HK1241784A1 - Methods of manufacturing devices for the neurorehabilitation of a patient - Google Patents

Abstract

A mouth clip that provides non-invasive nerve regulation for patients,The oral mouthpiece comprises an elongated shell,The slender shell has a front region and a rear region,The slender shell has a non planar outer top surface and several internal structural components installed inside the shell,The internal structural components elastically respond to the biting force generated by the patient,A gasket attached to the top surface of the shell,Used to restrict the contact between the patient's upper teeth and the outer top surface of the slender shell,A printed circuit board installed at the bottom of a slender shell,The printed circuit board has multiple electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue.

Description

Method for manufacturing a device for the neurological rehabilitation of a patient

Cross reference to related patent applications

This application claims priority and benefit from U.S. patent application serial No. 14/559,080 filed on day 12/3 of 2014, U.S. patent application serial No. 14/559,123 filed on day 12/3 of 2014, U.S. patent application serial No. 14/559,105 filed on day 12/3 of 2014, and U.S. patent application serial No. 14/559,118 filed on day 12/3 of 2014.

Technical Field

In general, the present invention relates to devices and methods for non-invasive neurostimulation of a subject's brain. More particularly, the present invention relates to devices and methods for non-invasive neurostimulation of a subject's brain to affect treatment of various diseases.

Background

Traumatic Brain Injury (TBI) is a major disabling cause in the world.

In the united states, approximately two million people suffer traumatic brain injury each year, many of which suffer long-term symptoms. Long-term symptoms include impaired attention, impaired judgment, decreased processing speed, abstract reasoning, planning, problem solving, and the inability to multitask.

Stroke is a loss of brain function due to a disturbance in the blood supply to the brain. Approximately 80 million people in the united states suffer a stroke each year. Stroke is a major cause of long-term disability in the united states, with nearly half of the elderly stroke survivors experiencing moderate to severe disability. Long term effects may include seizures, incontinence, vision disorders or loss, dysphagia, pain, fatigue, loss of cognitive function, aphasia, short and/or long term memory loss, and depression.

Multiple Sclerosis (MS) is a disease that causes damage to nerve cells of the brain and spinal cord. About two hundred and fifty thousand people worldwide suffer from multiple sclerosis. Depending on the specific location of the damaged portion of the brain or spinal cord, the symptoms may vary greatly. Symptoms include dysesthesia, coordination and balance difficulties, speech disorders, dysphagia, nystagmus, bladder and bowel distress, cognitive disorders, major depression, and the like.

Alzheimer's Disease (AD) is a neurodegenerative disease in which over 2500 million people are affected worldwide. Symptoms of alzheimer's disease include confusion, irritability, aggression, mood swings, language difficulties, and long-term and short-term memory loss. In developed countries, alzheimer's disease is one of the most socially costly diseases.

Parkinson's Disease (PD) is a degenerative disease of the central nervous system affecting over 700 million people worldwide. Symptoms of parkinson's disease include tremor, bradykinesia, rigidity, postural instability, cognitive disorders, behavioral and emotional changes.

One method of treating long-term symptoms associated with traumatic brain injury, stroke, multiple sclerosis, alzheimer's disease and parkinson's disease is neurorehabilitation. Neurorehabilitation refers to a process intended to help patients recover from injuries to the nervous system. Traditionally, neurorehabilitation has involved physical therapy (e.g., balance retraining), occupational therapy (e.g., safety training, memory cognition retraining), psychological therapy, speech and speech therapy, and therapy focused on daily functioning and community regression.

One method of treating long-term symptoms associated with traumatic brain injury, stroke, multiple sclerosis, alzheimer's disease and parkinson's disease is neurorehabilitation. Neurorehabilitation refers to a process intended to help patients recover from injuries to the nervous system. Traditionally, neurorehabilitation has involved physical therapy (e.g., balance retraining), occupational therapy (e.g., safety training, memory cognition retraining), psychological therapy, speech and speech therapy, and therapy focused on daily functioning and community regression.

Despite many advances in neurorehabilitation and neurostimulation, there remains an urgent need for treatment methods using combination approaches, including both neurorehabilitation and neurostimulation, to improve the rehabilitation of patients suffering from traumatic brain injury, stroke, multiple sclerosis, alzheimer's disease, parkinson's disease, depression and obsessive-compulsive disorder or any other neurologically impaired disease.

Disclosure of Invention

In various embodiments, the invention features methods and devices that combine noninvasive neuromodulation with traditional neurorehabilitation therapy. Clinical studies have shown that a method of combining neuromodulation with neurorehabilitation is effective in treating long-term neurological dysfunction caused by a range of diseases, such as traumatic brain injury, stroke, multiple sclerosis, alzheimer's disease, and parkinson's disease.

In one aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having anterior and posterior regions, the elongated housing having (i) a non-planar exterior top surface and (ii) a plurality of internal structural members (internal structural members) mounted within the housing, the internal structural members resiliently responding to a biting force generated by the patient. The mouthpiece also includes a pad attached to the top surface of the housing for limiting contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. In some embodiments, the mouthpiece also includes a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes a plurality of ribs arranged in a direction perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing and a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes a plurality of ribs of an interpenetrating network structure, wherein at least some of the ribs are aligned parallel to the longitudinal axis of the elongated housing and at least some of the ribs are aligned perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes pockets formed by ribs of the interpenetrating network structure in a posterior region of the elongated housing. In some embodiments, the mouthpiece also includes an integrated circuit located within the pocket. In some embodiments, the ribs have a rectangular cross-section. In some embodiments, the ribs are comprised of arches. In some embodiments, the mouthpiece also includes one or more posts extending away from an inner surface of the elongated housing configured to contact a mounted printed circuit board. In some embodiments, the structural member may withstand a force of 700N without causing plastic deformation of the mouthpiece. In some embodiments, the mouthpiece may also include a rectangular sheet embedded in the interior surface of the elongated housing and located in the rear region of the elongated housing, the rectangular sheet connecting the ribs of the interpenetrating network structure. In some embodiments, the mouthpiece also includes a curved tab embedded in the inner surface of the elongated housing at a region connecting the anterior region and the posterior region of the elongated housing, the curved tab connecting ribs arranged in a direction parallel to the longitudinal axis of the elongated housing.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having anterior and posterior regions, the elongated housing having (i) a non-planar exterior top surface and (ii) an internal structural member(s) mounted within the housing interior that resiliently responds to a biting force generated by the patient. The mouthpiece also includes a pad attached to the top surface of the housing for limiting contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. In some embodiments, the mouthpiece also includes a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes a plurality of ribs arranged in a direction perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing and a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes ribs of an interpenetrating network structure, wherein at least some of the ribs are aligned parallel to the longitudinal axis of the elongated housing and at least some of the ribs are aligned perpendicular to the longitudinal axis of the elongated housing. In some embodiments, the mouthpiece also includes pockets formed by ribs of the interpenetrating network structure in a posterior region of the elongated housing. In some embodiments, the mouthpiece also includes an integrated circuit located within the pocket. In some embodiments, the ribs have a rectangular cross-section. In some embodiments, the ribs are comprised of arches. In some embodiments, the mouthpiece also includes one or more posts extending away from an inner surface of the elongated housing configured to contact a mounted printed circuit board. In some embodiments, the structural member may withstand a force of 700N without causing plastic deformation of the mouthpiece.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar interior top surface and a plurality of interior fins located between the non-planar interior top surface and the bottom surface of the elongated housing, the plurality of interior fins forming a channel at the anterior region of the elongated housing. The mouthpiece also includes a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The mouthpiece also includes a cable having a first section mounted within the housing and a second section extending from the housing, the cable mounted in an S-shape along the channel formed by the inner fin, wherein one end of the first section of the cable is connected to the printed circuit board. In some embodiments, the mouthpiece also includes a right angle grommet mounted to the front region of the elongated housing, the grommet enclosing the cable as it extends from the channel formed by the inner fin, the grommet forcing the cable to make an approximately 90 degree turn as it extends from the elongated housing. In some embodiments, the cable forms two continuous S-shapes along the channel formed from the inner fin. In some embodiments, the mouthpiece also includes a grommet mounted to an anterior region of the elongated housing, the grommet covering the cable as it extends from the channel formed by the inner fin. In some embodiments, the mouthpiece also includes a cylindrically symmetric resilient member that wraps around a portion of the cable and has a slot in its central portion and is surrounded by two regions of decreasing radius as the distance from the slot increases. In some embodiments, the mouthpiece also includes an aperture in an anterior region of the elongate housing, the aperture configured to form a mechanical connection with the slot. In some embodiments, the mouthpiece also includes a cover having a flexible portion for connecting to the printed circuit board and a rigid portion for connecting to the elongated housing, the cover and the elongated housing together forming an aperture in a front region of the mouthpiece, the aperture configured to form a mechanical connection with the slot. In some embodiments, the mouthpiece also includes a groove on an inner surface of the elongated housing, the groove configured to receive a cable. In some embodiments, the mouthpiece also includes an elastic sleeve in contact with the cable, the anterior region of the elongate housing, the elastic sleeve providing resistance to bending and tensile strain in the cable.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar interior top surface and a bottom surface defined by a perimeter of the elongated housing. The mouthpiece also includes a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The mouthpiece also includes a first resilient ring along an inner sidewall of the elongated housing that forms a sealing surface with the printed circuit board. The mouthpiece also includes a plurality of mechanical projections extending from an inner sidewall of the elongated housing, the plurality of mechanical projections contacting the printed circuit board. The mouthpiece also includes a cable having a first section within the housing and a second section extending from the housing, one end of the first section of the cable being connected to the printed circuit board. In some embodiments, the mouthpiece also includes a groove on an inner surface of the elongated housing, the groove configured to receive a cable. In some embodiments, the mouthpiece also includes a number of internal fins extending from an internal top surface of the elongated housing, the number of internal fins forming a channel at an anterior region of the elongated housing. In some embodiments, the cable forms at least two continuous S-shapes along the channel formed by the number of inner fins. In some embodiments, the mouthpiece also includes a second resilient loop attached to the first resilient loop, the second resilient loop covering a portion of the cable forming a connection between the anterior region of the elongate housing and the cable. In some embodiments, the mouthpiece also includes a second resilient loop attached to the first resilient loop, the second resilient loop covering a portion of the cable forming a connection between the anterior region of the elongate housing and the cable, the second resilient loop causing the cable to extend away from the mouthpiece at a right angle of 90 degrees.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar interior top surface and a plurality of interior fins located between the non-planar interior top surface of the elongated housing and a bottom surface defined by a perimeter of the elongated housing, the plurality of interior fins forming a channel at the anterior region of the elongated housing. The mouthpiece also includes a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The mouthpiece also includes a cable having a first section within the housing and a second section extending from the housing, the cable mounted in an S-shape along the channel formed by the plurality of internal fins, an end of the first section of the cable connected to the printed circuit board. In some embodiments, the mouthpiece also includes a right angle grommet mounted to the anterior region of the elongated housing, the grommet enclosing the cable as it extends from the channel formed by the inner fin, the grommet forcing the cable to make an approximately 90 degree bend as it extends out of the elongated housing. In some embodiments, the cable forms two continuous S-shapes along the channel formed from the inner fin. In some embodiments, the mouthpiece also includes a grommet mounted to an anterior region of the elongated housing, the grommet covering the cable as it extends from the channel formed by the inner fin. In some embodiments, the mouthpiece also includes a cylindrically symmetric resilient member that wraps around a portion of the cable and has a slot in its central portion and is surrounded by two regions of decreasing radius as the distance from the slot increases. In some embodiments, the mouthpiece also includes an aperture in an anterior region of the elongate housing, the aperture configured to form a mechanical connection with the slot. In some embodiments, the mouthpiece also includes a cover having a flexible portion for connecting to the printed circuit board and a rigid portion for connecting to the elongated housing, the cover and the elongated housing together forming an aperture in a front region of the mouthpiece, the aperture configured to form a mechanical connection with the slot. In some embodiments, the mouthpiece also includes a groove on an inner surface of the elongated housing, the groove configured to receive a cable. In some embodiments, the mouthpiece also includes an elastic sleeve in contact with the cable, the anterior region of the elongate housing, the elastic sleeve providing resistance to bending and tensile strain in the cable.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface. The mouthpiece also includes a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a first printed circuit board mounted to the bottom of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The mouthpiece also includes a well shaped to receive an adhesive that bonds the first printed circuit board to the elongated housing. In some embodiments, a portion of the edge rests against an underside of the first printed circuit board, preventing the patient's teeth from contacting the printed circuit board. In some embodiments, the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board. In some embodiments, the first printed circuit board has a curved shape, and the plurality of electrodes are located on a curved surface of the first printed circuit board. In some embodiments, the plurality of electrodes in a front area of the first printed circuit board has a first density and the plurality of electrodes in a rear area of the first printed circuit board has a second density. In some embodiments, the mouthpiece also includes a second printed circuit board mounted on the first printed circuit board. In some embodiments, the rim is integral with the elongated housing. In some embodiments, the edge is a glue pit sized to form between the bottom of the elongated housing and the perimeter of the first printed circuit board. In some embodiments, the edge is concentric with the perimeter of the first printed circuit board. In some embodiments, the edge covers a bottom portion of the first printed circuit board along a perimeter of the first printed circuit board. In some embodiments, the edge covers a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board. In some embodiments, the edge covers the bottom portion and the sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

