SYSTEMS AND METHODS FOR NON-INVASIVE TREATMENT OF HEAD PAIN

• US 20170165485A1
• Filed: 12/06/2016
• Published: 06/15/2017
• Est. Priority Date: 12/15/2015
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation), Regents of The University of Minnesota (University of Minnesota)
• Original Assignee: Bryan Allen Clark
• Inventors: Arcand, Benjamin Y., Sullivan, Michael J., Clark, Bryan Allen, Huss, John, Shetake, Jai, Beverlin, II, Bryce Calvin
• Application Number:
  US15/371,177
• Publication Number:
  US 20170165485A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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: A61H 2201/0192 Specific means for adjusting dimensions
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/50 Control means thereof
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5046 Touch screens
• CPC Class Codes: A61H 2201/5048 Audio interfaces, e.g. voice or music controlled
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 2205/021 Scalp
• CPC Class Codes: A61H 2205/023 Nose
• CPC Class Codes: A61H 2205/024 Eyes
• CPC Class Codes: A61H 2230/06 Heartbeat rate
• CPC Class Codes: A61H 2230/10 Electroencephalographic signals
• CPC Class Codes: A61H 2230/20 Blood composition characteristics
• CPC Class Codes: A61H 2230/25 Blood flowrate, e.g. by Doppler effect
• CPC Class Codes: A61H 2230/50 Temperature
• CPC Class Codes: A61H 2230/60 : Muscle strain, i.e. measured on the user, e.g. Electromyography [EMG]
• CPC Class Codes: A61H 23/00 : Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61H 23/0245 : with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 1/20 : continuous direct currents
• CPC Class Codes: A61N 1/28 : Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36025 : for treating a mental or cerebral condition
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/008 : for pain treatment or analgesia
• CPC Class Codes: A61N 2/02 : using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence
• CPC Class Codes: A61N 2005/0647 : the applicator adapted to be worn on the head
• 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

Systems and methods for non-invasive management of head pain are disclosed. The system includes a headgear configured to be worn on a patient'"'"'s head. The headgear can include a base and an extension coupled to the base, and a number of therapy devices removably or adjustably attached to the base or the extension. The therapy devices can deliver various modes of therapeutic energy at respective target sites on the head, including neuromodulation of peripheral pain pathways and/or the cerebral cortex, and therapy modalities to facilitate or enhance the neuromodulation effects. The system can include a portable device that enables the user to control the therapy devices on the headgear. The user can use the portable device to optionally access a web-based repository to acquire information about headgear usage from other users, and use that information to guide the programming of the therapy devices.

Claims

1. A system for non-invasive management of head pain, comprising:

a headgear configured to be worn on a patient'"'"'s head, the headgear including;

a base;

an extension coupled to the base via one or more connectors;

at least first and second therapy devices removably or adjustably attached to one or more of the base or the extension, the first therapy device configured to deliver a first mode of therapeutic energy to a first target site on the head, the second therapy device configured to deliver a second mode of therapeutic energy to a second target site on the head; and

a first controller attached to the base, the first controller configured to control the at least first and second therapy devices for delivering the respective first and second modes of therapeutic energy to the respective first and second target sites.

2. The system of claim 1, wherein the extension includes one or more frame elements detachably or adjustably connected to the base via the one or more connectors, and wherein one or more of the at least first and second therapy devices are removably or adjustably attached to the one or more frame elements.

3. The system of claim 2, wherein:

the first therapy device is removably or adjustably attached to the base curved to conform to at least a portion of a transverse circumference of the head;

the second therapy device is removably or adjustably attached to one of the one or more frame elements of the extension, the one frame element curved to conform to at least a portion of a coronal circumference or a portion of a sagittal circumference of the head.

4. The system of claim 2, wherein the extension includes a cover securely interconnecting the base and the one or more frame elements of the extension.

5. The system of claim 2, wherein:

the base includes;

an eyepiece positioned close to one or both eyes of the patient;

at least two side elements connected to opposite sides of the eyepiece; and

a rear element connected to the two sidebars, and

the one or more frame elements include at least a cross element removably or adjustably attached to the two sidebars of the first frame element.

6. The system of claim 1, wherein the first and second therapy devices are respectively selected from the group consisting of:

a first neuromodulator configured to deliver transcutaneous electrical nerve stimulation (TENS);

a second neuromodulator configured to deliver transcranial direct current stimulation (tDCS);

a third neuromodulator configured to deliver transcranial magnetic stimulation (TMS);

a thermal energy transducer configured to generate thermal energy;

an ultrasound transducer configured to generate ultrasonic energy;

a vibrotactile transducer configured to generate vibration or tactile massage;

a radio-frequency (RF) transducer configured to generate high-frequency RF energy,

a laser device configured to generate laser light energy;

a visual stimulator configured to generate or prevent visual stimulation; and

an aural stimulator configured to generate aural stimulation.

