System and method for improving nerve finding for peripheral nerve stimulation

• US 9,764,128 B2
• Filed: 07/02/2014
• Issued: 09/19/2017
• 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, Leslie
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/322,172
• Publication Number:
  US 20150012067A1
• Time in Patent Office: 1,175 Days
• 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 identifying a location for applying a stimulation therapy to treat a patient includes stimulating a first body region of the patient transcutaneously via a stimulus generator. The body region contains a first portion of a nerve that has an elongate shape. In response to the stimulating, action potentials received from a second portion of the nerve are monitored over a period of time. The second portion of the nerve is in a second body region of the patient that is located remotely from the first body region. Based on the monitoring, an optimized location of the second portion of the nerve is determined for applying the stimulation therapy to treat the first body region.

Claims

1. A method of identifying a location for applying a stimulation therapy to treat a patient, the method comprising:

stimulating a first body region of the patient transcutaneously via a stimulus generator, wherein the first body region includes a foot that contains a first portion of a nerve that has an elongate shape;

monitoring, in response to the stimulating, action potentials received from a second portion of the nerve over a period of time, wherein the second portion of the nerve is in a second body region of the patient includes a thigh, and wherein the monitoring comprises engaging different fascicles of the second portion of the nerve as the first body region is being stimulated; and

determining, based on the monitoring, an optimized location of the second portion of the nerve for applying the stimulation therapy to treat the first body region.

2. The method of claim 1, wherein a different action potential is received each time a different fascicle is engaged.

3. The method of claim 1, wherein the engaging is performed at least in part via a needle or a paddle lead, each of which is configured to engage with the second portion of the nerve and receive the action potential arising therefrom.

4. The method of claim 3, further comprising:

inserting a percutaneous lead through the needle; and

placing the percutaneous lead at the optimized location of the second portion of the nerve.

5. The method of claim 4, further comprising, before the placing of the lead:

applying, through the needle, electrical stimulation to the optimized location of the second portion of the nerve; and

detecting a response from the first body region.

6. The method of claim 1, wherein the monitoring is performed via an instrument that is configured to measure electrical signals including the action potentials, and wherein the method further comprises sending a trigger signal to the instrument, the trigger signal specifying a time window within which the monitoring is performed.

7. The method of claim 1, wherein the determining comprises:

identifying a greatest action potential among the action potentials received from the second portion of the nerve; and

selecting a location of the second portion of the nerve that corresponds to the greatest action potential as the optimized location.

8. The method of claim 1, wherein the stimulating, the monitoring, and the determining are performed without receiving feedback from the patient.

9. The method of claim 1, wherein the monitoring is performed at least in part by using an indifferent electrode as a reference, the indifferent electrode being placed in a third body region remotely located from the first body region and the second body region.

10. A method of identifying a location for applying a stimulation therapy to treat a patient, the method comprising:

stimulating a first body region of the patient via an external pulse generator (EPG), the body region including a foot that contains a first portion of a nerve that has an elongate shape;

sending a trigger signal to a measurement instrument, the trigger signal defining a time window for making a measurement; and

measuring a plurality of different action potentials via the measurement instrument, the measuring being performed in response to a plurality of engagements with different fascicles of a second portion of the nerve while the first body region is stimulated, wherein the second portion of the nerve is in a second body region of the patient that is located in an upper leg, wherein the measuring is performed within the time window defined by the trigger signal, and wherein the stimulating, the sending, and the measuring are performed while the patient is sedated.

11. The method of claim 10, further comprising:

selecting, based on the measured action potentials, one of the fascicles that offered a greatest action potential as a target location of the second portion of the nerve for applying the stimulation therapy to treat the first body region.

12. The method of claim 11, further comprising:

receiving the different action potentials with one of;

a seeking needle or a paddle lead.

13. The method of claim 12, further comprising:

inserting a percutaneous lead through the needle; and

placing the percutaneous lead on the target location of the second portion of the nerve.

14. The method of claim 10, wherein the measuring is performed at least in part by using a reference electrode that is placed in a third body region remotely located from the first body region and the second body region.

15. A medical system, comprising:

a stimulus generator configured to apply stimulation to a foot of a patient, the foot containing a first portion of an elongate nerve;

a tool configured to engage with a second portion of the nerve that is in a thigh of the patient, wherein the tool is configured to receive action potentials from the second portion of the nerve in response to the stimulation at the foot of the patient, and wherein the tool includes one of;

a seeking needle or a paddle lead; and

a measurement instrument electrically coupled to the tool and configured to measure and analyze the action potentials received by the tool.

16. The medical system of claim 15, further comprising a telecommunications link between the stimulus generator and the measurement instrument, wherein the stimulus generator is configured to send, via the telecommunications link, a trigger signal to the measurement instrument, and wherein the measurement instrument is configured to measure the action potentials within a time window specified by the trigger signal.

17. The medical system of claim 15, wherein the measurement instrument contains a processor configured to:

analyze the action potentials received by the tool in response to a plurality of engagements with different fascicles of the second portion of the nerve while the stimulation is applied to the foot, the engagements with the different fascicles being made via the seeking needle or the paddle lead; and

determine, based on the analysis, an optimized location of the second portion of the nerve for applying a stimulation therapy to treat the patient.

18. The medical system of claim 15, further comprising a percutaneous lead that is configured to be inserted through the lead and placed on the second portion of the nerve.

19. The medical system of claim 18, further comprising:

an implantable pulse generator (IPG) configured to apply a stimulation therapy to the second portion of the nerve through one of;

the percutaneous lead or the paddle lead.

20. The medical system of claim 15, further comprising:

ultrasound equipment configured to display visual information regarding an engagement of the tool with the second portion of the nerve.