In another aspect, the invention features a mouthpiece for non-invasive neuromodulation in a patient. The mouthpiece includes an elongated housing having an anterior region and a posterior region, the elongated housing having a non-planar exterior top surface. The mouthpiece also includes a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The mouthpiece also includes a first printed circuit board mounted to the bottom of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The mouthpiece also includes a rim extending from the bottom of the elongated housing, the rim surrounding a perimeter of the first printed circuit board. The mouthpiece may also include a beveled pit shaped to receive an adhesive for adhering at least two orthogonal surfaces of the first printed circuit board to the elongated housing. In some embodiments, a portion of the edge rests against an underside of the first printed circuit board, preventing the patient's teeth from contacting the printed circuit board. In some embodiments, the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board. In some embodiments, the first printed circuit board has a curved shape, and the plurality of electrodes are located on a curved surface of the first printed circuit board. In some embodiments, the plurality of electrodes at a front area of the first printed circuit board has a first density and the plurality of electrodes at a rear area of the first printed circuit board has a second density, wherein the first density is greater than the second density. In some embodiments, the mouthpiece also includes a second printed circuit board mounted on the first printed circuit board. In some embodiments, the rim is integral with the elongated housing. In some embodiments, the edge is a glue pit sized to form between the bottom of the elongated housing and the perimeter of the first printed circuit board. In some embodiments, the edge is concentric with the perimeter of the first printed circuit board. In some embodiments, the edge covers a bottom portion of the first printed circuit board along a perimeter of the first printed circuit board. In some embodiments, the edge covers a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board. In some embodiments, the edge covers the bottom portion and the sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

In another aspect, the invention features a method of making a mouthpiece for providing non-invasive neuromodulation to a patient. The method includes providing an elongated housing having a non-planar interior top surface and a plurality of interior fins located between the non-planar interior top surface of the elongated housing and a bottom surface defined by a perimeter of the elongated housing, the plurality of interior fins forming a channel at a front region of the elongated housing. The method also includes attaching a spacer to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The method also includes installing a cable in an S-shape along the channel formed by the inner fin. The method also includes mounting a circuit board to the bottom of the elongated housing, the circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue. The method also includes connecting an end of the cable to the printed circuit board. In some embodiments, the method also includes forming the cable into a 90 degree bend at the exit of the elongated housing. In some embodiments, the method also includes passing the cable through a resilient member located at the outlet of the elongated housing. In some embodiments, the method also includes forming two continuous S-shapes along the cable. In some embodiments, the method also includes mounting a cylindrically symmetric resilient member to the cable, the resilient member covering a portion of the cable and having a groove in a central portion thereof, and being surrounded by two regions of decreasing radius as the distance from the groove increases. In some embodiments, the method also includes forming an aperture in a front region of the elongated housing, the aperture configured to form a mechanical connection with the slot. In some embodiments, the method also includes providing a cover having a flexible portion and a rigid portion. In some embodiments, the method also includes contacting the printed circuit board with the resilient portion of the cover and contacting the elongated housing with the rigid portion of the cover. In some embodiments, the method also includes forming an aperture using the cap and the elongated housing in cooperation, the aperture configured to form a mechanical connection with the slot. In some embodiments, the method also includes forming a groove in an inner surface of the elongated housing. In some embodiments, the method also includes placing a cable in the recess. In some embodiments, the method also includes forming an elastomeric sleeve around the cable that provides bending resistance and tensile strain resistance in the cable. In some embodiments, the method also includes applying an adhesive along a perimeter of the printed circuit board for adhering at least two orthogonal surfaces of the first printed circuit board to the elongated housing.

In another aspect, the invention features a method of making a mouthpiece for providing non-invasive neuromodulation to a patient. The method includes providing an elongated housing having a plurality of mechanical protrusions extending from an inner sidewall of the elongated housing and a first resilient ring positioned along the inner sidewall of the elongated housing. The method also includes attaching a spacer to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing. The method also includes contacting a printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue to the first elastomeric ring of the elongated housing to form a seal. The method also includes providing a cable having a first section mounted to the housing and a second section extending away from the housing. The method also includes connecting an end of the first section of the cable to a printed circuit board. In some embodiments, the method also includes forming the cable into a 90 degree bend at the exit of the elongated housing. In some embodiments, the method also includes passing the cable through a resilient member located at the outlet of the elongated housing. In some embodiments, the method also includes forming two continuous S-shapes along the cable. In some embodiments, the method also includes mounting a cylindrically symmetric resilient member to the cable, the resilient member covering a portion of the cable and having a groove in a central portion thereof, and being surrounded by two regions of decreasing radius as the distance from the groove increases. In some embodiments, the method also includes forming an aperture in a front region of the elongated housing, the aperture configured to form a mechanical connection with the slot. In some embodiments, the method also includes forming a groove in an inner surface of the elongated housing. In some embodiments, the method also includes placing a cable in the recess. In some embodiments, the method also includes forming an elastomeric sleeve around the cable, the elastomeric sleeve contacting a forward region of the elongate housing, the elastomeric sleeve providing bending resistance and tensile strain resistance in the cable.

The terms "about," "approximately," and "substantially" as used herein mean ± 10%, and in some embodiments, ± 5%. Reference to the description of the terms "one embodiment," "some embodiments," "an illustrative embodiment," "an example," "a specific example" or "some examples" or the like means that a particular feature, structure, procedure, step or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, procedures, steps, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the claimed technology.

Drawings

The advantages of the invention described above, as well as further advantages, will be better understood by reference to the following description taken in conjunction with the accompanying drawings. The drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.

Fig. 1 shows a schematic diagram of a non-invasive neurostimulation therapy session on a patient according to an exemplary embodiment of the present invention.

Fig. 2A and 2B illustrate a neurostimulation system according to an exemplary embodiment of the present invention.

Fig. 2C shows a schematic diagram of a neurostimulation system according to an exemplary embodiment of the present invention.

Fig. 3A shows a more detailed view of the neurostimulation system depicted in fig. 2A and 2B.

Fig. 3B is a more detailed view of the neurostimulation system depicted in fig. 2C.

