination comprising:

a flexible, small diameter guide wire having proximal and distal ends, with a valving portion of said distal end being of a larger diameter than the remainder of said guide wire;

a flexible elongate tubular shaft having a proximal end and a distal end and a single axially extending fluid conducting lumen adapted to receive said guide wire extending therethrough; and

a pair of axially spaced apart balloons each in fluid communication with said lumen and disposed in proximal and distal relative position, a waist portion of said catheter between said balloons including a perforate infusion portion having at least one perforation opening from said lumen outwardly on said catheter between said balloons, each one of said pair of balloons having a respective distal end coaxially aligned with said lumen and adapted to receive said guide wire, each of said distal ends being provided with means for releasably engaging said enlarged diameter distal end portion of said guide wire in sealing relationship.

18. The combination of claim 17 wherein said larger diameter guide wire distal end is defined by a cylindrical collar member coupled to said guide wire distal end for relative rotational movement and a selected axial relative movement.

19. The combination of claim 18 wherein said means for releasably engaging said enlarged diameter distal end portion of said guide wire is a resilient sleeve-like seal portion of said catheter extending from said distal end.

20. The combination of claim 19 wherein said elongated tubular shaft and said expandable balloon are formed of resilient polymeric material.

21. The combination of claim 19 wherein said resilient sleeve is formed from a lubricous polymeric material.