Method for estimating desired stimulation amplitude for electrode configuration

• US 8,825,169 B2
• Filed: 11/18/2013
• Issued: 09/02/2014
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Zhu, Changfang, Lee, Dongchul
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/082,958
• Publication Number:
  US 20140081350A1
• Time in Patent Office: 288 Days
• Field of Search: 607/59
• US Class Current: 607/59
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36128 Control systems
• CPC Class Codes: A61N 1/3616 Voltage density or current density
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/36192 Amplitude modulation
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method of providing therapy to a patient comprises (a) receiving input from a user, (b) selecting a first electrode configuration in response to receiving the user input, (c) predicting a neural response induced by electrical energy theoretically conveyed by the first electrode configuration at a specified amplitude, (d) deriving a metric value from the predicted neural response, (e) comparing the metric value to a reference threshold value, (f) adjusting the specified amplitude of the electrical energy if the metric value is not in a specified range relative to the reference threshold value, (g) repeating steps (c)-(f) using the adjusted amplitude as the specified amplitude until the metric value is in the specific range relative to the reference threshold value, and (h) instructing a neurostimulation device to deliver the electrical energy at the adjusted amplitude via the first electrode configuration to stimulate the patient.

Claims

1. A method of providing therapy to a patient, comprising:

(a) receiving input from a user;

(b) selecting a first electrode configuration in response to receiving the input from the user via the user input device;

(c) predicting a neural response in the patient induced by electrical energy theoretically conveyed by the first electrode configuration at a specified amplitude;

(d) deriving a metric value from the predicted neural response;

(e) comparing the metric value to a reference threshold value;

(f) adjusting the specified amplitude of the electrical energy if the metric value is not in a specified range relative to the reference threshold value;

(g) repeating steps (c)-(f) using the adjusted amplitude as the specified amplitude until the metric value is in the specific range relative to the reference threshold value; and

(h) instructing a neurostimulation device to deliver the electrical energy at the adjusted amplitude via the first electrode configuration to stimulate the patient.

2. The method of claim 1, wherein the first electrode configuration is a fractionalized electrode configuration.

3. The method of claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is adjusted in uniform increments.

4. The method claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is increased if the metric value is below the reference threshold value.

5. The method of claim 1, wherein the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration is decreased if the metric value exceeds the reference threshold value by more than a specific difference value.

6. The method of claim 1, wherein the metric value is an estimated transmembrane potential of at least one neuronal element, and the reference threshold value is a threshold transmembrane potential.

7. The method of claim 1, wherein the metric value is an estimated volume of activation, and the reference threshold value is a threshold volume of activation.

8. The method of claim 1, wherein the neural response in the patient is predicted by estimating a spatial distribution of electrical parameter values induced by electrical energy theoretically conveyed by the first electrode configuration at a unit amplitude value, multiplying the electrical parameters by the specified amplitude to obtain a spatial distribution of scaled electrical parameter values, and estimating a transmembrane potential of at least one neuronal element in the patient in response to the scaled electrical parameters.

9. The method of claim 8, wherein the electrical parameter values are in a linear relationship with the specified amplitude of the electrical energy theoretically conveyed by the first electrode configuration.

10. The method of claim 8, wherein each of the electrical parameter values is selected from one of a field potential value, an electrical field value, and a current density value.

11. The method of claim 8, wherein the neural response in the patient is predicted by generating an electric field model of the first electrode configuration, and generating an electrical model of the at least one neuronal element, wherein the electrical parameter values are estimated based on the electric field model of the first electrode configuration, wherein the transmembrane potential is estimated based on the electrical model of the at least one neuronal element.

12. The method of claim 11, wherein the electric field model is one of an analytical model and a numerical model, and the electrical model of the at least one neuronal element is one of a passive neuron model, an active neuron model, and an analog chip based circuit model.

13. The method of claim 11, wherein the induced transmembrane potential is estimated using one of an activating function and a total driving function of the electrical model of the at least one neuronal element.

14. The method of claim 1, wherein the amplitude of the electrical energy theoretically conveyed by the first electrode configuration is an amperage value.

15. The method of claim 1, wherein the amplitude of the electrical energy theoretically conveyed by the first electrode configuration is a voltage value.

16. The method of claim 1, wherein the neurostimulation device is instructed to deliver reference electrical energy at a known amplitude to a reference electrode configuration, the reference amplitude of the reference electrical energy is adjusted until a perception threshold of the patient is met or exceeded, a transmembrane potential of at least one reference neuron of the patient is that would be induced by the reference electrical energy of the reference amplitude by the reference electrode configuration is estimated, and the reference threshold value is derived based on the estimated transmembrane potential of the at least one reference neuron.

17. The neurostimulation system of claim 1, further comprising:

(i) selecting a second different electrode configuration in response to receiving the input from the user; and

(j) repeating steps (c)-(h) for the second electrode configuration.

18. The method of claim 17, wherein the user input comprises directional signals.

19. The method of claim 1, further comprising:

(i) determining a first scaling factor for the first electrode configuration;

(j) instructing the neurostimulation device to deliver the electrical energy at a known amplitude via the first electrode configuration to stimulate the patient;

(k) selecting another different electrode configuration in response to receiving the input from the user;

(l) repeating steps (c)-(g) for the second electrode configuration;

(m) determining a second scaling factor for the second electrode configuration;

(n) computing a boosting factor based on the first and second scaling factors;

(o) applying the boosting factor to the known amplitude to generate an estimated amplitude; and

(p) instructing the neurostimulation device to deliver the electrical energy at the estimated amplitude via the second electrode configuration to stimulate the patient.

20. The method of claim 19, wherein the first scaling factor is between the adjusted amplitude for the first electrode configuration and a reference amplitude, and the second scaling factor is between the adjusted amplitude for the second electrode configuration and the reference amplitude.

21. The method of claim 19, wherein the first scaling factor is between the metric value for the first electrode configuration and a reference metric value at a reference amplitude, and the second scaling factor is between the metric value for the second electrode configuration and the reference metric value at the reference amplitude.

22. The method of claim 19, wherein the known amplitude is the adjusted amplitude.

23. The method of claim 19, wherein the known amplitude is different from the adjusted amplitude.

24. The method of claim 19, wherein the boosting factor is computed in accordance with the equation BF=(SF_B−

SF_A)/SF_A, wherein BF is the boosting factor, SF_A is the first scaling factor, and SF_B is the second scaling factor.

25. The method of claim 19, wherein the boosting factor is applied to the known amplitude in accordance with the equation A_EST=A_KNOWN×

(1+BV), where A_EST is the estimated amplitude, and A_KNOWN is the known amplitude.

26. The method of claim 1, wherein the patient is suffering from chronic pain, and the therapy comprises alleviation of the chronic pain.