ADJUSTABLE EAR WORN APPARATUS
An auricular stimulation device having surface electrodes biased towards each other, and offset from one another, is provided. The stimulation device can be positioned about the ear of a patient with each of the electrodes overlaying auricular ear tissue containing innervation supplied by an auricular branch of the vagus nerve. The electrodes transcutaneously stimulate the auricular branch. Also provided is a method of treating a patient using the auricular stimulation device. The stimulation device can be used for treating patients with conditions such as high blood pressure, depression, high blood glucose level, and tinnitus. Also provided is a diagnostic and therapeutic system having the auricular stimulation device, a smart device and a monitoring device. The smart device controls the auricular stimulation device based on biomarker information received from the monitoring device; and on information related to the patient, such as age, musculoskeletal stability, etc.; and/or on user input.
1 . A wearable device adapted for placement relative to an ear of a user, comprising:
a housing containing electronics and a power source;
a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length;
a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures are separated by an adjustable distance, wherein the second extending structure is configured to abut a first inner portion of an ear to create an opposing force to the first extending structure which is configured to abut a second inner portion of the ear;
an anchor arm extending laterally from the first extending structure; and
an adjustment mechanism configured to impart a force to adjust the adjustable distance.
2 . The wearable device of claim 1 , wherein the adjustment mechanism is an individual adjustment mechanism that is configured to be actuated by contact from one or more digits on an individual hand of a person.
3 . The wearable device of claim 1 , wherein:
the adjustment mechanism is located at a first end of the housing; and
a portion of the adjustment mechanism extends a distance from the first end of the housing and
a portion of the adjustment mechanism is located inside of the housing.
4 . The wearable device of claim 1 , wherein the first inner portion of the ear is the inferior crus, the antihelix, or both, and wherein the second inner portion of the ear is the antitragus.
5 . The wearable device of claim 1 , wherein the adjustment mechanism is integral with a carriage, wherein the carriage is coupled to the first end of the second extending structure and is configured to move longitudinally along a length of the housing.
6 . The wearable device of claim 5 , wherein the adjustment mechanism is located on a first end of the carriage, and wherein the adjustment mechanism comprises a protrusion extending radially from the carriage.
7 . The wearable device of claim 1 , wherein a speaker, a sensor, or both the speaker and the sensor are positioned on the first extending structure or the second extending structure.
8 . The wearable device of claim 1 , wherein the adjustment mechanism comprises a separate component that is coupled to a carriage, wherein the carriage is coupled to the first end of the second extending structure and is configured to move longitudinally along a length of the housing.
9 . The wearable device of claim 8 , wherein the adjustment mechanism further comprises a rotatable adjustment mechanism including an annulus, wherein the rotatable adjustment mechanism is configured to rotate about the annulus relative to the carriage, the housing, or both the carriage and the housing.
10 . The wearable device of claim 9 , wherein:
the housing includes a slot extending through the first end of the housing;
the rotatable adjustment mechanism comprises:
a lever extending laterally therefrom through the slot to a position outside of the housing; and
teeth disposed along at least a portion of a periphery of the rotatable adjustment mechanism that is located in the housing; and
the carriage includes corresponding teeth that are configured to interface with the teeth to impart the longitudinal movement of the carriage responsive to rotation of the lever.
11 . The wearable device of claim 10 , wherein:
the carriage includes an elongated longitudinal slot extending along a portion of the length of the carriage; and
the housing includes a peg configured to extend into the elongated longitudinal slot.
12 . The wearable device of claim 9 , wherein:
the housing includes a slot extending through the first end of the housing; and
the rotatable adjustment mechanism comprises a wheel with a toothed surface along at least a portion of a periphery of the rotatable adjustment mechanism and a curvilinear slot extending within a portion of the wheel.
13 . The wearable device of claim 1 , wherein an electrode is positioned on the first extending structure or the second extending structure.
14 . The wearable device of claim 1 , wherein a first electrode is positioned on the first extending structure and a second electrode is positioned on the second extending structure.
15 . The wearable device of claim 14 , wherein:
the first electrode and the second electrode are configured to be positioned on opposing sides of the crus helix; or
the first electrode is configured to be positioned at the conchae caverna and the second electrode is configured to be positioned at the conchae cymba.
16 . A wearable device adapted for placement relative to an ear of a user, comprising:
a housing containing, electronics and a power source, wherein the housing comprises a lower container and an upper lid defining a cavity therebetween;
a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length;
an anchor arm extending laterally from the first extending structure;
a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures are separated by an adjustable distance, wherein the second extending structure is configured to abut a first inner portion of an ear to create an opposing force to the first extending structure which is configured to abut a second inner portion of the ear;
a carriage coupled to the first end of the second extending structure and being at least partially disposed within the cavity of the housing, wherein the carriage is configured to translate longitudinally along a portion of a length of the housing;
an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is an individual adjustment mechanism that is configured to impart a force to cause longitudinal translation of the carriage to adjust the adjustable distance; and
an electrode, a vibrating element, or both, wherein the electrode, the vibrating element or both, is positioned on the first extending structure, the second extending structure, or both the first extending structure and the second extending structure.
