Adjustable TMJ Headband

DESCRIPTION:

Temporomandibular Joint disorder, commonly known as TMJ frequently exhibits symptoms of pain and limited mobility of the jaw and surrounding tissue. TMJ affects people of all ages, and the discomfort it causes can range from mild to severe. According to experts, as many as ten million Americans suffer from some level of TMJ.

The causes of TMJ is often indeterminable, but sometimes it is attributed to medical and dental issues, trauma to the joint or joints, arthritis, grinding of the teeth and many other causes. Regardless of the reason, the resulting TMJ pain and discomfort forces many people to seek medical treatments for relief. Temporary treatments can range from changing eating habits such as resorting to soft foods, applying ice, avoiding extending the jaw and mouth, over the counter medications for pain, and other treatments that may provide temporary relief. Permanent treatments may include dental work to correct the bite, surgical, and orthopedic methods that can be challenging and expensive.

In many cases, with a physician’s help, TMJ will resolve itself on its own without the intervention of surgery or other invasive procedures.

Relieving the pain resulting from a Temporomandibular Joint disorder is often the most suitable solution for the condition. Pain-relieving medication can often help, and pain reducing procedures are often employed to bring relief to patients suffering from this disorder.

TENS therapy or transcutaneous electrical nerve stimulation can be an ideal solution to the pain and discomfort associated with persons afflicted with TMJ. TENS has been a successful therapeutic principle for decades and has been proven to reduce pain and promote healing. TENS units are transportable and can be applied directly to the skin and the source of the pain in many cases. LED light therapy encourages the restoration of the skin and is often used in conjunction with TENS therapy.

The Adjustable TMJ Headband is an innovative solution for combining the benefits of LED therapy with the stimulation and pain relieving qualities of a TENS unit.

Completely portable and wearable, the Adjustable TMJ headband is worn while doing daily tasks and almost anywhere. The product straps on to the head with a comfortable expandable headband that wraps around the circumference of the wearer’s head. Located at the front and back of the Adjustable TMJ Headband are adjustment connectors that will allow the user to adjust the size of the headband. The product’s headband will modify from a small child size increasingly up to a large adult size. Attached to the headband are lower sections conforming to the acupuncture points located around the Temporomandibular joint of the jaw. The headband has additional acupuncture points located at the base of the skull behind the ear. In addition to the acupuncture points on the headband, a set of extensions is available that will plug into the connectors on the headband. The extensions will cover several acupuncture points located on the head, face, and back of the shoulders for a more complete therapy. Each extension, as well as those built into the headband, offer a TENS and red LED contact points combined. The unique qualities of both the LED and TENS therapy and be applied using the Adjustable TMJ Headband. The product is completely portable and offers both TENS and Red LED therapy as a wearable, modifiable, and independent unit. A smart-phone app controls the unit for ultimate operability, portability, and ease of use.

SPECIFIC, UNIQUE FUNCTIONS OF INVENTION:

• Red LED and TENS therapy combined
• Comfortable headband of expandable material
• Complete adjustable sizing from child to adult
• Relieves TMJ pain
• Promotes healing
• Built in acupuncture points and extensions
• Facial re-invigoration and stimulation
• Extensions for more acupuncture points
• Extensions cover most acupuncture points on the face and head
• Extensions for back acupuncture points
• Smart-phone app control
• Portable therapy that can be worn almost anywhere
• Plug in power supply battery operated for portability

PRODUCT COMPONENT CLARIFICATION:

The “Adjustable TMJ Headband” is an innovative health product that has been designed to alleviate temporal mandibular joint (TMJ) pain plus promote facial reinvigoration and stimulation. The headband is supplied with a comfortable, head size adjustable, headband that contains red LEDs located at primary head acupuncture points and other locations to improve skin rejuvenation. The headband is provided with multiple connectors that can support transcutaneous electrical nerve stimulation (TENS) to reduce pain and enhance rehabilitation of the injured tissue causing the pain. The TENS leads that plug into the headband are sized to fit the treatment locations and the TENS generator will allow treatment of two pain sites at one time. The highly portable product can comfortably be worn while doing daily activities like working, walking, cleaning, or even driving.

Currently, the use of red light therapy and TENS electrical pulses are not usually performed at the same time. Additionally, the typical red light treatment of the skin is broadly distributed rather being localized at the acupuncture points. This broad application generally forces treatment to a dermatologist office or other medical center. Significant improvements can be made in the treatment of the TMJ pain through the use of a combined treatment capability and the headband invention is an excellent mechanism for combining both methods of treatment into one session.

Red light therapy: This therapy is very popular today, especially for improving skin appearance and anti-aging treatments. The effect of the red (660nm wavelength) light from cool operating LEDs has some unique benefits, resulting from the stimulation of the frequency of the typical human cell. When combined with placing the red LEDs directly over known acupuncture points, additional benefits are generated. The red LED technology has been chosen for its low energy requirement, low heat emission, and light weight, which are optimum for this application. Red light therapy benefits are, but not limited to, the following.

