Balloon catheter having an oscillating tip configuration

• US 6,264,630 B1
• Filed: 12/23/1998
• Issued: 07/24/2001
• Est. Priority Date: 12/23/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Harris, Chad G., Mickley, Timothy J.
• Primary Examiner(s): Seidel, Richard K.
• Assistant Examiner(s): Hayes, Michael J
• Application Number:
  US09/219,802
• Time in Patent Office: 944 Days
• Field of Search: 604/96-98, 604/523, 604/524, 604/528, 604/912, 604/915, 604/921, 604/103, 606/192-194
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter is disclosed which includes an over-the-wire type balloon catheter, with a guide wire, wherein the catheter incorporates an axially movable inner tubular member which extends proximally through a proximal manifold lumen. The inner tubular member extends distally beyond the distal end of the outer tubular member with the balloon member distal waist affixed to the inner tubular member proximate the distal end. The catheter incorporates axial tension members which function to transmit force to the distal tip when the movable inner tubular member is oscillated axially. The axial tension members are preferably a plurality of wires, each having a proximal end affixed to the outside diameter of the inner tubular member proximate the manifold, and each having a distal end affixed to the outside diameter of the inner tubular member a substantial distance distal of the manifold. When the inner tubular member is pulled proximally, energy is stored in the catheter, which when the inner is released, forces the distal tip forward with added force from the distal point of attachment of the axial tension members. An actuator and a valve assembly are preferably included.

Claims

1. A balloon catheter assembly for improved movement through severely obstructed or highly tortuous vessel lumens, said balloon catheter assembly comprising:

a. a manifold assembly having an outer tube extending distally therefrom and inner tube slidably disposed through a lumen of said manifold assembly in axial alignment with said outer tube, said inner tube having a proximal portion accessible for oscillating said inner tube in an axial direction within said lumen of said manifold assembly, said inner and outer tube extending distally from said manifold with said inner tube coaxially disposed within said outer tube to form an inflation lumen therebetween in fluid communication with a balloon affixed proximate a distal end of said inner and outer tubes; and

,

b. at least one axial tensioning member having a proximal portion affixed to said inner tube proximate said manifold assembly and a distal portion affixed to said inner tube distal of said manifold assembly.

2. The balloon catheter assembly of claim 1, wherein said axial tensioning member comprises a plurality of wire-like members.

3. The balloon catheter assembly of claim 2, wherein said plurality of wire-like members are less elastic in tension than said inner tube.

4. The balloon catheter assembly of claim 1, wherein said axial tensioning member is a tubular sheath disposed over said inner tube, said sheath less elastic in tension than said inner tube.

5. The balloon catheter assembly of claim 1, further comprising a seal assembly operatively disposed in relation to said inner tube and manifold assembly to prevent inflation fluid from leaking out of the proximal end of said manifold assembly around said inner tube outer surface as slidably disposed therein.

6. The balloon catheter assembly of claim 5, wherein said seal assembly includes means for engaging and disengaging said seal assembly so that when said seal is disengaged said inner tube is free to move axially.

7. The balloon catheter assembly of claim 5, further comprising a means for oscillating said inner tube in an axial direction, said means coupled to said proximal portion of said inner tube.

8. An over-the-wire type balloon catheter comprising:

a. an outer tube affixed to a manifold assembly proximate a proximal end of said outer tube and having a proximal portion of an inflatable balloon assembly affixed proximate a distal end of said outer tube, wherein said outer tube has a lumen extending therethrough in fluid communication with an interior volume of said balloon at a distal end of said lumen and a proximal end of said lumen is in fluid communication with a lumen extending within said manifold assembly to a first manifold port;

b. an inner tube coaxially disposed within said lumen of said outer tube to form an inflation lumen therebetween, said inner tube having a distal portion extending distally beyond said distal end of said outer tube and having a distal portion of said inflatable balloon assembly affixed proximate a distal end of said inner tube, said inner tube having a proximal portion slidably disposed within said lumen of said manifold assembly in axial alignment with said outer tube, wherein said proximal portion of said inner tube extends proximally to a second port in said manifold assembly so that at least a portion of said proximal portion of said inner tube is accessible for axially oscillating said inner tube; and

,

c. a plurality of axial tensioning members, each of said axial tensioning members having a proximal portion affixed to said inner tube proximate said manifold assembly and each of said tensioning members has a distal portion affixed to said inner tube at a point distal of said manifold assembly, wherein at least a portion of at least one axial tensioning member is located in said inflation lumen.

