IP Library Granted Patent US 12,070,604
Granted Patent B2
US 12,070,604 · App. 17/450,308 · Granted Aug 27, 2024

Optimizing neuromodulation stimulation parameters using blood parameter sensing

Inventors: Brian Pepin (South San Francisco, CA); Shiv Sabesan (South San Francisco, CA)
Assignee: GALVANI BIOELECTRONICS LIMITED
A61N1/36139A61N1/0534A61N1/36007A61N1/36031A61N1/36067A61N1/36135A61N1/3614A61N1/36171A61N1/36175A61N1/36062A61N1/36064A61N1/36071A61N1/36085A61N1/36096A61N1/3752
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Quick Facts
Patent No.
US 12,070,604
App. No.
17/450,308
Granted
Aug 27, 2024
Kind
B2
Abstract

This disclosure relates to implantable neuromodulation systems and methods, and in particular to systems and methods for sensing blood-based parameter changes triggered by neural stimulation and subsequently optimizing the stimulation parameters based on feedback from the sensed blood-based parameter changes. Embodiments are directed to a method that includes delivering neural stimulation to a nerve or artery/nerve plexus based on a first set of stimulation parameters, monitoring a response to the neural stimulation that includes monitoring responses of the nerve or artery/nerve plexus and blood-based parameters of the artery, modifying the first set of the stimulation parameters based on the blood-based parameters to create a second set of stimulation parameters, and delivering the neural stimulation based on the second set of the stimulation parameters.

Claims (32)

1. A system comprising:

a neurostimulator configured to delivery stimulation for a nerve or artery/nerve plexus based on a first set of stimulation parameters;

one or more sensors configured to monitor a response to the stimulation that includes monitoring responses of the nerve or artery/nerve plexus; and

a controller configured to modify the first set of stimulation parameters based on the responses of the nerve or artery/nerve plexus to create a second set of stimulation parameters, wherein the controller is configured to modify the first set of stimulation parameters based on a titration schedule;

wherein the neurostimulator is further configured to deliver the stimulation based on the second set of the stimulation parameters, wherein the neurostimulator, the one or more sensors, and the controller are provided within a distributed environment, and wherein at least the neurostimulator and the controller are in communication via a wireless communication network.

2. The system of claim 1 , wherein the stimulation parameters include at least one of stimulation amplitude, pulse width, frequency, duty cycle, stimulation waveform shape, and electrode configuration.

3. The system of claim 1 , wherein monitoring a response to the stimulation includes monitoring the blood-based parameters including at least one of blood flow, blood pressure, and arterial distension.

4. The system of claim 3 , wherein the blood-based parameters are measured using one or more sensors including at least one of: a blood flow sensor, a blood pressure sensor, and a distension sensor.

5. The system of claim 4 , wherein the blood flow sensor is a Doppler sensor configured to measure blood velocity or an impedance sensor configured to detect changes in electrical impedance of blood.

6. The system of claim 4 , wherein the blood pressure sensor is an impedance sensor configured to measure the blood pressure or a piezoresistive pressure sensor configured to measure the blood pressure.

7. The system of claim 4 , wherein the distension sensor is a capacitive sensor configured to measure the arterial distension, a photonic sensor configured to measure arterial distension based on a change in amount of photons transmitted, or a Doppler sensor configured to measure cardiac motion and artery diameter pulsation.

8. The system of claim 3 , wherein the modifying includes modifying the first set of stimulation parameters based on the blood-based parameters and the information regarding the electrical impulses to create the second set of stimulation parameters.

9. A system comprising:

an implantable neurostimulator including:

a controller configured to:

deliver neural stimulation using a pulse generator and one or more electrodes based on a first set of stimulation parameters to a nerve or artery/nerve plexus;

monitor a response to the neural stimulation that includes monitoring responses of the nerve or artery/nerve plexus, wherein monitoring the response to the neural stimulation includes determining whether the neural stimulation has a physiological effect;

modify the first set of stimulation parameters based on the monitored response to create a second set of stimulation parameters; and

deliver the neural stimulation using the pulse generator and the one or more electrodes based on the second set of the stimulation parameters,

wherein the controller is configured to modify the first set of stimulation parameters based on a titration schedule.

10. The system of claim 9 , wherein determining whether the neural stimulation has a physiological effect includes obtaining the blood-based parameters and comparing the blood-based parameters to one or more predetermined thresholds to determine whether the neural stimulation has an adverse physiological effect on the blood-based parameters.

11. The system of claim 10 , wherein when the neural stimulation has an adverse physiological effect, the operations further comprise modifying the first set of stimulation parameters based on the blood-based parameters to create the second set of stimulation parameters.

12. The system of claim 9 , wherein the controller is configured to determine whether adequate adaptation is achieved, further wherein the adequate adaptation is achieved when at least one of the following objectives is achieved: acceptable levels for the blood-based parameters, a target intensity level for one or more of the stimulation parameters, and a target physiological effect.

13. The system of claim 9 , wherein monitoring a response to the stimulation includes monitoring the blood-based parameters including at least one of blood flow, blood pressure, and arterial distension.

14. The system of claim 13 , wherein the blood-based parameters are measured using one or more sensors including at least one of: a blood flow sensor, a blood pressure sensor, and a distension sensor.

15. The system of claim 14 , wherein the blood flow sensor is a Doppler sensor configured to measure blood velocity or an impedance sensor configured to detect changes in electrical impedance of blood.

16. The system of claim 14 , wherein the blood pressure sensor is an impedance sensor configured to measure the blood pressure or a piezoresistive pressure sensor configured to measure the blood pressure.

17. A method comprising:

delivering, by a computing system, neural stimulation to a nerve or artery/nerve plexus based on a first set of stimulation parameters;

monitoring, by the computing system, a response to the neural stimulation that includes monitoring whether the neural stimulation has a physiological effect or changes to blood-based parameters;

modifying, by the computing system, the first set of stimulation parameters based on a titration schedule and on the physiological effect or blood-based parameters to create a second set of stimulation parameters; and

delivering, by the computing system, the neural stimulation based on the second set of the stimulation parameters.

Assignments (3)
CHANGE OF ADDRESS Recorded Apr 16, 2025
From: GALVANI BIOELECTRONICS LIMITED
To: GALVANI BIOELECTRONICS LIMITED
Reel/Frame 070854/0393 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2024
From: PEPIN, BRIAN; SABESAN, SHIV
To: VERILY LIFE SCIENCES LLC
Reel/Frame 067060/0216 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 10, 2024
From: VERILY LIFE SCIENCES LLC
To: GALVANI BIOELECTRONICS LIMITED
Reel/Frame 067060/0219 →
Continuity (3)
Continuation 16485673
Provisional Application 62458757 · Feb 14, 2017
Related Publication 20220023635A1 · Jan 27, 2022