Fig. 3C shows a more detailed view of the electrode array.

Fig. 3D shows a graph of an exemplary sequence of neurostimulation pulses used to affect a patient.

Fig. 4A shows a flow diagram of a method for operating a neurostimulation system according to one embodiment of the invention.

Fig. 4B shows a flow diagram of a method for operating a neurostimulation system according to one embodiment of the invention.

Figure 5A shows an isometric view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 5B illustrates a side view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 5C illustrates a top view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 5D illustrates a bottom view of a mouthpiece according to an exemplary embodiment of the present invention.

Figures 5E and 5F illustrate bottom views of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 6A illustrates an isometric view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 6B illustrates a bottom view of a mouthpiece according to an exemplary embodiment of the present invention.

Fig. 6C shows a schematic view of a glue pit according to an exemplary embodiment of the present invention.

Fig. 6D shows a schematic view of a glue pit according to an exemplary embodiment of the present invention.

Figure 7A illustrates an isometric view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 7B illustrates a bottom view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 7C illustrates a cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention.

Figures 8A and 8B illustrate isometric views of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 8C illustrates a cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 8D illustrates a cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention.

Figures 9A and 9B illustrate isometric views of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 9C illustrates a cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention.

Figures 10A and 10B illustrate isometric views of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 10C illustrates a cross-sectional view of a mouthpiece according to an exemplary embodiment of the present invention.

Figures 11A and 11B illustrate isometric views of a mouthpiece according to an exemplary embodiment of the present invention.

Figure 11C illustrates an isometric view of a mouthpiece according to an exemplary embodiment of the present invention.

FIG. 12 illustrates a flow diagram of a method of manufacturing a mouthpiece according to an embodiment.

Figures 13A-B illustrate an overmolded mouthpiece according to an exemplary embodiment of the present invention.

Figure 14 illustrates an overmolded mouthpiece according to an exemplary embodiment of the present invention.

Detailed Description

Fig. 1 shows a schematic of a noninvasive neuromodulation therapy session (Ν I Ν Μ) for a patient 101 by a neurostimulation system 100. During a treatment session, the neurostimulation system 100 non-invasively stimulates at least one of various nerves located within the oral cavity of the patient, including the trigeminal nerve and the facial nerve. In conjunction with Ν I Ν Μ, the patient also engages in exercise or other activities specifically designed to aid in the patient's neurological rehabilitation therapy. For example, during Ν Μ, the patient may engage in a physical therapy program (e.g., move the affected limb, or walk on a treadmill), engage in mental therapy (such as meditation or respiratory exercises), or cognitive exercises (such as computer-assisted memory exercises). Ν I Ν Μ in combination with appropriately selected exercise or activity has been shown to be useful in the treatment of a range of diseases including, for example, traumatic brain injury, stroke (TBI), Multiple Sclerosis (MS), balance, gait, vestibular disorders, visual deficits, tremor, headache, migraine, neuropathic pain, hearing loss, voice recognition, auditory problems, speech therapy, cerebral palsy, blood pressure, relaxation and heart rate. For example, U.S. patent No. 8849407, the entire contents of which are incorporated herein by reference, describes an effective noninvasive neurorehabilitation therapy (Ν Μ) therapy routine that has recently been developed.

Fig. 2A and 2B illustrate a non-invasive neurostimulation system 100. Noninvasive neurostimulation system 100 includes controller 120 and mouthpiece 140. The controller 120 includes a socket 126 and a button 122. The mouthpiece 140 includes an electrode array 142 and a cable 144. The cable 144 is connected to the socket 126 to electrically connect the mouthpiece 140 to the controller 120. In some embodiments, the controller 120 includes a cable. In some embodiments, the mouthpiece 140 and the controller 120 are connected wirelessly (e.g., without the use of a cable). During operation, the patient activates the neurostimulation system 100 by operating one of the buttons 122. In some embodiments, the neurostimulation system 100 periodically transmits electrical pulses to detect whether the electrode array 142 is in contact with the patient's tongue and automatically activates based on the results of the determination. After activation, the patient may start the Ν I Ν m therapy session, stop the Ν I Ν m therapy session, or pause the Ν I Ν m therapy session by pressing one of buttons 122. In some embodiments, neural stimulation system 100 periodically sends electrical pulses to detect whether the electrode array 142 is in contact with the patient's tongue and automatically pause an Ν Μ therapy session based on the detection results. During one Ν I Ν m therapy, the patient may engage in exercise or other activities aimed at promoting neurorehabilitation therapy. For example, during Ν Μ therapy, the patient may engage in physical exercise, psychomotor, or cognitive exercise. In some embodiments, the controller 120 is provided with buttons on both arms. In some embodiments, the mobile device may be used in conjunction with the controller 120 and the mouthpiece 140. The mobile device may have a software application that allows the user to activate the neural stimulation system 100 and start or stop Ν I Ν m therapy sessions, e.g., by pressing a button on the mobile device or speaking a command to the mobile device. The mobile device may obtain medical record information or treatment course information of the patient before, during, or after the Ν I Ν m treatment course. In some embodiments, controller 120 includes a secure cryptoprocessor that holds keys, which will be described in more detail below in conjunction with fig. 9A and 9B. The secure cryptoprocessor is in communication with the microcontroller. The secure cryptoprocessor may be tamper resistant. For example, if someone removes the outside of the cryptographic processor in an attempt to obtain the key, the cryptographic processor will erase all memory, thereby preventing unauthorized access to the key.

Fig. 2C shows a non-invasive neurostimulation system 100. As shown, the mobile device 121 is in communication with a mouthpiece 140. More specifically, the mobile device 121 includes a processor running a software application that facilitates communication with the mouthpiece 140. The mobile device 121 may be, for example, a mobile phone, a Portable Digital Assistant (PDA), or a notebook computer. The mobile device 121 may communicate with the mouthpiece 140 via a wireless or wired connection. During operation, the patient may activate the neurostimulation system 100 via the mobile device 121. Following activation, the patient may initiate, stop, or pause a NINM treatment session by manipulating movement device 121. During one NINM treatment, the patient may engage in exercise or activities intended to assist in neurological rehabilitation therapy. For example, during a NINM treatment, the patient may be engaged in physical exercise, mental exercise, or cognitive exercise.

Fig. 3A shows internal circuitry housed within the controller 120. The circuitry includes a microcontroller 360, an isolation circuit 379, a Universal Serial Bus (USB) connection 380, a battery management controller 382, a battery 362, a button interface 364, a display 366, a real time clock 368, an accelerometer 370, drive circuitry 372, tongue sensing circuitry 374, audio feedback circuitry 376, vibration feedback circuitry 377, and a non-volatile memory 378. The driver circuit 372 includes a multiplexer and resistor array to control the voltage delivered to the electrode array 142. Microcontroller 360 is electrically connected to each of the components shown in fig. 3A. Isolation circuit 379 provides electrical isolation between USB interface 380 and all other components included in controller 120. In addition, the circuitry shown in FIG. 3A is communicatively coupled to the mouthpiece 140 via an external cable 144. During operation, microcontroller 360 receives power from battery 362 and may store and read information from non-volatile memory 378. The battery may be charged through USB interface 380. The battery management circuit controls the charging of the battery 362. The patient may interact with the controller 120 via the button interface 122, and the controller 120 may convert the patient's presses of buttons (e.g., information button, power button, intensity increase button, intensity decrease button, and start/stop button) into electrical signals that are transmitted to the microcontroller 360. For example, the controller 120 may initiate a therapy session when the patient presses a start/stop button after power up. During a treatment session, drive circuitry 372 provides electrical signals to mouthpiece 140 via cable 144. The electrical signal is delivered to the patient's mouth via the electrode array 142. The accelerometer 370 may be used to provide information about the patient's motion during a therapy session. The information provided by the accelerometer 370 can be stored in the non-volatile memory 378 at a coarse or detailed level. A treatment session integrated motion index based on, for example, the number of times the acceleration rises above a predetermined threshold, with or without low pass filtering, may be stored. Alternatively, the acceleration readings may be stored at predetermined sampling intervals. The information provided by the accelerometer 370 may be used to determine whether the patient is performing physical activity. Based on the information received from the accelerometer 370, the microcontroller 360 can determine the activity level of the patient during the course of the therapy session. For example, if the patient is engaged in 30 minutes of physical activity during a therapy session, accelerometer 370 may periodically (e.g., once per second) communicate sensed motion to microcontroller 360 that is greater than a predetermined threshold (e.g., greater than 1 rice/second 2). In some embodiments, accelerometer data is stored in non-volatile memory 378 during a therapy session and is sent to mobile device 121 after the end of the therapy session. After the treatment session is complete, microcontroller 360 can record the time that the patient's activity was recorded during the treatment session. In some embodiments, the recorded information may include other data about the therapy session (e.g., the date and time the session started, the average intensity of electrical nerve stimulation delivered to the patient during the session, the average activity level of the patient during the session, the duration of the session with the mouthpiece in the patient's mouth, the time the session was paused, the number of session short circuit events, and/or the length of the session or the type of motion or activity engaged in during the therapy) and may be transmitted to the mobile device. A session short circuit event may occur if the current delivered from the drive circuit to the electrode array 142 exceeds a predetermined threshold, or if the charge delivered from the drive circuit to the electrode array exceeds a predetermined threshold for a predetermined time interval. After a session short event occurs, the patient must manually press a button to resume the session. A Real Time Clock (RTC)368 provides time and date information to the microcontroller 360. In some embodiments, the controller 120 is authorized by the physician for a predetermined period of time (e.g., two weeks). The RTC 368 periodically provides date and time information to the microcontroller 360. In some embodiments, the RTC 368 integrates a microcontroller. In some embodiments, the RTC 368 is powered by the battery 362, and when the battery 362 fails, the RTC 368 is powered by a backup battery. After the predetermined period of time has elapsed, the controller 120 may no longer send an electrical signal to the mouthpiece 140 and the patient must visit the physician in order to regain authorization to use the controller 120. The information received by microcontroller 360 is displayed to the patient by display 366. For example, the display 366 may display the time of day, therapy information, battery information, remaining time of therapy sessions, error information, and status of the controller 120. When the state of the device changes, the audio feedback circuit 376 and the vibration feedback circuit 377 may be fed back to the user. For example, at the beginning of a treatment session, audio feedback circuit 376 and vibration feedback circuit 377 may provide audible and/or vibratory cues to the patient informing the patient that the treatment session has begun. Other possible state changes that can trigger an audio and/or vibration prompt include a pause in a therapy session, a resumption in a therapy session, an end of a session timing, a cancellation of a session timing, or an error message. In some embodiments, the clinician may turn off the feedback of one or more audible or vibratory cues to suit the needs of a particular patient. Tongue sensing circuit 374 measures the current from the drive circuit to the electrode array 142. Upon detecting a current above a predetermined threshold, the tongue sensing circuit 374 sends a high level to the microcontroller 360 indicating that the tongue is in contact with the electrode array 142. If the current is below a predetermined threshold, the tongue sensing circuit 374 sends a low level to the microcontroller 360 indicating that the tongue is not in contact or partially in contact with the electrode array 142. The indication received from the tongue sensing circuit 374 may be stored in non-volatile memory 378. In some embodiments, the display 366 may be an Organic Light Emitting Diode (OLED) display. In some embodiments, the display 366 may be a Liquid Crystal Display (LCD). In some embodiments, the display 366 does not include a controller 120. In some embodiments, neither the controller 120 nor the mouthpiece 140 include a cable, and the controller 120 is in wireless communication with the mouthpiece 140. In some embodiments, neither the controller 120 nor the mouthpiece 140 include an accelerometer. In some embodiments, the driver circuit 372 is located within the mouthpiece. In some embodiments, a portion of the drive circuitry 372 is located within the mouthpiece 140 and a portion of the drive circuitry 372 is located within the controller 120. In some embodiments, neither the controller 120 nor the mouthpiece 140 includes the tongue sensing circuit 374. In some embodiments, the mouthpiece 140 includes a microcontroller and a multiplexer.

