Method and apparatus for measurement of neural response

• US 10,568,559 B2
• Filed: 05/11/2012
• Issued: 02/25/2020
• Est. Priority Date: 05/13/2011
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Parker, John Louis, Karantonis, Dean Michael
• Primary Examiner(s): Fernandes, Patrick
• Application Number:
  US14/117,140
• Publication Number:
  US 20140296737A1
• Time in Patent Office: 2,846 Days
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/40 Detecting, measuring or recording for evaluating the nervous system A61B5/4806, A61B5/4821, A61B5/4824 take precedence
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

A method for determining a desired location at which to apply a neural therapy. An array of electrodes is positioned proximal to neural tissue. A stimulus is applied from the array which evokes a neural compound action potential response in the neural tissue proximal to the array. A plurality of electrodes of the array simultaneously obtain respective measurements of the neural compound action potential response. From the measurements of the neural compound action potential response a desired location for a neural therapy is determined.

Claims

1. A method for determining a desired location at which to apply a neural therapy, the method comprising:

implanting an array of electrodes mounted on a common paddle proximal to neural tissue, where a first plurality of electrodes in the array are configured to provide an electrical stimulus, and a second plurality of electrodes in the array are configured to internally measure neural compound action potential responses;

applying a stimulus from the array which evokes a neural compound action potential response in the neural tissue proximal to the array using the first plurality of electrodes;

obtaining a plurality of simultaneous respective internal measurements of the neural compound action potential response evoked by applying the stimulus using the second plurality of electrodes, the plurality of simultaneous respective internal measurements being obtained from respective distinct measurement amplifiers each connected to respective distinct electrodes of the second plurality of electrodes; and

determining from the plurality of internal measurements of the neural compound action potential response a neural sensitivity map of the area alongside the array and determining therefrom a desired location at which to apply a neural therapy.

2. The method of claim 1, wherein the array comprises a large number of electrodes configured to obtain a plurality of simultaneous internal measurements of a neural response, in order to yield fine spatial resolution of the neural sensitivity map of the area alongside the array.

3. The method of claim 2, wherein the array comprises 24 electrodes arranged in 3 columns and 8 rows.

4. The method of claim 1, further comprising providing intra-operative information regarding the neural response.

5. The method of claim 4, further comprising generating a neural sensitivity map around the DREZ in order to guide DREZ lesioning, wherein the neural sensitivity map is generated intra-operatively.

6. The method of claim 5, further comprising performing DREZ lesioning in progressive increments, iteratively with neural sensitivity mapping, whereby the ongoing neural sensitivity mapping provides a progressive intra-operative gauge of the effects of lesioning.

7. The method of claim 5, wherein the DREZ lesioning is performed by RF ablation, applied from the same electrode array as is used for the sensitivity mapping.

8. The method of claim 1, further comprising generating a sensitivity map based upon the plurality of internal measurements, and optimizing the position of an electrode or electrode array being implanted using the sensitivity map, wherein the sensitivity map is generated intra-operatively.

9. The method of claim 8, further comprising positioning the electrode array laterally relative to the spinal cord.

10. The method of claim 8, further comprising positioning the electrode array caudorostrally relative to the spinal cord.

11. The method of claim 1, further comprising providing intra-operative information representing the plurality of internal measurements of the neural compound action potential response to a surgeon using an amplitude meter.

12. The method of claim 1, further comprising giving ongoing post-operative guidance as to the suitability of the site of the neural therapy.

13. The method of claim 12, further comprising determining when manual or automated re-fitting of a therapeutic device is required, to cause a site of the neural therapy to be revised in response to the ongoing measurements.

14. The method of claim 1, wherein a selection of which electrode(s) to use to apply a therapeutic stimulus is post-operatively altered in response to a map of neural sensitivity as measured at each electrode.

15. The method of claim 1, wherein the stimulus is applied under the control of a remote control of the implanted array.

16. The method of claim 1, wherein the first plurality of electrodes and the second plurality of electrodes share at least one electrode.

17. A system for determining a desired location at which to apply a neural therapy, the system comprising:

an array of electrodes mounted on a common paddle implanted into a patient configured to be positioned proximal to neural tissue, the array comprising;

a first plurality of electrodes configured to provide an electrical stimulus, and

a second plurality of electrodes configured to measure neural compound action potential responses;

a plurality of measurement amplifiers each connected to a respective electrode of the second plurality of electrodes;

a control unit configured to cause application of a stimulus from the array which evokes a neural compound action potential response in the neural tissue proximal to the array using the first plurality of electrodes, the control unit further configured to simultaneously obtain a plurality of respective internal measurements of the neural compound action potential response from a plurality of electrodes of the array using the second plurality of electrodes, the plurality of simultaneous respective internal measurements being obtained from the respective distinct measurement amplifiers each connected to respective distinct electrodes of the second plurality of electrodes, and the control unit further configured to determine from the plurality of internal measurements of the neural compound action potential response a neural sensitivity map of the area alongside the array and to determine therefrom a desired location at which to apply a neural therapy.

18. The system of claim 17, wherein the first plurality of electrodes and the second plurality of electrodes share at least one electrode.