Perfusion balloon catheter with differential compliance

• US 5,470,314 A
• Filed: 07/22/1994
• Issued: 11/28/1995
• Est. Priority Date: 07/22/1994
• Status: Expired due to Fees

• Current Assignee: Walinsky, Paul
• Original Assignee: Walinsky, Paul
• Inventors: Walinsky, Paul
• Primary Examiner(s): Maglione, Corrine M.
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/279,061
• Time in Patent Office: 494 Days
• Field of Search: 604/96, 604/99, 604/103, 604/104, 604/93, 604/264, 604/280, 604/282
• US Class Current: 604/103.11
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• 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
• CPC Class Codes: A61N 5/0601 Apparatus for use inside the body

Abstract

A perfusion balloon catheter (10), as for angioplasty by dilatation, has the balloon (30) formed so that, when inflated within a vas or coronary artery, one or more channels (40) are provided for the flow of bodily fluids or blood past the inflated balloon. In one embodiment, the balloon has a toroidal shape which defines a central open channel. In order to avoid closure of the central channel when the balloon inflation pressure is increased to distend the vas within which it is placed, a portion (44) of the balloon is made from a relatively elastic membrane, and the portion of the balloon (244) adjacent the channel (40) is made from a relatively less elastic material, or a rigid material, whereby additional pressure does not cause channel closure.

Claims

1. A catheter, comprising:

an elongated portion defining proximal and distal ends and also defining at least one elongated lumen adapted for the flow of fluid therethrough, said elongated portion having a particular cross-sectional area at a particular location near said distal end;

balloon means coupled near said particular location near said distal end of said elongated portion, said balloon means defining a peripheral closure including a relatively elastic membrane portion and a less elastic portion of said balloon means, said peripheral closure defining an interior surface which is adjacent the interior of said balloon, and also defining an exterior surface which is adjacent the exterior of said balloon, said balloon being adapted for inflation within a vas and being configured, when so inflated within a vas, to define an open channel adjacent said exterior surface of said closure, said open channel extending from a distal portion of said balloon to a proximal portion of said balloon, and having a cross-sectional area greater than said particular cross-sectional area of said elongated portion of said catheter, said elongated portion of said catheter extending through said open channel, and being coupled to said peripheral closure on one side of said open channel, whereby body fluids may flow through that portion of said cross-sectional area of said channel which is not occupied by said elongated portion of said catheters, said less elastic portion of said balloon means extending completely about said open channel from said distal portion of said balloon to said proximal portion of said balloon, to thereby tend to prevent closure of said channel when said balloon is inflated; and

at least one path for the flow of balloon inflation fluid extending between said elongated lumen defined by said elongated portion and the interior of said balloon, whereby said balloon may be inflated and deflated from said proximal end of said elongated portion of said catheter.

2. A catheter according to claim 1, wherein said membrane of said balloon means defines a surface which, when said balloon means is inflated, is substantially toroidal and defines a central opening, whereby said central opening of said toroidal surface defines said open channel.

3. A catheter according to claim 1, wherein said less elastic portion of said peripheral closure is a substantially rigid tube, the interior of which defines said open channel, and the exterior of which constitutes at least a portion of said inner surface of said balloon.

4. A catheter according to claim 3, wherein said peripheral closure of said balloon means defines a surface which, when said balloon means is inflated, is substantially toroidal and defines a central opening, whereby said central opening of said toroidal surface defines said open channel;

and

wherein said elongated portion is attached to said interior of said tube on one side of said central opening of said toroidal surface.

5. A catheter according to claim 1, wherein said less elastic portion has anisotropic elasticity.

6. A catheter according to claim 1, wherein said less elastic portion includes a reinforced elastic membrane.

7. A catheter according to claim 6, wherein said reinforcement is anisotropic.

8. A catheter according to claim 7, wherein said central channel defines a channel axis;

and

said anisotropic reinforcement comprises a plurality of relatively rigid elongated rods, each defining an axis of elongation, said rods being affixed to said peripheral closure at the interior of said open channel, with said axes of elongation mutually parallel and parallel to said channel axis.

10. A catheter according to claim 7, wherein said central channel defines a channel axis, and

wherein said anisotropic reinforcement is in the form of a helix centered about said channel axis.

11. A catheter according to claim 10, wherein said helical reinforcement is affixed to said peripheral closure adjacent the interior of said channel.

12. A catheter according to claim 1, wherein said relatively elastic membrane portion is made from polyethylene terephthalate.

13. A catheter according to claim 1, wherein said relatively elastic membrane portion of said peripheral closure is made from a first material, and defines a particular thickness between said interior surface and said exterior surface, and said less elastic portion of said peripheral closure is made from said same first material, and defines a second thickness, greater than said particular thickness, between said interior surface and said exterior surface.

14. A catheter according to claim 13, wherein said thickness tapers from said particular thickness to said second thickness, greater than said particular thickness.

15. A catheter according to claim 1, wherein said path extending between said elongated lumen defined by said elongated portion and the interior of said balloon for the flow of balloon inflation fluid comprises an aperture extending through said peripheral closure and the wall of said elongated portion.

9. A catheter comprising:

an elongated portion defining proximal and distal ends and also defining at least one elongated lumen adapted for the flow of fluid therethrough, said elongated portion having a particular cross-sectional area at a particular location near said distal end;

balloon means coupled near said particular location near said distal end of said elongated portion, said balloon means defining a peripheral closure including a relatively elastic membrane portion and a less elastic portion of said balloon means, said less elastic portion including an anisotropically reinforced elastic membrane comprising a plurality of relatively rigid elongated rods, each defining an axis of elongation, said peripheral closure defining an interior Surface which is adjacent the interior of said balloon, and also defining an exterior surface which is adjacent the exterior of said balloon, said balloon being adapted for inflation within a vas and being configured, when so inflated within a vas, to define an open channel, which defines a channel axis, adjacent said exterior surface of said closure, said open channel extending from a distal portion of said balloon to a proximal portion of said balloon, and having a cross-sectional area greater than said particular Cross-sectional area of said elongated portion of said catheter, said rigid elongated rods being affixed to said peripheral closure at the interior of said open channel, with said axes of elongation mutually parallel and parallel to said channel axis, said elongated portion of said catheter extending through said open channel, and being coupled to said peripheral closure on one side of said open channel, whereby body fluids may flow through that portion of said cross-sectional area of said channel which is not occupied by said elongated portion of said catheter;

at least one path for the flow of balloon inflation fluid extending between said elongated lumen defined by said elongated portion and the interior of said balloon, whereby said balloon may be inflated and deflated from Said proximal end of said elongated portion of said catheter; and

a relatively inelastic filamentary reinforcement wound about said balloon, passing repeatedly through said central channel and about said exterior surface of said balloon.