US2021252279A1PendingUtilityA1

System and method for ear-arranged transcutaneous vagus nerve stimulation

Assignee: MASSACHUSETTS GEN HOSPITALPriority: Nov 23, 2015Filed: May 5, 2021Published: Aug 19, 2021
Est. expiryNov 23, 2035(~9.3 yrs left)· nominal 20-yr term from priority
Inventors:Jian Kong
A61M 2205/502A61M 2021/0027A61M 21/00A61N 1/36025A61M 2021/0055A61N 1/0456A61N 1/0472A61N 1/37A61N 1/36036
63
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Claims

Abstract

A transcutaneous nerve stimulation system includes a multifunctional earphone assembly that receives a sound signal from a sound source or other sources (such as a signal generator). An amplifier receiving the sound signal from the sound source or independent signal generator amplifies the sound signal to generate an amplified electrical signal. A stimulator, which includes multiple conductive electrode contacts, is coupled to the amplifier to receive the amplified electrical signal. The electrode contacts may protrude from an earbud/headphone or extend from an adjustable probe arm. The amplified electrical signal is used to apply electrical stimulation while the earphone assembly emits audible sounds according to the sound signal. The combined functionality enhances compliance with treatment regimens involving electrical stimulation of vagus nerves and other regions of a subject. Potential indications include, without limitation, major depressive disorder, epilepsy, chronic pain, pre-diabetes, insomnia, cardiovascular disorders, tinnitus, autism, daily stress, and anxiety.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A transcutaneous peripheral nerve stimulation system comprising:
 a stimulator including an input configured to receive a stimulation signal based on a sound signal from a sound source and a probe arm configured to be removably coupled to an earbud;   at least one electrode contact located at a distal end of the probe arm;   wherein, when the stimulator is coupled to the earbud and the earbud is engaged with a person to hear the sound signal through the earbud, the at least one electrode contact is arranged to engage the person to deliver the stimulation signal to transcutaneously stimulate a peripheral nerve.   
     
     
         2 . The system of  claim 1 , further including a body having:
 an opening for receiving the probe arm; and   an earbud interface for receiving the earbud.   
     
     
         3 . The system of  claim 2 , wherein the earbud interface extends from the body and is sized to complementarity receive and grip the earbud. 
     
     
         4 . The system of  claim 3 , wherein the body includes an adjusting mechanism for adjusting how tightly the earbud interface grips the earbud. 
     
     
         5 . The system of  claim 2 , wherein the earbud interface includes a plurality of gripping arms configured to grip the earbud. 
     
     
         6 . The system of  claim 5 , wherein the plurality of gripping arms are formed of an elastomeric material. 
     
     
         7 . The system of  claim 2 , wherein the at least one electrode contact is a first electrode contact and a second electrode contact; and
 wherein the probe arm branches into first and second prongs at a distal end thereof, wherein the first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm.   
     
     
         8 . The system of  claim 7 , wherein the probe arm is slidably adjustable relative to the body at the opening, the probe arm being rotatable about a first axis defined by the probe arm; and
 wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate about a second axis.   
     
     
         9 . An earphone assembly adapted for transcutaneous peripheral nerve stimulation, the earphone assembly comprising:
 a listening unit including a speaker configured to receive a sound signal and emit audio according to the sound signal; and   a stimulator removably coupled to the listening unit and including a probe unit having at least one electrode contact;   wherein the stimulator is configured to apply, as audio is emitted from the speaker, an amplified electrical signal from an amplifier to transcutaneously electrically stimulate a peripheral nerve of a subject; and   wherein the amplified electrical signal is generated from the sound signal.   
     
     
         10 . The earphone assembly of  claim 9 , wherein the probe unit includes a probe arm having the at least one electrode contact at a distal end thereof, the probe arm including a bendable portion configured for adjustably positioning the at least one electrode contact. 
     
     
         11 . The earphone assembly of  claim 9 , wherein the listening unit is an earbud configured to be received in an ear canal of a subject. 
     
     
         12 . The earphone assembly of  claim 9 , wherein the stimulator further includes a body coupled to the probe unit,
 the body including an interface protrusion for receiving the listening unit, wherein the interface protrusion extends from the body and is shaped to complementarity receive a portion of the listening unit to be removably coupled.   
     
     
         13 . The earphone assembly of  claim 12 , wherein the interface protrusion is rigid. 
     
     
         14 . The earphone assembly of  claim 12 , wherein the interface protrusion is configured as a plurality of gripping arms configured to grip the listening unit. 
     
     
         15 . The earphone assembly of  claim 14 , wherein the plurality of gripping arms are formed of an elastomeric material. 
     
     
         16 . The earphone assembly of  claim 12 , wherein the at least one electrode contact is a first electrode contact and a second electrode contact; and
 wherein the probe unit includes a probe arm branching into first and second prongs separated by a gap, wherein the first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm.   
     
     
         17 . The earphone assembly of  claim 16 , wherein the probe arm is slidably adjustable relative to the body, the probe arm being rotatable about a first axis defined by the probe arm. 
     
     
         18 . The earphone assembly of  claim 16 , wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate. 
     
     
         19 . A method for adapting earbuds for transcutaneous peripheral nerve stimulation, the method comprising:
 providing a stimulator configured for removably coupling to an earbud;   receiving a sound signal from a sound source;   amplifying the sound signal using an amplifier to generate an amplified electrical signal;   emitting audio according to the sound signal using a speaker in the earbud; and   as audio is emitted from the earbud, transcutaneously electrically stimulating a peripheral nerve of a subject by applying the amplified electrical signal using the stimulator.   
     
     
         20 . The method of  claim 19 , wherein the stimulator includes a body having an interface protrusion extending therefrom, the interface protrusion configured for receiving the earbud,
 wherein the interface protrusion is shaped to complementarity receive a portion of the earbud to be removably coupled.

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