Implantable electrode positioning

• US 10,588,698 B2
• Filed: 11/30/2015
• Issued: 03/17/2020
• Est. Priority Date: 12/11/2014
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Parker, John Louis, Obradovic, Milan
• Primary Examiner(s): Ulsh, George J
• Application Number:
  US15/535,014
• Publication Number:
  US 20180228547A1
• Time in Patent Office: 1,569 Days
• CPC Class Codes: A61B 2034/2053 Tracking an applied voltage gradient
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 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 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

A method of surgically positioning an electrode array at a desired implantation location relative to a nerve. A temporary probe electrode is temporarily positioned adjacent to the nerve and at a location which is caudorostrally separate to the desired implantation location of the electrode array. The implanted position of the probe electrode is temporarily fixed relative to the nerve. During implantation of the electrode array, electrical stimuli are applied from one of the temporarily fixed probe electrode and the electrode array, to evoke compound action potentials on the nerve. Compound action potentials evoked by the stimuli are sensed from at least one electrode of the other of the temporarily fixed probe electrode and the electrode array. From the sensed compound action potentials a position of the electrode array relative to the nerve is determined.

Claims

1. A method of surgically positioning an electrode array at a desired implantation location relative to a nerve, the method comprising:

implanting a temporary probe electrode adjacent to the nerve and at a location which is caudorostrally separate to the desired implantation location of the electrode array;

temporarily fixing the implanted position of the probe electrode relative to the nerve;

wherein the probe electrode is fixed by being temporarily anchored upon a vertebra, within the epidural space;

during implantation of the electrode array, applying electrical stimuli from one of the temporarily fixed probe electrode and the electrode array, to evoke compound action potentials on the nerve;

sensing, from at least one electrode of the other of the temporarily fixed probe electrode and the electrode array, the compound action potentials evoked by the stimuli; and

determining from the sensed compound action potentials a position of the electrode array relative to the nerve.

2. The method of claim 1 wherein the probe electrode is surgically introduced via the same incision as the electrode array.

3. The method of claim 1 wherein the desired positioning of the electrode array is relative mediolaterally to a physiologic midline of the nerve.

4. The method of claim 3 wherein the probe electrode is configured to simultaneously stimulate an even distribution of fibres mediolaterally across the nerve.

5. The method of claim 3 wherein identification of the physiologic midline of the nerve, and positioning of the electrode array relative to the identified midline, is achieved by providing two laterally spaced apart sense electrodes on the electrode array, and monitoring a relative strength of the compound action potential sensed by each of the sense electrodes.

6. The method of claim 1 wherein a radial spacing of the electrode array from the nerve is determined.

7. The method of claim 6 wherein the probe electrode comprises first and second stimulus electrodes each at distinct radii away from the nerve, used to deliver stimuli of equal intensity, at different times.

8. The method of any one of claim 1 wherein the probe electrode is a peripheral nerve stimulator delivering transcutaneous stimuli, to evoke compound action potentials on peripheral nerves at a location of interest.

9. The method of claim 8 wherein an array location at which sense electrodes sense a maximal collision of compound action potentials evoked by spinal cord stimulus electrodes with compound action potentials evoked by the peripheral nerve stimulator is taken to be an optimal caudorostral position of the spinal stimulus electrodes relative to the location of interest.