Neurostimulator configured to sense evoked potentials in peripheral nerves

• US 9,248,279 B2
• Filed: 07/02/2014
• Issued: 02/02/2016
• Est. Priority Date: 07/02/2013
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Chen, Joey, Bradley, Kerry, Halberg, Leslie
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US14/322,716
• Publication Number:
  US 20150012064A1
• Time in Patent Office: 580 Days
• US Class Current: 1/1
• 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 providing stimulation therapy to a patient includes performing first and second calibration processes in first and second patient posture states, respectively. The first and second calibration processes respectively associates a sensation experienced by a patient, in the respective patient posture states, with first and second amounts of an evoked potential, respectively, and also with first and second values of a stimulation parameter to achieve the first and second amounts of evoked potential, respectively. Thereafter, a current patient posture state is detected. If the current patient posture state is detected as the first patient posture state, stimulation therapy is applied to the patient using the first value of the stimulation parameter as an initial value. If the current patient posture state is detected as the second patient posture state, stimulation therapy is applied to the patient using the second value of the stimulation parameter as the initial value.

Claims

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

performing a first calibration process in a first patient posture state, wherein the first calibration process associates a sensation experienced by a patient, in the first patient posture state, with a first amount of an evoked potential and a first value of a stimulation parameter for the stimulation therapy to achieve the first amount of evoked potential;

performing a second calibration process in a second patient posture state, wherein the second calibration process associates the sensation experienced by a patient, in the second patient posture state, with a second amount of the evoked potential and a second value of the stimulation parameter for the stimulation therapy to achieve the second amount of evoked potential;

detecting, after the first and second calibration processes have been performed, a current patient posture state;

if the current patient posture state is detected as the first patient posture state, applying the stimulation therapy to the patient using the first value of the stimulation parameter as an initial value; and

if the current patient posture state is detected as the second patient posture state, applying the stimulation therapy to the patient using the second value of the stimulation parameter as the initial value.

2. The method of claim 1, further comprising:

monitoring the evoked potential in the current patient posture state, and wherein;

the applying of the stimulation therapy in the first patient posture state comprises adjusting the initial value of the stimulation parameter until the first amount of the evoked potential is reached; and

the applying of the stimulation therapy in the second patient posture state comprises adjusting the initial value of the stimulation parameter until the second amount of the evoked potential is reached.

3. The method of claim 1, wherein the stimulation parameter includes one of:

stimulation pulse amplitude or stimulation pulse width.

4. The method of claim 1, further comprising:

storing results of the first and second calibration processes in an electronic storage.

5. The method of claim 1, wherein the first and second calibration processes each comprise:

delivering stimulation pulses to the patient, wherein the delivering includes ramping up or down a value of the stimulation parameter;

measuring a respective amount of evoked potential in response to each stimulation pulse having a different value of the stimulation parameter;

prompting the patient to indicate a plurality of sensations experienced by the patient in response to the stimulation pulses, the plurality of sensations experienced including paresthesia; and

recording the respective amount of evoked potential corresponding to each of the plurality of sensations experienced by the patient and the value of the stimulation parameter that resulted in the respective amount of evoked potential.

6. The method of claim 5, wherein the sensations experienced by the patient comprise:

initial perception of paresthesia, comfortable paresthesia, optimal paresthesia coverage for areas of pain, and uncomfortable stimulation.

7. The method of claim 1, wherein the detecting is performed automatically via one or more sensors and without input from the patient.

8. The method of claim 1, further comprising:

performing one or more additional calibration processes in one or more additional patient posture states, wherein the one or more additional calibration processes each associate the sensation experienced by the patient, in the respective one or more additional patient posture states, with a respective amount of the evoked potential and a respective value of the stimulation parameter for the stimulation therapy to achieve the respective amount of evoked potential; and

in response to the current patient posture state being detected as one of the one or more additional patient posture states, applying the stimulation therapy to the patient using the corresponding respective value of the stimulation parameter as the initial value.

9. A medical system for stimulating a patient, the medical system comprising:

an electronic storage configured to store;

an association of a sensation experienced by the patient in a first patient posture state with a first amount of an evoked potential and a first value of a stimulation parameter for a stimulation therapy to cause the first amount of evoked potential; and

an association of a sensation experienced by the patient in a second patient posture state with a second amount of the evoked potential and a second value of the stimulation parameter for the stimulation therapy to cause the second amount of evoked potential;

one or more sensors configured to detect a present patient posture state;

a microcontroller coupled to the one or more sensors and the electronic storage; and

stimulation circuitry configured to generate, in response to instructions from the microcontroller;

a first stimulation therapy using the first value as an initial value of the stimulation parameter in response to a detection of the patient being in the first patient posture state; and

a second stimulation therapy using the second value as the initial value of the stimulation parameter in response to a detection of the patient being in the second patient posture state.

