Auricular stimulation for inflammatory parasympathetic diseases

• US 9,415,220 B1
• Filed: 07/31/2013
• Issued: 08/16/2016
• Est. Priority Date: 07/31/2012
• Status: Expired due to Fees

• Current Assignee: Synchromax, Inc.
• Original Assignee: Synchromax, Inc.
• Inventors: Peresini, Marco, Spinelli, Julio Csar
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Bays, Pamela M
• Application Number:
  US13/956,065
• Time in Patent Office: 1,112 Days
• Field of Search: 607/2, 607/44, 607/115, 607/116, 607/118, 607/136, 607/137
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/03 Intensive care
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6815 Ear
• CPC Class Codes: A61H 21/00 Massage devices for cavities of the body , e.g. nose, ears and anus for the genitals A61H19/00; Vibration or percussion related aspects A61H23/00
• 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 2201/1207 with electric or magnetic drive
• CPC Class Codes: A61H 2201/1604 Head
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5012 using the internet
• CPC Class Codes: A61H 2201/5015 using specific interfaces or standards, e.g. USB, serial, parallel
• CPC Class Codes: A61H 2205/027 Ears
• CPC Class Codes: A61H 2230/04 Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
• CPC Class Codes: A61H 2230/207 partial O2-value
• CPC Class Codes: A61H 2230/30 Blood pressure A61H2230/04 takes precedence
• 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 2230/65 : Impedance, e.g. skin conductivity; capacitance, e.g. galvanic skin response [GSR]
• CPC Class Codes: A61H 23/0236 : using sonic waves, e.g. using loudspeakers
• CPC Class Codes: A61H 39/002 : Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/36031 : using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/36036 : of the outer, middle or inner ear
• CPC Class Codes: A61N 1/36053 : adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: G09B 19/00 : Teaching not covered by other main groups of this subclass teaching or practice apparatus for gun-aiming or gun-laying F41G3/26
• CPC Class Codes: G16H 20/00 : ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders

Abstract

Device, systems, methods and kits can be useful for auricular stimulation. One such device relates to auricular stimulation. The device includes an earpiece having an electrode arrangement configured and arranged to deliver a series of electrical stimulation signals to an auricular location. A pulse-generator circuit is configured and arranged to generate the series of electrical stimulation signals having a stimulation profile, and to deliver the electrical stimulation signals to the electrode arrangement. A sensor is configured and arranged to generate a feedback signal that is responsive to the electrical stimulation signals. A feedback circuit is configured and arranged to modify the stimulation profile in response to the feedback signal.

Claims

1. A method of auricular stimulation, comprising the steps of:

analyzing using a software data regarding anatomic points of an ear of a subject and determining using the software a stimulation location on the subject'"'"'s ear based on the analysis;

generating a desired response surface for the subject, comprising;

obtaining one or more earpieces, each of the earpieces comprising a stimulation electrode and being associated with mathematically and statistically modeled outcomes of providing stimulation through that earpiece to an ear having one of a plurality of anatomical patterns;

selecting a desired change to an initial state of the subject;

determining anatomical parameters of the subject'"'"'s ear;

identifying those of the outcomes modeled for the anatomical patterns matching the anatomical parameters of the subject'"'"'s ear; and

comparing the desired change to the initial state of the subject with the identified outcomes and determining the desired response surface based on the identified outcome that matches the desired change;

selecting the earpiece associated with the desired response surface for delivering stimulation to the subject;

positioning the stimulation electrode of the selected earpiece in the stimulation location;

delivering through a stimulation device a series of electrical stimulation signals to the stimulation electrode of the selected earpiece according to a stimulation profile; and

adjusting the stimulation profile, comprising the steps of;

obtaining by the stimulation device feedback to the stimulation signals;

revising the desired response surface based on the feedback and performing an evaluation of the revised response surface against a threshold indicative of the effectiveness of mitigation of inflammatory disease processes;

adjusting the stimulation profile based on the evaluation of the revised response surface; and

providing the adjusted stimulation profile for a delivery of electrical stimulation signals to the stimulation electrode.

2. The method of claim 1, wherein the effectiveness of stimulation of an auricular branch includes the effectiveness of hypertension treatment due to modulating activity of the parasympathetic system of the subject, and in response to the step of adjusting the stimulation profile, delivering another series of electrical stimulation signals to the stimulation electrode.

3. The method of claim 1, wherein the step of adjusting the stimulation profile includes increasing an amplitude of the electrical stimulation signals until the subject experiences discomfort, and further includes a step of decreasing amplitude of the electrical stimulation signals until the discomfort ceases.

4. The method of claim 1, wherein the step of positioning the earpiece further includes placing additional stimulation electrodes in three anatomic points of the subject'"'"'s ear;

activating the stimulation electrodes in sequence; and

measuring physiological changes that are produced by each of the stimulation electrodes.

5. The method of claim 1, further comprising a step of forming one or more of the earpieces from a cast of an ear of the subject.

6. The method of claim 1, further including a step of applying a conductive gel to the stimulating electrode and to a reference electrode, and a step of measuring the impedance therebetween and adjusting the stimulation profile until the impedance value is inside an established range.

7. The method of claim 1, further comprising:

identifying features of the subject comprising at least one of pathological features, physiological characteristics, and anatomical characteristics of the subject; and

determining the desired response surface further based on at least one of the identified features.

8. The method of claim 1, further comprising:

evaluating one or more changes to the initial state of the subject during the delivery of the electrical stimulation and signals; and

modifying the stimulation profile based on the evaluated changes.

9. The method of claim 1, further comprising one or more of:

using the earpiece to provide audio information in a form of air pressure waves to restore normal hearing;

using an audio amplifier in the earpiece as a hearing aid;

using an audio channel in the earpiece to receive audio from one or more electronic devices and to channel the received audio from the earpiece; and

using the earpiece to provide audio for music therapy.