Systems for regulation of blood pressure and heart rate

• US 8,768,469 B2
• Filed: 08/06/2009
• Issued: 07/01/2014
• Est. Priority Date: 08/08/2008
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: EnteroMedics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Tweden, Katherine S., Wilson, Richard R., Knudson, Mark B., Kim, Dennis Dong-Won, Bhole, Deepak
• Primary Examiner(s): BOCKELMAN, MARK
• Application Number:
  US12/537,019
• Publication Number:
  US 20100204741A1
• Time in Patent Office: 1,790 Days
• Field of Search: 607/2, 607/3, 607/44, 607/118, 607/62
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• 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 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method and apparatus for treating a condition associated with impaired blood pressure and/or heart rate in a subject comprising applying an electrical treatment signal, wherein the electrical treatment signal is selected to at least partially block nerve impulses, or in some embodiments, to augment nerve impulses.

Claims

1. A method of treating hypertension or congestive heart failure in a subject comprising:

applying an intermittent electrical treatment signal to a vagus nerve or tissue in proximity to the vagus nerve at a subdiaphragmatic location of the subject having hypertension or congestive heart failure, wherein said electrical treatment signal is selected to at least partially down-regulate neural activity on the vagus nerve during an on time, have a frequency of about 200 Hz to 25 kHz, and to at least partially restore neural activity on the nerve during an off time.

2. The method according to claim 1, wherein the electrical signal is selected for frequency, pulse width, amplitude, timing and ramp-up/ramp-down characteristics.

3. The method according to claim 1 wherein the on time of the electrical treatment signal is selected to down regulate the neural activity of the nerve at least 50%.

4. The method of claim 1, wherein the electrical signal is applied intermittently in a cycle including an on time of application of the signal followed by an off time during which the signal is not applied to the nerve, wherein the on and off times are applied multiple times per day over multiple days.

5. The method of claim 4, wherein the on time is elected to have a duration of no less than 30 seconds or no more than 180 seconds or both.

6. The method according to claim 1, wherein the electrical signal is applied to an electrode, wherein the electrode is positioned on the vagus nerve or on tissue adjacent to the vagus nerve.

7. The method according to claim 1, wherein the electrical signal is applied to an anterior vagus trunk, posterior vagus trunk, or both.

8. The method of claim 1, further comprising applying an up-regulating signal to a baroreceptor.

9. The method of claim 8, wherein the downregulating signal and the upregulating signal are applied at the same time or different time.

10. The method according to claim 1, further comprising administering an agent that improves blood pressure control.

11. The method of claim 10 wherein the agent that improves blood pressure control is selected from the group consisting of a diuretic, ACE inhibitor, calcium channel blocker, beta blocker, alpha blocker and mixtures thereof.

12. A method of treating hypertension or congestive heart failure comprising:

a) selecting a drug for treating hypertension for a patient where effective dosages for treating hypertension for such a patient are associated with disagreeable side effects or inadequate blood pressure control; and

treating a patient for hypertension with a concurrent treatment comprising;

i) applying an intermittent electrical treatment signal to a vagus nerve of the patient at multiple times per day and over multiple days with the electrical treatment signal selected to down-regulate afferent and/or efferent neural activity on the nerve, have a frequency of about 200 Hz to 25 kHz, and with neural activity at least partially restoring upon discontinuance of said block; and

ii) administering said drug to the patient.

13. A system comprising:

a) an electrode adapted to be placed on a vagus nerve at a subdiaphragmatic location;

b) an implantable neuroregulator connected to the electrode and configured to deliver an electrical signal to the vagus nerve, wherein the electrical signal is i) delivered with a duty cycle of an on time and an off time multiple times in a day ii) has a frequency of 200 to 5000 Hz selected to down regulate neural activity on the nerve during an on time, iii) has an off time selected to provide for at least partial recovery of nerve function, and iv) has an amplitude of at least 6 mA;

c) an external coil, wherein the external coil is configured to communicate data and power signals to the neuroregulator and to communicate data to another programming device; and

d) a sensor that is configured to sense blood pressure and to send a signal to the neuroregulator to deliver the electrical signal if the blood pressure becomes pre hypertensive or greater.

14. The system of claim 13, wherein the electrode is adapted to be placed on the vagus nerve at a subdiaphragmatic location.

15. The system of claim 13, wherein the neuroregulator is configured to deliver the electrical signal intermittently for a treatment period of no less than 12 hours and no more than 18 hours.

16. The system of claim 13, wherein the neuroregulator is configured to deliver a signal with an on time of 30 seconds to 5 minutes.

17. The system of claim 13, wherein the neuroregulator is configured to deliver an off time of 2 to 20 minutes.

18. The system of claim 13, wherein the amplitude is from about 6 to 18 mA.