Neurostimulator configured to sense evoked potentials in peripheral nerves

• US 9,526,897 B2
• Filed: 01/20/2016
• Issued: 12/27/2016
• Est. Priority Date: 07/02/2013
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbach Limited
• Inventors: Chen, Joey, Bradley, Kerry, Halberg, Leslie
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US15/001,327
• Publication Number:
  US 20160144188A1
• Time in Patent Office: 342 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 patient is detected to be in a first posture state. In response to the patient being detected to be in the first posture state, a first electrical stimulation therapy is applied to a body region of the patient by a pulse generator implanted in the patient. The patient is detected to be in a second posture state. In response to the patient being detected to be in the second posture state that is different from the first posture state, a second electrical stimulation therapy is applied to the body region of the patient by the pulse generator. The second electrical stimulation therapy is different from the first electrical stimulation therapy.

Claims

1. A method, comprising:

detecting that a patient is in a first posture state;

applying, via a pulse generator implanted in the patient, a first electrical stimulation therapy to a body region of the patient in response to the detecting that the patient is in the first posture state;

detecting that the patient is in a second posture state, the second posture state being different from the first posture state; and

applying, via the pulse generator implanted in the patient, a second electrical stimulation therapy to the body region of the patient in response to the detecting that the patient is in the second posture state, the second electrical stimulation therapy being different from the first electrical stimulation therapy, wherein;

the applying of the first electrical stimulation therapy comprises;

generating a first electrical stimulation signal;

measuring a first evoked potential in response to the first electrical stimulation signal; and

adjusting the first electrical stimulation signal until the measured first evoked potential reaches a first target evoked potential; and

the applying of the second electrical stimulation therapy comprises;

generating a second electrical stimulation signal;

measuring a second evoked potential in response to the second electrical stimulation signal; and

adjusting the second electrical stimulation signal until the measured second evoked potential reaches a second target evoked potential.

2. The method of claim 1, wherein:

the first electrical stimulation signal is generated using a first starting value of an electrical stimulation parameter;

the adjusting of the first electrical stimulation signal comprises adjusting the first starting value of the electrical stimulation parameter until the measured first evoked potential reaches the first target evoked potential;

the second electrical stimulation signal is generated using a second starting value of the electrical stimulation parameter; and

the adjusting of the second electrical stimulation signal comprises adjusting the second starting value of the electrical stimulation parameter until the measured second evoked potential reaches the second target evoked potential.

3. The method of claim 2, further comprising:

performing a first calibration process to obtain the first starting value of the electrical stimulation parameter and the first target evoked potential, the first calibration process being performed while the patient is in the first posture state; and

performing a second calibration process to obtain the second starting value of the electrical stimulation parameter and the second target evoked potential, the second calibration process being performed while the patient is in the second posture state.

4. The method of claim 3, wherein:

the performing of the first calibration process comprises determining the first starting value of the electrical stimulation parameter and the first target evoked potential that cause the patient to experience paresthesia in the first posture state; and

the performing of the second calibration process comprises determining the second starting value of the electrical stimulation parameter and the second target evoked potential that cause the patient to experience paresthesia in the second posture state.

5. The method of claim 1, wherein the detecting that the patient is in the first posture state or the detecting that the patient is in the second posture state is performed at least in part via one or more sensors implemented on the pulse generator, the one or more sensors including an accelerometer, a pressure sensor, or a temperature sensor.

6. The method of claim 1, wherein the first posture state and the second posture state are selected from the group consisting of:

a posture state where the patient is lying down, a posture state where the patient is stretching, a posture state where the patient is ambulatory, a posture state where the patient is running, and a posture state where the patient is applying pressure on the body region of the patient.

7. The method of claim 1, wherein the detecting that the patient is in the first posture state or the detecting that the patient is in the second posture state comprises:

displaying, via a graphical user interface, a plurality of icons that each represent a patient posture state; and

detecting a selection of one of the icons by the patient via the graphical user interface; and

determining that the first posture state or the second posture state is the posture state represented by the selected icon.

8. A medical system, comprising:

a pulse generator configured to be implanted in a patient, the pulse generator being configured to generate electrical stimulation pulses to stimulate a body region of the patient; and

an electronic programmer configured to program the pulse generator to generate the stimulation pulses, wherein the electronic programmer is further configured to perform operations comprising;

receiving a first detection that the patient is in a first posture state;

programming the pulse generator to produce a first electrical stimulation therapy to be applied to a body region of the patient in response to the receiving of the first detection;

receiving a second detection that the patient is in a second posture state, the second posture state being different from the first posture state; and

programming the pulse generator to produce a second electrical stimulation therapy to be applied to the body region of the patient in response to the receiving of the second detection, the second electrical stimulation therapy being different from the first electrical stimulation therapy, wherein;

the programming the pulse generator to produce the first electrical stimulation therapy comprises;

programming the pulse generator to generate a first electrical stimulation signal;

measuring a first evoked potential in response to the first electrical stimulation signal; and

programming the pulse generator to adjust the first electrical stimulation signal until the measured first evoked potential reaches a first target evoked potential; and

the programming the pulse generator to produce the second electrical stimulation therapy comprises;

programming the pulse generator to generate a second electrical stimulation signal;

measuring a second evoked potential in response to the second electrical stimulation signal; and

programming the pulse generator to adjust the second electrical stimulation signal until the measured second evoked potential reaches a second target evoked potential.

