System and method for determining the neurological position of epidural leads

• US 9,849,287 B2
• Filed: 02/08/2016
• Issued: 12/26/2017
• Est. Priority Date: 02/09/2015
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Hershey, Bradley Lawrence, Moffitt, Michael A.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US15/017,906
• Publication Number:
  US 20160228706A1
• Time in Patent Office: 687 Days
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

An system may include an electrode arrangement configured for implantation in an epidural space, a neural modulation generator configured to use electrodes in the electrode arrangement to generate modulation fields, at least one storage and a controller operably connected to the neural modulation generator. The storage(s) may be configured to store supra-perception threshold dorsal root modulation field parameter data and therapeutic modulation field parameter data, where the therapeutic modulation field parameter data may be different than the supra-perception threshold dorsal root modulation field parameter data. The system may be configured to deliver a placement modulation field from the electrode arrangement in the epidural space to the dorsal roots using the supra-perception threshold dorsal root modulation field parameter data, and deliver a therapeutic modulation field from the electrode arrangement placed in the desired position within the epidural space to a therapeutic neural target using the therapeutic modulation field parameter data.

Claims

1. A method for placing an electrode arrangement for use to deliver a therapeutic modulation field to a therapeutic modulation target, comprising:

inserting an electrode arrangement into an epidural space and moving the electrode arrangement within the epidural space; and

monitoring a position of the electrode arrangement with respect to a supra-perception dorsal root target to position the electrode arrangement in a desired position within the epidural space to deliver the therapeutic modulation field to the therapeutic modulation target, the supra-perception dorsal root target being different from the therapeutic modulation target, wherein the monitoring includes;

delivering supra-perception threshold stimulation from the electrode arrangement in the epidural space to dorsal roots;

receiving patient-perception information for the supra-perception threshold stimulation delivered to the dorsal roots, the patient-perception information indicating that the electrode arrangement is in the desired position when the supra-perception threshold stimulation stimulates the supra-perception dorsal root target; and

placing the electrode arrangement in the desired position within the epidural space using the patient-perception information.

2. The method of claim 1, further comprising performing a fitting procedure for the electrode arrangement, after placing the electrode arrangement in the desired position, to identify therapeutic modulation parameters for delivering the therapeutic modulation field from the electrode arrangement in the desired position to the therapeutic neural target.

3. The method of claim 2, further comprising delivering therapeutic neural stimulation to the therapeutic neural target using the therapeutic modulation parameters.

4. A method, comprising:

performing a placement procedure, including;

delivering supra-perception threshold modulation from an electrode arrangement in the epidural space to dorsal roots;

receiving patient-perception information for the supra-perception threshold modulation delivered to the dorsal roots; and

using the patient-perception information to either place the electrode arrangement in a desired position within the epidural space where the supra-perception threshold modulation stimulates a supra-perception dorsal root target or place a supra-perception modulation field to modulate the supra-perception dorsal root target; and

delivering therapeutic neural modulation to a therapeutic modulation target using the electrode arrangement in the desired position within the epidural space or using therapeutic modulation parameters derived from parameters used to place the supra-perception modulation field, the supra-perception dorsal root target being different from the therapeutic modulation target.

5. The method of claim 4, wherein the patient-perception information for the supra-perception threshold modulation includes dorsal root paresthesia.

6. The method of claim 4, wherein receiving patient-perception information includes using a body image on a user interface to receive the patient-perception information.

7. The method of claim 4, wherein the patient-perception information for the supra-perception threshold modulation includes a highest level that patient-perceived tingling is felt.

8. The method of claim 4, wherein the therapeutic neural modulation has a larger pulse width than the supra-perception threshold modulation.

9. The method of claim 4, wherein the therapeutic neural modulation includes bipolar modulation and the supra-perception threshold stimulation includes monopolar modulation.

10. The method of claim 4, wherein the supra-perception threshold modulation includes anodic monopolar modulation.

11. The method of claim 4, wherein the supra-perception threshold modulation includes cathodic monopolar modulation.

12. The method of claim 4, further comprising performing a fitting procedure, after placing the electrode arrangement in the desired position, for the placed electrode arrangement to identify therapeutic modulation parameters for delivering a therapeutic modulation field to the therapeutic neural target using the electrode arrangement.

13. The method of claim 4, further comprising:

collecting and aggregating patient data for a plurality of patients, the patient data including dorsal root location of the electrode arrangement and corresponding paresthesia generated for the dorsal root location of the electrode arrangement, and

co-registering patients to identify a likelihood of paresthesia for a supra-perception therapy or a likelihood of analgesia for a sub-perception therapy at selected dorsal roots.

14. The method of claim 4, further comprising creating an atlas based on neuroanatomy.

15. A system, comprising:

an electrode arrangement configured for implantation in an epidural space;

a neural modulation generator configured to use electrodes in the electrode arrangement to generate modulation fields;

at least one storage configured to store supra-perception threshold dorsal root modulation field parameter data and therapeutic modulation field parameter data, the therapeutic modulation field parameter data being different than the supra-perception threshold dorsal root modulation field parameter data; and

a controller operably connected to the neural modulation generator,

the system being configured to;

deliver a placement modulation field from the electrode arrangement in the epidural space to the dorsal roots using the supra-perception threshold dorsal root modulation field parameter data, and receive patient-perception information, the patient-perception information indicating that the electrode arrangement is in a desired position when the supra-perception threshold stimulation stimulates a supra-perception dorsal root target; and

deliver a therapeutic modulation field from the electrode arrangement placed in the desired position within the epidural space to a therapeutic neural target using the therapeutic modulation field parameter data, the supra-perception dorsal root target being different from the therapeutic modulation target.

16. The system of claim 15, wherein the system includes an implantable device and an external device configured to communicate with the implantable device, the external device configured to program the implantable device with the supra-perception threshold dorsal root modulation field parameter data and the therapeutic modulation field parameter data, the external device including a user interface to receive patient-perception information, the user interface including a graphical user interface with a body image configured to allow a patient to enter the patient-perception information by selecting one or more regions of the body image.

17. The system of claim 15, further comprising a remote service with a database accessible through Internet communication, wherein the service is configured to:

receive patient data from a plurality of patients, the patient data including dorsal root location of the electrode arrangement and corresponding paresthesia generated for the dorsal root location of the electrode arrangement;

perform data analytics on the patient data from the plurality of patients;

co-register patients to identify a likelihood of paresthesia for a supra-perception therapy or a likelihood of analgesia for a sub-perception therapy at a dorsal root location; and

create an atlas based on neuroanatomy.

18. The system of claim 15, wherein the therapeutic modulation field has a larger pulse width than the supra-perception threshold modulation field, and the supra-perception threshold modulation field includes monopolar modulation.

19. The system of claim 15, wherein the controller is configured to perform a fitting procedure for the placed electrode arrangement to identify therapeutic modulation parameters for delivering a therapeutic modulation field from the placed electrode arrangement to a therapeutic neural target.

20. The system of claim 15, wherein the therapeutic modulation parameters for delivering the therapeutic modulation field from the placed electrode arrangement in the desired position within the epidural space to the therapeutic neural target includes:

therapeutic modulation parameters for delivering sub-perception modulation to a neural target selected from the group consisting of;

a dorsal column;

a dorsal horn; and

a dorsal root;

or

therapeutic modulation parameters for delivering a modulation field to a dorsal horn;

or

therapeutic modulation parameters for delivering a modulation field to a dorsal column.