Catheter having unirail pullwire architecture

• US 8,894,610 B2
• Filed: 11/28/2012
• Issued: 11/25/2014
• Est. Priority Date: 11/28/2012
• Status: Active Grant

• Current Assignee: Auris Health, Inc. (Johnson & Johnson)
• Original Assignee: Hansen Medical Incorporated (Johnson & Johnson)
• Inventors: Macnamara, Francis, Bogusky, Joseph, Kokish, Arkady, Romo, Enrique, Hsu, Jason, Murthy, Kiran, Kadakia, Leena, Truong, Helen
• Primary Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US13/687,275
• Publication Number:
  US 20140148759A1
• Time in Patent Office: 727 Days
• Field of Search: 604/95.04, 604/528
• US Class Current: 604/95.04
• 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 2034/301 for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A steerable catheter comprises a flexible catheter body including a proximal shaft section and a distal articulating section, a proximal steering interface coupled to the proximal shaft section, and at least one hollow stiffening member extending through the proximal shaft section. The stiffening member(s) is more rigid than the proximal shaft section and is laterally offset from a geometric cross-sectional center of the proximal shaft section. The steerable catheter further comprises circumferentially spaced lumens extending through the distal articulating section, and pullwires extending through the stiffening member(s) in the proximal shaft section and the respective lumens in the distal articulating section. Each of the pullwires has a distal end that terminates in the catheter body distal to the distal articulating section and a proximal end that terminates in the steering interface. The steering interface is manipulatable to selectively tension the pullwires to bend the distal articulating section.

Claims

1. A steerable catheter, comprising:

a flexible catheter body including a proximal shaft section, a transition section, and a distal articulating section;

a proximal steering interface coupled to the proximal shaft section;

at least one hollow axially stiffening member extending through the proximal shaft section, the at least one stiffening member being laterally offset from a geometric cross-sectional center of the proximal shaft section;

a plurality of lumens extending through the transition section and the distal articulating section; and

a plurality of pullwires extending through the at least one hollow stiffening member in the proximal shaft section, each pullwire further extending through a respective lumen in the transition section into the distal articulating section, each of the pullwires having a distal end that terminates in the catheter body distal to the distal articulating section and a proximal end that terminates in the proximal steering interface, wherein the proximal steering interface is manipulatable to selectively tension one or more pullwires of the plurality to bend the distal articulating section.

2. The steerable catheter of claim 1, wherein the at least one stiffening member comprises a single stiffening member through which the plurality of pullwires extend.

3. The steerable catheter of claim 1, wherein the plurality of pullwires comprises at least three pullwires.

4. The steerable catheter of claim 1, wherein the plurality of lumens are circumferentially spaced within the distal articulating section.

5. The steerable catheter of claim 1, wherein the cross-sectional shape of the catheter body is either circular or rectangular.

6. The steerable catheter of claim 1, wherein each of the plurality of lumens is an unsupported lumen.

7. The steerable catheter of claim 4, wherein the plurality of lumens are equally circumferentially spaced from each other.

8. The steerable catheter of claim 1, wherein the plurality of lumens are spiraled within the transition section.

9. The steerable catheter of claim 1, wherein the transition body section is more rigid than the distal articulating section, such that when any of the plurality of pullwires is selectively tensioned, a resulting compressive force on the catheter body causes the distal articulating section to bend relative to the transition section.

10. The steerable catheter of claim 1, further comprising a control ring disposed within the catheter body distal to the distal articulating section, wherein the plurality of pullwires is connected to the control ring.

11. A robotically controlled catheter system, comprising:

the steerable catheter of claim 1;

a drive assembly coupled to the proximal steering interface of the steerable catheter; and

a master controller including a user interface configured for being manipulated to actuate the drive assembly, thereby selectively tensioning the plurality of pullwires to bend the distal articulating section.

12. The steerable catheter of claim 1, further comprising a guidewire lumen extending through the distal articulating section.

13. The steerable catheter of claim 12, further comprising a rapid exchange port in communication with the guidewire lumen, wherein the rapid exchange port is distal to the proximal shaft section.

14. The steerable catheter of claim 13, wherein the at least one stiffening member forms the proximal shaft section.

15. The steerable catheter of claim 1, further comprising an adapter mounted within the transition section, the adapter having a distal end that interfaces with the plurality of lumens, and a proximal end that interfaces with the at least one stiffening tube, the adapter further having a plurality of channels formed in an external surface of the adapter, the plurality of pullwires being disposed with the respective plurality of channels.

