Patent Application
20230320896
The present invention relates to intraoral devices, and more particularly to intraoral devices which cool an area of a plexus formed by one or more of a posterior superior or a middle superior alveolar branch of an ipsilateral maxillary nerve, known herein as the zone of intraoral tenderness.
A tension-type headache, migraine, post-traumatic headache, atypical facial pain, cervical muscle hyperactivity, and other conditions are each symptoms of ipsilateral intraoral tenderness, as discovered by Dr. Mark H. Friedman, DDS. As disclosed in U.S. Pat. No. 5,527,351, issued Jun. 18, 1996, U.S. Pat. No. 5,676,691, issued Oct. 14, 1997, and U.S. Patent Application Publication Number U.S. 2007/0032547, published Feb. 8, 2007, Dr. Friedman prevented numerous patients from ever experiencing a migraine and other ailments again, including the Inventor herein, by chilling the zone of intraoral tenderness for forty minute sessions via metal probes applied to the zone and cooling the temperature of the probes to a range of between 0° C.-10° C. In a 2004 publication entitled, “Local Inflammation as a Mediator of Migraine and Tension-Type Headache”, Dr. Friedman analyzed 1,100 migraine patients, 1,026 (93.2%) mostly asymptomatic migraine sufferers who had increased temperature or tenderness, classical signs of inflammation, on the gumline just above the second and third maxillary molars, a zone of intraoral tenderness, which closely related to laterality and severity of reported symptoms. In a clinical trial entitled, “Intraoral Chilling vs. Oral Sumatriptan (Imitrex) for Acute Migraine”, Dr. Friedman showed how intraoral chilling provided significant mean headache relief in pain levels at all time levels measured including the 1, 2, 4, and 24 hour time intervals after the treatment as compared to sumatriptan (Imitrex), with poor relief obtained by placebo. In an ongoing IRB study entitled, “Retrospective Survey of the Effects of Chilling the Zone of Intraoral Tenderness in Patients Experiencing Chronic Migraine and Headache Episodes”, 50% of migraine patients surveyed who underwent an intraoral chilling treatment answered that they were migraine free for 3+ years after their intraoral chilling treatments. 25% of patients reported their migraines did not return. Today, it's been observed that agitating a zone of intraoral tenderness can lead to a headache or migraine within the hour and even up to 24 hours later.
Despite 39 million Americans suffering from the debilitating symptoms of a migraine alone, no invention has been proposed to better chill the zone of intraoral tenderness than the original prototype and its similarly hard to utilize successors, which are collectively over twenty years old. Since Dr. Friedman's passing over a decade ago, no significant resources have been put into addressing or improving his apparatus or his treatment methodology despite their clinical success. Because his devices required a practitioner to properly position and a patient to hold the probes and the number of practitioners utilizing his methods remain limited, there is a need for an improved intraoral device for the treatment of migraines, headaches, and other head and neck disorders and conditions.
Research institutions, pharmaceutical and digital health companies, and charities have been set up to counteract migraines. Despite the billions of dollars in resources invested in the space, no improvements have been made on his clinically successful methodology.
Further, the user's application of Dr. Friedman's probes naturally led users to stick them as far back in the intraoral cavity as possible, due to the shape of the probe and location of the zone. Positioning errors remained due to the user manually holding the probes in position. To withstand the 40 minutes of holding the probes in position, users are encouraged to place a pillow under each arm to steady their arms and hold their hands in position. Then, wrap cloth around the medical tubes as a handle to tolerate the cold. Still, the free-wielding probes led to cooling the wrong area of the intraoral cavity and holding the probes in place for 40 minutes led to muscle fatigue. The difficulty in correctly applying the device and that a dentist needed to apply the treatment led to its lack of public acceptance along with a rise in the popularity of opioids at the time of discovery and far less frequent social media usage by the public.
Further, headache and migraine symptoms specifically are often misdiagnosed by doctors as a possible tumor leading to a costly and potentially dangerous CT Scan or MRI. If no tumor is present, treatment often includes medications, rest, TENs devices, and the avoidance of causal factors including but not limited to certain foods, work, the sun or light, and sound. The pain leaves many with only the hope of prayer because of the debilitating nature of a migraine and lack of reliable treatments available.
