Catheter apparatuses, systems, and methods for renal neuromodulation

• US 8,870,863 B2
• Filed: 05/28/2010
• Issued: 10/28/2014
• Est. Priority Date: 04/26/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Leung, Mark S., Clark, Benjamin J., Michlitsch, Kenneth J., Thai, Erik, Wu, Andrew, Zarins, Denise
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US12/790,639
• Publication Number:
  US 20110264075A1
• Time in Patent Office: 1,614 Days
• Field of Search: 606 27- 31, 606/33, 606/34, 606 41- 47
• US Class Current: 606/41
• 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

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 an energy delivery element to a renal artery via an intravascular path. Thermal 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 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 deflectable tubular body distal from the flexible tubular structure;

a flexure control element coupled to the deflectable tubular body;

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 deflectable tubular body;

a force dampening section distal from the deflectable tubular body; and

a single energy delivery element distal from and carried by the force dampening section;

wherein the deflectable tubular body is adapted for flexure in a predetermined direction upon application of the force from the flexure control element to position the energy delivery element into contact with the renal artery wall;

wherein the force dampening section comprises a passively flexible structure that is adapted for passive flexure in any plane through the axis in response to a force applied to the energy delivery element upon contact with the renal artery wall, and further wherein the force dampening section is configured to accommodate stable contact between the energy delivery element and the renal artery wall;

wherein at least one of the deflectable tubular body and the force dampening section comprises a force redirecting element that is adapted to facilitate atraumatic contact between the energy delivery element and the renal artery wall.

2. The catheter apparatus of claim 1 wherein the force redirecting element comprises a pre-shaped geometry incorporated into the deflectable tubular body.

3. The catheter apparatus of claim 2 wherein the pre-shaped geometry of the force redirecting element comprises an angular bend having a preset angle of about 20 to 40 degrees.

4. The catheter apparatus of claim 1 wherein the force redirecting element comprises a pre-shaped geometry that is adapted to facilitate flexure of the passively flexible structure.

5. The catheter apparatus of claim 4 wherein the pre-shaped geometry is configured to reduce the contact force between the energy delivery element and the renal artery wall necessary to cause flexure of the passively flexible structure.

6. The catheter apparatus of claim 1 wherein the passively flexible structure, force redirecting element and energy delivery element comprise a distal assembly that is distal from the deflectable tubular body.

7. The catheter apparatus of claim 6 wherein the passively flexible structure is distal from the force redirecting element.

8. The catheter apparatus of claim 6 wherein the passively flexible structure and the force redirecting element comprise a single element.

9. The catheter apparatus of claim 6 wherein the distal assembly has a length along the axis of the elongated tubular shaft that is no greater than 10 mm.

10. The catheter apparatus of claim 6 wherein the distal assembly has a length along the axis of the elongated tubular shaft that is no greater than 5 mm.

11. The catheter apparatus of claim 1 wherein the deflectable tubular body is configured for a state of maximum flexure, and wherein the state of maximum flexure is achieved when the deflectable tubular body moves the energy delivery element away from the axis of the elongated tubular shaft by a predetermined distance.

12. The catheter apparatus of claim 11 wherein the predetermined distance is about 2 mm to 20 mm.

13. The catheter apparatus of claim 11 wherein the predetermined distance is about 10 mm to 14 mm.

14. The catheter apparatus of claim 11 wherein the force dampening section, force redirecting element and energy delivery element comprise a distal assembly that is distal from the deflectable tubular body, and wherein the distal assembly has a length along the axis of the elongated tubular shaft from about 3 mm to about 6 mm, the deflectable tubular body has a length along the axis of the elongated tubular shaft from about 8 mm to about 15 mm.

15. The catheter apparatus of claim 14 wherein the predetermined distance is about 10 mm to about 14 mm.

16. The catheter apparatus of claim 11 wherein deflectable tubular body in the state of maximum flexure comprises a transitional bend having a radius of curvature no greater than about 25 mm.

17. The catheter apparatus of claim 11 wherein deflectable tubular body in the state of maximum flexure comprises a transitional bend having a radius of curvature no greater than about 15 mm.

18. The catheter apparatus of claim 1 wherein the deflectable tubular body has a length from about 5 mm to about 20 mm.

19. The catheter apparatus of claim 1 wherein the deflectable tubular body has a length of less than or equal to about 12.5 mm.

20. The catheter apparatus of claim 1 wherein the force redirecting element comprises a pre-shaped geometry that is biased in a radial direction that is opposite the predetermined direction of flexure of the deflectable tubular body.

21. The catheter apparatus of claim 1 wherein the force redirecting element comprises a pre-shaped geometry that is biased in a radial direction that is the same as the predetermined direction of flexure of the deflectable tubular body.

22. The catheter apparatus of claim 1 wherein the deflectable tubular body comprises a cutout pattern comprising a spine.

23. The catheter apparatus of claim 22 wherein the spine of the deflectable tubular body comprises a circumferentially positioned spine.

