Renal Denervation and Stimulation Employing Wireless Vascular Energy Transfer Arrangement

• US 20110307034A1
• Filed: 06/10/2011
• Published: 12/15/2011
• Est. Priority Date: 06/11/2010
• Status: Active Grant

• Current Assignee: Anthony Vrba, Clara Davis, Roger Hastings
• Original Assignee: Anthony Vrba, Clara Davis, Roger Hastings
• Inventors: Hastings, Roger, Vrba, Anthony, Davis, Clara
• Granted Patent: US 8,473,067 B2
• Time in Patent Office: Days
• US Class Current: 607/61
• 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 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00047 using Peltier effect
• 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 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 2018/167 Passive electrodes capacitively coupled to the skin
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components

Abstract

Devices, systems, and methods provide for intravascular or extravascular delivery of renal denervation therapy and/or renal control stimulation therapy. Wireless vascular thermal transfer apparatuses and methods provide for one or both of production of current densities sufficient to ablate renal nerves and terminate renal sympathetic nerve activity, and production of current densities sufficient to induce endothelium dependent vasodilation of the renal artery bed. A common apparatus may be used for both renal ablation and control of renal function locally after renal denervation.

Claims

1. An apparatus for intravascular delivery of a therapy to a renal artery of a patient, comprising:

a stent dimensioned for deployment within the renal artery, the stent adapted for chronic fixation within the renal artery;

an electrode arrangement supported by the stent;

an antenna arrangement supported by the stent and electrically coupled to the electrode arrangement, the antenna arrangement configured to receive energy from a power source external of the renal artery;

the electrode and antenna arrangements operative in at least one of;

an ablation configuration that produces current densities sufficient to ablate innervated renal nerve tissue at or proximate the renal artery; and

a stimulation configuration that produces current densities sufficient to induce endothelium dependent vasodilation of a renal artery bed;

wherein the power source supplies energy to the antenna arrangement other than by way of a percutaneous electrical lead for at least the stimulation configuration.

2. The apparatus of claim 1, wherein the electrode and antenna arrangements are selectively operative in the ablation configuration and the stimulation configuration.

3. The apparatus of claim 1, wherein the electrode arrangement comprises:

an anode contact arranged to electrically couple to an inner wall of the renal artery and electrically insulated from blood passing through a lumen of the stent; and

a cathode contact arranged to electrically couple with blood passing through the lumen of the stent and electrically insulated from the inner wall of the renal artery.

4. The apparatus of claim 1, wherein the power source comprises a power source external of the patient or an implantable power source.

5. The apparatus of claim 1, wherein the power source supplies energy to the antenna arrangement by way of the percutaneous electrical lead in the ablation configuration.

6. The apparatus of claim 1, wherein the power source comprises a power source configured to wirelessly couple energy to the antenna arrangement.

7. The apparatus of claim 1, wherein the power source comprises:

an implantable structure configured for deployment within a renal vein at a renal vein location proximate a location of the stent within the renal artery; and

a transmitter supported by the implantable structure and configured to transmit energy to the antenna arrangement via a transvascular pathway.

8. The apparatus of claim 1, wherein the stent comprises at least two struts, and the antenna arrangement comprises the at least two struts.

9. The apparatus of claim 1, comprising circuitry coupled to the antenna and electrode arrangements, the circuitry configured to receive current induced in the antenna arrangement and store a charge developed using the induced current.

10. The apparatus of claim 1, comprising a sensing circuit configured for sensing cardiac activity and supported by the stent, the controller configured to transmit stimulation pulses to the renal artery wall via the electrode arrangement in synchrony with sensed cardiac events.

11. The apparatus of claim 1, wherein the electrode and antenna arrangements, in the stimulation configuration, are configured to produce current densities sufficient to hyperpolarize endothelium adjacent the stent and cause production and release of nitric oxide into blood flowing past the stent, the amount of released nitric oxide sufficient to cause vasodilation of the renal artery bed distal to the stent.

12. The apparatus of claim 1, wherein the apparatus is configured to deliver repeated renal nerve ablation in response to detection of re-innervation of the renal artery.

13. The apparatus of claim 12, comprising a sensor configured for sensing a physiologic parameter that facilitates detection of renal sympathetic nerve activity associated with re-innervation of the renal artery.