10. The medical system of claim 9, wherein at least the microcontroller and the stimulation circuitry are integrated within a neurostimulator, and further comprising:

an electronic programmer configure to provide programming instructions for the neurostimulator.

11. The medical system of claim 10, further comprising:

one or more electrode-containing leads that are coupled to the neurostimulator, the leads being configured to deliver the first or second stimulation therapies to a target nerve site.

12. The medical system of claim 10, further comprising:

monitoring circuitry coupled to the microcontroller and configured to monitor the evoked potential from a nerve site in response to the first or second stimulation therapies;

and wherein, in response to instructions from the microcontroller or from the electronic programmer;

if the patient is in the first patient posture state, the stimulation circuitry adjusts the stimulation parameter until the monitoring circuitry reports that the first amount of evoked potential is measured; and

if the patient is in the second patient posture state, the stimulation circuitry adjusts the stimulation parameter until the monitoring circuitry reports that the second amount of evoked potential is measured.

13. The medical system of claim 9, wherein the stimulation parameter includes one of:

stimulation pulse amplitude or stimulation pulse width.

14. The medical system of claim 9, wherein the electronic storage is further configured to store a plurality of associations of a plurality of additional sensations experienced by the patient in the first and second patient posture states with respective amounts of the evoked potential and respective values of the stimulation parameter to cause the respective amounts of evoked potential.

15. The medical system of claim 14, wherein the sensation and the plurality of additional sensations experienced by the patient include two or more of the following sensations:

an initial perception of paresthesia, a comfortable paresthesia, an optimal paresthesia coverage for areas of pain, and an uncomfortable stimulation sensation.

16. A medical device for providing a stimulation therapy to a patient, the medical device comprising:

an electronic storage storing respective results of a first calibration process and a second calibration process, wherein;

the result of the first calibration process associates a sensation experienced by the patient, in a first patient posture state, with a first amount of an evoked potential and a first value of a stimulation parameter for the stimulation therapy to achieve the first amount of evoked potential; and

the result of the second calibration process associates the sensation experienced by the patient, in a second patient posture state, with a second amount of the evoked potential and a second value of the stimulation parameter for the stimulation therapy to achieve the second amount of evoked potential;

one or more sensors configured to detect a current patient posture state;

a microcontroller coupled to the electronic storage and to the one or more sensors; and

stimulation circuitry configured to generate the stimulation therapy to be delivered to a nerve site of the patient in response to instructions from the microcontroller in a manner such that;

the stimulation therapy is generated using the first value as an initial value of the stimulation parameter in response to the first patient posture state being detected as the current patient posture state; and

the stimulation therapy is generated using the second value as the initial value of the stimulation parameter in response to the second patient posture state being detected as the current patient posture state.

17. The medical device of claim 16, further comprising:

monitoring circuitry coupled to the microcontroller and configured to monitor the evoked potential from the nerve site in response to the stimulation therapy;

and wherein the microcontroller is configured to send instructions to the stimulation circuitry to adjust the initial value of the stimulation parameter such that;

the initial value of the stimulation parameter is adjusted until the first amount of the evoked potential is reached if the detected patient posture state is the first patient posture state; and

the initial value of the stimulation parameter is adjusted until the second amount of the evoked potential is reached if the detected patient posture state is the second patient posture state.

18. The medical device of claim 16, wherein the stimulation parameter includes one of:

stimulation pulse amplitude or stimulation pulse width.

19. The medical device of claim 16, wherein the electronic storage is further configured to store results of a plurality of additional calibration processes that associate a plurality of additional sensations experienced by the patient in the first and second patient posture states with respective amounts of the evoked potential and respective values of the stimulation parameter to cause the respective amounts of evoked potential.

20. The medical device of claim 19, wherein the sensation and the plurality of additional sensations experienced by the patient include two or more of the following sensations:

an initial perception of paresthesia, a comfortable paresthesia, an optimal paresthesia coverage for areas of pain, and an uncomfortable stimulation sensation.