# US 5,792,067 A · Apparatus and method for mitigating sleep and other disorders through electromuscular stimulation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,792,067 A - Document ID: US5792067A - Status: Granted - Kind: A - Application number: 08/615,094 - Filed: 1996-03-13 - Granted: 1998-08-11 - Earliest claimed: 1996-03-13 - Inventors: Manuel L. Karell - Web page: https://patentgrep.com/patent/US5792067A ## CPC - A61N 1/0548: {Oral electrodes} - A61N 1/36031: {using physiological parameters for adjustment} - A61N 1/36034: {specified by the stimulation parameters} - A61N 1/3601: {of respiratory organs} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract An electromuscular stimulator that effects a beneficial medical purpose selected from the group consisting of mitigating snoring, mitigating obstructive sleep apnea, mitigating hypertension, dental analgesia, general analgesia, monitoring physiological conditions and facilitating the intraoral delivery of medication is disclosed. The electromuscular stimulator includes a first electrode for making electrical contact with a first anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second anatomical structure; a control unit operably connected to the first and second electrodes; and a means for positioning the first and second electrodes relative to the first and second anatomical structures, respectively. ## Claims ### Claim 1 An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising: a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second intraoral anatomical structure; a control unit operably connected to the first and second electrodes, the control unit comprising an electrical signal generator and further comprising a sensor for detecting the presence of a physiological condition; and an intraoral member for positioning the first and second electrodes intraorally relative to the first and second anatomical structures, respectively. ### Claim 2 (depends on 1) The stimulator of claim 1, wherein the first electrode is adapted to be permanently attached to the first anatomical structure. ### Claim 3 (depends on 1) The stimulator of claim 1, wherein the first electrode comprises a pliable electroconductive material. ### Claim 4 (depends on 1) The stimulator of claim 1, wherein the first electrode comprises a carbon-impregnated metal. ### Claim 5 (depends on 1) The stimulator of claim 1, wherein the first electrode comprises an electroconductive carbon-impregnated plastic. ### Claim 6 (depends on 1) The stimulator of claim 1, wherein the first electrode comprises an electroconductive rubber. ### Claim 7 (depends on 1) The stimulator of claim 1, wherein the first electrode comprises an electroconductive gel. ### Claim 8 (depends on 1) The stimulator of claim 1, wherein the first and second anatomical structures comprise the same anatomical structure. ### Claim 9 (depends on 1) The stimulator of claim 1, wherein the control unit is sized to fit within the mouth of the user during operation. ### Claim 10 (depends on 9) The stimulator of claim 9, wherein the control unit is hermetically sealed. ### Claim 11 (depends on 1) The stimulator of claim 1, wherein the control unit is microminiaturized. ### Claim 12 (depends on 1) The stimulator of claim 1, wherein the control unit is capable of residing outside of the mouth of the user during operation. ### Claim 13 (depends on 1) The stimulator of claim 1, wherein the electrical signal generator comprises a pulse generator. ### Claim 14 (depends on 1) The stimulator of claim 1, wherein the electrical signal generator comprises a transcutaneous electrical nerve stimulator. ### Claim 15 (depends on 1) A method of determining a preferred characteristic of the electrical signal of the stimulator of claim 1, comprising the following steps: a. positioning the stimulator in the mouth of the user; b. applying an electrical signal having a characteristic to the first electrode; c. measuring a physiological response of the user to the application of the electrical signal; d. recording the characteristic and corresponding physiological response in a storage device; e. varying the characteristic based on information recorded in the storage device, if the response is not minimally satisfactory; and f. repeating steps (b) through (e), inclusive, until a minimally satisfactory response is measured. ### Claim 16 (depends on 1) The stimulator of claim 1, wherein the electrical signal generator generates an electrical signal having a characteristic selected from the group consisting of shape, amplitude, length, frequency, intermittent mode and constant mode. ### Claim 17 (depends on 16) The stimulator of claim 16, wherein the characteristic is controlled by the user. ### Claim 18 (depends on 1) The stimulator of claim 1, wherein the electrical signal generator comprises a digital integrated circuit. ### Claim 19 (depends on 1) The stimulator of claim 1, wherein the positioning means comprises a denture-like plate. ### Claim 20 (depends on 1) The stimulator of claim 1, wherein the positioning means is capable of being molded by the user. ### Claim 21 (depends on 1) The stimulator of claim 1, wherein the positioning means is fixedly attached to the control unit. ### Claim 22 (depends on 1) The stimulator of claim 1, further comprising a connecting means for removably attaching the positioning means to a third anatomical structure. ### Claim 23 (depends on 22) The stimulator of claim 22, wherein the connecting means utilizes an adhesive. ### Claim 24 (depends on 22) The stimulator of claim 22, wherein the connecting means utilizes a clamping device. ### Claim 25 (depends on 22) The stimulator of claim 22, wherein the connecting means utilizes a suction device. ### Claim 26 (depends on 22) The stimulator of claim 22, wherein the third anatomical structure comprises a palate. ### Claim 27 (depends on 22) The stimulator of claim 22, wherein the third anatomical structure comprises a tooth. ### Claim 28 (depends on 1) The stimulator of claim 1, wherein the positioning means is disposable. ### Claim 29 (depends on 1) The stimulator of claim 1, wherein the sensor comprises electrodes that monitor electrical activity in a brain. ### Claim 30 (depends on 1) The stimulator of claim 1, wherein the sensor comprises electrodes that monitor electrical activity in an intraoral muscle. ### Claim 31 (depends on 1) The stimulator of claim 1, wherein the sensor comprises a chemical sensor that monitors an intraoral level of a gas selected from the group consisting of CO.sub.2, O.sub.2 and any hydrocarbon emitted from tissue. ### Claim 32 (depends on 1) The stimulator of claim 1, wherein the sensor comprises a force gauge that monitors the tone of an intraoral muscle. ### Claim 33 (depends on 1) The stimulator of claim 1, wherein the sensor comprises an air flow sensor that monitors intraoral air flow. ### Claim 34 (depends on 1) The stimulator of claim 1, wherein the sensor comprises a microphone that monitors intraoral sounds. ### Claim 35 (depends on 1) The stimulator of claim 1, wherein the control unit further comprises a controller operably connected to the electrical signal generator for activating the electrical signal generator. ### Claim 36 (depends on 35) The stimulator of claim 35, wherein the controller comprises a digital integrated circuit. ### Claim 37 (depends on 1) The stimulator of claim 1, wherein the control unit further comprises a controller operably connected to the sensor and operably connected to the electrical signal generator for activating the electrical signal generator in response to detection of the physiological condition. ### Claim 38 (depends on 27) The stimulator of claim 27, wherein the controller determines the type of electrical signal to be generated in response to the physiological condition. ### Claim 39 (depends on 1) The stimulator of claim 1, wherein the control unit further comprises a power supply. ### Claim 40 (depends on 39) The stimulator of claim 39, wherein the power supply is chemical-based. ### Claim 41 (depends on 39) The stimulator of claim 39, wherein the power supply comprises a battery. ### Claim 42 (depends on 39) The stimulator of claim 39, wherein the power supply comprises an external energy source. ### Claim 43 (depends on 1) The stimulator of claim 1, wherein the control unit comprises: an intraoral control unit; an extraoral control unit; and a communication element operably connecting the intraoral control unit to the extraoral control unit. ### Claim 44 (depends on 43) The stimulator of claim 43, wherein the communication element is an electromagnetic signal. ### Claim 45 (depends on 44) The stimulator of claim 44, wherein the electromagnetic signal is a radio frequency signal. ### Claim 46 (depends on 43) The stimulator of claim 43, wherein each of the intraoral control unit and the extraoral control unit further comprises an electromagnetic signal communication device selected from the group consisting of a transmitter, a receiver and a transceiver for communicating the electromagnetic signal between the intraoral control unit and the extraoral control unit. ### Claim 47 (depends on 1) The stimulator of claim 1, further comprising an air channel operatively connected to the positioning member and having an intraoral end and an extraoral end for providing free flow of air between the mouth of the user and ambient atmosphere. ### Claim 48 (depends on 47) The stimulator of claim 47, wherein said extraoral end of said air channel comprises a tube, and said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube. ### Claim 49 (depends on 1) A method of determining a preferred intraoral position for the first electrode of the stimulator of claim 1, comprising the following steps: a. positioning the first electrode in a position on the first anatomical structure; b. applying an electrical signal to the first electrode; c. measuring a physiological response of the user to the application of the electrical signal; d. recording the position and corresponding physiological response in a storage device; e. varying the position based on information recorded in the storage device, if the response is not minimally satisfactory; and f. repeating steps (a) through (e), inclusive, until a minimally satisfactory response is measured. ### Claim 50 (depends on 1) A method of modifying the positioning means of the stimulator of claim 1 to effect an anatomical fit with the mouth of the user, comprising the following steps: softening the positioning means by placing it in a hot liquid bath; molding the positioning means into a desired anatomical shape; and cooling the device until it hardens. ### Claim 51 An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising: a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second intraoral anatomical structure; a control unit operably connected to the first and second electrodes; an intraoral member adapted to position the first and second electrodes intraorally relative to the first and second anatomical structures, respectively; and an air channel operably connected to said intraoral member and having an intraoral end and an extraoral end, said extraoral end comprising a tube adapted for location outside the user's mouth when in use to provide a free flow of air between the user and ambient atmosphere. ### Claim 52 (depends on 51) The stimulator of claim 51, wherein said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube. ### Claim 53 An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising: a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second intraoral anatomical structure; an intraoral member adapted to position the first and second electrodes intraorally relative to the first and second anatomical structures, respectively; an intraoral control unit operably connected to the first and second electrodes; and an extraoral control unit in operable communication with the intraoral control unit through an electromagnetic signal; wherein each of the intraoral control unit and the extraoral control unit further comprises an electromagnetic signal communication device selected from the group consisting of a transmitter, a receiver and a transceiver for communicating the electromagnetic signal between the intraoral control unit and the extraoral control unit. ### Claim 54 (depends on 53) The stimulator of claim 53, further comprising an air channel operably connected to said intraoral member and having an intraoral end and an extraoral end, said extraoral end comprising a tube adapted for location outside the user's mouth when in use to provide a free flow of air between the user and ambient atmosphere. ### Claim 55 (depends on 54) The stimulator of claim 54, wherein said intraoral end of said air channel comprises a plurality of tubes that merge into said extraoral end tube. ### Claim 56 An electromuscular stimulator for providing electrical stimulation to tissues within the mouth of a user, comprising: a first electrode for making electrical contact with a first intraoral anatomical structure selected from the group consisting of a hard palate, a soft palate and a pharynx; a second electrode for making electrical contact with a second intraoral anatomical structure; a control unit operably connected to the first and second electrodes, the control unit comprising an electrical signal generator and further comprising a controller operatively connected to the electrical signal generator for activating the electrical signal generator; and an intraoral member for positioning the first and second electrodes intraorally relative to the first and second anatomical structures, respectively. ### Claim 57 (depends on 56) The stimulator of claim 56, wherein the controller comprises a digital integrated circuit.