Method and system for ultrasonic neural modulation in a limb

• US 9,020,591 B2
• Filed: 12/09/2013
• Issued: 04/28/2015
• Est. Priority Date: 12/05/2007
• Status: Expired due to Fees

• Current Assignee: Soovu Labs, Inc.
• Original Assignee: The Invention Science Fund I, L.L.C. (Intellectual Ventures LLC)
• Inventors: Dacey, Ralph G. Jr., 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., Myhrvold, Nathan P., Smith, Michael A., Wood, Lowell L. Jr., Wood, Victoria Y. H., Zipfel, Gregory J.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/100,998
• Publication Number:
  US 20140163432A1
• Time in Patent Office: 505 Days
• Field of Search: None
• US Class Current: 607/2
• 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 cyclical blocking of conduction in peripheral neural structures with ultrasound are disclosed. In an aspect, neural activity is blocked cyclically with an ultrasonic blocking stimulus source positioned adjacent a skin surface in a vicinity of a nerve. In an aspect, a conduction block is produced in a sensory nerve. Neural modulation may be used, for example, to modulate an immune or inflammatory response or process.

Claims

1. A method of modulating an immune or inflammatory response or process in a subject in need thereof, comprising:

delivering an ultrasonic blocking stimulus sufficient to produce a reversible conduction block in at least a portion of a sensory nerve of a subject with an ultrasound source; and

repeating delivery of the ultrasonic blocking stimulus in a cyclical application pattern for a duration or period sufficient to modulate the immune or inflammatory response or process.

2. The method of claim 1, comprising delivering the ultrasonic blocking stimulus with an ultrasound source secured to a limb of the subject.

3. The method of claim 1, wherein the delivery of the ultrasonic blocking stimulus in a cyclical application pattern is repeated until a measurement of an indicator of immune or inflammatory response or process indicates that the modulation of the immune or inflammatory response or process has been obtained.

4. The method of claim 1, comprising:

measuring an indicator of an immune or inflammatory response or process in a region of the body of the subject innervated by the sensory nerve; and

determining whether a modulation of the immune or inflammatory response or process has been obtained based on the measurement of the indicator of the immune or inflammatory response or process.

5. The method of claim 4, wherein the delivery of the ultrasonic blocking stimulus in a cyclical application pattern is repeated until measurement of the indicator of immune or inflammatory response or process indicates that the modulation of the immune or inflammatory response or process has been obtained.

6. The method of claim 1, wherein a cycle of the cyclical application pattern includes:

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

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

7. The method of claim 6, comprising:

detecting at least one of the onset of the first activity state and the onset of the second activity state in the subject.

8. The method of claim 6, comprising receiving the signal indicative of at least one of the first activity state and the second activity state of the subject from a user input device.

9. The method of claim 6, comprising receiving the signal indicative of at least one of the first activity state and the second activity state of the subject from a sensor associated with the package adapted to sense a parameter indicative of an activity state of the subject.

10. The method of claim 1, wherein the sensory nerve innervates at least a portion of a joint of the subject.

11. The method of claim 1, wherein the sensory nerve innervates at least a portion of a limb of the subject.

12. The method of claim 1, wherein the sensory nerve innervates at least a portion of a digit of the subject.

13. The method of claim 1, wherein the immune or inflammatory response or process is associated with an arthritic condition in the subject.

14. The method of claim 1, wherein the immune or inflammatory response or process is associated with a neuropathy in the subject.

15. The method of claim 1, wherein the immune or inflammatory response or process is associated with a vascular disease in the subject.

16. A neural modulation system, comprising:

a package configured to be secured to a limb of a subject adjacent a skin surface in the vicinity of a sensory nerve;

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

an ultrasound source within the package, the ultrasound source configured to produce an ultrasonic blocking signal sufficient to reversibly block conduction in the sensory nerve; 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 blocking stimulus control signal for driving production of the ultrasonic blocking stimulus by the ultrasound source in a cyclical application pattern in response to at least one of the first activity state and the second activity state.

17. The neural modulation system of claim 16, wherein the cyclical application pattern includes:

a blocking period during which the ultrasonic blocking 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 ultrasonic blocking stimulus is applied, the release period coinciding at least in part with the second activity state in the subject.

18. The neural modulation system of claim 17, wherein the signal input structure is configured to receive the signal indicative of the activity state of the subject from the sensor.

19. The neural modulation system of claim 18, 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.

20. The neural modulation system of claim 18, wherein the sensor includes a physiological sensor 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.

21. The neural modulation system of claim 16, comprising:

a sensor associated with the package adapted to sense a parameter indicative of an activity state of the subject.

22. The neural modulation system of claim 16, wherein the signal input structure is configured to receive the signal indicative of the activity state of the subject from a user input device.

23. The neural modulation system of claim 22, 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.

24. The neural modulation system of claim 16, comprising:

at least one of a wrap adapted to be positioned around 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, a bracelet, an anklet, an armband, a cuff, a fitted garment, or an item of clothing configured to be worn by the subject.

25. The neural modulation system of claim 16, wherein the package is configured to be secured to the limb of the subject with a strap or elastic band.

26. An article of manufacture, comprising:

one or more non-transitory machine-readable data storage media bearing one or more instructions relating to;

delivering an ultrasonic blocking stimulus sufficient to produce a reversible conduction block in at least a portion of a sensory nerve of a subject with an ultrasound source secured to a limb of a subject; and

repeating delivery of the ultrasonic blocking stimulus in a cyclical application pattern for a duration or period sufficient to modulate the immune or inflammatory response or process.

27. The article of manufacture of claim 26, wherein the one or more non-transitory machine-readable data storage media bear one or more instructions relating to:

receiving a measurement indicative of an immune or inflammatory response or process in a region of the body of the subject innervated by the sensory nerve; and

determining whether a modulation of the immune or inflammatory response or process has been obtained based on the measurement indicative of the immune or inflammatory response or process.

28. The article of manufacture of claim 26, wherein the one or more non-transitory machine-readable data storage media bear one or more instructions relating to:

repeating delivery of the ultrasonic blocking stimulus in a cyclical application pattern until the measurement indicative of the immune or inflammatory response or process indicates that the modulation of the immune or inflammatory response or process has been obtained.

29. The article of manufacture of claim 26, wherein the one or more instructions relating to repeating delivery of the ultrasonic blocking stimulus in a cyclical application pattern include one or more instructions relating to repeating delivery of the ultrasonic blocking stimulus in a cyclical application pattern having:

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

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

30. The article of manufacture of claim 29, wherein the one or more non-transitory machine-readable data storage media bear one or more instructions relating to:

detecting at least one of the onset of the first activity state and the onset of the second activity state in the subject.

31. The article of manufacture of claim 29, wherein the one or more non-transitory machine-readable data storage media bear one or more instructions relating to:

receiving the signal indicative of at least one of the first activity state and the second activity state of the subject from a sensor associated with the package.