Fig. 3B shows a more detailed view of fig. 2C. The mouthpiece 140 includes a battery 362, tongue sensing circuitry 374, an accelerometer 370, a microcontroller 360, drive circuitry 372, a non-volatile memory 378, a USB controller 380, and battery management circuitry 382. During operation, the microcontroller receives power from the battery 362 and can store and read the non-volatile memory 378. The battery may be charged through USB interface 380. The battery management circuit 382 controls charging of the battery 362. The patient may interact with the mouthpiece 140 via the mobile device 121. The mobile device 121 includes an application (e.g., software running on a processor) that allows the patient to control the mouthpiece 140. For example, the applications may include a visual information button, a power button, an intensity increase button, an intensity decrease button, and a start/stop button that are displayed to the user via the mobile device 121. When the patient presses a button displayed by an application running on the mobile device 121, a signal is sent to the microcontroller 360 housed within the mouthpiece 140. For example, a start/stop button on the mobile device 121 may be pressed by the patient to start a therapy session. During a treatment session, the drive circuit 372 provides electrical signals to the electrode array 142 located on the mouthpiece 140. The accelerometer 370 may be used to provide information about the patient's motion during a therapy session. The information provided by the accelerometer 370 may be used to determine whether the patient is performing physical activity. Based on the information received from the accelerometer 370, the microcontroller 360 can determine the activity level of the patient during the course of the therapy session. For example, if the patient is engaged in 30 minutes of physical activity during a therapy session, accelerometer 370 may periodically (e.g., once per second) communicate sensed motion to microcontroller 360 that is greater than a predetermined threshold (e.g., greater than 1 rice/second 2). After the treatment session is complete, microcontroller 360 can record the time that the patient's activity was recorded during the treatment session. In some embodiments, the accelerometer 370 is located within the mobile device 121, and the mobile device 121 determines the activity level of the patient during the therapy session based on information from the accelerometer 370. The mobile device may then record the length of the patient's activity during the treatment session. The mobile device 121 includes a real time clock 368 that provides time and date information to the microcontroller 360. In some embodiments, the mouthpiece 140 is authorized by the physician for a predetermined period of time (e.g., two weeks). After the predetermined period of time has elapsed, the mouthpiece 140 no longer sends electrical signals to the patient via the electrode array 142 and the patient must visit a physician to regain authorization to use the mouthpiece 140. In some embodiments, the mouthpiece 140 includes a button (e.g., an on/off button) and the patient can manually operate the mouthpiece 140 via the button. After a treatment session, the mouthpiece 140 may send information about the treatment session to the mobile device. In some embodiments, the mouthpiece 140 does not include a USB controller 380, but rather communicates with the controller only via wireless communication.

Fig. 3C shows a more detailed view of the electrode array 142. The electrode array 142 may be divided into 9 sets of electrodes labeled a through i, except that there are 15 electrodes in group b, each set of electrodes containing 16 electrodes. Each electrode within the group corresponds to one of the 16 electrical channels. During operation, the drive circuit may deliver a sequence of electrical pulses to the electrode array 142 to provide neural stimulation to at least one of the trigeminal or facial nerves of the patient. The electrical pulse amplitude delivered to each set of electrodes near the front of the tongue is larger and the electrical pulse amplitude delivered to each set of electrodes near the back of the tongue is smaller. For example, the pulse amplitude of the electrical signals delivered to groups a through c may be 19 volts or 100% of maximum, the pulse amplitude of the electrical signals delivered to groups d through f may be 14.25 volts or 75% of maximum, the pulse amplitude of the electrical signals delivered to groups g through h may be 11.4 volts or 60% of maximum, and the pulse amplitude of the electrical signals delivered to group i may be 9.025 volts or 47.5% of maximum. In some embodiments, the maximum voltage is in the range of 0 to 40 volts. The pulses delivered to the patient by the electrode array 142 may be random or repetitive. The position of the pulse may vary across the electrode array 142 such that different electrodes are activated at different times, and the duration and/or intensity of the pulse may also vary from electrode to electrode. For oral tissue stimulation, a current of 0.5 to 50 milliamps and a voltage of 1 to 40 volts may be used. In some embodiments, the transient current may be greater than 50 milliamps. The stimulation waveform may have various time-dependent forms, and for electrical skin stimulation pulse trains and pulse trains may be used. When pulses are provided continuously, the pulses may be 1 to 500 microseconds long and may be repeated at a rate of 1 to 1000 pulses/second. When pulses are delivered in bursts, the pulses may be grouped in 1 to 100 pulses/burst and delivered at a burst rate of 1 to 100 bursts/second.

In some embodiments, the pulse waveform is delivered to the electrode array 142. Fig. 3D shows an exemplary pulse sequence that may be delivered to electrode array 142 by drive circuitry 372. There are three bursts, each delivered to each of the 16 lanes 5 milliseconds apart. The pulses in adjacent channels are 312.5 microseconds apart from each other. The burst of pulses repeats every 20 milliseconds. The width of each pulse may vary from 0.3 to 60 microseconds to control the intensity of the neural stimulation (e.g., a pulse having a width of 0.3 microseconds will result in an amount of neural stimulation that is less than a pulse having a width of 60 microseconds).

Fig. 4A illustrates a method 400 of operation of the controller 120 described in fig. 2A, 2B, and 3A. The patient connects the mouthpiece 140 to the controller 120 (step 404). The patient turns on the controller 120 by using, for example, a power button (step 408). The patient rests the controller 120 on his/her neck (step 412), as shown in fig. 1B. The patient places a mouthpiece 140 in his/her mouth (step 416). The patient initiates a treatment session by pressing the start/stop button (step 420). During a treatment session, the controller 120 provides an electrical signal to the mouthpiece 140. The strength of the patient calibrated electrical signal (step 424). The patient increases the intensity of the electrical signal delivered to the mouthpiece by pressing an intensity increase button until the neural stimulation is above the patient's sensitivity level. The patient can press the intensity down button until the nerve stimulation is comfortable and not painful. After the calibration step, the patient may engage in a prescribed exercise (step 428). The exercise may be cognitive exercise, mental exercise, or physical exercise. In some embodiments, physical exercise may include the patient attempting to maintain a normal postural gait, or moving his/her limbs, or the patient receiving voice training. Cognitive exercises may include "brain training" exercises, typically computerized, designed to require the use of attention, memory or reading comprehension. Psychological exercises may include imagination, meditation, relaxation skills, gradual approach to mandatory behavior "triggers".

In some embodiments, the patient may rest for a period of time during the treatment session (e.g., the patient may rest for 2 minutes during a 30 minute treatment session). After a predetermined period of time (e.g., 30 minutes) has elapsed, the treatment session is ended (step 432) and the controller 120 stops delivering electrical signals to the mouthpiece 140. In some embodiments, the intensity of the electrical signal continuously increases from zero to the last usage level selected by the patient for a period of 1 to 5 seconds after the patient begins to start a therapy session by pressing the start/stop button. In some embodiments, after the patient initiates a therapy session by pressing the start/stop button, the strength of the electrical signal may be set to a fraction of the last used level selected by the patient (e.g., 3/4 for the last selected level). In some embodiments, after the patient begins the treatment session by pressing the start/stop button, the intensity of the electrical signal continuously increases from zero to a portion of the last used level selected by the patient (e.g., 3/4 for the last level selected) for a period of 1-5 seconds. In some embodiments, the intensity of the electrical signal increases momentarily from zero to a last use level selected by the patient after the patient begins the treatment session by pressing the start/stop button.

