MULTI-DIRECTIONAL DEFLECTABLE CATHETER APPARATUSES, SYSTEMS, AND METHODS FOR RENAL NEUROMODULATION

• US 20110264011A1
• Filed: 08/30/2010
• Published: 10/27/2011
• Est. Priority Date: 04/26/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Leung, Mark S., Thai, Erik, Clark, Benjamin J., Zarins, Denise, Wu, Andrew, Michlitsch, Kenneth J.
• Granted Patent: US 8,728,075 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/0206 ultrasonic, e.g. for destroying tissue or enhancing freezing
• CPC Class Codes: A61B 18/082 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 18/1815 using microwaves
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61F 5/0013 Implantable devices or invasive measures
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

Multi-directional deflectable catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present application, for example, is directed to apparatuses, systems, and methods that incorporate a catheter treatment device comprising an elongated shaft. The elongated shaft is sized and configured to deliver a thermal element to a renal artery via an intravascular path. Thermally or electrical renal neuromodulation may be achieved via direct and/or via indirect application of thermal and/or electrical energy to heat or cool, or otherwise electrically modulate, neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Claims

1. A multi-directional deflectable catheter apparatus for thermally modulating renal nerves from within a renal artery of a patient, the catheter apparatus comprising:

an elongated tubular shaft extending along an axis, the elongated tubular shaft having a proximal end and a distal end;

a handle proximal to the proximal end of the elongated tubular shaft;

a flexible tubular structure distal from the distal end of the elongated tubular shaft, the flexible tubular structure adapted to make a transitional bend from the aorta of the patient to the renal artery;

a multi-directional deflectable assembly distal from the flexible tubular structure;

a flexure control element coupled to the multi-directional deflectable assembly;

a flexure controller carried by the handle and coupled to the flexure control element, the flexure controller adapted to apply a force via the flexure control element to the multi-directional deflectable assembly; and

a thermal element carried by or distal from the multi-directional deflectable assembly;

wherein the multi-directional deflectable assembly is adapted for flexure in at least two radial directions in a common plane through the axis of the elongated tubular shaft upon application of force via the flexure control element;

wherein the multi-directional deflectable assembly is adapted upon flexure to position the thermal element in contact with an inner wall of the renal artery.

2. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly comprises a centrally-positioned spine.

3. The catheter apparatus of claim 2 wherein the centrally-positioned spine comprises a spinal flexure element.

4. The catheter apparatus of claim 3 wherein the spinal flexure element comprises a ribbon, and wherein the flexure control element comprises a first control wire coupled to the multi-directional deflectable assembly on a first side of the ribbon and a second control wire coupled to the multi-directional deflectable assembly on a second side of the ribbon.

5. The catheter apparatus of claim 4 wherein the ribbon is configured for flexure towards the first control wire in response to tension applied by the first control wire and towards the second control wire in response to tension applied by the second control wire.

6. The catheter apparatus of claim 2 wherein the centrally-positioned spine comprises a first spinal flexure element and a second spinal flexure element, each spinal flexure element adapted for bi-directional movement.

7. The catheter apparatus of claim 6 wherein the first spinal flexure element is angularly offset from the second spinal flexure element about the axis of the elongated tubular shaft.

8. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly has a length from about 5 mm to about 15 mm.

9. The catheter apparatus of claim 1 wherein the thermal element is configured to apply thermal treatment using at least one of radiofrequency energy, cooled radiofrequency energy, microwave energy, ultrasound energy, laser/light energy, thermal fluid, resistive heating, and cryogenic fluid.

10. The catheter apparatus of claim 1 wherein the thermal element comprises a single electrode.

11. The catheter apparatus of claim 1 wherein the thermal element comprises multiple electrodes.

12. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly is configured for a state of maximum flexure, and wherein the state of maximum flexure is achieved when the multi-directional deflectable assembly comprises a transitional bend having a radius of curvature.

13. The catheter apparatus of claim 12 wherein the radius of curvature is no greater than about 25 mm.

14. The catheter apparatus of claim 1 wherein the flexible tubular structure is more flexible than the elongated tubular shaft, and wherein the multi-directional deflectable assembly is more flexible than the flexible tubular structure.

15. The catheter apparatus of claim 14 wherein the elongated tubular shaft, the flexible tubular structure and the multi-directional deflectable assembly comprise a single piece tubular structure.

16. The catheter apparatus of claim 15 wherein the increased flexibility of the flexible tubular structure and the multi-directional deflectable assembly result from laser cutting of the single piece tubular structure.

17. The catheter apparatus of claim 1 wherein the thermal element is configured to create a thermal lesion comprising at least 30% circumferential coverage of the renal artery wall.

18. The catheter apparatus of claim 1 wherein the elongated tubular shaft, the multi-directional deflectable assembly and the thermal element are sized and configured for intravascular delivery into the renal artery via a 6 French guide catheter.

19. The catheter apparatus of claim 1, further comprising a sensor adjacent to, on, or within the thermal element, the sensor configured to monitor a parameter of at least one of the apparatus and the renal artery wall.

20. The catheter apparatus of claim 19 wherein the sensor comprises at least one of a temperature sensor, impedance sensor, optical sensor, force sensor, strain sensor or micro sensor.

21. A system comprising the catheter apparatus of claim 19, an energy generator and a feedback control system configured to alter thermal treatment applied by the thermal element in response to the monitored parameter.

