Method and apparatus for controlling spinal cord stimulation to treat hypertension

Patent metadata

Field	Value
Publication number	US-10576285-B2
Application number	US-201715812788-A
Country	US
Kind code	B2
Filing date	Nov 14, 2017
Priority date	Nov 14, 2016
Publication date	Mar 3, 2020
Grant date	Mar 3, 2020

Abstract

An example of a system for modulating blood pressure may include a blood pressure monitoring circuit, a blood pressure modulation device, and a control circuit. The blood pressure monitoring circuit may be configured to sense signals and generate one or more blood pressure parameters indicative of the blood pressure and/or a vascular resistance and one or more activity parameters indicative of an activity level and/or a postural change using the sensed signals. The blood pressure modulation device may be configured to deliver a therapy modulating the blood pressure. The control circuit may be configured to control the therapy using therapy parameters, receive the one or more blood pressure parameters and the one or more activity parameters, analyze changes in the one or more blood pressure parameters that are correlated to changes in the one or more activity parameters, and adjust the therapy parameters using an outcome of the analysis.

First claim

What is claimed is:

1. A system for modulating blood pressure of a patient, the system comprising:
a blood pressure monitoring circuit configured to sense signals from the patient and generate one or more blood pressure parameters indicative of one or more of a blood pressure or a vascular resistance of the patient and one or more activity parameters indicative of one or more of an activity level or a postural change of the patient using the sensed signals, the blood pressure monitoring circuit including an extravascular physiological sensor configured to indirectly sense the blood pressure using a surrogate of the blood pressure;
a blood pressure modulation device configured to deliver a therapy for treating hypertension by modulating the blood pressure; and
a control circuit configured to control the therapy using therapy parameters, to receive the one or more blood pressure parameters and the one or more activity parameters, to analyze changes in the one or more blood pressure parameters that are correlated to changes in the one or more activity parameters, and to adjust the therapy parameters using an outcome of the analysis for delivering the therapy when a risk of blood pressure elevation is indicated.

2. The system of claim 1 , wherein the blood pressure monitoring circuit is further configured to receive one or more user commands, and the control circuit is further configured to incorporate the received one or more user commands into the analysis of the changes in the one or more blood pressure parameters that are correlated to the changes in the one or more activity parameters.

3. The system of claim 1 , wherein the control circuit is further configured to optimize the therapy parameters by executing an optimization algorithm for an optimal therapeutic effect as indicated by the one or more blood pressure parameters and the one or more activity parameters.

4. The system of claim 3 , wherein the control circuit is further configured to allow for calibration of the optimization algorithm in response to the optimal therapeutic effect falling outside a specified threshold or in response to a user command for calibration.

5. The system of claim 4 , further comprising a power management circuit configured to control a power mode of the system, the power management circuit configured to place the system in a low-power mode while the patient is sleeping, as indicated by one or more of the one or more activity parameters or a user command indicating a patient-specified sleeping period.

6. The system of claim 4 , comprising an implantable medical device configured to be placed within the patient, the implantable medical device including the blood pressure modulation device, the control circuit, and at least a portion of the blood pressure monitoring circuit.

7. The system of claim 6 , wherein the blood pressure monitoring circuit comprises an intravascular blood pressure sensor configured to directly sense the blood pressure.

8. The system of claim 1 , wherein the extravascular physiological sensor sense at least one of a heart sound sensor configured to sense a heart sound signal, a photoplethysmographic sensor, or an impedance sensor.

9. The system of claim 6 , wherein the implantable medical device comprises an implantable neuromodulator, and the blood pressure modulation device is configured to deliver a spinal cord stimulation (SCS).

10. The system of claim 9 , further comprising an implantable lead configured to be connected to the implantable neuromodulator, the implantable lead including electrodes configured for delivering the SCS and at least one sensor configured to sense one of the signals from the patient.

11. A method for modulating blood pressure of a patient, including:
sensing signals from the patient, including sensing an extravascular signal as a surrogate for the blood pressure using an extravascular physiological sensor;
generating parameters using the sensed signals, the parameters including one or more blood pressure parameters indicative of one or more of the blood pressure or a vascular resistance of the patient and one or more activity parameters indicative of one or more of an activity level or a postural change of the patient;
analyzing changes in the one or more blood pressure parameters correlated to changes in the one or more activity parameters;
adjusting therapy parameters using an outcome of the analysis so that a therapy for treating hypertension by modulating the blood pressure is delivered when a risk of blood pressure elevation is indicated;
controlling the therapy using the therapy parameters; and
delivering the therapy to the patient.

12. The method of claim 11 , further comprising:
receiving one or more user commands; and
incorporating the one or more user commands into the analysis of the changes in the one or more blood pressure parameters correlated to the changes in the one or more activity parameters.

13. The method of claim 11 , further comprising approximately optimizing the therapy parameters by executing an optimization algorithm, the optimization algorithm allowing the therapy parameters to be set for an approximately optimal therapeutic effect as indicated by the one or more blood pressure parameters and the one or more activity parameters.

14. The method of claim 11 , wherein delivering the therapy comprises delivering spinal cord stimulation (SCS) using an implantable medical device.

15. The method of claim 14 , wherein sensing the signals comprises sensing the blood pressure using an intravascular blood pressure sensor connected to the implantable medical device.

16. The method of claim 14 , wherein sensing the extravascular signal using the extravascular physiological sensor comprises sensing the extravascular signal using an implantable sensor contained in or connected to the implantable medical device.

17. The method of claim 16 , wherein sensing the extravascular signal comprises sensing a heart sound signal indicative of heart sounds of the patient.

18. The method of claim 16 , wherein sensing the extravascular signal comprises sensing a photoplethysmographic signal.

19. The method of claim 16 , wherein sensing the extravascular signal comprises sensing an impedance signal.

20. A non-transitory computer-readable storage medium including instructions, which when executed by a system, cause the system to perform a method for modulating blood pressure of a patient, the method comprising:
sensing signals from the patient, including sensing an extravascular signal as a surrogate for the blood pressure using an extravascular physiological sensor;
generating parameters using the sensed signals, the parameters including one or more blood pressure parameters indicative of one or more of the blood pressure or a vascular resistance of the patient and one or more activity parameters indicative of one or more of an activity level or a postural change of the patient;
analyzing changes in the one or more blood pressure parameters correlated to changes in the one or more activity parameters;
adjusting therapy parameters using an outcome of the analysis so that a therapy for treating hypertension by modulating the blood pressure is delivered when a risk of blood pressure elevation is indicated;
controlling the therapy using the therapy parameters; and
delivering the therapy to the patient.

Assignees

• Boston Scient Neuromodulation Corp

Inventors

• Annoni Elizabeth Mary
• Srivastava Kyle Harish
• Stolen Craig
• Thakur Pramodsingh Hirasingh
• Hershey Bradley Lawrence
• Ruble Stephen B
• Stoffregen William Conrad
• Clark Bryan Allen

Classifications

• A61N1/36117 Primary

  for treating hypertension · CPC title

• A61N1/36564

  controlled by blood pressure · CPC title

• A61B5/02255

  the pressure being controlled by plethysmographic signals, e.g. derived from optical sensors · CPC title

• A61N1/36114

  Cardiac control, e.g. by vagal stimulation (stimulating the heart A61N1/362) · CPC title

• A61B5/02158

  provided with two or more sensor elements · CPC title