Fixed-wire dilatation catheter with rotatable balloon assembly

• US 5,397,305 A
• Filed: 11/30/1992
• Issued: 03/14/1995
• Est. Priority Date: 12/21/1990
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Kawula, Paul J., Beitelia, Ray R., vander Burg, Erik J., Williams, Michael S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US07/983,602
• Time in Patent Office: 834 Days
• Field of Search: 604/95-99, 604/103, 604/126, 606/191, 606/192, 606/194, 606/195
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/008 Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A fixed-wire dilatation catheter for angioplasty procedures which has an inflated balloon on the distal end with little or no tendency to wrap on itself when the catheter is advanced through a patient'"'"'s vascular system. The catheter comprises an elongated torquable shaft which is longitudinally relatively flexible but diametrically relatively rigid, a guide extension secured to the distal end of the elongated torquable shaft, and a balloon assembly which is mounted about the distal section of the torquable shaft and the guide member so that the balloon assembly is free to rotate about the torquable shaft and guide member and thereby avoid balloon wrapping. An elongated flexible member such as a helical coil is secured to the portion of the guide member which extends distally of the balloon.

Claims

1. An intravascular catheter, comprising:

a) an elongated catheter body with an inner lumen extending therein;

b) an expandable member freely rotatably mounted to the catheter body near its distal extremity;

c) means for setting the interior of said expandable member in fluid communication with the inner lumen of the catheter body;

d) a guide element supported within the catheter which extends through at least part of the interior of the expandable member and out the distal end thereof;

e) means for preventing the loss of fluid from within the expandable member'"'"'s interior; and

f) means for preventing longitudinal movement of the guide element relative the catheter.

2. The intravascular catheter of claim 1 including means disposed between the distal end of the expandable member and the portion of the guide element extending therethrough to allow the passage of gas but preclude the passage of liquid therethrough.

3. The intravascular catheter of claim 2 wherein the means to allow the passage of gas but preclude the passage of liquid therethrough is a hydrophilic material disposed between the distal end of the expandable member and the guide element which expands sufficiently upon contact with an aqueous based liquid to prevent the passage therethrough of liquid under relatively high pressure.

4. The intravascular catheter of claim 3 wherein the hydrophilic material which expands upon contact with aqueous based liquid is in porous form.

5. The intravascular catheter of claim 3 wherein the hydrophilic material is selected from the group consisting of polyacrylamide or high molecular weight polyethylene.

6. The intravascular catheter of claim 1 comprising means to prevent relative longitudinal movement between the guide element and the distal end of the expandable member.

7. The intravascular catheter of claim 6 wherein the means to prevent relative longitudinal movement between the guide element and the distal end of the expandable member include at least two radially extending protrusions longitudinally spaced along the exterior of the guide element and an annular bearing affixed to said expandable member which is rotatably mounted about the guide element between two of the radially extending protrusions.

8. An intravascular catheter, comprising:

a) an elongated catheter body with an inner lumen extending therein;

b) an expandable member freely rotatably mounted to the catheter body near its distal extremity so as to prevent relative longitudinal movement;

c) means for setting the interior of said expandable member in fluid communication with the inner lumen of the catheter body;

d) a guide element supported within the catheter which extends through at least part of the interior of the expandable member and out the distal end thereof;

e) bearing means to support the distal end of the expandable member about the guide element so as to prevent relative longitudinal movement while allowing free relative rotation therebetween; and

f) means for preventing the loss of fluid from within the expandable member'"'"'s interior out its distal end.

9. The fixed-wire dilatation catheter, comprising:

a) an elongated torquable shaft;

which has a main tubular section and a more flexible, relatively short distal tubular section distal to the main tubular section;

which has an inner lumen extending through the main and distal tubular sections; and

which has at least one inflation port in the distal tubular section in fluid communication with the inner lumen;

b) a guide member;

which has proximal and distal ends; and

which is secured by the proximal end thereof to the distal tubular section of the torquable shaft;

c) an inflatable assembly disposed about said torquable shaft so as to be freely rotatable relative thereto, and longitudinally fixed relative thereto;

which has proximal and distal ends;

which has an inflatable member with an interior in fluid communication with the inflation port; and

which has a proximal tubular extension disposed about at least a portion of the distal tubular section of the torquable shaft and at least a portion of the guide element which is in fluid communication with said inflatable member and said inflation port to thereby define an inflation lumen;

d) means to allow free relative rotational movement between the inflatable member assembly and the torquable shaft; and

e) means for sealing the inflatable assembly about said torquable shaft to prevent loss of inflation fluid from the inflatable assembly upon the inflation of the inflatable member.

10. A fixed-wire dilatation catheter, comprising:

a) an elongated torquable shaft which includes a main tubular section and a relatively more flexible distal tubular section;

an inner lumen extending through the main and distal tubular sections; and

at least one inflation port in the distal tubular section which sets said tubular section'"'"'s exterior into fluid communication with the inner lumen;

b) a guide member which has proximal and distal ends, and which is secured by its proximal end to the distal tubular section of the torquable shaft; and

c) a balloon assembly which includes;

a tubular extension having a proximal end and a distal end, and which is disposed about at least a portion of the distal tubular section of the torquable shaft and at least a portion of the guide member such that the interior of said tubular extension is in fluid communication with said inner lumen via said inflation port;

means for rotatably attaching the proximal end of said tubular extension to said elongated torquable shaft so as to allow free rotation therebetween;

means for sealing between said tubular extension and said torquable shaft allowing free rotation therebetween

an inflatable balloon, having a proximal end and a distal end, and which is disposed about said guide member, its proximal end being affixed to said tubular extension and in fluid communication therewith;

means for rotatably attaching the distal end of said balloon to said guide member so as to allow free rotation therebetween; and

means for sealing between the distal end of said balloon and said guide member allowing free rotation therebetween whereby the balloon assembly is freely rotatable about the torquable shaft and guide member.