9. The balloon catheter of claim 8, wherein said axial tensioning member comprises a plurality of wire-like members.

10. The balloon catheter of claim 9, wherein said plurality of wire-like members are less elastic in tension than said inner tube.

11. The balloon catheter of claim 8, wherein said plurality of axial tensioning members are disposed equidistant about the circumference of said inner tube.

12. The balloon catheter of claim 8, wherein at least some of said plurality of axial tensioning members are affixed to said inner tube over at least a portion of their length, in addition to proximal and distal portions.

13. The balloon catheter of claim 8, further comprising a seal assembly operatively disposed in relation to said inner tube and manifold assembly to prevent inflation fluid from leaking out of the proximal end of said manifold assembly around said inner tube outer surface as slidably disposed therein.

14. The balloon catheter of claim 13, wherein said seal assembly includes means for engaging and disengaging said seal assembly so that when said seal is disengaged said inner tube is free to move axially.

15. In an over-the-wire type catheter having an outer tube affixed to a manifold, and inner tube coaxially disposed with a lumen of the outer tube to form an inflation lumen therebetween which is in fluid communication with a balloon, said balloon having a proximal portion affixed to said distal portion of said outer tube and a distal portion affixed to said distal portion of said inner tube, with said balloon extending axially therebetween, the improvement comprising:

a. a proximal portion of said inner tube slidably disposed within a lumen of said manifold assembly axially aligned therewith; and

,

b. a plurality of axial tensioning members extending over a portion of the length of said inner tube from proximate said manifold assembly to a selected distal location on said inner tube, said axial tensioning members affixed to said inner tube, wherein at least a portion of at least one axial tensioning member is located in said inflation lumen.

16. The catheter of claim 15, wherein said axial tensioning member comprises a plurality of wire-like members.

17. The catheter of claim 16, wherein said plurality of wire-like members are less elastic in tension than said inner tube.

18. The catheter of claim 15, wherein said plurality of axial tensioning members are disposed equidistant about the circumference of said inner tube.

19. The catheter of claim 15, wherein at least some of said plurality of axial tensioning members are affixed to said inner tube over at least a portion of their length, in addition to proximal and distal portions.

20. The catheter of claim 15, further comprising a seal assembly operatively disposed in relation to said inner tube and manifold assembly to prevent inflation fluid from leaking out of the proximal end of said manifold assembly around said inner tube outer surface as slidably disposed therein.

21. A single operator exchange catheter comprising:

a. an outer tube affixed to a manifold assembly proximate a proximal end of said outer tube and having a proximal portion of an inflatable balloon assembly affixed proximate a distal end of said outer tube, wherein said outer tube has a lumen extending therethrough in fluid communication with an interior volume of said balloon at a distal end of said lumen and a proximal end of said lumen is in fluid communication with a lumen extending within said manifold assembly to a first manifold port;

b. a distal inner tube coaxially disposed within said lumen of said outer tube, said distal inner tube having a distal portion extending distally beyond said distal end of said outer tube and having a distal portion of said inflatable balloon assembly affixed proximate a distal end of said distal inner tube, said distal inner tube having a guidewire lumen;

c. a proximal inner tube coaxially disposed within said lumen of said outer tube, said proximal inner tube having a proximal portion slidably disposed within said lumen of said manifold assembly in axial alignment with said outer tube, wherein said proximal portion of said proximal inner tube extends proximally to a second port in said manifold assembly so that at least a portion of said proximal portion of said proximal inner tube is accessible for axially oscillating said proximal inner tube; and

d. a plurality of axial tensioning members, each of said axial tensioning members having a proximal portion affixed to said proximal inner tube and each of said tensioning members has a distal portion affixed to said distal inner tube.

22. The balloon catheter of claim 21, wherein said plurality of axial tensioning members comprises a plurality of wire-like members.

23. The balloon catheter of claim 22, wherein said plurality of wire-like members are less elastic in tension than said inner tube.