14. A method for delivering of a therapy to a renal artery of a patient, comprising:

receiving energy by an antenna arrangement supported by a stent adapted for chronic fixation within the renal artery from a power source external of the renal artery;

communicating the energy received by the antenna arrangement to an electrode arrangement supported by the stent; and

operating the electrode and antenna arrangements in at least one of;

an ablation configuration for producing current densities sufficient to ablate innervated renal nerve tissue at or proximate the renal artery; and

a stimulation configuration for producing current densities sufficient to induce endothelium dependent vasodilation of a renal artery bed;

wherein the power source supplies energy to the antenna arrangement other than by way of a percutaneous electrical lead for at least the stimulation configuration.

15. The method of claim 14, comprising selectively operating the electrode and antenna arrangements in the ablation configuration and the stimulation configuration.

16. An apparatus for delivering a therapy to a renal artery of a patient, comprising:

a support structure dimensioned for deployment at the renal artery, the support structure configured for chronic fixation at the renal artery;

a thermal transfer arrangement supported by the support structure and comprising one or more thermoelectric elements configured to thermally couple to the renal artery and capable of operating in at least one of a hyperthermic configuration and a hypothermic configuration;

power circuitry supported by the support structure and coupled to the thermal transfer arrangement, the power circuit comprising a receiver configured to receive energy from a power source external of the renal artery, the power source supplying energy to the receiver other than by way of a percutaneous lead; and

a control circuit supported by the support structure and coupled to the power circuitry, wherein the control circuit, if in the hyperthermic configuration, is configured to coordinate delivery of hyperthermic ablation therapy to ablate innervated renal nerve tissue at or proximate the renal artery and, if in the hyporthermic configuration, is configured to coordinate delivery of hypothermic ablation therapy to freeze innervated renal nerve tissue at or proximate the renal artery.

17. The apparatus of claim 16, wherein one or more of the thermoelectric elements are configured to operate in a hypothermic configuration and situated on the thermal transfer arrangement to cool non-targeted tissues of the renal artery.

18. The apparatus of claim 16, wherein the control circuit is configured to deliver one or both of a sequence of freeze/thaw therapy cycles and a sequence of freeze/thaw/heat therapy cycles.

19. The apparatus of claim 16, wherein the control circuit, in a monitoring configuration in which hypothermic and hypothermic therapy delivery are suspended, coordinates monitoring of at least one physiologic parameter that facilitates detection of renal sympathetic nerve activity associated with re-innervation of the renal artery.

20. The apparatus of claim 16, wherein the one or more thermoelectric elements comprise solid-state thermoelectric elements.

21. The apparatus of claim 16, wherein the support structure is configured for intravascular chronic deployment within the renal artery.

22. The apparatus of claim 16, wherein the support structure is configured for extravascular chronic deployment at the renal artery.

23. The apparatus of claim 16, wherein the power source comprises a power source external of the patient or an implantable power source.

24. The apparatus of claim 16, wherein the power source comprises:

an implantable structure configured for deployment within a renal vein at a renal vein location proximate a location of the support structure within the renal artery; and

a transmitter supported by the implantable structure and configured to transmit energy to the receiver.

25. The apparatus of claim 16, wherein the implantable structure comprises a stent.

26. The apparatus of claim 16, comprising a sensing circuit configured for sensing cardiac activity and supported by the support structure, the controller configured to control transfer of thermal energy to the renal artery wall via the thermal transfer arrangement in synchrony with sensed cardiac events.

27. A method for delivering a therapy to a renal artery of a patient, comprising:

receiving energy by a receiver supported by a support structure adapted for chronic fixation within the renal artery from a power source external of the renal artery;

communicating the energy received by the receiver to a power circuit supported by the support structure;

supplying power from the power circuit to a thermal transfer arrangement supported by the support structure and comprising one or more thermoelectric elements configured to thermally couple to the renal artery; and

operating the receiver and the power circuit in at least one of;

a hyperthermic configuration for delivering a hyperthermic therapy to ablate innervated renal nerve tissue at or proximate the renal artery; and

a hypothermic configuration for delivering a hypothermic therapy to freeze innervated renal nerve tissue at or proximate the renal artery;

wherein the power source supplies energy to the receiver other than by way of a percutaneous electrical lead.

28. The method of claim 27, wherein operating the receiver and the power circuit comprises operating the receiver and the power circuit to deliver one or both of a sequence of freeze/thaw therapy cycles and a sequence of freeze/thaw/heat therapy cycles.