TECHNICAL FIELD

[0001] The present disclosure relates generally to the field of physiotherapy devices. In particular, the present disclosure pertains to a physio-therapeutic device for use in various pathological conditions in which a person is suffering from reduced opening of mouth.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Normal mouth opening is the maximum range of jaw motion or gap between upper and lower incisors during wide opening of mouth of a person and it depends on body size and height of the person. Further, it is also observed that the normal mouth opening ranges from 35 to 45 mm. Males usually have slightly greater mouth opening than females.

[0004] Many people are afflicted by reduced mouth opening, a medical condition that limits extent of an afflicted person to which they are able to open his/her mouth. Trismus, a commonly known pathological condition, is reduced mouth opening that results from trauma, rheumatoid and osteo-arthritis, tumors, tendonitis or internal derangment of the jaw joint, infection, muscle spasm of the muscles of mastication, Oral Sub-Moucus Fibrosis or a sequaele of surgery, etc. A person afflicted with Trismus has limited lower jaw mobility. This is problematic in that, often, access to interior of the afflicted person's mouth and throat is necessary to effectively treat the cause of the affliction. Trismus is a condition that impairs eating, interferes with oral hygiene, restricts access to dental procedures, and adversely affects speech and facial appearances.

[0005] Efforts have been made in the past to overcome problems associated with Trismus. For example, a conventional technique involves a surgical procedure incorporating a physiotherapy device that applies pressure on jaw muscles to enable stretching of upper and lower jaw away from each other. The physiotherapy device applies pressure on single rooted anterior teeth that may inflict fracture in case excess pressure is applied. Also, in cases when the person is missing anterior teeth, such conventional techniques become useless and hence fail to treat the person. [0006] Another major drawback associated with the conventional physiotherapy devices is that jaw supporting portions of such devices move away from and towards one another in a straight linear fashion. However, lower jaw/mandible does not move in such a linear fashion. The jaw joint is a ginglymoarthrodial joint and, as such, moves in a sliding pivotal articulation such that the lower jaw pivotally moves away from and towards the upper jaw in a substantially arcuate path. Thus, if the conventional devices would be utilized for jaw exercise of people afflicted by the Trismus, the tooth engaging portions thereof, while moving linearly, would slip or ride over the teeth of the jaw which moves arcuately. Such an arrangement can result in breaking and/or damage of the teeth or jaw of the people.

[0007] There is, therefore a need in the art to provide a simple, efficient and cost- effective physio-therapeutic device to allow guided mouth opening of a person afflicted by a medical condition associated with reduced mouth opening, such as Trismus. Further, there exists a need to provide for a physio-therapeutic device that supports arcuate movement of the lower jaw in order to effectively guide opening of mouth of the person. Also, there is need in the art to provide for a jaw rehabilitation device that is useful in treatment of a person having reduced opening of mouth due to spasm or stiffness of muscles associated with jaw movement.

[0008] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

[0009] In some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0010] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0011] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all groups used in the appended claims.

OBJECTS OF THE INVENTION

[0012] A general object of the present disclosure is to provide a physio-therapeutic device to allow guided mouth opening of a person afflicted by a medical condition associated with reduced mouth opening, such as Trismus.

[0013] Another object of the present disclosure is to provide a physio-therapeutic device that is simple to operate for exercising temporomandibular joint of the jaw.

[0014] Another object of the present disclosure is to provide a physio-therapeutic device that is used for opening the mouth of the user during therapy of the user.

[0015] Yet another object of the present disclosure is to provide a cost-effective physiotherapeutic device for exercising mouth muscles of the patient.

[0016] Still another object of the present disclosure is to provide a physio-therapeutic device that does not damage the person's jaw and/or teeth.

