Renal nerve stimulation method and apparatus for treatment of patients

• US 7,162,303 B2
• Filed: 04/08/2003
• Issued: 01/09/2007
• Est. Priority Date: 04/08/2002
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Ardian, Inc. (Medtronic Plc)
• Inventors: Levin, Howard R., Gelfand, Mark
• Primary Examiner(s): Jastrzab; Jeffrey R.
• Application Number:
  US10/408,665
• Publication Number:
  US 20030216792A1
• Time in Patent Office: 1,372 Days
• Field of Search: 607/2, 607/3, 607/44, 607/62, 607/117, 607/118, 604/891.1
• US Class Current: 607/44
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• 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 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• 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 1/36114 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 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• 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 1/40 : Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals
• CPC Class Codes: A61N 1/403 : for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/00 : Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

A method and apparatus for treatment of heart failure, hypertension and renal failure by stimulating the renal nerve. The goal of therapy is to reduce sympathetic activity of the renal nerve. Therapy is accomplished by at least partially blocking the nerve with drug infusion or electrostimulation. Apparatus can be permanently implanted or catheter based.

Claims

1. A method for treating a human patient comprising:

a. positioning a nerve stimulation device adjacent to a renal nerve of at least one kidney of the patient, wherein the nerve stimulation device comprises a cuff placed around a renal blood vessel of the kidney; and

b. at least partially blocking the renal nerve of the kidney.

2. A method as in claim 1 wherein the cuff comprises an electrode, and the electrode is positioned surgically in the patient.

3. A method as in claim 1 wherein the cuff comprises a drug delivery device, and the device is positioned surgically in the patient.

4. The method of claim 1 wherein the nerve stimulation device is implanted in the patient.

5. The method as in claim 1 wherein afferent fibers of the renal nerve are blocked and efferent fibers are not blocked.

6. The method as in claim 1 wherein efferent fibers of the renal nerve are blocked and afferent fibers are not blocked.

7. A method as in claim 1 wherein the step of blocking the renal nerve is accomplished by a block selected from a group consisting of an anodal block, a cathodal block and a collision block.

8. A method as in claim 1 wherein the step of blocking the renal nerve is accomplished by overpacing the nerve.

9. A method as in claim 1 wherein the step of blocking is accomplished by continuous infusion of an anesthetic drug to the nerve.

10. A method as in claim 1 further comprising monitoring blood pressure of the patient, and adjusting a level of blocking in response to said blood pressure.

11. A method as in claim 1 wherein the nerve stimulation device is a catheter.

12. A method as in claim 1 wherein the nerve stimulation device is a lead with multiple electrodes.

13. A method as in claim 1 wherein the step of blocking is accomplished by the injection of a neurotoxin.

14. A method as in claim 1 wherein the step of blocking is accomplished by ablation of the renal nerve.

15. A method as in claim 1 wherein the step of blocking is accomplished by cooling of the renal nerve.

16. A method as in claim 1 applied to a patient suffering from at least one of heart failure, chronic renal failure and hypertension.

17. A method to stimulate a renal nerve in a mammalian patient to treat at least one of acute myocardial infarction, heart failure, chronic renal failure and hypertension, the method comprising:

a. positioning a renal nerve stimulation device in the patient such that an electrode at a distal section of the stimulation device can apply an electrical field to a renal nerve of a kidney of the patient and a proximal section of the stimulation device is connected to an electro stimulation apparatus outside of the patient;

b. applying an electrical stimulation signal with the device to the renal nerve;

c. at least partially blocking the renal nerve by application of the stimulation signal; and

d. removing the distal section of the stimulation device from the patient.

18. A method as in claim 17 wherein stimulation signal is an electrical current applied by the electrode to the renal nerve.

19. A method as in claim 17 wherein the nerve stimulation device further comprises a drug delivery device and the stimulation signal is a nerve blocking drug applied to the renal nerve.

20. A method for reducing abnormally elevated sympathetic renal nerve signals to treat at least one of acute myocardial infarction, heart failure, chronic renal failure and hypertension, the method comprising:

a. positioning a renal nerve stimulator such that at least one electrode at a distal end is proximate to a renal nerve of a mammalian patient and a proximal end of the renal nerve stimulator is outside of the patient;

b. applying an electrical current to the electrode with an electric controller to stimulate the renal nerve to at least reduce signal traffic in sympathetic efferent renal nerve fibers;

c. regulating the current applied to the electrode based on at least one condition of the patient being monitored by a sensor; and

d. removing the distal end of the renal nerve stimulator from the patient.

21. A method as in claim 20 wherein a controller monitors blood pressure in the patient and the sensor is a blood pressure sensor.

22. A method as in claim 20 wherein a controller monitors blood oxygen in the patient and the sensor is a blood oxygen sensor.

23. A method for treating at least one of acute myocardial infarction, heart failure, chronic renal failure and hypertension in a human patient comprising:

positioning a distal section of an electrical nerve stimulation device within a renal vasculature adjacent to a renal nerve of at least one kidney of the patient and a proximal section of the electrical nerve stimulation device outside of the patient; and

at least partially blocking the renal nerve of the kidney via the intravascularly-positioned electrical nerve stimulation device; and

removing the distal section of the electrical nerve stimulation device from the patient.

24. The method of claim 23, wherein positioning the electrical nerve stimulation device within renal vasculature further comprises positioning an electrode within the renal vasculature.

25. The method of claim 24, wherein positioning the electrode within the renal vasculature further comprises positioning a bipolar electrode pair within the renal vasculature.

26. The method of claim 25, wherein at least partially blocking the renal nerve of the kidney further comprises delivering an electric field across the bipolar electrode pair.

27. The method of claim 23, wherein positioning an electrical nerve stimulation device within the renal vasculature of the patient further comprises positioning the electrical nerve stimulation device within a renal vein of the patient.

28. The method of claim 23, wherein positioning an electrical nerve stimulation device within the renal vasculature of the patient further comprises positioning the electrical nerve stimulation device within a renal artery of the patient.

29. A method for treating a human patient comprising:

a. positioning a nerve stimulation device adjacent to a renal nerve of at least one kidney of the patient, and

b. at least partially blocking the renal nerve of the kidney, wherein the step of blocking is accomplished by ablation of the renal nerve.

30. A method for treating a human patient comprising:

a. positioning a nerve stimulation device adjacent to a renal nerve of at least one kidney of the patient, and

b. at least partially blocking the renal nerve of the kidney, wherein the step of blocking is accomplished by cooling of the renal nerve.