Dilation catheter method and apparatus

• US 4,271,839 A
• Filed: 07/25/1979
• Issued: 06/09/1981
• Est. Priority Date: 07/25/1979
• Status: Expired due to Term

• Current Assignee: Thomas J. Fogarty
• Original Assignee: Thomas J. Fogarty
• Inventors: Chin, Albert K., Fogarty, Thomas J.
• Primary Examiner(s): BERNSTEIN, HIRAM H
• Application Number:
  US06/060,408
• Time in Patent Office: 685 Days
• Field of Search: 128/262, 128/348, 128/349 B, 128/344, 128/325
• US Class Current: 606/194
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter wherein the balloon is inverted within the distal end of the catheter for eversion therefrom and extrusion through a partially occluded blood vessel in response to the exertion of internal fluid pressure on the balloon. The catheter is designed to extrude through the occluded vessel in advance of substantial lateral expansion and, upon full extension, is adapted to expand to a condition at least partially dilating the occlusion. A cord connected to the balloon and extending through the catheter provides means whereby tension may be applied to the balloon to reinvert it within the catheter. A reservoir in communication with the inner lumen of the catheter provides a closed fluid-filled system whereby the balloon may be sequentially everted and reinverted without venting outside of the system.

Claims

1. Apparatus for dilating a partially occluded section of a blood vessel, said apparatus comprising:

an elongated flexible generally inelastic catheter having an outside diameter less than the internal diameter of the nonoccluded vessel;

balloon means inverted within the catheter, said balloon means having a mouth peripherally sealed to the distal end of the catheter and being evertable out of the catheter in response to the exertion of fluid pressure within the catheter for substantially anisotropic expansion out of the catheter and through the occluded section of the vessel in advance of substantial lateral expansion and, upon eversion out of the catheter, being laterally expansible in response to the continued exertion of fluid pressure internally of the catheter to an outside diameter equal to or greater than the internal diameter of the vessel; and

means to selectively impart internal pressure to the catheter.

2. An apparatus according to claim 1 wherein the balloon means comprises a bag having an outside diameter wall thickness and length such that the bag does not drag on the inner walls of the catheter when everted out of the catheter symmetrically.

3. An apparatus according to claim 2, wherein the catheter has an outside diameter approximately equal to one-half the internal diameter of the nonoccluded vessel.

4. An apparatus according to claim 1 wherein the balloon means, when in the inverted condition within the catheter, has a length no more than twenty-five times the internal diameter of the catheter.

5. An apparatus according to claim 1 further compising cord means extending through the catheter and connected to the balloon means, said cord means having a length greater than that of the catheter whereby the balloon may be fully everted out of the catheter without resistance by said cord means and, upon release of internal fluid pressure from the catheter, being tensionable to reinvert the balloon means within the catheter;

and means to selectively apply tension to the cord means.

6. An apparatus according to claim 5 wherein:

the cord means comprises a flexible catheter; and

, the balloon means comprises an annular elastomeric member having the inner periphery thereof sealingly secured to the cord means catheter and the outer periphery thereof sealingly secured to the catheter within which the balloon means is inverted.

7. A method for dilating an occlusion within a blood vessel, said method comprising:

providing a flexible catheter having a balloon with the mouth thereof peripherally sealed to the distal end of the catheter and the body thereof inverted within the catheter;

introducing said catheter into the vessel so as to position the distal end thereof proximate one end of the occlusion;

applying internal fluid pressure to the catheter so as to evert the body of the balloon out of the catheter and extrude said body through at least a portion of the occlusion; and

applying continued internal pressure to the catheter to expand the balloon to an outside sufficient to at least partially dilate the occlusion.

8. A method according to claim 7, further comprising:

reinverting to balloon within the catheter and withdrawing the catheter from the vessel.

9. A method according to claim 7, further comprising:

extending a cord through the catheter and connecting one end of the cord to the end of the balloon so that the cord is normally slack and does not restrict eversion or expansion of the balloon;

releasing the fluid pressure on said catheter after expansion of the balloon to an outside diameter equal to or greater than the nonoccluded inner diameter of the vessel; and

, after so releasing the internal pressure on the catheter, applying tension to the cord to reinvert the balloon within the catheter.

10. A method according to claim 7 wherein the balloon when everted within the catheter, has an outside diameter less than the internal diameter of the catheter and length no greater than twenty-five times the internal diameter of the catheter.

11. Apparatus for dilating a partially occluded section of a blood vessel, said apparatus comprising an elongated flexible catheter adapted for passage through the vessel;

balloon means inverted within the catheter, said balloon means having a mouth peripherally sealed to the distal end of the catheter and being evertable out of the catheter in response to the exertion of fluid pressure within the catheter for eversion out of the catheter and extrusion through the occluded section of the vessel in advance of substantial lateral expansion and, upon eversion out of catheter, being laterally expansible in response to continued exertion of fluid pressure internally of the catheter to an outside diameter sufficiently large to at least partially dilate the occlusion; and

means to selectively impart internal pressure to the catheter.

12. An apparatus according to claim 11 wherein the means to selectively impart internal pressure to the catheter comprises a syringe connected to the proximal end of the catheter, said syringe having a piston moveable in a first direction for displacing fluid into the catheter and a second direction for displacing fluid out of the catheter;

and wherein said apparatus further comprises cord means extending through the catheter and connected between the balloon and piston to permit unrestricted eversion and expansion of the balloon means in response to movement of the piston in the first direction and to exert reinverting tension force on the balloon in response to movement of the piston beyond a predetermined limit in the second direction.

13. An apparatus according to claim 12 wherein:

the cord means comprises a flexible catheter; and

, the balloon means comprises an annular elastomeric member having the inner periphery sealingly secured to the cord means catheter and the outer periphery thereof sealingly secured to the catheter within which the balloon means is inverted.

14. An apparatus according to claim 12, further comprising:

a reservoir interposed between the catheter and syringe;

valve means to selectively open and close said reservoir to fluid communication with the catheter.