Fig. 4B illustrates a method 449 of operation of noninvasive neurostimulation system 100 of fig. 2C and 3B. The patient activates the mobile device 121 (step 450). The patient places the mouthpiece 140 in his/her mouth (step 454). The patient presses the start/stop button in the application running on the mobile device 121 to start the therapy session (step 458). During a treatment session, circuitry within the mouthpiece 140 provides electrical signals to an electrode array 142 located on the mouthpiece 140. The patient calibrates the strength of the electrical signal (step 462). The patient first increases the strength of the electrical signal delivered to the mouthpiece 140 by pressing an intensity increase button within the application running on the mobile device 121 until the neural stimulation increases above the patient's sensitivity level. The patient can press the intensity-down button within the application running on the mobile device 121 until the nerve stimulation is comfortable and not painful. After the calibration step, the patient engages in the prescribed exercise (step 464). The exercise may be cognitive exercise, mental exercise, or physical exercise. In some embodiments, the patient may rest for a period of time during the treatment session (e.g., the patient may rest for 5 minutes during a 30 minute treatment session). After a predetermined period of time (e.g., 30 minutes) has elapsed, the treatment session is ended (step 468) and the circuitry located within the mouthpiece 140 ceases to deliver electrical signals to the electrode array 142. In some embodiments, the calibration of the intensity of the electrical signal is performed before the patient initiates a therapy session.

Figures 5A-5F illustrate a mouthpiece 500. The mouthpiece 500 includes a housing 504, a gasket 508, a transition region 520, a rear region 524, a front region 528, a printed circuit board 532, internal circuitry 533, an electrode array 542, and a cable 544. Housing 504 includes a shell 505, longitudinal ribs 550, transverse ribs 551, posts 552, grooves 553, gussets 554, pockets 555, and a platform 558. The mouthpiece 500 has three regions, a posterior region 524, a transition region 520, and an anterior region 528. The transition region 520 smoothly connects the front region 528 and the rear region 524. A printed circuit board 532 is attached to the bottom surface of the housing 504. The internal circuit 533 is mounted to the top surface of the printed circuit board 532 and covered by the housing 504. The cable 544 may be in communication with the internal circuitry 533 described above, which may be in communication with the electrode array 542. The outer shell 505 of the housing 504 has an exemplary thickness in the range of 0.5 to 2 millimeters. The housing may be made of glass filled nylon, Acrylonitrile Butadiene Styrene (ABS), Polycarbonate (PC), Polyetheretherketone (PEEK), alloyed metals or metals, which have a compressive strength in the range of 375 to 590N. In some embodiments, the casing 505 has two different thicknesses. For example, the thickness of the front region of the casing 505 may be in the range of 1.2 to 2 millimeters, and the thickness of the rear region of the casing 505 may be in the range of 0.5 to 1.2 millimeters. The thickness of the casing 505 changes smoothly in the transition region so that there is no discontinuity or step in the thickness of the casing 505. In some embodiments, the thickness of the front region of the housing 505 is selected to withstand the bite of a patient. In some embodiments, the thickness of the posterior region of the housing 505 is selected to provide retention of the mouthpiece 500 to avoid accidental dislodgement of the mouthpiece 500. By itself, the shell 505 cannot withstand biting forces from the patient (e.g., the shell undergoes substantial deformation and/or undergoes plastic deformation). The longitudinal ribs 550, transverse ribs 551, struts 552, gussets 554, pockets 555, and platforms 558 may provide structural support to the housing 505 to prevent damage due to patient generated bite forces. The longitudinal ribs 550 may extend longitudinally along the housing 504. The plurality of longitudinal ribs 550 may be regularly arranged to form a plurality of grooves 553 between the longitudinal ribs as shown in fig. 5E. An internal circuit 533 may be located in the recess 553. In an exemplary embodiment, the longitudinal ribs 550 have a width ranging between 0.5 and 2 millimeters and a height ranging from approximately 6 millimeters at the rear region 524 to 1 millimeter at the front region 528. In some embodiments, the plurality of longitudinal ribs are irregularly arranged, with the spaces between the longitudinal ribs being larger toward the perimeter of the casing 505 and smaller toward the central portion of the casing 505. In some embodiments, the longitudinal ribs are spaced apart 4 to 0.9 mm at their centers. Lateral ribs 551 may be located in the rear region 524 and span the width of the housing 504. The transverse ribs may be regularly arranged as shown in fig. 5E. In an exemplary embodiment, the transverse ribs 551 have a width in the range of 0.5 to 105 millimeters and a height in the range of 4 to 7 millimeters. In some embodiments, the transverse ribs 551 may intersect the longitudinal ribs 550, forming pockets 555 as shown in fig. 5E. Internal circuitry 533 may also be located in these pockets 555, which in some embodiments are non-regularly arranged, with the spaces between the longitudinal ribs being larger toward the perimeter of the housing 505 and smaller toward the central portion of the housing 505. The post 552 may have a rectangular cross-section and be located in the front region 528 of the housing 504. In some embodiments, one or more struts 552 are regularly arranged and span the width of housing 504. The struts 552 may provide resistance to compressive forces exerted on the mouthpiece 500, thereby providing protection to the internal circuitry 533. The pillars 552 have a thickness in the range of 0.5 to 2 millimeters. In some embodiments, the height of the strut 552 is greater than the thickness of the internal circuit 533, thereby providing a gap between the internal circuit 533 and the housing 505. In some embodiments, the height of the post 552 is at least 1 millimeter greater than the thickness of the internal circuit 533. In some embodiments, the platforms 558 are directly connected to one or more longitudinal ribs and one or more transverse ribs, thereby providing an increased ability to withstand shear and compression loads. The thickness of the platform 558 may range between 1.5 to 3.5 millimeters. In some embodiments, gussets 554 comprise a layer of material having a thickness greater than the thickness of shell 505. The thickness of the gussets 554 may be in the range of 0.5 to 2 millimeters. In some embodiments, the thickness of the shell 505 in the area of the gussets 554 is less than in the area of the other adapter pads 508. For example, the thickness of the shell may be 1.5 mm in the front and rear regions and 0.5 mm in the region at the strut 554. During operation, a portion of the patient puts a mouthpiece 500 in the mouth for a NINM treatment session. The patient engages the mouthpiece 500 with his/her anterior teeth to determine the position of the fixed mouthpiece. The patient's lower teeth may contact the printed circuit board 532 and the patient's tongue may contact the electrode array 542. In some embodiments, the patient relaxes his/her mouth to fix the position of the mouthpiece. The internal circuitry delivers electrical neural stimulation signals to the patient's tongue through the electrode array 542. In some embodiments, the pad 508 may provide a soft and comfortable bite surface so that pressure does not concentrate on a small area of the mouthpiece 500 that the patient bites into. For example, the gasket 508 may be made of Thermoplastic Polyurethane (TPU), thermoplastic elastomer (TPE), or silicone. In some embodiments, transverse ribs 551 are located at the forward region and transverse to the width of housing 504.

Fig. 6A-6B show a more detailed view of the housing 505. The housing includes a glue well 570, inner fins 561 and 562, and a central longitudinal axis 590. The inner fin includes at least a pair of inlet fins 561. The inlet fins 561 may be symmetrical about the longitudinal axis 590 and may direct the cable 544 along the longitudinal axis 590 without substantial bending of the cable itself. Glue, adhesive or epoxy may provide a rigid mechanical connection between the cable 544 and the inlet fins 561. For example, the glue, adhesive or epoxy may be a UV curable adhesive or cyanoacrylate. The inner fins may also include an even number of guide fins 562. In some embodiments, the inner fins include an odd number of guide fins 562. For example, the inner fin may include 3 guide fins 562. In some embodiments, the guide fins 562 are not symmetrical about the longitudinal axis 590, each guide fin 562 causing an approximately 90 degree bend in the cable 544, each bend having a radius of curvature approximately equal to two diameters of the cable 544. In some embodiments, each guide fin 562 causes the cable 544 to bend more than 90 degrees but less than 180 degrees. The guide fins 562 are in mechanical contact with the cable 544 and provide a means for compensating for any tensile strain frictional resistance applied to the cable, for example due to longitudinal forces applied along the cable 544. In some embodiments, the guide fins 562 provide a frictional resistance of at least 100 newtons. In some embodiments, the guide fins provide a frictional resistance greater than the weight of the mouthpiece. In some embodiments, the guide fins provide a frictional resistance greater than the amount of force required to disconnect the mouthpiece 140 from the controller 120. In some embodiments, where the housing 505 provides resistance against any bending strain applied to the cable 544, a rubber grommet 563 provides a resilient mechanical connection between the housing 505 and the cable 544 (e.g., the patient may accidentally pull or drag on the cable when the mouthpiece 500 is secured in the patient's mouth). In some embodiments, spacer 508 includes a resilient member to provide a mechanical connection between cable 544 and inlet fins 561. The resilient member provides a frictional force that provides a frictional resistance for resisting any bending stresses applied to the cable 544. In some embodiments, the cable 544 may exit the housing at a 90 degree angle and be attached to the housing by an epoxy that provides up to 100 newtons of mechanical resistance to accommodate bending strain induced by the patient. In some embodiments, cable 544 is attached to the housing by an adhesive or glue. In some embodiments, the cable 544 may exit the housing at a 90 degree angle and be mechanically attached to the housing by a right angle elastic member that interlocks with the housing and provides a mechanical resistance of up to 100 newtons to accommodate patient induced bending and tensile strains.