Migraine treatment is a specifically crowded space. Current options have a low efficacy rate, are primarily pharmaceutical solutions, and are temporary, meaning at some point in time the user will get another migraine. Despite early success in treating and preventing migraines and other ailments by chilling the zone of intraoral tenderness, none of the current devices or methodologies provide assurance in knowing the hard to reach zone is cooled with a high enough consistency to ensure effective treatment.
It is therefore an object of the present invention to provide more effective treatment solutions for migraines and other ailments mentioned above by chilling the zone of intraoral tenderness.
More particularly, it is an object of the present invention to cool the zone of intraoral tenderness by providing a hands-free device that is more easily applied, yet still more reliably positions the cooling element in abutment with the zone of intraoral tenderness, as further described herein.
Furthermore, it is an object of the current invention that the cooling medium can come in many forms to better cool the hard to access zone of intraoral tenderness.
It is another object of the current invention to provide for more approximate sizing by relying on external factors including but not limited to standing height or jaw size, or a custom mold model allowing users to more reliably point the cooling element towards the zone of intraoral tenderness.
It is another object of the current invention to provide a cooling element extending, protruding, or attached to a device, carrier, clip, or any general widget, allowing users to more reliably direct the cold towards the zone of intraoral tenderness.
In one aspect of the present invention, a hands-free intraoral device for imparting a chilling to an area of a plexus formed by one or more of a posterior superior or a middle superior alveolar branch of an ipsilateral maxillary nerve, known herein as the zone of intraoral tenderness, within an oral cavity of a user is disclosed. The hands-free intraoral device includes a carrier having a proximal end and a distal end. The distal end is configured to be received within the back of the oral cavity and the proximal end is configured to extend to a front and/or external of the oral cavity. A cooling element is disposed at the distal end of the carrier. The cooling element is formed of a thermally conductive material selected to impart the chilling to the zone of intraoral tenderness. A conduit communicates a cooling fluid through the hands-free device to the cooling element. A positioning element to position at least a portion of the cooling element in abutment with the zone of intraoral tenderness. The positioning element provides for a hands-free positioning of the cooling element in abutment with the zone of intraoral tenderness.
In other aspects of the invention, a hands-free intraoral device for imparting a heat transfer from the zone of intraoral tenderness within an oral cavity of a user is disclosed. The hands-free intraoral device includes a carrier having a proximal end and a distal end, the distal end is configured to be received within the oral cavity and the proximal end is configured to extend to a front and/or externally from the oral cavity. A cooling element is disposed at the distal end of the carrier. The cooling element is formed of a thermally conductive material selected to receive the heat transfer from the zone of intraoral tenderness to the cooling element. A heat exchanger is configured to transfer the heat from the cooling element. A positioning element to position at least a portion of the cooling element in abutment with the zone of intraoral tenderness. The positioning element provides for a hands-free positioning of the cooling element in abutment with the zone of intraoral tenderness.
In some embodiments, the heat exchanger includes a thermoelectric device. The hands-free intraoral device may also include an electronics package for controlling the thermoelectric device.
In some embodiments, a communications module is configured for a wireless communication with a mobile computing device for controlling the thermoelectric cooler.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following drawings, description and claims.
The following detailed description is of the best currently contemplated modes of carrying out exemplary embodiments of the invention. The description is not to be taken in a limiting sense but is made merely for the purpose of illustrating the general principles of the invention. Further, each instance of a hands-free intraoral device, a prong, or the like is intended as one of several different alternative embodiments of the present subject matter.
Broadly, embodiments of the present invention provide a hands-free intraoral device for imparting a chilling treatment to a zone of intraoral tenderness within an oral cavity of a user. The zone of intraoral tenderness is defined by an area of a plexus formed by one or more of a posterior superior or a middle superior alveolar branch of an ipsilateral maxillary nerve, as described in the foregoing patents and patent application publication of Dr. Mark H. Friedman, DDS.
As seen in reference to the drawings of
A cooling element 12 is disposed at the distal end of the carrier 14. The cooling element 12 is formed of a thermally conductive material selected to impart a chilling treatment to the zone of intraoral tenderness. In some embodiments, a cooling fluid is configured to chill the cooling element. A conduit 18 communicates a cooling fluid through the hands-free intraoral device 10 to the cooling element 12. The conduit 18 may include an inflow conduit 18a and an outflow conduit 18b for circulation of a cooling fluid through the conduit 18. The conduit 18 is in a thermally conductive contact with the cooling element 12. The thermally conductive contact may include a circulation of a cooling fluid through the cooling element 12. The conduit 18 is at least partially covered with an insulating material 20 to enhance the chilling effect at the cooling element 12, to prevent the cooling effect from being applied to other areas of the user's oral cavity, and to prevent the cooling element 12 from sticking to the user's gums, though a plastic sheath can be used in some embodiments.
