Torquable catheter and method

• US 5,322,064 A
• Filed: 09/24/1993
• Issued: 06/21/1994
• Est. Priority Date: 02/15/1991
• Status: Expired due to Term

• Current Assignee: BioCardia, Inc
• Original Assignee: Ingemar H. Lundquist
• Inventors: Lundquist, Ingemar H.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/126,431
• Time in Patent Office: 270 Days
• Field of Search: 128/4, 128/6, 128/772-774, 128/642, 607/116, 607/119, 607/122, 607/125-128, 604/94, 604/95, 604/280, 604/282
• US Class Current: 600/381
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0053 having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61N 1/06 for high-frequency therapy

Abstract

Catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities. The shaft is comprised of a torque tube extending substantially the entire length of the shaft. The torque tube has a cylindrical wall with at least one flexible portion therein with the flexible portion being characterized in that at least one slot is provided in the cylindrical wall subtending an angle of less than 360°. A flexible sleeve encloses the torque tube and serves to cover the flexible portion while permitting the torque tube to bend in the vicinity of the slot a predetermined amount which is less than that which would create a permanent strain in the torque tube.

Claims

1. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities, a length and a longitudinal axis, said shaft being comprised of a torque tube extending through at least a portion of the length of the shaft, said torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

, a flexible sleeve enclosing said torque tube and serving to cover said flexible portion and permitting said torque tube to bend in the vicinity of said slot, a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, first and second pull strings secured between the handle and the distal extremity of the shaft, means carried by the handle for pulling on said pull strings for causing bending of the distal extremity of the flexible elongate tubular member, said torque tube being provided with a tip section and a tractable section proximal of the tip section and means for connecting one of said pull strings to said tip section and the other of said pull strings to said tractable section whereby the tip section can be bent by pulling on one of said pull strings and the tractable section can be bent by pulling on the other of said pull strings.

2. A catheter as in claim 1 wherein said tip section and said tractable section each have proximal and distal extremities, said one pull string being secured to said tip section at the distal extremity of the tip section, said other pull string being secured to the tractable section at the distal extremity of the tractable section, anchoring means for anchoring the tip section at the proximal extremity of the tip section and anchoring means for anchoring the tractable section at the proximal extremity of the tractable section.

3. A catheter as in claim 2 wherein said pull strings are formed of Kevlar.

4. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities, a length and a longitudinal axis, said shaft being comprised of a torque tube extending through at least a portion of the length of the shaft, said torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

, a flexible sleeve enclosing said torque tube and serving to cover said flexible portion and permitting said torque tube to bend in the vicinity of said slot, a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, first and second pull strings secured between the handle and the distal extremity of the shaft, means carried by the handle for pulling on said pull strings for causing bending of the distal extremity of the flexible elongate tubular member, and a coil spring jacket disposed on each of said pull strings for minimizing friction between the pull strings and for minimizing friction of the pull strings in the tubular shaft.

5. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities a length and a longitudinal axis, said shaft being comprised of a torque tube extending through at least a portion of the length of the shaft, said torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

, a flexible sleeve enclosing said torque tube and serving to cover said flexible portion and permitting said torque tube to bend in the vicinity of said slot, a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, first and second pull strings secured between the handle and the distal extremity of the shaft, means carried by the handle for pulling on said pull strings for causing bending of the distal extremity of the flexible elongate tubular member, first and second knobs mounted on the handle and means for securing the first and second pull strings to the first and second knobs so as the first and second knobs are moved the pull strings are tensioned.

6. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities a length and a longitudinal axis, said shaft being comprised of a torque tube extending through at least a portion of the length of the shaft, said torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

, a flexible sleeve enclosing said torque tube and serving to cover said flexible portion and permitting said torque tube to bend in the vicinity of said slot, a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, first and second pull strings secured between the handle and the distal extremity of the shaft, means carried by the handle for pulling on said pull strings for causing bending of the distal extremity of the flexible elongate tubular member, first and second knobs mounted on the handle and means for securing the first and second pull strings to the first and second knobs so as that the first and second knobs are moved the pull strings are tensioned and means carried by the first and second knobs for distinguishing by feel of the human hand which is the first knob and which is the second knob.

7. A catheter as in claim 6 wherein said means carried by the knobs is in the form of first and second protuberances carried by the knobs and where one of the protuberances has a different shape than the other of the protuberances.

8. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities, a length and a longitudinal axis, said shaft being comprised of a metal torque tube extending for at least a portion of the length of the shaft, said metal torque having a thin cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

and a flexible sleeve of shrink tubing enclosing and in contact with said flexible portion of said metal torque tube and serving to cover said flexible portion and permitting said flexible portion of said torque tube to bend in the vicinity of said slot but inhibiting placing a permanent strain in said flexible portion of said torque tube, said metal torque tube being provided with a flexible tip section having a plurality of longitudinally spaced apart slots to provide a metal backbone which is substantially planar extending longitudinally of the tip section and generally lying in a plane to permit bending of the tip section only in a direction which is perpendicular to the plane of the backbone.

9. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities, a length and a longitudinal axis, said shaft being comprised of a metal torque tube extending for at least a portion of the length of the shaft, said metal torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less of 360°

, a flexible sleeve of shrink tubing enclosing and in contact with said flexible portion of said torque tube and serving to cover said flexible portion of said torque tube and permitting said flexible portion of said torque tube to bend in the vicinity of said slot but inhibiting placing a permanent strain on said flexible portion of said torque tube, a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, said torque tube being provided with a tractable section proximal of the distal extremity of the shaft, said tractable section having a plurality of longitudinally spaced apart slots subtending angles of less than 360°

with certain of said slots being radially offset from other of said slots whereby the tractable section can be prebent in at least two directions.

10. A catheter having a high torque capability adapted to be inserted into and through a lumen of a blood vessel comprising a flexible elongate tubular shaft having proximal and distal extremities, a length and a longitudinal axis, said shaft being comprised of a torque tube extending substantially the entire length of the shaft, said torque tube having a cylindrical wall with at least one flexible portion therein, said flexible portion being characterized in that at least one slot is provided in said cylindrical wall subtending an angle of less than 360°

, a flexible sleeve enclosing said torque tube and serving to cover said flexible portion and permitting said torque tube to bend i the vicinity of said slot a handle adapted to be grasped by the human hand and secured to the proximal extremity of said tubular shaft for causing rotation of the tubular shaft, said torque tube being provided with a tractable section proximal of the distal extremity of the shaft, said tractable section having a plurality of longitudinally spaced apart slots subtending angles of less than 360°

with adjacent slots being radially offset from one another, said torque tube being provided with a tip section distal of the tractable section and having a plurality of longitudinally spaced apart slots substantially in radial alignment with each other and serving to provide a rib extending longitudinally of the tip section and generally lying in a plane.

11. A catheter as in claim 10 wherein said slots in said tip section subtend various angles to provide a backbone at least a portion of which is tapered to provide variable flexibilities in the tip section.

12. A method for positioning a catheter in a vessel with the catheter having proximal and distal extremities, and having first and second pull lines having distal extremities secured to the distal extremity of the catheter and means for applying a tension to the pull lines with the catheter having a tip section and a tractable section proximal of the tip section, the method comprising forming a slight bend in the tractable section of the catheter outside of the vessel, introducing the catheter into the vessel and using one of the pull lines to place an additional bend in the tractable section and utilizing the other pull line to place a bend in the tip section.

13. A method as in claim 12 wherein the tractable section is bent at an angle which can extend through 360°

of rotation and wherein the tip section can be bent in a plane.

14. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable metal wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve of shrink tubing enclosing and in contact with the slotted-wall segment to permit the slotted-wall segment to bend along the axis but inhibiting placing a permanent strain in said slotted-wall segment, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body.

15. A catheter according to claim 14 wherein said at least one slot extends radially through the wall.

16. A catheter according to claim 14 wherein the slotted-wall segment includes a plurality of slots spaced along the longitudinal axis and extending radially through the wall, each slot subtending an angle of less than 360°

.

17. A catheter according to claim 16 wherein adjacent slots of the plurality of slots are radially offset from each other.

18. A catheter according to claim 16 wherein adjacent slots of the plurality of slots are in radial alignment with each other.

19. A catheter according to claim 17 or 18 wherein at least some of the slots subtend different angles.

20. A catheter according to claim 14 wherein the elongate flexible body includes an additional slotted-wall segment that is spaced from said at least one slotted-wall segment and including a malleable metal wall having at least one slot extending through the wall that subtends an angle of less than 360°

, that is capable of retaining at a different radial angle another curvature different from said one different curvature and wherein the flexible sleeve also encloses and is in contact with the additional slotted-wall segment to permit the additional slotted-wall segment to bend but inhibiting the placement of a permanent strain therein.

21. A catheter according to claim 20 wherein the additional slotted-wall segment is disposed in the distal end of the body, wherein the first means rotates said at least one slotted-wall segment and said additional slotted-wall segment and wherein said second means bends the additional slotted-wall segment.

22. A catheter according to claim 14 wherein the first means is in the form of a handle adapted to be grasped by the human hand and wherein the second means includes first and second pull strings secured to the handle and to the distal end of the body and extending through the body and means carried by the handle for pulling on said pull strings for causing bending of the distal end of the body.

23. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing said slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said elongate flexible body including an additional slotted-wall segment that is spaced from said at least one slotted-wall segment and including a malleable wall having at least one slot extending through the wall that subtends an angle of less than 360°

that is capable of retaining at a different radial angle another curvature different from said one different curvature, said flexible sleeve also enclosing the additional slotted-wall segment to permit the additional slotted-wall segment to bend without breaking, said at least one slotted-wall segment including a first array of slots, each slot subtending an angle of less than 360°

to impart flexibility in more than two bend directions about the longitudinal axis, said additional slotted wall segment including a second array of slots with each slot in the second array of slots subtending an angle of less than 360° and

differing from the first array to impart flexibility in no more than two bend directions about the longitudinal axis.

24. A catheter according to claim 23 wherein the first array of slots includes a plurality of slots spaced longitudinal along the longitudinal axis with adjacent slots in the plurality of slots being radially offset from each other.

25. A catheter according to claim 24 wherein the second array of slots includes a plurality of slots longitudinally spaced along the longitudinal axis with adjacent slots in the plurality of slots being in radial alignment with each other.

26. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable metal wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve of shrink tubing enclosing and in contact with the slotted-wall segment to permit the slotted-wall segment to bend along the axis but inhibiting placing a permanent strain in said slotted-wall segment, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said at least one slotted-wall segment comprising a plurality of segments aligned along the longitudinal axis with a plurality of slots therebetween and having interconnecting hinges permitting bending at the hinges.

27. A catheter according to claim 26 wherein the hinges between adjacent segments are radially offset.

28. A catheter according to claim 27 wherein at least certain of the hinges are axially aligned.

29. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing the slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said at least one slotted-wall segment comprising a plurality of segments aligned along the longitudinal axis with a plurality of slots therebetween and having interconnecting hinges permitting bending at the hinges, the slots having a width which determines the maximum amount of bending between one segment and another.

30. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing the slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said first means being in the form of a handle adapted to be grasped by the human hand, said second means including first and second pull strings secured to the handle and to the distal end of the body and extending through the body means carried by the handle for pulling on said pull strings for causing bending of the distal end of the body, said body being provided with a tip section and a tractable section proximal of the tip section and means for connecting said first pull string to said tip section and said second pull string to said tractable section whereby the tip section can be bent by pulling on first said pull string and the tractable section can be bent by pulling on said second pull string.

31. A catheter according to claim 30 wherein said first pull string is secured to said tip section at the distal extremity of the tip section and wherein said second pull string is secured to the tractable section at the distal extremity of the tractable section together with anchoring means for anchoring the tip section at the proximal extremity of the tip section and anchoring means for anchoring the tractable section at the proximal extremity of the tractable section.

32. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing the slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said first means being in the form of a handle adapted to be grasped by the human hand, said second means including first and second pull strings secured to the handle and to the distal end of the body and extending through the body, means carried by the handle for pulling on said pull strings for causing bending of the distal end of the body and a coil spring jacket disposed on each of said first and second pull strings for minimizing friction between the first and second pull strings and for minimizing friction between the first and second pull strings and the malleable wall.

33. A catheter comprising an elongate flexible body having longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing the slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment and second means on the proximal end of the body and extending to the distal end of the body for transmitting a bending force to the distal end of the body, said first means being in the form of a handle adapted to be grasped by the human hand, said second means including first and second pull strings secured to the handle and to the distal end of the body and extending through the body and means carried by the handle pulling on said pull strings for causing bending of the distal end of the body and, said first and second pull strings being formed of Kevlar.

34. A catheter comprising an elongate flexible body having a longitudinal axis, a proximal end and a distal end, the body including a malleable wall having at least one slotted-wall segment proximal of the distal end that includes at least one slot extending through the wall that subtends an angle of less than 360°

so that said at least one slotted-wall segment is capable of retaining at least one different curvature in response to external manipulation, a flexible sleeve encasing the slotted-wall segment to permit the slotted-wall segment to bend along the axis without breaking, first means on the proximal end of the body for applying rotational torque for rotating the body about the longitudinal axis by transmitting the rotational torque to and through the slotted-wall segment, second means on the proximal end of the body and extending to the distal end of the body of transmitting a bending force to the distal end of the body, said at least one slotted-wall segment comprising a plurality of segments aligned along the longitudinal axis with a plurality of slots therebetween and having interconnecting hinges permitting bending at the hinges and superelastic memory metal elements disposed within the hinges and extending into the segments to urge the segments to return to a position in which the hinges are not bent.

35. A catheter as in claim 34 wherein said superelastic memory elements are formed in TINEL.