SUMMARY

[0017] The present disclosure provides a physio-therapeutic device, the device including at least two plates adapted to be inserted in a mouth cavity of a user, wherein each of the at least two plates are to be in contact with an upper teeth and a lower teeth respectively of the user, at least two prongs, each prong attached to at least one of the at least two plates, wherein a first prong of the at least two prongs is hinged at a first end of a frame and a second prong of the at least two prongs is fixed to a second end of the frame, said first prong adapted to rotate about the first end of the frame, and a screw mechanism adapted to effect separation between the at least two plates by effecting rotation of the first prong hinged at the first end of the frame, wherein separation between the at least two plates allows separation of the upper teeth and the lower teeth in contact with each of the at least two plates, thereby guiding mouth opening of the user.

[0018] In an embodiment, the physio-therapeutic device further includes one or more gauge members having a plurality of markings to indicate separation between the at least two plates, said one or more gauge members being attached to the second prong.

[0019] In an embodiment, each of the first prong and the second prong includes at least two links joined end-to-end at a defined angle.

[0020] In an embodiment, the screw mechanism includes a screw shaft adapted to allow rotation of the first prong about the first end of the frame by exerting pressure on the first prong in a longitudinal direction, and wherein the screw shaft passes through a hub section of the frame configured with one or more bearings to support movement of the screw shaft.

[0021] In an embodiment, the screw shaft enables rotation of the first prong about the first end of the frame during linear movement of the screw shaft in the longitudinal direction. In an embodiment, linear movement of the screw shaft is effected by rotation of the screw shaft.

[0022] In an embodiment, separation between the at least two plates allows mandible of the user to move away from maxilla of the user in an arcuate manner about temporomandibular joint of the mandible.

[0023] In an embodiment, the at least two plates are coated with a pad made of a pliable material on at least teeth contacting portions of the at least two plates to dissipate pressure exerted on any or a combination of the upper teeth and the lower teeth.

[0024] In an embodiment, shape of the frame is selected from a group consisting of semicircular shape, C shape, U shape and arc shape. In an embodiment, shape of the at least two plates is selected from a group consisting of U shape and arc shape.

[0025] Those skilled in the art will further appreciate the advantages and superior features of the disclosure together with other important aspects thereof on reading the detailed description that follows in conjunction with the drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0027] FIG. 1 illustrates an exemplary representation of proposed physio-therapeutic device for exercising jaw muscles of a user in accordance with an embodiment of the present disclosure.

[0028] FIGs. 2A and 2B illustrate exemplary representations of prongs incorporated with the proposed physio-therapeutic device in accordance with an embodiment of the present disclosure.

[0029] FIG. 3 illustrates an exemplary representation of screw mechanism of the proposed physio-therapeutic device in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION

[0030] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such details as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0031] If the specification states a component or feature "may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0032] Exemplary embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments are shown. This disclosure may however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those of ordinary skill in the art. Moreover, all statements herein reciting embodiments of the disclosure, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure).

[0033] Various terms as used herein are shown below. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0034] Embodiment explained herein relates to a Reduced Mouth Opening Exerciser (ROME) for exercising of jaw muscles of a user afflicted by a medical condition associated with reduced opening of mouth of the user, such as Trismus. In an embodiment, the proposed device can be used for treatment of the user having medical condition associated with difficulty in the normal mouth opening of any cause such as muscles injury, surgical procedures, Head & Neck Radiation therapy, temporomandibular joint dysfunction, osteoarthritis, post infection, burn cases and the likes.

[0035] The proposed physio-therapeutic device can include at least two plates adapted to be inserted in a mouth cavity of a user, wherein each of the at least two plates are to be in contact with an upper teeth and a lower teeth respectively of the user, at least two prongs, each prong attached to at least one of the at least two plates, wherein a first prong of the at least two prongs is hinged at a first end of a frame and a second prong of the at least two prongs is fixed to a second end of the frame, said first prong adapted to rotate about the first end of the frame, and a screw mechanism adapted to effect separation between the at least two plates by effecting rotation of the first prong hinged at the first end of the frame, wherein separation between the at least two plates allows separation of the upper teeth and the lower teeth in contact with each of the at least two plates, thereby guiding mouth opening of the user.

[0036] In an embodiment, the physio-therapeutic device further includes one or more gauge members having a plurality of markings to indicate separation between the at least two plates, said one or more gauge members being attached to the second prong.