Fig. 6C shows a more detailed cross-sectional view of the glue wells 570. Glue wells 570 follow the outer boundaries of the housing 505 and are used to receive an adhesive (e.g., a biomedical compatible epoxy or glue) to provide a mechanical connection between the printed circuit board 532 and the housing 505. The glue puddle 570 includes an inclined edge 571 and a discontinuously connected cross-section including a recess 572 and a vertical portion 573, the recess 572 and vertical portion 573 intersecting to form the lowest point of the glue puddle 570. In some embodiments, the shape of the glue wells may be trapezoidal. In some embodiments, the shape of the puddle may be wedge-shaped. In some embodiments, the shape of the glue wells may be triangular. In some embodiments, the switches of the glue wells may be rectangular. In some embodiments, a portion of the glue wells may protrude above the printed circuit board 532, thereby protecting the patient's teeth from damage to the portion of the printed circuit board. In some embodiments, the adhesive is in contact with the top of the housing 505 and the printed circuit board 532. In some embodiments, the adhesive is in contact with the top and sides of the housing 505 and the printed circuit board 532. In some embodiments, the glue wells are shaped such that the adhesive is in contact with the side of the housing 505, the printed circuit board 532, but is in negligible contact with the top of the printed circuit board 532 (e.g., the glue wells have a width greater than their depth).

Fig. 6D shows an embodiment in which the casing 505 includes two glue wells 570 and 574. First and second glue wells 570, 574 are disposed along an outer boundary of housing 505 and are for receiving an adhesive (e.g., a biomedical compatible epoxy or glue) to provide a mechanical connection between printed circuit board 532 and housing 505. The second glue wells 574 are designed to accommodate glue or adhesive that overflows from the first glue wells 570, thereby preventing glue or adhesive from overflowing onto the bottom side of the printed circuit board. Step 578 is located between the first puddle and the second puddle to define a height of the first puddle.

Figures 7A-7C illustrate a mouthpiece 700. The mouthpiece 700 includes a housing 705 having a central longitudinal axis 790, a spacer 708, a cable 744, a sleeve 764, outlet fins 761, a glue well 770. Sleeve 764 is integral with cable 744 and mechanically couples cable 744 to housing 705. The sleeve 764 includes two tapered outer portions 765 and a gap 766 separating the two tapered outer portions. The cable 744 may be pulled toward the housing 705 until the gap 766 aligns with the outer boundary of the mouthpiece 700. Once aligned with housing 705, sleeve 764 provides up to 100 newtons of mechanical resistance to counteract the tensile and bending stresses applied to cable 744. As shown in fig. 7C, cable 744 may also be sandwiched between printed circuit board 732 and housing 705. The additional clamping may provide additional mechanical resistance to tensile stress applied to cable 744.

Figures 8A-8D illustrate a mouthpiece 800. The mouthpiece 800 includes a housing 805, a gasket 808, a printed circuit board 832, a cable 844, a sleeve 864, a glue hole 870, and a clamp 809. The rear of the cable 844 is connected to the printed circuit board 832 by solder, ribbon connector or other mechanical connection. Sleeve 864 is integral with cable 844 and mechanically couples cable 844 with housing 805, clamp 809. The sleeve 864 is similar to the sleeve 764 having two tapered outer portions and a gap. Instead of being pulled through housing 805 as shown in fig. 7, sleeve 864 is held by clamp 809 attached to the bottom of housing 805. Clip 809 mechanically secures printed circuit board 832 to housing 805, and in addition, secures sleeve 864 to housing 805. In some embodiments, an adhesive or glue is added to glue wells 870 to secure printed circuit board 832 to housing 805. The sleeve 864 provides mechanical resistance (up to 100 newtons) to bending and tensile stresses in the cable 844. Clamp 809 includes a rigid plastic portion 809b and a resilient portion 809 a. Rigid plastic portion 809b provides structural integrity, while resilient portion 809a provides a sealing mechanism. For example, a clamp 809 can be placed in contact with the housing 805 as shown in fig. 8D. A narrow protrusion 810 extends from rigid plastic portion 809b of clamp 809, narrow protrusion 810 interlocking with recess 806 of housing 805. Resilient portion 809a contacts housing 805, glue wells 870, and printed circuit board 832, forming an airtight seal. The hermetic seal may protect portions of the printed circuit board 832 from moisture. In some embodiments, the clamp 809 is secured to the housing 805 by adding adhesive or glue to the glue wells 870 contacting the housing and the clamp.

Figures 9A-9C illustrate a mouthpiece 900. The mouthpiece 900 includes a housing 905, a printed circuit board 932, a cable 944, a glue well 970, and a boot 945. The housing 905 includes a recess 971 and a glue well 970. The groove 971 guides the cable 944 into the housing 905 and the glue pit 970 contains an epoxy or other adhesive to provide a mechanical connection between the printed circuit board 932, the housing 905, and the cable 944. The shape of the glue pits 970 may be wedge-shaped to advantageously provide an interface between the adhesive or epoxy and the printed circuit board 932, the housing 905, and the cable 944. A tab 946 extends from the housing 905 and interlocks with the recess 947 of the shoe 945. The interlocked shoes 945 mechanically contact along the outer diameter of the cable 944 (e.g., the interlocked shoes 945 may contact the outer diameter of the cable 944 a distance of 0.5 to 10 mm). In some embodiments, the interlocked shoes 945 can be overmolded or glued onto the cable 944. In some embodiments, the interlocked shoes 945 are mechanically connected to the cable 944. The interlocked shoes 945 may provide mechanical resistance for resisting patient traction or pulling (e.g., up to 100 newtons) of the cable. In some embodiments, the interlocked shoes 945 may provide resistance to both bending and tensile strains. In some embodiments, the boot 945 may cover the glue well 970. In some embodiments, the shoe 945 may be extended to cover portions of the printed circuit board 932 not covered by the electrode array.

Figures 10A-10C illustrate a mouthpiece 1000. The mouthpiece 1000 includes a housing 1005, a printed circuit board 1032, a cable 1044, a groove 1071, a sealing ring 1081, and a spring 1080. No epoxy and/or adhesive is present in the mouthpiece 1000. The printed circuit board 1032 contacts the seal ring 1081 and retains its position by the spring 1080. The clips 1080 may have vertical sidewalls and downwardly sloping depending ends as shown in fig. 10B. In some embodiments, the clips are spaced apart along an inner boundary of the housing 1005. The cable 1044 is electrically connected to the printed circuit board 1032. In addition, the seal ring 1081 forms a hole in the front region of the housing 1005 through which the cable 1044 passes. The groove 1071 guides the cable 1044 from the printed circuit board 1132 to the above-mentioned hole. The holes contact the cable 1044 and provide a force against the patient pulling or pulling the cable 1044. In some embodiments, the holes may provide resistance to bending and tensile strain on the cable 1044. In some embodiments, the seal ring 1081 is composed of a low durometer elastomer such as TPE, TPU, or silicone. In some embodiments, the sealing ring may be replaced by a glue well or glue layer.

Figures 11A-11C illustrate a mouthpiece 1100. The mouthpiece 1100 includes a housing 1105, a printed circuit board 1132, a cable 1144, and a fastener 1191. The housing includes a glue well 1170, a recess 1117, and a port 1172 that is shaped to fit a fastener 1191. The glue wells 1170 may receive epoxy or other adhesive that connects the housing 1105 to the printed circuit board 1132. The cable 1144 is connected to the printed circuit board 1132 by solder, ribbon cable, or other mechanical connection. The cable rests in recess 1117 before exiting from port 1172. At port 1172, an O-ring surrounds the cable 1144. A fastener 1191 is attached to the housing 1105 at the location of port 1172. The fastener applies a force to the O-ring to retain the cable at the port. The O-ring along with the fastener 1172 protects the cable from being pulled or pulled by the patient. In some embodiments, the O-ring and fastener 1172 provide resistance to bending and tensile strain. In some embodiments, an epoxy or adhesive surrounds the cable 1144 at port 1172.

Figure 12 illustrates a method 1200 of making a mouthpiece like the mouthpiece shown in figure 15. First, a housing is provided (step 1204). A gasket is attached to the housing (step 1208). In some embodiments, the gasket is molded directly onto the housing. In some embodiments, the gasket is attached to the housing by an adhesive or glue. The housing is attached to a printed circuit board (step 1212). In some embodiments, the housing is molded directly onto the printed circuit board. The molded housing may be wrapped around the edges of the printed circuit board and form edges on the bottom side of the printed circuit board for better engagement. In some embodiments, features may be added to the printed circuit board (e.g., counter-sunk holes, beveled edges of the board, stepped edges of the board, tongue and groove edges of the board) so that the plastic hardens around the features when the molded housing is molded onto the board to create a better joint. In some embodiments, the housing is attached to the printed circuit board by an adhesive and/or mechanical clips, or the like. In some embodiments, the housing is attached to the printed circuit board by a mechanical bond. In some embodiments, the housing is attached to the printed circuit board by chemical bonding. In some embodiments, an attached housing covers and encapsulates surface-mounted electronic components on a printed circuit board while leaving the electrode array exposed so that the electrode array can be placed in contact with the patient's tongue for NINM treatment. The cable is provided (step 1216). The cable is connected to the printed circuit board (step 1220). In some embodiments, the cable is connected to the printed circuit board prior to molding the housing onto the printed circuit board. After the molding process, the cable may be encapsulated by the housing portion. In some embodiments, the housing is molded onto the printed circuit board in two steps. In a first step, a first injection molding of plastic can be molded onto the board, wherein the mold temperature and pressure are sufficiently low that it is not harmful to the electrical components on the board. A first shot may be used to close the elements and thereby protect them. The first shot may be a softer material (TPE, TPU) or a rigid material (Polyamide, polyofm) with lower mold pressure and/or temperature. A second shot is molded over at least a portion of the first shot, wherein the mold is at a higher temperature and pressure than the first shot. The second shot may be a harder, more durable material (e.g., nylon or glass filled nylon, ABS, PC, etc.). In some embodiments, the housing is molded onto and completely surrounds the printed circuit board such that only the electrode array is not covered by the housing. In this case, the printed circuit board material does not come into contact with the patient, thereby protecting the patient in the case of harmful printed circuit board material. In some embodiments, the electrode array is non-planar on the printed circuit board (e.g., the electrode array may protrude a distance of 0.1 to 1 millimeter from the printed circuit board). In some embodiments, the electrode array is an array of pins protruding from a printed circuit board. The pin array remains exposed after the housing is molded onto the printed circuit board.

