Controllable flexibility catheter

• US 4,822,345 A
• Filed: 03/16/1988
• Issued: 04/18/1989
• Est. Priority Date: 08/14/1986
• Status: Expired due to Term

• Current Assignee: John W. Danforth
• Original Assignee: John W. Danforth
• Inventors: Danforth, John W.
• Primary Examiner(s): Truluck, Dalton L.
• Application Number:
  US07/170,596
• Time in Patent Office: 398 Days
• Field of Search: 604/95, 604/96, 604/103, 604/280-282, 128/344, 128/348.1
• US Class Current: 604/524
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/09025 with sliding mandrils

Abstract

A guiding catheter 40 of variable, operator-controlled flexibility to be used in the performance of a percutaneous translumenal coronary angioplasty procedure is described which includes an elongate housing 42 suitable for insertion into an artery, as well as an operator-controlled variable stiffener coupled to the distal aspect of the catheter to permit the operator performing the angioplasty procedure to increase the rigidity of the catheter. In a preferred embodiment the stiffening apparatus consists of a balloon 50 extending longitudinally along the distal end of the catheter to allow increases in rigidity of the distal end as desired by the operator. Increasing the rigidity of the guiding catheter, once installed within the coronary ostium, precludes disengagement of the guiding catheter, thus expediting the performance and enhancing the safety of the procedure.

Claims

1. A catheter comprising:

an elongate housing having an opening extending from a proximal end to a distal end of its length, the housing adapted to be inserted into a vessel wherein said housing, when inserted in the vessel, has a first substantially curved portion and a second substantially straight portion, said first portion being more proximate to the distal end than said second portion; and

controllable stiffening means coupled to said first portion of the length of the elongated housing to provide at least a first higher flexibility of said first portion of the elongated housing and a second lower flexibility of said first portion of the elongated housing as selected by a user of the catheter,

wherein the flexibility of said second portion of said elongate housing is substantially unchanged by said user-selected change in flexibility of said first portion of said elongated housing, and wherein the curvature of said curved portion is not substantially decreased when said housing has said second lower flexibility.

2. A catheter as in claim 1 wherein the controllable stiffening means comprises a longitudinally-extending primary balloon disposed along said first portion of the elongate housing.

3. A catheter as in claim 2 further comprising an enclosed channel extending adjacent the opening of the elongate housing and coupled to the balloon to permit inflation thereof.

4. A catheter as in claim 3 wherein the channel extends from the proximal end to the primary balloon.

5. A catheter as in claim 2 wherein a wall of the balloon comprises a first region of the exterior surface of said first portion of the elongate housing.

6. A catheter as in claim 2 wherein the balloon is disposed around only a selected part of the cross sectional circumference of the exterior surface of said first portion of the elongate housing, wherein the curvature of said second portion when said balloon is uninflated is less than the curvature of said second portion when the balloon is inflated.

7. A catheter as in claim 1 wherein the controllable stiffening means comprises at least one wire to be inserted into the elongate housing, the wire having been previously bent to have a desired configuration along a selected part of its length corresponding to said first portion of the length of the elongate housing.

8. A catheter as in claim 1 wherein the controllable stiffening means comprises a channel eccentrically disposed along said first portion of the housing for containing fluid.

18. A catheter as in claim 1 wherein said first portion of the length comprises a region in closer proximity to the distal end than to the proximal end.

19. A catheter as in claim 2 wherein the primary balloon is eccentrically disposed along said first portion of the elongate housing.

20. A catheter as in claim 1 wherein the controllable stiffening means comprises at least one tensionable element secured to the distal end and disposed within a channel in the elongate housing.

9. A catheter comprising:

an elongate housing having an opening extending from a proximal end to a distal end of its length, the housing adapted to be inserted into a vessel;

controllable stiffening means comprising a longitudinally extending primary balloon coupled to a portion of the length of the elongate housing to provide at least a first higher flexibility of that portion of the elongate housing and a second lower flexibility of that portion of the elongate housing as selected by a user of the catheter; and

a secondary balloon disposed along the elongate housing more proximal to the distal end than the primary balloon.

10. A catheter as in claim 9 further comprising a secondary channel extending adjacent the opening of the elongate housing and coupled to the secondary balloon to permit inflation thereof.

11. A catheter as in claim 10 wherein a wall of the secondary balloon comprises a second region of the exterior surface of the elongate housing.

12. A catheter as in claim 11 wherein the secondary balloon is positioned axially offset from the primary balloon.

13. A catheter comprising:

an elongate housing having an opening extending from a proximal end to a distal end of its length, the housing adapted to be inserted into a vessel;

controllable stiffening means coupled to a portion of the length of the elongate housing to provide at least a first higher flexibility of that portion of the elongate housing and a second lower flexibility of that portion of the elongate housing as selected by a user of the catheter; and

an angioplasty dilation catheter disposed within the opening.

14. A guiding catheter for use in angioplasty comprising:

an elongate tube having an opening therethrough extending from a proximal end to a distal end, the tube adapted to be inserted into a vascular member; and

controllable stiffening means coupled to a surface of the elongate tube along a first non-linear portion of its length, said stiffening means being substantially uncoupled along a second portion of the length of the tube, said first portion being more proximate to the distal end than said second portion, said stiffening means being adapted to allow said first portion of the elongate tube to which the controllable stiffening means is coupled to be made more rigid at selected times, without substantially affecting the flexibility of said second portion, and wherein the tube and a guidewire may be introduced into a vesicular member in a first less rigid state, then changed to a second more rigid state to facilitate introduction of an angioplasty dilation balloon catheter across a region of coronary stenosis.

16. A catheter as in claim 14 wherein the second more rigid state places the catheter in a configuration which is more highly bent than when the catheter is in the first less rigid state.

17. A catheter as in claim 14 wherein the second more rigid state places the catheter in a configuration adapted for maintaining the catheter in a position suitable for the performance of coronary angioplasty.

15. A method for performing an angioplasty procedure using a guiding catheter having controllable stiffening means affixed to a portion of the catheter in proximity to the distal end comprising:

introducing the guiding catheter to a desired position within a patient;

employing the controllable stiffening means to increase the rigidity of the portion of the catheter to which the controllable stiffening means is affixed;

performing the angioplasty procedure;

employing the controllable stiffening means to reduce the rigidity of the portion of the catheter; and

removing the catheter.

21. A method as claimed in claim 15 further comprising:

employing the controllable stiffening means to position the distal end of the guiding catheter for alignment in the coronary ostium.

22. A method as claimed in claim 15 further comprising:

continuously varying the rigidity of a portion of the catheter during said performance of the angioplasty procedure.

23. A guiding catheter for use in angioplasty comprising:

an elongate tube having an opening therethrough extending from a proximal end to a distal end, the tube adapted to be inserted into a vascular member; and

controllable stiffening means coupled to a surface of the elongate tube along a first non-linear portion of its length, said stiffening means being substantially uncoupled along a second portion of a length of the tube, said stiffening means being adapted to allow said first portion of the elongate tube to which the controllable stiffening means is coupled to be more rigid at selected times, without substantially affecting the flexibility of said second portion, and wherein the controllable stiffening means is effective to position the distal end of said elongate tube for alignment in the coronary ostium.