• Increased cellular activity and improved cellular energy
• Increased circulation and formation of new capillaries
• Increased lymph system activity
• Increased production of collagen and fibroblasts
• Increased cellular clean up (phagocytosis)
• Inflammation reduced

TENS therapy: This therapy employs electrical pulses conducted into the skin to stimulate the nerves for therapeutic purposes. TENS employs electrodes to conduct transcutaneously applied electrical pulses into the skin and to the nerves below to excite them. This excitation can block pain and promote rehabilitation of the damaged tissue. The battery powered TENS unit supplied with the headband is able to supply various modes of pulses and amplitudes to excite various nerves for various applications. In this document, the focus will be on TMJ pain management and rehabilitation. TENS therapy benefits are, but not limited to, the following.

• Reduction of muscle pain around the jaw
• Reduction of clicking or popping noises when the jaw is moved or is engaged in chewing
• Reduction in jaw muscle tightness
• Reduction in pain in front of the ear that spreads to the cheeks and temple
• Reduction of recurring headaches or migraines
• Reduction of buzzing or blocking sensations in the ear
• Improved sleep through reduced pain in the neck and back

The “Adjustable TMJ Headband” has been fabricated to allow the combination of both red light and TENS therapy in one, easy to use, comfortable appliance. The fabric and foam headband has built in LEDs that are located over the acupuncture point in and around the ear, with additional lighting under the chin. The headband also is a suspension appliance for the TENS connectors, allowing freedom for the user to combine TENS pain relief and cellular rehabilitation with the red light therapy. The headband is light in weight so the user can wear it and the TENS leads while going about normal tasks in the home or even driving. The LEDs are powered with replaceable AA batteries, which are turned on using the tactile membrane switch on the battery holder. The TENS controller is placed in the pocket or suspended on the belt and the leads with electrodes are placed in the mating connectors. After electrode placement on the appropriate pain control locations, the TENS controller can be engaged and used to reduce the pain. After use, the TENS leads can be unclipped and re-stored in the protective carrying case.

• As an option: The headband LEDs and the TENS device can be controlled using the headband application program that is included as part of the system. In this case, the battery holder has an electronic board that contains a microcontroller, a Bluetooth transceiver, and a LED driver. A similar upgrade in the TENS controller is required. The more sophisticated headband and TENS device would be sold as a higher priced product for those user’s that like to use smartphones or tablets to control their devices.

The headband: The head band is sewn from Lycra® fabric as the outer layer. This stretchy, soft to the feel fabric is woven from 40% polyurethane and 60% cotton fibers. This strong and durable fabric can be supplied in almost any vibrant color, so a distinctive color may be chosen to enhance the product recognition factor, which can dramatically improve the market adoption of the product. Sandwiched between the layer Lycra® on the outside and a thin layer of medical grade EVA foam are the Kapton flexible circuit of the TENS device and the low voltage wires connecting the LEDS. The LEDs are located in headband where they project the light toward the acupuncture points in front and below the ear. The wiring is split into 2 sides, one right and the other left side of the head. The foam layer is adhesively bonded to the Lycra® and the edge turned under and sewn to provide a high quality headband with nicely finished edges. The headband is adjustable using a hook and loop (H&L) fastener that is sewn to the front of the headband and under the chin. These H&L fasteners allow only one size to be required for adult and teen wearers. After the sewing is completed the battery pack is attached to the back of the headband and the appropriate connections made for the LEDs and the TENS connectors.

The TENS device: This commercially available transcutaneous electrical nerve stimulation (TENS) system consists of 3 basic components. These components are supplied to the headband manufacturer’s requirements and are as follows.

• The TENS controller: this controller is a small size unit that weighs approximately a pound. It is supplied with a rubber and plastic case and is operated using the buttons and touch screen. The compact device and be placed in the pocket or clipped onto the belt. The device has a rechargeable battery and can operate 2 channels of electrical pulses independently. This means the user can stimulate the jaw area on one side and the neck area on the other at the same time, using differ frequencies, modes and amplitude of signals, while continuing the red light therapy. The controller can provide these, but not limited to, the following functions.
  • The controller provides 2 independent channels of electrical pulses,which are user set using the buttons and touch screen on the controller.
  • 5 modes of operation: Burst normal, modulation, strength duration1, and strength duration 2.
  • The user can set the frequency, amplitude, and time of operation.
  • The memory holds multiple past sessions andcan repeat any of them as requested.
  • The unit beeps when the battery needs to be discharged or the electrodes are not making acceptable contact
• The headband connectors: These plastic bodied, commercially available, connectors are soldered to the flexible circuit prior to assembly and are fed through the Lycra® outer layer so they are available for use as required. The connector wire is reinforced at the fabric opening using a controlled puddle of fabric matching color hot melt adhesive. Each of the connectors is marked with the appropriate legend so the user can select the matching wires and electrodes for use. The right and left hemisphere are isolated for the optimum in therapy. This allows TMJ pain to be treated on both sides independently.
• The TENS connectors, lead, and electrodes: These connecting devices connect the remote TENS controller to the headband and the headband to the user’s skin for the optimum stimulation. The flexible wires from the headband to the electrodes allow the user to wear the headband and the TENS connections in total comfort, without binding or having to re-adjust lead location often. The ends of the headband leads have a clip, which allows quick exchange of the electrode if the gel contact becomes compromised. The leads, when not in use, are stored in the plastic case as are several replacement electrodes.
  • For example: The left and right neck leads are supplied with optimum length leads to reach acupuncture points GB 20. The leads are optimized to reach from the headband to the body site with just a little slack to allow unrestricted head movement, etc.