11. The fixed-wire dilatation catheter of claim 10 wherein the means for rotatably attaching the tubular extension to said elongated shaft includes an annular bearing which is secured to the inside of the tubular extension of the balloon assembly and is rotatably disposed about the distal tubular section.

12. The fixed-wire dilatation catheter of claim 11 further comprising means to prevent relative longitudinal movement between the annular bearing and the distal tubular section of the torquable shaft.

13. The fixed-wire dilatation catheter of claim 12 wherein the longitudinal movement preventing means include radially extending protrusions longitudinally spaced along the exterior of the distal tubular section of the torquable shaft.

14. The fixed-wire dilatation catheter of claim 13 wherein said annular bearing is rotatably mounted about the distal tubular section between said radially extending protrusions that are longitudinally spaced along the exterior of the distal tubular section of the torquable shaft.

15. The fixed-wire dilatation catheter of claim 10 wherein a portion of said guide member extends out the distal end of the balloon assembly and wherein a flexible body is disposed about and secured thereto.

16. The fixed wire dilatation catheter of claim 15 wherein said flexible body has a distal end and wherein a rounded plug is formed in said distal end.

17. The fixed-wire dilatation catheter of claim 16 wherein a shaping ribbon having proximal and distal ends is secured at the proximal end thereof to the guide member and at the distal end thereof to the rounded plug.

18. The fixed-wire dilatation catheter of claim 17 wherein the shaping ribbon is formed of a metal selected from the group consisting of tungsten, rhenium, and alloys thereof and stainless steel.

19. The fixed-wire dilatation catheter of claim 15 wherein the flexible body is a helical coil.

20. The fixed-wire dilatation catheter of claim 19 wherein a distal portion of the coil is formed of radiopaque material.

21. The fixed-wire dilatation catheter of claim 15 wherein the flexible body is a helical coil or an elongated body of flexible plastic.

22. The fixed-wire dilatation catheter of claim 16 wherein the distal end of the guide member is secured to the rounded plug.

23. The fixed-wire dilatation catheter of claim 16 wherein the distal end of the guide member terminates short of the rounded plug.

24. The fixed-wire dilatation catheter of claim 15 wherein said flexible body has a distal end and wherein the distal end of the guide member is secured to the flexible body at an intermediate location proximal to the distal end thereof.

25. The fixed-wire dilatation catheter of claim 10 including means to vent air from the interior of the balloon displaced during the inflation of the balloon with inflating liquid.

26. The fixed-wire dilatation catheter of claim 25 wherein the venting means includes hydrophilic material disposed between the distal end of the balloon and the guide member which expands sufficiently upon contact with an aqueous based liquid to prevent the passage therethrough of liquid under relatively high pressure.

27. The fixed-wire dilatation catheter of claim 26 wherein the hydrophilic material is formed of polyacrylamide or high molecular weight polyethylene.

28. The fixed-wire dilatation catheter of claim 26 wherein the tubular extension is formed of polyimide.

29. The fixed-wire dilatation catheter of claim 10 wherein the means for sealingly between the distal end of the balloon and the guide member prevents the loss of fluid but allows the passage of air therethrough.

30. The fixed-wire dilatation catheter of claim 29 wherein the means for sealingly attaching the distal end of the balloon and the guide member include a porous body which swells upon contact with an aqueous liquid.

31. The fixed-wire dilatation catheter of claim 29 wherein the means for sealing between the distal end of the balloon and the guide member extending therethrough is secured to the inside of the distal end of the balloon.

32. The fixed-wire dilatation catheter of claim 10 wherein the main tubular section of the torquable member is formed of metal and is relatively flexible with respect to lateral loads but relatively rigid with respect to torque loads.

33. The fixed-wire dilatation catheter of claim 32 wherein the metal is selected from the group consisting of stainless steel and a nickel-titanium alloy having superelastic properties.

34. The fixed-wire dilatation catheter of claim 10 wherein the outer diameter of the main tubular section is less than 0.02 inch.

35. The fixed-wire dilatation catheter of claim 10 wherein the balloon is formed from a plastic material selected from the group consisting of polyethylene, polyethylene terephthalate, nylon, polyimide, polyvinyl chloride and polyurethane.

36. The fixed-wire dilatation catheter of claim 10 wherein torque means is secured to the main tubular section at or near the proximal end thereof.

37. The fixed-wire dilatation catheter of claim 10 wherein a removable hub is secured to the proximal end of the main tubular section.

38. The fixed-wire dilatation catheter of claim 10 wherein the guide member extends through the interior of the balloon and the distal end of the balloon is sealed about the distal end of the guide member.

39. The fixed-wire dilatation catheter of claim 10 wherein the tubular extension has a wall thickness of less than 0.002 inch.

40. The fixed-wire dilatation catheter of claim 10 wherein said balloon is formed from a tube of polyethylene terephthalate material having an intrinsic viscosity of less than 1.