[0037] In an embodiment, each of the first prong and the second prong includes at least two links joined end-to-end at a defined angle.

[0038] In an embodiment, the screw mechanism includes a screw shaft adapted to allow rotation of the first prong about the first end of the frame by exerting pressure on the first prong in a longitudinal direction, and wherein the screw shaft passes through a hub section of the frame configured with one or more bearings to support movement of the screw shaft. [0039] In an embodiment, the screw shaft enables rotation of the first prong about the first end of the frame during linear movement of the screw shaft in the longitudinal direction. In an embodiment, linear movement of the screw shaft is effected by rotation of the screw shaft.

[0040] In an embodiment, separation between the at least two plates allows mandible of the user to move away from maxilla of the user in an arcuate manner about temporomandibular joint of the mandible.

[0041] In an embodiment, the at least two plates are coated with a pad made of a pliable material on at least teeth contacting portions of the at least two plates to dissipate pressure exerted on any or a combination of the upper teeth and the lower teeth.

[0042] In an embodiment, shape of the frame is selected from a group consisting of semi-circular shape, C shape, U shape and arc shape. In an embodiment, shape of the at least two plates is selected from a group consisting of U shape and arc shape.

[0043] In an embodiment, the physio-therapeutic device can be used as a self-help physio-therapeutic device under experts supervision for treatment of the user having difficulty with mouth opening as per indicated by the experts.

[0044] In an embodiment, the physio-therapeutic device can assist mouth opening of the user by applying pressure to jaw muscles with help of the at least two plates inserted in the mouth cavity that can be in contact of the upper teeth and lower teeth, the gap between the at least two plates can be gradually increased by the screw mechanism, thereby guiding separation between mandible and maxilla of the user. In an embodiment, the physiotherapeutic device allows the mandible to move away from maxilla in an arcuate manner about the temporomandibular joint of the mandible.

[0045] It would be appreciated that although the present disclosure is explained in terms of a physio-therapeutic device for exercising jaw muscles of the user, the scope of the present disclosure is not limited to the same in any way whatsoever, and any other form of device or apparatus that involves exercise of jaw muscles for guiding of mouth opening of the user is well within the scope of the present disclosure.

[0046] FIG. 1 illustrates an exemplary representation of proposed physio-therapeutic device for exercising jaw muscles of a user in accordance with an embodiment of the present disclosure. In an aspect, the proposed physio-therapeutic device (also referred to as "jaw rehabilitation device" hereinafter) can include at least two plates (also referred to as "mouthpieces" hereinafter) 102 adapted to be inserted in a mouth cavity of a user. A first mouthpiece 102-1 can be inserted into the mouth cavity of the user such that it remains in contact with a lower teeth, for example, a teeth from any of a lower central incisor to posterior second molar of the user, and a second mouthpiece 102-2 can be inserted into the mouth cavity along with upper mouthpiece in the user such that it remains in contact with an upper teeth, for example, a teeth from any of an upper central incisor to posterior second molar of the user. In an embodiment, the at least two plates 102 can have any of a semicircular shape, a U shape or an arcuate shape. In an embodiment, the at least two plates 102 can be coated with a pad made up of a pliable material on teeth contacting portions of the plates 102, such as, but not limited to, rubber having biocompatibility with oral tissues, to dissipate pressure exerted on any or a combination of the upper anterior teeth and the lower anterior teeth. In an embodiment, the mouthpieces 102 can have serrations on their teeth- facing surfaces which increase their resistance on teeth surface.

