Neuromodulation systems and methods for treatment of sexual dysfunction

• US 10,561,460 B2
• Filed: 07/19/2017
• Issued: 02/18/2020
• 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 F
• Assistant Examiner(s): Vahdat, Khadijeh A
• Application Number:
  US15/654,062
• Publication Number:
  US 20170319272A1
• Time in Patent Office: 944 Days
• Field of Search: 606 28- 50
• 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 method for treating a human patient diagnosed with erectile dysfunction or premature ejaculation, the method comprising:

advancing a neuromodulation assembly along an intravascular path to a position within a target blood vessel of a human patient, wherein the neuromodulation assembly is at a distal portion of a treatment device, and wherein the position within the target blood vessel is proximate to neural fibers innervating penile tissue of the human patient;

at least partially disrupting function of the neural fibers innervating the penile tissue by applying thermal energy to the neural fibers via the neuromodulation assembly; and

retracting the neuromodulation assembly along the intravascular path to remove the neuromodulation assembly from the patient after treatment,

wherein at least partial disruption of the function of the neural fibers innervating the penile tissue therapeutically treats the diagnosed erectile dysfunction or premature ejaculation.

2. The method of claim 1 wherein the neuromodulation assembly is introduced percutaneously.

3. The method of claim 1 wherein the patient is diagnosed with premature ejaculation, and wherein at least partial disruption of the function of the neural fibers decreases a frequency of premature ejaculation in the patient.

4. The method of claim 1 wherein the patient is diagnosed with erectile dysfunction, and wherein at least partial disruption of the function of the neural fibers increases a frequency of penile erections in the patient.

5. The method of claim 1 wherein the target blood vessel is the inferior mesenteric artery of the patient.

6. A method for treating erectile dysfunction in a human patient, the method comprising:

transluminally advancing a catheter along an intravascular path to position an energy delivery element of the catheter within a target blood vessel of the patient and adjacent to neural fibers that innervate penile tissue of the patient;

at least partially ablating the neural fibers innervating the penile tissue of the patient via the energy delivery element; and

retracting the catheter along the intravascular path to remove the neuromodulation assembly from the patient after treatment,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in one or more physiological conditions associated with erectile dysfunction of the patient.

7. The method of claim 6 wherein the reduction in one or more physiological conditions associated with erectile dysfunction includes a reduction in the number of instances of impotence in the patient.

8. The method of claim 6 wherein the target blood vessel the inferior mesenteric artery of the patient.

9. A method of treating a human patient diagnosed with erectile dysfunction, the method comprising:

intravascularly advancing a neuromodulation assembly along an intravascular path to a position within a target blood vessel of the patient that is adjacent to a target sympathetic nerve of the patient;

reducing sympathetic neural activity in the patient by delivering energy to the target sympathetic nerve via the neuromodulation assembly; and

retracting the neuromodulation assembly along the intravascular path to remove the neuromodulation assembly from the patient after treatment,

wherein reducing sympathetic neural activity therapeutically treats the diagnosed erectile dysfunction.

10. The method of claim 9 wherein reducing sympathetic neural activity in the patient increases a frequency of penile erections in the patient.

11. The method of claim 9 wherein reducing sympathetic neural activity in the patient by delivering energy to the target sympathetic nerve comprises at least partially inhibiting efferent neural activity.

12. The method of claim 9 wherein reducing sympathetic neural activity in the patient by delivering energy to the target sympathetic nerve comprises selectively neuromodulating efferent penile nerves in the patient compared to afferent penile nerves in the patient.

13. The method of claim 9 wherein reducing sympathetic neural activity in the patient by delivering energy to the target sympathetic nerve comprises at least partially inhibiting afferent neural activity.

14. The method of claim 9 wherein reducing sympathetic neural activity in the patient by delivering energy to the target sympathetic nerve comprises thermally modulating the target sympathetic nerve of the patient via an intravascularly positioned catheter carrying the neuromodulation assembly.

15. The method of claim 14 wherein thermally modulating the target sympathetic nerve comprises at least partially ablating the target sympathetic nerve via the neuromodulation assembly.

16. The method of claim 14 wherein thermally modulating the target sympathetic nerve comprises cryotherapeutically cooling the target sympathetic nerve.

17. The method of claim 14 wherein thermally modulating the target sympathetic nerve comprises heating the target sympathetic nerve.

18. The method of claim 9 wherein the target blood vessel is the inferior mesenteric artery of the patient.