SYSTEM AND METHOD FOR SELECTIVE AND MAINTAINED ACTIVATION OF SENSORY PERIPHERAL NERVE FIBERS

• US 20150012068A1
• Filed: 07/02/2014
• Published: 01/08/2015
• Est. Priority Date: 07/02/2013
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Bradley, Kerry, Halberg, Les
• Granted Patent: US 9,415,211 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61B 5/064 using markers A61B5/062 takes precedence
• CPC Class Codes: A61B 8/0841 for locating instruments
• 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 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36153 Voltage A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A method of establishing a stimulation treatment protocol includes delivering electrical stimulation to a nerve site of the patient. The electrical stimulation is delivered using a stimulation configuration with respect to one or more of the following: activation of a subset of a plurality of electrodes on a lead, electrode polarity for the activated electrodes, stimulation pulse width, and stimulation pulse amplitude. An action potential evoked from the nerve site in response to the electrical stimulation is measured. The action potential includes a sensory fiber contribution and a motor fiber contribution. Both the sensory fiber contribution and the motor fiber contribution are measured. The delivering and the measuring are repeated for a plurality of cycles. Each cycle is performed using a different stimulation configuration. The stimulation configuration that offers a greatest sensory fiber contribution relative to the motor fiber contribution is recommended as a candidate for optimized stimulation configuration.

Claims

1. A method of establishing a stimulation treatment protocol for a patient, the method comprising:

delivering electrical stimulation to a nerve site of the patient, wherein the electrical stimulation is delivered using a stimulation configuration with respect to one or more of the following;

activation of a subset of a plurality of electrodes on a lead, electrode polarity for the activated electrodes, stimulation pulse width, and stimulation pulse amplitude;

measuring an action potential evoked from the nerve site in response to the electrical stimulation, wherein the action potential includes a sensory fiber contribution and a motor fiber contribution, and wherein the measuring comprises measuring the sensory fiber contribution and the motor fiber contribution;

repeating the delivering and the measuring for a plurality of cycles, wherein each cycle is performed using a different stimulation configuration; and

thereafter recommending, as a candidate for optimized stimulation configuration, the stimulation configuration that offers a greatest sensory fiber contribution relative to the motor fiber contribution.

2. The method of claim 1, wherein the repeating is performed according to a predefined algorithm that specifies the activation of electrodes, electrode polarity, the stimulation pulse width, and the stimulation pulse amplitude for each cycle.

3. The method of claim 2, wherein the algorithm comprises:

selecting an electrode combination that specifies a subset of electrodes to be activated and a respective electrode polarity for each activated electrode;

ramping up or down the stimulation pulse amplitude for the selected electrode combination; and

repeating the selecting and the ramping a plurality of times until a predetermined list of electrode combinations have been exhausted, wherein a different electrode combination is selected each time.

4. The method of claim 3, wherein the selecting, the ramping, and the repeating are performed while holding the stimulation pulse width constant, and wherein the algorithm further comprises:

picking, after the exhaustion of the predetermined list of electrode combinations, one or more electrode combinations with their corresponding stimulation amplitudes that maximized the sensory fiber contribution; and

ramping up or down the stimulation pulse width for the one or more electrode combinations.

5. The method of claim 3, wherein the electrode combinations in the predetermined list each include a different cathode.

6. The method of claim 1, wherein the measuring comprises:

measuring the motor fiber contribution within a first time window; and

measuring the sensory fiber contribution within a second time window, the second time window being a later time window than the first time window.

7. The method of claim 1, wherein the delivering, the measuring, and the repeating are performed without requiring verbal or tactile feedback from the patient.

8. A medical system for establishing a stimulation treatment protocol for a patient, the medical system comprising:

a stimulation component configured to deliver electrical stimulation to a nerve site of the patient, wherein the electrical stimulation is delivered using a stimulation configuration with respect to one or more of the following;

activation of a subset of a plurality of electrodes on a lead, electrode polarity for the activated electrodes, stimulation pulse width, and stimulation pulse amplitude;

a measurement component configured to measure an action potential evoked from the nerve site in response to the electrical stimulation, wherein the action potential includes a sensory fiber contribution and a motor fiber contribution, and wherein the measurement component is configured to measure both the sensory fiber contribution and the motor fiber contribution; and

a processor component configured to;

instruct the stimulation component and the measurement component to repeat the delivering of the electrical stimulation and the measurement of the action potential for a plurality of cycles, wherein each cycle is performed using a different stimulation configuration; and

thereafter recommend, as a candidate for optimized stimulation configuration, the stimulation configuration that offers a greatest sensory fiber contribution relative to the motor fiber contribution.