16. The steerable catheter of claim 15, wherein the at least one stiffening member comprises a single stiffening member through which the plurality of pullwires extend, the distal end of the adapter has a plurality of lumens in respective communication with the plurality of lumens in the distal articulating section, the proximal end of the adapter has a single port in communication with the stiffening tube, and the plurality of pullwires respectively extend through the plurality of lumens of the adapter, along the channels formed in the external surface of the adapter, and into the single port of the adapter.

17. The steerable catheter of claim 16, wherein at least one of the channels is spiraled around the external surface of the adapter.

18. The steerable catheter of claim 1, wherein the at least one stiffening member comprises a plurality of stiffening members through which the plurality of pullwires respectively extend.

19. The steerable catheter of claim 18, wherein the plurality of stiffening members are grouped in a manner that locates a centers of each stiffening member within an arcuate angle of less than one hundred eighty degrees relative to the geometric cross-sectional center of the proximal shaft section.

20. The steerable catheter of claim 19, wherein the arcuate angle is less than ninety degrees.

21. The steerable catheter of claim 19, wherein the arcuate angle is less than forty-five degrees.

22. The steerable catheter of claim 1, wherein the catheter body has a neutral axis, and wherein each of the pullwires is located relative to the neutral axis in the proximal shaft section a first distance, and located relative to the neutral axis in the distal articulating section a second distance, thereby defining the extent to which each of the proximal shaft section and the distal articulating section articulates when the respective pullwires are tensioned.

23. The steerable catheter of claim 22, wherein the second distance is greater than the first distance, such that the distal articulating section articulates independent of the relative bending stiffness between the proximal shaft section and the distal articulating section when the each pullwire is tensioned.

24. The steerable catheter of claim 22, wherein the proximal shaft section has a first bending stiffness, and the distal articulating section has a second bending stiffness, thereby further defining the extent to which each of the proximal shaft section and the distal articulating section articulates when the each pullwire is tensioned.

25. The steerable catheter of claim 24, wherein the second distance is greater than the first distance, and the first bending stiffness is greater than the second bending stiffness.

26. The steerable catheter of claim 1, wherein the catheter body includes a proximal articulating section between the proximal shaft section and the transition section, the plurality of lumens are equally circumferentially spaced from each other, such that when all of the pullwires are uniformly tensioned, the resulting compressive force on the catheter body causes the proximal articulating section to bend relative to the proximal shaft section without bending the distal articulating section relative to the transition section.

27. The steerable catheter of claim 26, wherein the proximal articulating section is more rigid than the distal articulating section, such that when only one of the pullwires is tensioned, the resulting compressive force on the catheter body causes the distal articulating section to bend relative to the transition section more than the proximal articulating section bends relative to the proximal shaft section.

28. The steerable catheter of claim 26, further comprising:

a lumen extending through the proximal articulating section; and

a counteracting pullwire extending through the lumen in the proximal articulating section, the counteracting pullwire having a distal end terminating in the transition section and a proximal end that terminates in the proximal steering interface, wherein the proximal steering interface is further manipulatable to tension the counteracting pullwire to provide a compressive force on the catheter body that opposes the compressive force provided by the plurality of pullwires when tensioned.

29. The steerable catheter of claim 28, wherein the counteracting pullwire is circumferentially disposed 180 degrees from a common mode of the plurality of pullwires in the proximal articulating section.

30. The steerable catheter of claim 28, further comprising:

another lumen extending through the proximal articulating section; and

another counteracting pullwire extending through the other lumen in the proximal articulating section, the other counteracting pullwire having a distal end terminating in the transition section and a proximal end that terminates in the proximal steering interface, wherein the proximal steering interface is further manipulatable to tension the other counteracting pullwire to provide a compressive force on the catheter body that opposes the compressive force provided by the plurality of pullwires when tensioned.

31. The steerable catheter of claim 30, wherein the counteracting pullwires are respectively circumferentially disposed 120 degrees and 240 degrees from a common mode of the plurality of pullwires in the proximal articulating section.