The Adjustable TMJ Headband is designed to be aesthetic and effective in the application. The reasonably uncomplicated fabrication and the favorably priced components provide good marketability for the manufacturer. The user benefits from dramatically reduced pain while wearing a comfortable appliance, which should provide considerable market interest in the product.

The invention is illustrated in the attached drawings of the essential points as explained to us in the documentation.

Drawing 1, Block 1: Adjustable TMJ Headband – Headband Detail

(1) The comfortable headband is adjusted to fit snugly on the head and under the chin.

(2) The LEDs illuminate various acupuncture points on the face and neck.

(3) The TENS connectors are soldered to the flexible circuit mounted between the fabric and foam layers.

(4) The TENS connectors lay flat against the headband and are reinforced with hot melt adhesive on the Lycra fabric.

(5) The LEDs project inward from the band toward the skin.

(6) The LEDs are powered with 2 AA replaceable batteries in the housing.

(7) The TENS input connector is mounted near the battery housing on the headband. There is one for each side of the headband.

(8) The 2 ear flaps located the LEDs on the acupuncture points just below and in front of the ear. These are (Ex HN, Ex HN 14, GB 12) and (TB 22, TB 21, SI 19, and GB 2) respectively.

Drawing 1, Block 2: Adjustable TMJ Headband – LED Construction

(9) The stretch Lycra fabric is located on the outside of the headband and can be any vibrant color.

(10) The LED is powered using the wires imbedded between the foam and fabric layer.

(11) The red light is projected in a 120 degree solid angle directly into the face to stimulate the skin and cells.

(12) The medical grade EVA foam shields the LED device and allows it to gently rest against the skin for better light penetration.

Drawing 1, Block 3: Adjustable TMJ Headband – TENS Connectors

(13) The optimum application of the TENS signal requires 2 skin contact electrodes located no more than 1.5” apart.

(14) Each of the connectors is marked and the mating leads are stored in the electrode/lead organization box.

(15) The leads and electrodes are longer and shorter depending upon where they are to be used, i.e., shoulder ones are about 18” and rear neck ones are about 6” long.

(16) The TENS input feed is polarized and has slightly larger diameter pins so it cannot be placed in any of the TENS output connectors.

Drawing 2, Block 1: Adjustable TMJ Headband – TENS Device

(17) The TENS unit applies electronic nerve stimulation for pain management and to improve rehabilitation rapidity.

(18) The commercially available TENS unit has 2 modes of operation, 1) using the buttons and touch screen and 2) using the optional App on the user’s smartphone.

(19) The TENS unit can drive 4 electrodes at one time with each channel of 2 electrodes under individual control.

(20) The lead wire plugs into each channel outlet on the TENS unit and then runs to the left or right side of the headband, plugging into the polarized connector in the headband, see Dwg 1, block 3.

(21) The TENS unit can be placed in the pocket or clipped onto the belt and the channel feed wires are long enough to allow comfortable movement of the head and headband without binding.

(22) The TENS unit‘s battery is recharged using the USB connector and the supplied AC to DC adapter.

Drawing 2, Block 2: Adjustable TMJ Headband – Supplied Electrodes

(23) The TENS electrode is a 1.5” square, commercially available product that clips onto the TENS power lead from the headband.

(24) The clip is soldered onto the power lead and is clipped onto the snap on the electrode.

(25) The 4 layer electrode conducts the electrical signal from the lead through the electrode to the skin.

(26) The final layer of the electrode is a firm gel layer that touches the skin for optimum conduction. The electrode is easy to replace if the gel layer becomes worn out or contaminated. The gel layer is not soft like Vaseline and is not messy.

(27) The outer edge of the electrode has repositionable adhesive to allow more than one use.

Drawing 2, Block 3: Adjustable TMJ Headband – Lead And Electrode Container

(28) The molded plastic case snaps shut to retain the electrodes and leads in an organized and clean format.

(29) The hinged door snaps shut and retains new electrodes in an easily accessible location.

(30) When the upper section is closed over the lower section, the leads are pressed down into the foam bar and retained.

(31) The neck leads and electrodes are shown here as an example of the organization.

Although a single embodiment of the invention has been illustrated in the accompanying drawings and described in the above detailed description, it will be understood that the invention is not limited to the embodiment developed herein, but is capable of numerous rearrangements, modifications, substitutions of parts and elements without departing from the spirit and scope of the invention.

This document has been prepared for the manufacturer’s elucidation. The manufacturer’s decision makers should consider this product for licensing (providing intellectual property protection for their sales of the product in return for a royalty payment for a period of years) or an outright purchase of the patent for a negotiated fee. The inventor and her team are standing by to consider offers for licensing or outright purchase of the patent.