7. The system of claim 6, wherein:

the first therapy device includes the first neuromodulator configured to deliver TENS to a first target site innervated by a trigeminal nerve or an occipital nerve; and

the second therapy device includes the second neuromodulator configured to deliver tDCS to a second target site corresponding to a motor cortex target of the head.

8. The system of claim 6, wherein the TENS includes a pulse train with one or more time-variant stimulation parameters.

9. The system of claim 1, further comprising a portable device, the portable device including:

a communicator configured to communicate with the at least first and second therapy devices on the headgear via a transmitter-receiver circuit of the headgear;

a user interface including a display and an input device configured to receive user input;

a second controller coupled to the user interface and the communicator, the second controller including a programmer circuit configured to generate one or more therapy parameters associated with the delivery of the first and second modes of therapeutic energy; and

a memory configured to store personal therapy information of the patient including the one or more therapy parameters.

10. The system of claim 9, wherein the portable device includes a personal mobile communication device communicatively coupled to the headgear through a wired or wireless connection.

11. The system of claim 9, further comprising:

one or more physiological sensors coupled to the portable device, and configured to sense respective one or more physiological signals;

the portable device includes a signal processor configured to detect from the one or more physiological signals a physiological event; and

the programmer circuit of the portable device is configured to initiate, or adjust the parameters associated with, the delivery of the respective first and second modes of therapeutic energy in response to the detected physiological event.

12. The system of claim 9, wherein the portal device is communicatively connected to a web-based data repository configured to store public therapy information obtained from two or more users, the portable device configured to enable the patient to:

access content in the web-based data repository;

upload personal therapy information of the patient onto the data repository;

or

download from the data repository the public therapy information into the portable device for storing in the memory or programming the at least first and second therapy devices.

13. A method for non-invasively managing head pain in a patient using a headgear wearable on a patient'"'"'s head, the method comprising:

placing the headgear on the patient'"'"'s head;

positioning at least a first therapy device removably or adjustably attached the headgear to a first target site on the head;

positioning at least a second therapy device removably or adjustably attached the headgear to a second site on the head;

delivering a first mode of therapeutic energy at the first target site using the at least first therapy device; and

delivering a second mode of therapeutic energy at the second target site using the at least second therapy device.

14. The method of claim 13, further comprising:

providing a portable device configured to communicate with the at least first and second therapy devices on the headgear;

establishing a communication between the at least first and second therapy device and the portable device; and

programming the at least first and second therapy device using the portable device,

wherein delivering the first and second modes of therapeutic energy includes delivering the first and second modes of therapeutic energy using the respective first and second therapy devices according to the programming.

15. The method of claim 14, wherein the communication between the at least first and second therapy device and the portable device includes a wired or wireless connection.

16. The method of claim 13, wherein the at least first and second modes of therapeutic energy are respectively selected from the group consisting of:

a transcutaneous electrical nerve stimulation (TENS);

a transcranial direct current stimulation (tDCS);

a transcranial magnetic stimulation (TMS);

a thermal energy mode;

an ultrasonic energy mode;

a vibration or tactile massage mode;

a high-frequency RF energy mode;

a laser light energy mode;

a visual stimulation; and

an aural stimulation.

17. The method of claim 16, wherein:

delivering the first mode of therapeutic energy includes delivering the TENS to a first target site innervated by a trigeminal nerve or an occipital nerve; and

delivering the second mode of therapeutic energy includes delivering the tDCS to a second target site corresponding to a motor cortex target of the head.

18. The method of claim 17, wherein the TENS includes a pulse train with one or more time-variant stimulation parameters.

19. The method of claim 13, further comprising detecting a physiological event,

wherein delivering the first and second modes of therapeutic energy includes initiating, or adjusting one or more parameters associated with, the delivery of the respective first and second modes of therapeutic energy in response to the detection of the physiological event.

20. The method of claim 13, further comprising one or more of:

establishing a communication between the portable device and a web-based data repository that stores public therapy information obtained from two or more users;

using the portable device to access content in the web-based data repository;

uploading personal therapy information of the patient onto the data repository;

or

downloading from the data repository the public therapy information into the portable device for storing in the portable device or programming the at least first and second therapy devices.