Methods and apparatus for intravasculary-induced neuromodulation

• US 8,774,913 B2
• Filed: 11/14/2006
• Issued: 07/08/2014
• Est. Priority Date: 04/08/2002
• Status: Expired due to Fees

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Demarais, Denise, Gifford, Hanson III, Deem, Mark, Sutton, Douglas, Thai, Erik, Clark, Benjamin J., Zadno, Nicolas
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US11/599,649
• Publication Number:
  US 20070129760A1
• Time in Patent Office: 2,793 Days
• Field of Search: 607/2, 607/3
• US Class Current: 607/3
• 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 2018/00214 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 2007/003 Destruction of nerve tissue
• CPC Class Codes: A61N 7/022 intracavitary

Abstract

Methods and apparatus are provided for intravascularly-induced neuromodulation or denervation. Neuromodulation may be achieved via direct and/or via indirect application of energy or neuromodulatory agents to target neural matter, or to vascular structures that support the target neural matter. In some embodiments, parameters of the target neural matter, of non-target tissue, or of the apparatus may be monitored via one or more sensors for controlling the neuromodulation or denervation. Such monitoring data optionally may be utilized for feedback control of the neuromodulation or denervation.

Claims

1. A device for renal neuromodulation, the device being sized and shaped for placement within a renal blood vessel of a human patient, the device comprising:

a neuromodulation element,

wherein the device is configured to be connected to a controller for selectively delivering stimulation parameters to the neuromodulation element for application within the renal blood vessel,

wherein the neuromodulation element is configured to contact, but not pass through, a wall of the renal blood vessel in proximity to a target neural matter that innervates a kidney of the patient,

wherein the neuro modulation element is configured to deliver sufficient electrical energy from within the renal blood vessel to inhibit neural activity across the target neural matter, and

wherein the device is further configured to deliver a cooling fluid at or through the neuromodulation element to remove excess thermal energy and protect non-target tissues.

2. The device of claim 1, wherein the neuromodulation element is configured to deliver an electric field relative to the target neural matter.

3. The device of claim 1, further comprising at least one sensor carried by the device.

4. The device of claim 3, further comprising a feedback control in communication with the sensor.

5. The device of claim 1, wherein the neuromodulation element further comprises at least one thermal element configured to deliver thermal energy relative to the target neural matter.

6. The device of claim 1, wherein neuromodulation element comprises a wall-contact electrode.

7. The device of claim 6, wherein the wall-contact electrode comprises a monopolar electrode.

8. The device of claim 6, wherein the wall-contact electrode is configured to deliver RF energy to the target neural matter adjacent the wall of the renal blood vessel.

9. The device of claim 6, wherein the wall-contact electrode is configured to ablate the target neural matter.

10. The device of claim 1 wherein the neuromodulation element is carried by a positioning element at a distal portion of the device, and wherein the positioning element is transformable between a low-profile, delivery configuration and a deployed configuration sized and shaped to fit within the renal blood vessel, and wherein, in the deployed configuration, the positioning element is configured to place the neuromodulation element in apposition with the wall of the renal blood vessel.

11. The device of claim 10 wherein the positioning element is configured to self-expand from the low-profile, delivery configuration to the deployed configuration.

12. The device of claim 1 wherein the neuromodulation element comprises a first neuromodulation element, and wherein the device further comprises at least a second neuromodulation element.

13. The device of claim 1, further comprising a helical section at a distal portion of the device and sized and shaped for placement within the renal blood vessel of the patient, and wherein:

the neuromodulation element is carried by the helical section; and

the helical section is transformable between a low-profile delivery configuration for intravascular placement within the renal blood vessel and an expanded treatment configuration, and

wherein, in the expanded treatment configuration, the helical section is adapted to bring the neuromodulation element into contact with the wall of the renal blood vessel.

14. The device of claim 13 wherein the helical section is configured to self expand from the delivery configuration to the treatment configuration.

15. The device of claim 1 wherein the device is configured for placement in the renal blood vessel over a guidewire.