Angioplasty dilitation balloon catheter

• US 4,881,547 A
• Filed: 09/01/1988
• Issued: 11/21/1989
• Est. Priority Date: 08/31/1987
• Status: Expired due to Fees

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Mallinckrodt Incorporated (Mallinckrodt plc)
• Inventors: Danforth, John W.
• Primary Examiner(s): CROSS, ETHEL R
• Application Number:
  US07/239,061
• Time in Patent Office: 446 Days
• Field of Search: 128/344, 604/101, 604/53
• US Class Current: 606/194
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• 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 dilitation balloon catheter with an inelastic balloon disposed in a streamlined configuration having a smaller deflated cross-sectional profile than any catheter hereto available and yet a potentially larger inflation caliber than prior art "low profile" catheters. During introduction across a region of stenosis, the balloon is wrapped around a guidewire in such a way that the guidewire contained therein can move freely. The wrapped configuration is maintained by means of a temporary bond. Inflation of the balloon, following proper positioning of the catheter results in disruption of the aforementioned bond, permitting a balloon to unwrap from the guidewire contained therein.

Claims

1. A catheter comprising:

a guidewire extending from a proximal end to a distal end;

an inflatable dilitation balloon having a wall defining the interior of the balloon and with at least a portion of said balloon wrapped around a portion of the guidewire proximate the distal end of the guidewire without any portion of said guidewire being in said interior of said balloon; and

means for inflating the balloon.

2. A catheter as in claim 1 further comprising means for securing the balloon wrapped around the guidewire to enable insertion into a vessel.

3. A catheter as in claim 2 wherein the balloon comprises an inflatable elongate member having a generally tapered shape attached along at least a portion of its exterior length to the guidewire.

4. A catheter as in claim 2 wherein the means for securing comprises means for securing a first region of the balloon to a second region of the balloon to thereby maintain the balloon wrapped around the guidewire.

6. A catheter as in claim 1 wherein the means for inflating comprises longitudinal channel means extending from the balloon toward the proximal end of the guidewire, the channel communicating with the balloon.

7. A catheter as in claim 1 wherein the longitudinal channel means comprises at least two channels extending from the balloon toward the proximal end of the guidewire.

8. A catheter as in claim 1 further comprising an elongate housing adapted to be inserted into a vessel through which housing the guidewire extends.

10. A catheter as in claim 8 wherein the elongate housing extends from the proximal to the distal end of the catheter.

11. A catheter as in claim 8 wherein the elongate housing extends from the distal end of the catheter a selected distance.

12. A catheter as in claim 1 further comprising a cover adapted to cover the dilitation balloon and at least a portion of the distal end of the guidewire.

13. A catheter as in claim 1, further comprising a cover adapted to cover the dilitation balloon, wherein the cover surrounds the dilitation balloon to prevent it from inflating.

14. A catheter as in claim 13 wherein the cover comprises an elongate body having an opening therethrough within which the dilitation balloon is disposed.

15. A catheter, as claimed in claim 4, wherein said means for securing comprises at least a first ultrasonic weld between part of said first region of the balloon and part of said second region of the balloon.

19. A catheter, as claimed in claim 1, further comprising stiffener means attached to said wall of said balloon.

22. A catheter, as claimed in claim 1, further comprising a deformable stint adjacent to said balloon.

33. A catheter, as claimed in claim 13, wherein said cover includes a cone-shaped surface for threading the guidewire.

5. A catheter comprising:

an inflatable dilitation balloon with at least a first region of said balloon positioned adjacent a second region to define a lumen of a size to accommodate a guidewire;

means for inflating said balloon; and

means for providing a temporary bond between the first and second regions, which bond breaks when the balloon is inflated.

16. A catheter, as claimed in claim 5, wherein said means for providing a temporary bond comprises an ultrasonic weld between at least parts of the first and second regions.

20. A catheter, as claimed in claim 5, further comprising stiffener means attached to a wall of said balloon.

23. A catheter, as claimed in claim 5, further comprising a deformable stint adjacent to said balloon.

9. A catheter comprising:

an inflatable dilitation balloon with at least a first region of said balloon positioned adjacent a second region to define a lumen;

means for inflating said balloon;

an elongate housing adapted to be inserted into a vessel, said balloon being attached to the distal end of said housing; and

wherein the housing includes a longitudinal slot extending from a distal end thereof.