Fig. 13A and 13B illustrate a mouthpiece 1300, the mouthpiece 1300 being manufactured by overmolding the housing 1304 directly onto the printed circuit board 1332. The mouthpiece 1300 includes a pad 1308 and a cable 1344. In some embodiments, the printed circuit 1332 board includes features for mechanically engaging the molded housing 1304 (e.g., beveled edges of the board, stepped edges of the board, cut-out edges of the board, etc.). In some embodiments, the molded housing 1304 may be wrapped around an edge of the printed circuit board 1332 and form an edge on the bottom side of the printed circuit board to mechanically engage the printed circuit board 1332. In some embodiments, the printed circuit board includes a counterbore 1340. When the housing 1304 is molded onto a printed circuit board, the counterbore is filled with plastic. A rivet is formed within the counterbore 1340, which is an integral part of the housing 1304. The tapered shape of the rivet provides a force that holds the printed circuit board 1332 in mechanical contact with the housing 1304.

FIG. 14 shows a mouthpiece 1400 according to a dual injection molding manufacturing method, where injection molding refers to the volume of material used to fill the mold cavity and compensate for material shrinkage. The mouthpiece 1400 includes a housing 1404, a printed circuit board 1432, a cable 1444, and a frame 1450. Frame 1450 is formed around printed circuit board (one or both sides) 1432 during the first shot, which provides a seal between the printed circuit board and the external environment. Housing 1404 is formed around printed circuit board 1432 and frame 1450 during a second shot to enclose and chemically bond the elements on printed circuit board 1432 to frame 1450. The first cold shot and the second shot may be rigid, elastomeric, or a combination of both.

The terminology used herein is for the purpose of describing particular embodiments and is not intended to be limiting of the inventive concept. It will be understood that, although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present application.

While the inventive concept has been particularly shown and described with reference to exemplary embodiments thereof, it will be understood by those of ordinary skill in the art that various changes in form and details may be made therein without departing from the spirit and scope of the inventive concept as described and defined by the following claims.

Claims (99)

1. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having an anterior region and a posterior region, said elongated housing having (i) a non-planar exterior top surface and (ii) a plurality of internal structural members mounted within the housing, said internal structural members being resiliently responsive to a biting force generated by the patient;

a spacer attached to the top surface of the housing for limiting contact between the patient's upper teeth and the outer top surface of the elongated housing;

a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue.

2. The mouthpiece of claim 1 further comprising a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing.

3. The mouthpiece of claim 1 further comprising a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing.

4. The mouthpiece of claim 1 further comprising a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing and a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing.

5. The mouthpiece of claim 1 further comprising a plurality of ribs of the interpenetrating network structure wherein at least some of the ribs are aligned parallel to the longitudinal axis of the elongated housing and at least some of the ribs are aligned perpendicular to the longitudinal axis of the elongated housing.

6. The mouthpiece of claim 5 further comprising pockets formed by ribs of the interpenetrating network structure in a posterior region of the elongated housing.

7. The mouthpiece of claim 6 further comprising an integrated circuit located in the pocket.

8. The mouthpiece of claim 2 wherein the ribs have a rectangular cross-section.

9. The mouthpiece of claim 2 wherein the ribs are comprised of arches.

10. The mouthpiece of claim 1 further comprising one or more struts extending away from an inner surface of the elongated housing, the one or more clouds configured to contact a mounted printed circuit board.

11. The mouthpiece of claim 1 wherein the plurality of structural members can withstand a force of 700N without causing plastic deformation of the mouthpiece.

12. The mouthpiece of claim 5 further comprising a rectangular plate embedded in the interior surface of the elongated housing and located in the rear region of the elongated housing, the rectangular plate connecting the ribs of the interpenetrating network structure.

13. The mouthpiece of claim 5 further comprising a curved tab embedded in the interior surface of the elongated housing at a region connecting the anterior region and the posterior region of the elongated housing, the curved tab connecting ribs aligned parallel to the longitudinal axis of the elongated housing.

14. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having an anterior region and a posterior region, said elongated housing having (i) a non-planar exterior top surface and (i i) a plurality of internal structural members mounted within the housing, said internal structural members being resiliently responsive to a biting force generated by the patient; and

a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue.

15. The mouthpiece of claim 14 further comprising a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing.

16. The mouthpiece of claim 14 further comprising a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing.

17. The mouthpiece of claim 14 further comprising a plurality of ribs aligned parallel to the longitudinal axis of the elongated housing and a plurality of ribs aligned perpendicular to the longitudinal axis of the elongated housing.

18. The mouthpiece of claim 14 further comprising a plurality of ribs of the interpenetrating network structure wherein at least some of the ribs are aligned parallel to the longitudinal axis of the elongated housing and at least some of the ribs are aligned perpendicular to the longitudinal axis of the elongated housing.

19. The mouthpiece of claim 18 further comprising pockets formed by ribs of the interpenetrating network structure in a posterior region of the elongated housing.

20. The mouthpiece of claim 19 further comprising an integrated circuit located in the pocket.

21. The mouthpiece of claim 15 wherein the ribs have a rectangular cross-section.

22. The mouthpiece of claim 15 wherein the ribs are comprised of arches.

23. The mouthpiece of claim 14, further comprising one or more struts extending away from the inner surface of the elongated housing, the one or more clouds configured to contact a mounted printed circuit board.

24. The mouthpiece of claim 14 wherein the plurality of structural members can withstand a force of 700N without causing plastic deformation of the mouthpiece.

25. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having a front region and a rear region, the elongated housing having a non-planar interior top surface and a plurality of interior fins located between the non-planar interior top surface and the bottom surface of the elongated housing, the plurality of interior fins defining a channel at the front region of the elongated housing;

a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing; a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue; and

a cable having a first section mounted within the housing and a second section extending from the housing, the cable mounted in an S-shape along the channel formed by the inner fin.

26. The mouthpiece of claim 25 further comprising a right angle grommet mounted to the forward region of the elongated housing, the grommet covering the cable as it extends from the passageway formed by the inner fins, the grommet forcing the cable to make an approximately 90 degree bend as it extends out of the elongated housing.

27. The mouthpiece of claim 25 wherein the cable forms two continuous S-shapes along the channel formed from the inner fin.

28. The mouthpiece of claim 25 further comprising a grommet mounted to the anterior region of the elongated housing, the grommet covering the cable as the cable extends from the channel formed by the inner fins.

29. The mouthpiece of claim 25 further comprising a cylindrically symmetric resilient member, the resilient member covering a portion of the cable and having a groove in a central portion thereof and being surrounded by two regions of decreasing radius as the distance from the groove increases.

30. The mouthpiece of claim 29 further comprising an aperture in an anterior region of the elongated housing, the aperture configured to form a mechanical connection with the slot.

31. The mouthpiece of claim 29 further comprising a cover having a flexible portion for connecting to the printed circuit board and a rigid portion for connecting to the elongated housing, the cover and the elongated housing together forming an aperture in a front region of the mouthpiece, the aperture configured to form a mechanical connection with the slot.

32. The mouthpiece of claim 25 further comprising a groove in an inner surface of the elongated housing, the groove configured to receive a cable.

33. The mouthpiece of claim 25 including an elastomeric sleeve in contact with the cable, the forward region of the elongated housing, the elastomeric sleeve providing resistance to bending and tensile strain in the cable.

34. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having a front region and a rear region, the elongated housing having a non-planar interior top surface and a bottom surface defined by a perimeter of the elongated housing;

a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing;

a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue;

a first resilient ring disposed along an inner sidewall of the elongated housing, the first resilient ring forming a sealing surface against the printed circuit board;

a plurality of mechanical protrusions extending from an inner sidewall of the elongated housing, the plurality of mechanical protrusions contacting the printed circuit board;

a cable having a first section within the housing and a second section extending from the housing, one end of the first section of the cable being connected to the printed circuit board.

35. The mouthpiece of claim 34 further comprising a groove in an inner surface of the elongated housing, the groove configured to receive a cable.

36. The mouthpiece of claim 34 further comprising a plurality of internal fins extending from the internal top surface of the elongated housing, the plurality of internal fins forming a channel in an anterior region of the elongated housing.

37. The mouthpiece of claim 36, wherein the cable forms at least two continuous S-shapes along the channel formed by the plurality of internal fins.

38. The mouthpiece of claim 34 including a second resilient loop attached to the first resilient loop, the second resilient loop surrounding a portion of the cable forming a connection between the front region of the elongated housing and the cable.

39. The mouthpiece of claim 34 including a second resilient loop attached to the first resilient loop, the second resilient loop covering a portion of the cable forming a connection between the forward region of the elongated housing and the cable, the second resilient loop causing the cable to extend away from the mouthpiece at a 90 degree right angle.

40. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having a front region and a rear region, the elongated housing having a non-planar interior top surface and a plurality of interior fins located between the non-planar interior top surface of the elongated housing and a bottom surface defined by a perimeter of the elongated housing, the plurality of interior fins forming a channel at the front region of the elongated housing;

a printed circuit board mounted to the bottom of the elongated housing, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue; and

a cable having a first section within the housing and a second section extending from the housing, the cable mounted in an S-shape along the channel formed by the plurality of internal fins, an end of the first section of the cable connected to the printed circuit board.