9. The medical system of claim 8, wherein:

the first electrical stimulation signal is generated using a first starting value of an electrical stimulation parameter;

the programming the pulse generator to adjust the first electrical stimulation signal comprises adjusting the first starting value of the electrical stimulation parameter until the measured first evoked potential reaches the first target evoked potential;

the second electrical stimulation signal is generated using a second starting value of the electrical stimulation parameter; and

the programming the pulse generator to adjust the second electrical stimulation signal comprises adjusting the second starting value of the electrical stimulation parameter until the measured second evoked potential reaches the second target evoked potential.

10. The medical system of claim 9, wherein the operations further comprise:

performing a first calibration process to obtain the first starting value of the electrical stimulation parameter and the first target evoked potential, the first calibration process being performed while the patient is in the first posture state; and

performing a second calibration process to obtain the second starting value of the electrical stimulation parameter and the second target evoked potential, the second calibration process being performed while the patient is in the second posture state.

11. The medical system of claim 10, wherein:

the performing of the first calibration process comprises determining the first starting value of the electrical stimulation parameter and the first target evoked potential that cause the patient to experience paresthesia in the first posture state; and

the performing of the second calibration process comprises determining the second starting value of the electrical stimulation parameter and the second target evoked potential that cause the patient to experience paresthesia in the second posture state.

12. The medical system of claim 8, wherein:

the pulse generator includes one or more sensors selected from the group consisting of;

an accelerometer, a pressure sensor, and a temperature sensor; and

the pulse generator is configured to detect a current posture state of the patient at least in part via the one or more sensors, the current posture state being one of;

a posture state where the patient is lying down, a posture state where the patient is stretching, a posture state where the patient is ambulatory, a posture state where the patient is running, or a posture state where the patient is applying pressure on the body region of the patient.

13. The medical system of claim 8, wherein the receiving the first detection that the patient is in the first posture state or the receiving the second detection that the patient is in the second posture state comprises:

displaying, via a graphical user interface of the electronic programmer, a plurality of icons that each represent a patient posture state; and

detecting a selection of one of the icons by the patient via the graphical user interface; and

determining that the first posture state or the second posture state is the posture state represented by the selected icon.

14. The medical system of claim 8, wherein the graphical user interface is a touch-sensitive user interface.

15. A medical apparatus, comprising:

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

controller circuitry and stimulation circuitry telecommunicatively coupled to the one or more sensors, wherein the controller circuitry and the stimulation circuitry are configured to perform the following operations;

applying a first electrical stimulation therapy to a body region of the patient in response to a detection, by the one or more sensors, that the present posture of the patient is a first posture; and

applying a second electrical stimulation therapy to the body region of the patient in response to a detection, by the one or more sensors, that the present posture of the patient is a second posture, wherein the second electrical stimulation therapy is different from the first electrical stimulation therapy, and wherein the second patient posture is different from the first patient posture;

wherein;

the applying of the first electrical stimulation therapy comprises;

generating a first electrical stimulation signal;

measuring a first evoked potential in response to the first electrical stimulation signal; and

adjusting the first electrical stimulation signal until the measured first evoked potential reaches a first target evoked potential; and

the applying of the second electrical stimulation therapy comprises;

generating a second electrical stimulation signal;

measuring a second evoked potential in response to the second electrical stimulation signal; and

adjusting the second electrical stimulation signal until the measured second evoked potential reaches a second target evoked potential.

16. The medical apparatus of claim 15, wherein:

the first electrical stimulation signal is generated using a first starting value of an electrical stimulation parameter;

the adjusting of the first electrical stimulation signal comprises adjusting the first starting value of the electrical stimulation parameter until the measured first evoked potential reaches the first target evoked potential;

the second electrical stimulation signal is generated using a second starting value of the electrical stimulation parameter; and

the adjusting of the second electrical stimulation signal comprises adjusting the second starting value of the electrical stimulation parameter until the measured second evoked potential reaches the second target evoked potential.

17. The medical apparatus of claim 16, wherein the operations further comprise:

performing a first calibration process to obtain the first starting value of the electrical stimulation parameter and the first target evoked potential, the first calibration process being performed while the patient is in the first posture; and

performing a second calibration process to obtain the second starting value of the electrical stimulation parameter and the second target evoked potential, the second calibration process being performed while the patient is in the second posture.

18. The medical apparatus of claim 17, wherein:

the performing of the first calibration process comprises determining the first starting value of the electrical stimulation parameter and the first target evoked potential that cause the patient to experience paresthesia in the first posture; and

the performing of the second calibration process comprises determining the second starting value of the electrical stimulation parameter and the second target evoked potential that cause the patient to experience paresthesia in the second posture.

19. The medical apparatus of claim 15, wherein the one or more sensors include one or more of:

an accelerometer, a pressure sensor, or a temperature sensor.

20. The medical apparatus of claim 15, wherein the first posture and the second posture are selected from the group consisting of:

a posture where the patient is lying down, a posture where the patient is stretching, a posture where the patient is ambulatory, a posture where the patient is running, and a posture where the patient is applying pressure on the body region of the patient.