Variable stiffness angioplasty catheter

• US 4,976,690 A
• Filed: 03/22/1990
• Issued: 12/11/1990
• Est. Priority Date: 08/10/1989
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Solar, Ronald J., Kagan, Jonathan
• Primary Examiner(s): Yasko, John D.
• Application Number:
  US07/497,812
• Time in Patent Office: 264 Days
• Field of Search: 604/95-103, 604/280, 128/325, 128/344, 128/348
• US Class Current: 604/103.06
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An improved vascular catheter for angioplasty providing a variable stiffness lengthwise of the catheter. A relatively stiff shaft portion is provided for transmitting the necessary axial forces for advancing the catheter along a guide wire through a series of sharp bend to the arterial branch for dilatation, and a more flexible waist portion connects from the shaft to the balloon and tip portion. This allows the tip and balloon portions to follow sharply bending turns in the guide wire without the shaft portion tending to push the tip beyond a branch or dislodge the guide wire. A set of such catheters may be provided for a surgical procedure, having varying lengths of the waist portion according to the circumstances of the case. If a sharp turn is encountered that cannot be tracked, the catheter can be withdrawn leaving the guide wire in place, and another catheter of the set having a longer waist portion can be inserted to successfully follow the turn.

Claims

1. A coronary angioplasty dilation catheter, comprising:

(a) an elongated flexible shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilation procedure;

(b) means for defining a guide wire receiving lumen, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

(c) an inflatable balloon member disposed at the distal end of the shaft;

(d) means for fluid communication between the proximal end of said shaft and said balloon so as to provide an inflation pressure; and

(e) means for defining a waist portion disposed between said balloon member and said shaft, said waist portion being disposed at the distal end of said shaft and being of reduced outer diameter and reduced wall thickness as compared to said shaft, the length of said waist portion between said balloon member and said shaft being equal to at least one-half of the length of said balloon member.

2. A vascular dilatation catheter according to claim 1, wherein said waist portion is made of a different material than that of said shaft.

3. A vascular dilatation catheter according to claim 2, wherein said means defining a guide wire lumen and said elongate flexible shaft comprise an elongate double lumen tubular member.

7. A vascular dilatation catheter according to claim 1, wherein said balloon member is formed integrally with said waist portion.

8. A vascular dilatation catheter according to claim 1, wherein said waist portion is formed integrally with said shaft.

4. A coronary angioplasty dilatation catheter comprising:

(a) an elongated tubular shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

(b) an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient, the distal end of said tubular member extending beyond the distal end of said shaft said tubular member having a first section and a second section, said second section disposed distally of said first section;

(c) an inflatable balloon member disposed at the distal end of the shaft, positioned substantially coaxially over said tubular member, sealably connected at the distal end to said tubular member, and sealably connected at the proximal end to said shaft;

(d) means for fluid communication between the proximal end of said shaft and said balloon member so as to provide an inflation pressure; and

(e) means for defining a waist portion disposed between said balloon member and said first section of said tubular member wherein said second section of said tubular member is of reduced outer diameter and reduced wall thickness as compared to said first section of said tubular member, the length of said waist portion between said balloon member and said first section being equal to at least one-half of the length of said balloon member.

5. A vascular dilatation catheter according to claim 4, wherein said waist portion is made of a different material than that of said shaft.

6. A vascular dilatation catheter according to claim 5, wherein said tubular member and said shaft comprise an elongate double lumen tubular member.

9. A vascular dilatation catheter according to claim 4, wherein said balloon member is formed integrally with said waist portion.

10. A vascular dilatation catheter according to claim 4, wherein said waist portion is formed integrally with said shaft.

11. An angioplasty dilatation catheter, comprising:

an elongated flexible shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

an inflatable balloon member disposed at the distal end of the shaft, positioned substantially coaxially over said tubular member, sealably connected at the distal end to said tubular member;

means for fluid communication between the proximal end of the shaft and said balloon member; and

means for defining a waist portion formed integrally with said balloon member and disposed at the distal end of said shaft between said shaft and said balloon member, said waist portion being of reduced outer diameter and reduced wall thickness as compared to said shaft, the length of said waist portion between said balloon member and said shaft being equal to at least one-half of the length of said balloon member.

12. The angioplasty dilatation catheter of claim 11 wherein the waist portion and said balloon member are made of a material comprising a polyolefin.

13. The angioplasty dilatation catheter of claim 12 wherein said polyolefin comprises a polyethylene.

14. The angioplasty dilatation catheter of claim 11 further including at least one radiopaque marker disposed within said balloon member.

15. The angioplasty dilatation catheter of claim 11 further including a tip member extending distally from said balloon member, said tip member being more flexible than said balloon member.

16. The angioplasty dilatation catheter of claim 15 wherein said tip member comprises a length of said annular tubular member extending distally of said balloon member.

17. The angioplasty dilatation catheter of claim 11 wherein said shaft is formed integrally with said waist portion.

18. An angioplasty dilatation catheter, comprising:

an elongated flexible main shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

an inflatable balloon member;

means for fluid communication between the proximal end of the main shaft and said balloon member so as to provide an inflation pressure; and

a waist portion shaft disposed between said balloon member and said main shaft, the distal end of said waist portion shaft being formed integrally with said balloon member and the proximal end of said waist portion shaft being bonded to the distal end of said main shaft, said waist portion shaft being of reduced outer diameter and reduced wall thickness as compared to said main shaft, the length of said waist portion shaft between said balloon member and said main shaft being equal to at least one-half the length of said balloon member.

