Apparatus, systems, and methods for achieving intravascular, thermally-induced renal neuromodulation

• US 8,777,942 B2
• Filed: 10/22/2010
• Issued: 07/15/2014
• Est. Priority Date: 12/31/2008
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Wu, Andrew, Clark, Benjamin J., Zarins, Denise, Thai, Erik
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US12/910,631
• Publication Number:
  US 20110060324A1
• Time in Patent Office: 1,362 Days
• Field of Search: 606 27- 34, 606 41- 47, 606 50- 52
• 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 18/1206 Generators 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2018/00172 Connectors and adapters therefor
• 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue

Abstract

Apparatus, systems, and methods for achieving thermally-induced 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 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-induced renal neuromodulation may be achieved via direct and/or via indirect application of thermal energy to heat or cool neural fibers that contribute to renal function, or of vascular structures that feed or perfuse the neural fibers.

Claims

1. A catheter apparatus, comprising:

an elongated shaft extending along an axis and comprising a controlled flexure zone and an unrestrained flexure zone coupled to and extending distally from the controlled flexure zone, the elongated shaft sized and configured for intravascular delivery into a renal blood vessel;

wherein the unrestrained flexure zone is configured to carry a thermal element, and wherein the thermal element comprises a single distal tip electrode having an atraumatic tip;

wherein the controlled flexure zone is sized and configured for placement into contact against a first wall region of the renal blood vessel and, in response to application of a force applied by a remotely controlled element, for flexure relative to the axis in a predetermined radial direction away from the first wall region toward a second wall region of the renal blood vessel generally opposite to the first wall region;

wherein the unrestrained flexure zone is sized and configured, when the controlled flexure zone is in flexure against the first wall region, for passive flexure in any plane relative to the axis to place a side of the thermal element into contact against the second wall region; and

wherein the controlled flexure zone is configured to apply, when in flexure against the first wall region, through the unrestrained flexure zone a stabilizing force to the thermal element against the second wall region.

2. The catheter apparatus of claim 1 wherein the elongated shaft is configured for rotation within the renal blood vessel when the controlled flexure zone is in flexure against the first wall region and when the thermal element is in contact with the second wall region, wherein rotation of the elongated shaft positions the controlled flexure zone against a third wall region and positions the thermal element against a fourth wall region, wherein the third wall region is circumferentially offset from the first wall region and the fourth wall region is circumferentially offset from the second wall region, and wherein the third wall region is generally opposite the fourth wall region.

3. The catheter apparatus of claim 1 wherein the remotely controlled element comprises a wire coupled to a distal portion of the controlled flexure zone, and wherein the force applied by the wire is a bending or compressive force against the controlled flexure zone.

4. The catheter apparatus of claim 1 wherein the controlled flexure zone comprises a tubular structure having a directionally-biased stiffness.

5. The catheter apparatus of claim 4 wherein the tubular structure comprises a laser-cut metal tube.

6. The catheter apparatus of claim 5 wherein the laser-cut metal tube comprises a spine and a plurality of ribs, and wherein the directionally-biased stiffness of the tubular structure is determined by the location of the spine in relation to the plurality of ribs on the tubular structure.

7. The catheter apparatus of claim 4 wherein the tubular structure further comprises a polymer laminate, coating or sheath.

8. The catheter apparatus of claim 1, further comprising a sensor adjacent to, on, or within the thermal element, and wherein the sensor is configured to monitor a parameter of at least one of the apparatus and the renal blood vessel.

9. The catheter apparatus of claim 8 wherein the sensor comprises at least one of a temperature sensor, impedance sensor, optical sensor or micro sensor.

10. The catheter apparatus of claim 8, further comprising a feedback control system configured to alter treatment delivered to the tissue surface in response to the monitored parameter.

11. The catheter apparatus of claim 10 wherein the feedback control system comprises an algorithm for controlling output of the thermal element.

