Intravascular, thermally-induced renal neuromodulation for treatment of polycystic ovary syndrome or infertility

• US 10,537,385 B2
• Filed: 07/19/2017
• Issued: 01/21/2020
• 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:
  US15/654,106
• Publication Number:
  US 20170319273A1
• Time in Patent Office: 916 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, comprising:

percutaneously introducing an energy delivery element at a distal portion of a treatment device proximate to neural fibers innervating a kidney of a female human patient diagnosed with polycystic ovary syndrome or infertility; and

at least partially disrupting function of the neural fibers innervating the kidney by applying thermal energy to the neural fibers via the energy delivery element,

wherein at least partially disrupting the function of the neural fibers innervating the kidney therapeutically treats the diagnosed polycystic ovary syndrome or infertility of the female human patient.

2. The method of claim 1 wherein at least partially disrupting the neural fibers innervating the kidney reduces central sympathetic drive in the patient in a manner that therapeutically treats the diagnosed polycystic ovary syndrome or infertility.

3. The method of claim 1 wherein the patient is diagnosed with polycystic ovary syndrome, and wherein therapeutically treating the diagnosed polycystic ovary syndrome comprises reducing at least one of insulin resistance and blood pressure in the patient.

4. The method of claim 1 wherein the patient is diagnosed with infertility, and wherein at least partially disrupting of the function of the neural fibers innervating the kidney reverses infertility in the patient.

5. The method of claim 1 wherein at least partially disrupting function of the neural fibers innervating the kidney by applying thermal energy to the neural fibers comprises blocking or inhibiting communication along the neural fibers.

6. The method of claim 1 wherein at least partially disrupting function of the neural fibers innervating the kidney by applying thermal energy to the neural fibers comprises ablating the neural fibers.

7. The method of claim 1 wherein at least partially disrupting function of the neural fibers innervating the kidney by applying thermal energy to the neural fibers comprises partially ablating the neural fibers.

8. The method of claim 1, further comprising removing the energy delivery element from the patient after applying thermal energy to the neural fibers.

9. A method of treating a human patient diagnosed with polycystic ovary syndrome, the method comprising:

intravascularly positioning a neuromodulation assembly within a renal blood vessel of the patient and adjacent to sympathetic nerves proximate to the renal blood vessel of the patient; and

reducing central sympathetic drive in the patient by delivering energy to the sympathetic nerves via the neuromodulation assembly,

wherein reducing central sympathetic drive therapeutically treats the diagnosed polycystic ovary syndrome.

10. The method of claim 9 wherein reducing central sympathetic drive in the patient reduces whole body norepinephrine spillover to plasma in the patient.

11. The method of claim 9 wherein reducing central sympathetic drive in the patient by delivering energy to the sympathetic nerves comprises at least partially inhibiting afferent neural activity.

12. The method of claim 9 wherein reducing central sympathetic drive in the patient by delivering energy to the sympathetic nerves comprises at least partially inhibiting efferent neural activity.

13. The method of claim 9 wherein:

intravascularly positioning a neuromodulation assembly comprises intravascularly positioning a catheter carrying a thermal energy delivery element; and

reducing central sympathetic drive in the patient comprises at least partially ablating a renal nerve of the patient via thermal energy from the thermal energy delivery element positioned at least proximate to the renal nerve.

14. The method of claim 9 wherein intravascularly positioning a neuromodulation assembly within a renal blood vessel of the patient comprises positioning the neuromodulation assembly within a renal artery or a branch thereof.

15. The method of claim 9 wherein reducing central sympathetic drive in the patient by delivering energy to the sympathetic nerves comprises delivering at least one of radiofrequency (RF) energy, microwave energy, ultrasound energy, laser/light energy, and thermal fluid.

16. The method of claim 9 wherein reducing central sympathetic drive in the patient by delivering energy to the sympathetic nerves comprises thermally modulating the sympathetic nerves via RF energy.

17. A method of treating a human patient diagnosed with polycystic ovary syndrome, comprising:

intravascularly positioning an electrode within a renal artery of the patient and adjacent to a renal nerve of the patient; and

attenuating neural traffic along the renal nerves proximate the renal artery via energy from the electrode,

wherein attenuating neural traffic along the renal nerves results in a therapeutically beneficial improvement in one or more physiological conditions associated with the diagnosed polycystic ovary syndrome.

18. The method of claim 17 wherein attenuating neural traffic along the renal nerves proximate the renal artery reduces central sympathetic drive in the patient in a manner that improves the one or more physiological conditions associated with the diagnosed polycystic ovary syndrome.

19. The method of claim 17 wherein the therapeutically beneficial improvement in one or more physiological conditions associated with polycystic ovary syndrome comprises a reduction in insulin resistance in the patient, a reduction in blood pressure, and/or an improvement in a hormonal response in the patient.

20. The method of claim 17, further comprising administering one or more pharmaceutical drugs to the patient, wherein the pharmaceutical drugs are selected from the group consisting of sympatholytic drugs and antihypertensive drugs.