[0047] In an aspect, the proposed jaw rehabilitation device can include at least two prongs 104 attached to the at least two mouthpieces 102 to allow separation between ends of the at least two mouthpieces 102 while the at least two mouthpieces 102 is inserted within the mouth cavity of the user and the upper teeth and the lower teeth of the user are exerting pressure on the at least two mouthpieces 102. Pressure exerted over the mandibular and maxillary teeth are lesser than crushing pressure for teeth. As illustrated, a first prong 104-1 can be attached to the first mouthpiece 102-1 and a second prong 104-2 can be attached to the second mouthpiece 102-2 such that movement of the first prong 104-1 with respect to the second prong 104-2 can engender separation of the first mouthpiece 102-1 and the second mouthpiece 102-2, thereby effecting movement of the mandible of the user away from the maxilla of the user in an arcuate manner about temporomandibular joint of the mandible. In an embodiment, as the separation between the mouthpieces 102 increases resistance also increases, and thus, the fulcrum causes more pressure on mandibular posterior teeth which are multi-rooted, thereby depleting pressure over wide area of bone which is known to have strong bony trabacule pattern arrangement. In an embodiment, the first mouthpiece 102-1 and the second mouthpiece 102-2 can be separated by a distance of up to 40mm at the point where the mouthpieces 102 are attached to the prongs 104.

[0048] In an embodiment, the proposed jaw rehabilitation device can include a frame 106 to allow coupling of the prongs 104 to its ends in order to impart a desired movement of the any of the mouthpieces 102. In an embodiment, the frame 106 can have any of a semicircular shape, a C shape, a U shape or an arcuate shape.

[0049] In an embodiment, the proposed jaw rehabilitation device can further include one or more gauge members 108 having a plurality of markings to indicate separation between the at least two mouthpieces 102. The gauge members 108 can be attached to the second prong 104-2 to measure the any or a combination of separation angle and separation distance between the mouthpieces 102. In an embodiment, two gauge members 108 can be attached on both sides of the second prong 104-2 and can be used to reference out a desired separation between the first mouthpiece 102-1 and the second mouthpiece 102-2. The gauge members 108 can be made up of corrosion resistant material, for example, stainless steel having biocompatibility with oral tissues.

[0050] In an embodiment, the first prong 104-1 can be hinged to a first end of a frame 106 and the lower prong 104-2 can be fixed to a second end of a frame 106. The first prong 104-1 can rotate about the first end of the frame 106 such that rotation of the first prong 104- 1 about the first end of the frame 106 can allow the first mouthpiece 102-1 to get separated from the second mouthpiece 102-2 while the mouthpieces 102 are inserted into the mouth cavity of the user, thereby varying angle between the mouthpieces 102 and separating the upper teeth and the lower teeth of the user. In another embodiment, the first prong 104-1 that is hinged at the first end of the frame 106 can be attached to the second mouthpiece 102-1, and the second prong 104-2 that is fixed to the second end of the frame 106 can be attached to the first mouthpiece 102-2 such that rotation of the first prong 104-1 about the first end of the frame 106 can allow the second mouthpiece 102-2 to get separated from the first mouthpiece 102-1.

[0051] Referring now to FIGs. 2A and 2B, where exemplary illustrations of the prongs 104 are shown, the prongs 104 can include a set of links joined end-to-end at a defined angle. As illustrated in FIG. 2 A, the prongs 104 can include two links 202-1 and 202-2 joined at an acute angle with respect to each other. As illustrated in FIG. 2B, the prongs 104 can include two links 204-1 and 204-2 joined at a right angle with respect to each other. In an embodiment, the prongs 104 can be made of corrosion resistant material, such as, but not limited to, stainless steel having biocompatibility with oral tissues.

[0052] The proposed jaw rehabilitation device allows rotary as well as transitory movement of the mandible. In order to keep the first prong 104-1 in maximum contact with mandibular teeth while in activation (or assisted opening), the fist prong 104-1 as well as the first mouthpiece 102-1 have specific angulations in order to compensate for movement of the mandible. In an embodiment, the proposed jaw rehabilitation device provides the lower jaw prong with a specific angulation to compensate for rotary and hinge movement of condylar head of the mandible. [0053] In an embodiment, the mouthpieces 102-1 and 102-2 are designed such that it can cover most part of the teeth present till second molar in bucco-lingual dimension. In an embodiment, the mouthpieces 102-1 and 102-2 are designed such that it can cover the entire occlusal surface of the maxillary and mandibular teeth to enable uniform distribution of pressure gradient over the maxillary and mandibular teeth. The pressure exerted over the mandibular posterior teeth is bilaterally symmetrical.