24. The catheter apparatus of claim 22 wherein the spine of the deflectable tubular body comprises a centrally positioned spine.

25. The catheter apparatus of claim 1 wherein the flexible tubular structure is more flexible than the elongated tubular shaft, the deflectable tubular body is more flexible than the flexible tubular structure, and the force dampening section is more flexible than the deflectable tubular body.

26. The catheter apparatus of claim 25 wherein the elongated tubular shaft, the flexible tubular structure, and the deflectable tubular body comprise a single piece tubular structure.

27. The catheter apparatus of claim 26 wherein the increased flexibility of the flexible tubular structure and the deflectable tubular body result from laser cutting of the single piece tubular structure.

28. The catheter apparatus of claim 1 wherein the deflectable tubular body varies between a relaxed configuration and a deflected configuration and wherein the deflectable tubular body in the relaxed configuration is more flexible than the flexible tubular structure and the deflectable tubular body in the deflected configuration is less flexible than the flexible tubular structure.

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

30. The catheter apparatus of claim 1 wherein the elongated tubular shaft and the energy delivery element are sized and configured for intravascular delivery into the renal artery via a 6 French guide catheter.

31. The catheter apparatus of claim 1 wherein the elongated tubular shaft and the energy delivery element are sized and configured for intravascular delivery into the renal artery via a 5 French guide catheter.

32. The catheter apparatus of claim 1 wherein the deflectable tubular body and force dampening section are configured to apply a stabilizing contact force between the energy delivery element and the renal artery wall sufficient to maintain wall contact during movement of the renal artery caused by respiration of the patient.

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

34. The catheter apparatus of claim 33, further comprising a temperature sensor, impedance sensor, optical sensor or micro sensor.

35. The catheter apparatus of claim 33, further comprising a feedback control system configured to alter thermal treatment delivered by the energy delivery element in response to the monitored parameter.

36. The catheter apparatus of claim 35 wherein the feedback control system comprises an algorithm for controlling thermal treatment delivered by the energy delivery element.

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

38. The catheter apparatus of claim 1 wherein the energy delivery element comprises an electrode for applying radiofrequency energy to tissue.

39. The catheter apparatus of claim 1 wherein the handle comprises a rotator coupled to the tubular elongated shaft and configured to rotate the tubular elongated shaft about its axis without rotating the handle, and wherein the rotator and handle are adapted to prevent the rotation of the tubular elongated shaft beyond a predetermined number of revolutions.

40. The catheter apparatus of claim 1, wherein the catheter apparatus is a component of a medical treatment kit, and wherein the medical treatment kit further comprises a cable configured to electrically connect the catheter apparatus to an energy source and a dispersive electrode configured to provide a return path for an energy field from the catheter apparatus.

41. The catheter apparatus of claim 1, further comprising instructions for delivering the catheter apparatus into a renal artery of the patient and at least partially denervating a kidney of the patient corresponding to the renal artery to treat the patient for a condition associated with at least one of hypertension, heart failure, kidney disease, chronic renal failure, central sympathetic hyperactivity, insulin resistance diabetes, metabolic disorder, arrhythmia, acute myocardial infarction and cardio-renal syndrome.

42. A 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 deflectable tubular body distal from the flexible tubular structure;

a flexure control element coupled to the deflectable tubular body;

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 deflectable tubular body; and

a distal assembly distal from the deflectable tubular body comprising a force dampening section, a force redirecting element and an energy delivery element distal from and carried by the force dampening section, wherein the energy delivery element comprises a single distal tip electrode;

wherein the deflectable tubular body is adapted for flexure in a predetermined direction upon application of the force from the flexure control element to position the energy delivery element into contact with the renal artery wall;

wherein the force dampening section comprises a passively flexible structure that is adapted for passive flexure in any plane through the axis in response to a force applied to the energy delivery element upon contact with the renal artery wall, and further wherein the force dampening section is configured to accommodate stable contact between the energy delivery element and the renal artery wall;

wherein the force redirecting element is adapted to facilitate flexure of the catheter apparatus and atraumatic contact between the energy delivery element and renal artery wall.

43. A 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 deflectable tubular body distal from the flexible tubular structure;

a flexure control element coupled to the deflectable tubular body;

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 deflectable tubular body; and

a distal assembly distal from the deflectable tubular body comprising a passively flexible structure, a pre-shaped geometry and a thermal element distal from and carried by the passively flexible structure, wherein the thermal element comprises a single distal tip electrode;

wherein the deflectable tubular body is adapted for flexure in a predetermined direction upon application of the force from the flexure control element to position the thermal element into contact with the renal artery wall;

wherein the passively flexible structure is adapted for passive flexure in any plane through the axis in response to a force applied to the thermal element upon contact with the renal artery wall, and further wherein the passively flexible structure is configured to accommodate stable contact between the thermal element and the renal artery wall;

wherein the pre-shaped geometry is adapted to facilitate flexure of the passively flexible structure and atraumatic contact between the thermal element and renal artery wall.