Methods for intravascularly-induced neuromodulation

• US 8,818,514 B2
• Filed: 07/02/2013
• Issued: 08/26/2014
• 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: Zarins, Denise, Zadno, Nicolas, Clark, Benjamin J., Thai, Erik
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US13/934,133
• Publication Number:
  US 20140012258A1
• Time in Patent Office: 420 Days
• Field of Search: 607/2, 607/44, 607/116, 604/21, 606/50
• US Class Current: 607/44
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/36182 Direction of the electrical field, e.g. with sleeve around stimulating electrode
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

Methods for intravascularly-induced renal neuromodulation. In some embodiments, a method can include positioning a pair of bipolar electrodes within renal vasculature of a human patient and expanding a balloon within the renal vasculature. The method can further include delivering an electric field via the bipolar electrodes.

Claims

1. A method for intravascularly-induced renal neuromodulation, the method comprising:

intravascularly positioning a catheter comprising a balloon and a pair of bipolar electrodes within renal vasculature of a human patient;

expanding the balloon within the renal vasculature; and

delivering an electric field via the bipolar electrodes to induce renal neuromodulation,

wherein inducing renal neuromodulation results in a therapeutically beneficial reduction in blood pressure of the patient.

2. The method of claim 1 wherein intravascularly positioning a catheter within renal vasculature of a human patient comprises positioning the catheter within a renal artery of the patient.

3. The method of claim 1 wherein intravascularly positioning a catheter within renal vasculature of a human patient comprises intravascularly delivering the catheter to the renal vasculature over a guidewire.

4. The method of claim 1 wherein intravascularly positioning a catheter within renal vasculature of a human patient comprises intravascularly delivering the catheter to the renal vasculature within a guide catheter.

5. The method of claim 1 wherein expanding the balloon within the renal vasculature further comprises occluding blood flow in the renal vasculature with the balloon.

6. The method of claim 1 wherein expanding the balloon within the renal vasculature further comprises locally increasing impedance within the renal vasculature via the balloon.

7. The method of claim 6 wherein locally increasing impedance further comprises directing the electric field across a wall of the renal vasculature between the bipolar electrodes.

8. The method of claim 1 wherein the pair of bipolar electrodes are carried by a shaft of the catheter.

9. The method of claim 1 wherein the bipolar pair of electrodes comprises a first pair of bipolar electrodes arranged about the balloon, and wherein the catheter further comprises a second pair of bipolar electrodes arranged thereabout.

10. The method of claim 1 wherein delivering an electric field via the bipolar electrodes to induce renal neuromodulation comprises thermally inhibiting neural communication along neural fibers innervating a kidney of the patient.

11. The method of claim 1 wherein delivering an electric field via the bipolar electrodes to induce renal neuromodulation comprises ablating neural fibers innervating a kidney of the patient via the electric field.

12. The method of claim 1 wherein delivering an electric field via the bipolar electrodes to induce renal neuromodulation comprises partially ablating neural fibers innervating a kidney of the patient via the electric field.

13. The method of claim 1 wherein delivering an electric field via the bipolar electrodes to induce renal neuromodulation comprises at least partially denervating a kidney of the patient.

14. The method of claim 1, further comprising removing the catheter from the patient after therapy.

15. The method of claim 1, further comprising monitoring a parameter of target tissue and/or non-target tissue within the patient before and during energy delivery.

16. The method of claim 15 wherein monitoring a parameter comprises monitoring temperature of target tissue, and wherein the method further comprises maintaining the target tissue at a desired temperature during energy delivery.

17. The method of claim 15, further comprising altering energy delivery in response to the monitored parameter.

18. A method for catheter-based renal denervation of a human patient, the method comprising:

transluminally positioning a renal denervation catheter within a renal artery of the patient and adjacent to neural fibers that innervate a kidney of the patient, wherein the catheter includes a balloon and a pair of bipolar electrodes;

inflating the balloon within the renal artery of the patient; and

after inflating the balloon, at least partially ablating the neural fibers of the patient via energy from the bipolar electrodes,

wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in central sympathetic overactive of the patient.

19. The method of claim 18 wherein at least partially ablating the neural fibers results in a therapeutically beneficial reduction in blood pressure in the patient.

20. The method of claim 18, further comprising monitoring temperature of target tissue within the patient before and during energy delivery, and wherein the method further comprises altering energy delivery to the neural fibers via the bipolar electrodes throughout therapy to maintain the target tissue at a predetermined temperature.

21. A method for treating a human patient diagnosed with hypertension, the method comprising:

positioning a catheter comprising a balloon and a pair of electrode poles within renal vasculature of the patient;

expanding the balloon within the renal vasculature; and

thermally inhibiting neural communication along neural fibers that innervate a kidney of the patient via an electric field from the electrode poles,

wherein inhibiting the neural communication results in a therapeutically beneficial reduction in blood pressure of the patient.

22. The method of claim 21 wherein positioning a catheter comprising a balloon and a pair of electrode poles within renal vasculature of the patient comprises positioning the catheter within a renal artery of a patient.

23. The method of claim 21 wherein positioning a catheter comprising a balloon and a pair of electrode poles within renal vasculature of the patient comprises intravascularly delivering the catheter to the renal vasculature within a guide catheter.

24. The method of claim 21 wherein expanding the balloon within the renal vasculature comprises occluding blood flow in the renal vasculature with the balloon.

25. The method of claim 21 wherein thermally inhibiting neural communication along neural fibers that innervate a kidney of the patient via an electric field from the electrode poles comprises ablating the neural fibers.

26. The method of claim 21, further comprising removing the catheter from the patient after thermally inhibiting neural communication along neural fibers that innervate the kidney of the patient via the electric field from the electrode poles.