17 . The wearable device of claim 16 , wherein:
the adjustment mechanism comprises a fixed protrusion extending radially from the carriage or a rotatable adjustment mechanism coupled to an end of the carriage; or
the carriage, the housing, or both the carriage and the housing include detents configured to predispose the carriage to one or more longitudinal positions along a length of travel of the carriage.
18 . The wearable device of claim 16 , wherein the first extending structure or the second extending structure is integral with the housing.
19 . The wearable device of claim 16 , wherein:
the first inner portion of the ear is the inferior crus, the antihelix, or both, and wherein the second inner portion of the ear is the antitragus;
the wearable device includes the electrode, and
the electrode includes a first electrode is positioned on the first extending structure and a second electrode is positioned on the second extending structure.
20 . The wearable device of claim 16 , wherein the electronics comprise wireless communication circuitry configured to wirelessly communicate with a mobile device application, wherein the mobile device application is configured to remotely control electrical stimulation parameters delivered via the electrode, the vibrating element, or both, and wherein the wireless communication circuitry comprises Bluetooth or WiFi communication capability.
21 . A method of treating inflammation in a patient, the method comprising:
applying a wearable device to an ear of the patient, the wearable device comprising a housing containing electronics, one or more electrodes, and a power source, a first extending structure having a second end positioned within the ear when the wearable device is worn, an anchor arm extending laterally from the first extending structure, a second extending structure having a second end positioned within the ear when the wearable device is worn, a carriage coupled to a first end of the second extending structure and being at least partially disposed within the housing, wherein the carriage is configured to move longitudinally along a length of the housing, and an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is configured to impart a force to cause longitudinal movement of the carriage to adjust a distance between the first extending structure and the second extending structure; and
delivering electrical stimulation via the one or more electrodes of the wearable device to activate a neuroimmune anti-inflammatory pathway in the patient to treat the inflammation.
22 . The method of claim 21 , wherein the applying further comprises placing the anchor arm in the ear of the user, and wherein the method further comprises actuating the adjustment mechanism to vary an adjustable distance between the first extending structure and the second extending structure to secure the wearable device to the ear of the patient.
23 . The method of claim 22 , wherein actuating the adjustment mechanism further comprises actuating the adjustment mechanism with one or more digits of an individual hand of a user subsequent to placing the anchor arm in the ear of the user until the second extending structure abuts the helix, the antihelix, the inferior crus, or any combination thereof.
24 . The method of claim 21 , further comprising delivering the electrical stimulation at a current amplitude in a range of about 0.1 mA to about 20 mA, a pulse width in a range of about 10 microseconds to about 20 milliseconds, and a frequency in a range of about 1 Hz to about 200 Hz.
25 . The method of claim 21 , wherein the inflammation is associated with one or more conditions selected from the group consisting of: cerebrovascular disorders including stroke and post-stroke inflammatory response; metabolic disorders including diabetes mellitus and glycemic control disorders; drug-induced inflammatory responses including diabetes drug therapy complications; rheumatoid arthritis; inflammatory bowel disease; Alzheimer's disease, Crohn's disease; ulcerative colitis; multiple sclerosis; psoriatic arthritis; osteoarthritis; psoriasis; chronic inflammatory symptoms; and chronic fatigue syndrome.
26 . A wearable device adapted for placement relative to an ear of a user, comprising:
a housing containing electronics and a power source;
a first extending structure having a first end at the housing and a second end apart from the housing, the first extending structure having a first length, the second end configured for contacting the posterior edge of the crus and/or antitragus;
a first anchor arm extending laterally from the first extending structure and carrying an anchor element thereon, the anchor element configured for positioning beneath a tragus of the ear of the user to thereby support positioning of the wearable device;
a second extending structure comprising a first end at the housing and a second end apart from the housing, wherein the first and second extending structures are separated by an adjustable distance;
a carriage coupled to the first end of the second extending structure and being at least partially disposed within the housing, wherein the carriage is configured to move longitudinally along a length of the housing;
an adjustment mechanism coupled to the carriage, wherein the adjustment mechanism is configured to impart a force to cause longitudinal movement of the carriage to adjust the adjustable distance; and;
an electrode, a vibrating element, or both, wherein the electrode, the vibrating element, or both, is located on the first extending structure, the second extending structure, or both.
27 . The wearable device of claim 26 , wherein the wearable device is configured to treat inflammation in the user.
28 . The wearable device of claim 27 , wherein the inflammation is associated with one or more conditions selected from the group consisting of: cerebrovascular disorders including stroke and post-stroke inflammatory response; metabolic disorders including diabetes mellitus and glycemic control disorders; drug-induced inflammatory responses including diabetes drug therapy complications; rheumatoid arthritis; inflammatory bowel disease; Alzheimer's disease, Crohn's disease; ulcerative colitis; multiple sclerosis; psoriatic arthritis; osteoarthritis; psoriasis; chronic inflammatory symptoms; and chronic fatigue syndrome.
29 . The wearable device of claim 27 , including the electrode on the first extending structure, the second extending structure, or both.
30 . The wearable device of claim 27 , including the vibrating element on the first extending structure, the second extending structure, or both.