The cooling element 12 should have a smooth outer surface for a thermally conductive contact with the zone of intraoral tenderness and for comfort when positioned within a cheek fold at the juncture of the user's upper jaw line and cheek. The cooling element 12 may also have a bulbous, form-fitting (such as formed by a mold or a gel-like material), or other shape to enhance the thermal contact surface area of the cooling element 12 with the zone of intraoral tenderness.
In this regard,
Each embodiment of the hands-free intraoral device 10 includes a positioning element 16 to position at least a portion of the cooling element 12 in abutment with the zone of intraoral tenderness. The positioning element 16 provides for a hands-free positioning of the cooling element 12 in abutment with the zone of intraoral tenderness. The positioning element 16 also facilitates the retention of the hands-free intraoral device 10 in the oral cavity of the user while the user undergoes a cooling treatment session utilizing the hands-free intraoral device 10.
In some embodiments of the hands-free intraoral device 10, such as shown in
Non-limiting representative dimensions of the probe are shown in
In
A bite pad 24 extends from the connector 22 along a transverse plane towards a sagittal centerline of the intraoral cavity. The bite pad 24 is configured to be operably engaged by a biting of one or more molar teeth of the user to urge the cooling element 12 in abutment with the zone of intraoral tenderness and to retain the hands-free intraoral device 10 within the intraoral cavity. The bite pads 24 and connector 22 may be formed of a rigid, a semi-rigid material, or a resilient material.
The connector 22 may also be adjustably coupled to provide a positioning adjustment such that the cooling element 12 can be positioned in abutment with the zone of intraoral tenderness. Thus, when the user engages the bite pad 24 between a selected one or more their teeth the cooling element 12 may be reliably positioned within the intraoral cavity to contact the zone of intraoral tenderness. A representative fitting of the hands-free intraoral device 10 is shown in reference to
As seen in the embodiment of
The one or more angular offsets may include a first angular offset of the bite pad 24 about a frontal axis F perpendicular to the sagittal plane. The first angular offset may accommodate for a vertical elevation of the zone of intraoral tenderness from the bottom of the upper molars, by a tilting of the probes. The first angular offset is selected to elevate or lower the cooling element 12. The first angular offset may be between about 0° and 15° from the transverse plane. In some embodiments the first angular offset may be about 0° and 25° from the transverse plane. In some embodiments the first angular offset may be greater than 25° though a first angular offset less than 25° seems appropriate.
The one or more angular offsets may include a second angular offset about a sagittal axis S perpendicular to the frontal plane of between about +10° and −10°. In some embodiments the second angular offset may be about −15° and 15° from the transverse plane. The second angular offset may be greater than 15° or less than −15° though a second angular offset less than 15° or greater than −15° seems appropriate. The second angular offset accommodates for variations in a lateral displacement of the zone of intraoral tenderness. The second angular offset of the bite pad 24 effectively rotates the cooling element 12 inwardly or outwardly, depending on the selected second angular offset, for proper abutment of the cooling element 12 with the zone of intraoral tenderness and so that the user remains comfortable with the hands-free intraoral device 10 throughout the treatment period. When the positioning element 16 is formed of a resilient material, the cooling element 12 may be resiliently urged in abutment with the zone of intraoral tenderness. In an exemplary embodiment, a vertex angle formed at an intersection of a longitudinal centerline of the cooling element 12 and a distal edge of the bottom of the bite pad 24 may be about 20 degrees to about 50 degrees.
The bite pad 24 and connector 22 allow for fitting the device 10 to a number of mouth sizes since the bite pad 24, when operably engaged, will naturally push the cooling element 12 into the zone of intraoral tenderness for at least 75% of mouth sizes. Even among the smallest and largest mouth sizes, the difference in reaching the zone of intraoral tenderness can be best measured in millimeters. Thus, it has been seen in initial testing that the bite pads 24 and connector 22 allow for a natural fit for a greater percentage of patients' mouths than just 75%. Accordingly, the bite pads 24 and connector 22 can allow for a natural fit for at least 75% up to 97% of patients, possibly greater. As a result, less skus would be required, possibly only one, to accommodate nearly all patients, which is desirable for manufacturing. It is achievable by considering where most mouth sizes are similarly sized such that any differences across patients can be accounted for in millimeters.
