Method and system for modulating neural activity

• US 9,789,315 B2
• Filed: 06/06/2016
• Issued: 10/17/2017
• Est. Priority Date: 12/05/2007
• Status: Expired due to Fees

• Current Assignee: Soovu Labs, Inc.
• Original Assignee: Gearbox LLC (Intellectual Ventures LLC)
• Inventors: Dacey, Jr., Ralph G., Myhrvold, Nathan P., Smith, Michael A., Wood, Jr., Lowell L., Wood, Victoria Y. H., Zipfel, Gregory J., Della Rocca, Gregory J., Derdeyn, Colin P., Dowling, Joshua L., Goodall, Eleanor V., Hyde, Roderick A., Ishikawa, Muriel Y., Kare, Jordin T., Leuthardt, Eric C.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/173,957
• Publication Number:
  US 20160354606A1
• Time in Patent Office: 498 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/369 Electroencephalography [EEG] devices for psychotechnics A61B5/16
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: A61B 5/4821 Determining level or depth of anaesthesia A61B5/1106 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 7/00 Heating or cooling appliances for medical or therapeutic treatment of the human body heating or cooling means in connection with bedsteads or mattresses A47C21/00 ; massage, therapeutic baths A61H; hyperthermia using electric or magnetic fields or ultrasound A61N; electric heating elements H05B
• CPC Class Codes: A61F 7/0085 Devices for generating hot or cold treatment fluids
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2205/0244 : Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 35/10 : Wearable devices, e.g. garments, glasses or masks
• CPC Class Codes: A61M 37/00 : Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 : by using microneedles
• CPC Class Codes: A61M 37/0092 : using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/0412 : Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: A61N 1/0428 : Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/30 : Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 : Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/306 : Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 : for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/327 : for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 1/36103 : Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/36135 : using physiological parameters
• 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 2/002 : in combination with another treatment
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2007/0026 : Stimulation of nerve tissue
• CPC Class Codes: A61N 7/00 : Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

Methods and related systems for modulating neural activity by cyclically modulating neural activity in peripheral neural structures are disclosed. Neural activity may be modulated cyclically by stimuli delivered via various types of stimulus sources. In an aspect, activity of a sensory nerve is modulated. Neural modulation may be used, for example, to modulate an undesired sensation, such as pain, or an immune or inflammatory response or process. Delivery of stimuli for modulating neural activity may be controlled in part in response to an input from a user input device.

Claims

1. A neural modulation system comprising:

a first signal input structure adapted to receive a user input signal indicative of an instruction from a user regarding operation of a neural modulation system to deliver a stimulus configured to reversibly modulate neural activity in at least a portion of a peripheral neural structure of a subject, the user input signal transmitted from a user input device adapted to receive a user input indicative of the instruction from the user;

a second signal input structure adapted to receive an activity signal indicative of an activity state of at least a portion of a body of the subject innervated by the peripheral neural structure from a sensor operatively connected to the second signal input structure; and

a signal processing portion including

circuitry for modifying operation of the neural modulation system responsive to receipt of the user input signal;

circuitry for distinguishing a first activity state of the at least a portion of the body of the subject innervated by the peripheral neural structure from a second activity state of the at least a portion of the body of the subject innervated by the peripheral neural structure from the activity signal received at the second signal input structure; and

circuitry for generating a stimulus control signal for driving production of the stimulus by a stimulus source, the stimulus configured to modulate neural activity in at least a portion of a peripheral neural structure of the subject during at least a portion of the first activity state.

2. The neural modulation system of claim 1, wherein the circuitry for generating a stimulus control signal includes circuitry for generating a blocking stimulus control signal for driving production of a blocking stimulus by the stimulus source.

3. The neural modulation system of claim 1, wherein the circuitry for generating a stimulus control signal includes circuitry for generating a stimulus control signal for driving production of the stimulus by a stimulus source implanted in the body of the subject.

4. The neural modulation system of claim 1, wherein the circuitry for generating the stimulus control signal includes circuitry for generating the stimulus control signal for driving production of the stimulus by a stimulus source positioned on or substantially adjacent the body of the subject.

5. The neural modulation system of claim 1, wherein the circuitry for generating a stimulus control signal includes circuitry for generating the stimulus control signal for driving production of an electrical stimulus, a magnetic stimulus, an ultrasonic stimulus, an optical stimulus, a thermal stimulus, or a chemical stimulus.

6. The neural modulation system of claim 1, wherein the first signal input structure is configured to receive the user input signal from a cell phone.

7. The neural modulation system of claim 1, wherein the first signal input structure is configured to receiving the user input signal from a remote controller.

8. The neural modulation system of claim 1, wherein the first signal input structure is configured to receive the user input signal from a computer.

9. The neural modulation system of claim 1, wherein the circuitry for generating the stimulus control signal is configured to generate the stimulus control signal based at least in part upon the user input signal indicative of the instruction from the user.

10. The neural modulation system of claim 1, wherein the circuitry for generating the stimulus control signal is configured to generate the stimulus control signal based at least in part upon the activity signal.

11. The neural modulation system of claim 1, wherein the second signal input structure is adapted to receive the activity signal via a wireless connection.

12. The neural modulation system of claim 1, wherein the second signal input structure is adapted to receive the activity signal via a wired connection.

13. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive the user input signal via a wireless connection.

14. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive the user input signal via a wired connection.

15. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive the user input signal from a cell phone.

16. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive the user input signal from a remote controller.

17. The neural modulation system of claim 1 wherein the first signal input structure is adapted to receive the user input signal from a computer.

18. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive an instruction from the user to override delivery of the stimulus, and wherein the circuitry for modifying operation of the neural modulation system responsive to receipt of the user input signal is configured to discontinue generation of the stimulus control signal for driving production of the stimulus by the stimulus source.

19. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive an instruction from the user to modify a pattern of delivery of the stimulus, and wherein the circuitry for modifying operation of the neural modulation system responsive to receipt of the user input signal includes circuitry for modifying generation of the stimulus control signal.

20. The neural modulation system of claim 1, wherein the first signal input structure is adapted to receive an instruction from the user to modify a definition of at least one of the first activity state and the second activity state, and wherein the circuitry for modifying operation of the neural modulation system is adapted to modify the definition of the at least one of the first activity state and the second activity state based upon the instruction from the user.

21. A method of modulating an undesired sensation in a subject, comprising:

receiving a signal indicative of a first activity state or a second activity state of at least a portion of the body of a subject;

delivering a stimulus sufficient to produce a reversible modulation of neural activity in at least a portion of a peripheral neural structure of the subject, the stimulus sufficient to modulate an undesired sensation resulting from neural activity in the peripheral neural structure, the stimulus delivered in response to receipt of the signal indicative of the first activity state or the second activity state of a subject, wherein the stimulus is delivered by a stimulus source positioned substantially adjacent a skin surface in the vicinity of the peripheral neural structure; and

repeating delivery of the stimulus in a cyclical application pattern, the cyclical application pattern including

a modulation period during which the stimulus is applied at least intermittently, the modulation period coinciding at least in part with the first activity state in the subject; and

a release period during which no stimulus is applied, the release period coinciding at least in part with the second activity state in the subject.

22. The method of claim 21, wherein the undesired sensation includes pain.

23. The method of claim 21, wherein the reversible modulation of neural activity includes reversible blocking of neural activity.

24. The method of claim 23, wherein the reversible blocking of neural activity includes one or more of blocking conduction of action potentials along a nerve fiber or blocking conduction or transmission of neural activity across a synapse.

25. The method of claim 21, wherein delivering the stimulus with the stimulus source includes delivering the stimulus with a stimulus source in a package secured to a portion of the body of the subject.

26. The method of claim 25, including delivering the stimulus in the cyclical application pattern under control of a signal processing portion located in the package.

27. The method of claim 25, wherein delivering the stimulus with the stimulus source includes delivering the stimulus with a stimulus source in a package secured to a limb of the subject.

28. The method of claim 21, wherein repeating delivery of the stimulus in the cyclical application pattern includes repeating delivery of the stimulus in the cyclical application pattern for a duration or period sufficient to modulate the undesired sensation.

29. The method of claim 21, further including

receiving an indicator of the undesired sensation in a region of the body of the subject innervated by the peripheral neural structure;

and

determining whether a modulation of undesired sensation has been obtained based on the indicator of the undesired sensation.

30. The method of claim 29, wherein the delivery of the stimulus in the cyclical application pattern is repeated until the indicator of the undesired sensation indicates that modulation of the undesired sensation has occurred.

31. The method of claim 21, including receiving the signal indicative of the first activity state or the second activity state of the subject from a user input device.

32. The method of claim 21, including receiving the signal indicative of the first activity state or the second activity state of the subject from a sensor adapted to sense a parameter indicative of an activity state of the subject.

33. A neural modulation system, comprising:

a package configured to be secured to a portion of a body of a subject adjacent a skin surface in the vicinity of a peripheral neural structure;

a signal input structure configured to receive a signal indicative of an activity state of the subject;

a stimulus source, the stimulus source adapted to produce a stimulus sufficient to reversibly modulate neural activity in at least a portion of the peripheral neural structure; and

a signal processing portion within the package, the signal processing portion including circuitry configured to;

distinguish a first activity state of the subject from a second activity state of the subject based on the signal received at the signal input structure; and

generate a stimulus control signal for driving production of the stimulus by the stimulus source in a cyclical application pattern in response to at least one of the first activity state and the second activity state.

34. The neural modulation system of claim 33, including at least one of a wrap adapted to be positioned around the at least a portion of the body of the subject, a bandage or patch configured to be adhered or secured to at least a portion of skin of the subject, or a bracelet, an anklet, an armband, a cuff, a fitted garment, or an item of clothing configured to be worn by the subject.

35. The neural modulation system of claim 33, wherein the package is configured to be secured to at least a portion of the body of the subject with a strap or elastic band.

36. The neural modulation system of claim 33, wherein the cyclical application pattern includes

a modulation period during which the stimulus is applied at least intermittently, the blocking period coinciding at least in part with the first activity state in the subject;

and

a release period during which no stimulus is applied, the release period coinciding at least in part with the second activity state in the subject.

37. The neural modulation system of claim 33, wherein the signal input structure is configured to receive the signal indicative of the activity state of the subject from a sensor adapted to sense a parameter indicative of an activity state of the subject.

38. The neural modulation system of claim 37, wherein the sensor is associated with the package.

39. The neural modulation system of claim 38, wherein the sensor includes at least one of a pressure sensor, a force sensor, a chemical sensor, a temperature sensor, an electrical sensor, a magnetic sensor, an optical sensor, a motion sensor, an accelerometer, a gyro, a mercury switch, a piezoelectric device and a switch.

40. The neural modulation system of claim 38, wherein the sensor includes a physiological sensor.

41. The neural modulation system of claim 40, wherein the sensor is configured to generate a signal indicative of activity of at least one of a heart, a peripheral neural system, a muscle, or a body temperature of the subject.

42. The neural modulation system of claim 33, wherein the signal input structure is configured to receive the signal indicative of the activity state of the subject from a user input device.

43. The neural modulation system of claim 42, wherein the user input device includes at least one of a voice or sound activated input, a switch, a knob, a keyboard, a mouse, a touch screen, a remote controller, a cell phone, or a remote computer operated by the user.