[0054] In an aspect, rotation of the first prong 104-1 can be effected by a screw mechanism that includes a screw shaft 110 passing through a hub section 112 of the frame 106 and adapted to exert pressure on the first prong 104-1 in a longitudinal direction so as to effect desired rotation of the first prong 104-1. The screw shaft 110 can move linearly in the longitudinal direction when rotated about one of its end. In an embodiment, the screw shaft 110 can be manually rotated by a handscrew arrangement/screw holder 114 configured at an end of the screw shaft 110, rotation of which can enable movement of the screw shaft 110 in the longitudinal direction. In another embodiment, the screw shaft 110 can be rotated with the help of a rotary device, such as a servo motor, a stepper motor and the like motors. The hub section 112 of the frame 106 can include a set of bearings to support movement of the screw shaft 110.

[0055] In an embodiment, the second prong 104-2 is fixed to the frame 106 and acts as fulcrum by exerting pressure on upper anterior and posterior teeth. The first prong 104-1 is attached to the first end of the frame 106 where it can rotate around. When the hand screw arrangement 114 is rotated in anti -clockwise direction, the screw shaft 110 moves forward in the longitudinal direction and exerts pressure at a point on the first prong 104-1. As a result, the first prong 104-1 starts rotating around the first end of the frame 106 and enables separation of the mouthpieces 102, thereby causing guided separation of teeth, jaw and in turn opening the mouth of the user.

[0056] FIG. 3 illustrates an exemplary representation of screw mechanism of the proposed physio-therapeutic device in accordance with an embodiment of the present disclosure. In an embodiment, the screw mechanism can activate rotation of the first prong 104-1. The screw holder 114 of the screw mechanism can allow manual rotation of the screw shaft 110. In an embodiment, shape of the screw holder 114 can be selected from the group consisting of I shape, T shape or knob shape. In another embodiment, rotation of the screw shaft 110 can be actuated by an electric motor. In an embodiment, the screw arrangement can allow gradual opening of the mouth by controlling movement of the screw shaft 110. [0057] In an embodiment, the proposed jaw rehabilitation device takes fulcrum from anterior as well as posterior teeth of the maxillary symmetrically on either side in order to increase pressure distribution area.

[0058] In an embodiment, components of the proposed jaw rehabilitation device can be made up of corrosive resistant materials having biocompatibility with oral tissues. Weight and dimensions of the components are designed in such a way that the proposed jaw rehabilitation device can be accommodated in mouth cavity of people having a medical condition associated with reduced mouth opening.

[0059] In an embodiment, the proposed jaw rehabilitation device is an ergonomically designed passive action device as it exerts pressure onto the upper and lower teeth which in turn bring about jaw separation by exerting pressure on jaw opening muscles. In an embodiment, anti -clockwise movement of the screw shaft 110 provides better grip as pressure exerted by thumb makes the pressure application easier. In an embodiment, proposed jaw rehabilitation device can be inserted into a mouth cavity having separation between the mandible and the maxilla as low as 5mm, and can allow opening of the mouth in order to enlarge the separation between the mandible and the maxilla to an upper limit of 45mm.

[0060] It should be apparent to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C ....and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc. The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.

[0061] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

ADVANTAGES OF THE INVENTION

[0062] The present disclosure provides a physio-therapeutic device to allow guided mouth opening of a person afflicted by a medical condition associated with reduced mouth opening, such as Trismus.

[0063] The present disclosure provides a physio-therapeutic device that is simple to operate for exercising temporomandibular joint of the jaw.

[0064] The present disclosure provides a physio-therapeutic device that is used for opening the mouth of the user during therapy of the user.

[0065] The present disclosure provides a cost-effective physio-therapeutic device for exercising mouth muscles of the patient.

[0066] The present disclosure provides a physio-therapeutic device that does not damage the person's jaw and/or teeth.