9. The medical system of claim 8, wherein the processor component executes a predefined algorithm that specifies the activation of electrodes, electrode polarity, the stimulation pulse width, and the stimulation pulse amplitude for each cycle.

10. The medical system of claim 9, wherein the algorithm:

defines a predetermined list of electrode combinations to be stepped through, wherein each electrode combination specifies a subset of electrodes to be activated and a respective electrode polarity for each activated electrode; and

instructs the stimulation component to ramp up or down the stimulation pulse amplitude as each electrode combination on the predetermined list is being stepped through.

11. The medical system of claim 10, wherein the algorithm:

instructs the stimulation component to hold the stimulation pulse fixed as each electrode combination on the predetermined list is being stepped through;

picks, after each electrode combination on the predetermined list has been stepped through, one or more electrode combinations with their corresponding stimulation amplitudes that maximized the sensory fiber contribution; and

instructs the stimulation component to ramp up or down the stimulation pulse width for the one or more electrode combinations.

12. The medical system of claim 10, wherein the electrode combinations on the predetermined list each include a different cathode.

13. The medical system of claim 8, wherein the measurement component is configured to:

measure the motor fiber contribution within a first time window; and

measure the sensory fiber contribution within a second time window, the second time window being a later time window than the first time window.

14. The medical system of claim 8, wherein:

the stimulation component and the measurement component are integrated within an implantable pulse generator; and

the processor is integrated within the implantable pulse generator or integrated within an electronic programmer that is configured to send instructions to the implantable pulse generator via a telecommunications link.

15. A medical device for establishing a stimulation treatment protocol for a patient, the medical device comprising:

stimulation circuitry configured to deliver electrical stimulation to a nerve site of the patient, wherein the electrical stimulation is delivered using a stimulation configuration with respect to one or more of the following;

activation of a subset of a plurality of electrodes on a lead, electrode polarity for the activated electrodes, stimulation pulse width, and stimulation pulse amplitude;

measurement circuitry configured to measure an action potential evoked from the nerve site in response to the electrical stimulation, wherein the action potential includes a sensory fiber contribution and a motor fiber contribution, and wherein the measurement circuitry is configured to measure both the sensory fiber contribution and the motor fiber contribution; and

controller circuitry configured to;

instruct the stimulation circuitry and the measurement circuitry to repeat the delivering of the electrical stimulation and the measurement of the action potential for a plurality of cycles, wherein each cycle is performed using a different stimulation configuration; and

thereafter recommend, as a candidate for optimized stimulation configuration, the stimulation configuration that offers a greatest sensory fiber contribution relative to the motor fiber contribution.

16. The medical device of claim 15, wherein the controller circuitry executes a predefined algorithm that specifies the activation of electrodes, electrode polarity, the stimulation pulse width, and the stimulation pulse amplitude for each cycle.

17. The medical device of claim 16, wherein the algorithm:

defines a predetermined list of electrode combinations to be stepped through, wherein each electrode combination specifies a subset of electrodes to be activated and a respective electrode polarity for each activated electrode; and

instructs the stimulation circuitry to ramp up or down the stimulation pulse amplitude as each electrode combination on the predetermined list is being stepped through.

18. The medical device of claim 17, wherein the algorithm:

instructs the stimulation circuitry to hold the stimulation pulse fixed as each electrode combination on the predetermined list is being stepped through;

picks, after each electrode combination on the predetermined list has been stepped through, one or more electrode combinations with their corresponding stimulation amplitudes that maximized the sensory fiber contribution; and

instructs the stimulation circuitry to ramp up or down the stimulation pulse width for the one or more electrode combinations.

19. The medical device of claim 17, wherein the electrode combinations on the predetermined list each include a different cathode.

20. The medical device of claim 15, wherein the measurement circuitry is configured to:

measure the motor fiber contribution within a first time window; and

measure the sensory fiber contribution within a second time window, the second time window being a later time.