32. A robotically controlled catheter system, comprising:

the steerable catheter of claim 28;

a drive assembly coupled to the proximal steering interface of the steerable catheter;

a master controller including a user interface configured for being manipulated to actuate the drive assembly, thereby selectively tensioning the plurality of pullwires and the counteracting pullwire; and

a processor configured for receiving an input from the user interface defining a distal articulation angle and a distal articulation roll of the distal articulating section of the steering catheter, and further defining a proximal articulation angle of the proximal articulating section, determining which of the pullwires to be displaced and the respective distances that the pullwires should be displaced to achieve the defined distal articulation angle and distal articulation roll of the distal body section of the steering catheter, predicting a proximal articulation angle of the proximal articulating section solely caused by a moment applied to the distal articulating section and a moment applied to the transition section by the displacement of the pullwires, computing a difference between the predicted proximal articulation angle and the defined proximal articulation angle to obtain a corrected proximal articulation angle, and determining an additional distance that at least one of the plurality of pullwires and the counteracting pullwire should be displaced to further achieve the corrected proximal articulation angle.

33. The robotically controlled catheter system of claim 32, wherein the plurality of lumens are equally circumferentially spaced from each other, and the at least one of the plurality of pullwires and the counteracting pullwire comprises the plurality of pullwires.

34. A steerable catheter, comprising:

a flexible catheter body including a proximal shaft section and a distal articulating section;

a proximal steering interface coupled to the proximal shaft section;

one or more hollow axially stiffening members extending through the proximal shaft section, the one or more stiffening members being laterally offset from, and disposed asymmetrically with respect to, a geometric cross-sectional center of the proximal shaft section so as to shift a neutral axis of the proximal shaft section away from said geometric cross-sectional center of the proximal shaft section;

a plurality of lumens extending through the distal articulating section; and

a plurality of pullwires extending through the one or more stiffening members in the proximal shaft section, each pullwire of the plurality further extending through a respective lumen of the distal articulating section, each of the pullwires having a distal end that terminates in the catheter body distal to the distal articulating section and a proximal end that terminates in the proximal steering interface, wherein the proximal steering interface is manipulatable to selectively tension one or more pullwires of the plurality to bend the distal articulating section.

35. The steerable catheter of claim 34, wherein the one or more stiffening members comprises a plurality of stiffening members grouped in a manner that locates a center of each stiffening member within an arcuate angle of less than one hundred eighty degrees relative to the geometric cross-sectional center of the proximal shaft section.

36. The steerable catheter of claim 34, wherein each of the pullwires is located relative to the neutral axis in the proximal shaft section a first distance, and located relative to a neutral axis of the distal articulating section a second distance, thereby defining the extent to which each of the proximal shaft section and the distal articulating section articulates when the respective pullwires are tensioned.

37. The steerable catheter of claim 34, wherein the plurality of lumens are circumferentially spaced in the distal articulating section.

38. A robotically controlled catheter system, comprising:

the steerable catheter of claim 34;

a drive assembly coupled to the proximal steering interface of the steerable catheter; and

a master controller including a user interface configured for being manipulated to actuate the drive assembly, thereby selectively tensioning pullwires of the plurality of pullwires to bend the distal articulating section.

39. The steerable catheter of claim 34, wherein the catheter body includes a transition section between the proximal shaft section and the distal articulating section, and a proximal articulating section between the proximal shaft section and the transition section, the plurality of lumens being equally circumferentially spaced from each other, such that when all of the pullwires are uniformly tensioned, the resulting compressive force on the catheter body causes the proximal articulating section to bend relative to the proximal shaft section without bending the distal articulating section relative to the transition section.

40. The steerable catheter of claim 39, further comprising:

a first further lumen extending through the proximal articulating section; and

a first counteracting pullwire extending through the first further lumen in the proximal articulating section, the first counteracting pullwire having a distal end terminating in the transition section and a proximal end that terminating in the proximal steering interface, wherein the proximal steering interface is further manipulatable to tension the first counteracting pullwire to provide a compressive force on the catheter body that opposes a compressive force provided by tensioning pullwires of the plurality of pullwires.

41. The steerable catheter of claim 40, further comprising:

a second further lumen extending through the proximal articulating section; and

a second counteracting pullwire extending through the second further lumen in the proximal articulating section, the second counteracting pullwire having a distal end terminating in the transition section and a proximal end terminating in the proximal steering interface, wherein the proximal steering interface is further manipulatable to tension the second counteracting pullwire to provide a compressive force on the catheter body that opposes the compressive force provided by tensioning pullwires of the plurality of pullwires.