In the present example, differences in the distance from the teeth which engage the bite pads 24 during treatment and the patient's zone of intraoral tenderness can be measured in millimeters. Further, the angular offsets (AO) needed to position the cooling element 12 in abutment with the zone of intraoral tenderness when the device is inserted are also similar. Refer to Tables 1 and 2.
Molds are also possible to achieve marginally better treatment coverage and easier application. Further, not shown, the device can be affixed to a patient's head, neck, face, chin, nose, shoulders, arms, underarms, ears, or other body part to achieve marginally better treatment coverage or easier application.
As seen in TABLE 1 below, a comparison of representative first angular offsets and second angular offsets (AO) of the bite pad 24 orientation are shown versus factors of comfort, secure fit, and cooling element 12 position are presented. The factors were rated on a scale of 1 to 5, with a score of 5 being the best and a score of 1 being the worst. The table illustrates that each combination was effective in positioning at least a portion of the cooling element 12 in abutment with the zone of intraoral tenderness.
As set forth in Table 2 below, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can be graded so as to hug the teeth according to the anticipated size of each tooth:
As described in Table 2, the M-D measurements stand for mesiodistal crown diameter, which relates to the mesio and distal surfaces of the teeth, or tooth length. The distal tooth surface refers to the back surface of the tooth, whereas the mesial tooth surface refers to the front surface of the tooth. Similarly, the F-L measurements stand for the faciolingual dimensions of the teeth, or tooth width, with the facio side being the front, or face (or cheek) side of the tooth, and the lingual side being the back, or tongue side of the tooth.
Accordingly, in an embodiment, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can be graded to align with the typical size of the premolars and molar teeth. In this regard, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can have a tapered width, in the F-L and M-D direction, with the bite pads 24 and/or vertical teeth guard/guidance plate 25 getting incrementally narrower going from the side positioned at the back of the mouth, or closest to the first molar, and extending toward the side positioned towards the front of the mouth, or towards the premolars. In one exemplary, non-limiting embodiment in this regard, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can have an about 22 mm width at the first molar side tapering down to an about 18 mm width at the premolar side.
Similarly, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can have a tapered height, with the bite pads 24 and/or vertical teeth guard/guidance plate 25 getting incrementally longer, or increasing in height, going from the side positioned at the back of the mouth, or closest to the first molar, and extending toward the side positioned towards the front of the mouth, or towards the premolars. In one exemplary, non-limiting embodiment in this regard, the bite pads 24 and/or vertical teeth guard/guidance plate 25 can have an about 10 mm height at the first molar side tapering up to an about 12 mm height at the premolar side.
In certain embodiments, the full length of the bite pads 24 and/or vertical teeth guard/guidance plate 25 extending from the front of the mouth/chin side to the back of the mouth/neck side can be maintained, by way of non-limiting example, at about 35 mm, obtained by adding the M-D measurements of the premolars, the 1st molar, plus a certain extension amount, or any other suitable length. An aspect of the discovery herein is that any standard deviation in the distance from certain teeth to the zone of intraoral tenderness can be best measured in millimeters and thus makes a generalized design concept possible even though large and small mouths may physically present different challenges when it comes to reaching and appropriately treating the zone of intraoral tenderness. In conjunction, the similarly sized teeth from small patient to large patient where differences can also be measured in millimeters was known and can make the generalized designs possible. These sizing considerations will be particularly effective for the tooth clip variation functioning as a tooth wedge, but can play a fundamental role in all bite pad embodiments. The tooth wedge application can be very effective in treating unconscious patients. It, as well as other embodiments, can be equipped with something to in some way affix the device to the patient's head, neck, face, chin, nose, shoulders, arms, underarms, ears, or other body part for stabilization.
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In the example shown in reference to
In some embodiments, such as the embodiment of
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A flexible loop 30 positioning element may be seen in reference to the drawings of
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In some embodiments, a cooling medium (not shown) is in communication with the conduit 18. The cooling medium is configured to circulate the cooling fluid through the conduit 18 of hands-free intraoral device 10 and may be used to provide the cooling of the cooling element 12.
