Methods and apparatus for thermally-induced renal neuromodulation

• US 10,034,708 B2
• Filed: 06/11/2015
• Issued: 07/31/2018
• Est. Priority Date: 04/08/2002
• Status: Expired due to Term

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Zarins, Denise, Wu, Andrew, Gifford, III, Hanson, Deem, Mark, Gelfand, Mark, Levin, Howard R.
• Primary Examiner(s): Osinski, Bradley J
• Application Number:
  US14/737,254
• Publication Number:
  US 20150282877A1
• Time in Patent Office: 1,146 Days
• 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 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/123 using a flexible balloon containing the thermal element
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• 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 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 5/045 : specially adapted for treatment inside the body
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Methods and apparatus are provided for thermally-induced renal neuromodulation. 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. In some embodiments, parameters of the neural fibers, of non-target tissue, or of the thermal energy delivery element, may be monitored via one or more sensors for controlling the thermally-induced neuromodulation. In some embodiments, protective elements may be provided to reduce a degree of thermal damage induced in the non-target tissues. In some embodiments, thermally-induced renal neuromodulation is achieved via delivery of a pulsed thermal therapy.

Claims

1. A method for renal neuromodulation of a human patient, the method comprising:

intravascularly positioning a catheter within a renal artery of the human patient and proximate to neural fibers innervating a kidney of the patient, the catheter comprising a first infusion needle and a second infusion needle;

deploying the first and second infusion needles to pierce a wall of the renal artery; and

injecting a neuromodulatory agent through the first and second infusion needles to at least partially ablate the neural fibers innervating the kidney of the patient,

wherein at least partially ablating the neural fibers blocks or reduces neural transmission along the neural fibers.

2. The method of claim 1, wherein the neuromodulatory agent comprises a drug or medicament.

3. The method of claim 1, wherein the neuromodulatory agent comprises a neurotoxin.

4. The method of claim 3, wherein the neuromodulatory agent comprises botulinum toxin.

5. The method of claim 1, wherein the catheter further comprises an expandable positioning element.

6. The method of claim 5, wherein the expandable positioning element comprises a balloon.

7. The method of claim 5, wherein the expandable positioning element comprises an expandable basket or cage.

8. The method of claim 5, further comprising expanding the expandable positioning element within the renal artery.

9. The method of claim 8, wherein deploying the first and second infusion needles further comprises deploying the first and second infusion needles after expanding the expandable positioning element within the renal artery.

10. The method of claim 1, further comprising deploying the first and second infusion needles approximately to the same depth within the renal artery wall.

11. The method of claim 1, further comprising alleviating clinical symptoms of hypertension in the human patient.

12. The method of claim 11, wherein the method comprises alleviating clinical symptoms of hypertension in the human patient for a period of up to six months or more.

13. The method of claim 1, further comprising alleviating clinical symptoms of chronic heart failure in the human patient.

14. The method of claim 1, further comprising alleviating clinical symptoms of renal disease in the human patient.

15. The method of claim 1, further comprising alleviating clinical symptoms of myocardial infarction in the human patient.

16. The method of claim 1, further comprising alleviating clinical symptoms of atrial fibrillation in the human patient.

17. The method of claim 1, wherein the catheter comprises a shaft having first and second side ports.

18. The method of claim 17, wherein deploying the first and second infusion needles comprises advancing the first infusion needle through the first side port and the second infusion needle through the second side port.

19. A method for renal neuromodulation of a human patient having clinical symptoms of hypertension, the method comprising:

intravascularly advancing a catheter within a renal artery of the human patient and proximate to a renal nerve innervating a kidney of the patient, the catheter comprising a balloon and a plurality of infusion needles;

expanding the balloon to position or center the catheter within the renal artery;

deploying the plurality of infusion needles to pierce a wall of the renal artery;

injecting a neuromodulatory agent through the plurality of infusion needles to at least partially ablate the renal nerve innervating the kidney and inhibit neural traffic along the renal nerve; and

intravascularly removing the catheter from the renal artery after injecting the neuromodulatory agent,

wherein the method comprises alleviating the clinical symptoms of hypertension in the human patient.

20. The method of claim 19, wherein deploying the plurality of infusion needles locates distal regions of the plurality of infusion needles extravascularly.

21. The method of claim 19, wherein the neuromodulatory agent comprises a drug or medicament.

22. The method of claim 19, wherein the method comprises alleviating the clinical symptoms of hypertension in the human patient for a period of up to six months or more.

23. The method of claim 19, wherein intravascularly advancing a catheter within a renal artery of the human patient comprises advancing the catheter over a guidewire.

24. The method of claim 19, wherein the catheter comprises a shaft having a plurality of side ports.

25. The method of claim 24, wherein deploying the plurality of infusion needles comprises advancing each of the plurality of infusion needles through a corresponding side port in the shaft of the catheter.