41. The mouthpiece of claim 40 further comprising a right angle grommet mounted to the forward region of the elongated housing, the grommet covering the cable as it extends from the channel formed by the inner fins, the grommet forcing the cable to make an approximately 90 degree bend as it extends out of the elongated housing.

42. The mouthpiece of claim 40, wherein the cable forms two continuous S-shapes along the channel formed from the inner fin.

43. The mouthpiece of claim 40 further comprising a grommet mounted to the anterior region of the elongated housing, the grommet covering the cable as the cable extends from the channel formed by the inner fins.

44. The mouthpiece of claim 40 further comprising a cylindrically symmetric resilient member, the resilient member covering a portion of the cable and having a groove in a central portion thereof and being surrounded by two regions of decreasing radius as the distance from the groove increases.

45. The mouthpiece of claim 44 further comprising an aperture in an anterior region of the elongated housing, the aperture configured to form a mechanical connection with the slot.

46. The mouthpiece of claim 44 further comprising a cover having a flexible portion for connecting to the printed circuit board and a rigid portion for connecting to the elongated housing, the cover and the elongated housing together forming an aperture in a front region of the mouthpiece, the aperture configured to form a mechanical connection with the slot.

47. The mouthpiece of claim 40 further comprising a groove in an inner surface of the elongated housing, the groove configured to receive a cable.

48. The mouthpiece of claim 40 further comprising an elastomeric sleeve in contact with the cable, the forward region of the elongated housing, the elastomeric sleeve providing resistance to bending and tensile strain in the cable.

49. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having a front region and a rear region, the elongated housing having a non-planar exterior top surface;

a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing; a first printed circuit board mounted to the bottom of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue;

a rim extending from the bottom of the elongated housing, the rim surrounding the perimeter of the first printed circuit board and having a U-shaped cross-section; and

a well shaped to receive an adhesive that bonds the first printed circuit board to the elongated housing.

50. The mouthpiece of claim 49 wherein a portion of the rim rests against an underside of the first printed circuit board to prevent the patient's teeth from contacting the printed circuit board.

51. The mouthpiece of claim 49, wherein the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board.

52. The mouthpiece of claim 49, wherein the first printed circuit board has a curvilinear shape and the plurality of electrodes are located on the curvilinear shaped surface of the first printed circuit board.

53. The mouthpiece of claim 49, wherein the plurality of electrodes in an anterior region of the first printed circuit board have a first density and the plurality of electrodes in a posterior region of the first printed circuit board have a second density, wherein the first density is greater than the second density.

54. The mouthpiece of claim 49 further comprising a second printed circuit board mounted on the first printed circuit board.

55. The mouthpiece of claim 49 wherein the rim is integral with the elongated housing.

56. The mouthpiece of claim 49 wherein the rim is sized to form a glue pocket between the bottom of the elongated housing and the perimeter of the first printed circuit board.

57. The mouthpiece of claim 49 wherein the rim is concentric with the perimeter of the first printed circuit board.

58. The mouthpiece of claim 49 wherein the rim covers a bottom portion of the first printed circuit board along a perimeter of the first printed circuit board.

59. The mouthpiece of claim 49 wherein the rim covers a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

60. The mouthpiece of claim 49 wherein the rim covers a bottom portion and a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

61. A mouthpiece for providing non-invasive neuromodulation to a patient, the mouthpiece comprising:

an elongated housing having a front region and a rear region, the elongated housing having a non-planar exterior top surface;

a spacer attached to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing; a first printed circuit board mounted to the bottom of the elongated housing, the first printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue;

a rim extending from the bottom of the elongated housing, the rim surrounding a perimeter of the first printed circuit board; and

a beveled pit shaped to receive an adhesive for bonding at least two orthogonal surfaces of the first printed circuit board to the elongated housing.

62. The mouthpiece of claim 49 wherein a portion of the rim rests against an underside of the first printed circuit board to prevent the patient's teeth from contacting the first printed circuit board.

63. The mouthpiece of claim 49, wherein the first printed circuit board is non-planar and the plurality of electrodes are located on a non-planar surface of the first printed circuit board.

64. The mouthpiece of claim 49, wherein the first printed circuit board has a curvilinear shape and the plurality of electrodes are located on the curvilinear shaped surface of the first printed circuit board.

65. The mouthpiece of claim 49, wherein the plurality of electrodes in an anterior region of the first printed circuit board have a first density and the plurality of electrodes in a posterior region of the first printed circuit board have a second density, wherein the first density is greater than the second density.

66. The mouthpiece of claim 49 further comprising a second printed circuit board mounted on the first printed circuit board.

67. The mouthpiece of claim 49 wherein the rim is integral with the elongated housing.

68. The mouthpiece of claim 49 wherein the rim is sized to form a glue pocket between the bottom of the elongated housing and the perimeter of the first printed circuit board.

69. The mouthpiece of claim 49 wherein the rim is concentric with the perimeter of the first printed circuit board.

70. The mouthpiece of claim 49 wherein the rim covers a bottom portion of the first printed circuit board along a perimeter of the first printed circuit board.

71. The mouthpiece of claim 49 wherein the rim covers a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

72. The mouthpiece of claim 49 wherein the rim covers a bottom portion and a sidewall portion of the first printed circuit board along a perimeter of the first printed circuit board.

73. A method of manufacturing a mouthpiece for providing non-invasive neuromodulation to a patient, the method comprising:

providing an elongated housing having a plurality of inner fins located between a non-planar inner top surface of the elongated housing and a bottom surface defined by a perimeter of the elongated housing, the plurality of inner fins forming a channel at a front region of the elongated housing;

attaching a spacer to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing;

installing a cable in an S-shape along the channel formed by the inner fin;

mounting a circuit board to the bottom of the elongated housing, the circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue; and

one end of the cable is connected to the printed circuit board.

74. The method of claim 73, further comprising forming the cable into a 90 degree bend at the exit of the elongated housing.

75. The method of claim 73, further comprising: the cable is passed through a resilient member located at the outlet of the elongate housing.

76. The method of claim 73, further comprising: two successive S-shapes are formed along the cable.

77. A method as claimed in claim 73, comprising mounting to the cable a cylindrically symmetric resilient member which surrounds a portion of the cable and has a groove in its central portion, and is surrounded by two regions of decreasing radius with increasing distance from the groove.

78. The method of claim 77, further comprising forming an aperture in a front region of the elongated housing, the aperture configured to form a mechanical connection with the slot.

79. The method of claim 77, further comprising providing a cap having a flexible portion and a rigid portion.

80. The method of claim 79 further comprising contacting the printed circuit board with a resilient portion of the cover and contacting the elongated housing with a rigid portion of the cover.

81. The method of claim 80, further comprising using a cap and an elongated housing to cooperate to form an aperture configured to form a mechanical connection with the slot.

82. The method of claim 73, further comprising forming a groove in an inner surface of the elongated housing.

83. The method of claim 82, further comprising positioning a cable in the recess.

84. The method of claim 73, further comprising forming an elastomeric sleeve around the cable, the elastomeric sleeve providing bending resistance and tensile strain resistance in the cable.

85. The method of claim 73, further comprising: an adhesive is applied along the perimeter of the printed circuit board for adhering at least two orthogonal surfaces of the first printed circuit board to the elongated housing.

86. A method of manufacturing a mouthpiece for providing non-invasive neuromodulation to a patient, the method comprising:

providing an elongated housing having a plurality of mechanical protrusions extending from an inner sidewall of the elongated housing and a first resilient ring positioned along the inner sidewall of the elongated housing;

attaching a spacer to the top surface of the housing for minimizing contact of the patient's upper teeth with the outer top surface of the elongated housing;

contacting a printed circuit board to the first elastomeric ring of the elongated housing to form a seal, the printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to the patient's tongue;

providing a cable having a first section mounted to the housing and a second section extending away from the housing; and

one end of the first section of the cable is connected to the printed circuit board.

87. The method of claim 86, further comprising forming the cable into a 90 degree bend at the exit of the elongated housing.

88. The method of claim 86, further comprising: the cable is passed through a resilient member located at the outlet of the elongate housing.

89. The method of claim 86, further comprising: two successive S-shapes are formed along the cable.

90. A method as claimed in claim 73, comprising mounting to the cable a cylindrically symmetric resilient member which surrounds a portion of the cable and has a groove in its central portion, and is surrounded by two regions of decreasing radius with increasing distance from the groove.

91. The method of claim 90, further comprising forming an aperture in a front region of the elongated housing, the aperture configured to form a mechanical connection with the slot.

92. The method of claim 73, further comprising forming a groove in an inner surface of the elongated housing.

93. The method of claim 92 further comprising positioning a cable in the recess.

94. The method of claim 73, further comprising forming an elastomeric sleeve around the cable, the elastomeric sleeve contacting a front region of the elongate housing, the elastomeric sleeve providing bending resistance and tensile strain resistance in the cable.

95. A method of manufacturing a mouthpiece for providing non-invasive neuromodulation to a patient, the method comprising:

providing a printed circuit board having a plurality of electrodes for delivering subcutaneous local electrical stimulation to a patient's tongue;

fabricating an elongated housing directly onto the printed circuit board; and attaching a spacer to the top surface of the elongated housing for minimizing contact between the patient's upper teeth and the top surface of the elongated housing.

96. The method of claim 95, further comprising forming the strain relief mechanism integral with the elongated housing.

97. The method of claim 96 further comprising providing a cable having a first section mounted within the housing and a second section extending away from the housing.

98. The method of claim 97, further comprising connecting an end of the first section of the cable to a printed circuit board.

99. The method of claim 95, further comprising encapsulating the electronic circuit on a printed circuit board.