17. A catheter, as claimed in claim 9, further comprising means for providing a temporary bond between parts of said first and second regions of said balloon, which bond breaks when the balloon is inflated.

18. A catheter, as claimed in claim 17, wherein said means for providing a temporary bond comprises an ultrasonic weld between parts of said first region and said second region.

21. A catheter, as claimed in claim 9, further comprising stiffener means attached to a wall of said balloon.

24. A catheter, as claimed in claim 9, further comprising a deformable stint adjacent to said balloon.

25. A catheter, comprising:

a guidewire extending from a proximal end to a distal end; and

a dilitation balloon inflatable from a first uninflated configuration to a second inflated configuration, wherein at least a portion of said balloon is wrapped around a portion of said guidewire when said balloon is in said uninflated condition, and wherein said guidewire and said balloon part when said balloon is in said inflated condition, such that said guidewire is substantially not surrounded by said balloon.

26. A catheter, comprising:

a guidewire extending from a proximal end to a distal end;

a dilitation balloon inflatable from a first uninflated configuration to a second inflated configuration, said balloon having a wall defining the interior of the balloon;

at least a portion of said balloon in said uninflated condition wrapped around a portion of the guidewire proximate the distal end of the guidewire;

means for inflating the balloon;

means for securing a first region of the balloon to a second region of the balloon by ultrasonic welding to maintain the balloon wrapped around the guidewire when said balloon is in said uninflated condition, wherein said ultrasonic weld breaks when said balloon is inflated to said inflated condition;

an elongate housing adapted to be inserted into a vessel through which housing the guidewire extends, said elongate housing having a longitudinal slot extending from a distal end thereof;

said elongate housing defining a first and a second channel extending from the balloon toward the proximal end of the guidewire, said first channel for flushing said catheter, and said second channel usable for venting and for flushing said catheter; and

a cover comprising an elongate body having an opening therethrough within which the dilitation balloon is disposed to prevent the balloon from inflating.

27. A catheter, comprising:

an elongate housing adapted to be inserted into a vessel, said housing defining a lumen having a first diameter and having a proximal end and a distal end;

a dilitation balloon having a wall defining the interior of the balloon, the wall having an exterior surface and an interior surface, the balloon being inflatable from a first uninflated configuration to a second inflated configuration attached proximate the distal end of the housing;

means for inflating the balloon;

said balloon wall exterior surface, while said balloon is in said uninflated condition, defining a lumen of a size to accommodate a guidewire and substantially coaxial with said housing lumen.

28. A catheter, as claimed in claim 27, wherein said balloon in said uninflated condition has a diameter greater than said diameter of said housing lumen.

29. A catheter, comprising:

an elongate housing adapted to be inserted into a vessel, defining a lumen with a first diameter;

a dilitation balloon attached to the distal end of the housing, said balloon being inflatable from a first uninflated condition to a second inflated condition;

said balloon in said uninflated condition with at least a first region of said balloon positioned adjacent a second region to define a balloon lumen having a second diameter less than said first diameter; and

a guidewire having a proximal end and a distal end, a portion of said guidewire tapering in a direction toward said distal end, a portion of said guidewire disposed in said housing lumen, at least a part of said tapered portion of said guidewire disposed in said balloon lumen.

30. A catheter, comprising:

a guidewire extending from a proximal end to a distal end;

an inflatable dilitation balloon with at least a portion of said balloon wrapped around a portion of the guidewire proximate the distal end of the guidewire;

stiffening means attached to said balloon and spaced from said guidewire; and

means for inflating the balloon.

31. A catheter, comprising:

an elongate housing having a distal end and a proximate end, adapted to be inserted into a vessel;

an inflatable dilitation balloon attached to said distal end of said housing with at least a first region of said balloon positioned adjacent said second region to define a lumen of a size to accommodate a guidewire;

first channel means in said housing for flushing said catheter; and

second channel means in said housing for venting said catheter, wherein said second channel means is configurable as a second means for flushing.

32. A method for inflating a balloon of a catheter, comprising:

providing a guidewire extending from a proximal to a distal end;

providing an inflatable dilitation balloon having a wall defining the interior of the balloon with at least a portion of said balloon wrapped around a portion of the guidewire proximate the distal end of the guidewire;

providing flushable channel means in fluid communication with said interior of said balloon; and

flushing said flushable channel means to inflate said inflatable balloon to an inflated condition, wherein substantially no portion of said guidewire is in said interior of said balloon.