22. The system of claim 21 wherein the feedback control system comprises an algorithm for controlling thermal treatment applied by the thermal element.

23. The system of claim 22 wherein the algorithm for controlling thermal treatment applied by the thermal element comprises instructions that limit thermal treatment to no greater than 8 watts.

24. The system of claim 22 wherein the algorithm for controlling thermal treatment applied by the thermal element comprises instructions that limit thermal treatment to no greater than 10 watts.

25. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly is adapted upon flexure in a first direction to position the thermal element in contact with a first inner wall of the renal artery and adapted upon flexure in a second direction to position the thermal element in contact with a second inner wall of the renal artery, and wherein the first inner wall and the second inner wall are generally opposite one another.

26. The catheter apparatus of claim 1 wherein the flexure control element comprises a first control wire and a second control wire, and wherein the first control wire and second control wire are connected to the multi-directional deflectable assembly on radial opposite sides.

27. The catheter apparatus of claim 26 wherein the first control wire and second control wire comprise electrically connected control wires, and wherein the multi-directional deflectable assembly is configured for electrically initiated deflection via the electrically connected control wires.

28. The catheter apparatus of claim 1, further comprising a distal flexure zone attached to and distal from the multi-directional deflectable assembly, wherein the thermal element is coupled to the distal flexure zone.

29. The catheter apparatus of claim 28 wherein the distal flexure zone comprises a force dampening section.

30. The catheter apparatus of claim 28 wherein the distal flexure zone comprises a force redirecting element.

31. The catheter apparatus of claim 28 wherein the distal flexure zone comprises a sensor configured to monitor contact force between the thermal element and renal artery wall.

32. The catheter apparatus of claim 28 wherein the distal flexure zone has a length of about 3 mm to 6 mm, the multi-directional deflectable assembly has a length of about 8 mm to 15 mm and has a maximum flexure displacing the energy delivery element a predetermined distance of about 10 to 15 mm.

33. The catheter apparatus of claim 28 wherein the multi-directional deflectable assembly comprises a hinge joint and the distal flexure zone is less than about 16 mm long.

34. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly comprises a pre-formed shape.

35. The catheter apparatus of claim 1 wherein the multi-directional deflectable assembly comprises a circumferentially positioned spine.

36. A multi-directional deflectable catheter apparatus for thermally modulating renal nerves from within a renal artery of a patient, the catheter apparatus comprising:

an elongated tubular shaft extending along an axis, the elongated tubular shaft having a proximal end and a distal end;

a handle proximal to the proximal end of the elongated tubular shaft;

a flexible tubular structure distal from the distal end of the elongated tubular shaft, the flexible tubular structure adapted to make a transitional bend from the aorta of the patient to the renal artery;

a multi-directional deflectable assembly distal from the flexible tubular structure, the multi-directional deflectable assembly having a circumferentially-positioned spine;

a flexure control element coupled to the multi-directional deflectable assembly;

a flexure controller carried by the handle and coupled to the flexure control element, the flexure controller adapted to apply a force via the flexure control element to the multi-directional deflectable assembly; and

a thermal element carried by or distal from the multi-directional deflectable assembly;

wherein the multi-directional deflectable assembly is adapted for flexure in at least two radial directions in a plane through the axis of the elongated tubular shaft upon application of force via the flexure control element;

wherein the multi-directional deflectable assembly is adapted upon flexure to position the thermal element in contact with an inner wall of the renal artery.

37. The catheter apparatus of claim 36 wherein the multi-directional deflectable assembly comprises a laser cut tube comprising a first circumferentially-positioned spine and a second circumferentially-positioned spine, the first circumferentially-positioned spine and a second circumferentially-positioned spine separated by a plane.

38. The catheter apparatus of claim 37 wherein the flexure control element comprises a first control wire coupled to the first circumferentially-positioned spine on a first side of the plane and a second control wire coupled to the second circumferentially-positioned spine on a second side of the plane.

39. The catheter apparatus of claim 38 wherein the multi-directional deflectable assembly is configured for flexure towards the first control wire in response to tension applied by the first control wire and towards the second control wire in response to tension applied by the second control wire.

40. The catheter apparatus of claim 36 wherein the multi-directional deflectable assembly has a length from about 5 mm to about 15 mm.

41. The catheter apparatus of claim 36 wherein the multi-directional deflectable assembly is configured for a state of maximum flexure, and wherein the state of maximum flexure is achieved when the multi-directional deflectable assembly comprises a transitional bend having a radius of curvature.

42. The catheter apparatus of claim 41 wherein the radius of curvature is no greater than about 25 mm.

43. The catheter apparatus of claim 36 wherein the elongated tubular shaft, the multi-directional deflectable assembly and the thermal element are sized and configured for intravascular delivery into the renal artery via a 6 French guide catheter.

44. The catheter apparatus of claim 36 wherein the multi-directional deflectable assembly is adapted upon flexure in a first direction to position the thermal element in contact with a first inner wall of the renal artery and adapted upon flexure in a second direction to position the thermal element in contact with a second inner wall of the renal artery, and wherein the first inner wall and the second inner wall are generally opposite one another.

45. The catheter apparatus of claim 36 further comprising a distal flexure zone attached to and distal from the multi-directional deflectable assembly, wherein the thermal element is coupled to the distal flexure zone.

46. The catheter apparatus of claim 45 wherein the distal flexure zone comprises a force dampening section.

47. The catheter apparatus of claim 45 wherein the distal flexure zone comprises a force redirecting element.