A much more relaxing experience from a breathability and a comfort perspective is achieved with the open front mouth designs which the bite pads 24 allow for, increasing the likelihood of treatment compliance. Patients can hold conversations with the device in their mouth. Perhaps most importantly, patients no longer have to worry about the probes moving out of the treatment area with a slight movement of their hand, wrist arm, or mouth, which can routinely happen via fatigue, human error, or practitioner error without a positioning element 16.
In some embodiments, the hands-free intraoral device 10 has a vertical teeth guard/guidance plate 25 that includes a diode, helium-neon, or other laser 60 as shown in
In an alternative embodiment, as shown in
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In certain embodiments, as shown in
In other embodiments such as in
In embodiments shown in
In
In some embodiments, as shown in
The hands-free intraoral device 10 may also be described as imparting a heat transfer from the zone of intraoral tenderness within an oral cavity of a user. A heat exchanger 40 may be configured to transfer heat from the cooling element 12. The heat exchanger 40 may include the previously described cooling fluid circulated through the conduits 18 via the cooling medium, a thermoelectric cooler, or a thermally conductive material in contact with the vascularization of the cheek or tongue. A heat sink may be used as well and positioned under the tongue or in the upper or lower cheek fold.
As shown in reference to
The mobile computing device 48 may include an application for sensing and controlling the temperature at the cooling element 12 and the zone of intraoral tenderness. The application may also be configurable by the user for setting a temporal duration of the treatment session via a timer. Data, such as the temperature, duration, date, and user information may be stored in a memory of the mobile computing device 48 as a record of the treatments.
The application may also include a user interface for the user to score the subjective effectiveness of the treatments. The user interface may also allow the user to enter incidents or events that may occur between treatments. Likewise, the user interface may allow the user to enter positioning parameters for each treatment and optionally, a comfort assessment of the hands-free intraoral device 10 and the positioning of the cooling element 12 of the hands-free intraoral device 10 parameters for the treatment session. The data may be analyzed to present one or more trends for the patient's progress or to suggest or recommend one or more positioning parameter adjustments for a subsequent treatment.
The application and the mobile computing device 48 may also communicate the data, with a server, where the data may be retained as a backup for the user. The server may also be configured to analyze data from a plurality of users. An artificial intelligence (AI) module may assess the data to provide insights into treatment and/or device parameters to enhance the effectiveness of the hands-free intraoral device 10 treatment across a broad population. As will be appreciated, the electronics package 42, associated electronics component and application may be utilized with one or more embodiments disclosed herein.
A bite knob embodiment of the hands-free intraoral device 10 is illustrated in reference to
A bite pad 24 extends transversely from the inner face of the disc shaped housing 50 at a connector 22 and is operable by the molars of the user to position the cooling element 12 in abutment with the zone of intraoral tenderness. In this embodiment, a heat exchanger 40 is disposed at an interior end of the bite pad 24. The heat exchanger 40 is configured to communicate heat from the TEC to be dissipated by the vascularization of the user's tongue. The TEC may be powered by a battery source carried within the disc shaped housing 50, which may be charged via a charging port-54. Alternatively, an external power supply may be attached to the charging port 54.
A clamping embodiment of the hands-free intraoral device 10 may be seen in reference to
In this embodiment, the positioning element 16 includes a tensioning mechanism at a proximal end of the carrier 14, that is operable via a button 58 on one or opposed ends of the positioning element 16. In the embodiment shown, a pressing of the buttons 58 operably urges the left and the right arms of the carrier 14 outwardly, whereas a releasing of the button 58 urges the left and right arms of the carrier 14 inwardly to urge the cooling element 12 in abutment with the zone of intraoral tenderness. In this embodiment, the positioning element 16 may be carried externally of the intraoral cavity.
It should be understood, of course, that the foregoing relates to exemplary embodiments of the invention and that modifications may be made without departing from the spirit and scope of the invention as set forth in the following claims.
This application is a Continuation-in-Part of U.S. patent application Ser. No. 17/822,967, filed Aug. 29, 2022, which application claims the benefit of priority of U.S. provisional application No. 63/238,832 filed Aug. 31, 2021, the contents of each of which are herein incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63238832 | Aug 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17822967 | Aug 2022 | US |
| Child | 18129465 | US |
