Neural stimulation dosing

• US 10,632,307 B2
• Filed: 07/27/2015
• Issued: 04/28/2020
• Est. Priority Date: 07/25/2014
• Status: Active Grant

• Current Assignee: Saluda Medical Pty Ltd.
• Original Assignee: Saluda Medical Pty Ltd.
• Inventors: Parker, John Louis
• Primary Examiner(s): Mahmood, Nadia A
• Application Number:
  US15/327,981
• Publication Number:
  US 20170216587A1
• Time in Patent Office: 1,737 Days
• Field of Search: 607 46
• 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 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36021 for treatment of pain
• 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 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Applying therapeutic neural stimuli involves monitoring for at least one of sensory input and movement of a user. In response to detection of sensory input or user movement, an increased stimulus dosage is delivered within a period of time corresponding to a duration of time for which the detected sensory input or user movement gives rise to masking, the increased stimulus dosage being configured to give rise to increased neural recruitment.

Claims

1. A method of applying therapeutic neural stimuli, the method comprising:

monitoring for at least one of sensory input and movement of a user using a control unit; and

in response to detection of at least one of sensory input and a user movement, delivering an increased stimulus dosage via at least one stimulus electrode within a period of time corresponding to a duration of time for which the detected sensory input or user movement gives rise to masking, the increased stimulus dosage being configured to give rise to increased neural recruitment.

2. The method of claim 1, wherein the increased stimulus dosage is effected by increasing one or more of the stimulus amplitude, the stimulus pulse width and/or the stimulus frequency.

3. The method of claim 2, wherein the increased stimulus dosage comprises a burst of high frequency stimuli.

4. The method of claim 1 wherein at times when neither sensory input nor movement is detected stimuli are delivered at a reduced dosage.

5. The method of claim 1 wherein at times when neither sensory input nor movement is detected no stimuli are delivered.

6. The method of claim 1 further comprising monitoring a cumulative stimulus dosage delivered to the user, and using the cumulative stimulus dosage as a basis to define a required stimulus regime either during or between movements in order to seek to deliver a desired total stimulus dosage.

7. The method of claim 1 wherein at least one of sensory input and movement of the user is detected by measuring neural activity upon the neural pathway.

8. The method of claim 7 wherein the measured neural activity comprises evoked neural responses resulting from electrical stimuli applied to the neural pathway.

9. The method of claim 8 wherein movement is detected when a change is detected in the neural response evoked from a given stimulus.

10. The method of claim 7 wherein the measured neural activity comprises non-evoked neural activity.

11. The method of claim 1 wherein movement of the user is detected by an accelerometer.

12. The method of claim 1 wherein the period of time within which the increased stimulus dosage is delivered is a predefined approximation of the duration of a typical human movement.

13. The method of claim 1 wherein the period of time for which the increased stimulus dosage is delivered is adaptively determined by performing the further step of detecting a cessation of sensory input or movement by the user, and in turn ceasing the delivery of the increased stimulus dosage.

14. The method of claim 1 wherein the increased stimulus dosage is delivered at select moments within the period of time.

25. A computer program product comprising computer program code means to make a computer execute a procedure, the computer program product comprising computer program code means for carrying out the method of claim 1.

15. A device for applying therapeutic neural stimuli, the device comprising:

at least one electrode configured to be positioned alongside a neural pathway of a user; and

a control unit configured to monitor for at least one of sensory input and movement of the user, and configured to deliver an increased stimulus dosage via the at least one electrode within a period of time corresponding to a duration of time for which the detected sensory input or user movement gives rise to masking, the increased stimulus dosage being configured to give rise to increased neural recruitment.

16. A method for effecting a neural blockade, the method comprising:

delivering a sequence of electrical stimuli to neural tissue using at least one stimulus electrode, each stimulus configured at a level whereby at least at a given relative position of a stimulus electrode to the neural tissue a first stimulus of the sequence generates an action potential and whereby each subsequent stimulus alters a membrane potential of the neural tissue without causing depolarisation of the neural tissue nor evoking an action potential, each subsequent stimulus being delivered prior to recovery of the membrane potential of the neural tissue from a preceding stimulus such that the sequence of stimuli maintains the membrane potential in an altered range in which conduction of action potentials is hindered or prevented.

17. The method of claim 16, wherein the blockade is effected by applying a sequence of supra-threshold stimuli, the first of which will evoke an action potential.

18. The method of claim 16 wherein the blockade is effected by applying a sequence of stimuli which are sub-threshold in a first posture, but which become supra-threshold at times when the user moves to a second posture.

19. The method of claim 16 wherein the sequence of stimuli is delivered at a frequency greater than 500 Hz.

20. The method of claim 19 wherein the sequence of stimuli is delivered at a frequency greater than 1 kHz.

21. The method of claim 20 wherein the sequence of stimuli is delivered at a frequency in the range of 5-15 kHz.

22. The method of claim 16 wherein a nominal sub-threshold stimulation level is predetermined by a clinician at a time of fitting of an implanted stimulator for the user.

23. The method of claim 16 wherein the nominal sub-threshold level is adaptively determined by repeatedly determining a recruitment threshold of the neural tissue from time to time.

26. A computer program product comprising computer program code means to make a computer execute a procedure, the computer program product comprising computer program code means for carrying out the method of claim 16.

24. A device for effecting a neural blockade, the device comprising:

at least one electrode configured to be positioned alongside a neural pathway of a user; and

a control unit configured to deliver a sequence of electrical stimuli to neural tissue, each stimulus configured at a level whereby at least at a given relative position of the electrode to the neural tissue a first stimulus of the sequence generates an action potential and whereby each subsequent stimulus alters a membrane potential of the neural tissue without causing depolarisation of the neural tissue nor evoking an action potential, each subsequent stimulus being delivered prior to recovery of the membrane potential of the neural tissue from a preceding stimulus such that the sequence of stimuli maintains the membrane potential in an altered range in which conduction of action potentials is hindered or prevented.