19. The angioplasty dilatation catheter of claim 18 wherein said waist portion shaft and said balloon member are made of a material comprising a polyolefin.

20. The angioplasty dilatation catheter of claim 19 wherein said polyolefin comprises a polyethylene.

21. The angioplasty dilatation catheter of claim 18 further including at least one radiopaque marker disposed within said balloon member.

22. The angioplasty dilatation catheter of claim 18 further including a tip member extending distally from said balloon member, said tip member being more flexible than said balloon member.

23. The angioplasty dilatation catheter of claim 22 wherein said tip member comprises a length of said annular tubular member extending distally of said balloon member.

24. An angioplasty dilatation catheter, comprising:

an elongated flexible main shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

an inflatable balloon member, positioned substantially coaxially over said tubular member, sealably connected at the distal end to said tubular member;

a tip member extending distally from said balloon member, said tip member being more flexible than said balloon member;

a waist portion shaft disposed substantially coaxially over said tubular shaft member between said balloon member and said main shaft, the distal end of said waist portion shaft being formed integrally with said balloon member and the proximal end of said waist portion shaft being bonded to the distal end of said main shaft, said waist portion shaft being made of a different material than said main shaft and being of reduced outer diameter and reduced wall thickness as compared to said main shaft, the length of said waist portion shaft between said balloon member and said main shaft being equal to at least one-half of the length of said balloon member; and

an annular lumen being defined through said tubular shaft, said main shaft and said waist portion shaft, said annular lumen providing fluid communication between the proximal end of said main shaft and said balloon member so as to provide an inflation pressure.

25. The angioplasty dilatation catheter of claim 24 wherein said waist portion shaft and said balloon member are made of a material comprising a polyolefin.

26. The angioplasty dilatation catheter of claim 25 wherein said polyolefin comprises a polyethylene.

27. The angioplasty dilatation catheter of claim 24 further including at least one radiopaque marker disposed within said balloon member.

28. The angioplasty dilatation catheter of claim 25 further including at least one radiopaque marker disposed within said balloon member.

29. A coronary angioplasty dilatation catheter, comprising:

(a) an elongated flexible shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

(b) means for defining a guide wire receiving lumen, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

(c) an inflatable balloon member disposed at the distal end of the shaft;

(d) means for fluid communication between the proximal end of said shaft and said balloon so as to provide an inflation pressure; and

(e) means for defining a waist portion disposed between said balloon member and said shaft, said waist portion being disposed at the distal end of said shaft and being of reduced outer diameter and reduced wall thickness as compared to said shaft, the length of said waist portion between said balloon member and said shaft being equal to at least one length of said balloon member.

30. A coronary angioplasty dilatation catheter, comprising:

(a) an elongated tubular shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

(b) an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient, the distal end of said tubular member extending beyond the distal end of said shaft said tubular member having a first section and a second section, said second section disposed distally of said first section;

(c) an inflatable balloon member disposed at the distal end of the shaft, positioned substantially coaxially over said tubular member, sealably connected at the distal end to said tubular member, and sealably connected at the proximal end to said shaft;

(d) means for fluid communication between the proximal end of said shaft and said balloon member so as to provide an inflation pressure; and

(e) means for defining a waist portion disposed between said balloon member and said first section of said tubular member wherein said second section of said tubular member is of reduced outer diameter and reduced wall thickness as compared to said first section of said tubular member, the length of said waist portion between said balloon member and said first section being equal to at least one length of said balloon member.

31. An angioplasty dilatation catheter, comprising:

an elongated flexible main shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

an inflatable balloon member;

means for fluid communication between the proximal end of the main shaft and said balloon member so as to provide an inflation pressure; and

a waist portion shaft disposed between said balloon member and said main shaft, the distal end of said waist portion shaft being formed integrally with said balloon member and the proximal end of said waist portion shaft being bonded to the distal end of said main shaft, said waist portion shaft being of reduced outer diameter and reduced wall thickness as compared to said main shaft, the length of said waist portion shaft between said balloon member and said main shaft being equal to at least one length of said balloon member.

32. An angioplasty dilatation catheter, comprising:

an elongated flexible main shaft having a distal end for entry into the vascular system and a proximal end for manipulation externally of the body and for attachment to instruments for use in a dilatation procedure;

an elongated tubular member defining a guide wire receiving lumen, disposed axially within said shaft, so that the catheter can be advanced along a guide wire in the vascular system of the patient;

an inflatable balloon member, positioned substantially coaxially over said tubular member, sealably connected at the distal end to said tubular member;

a tip member extending distally from said balloon member, said tip member being more flexible than said balloon member;

a waist portion shaft disposed substantially coaxially over said tubular shaft member between said balloon member and said main shaft, the distal end of said waist portion shaft being formed integrally with said balloon member and the proximal end of said waist portion shaft being bonded to the distal end of said main shaft, said waist portion shaft being made of a different material than said main shaft and being of reduced outer diameter and reduced wall thickness as compared to said main shaft, the length of said waist portion shaft between said balloon member and said main shaft being equal to at least one length of said balloon member; and

an annular lumen being defined through said tubular shaft, said main shaft and said waist portion shaft, said annular lumen providing fluid communication between the proximal end of said main shaft and said balloon member so as to provide an inflation pressure.