12. The catheter apparatus of claim 11 wherein the algorithm comprises instructions for delivering energy to the thermal element according to a predetermined energy delivery profile, and wherein the predetermined energy delivery profile comprises:

increasing energy delivery to a predetermined first power level over a first period of time;

maintaining energy delivery at the first power level for a second period of time; and

increasing energy delivery to a predetermined second power level if a temperature value of a treatment site or of the thermal element is less than a preset threshold temperature following the second period of time.

13. The catheter apparatus of claim 1 wherein the thermal element is configured to apply treatment to neural tissue adjacent to the renal blood vessel using at least one of radiofrequency energy and microwave energy.

14. The catheter apparatus of claim 1 wherein the electrode is configured for applying radiofrequency energy to tissue.

15. The catheter apparatus of claim 1 wherein the controlled flexure zone has a length of from about 5 millimeters to about 15 millimeters.

16. The catheter apparatus of claim 1 wherein the thermal element has an outer diameter of from approximately 1.24 millimeters to 1.30 millimeters.

17. The catheter apparatus of claim 1 wherein the unrestrained flexure zone has a first length and the controlled flexure zone has a second length less than the first length.

18. The catheter apparatus of claim 1 wherein the electrode is configured for applying radiofrequency energy to the tissue, and wherein the electrode comprises a generally circular cylinder having a length and a diameter less than the length.

19. The catheter apparatus of claim 1 wherein the stabilizing force causes at least 25% of a total surface area of the thermal element to contact the second wall region.

20. The catheter apparatus of claim 1 wherein the unrestrained flexure zone is configured for passive flexure in any plane in response to a force applied to the thermal element via contact with the second wall region of the renal blood vessel.

21. The catheter apparatus of claim 1 wherein the thermal element is configured to apply energy to a wall of the renal blood vessel and form a focal lesion.

22. A medical treatment kit, comprising:

an intravascular treatment device including—

an elongated shaft extending along an axis and comprising a controlled flexure zone and an unrestrained flexure zone coupled to and extending distally from the controlled flexure zone, the elongated shaft sized and configured for intravascular delivery into a renal blood vessel;

wherein the unrestrained flexure zone is configured to carry a thermal element, and wherein the thermal element comprises a single distal tip electrode having an atraumatic tip;

wherein the controlled flexure zone is sized and configured for placement into contact against a first wall region of the renal blood vessel and, in response to application of a force applied by a remotely controlled element, for flexure relative to the axis in a predetermined radial direction away from the first wall region toward a second wall region of the renal blood vessel generally opposite to the first wall region;

wherein the unrestrained flexure zone is sized and configured, when the controlled flexure zone is in flexure against the first wall region, for passive flexure in any plane relative to the axis to place a side of the thermal element into contact against the second wall region; and

wherein the controlled flexure zone is configured to apply, when in flexure against the first wall region, through the unrestrained flexure zone a stabilizing force to the thermal element against the second wall region;

a cable configured to electrically connect the intravascular treatment device to an energy generator;

a guide catheter configured to facilitate intravascular delivery of the treatment device into a patient; and

instructions for delivering the treatment device 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, sympathetic hyperactivity, diabetes, metabolic disorder, arrhythmia, acute myocardial infarction and cardio-renal syndrome.

23. The medical treatment kit of claim 22, further comprising a dispersive electrode configured to provide a return path for an energy field from the treatment device.

24. The medical treatment kit of claim 22 wherein:

the elongated shaft comprises a proximal end region and a distal end region, the distal end region including the controlled flexure zone and the unrestrained flexure zone coupled to and extending distally from the controlled flexure zone; and

the intravascular treatment device further comprises a handle carried by the proximal end region of the elongated shaft, wherein the cable is integral with the handle.

25. The medical treatment kit of claim 22 wherein:

the elongated shaft comprises a proximal end region and a distal end region, the distal end region including the controlled flexure zone and the unrestrained flexure zone coupled to and extending distally from the controlled flexure zone; and

the intravascular treatment device further comprises a handle carried by the proximal end region of the elongated shaft,

wherein the cable and the treatment device are discrete elements configured to be releasably connected to each other, and

wherein the cable is configured to be connected to the handle of the treatment device.