Oral cavity opening apparatus and method

Abstract

Embodiments pertain to an apparatus configured, when operably engaged with a user, for employment by the user within an oral cavity of a subject having a lower dental arch and an upper dental arch. The apparatus comprises a protective cover having an axial phalange extension direction and which is configured to at least partially cover a finger of the user such to protect the finger from biting force applied by the subject; and a projection extending laterally from the protective cover and shaped and sized to be pushed by the user between the upper dental arch and the lower dental arch such to separate the dental arches from each other to facilitate accessing the oral cavity of the subject.

Description

[0001] ORAL CAVITY OPENING APPARATUS AND METHOD

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003]

[0001] This patent application claims priority and / or benefit from Israel Patent Application 318440, filed January 16, 2025, titled "ORAL CAVITY OPENING APPARATUS AND METHOD", and which is incorporated herein by reference in its entirety.

[0004] TECHNICAL FIELD

[0005]

[0002] Embodiments generally relate to oral health assistive devices and methods.

[0006] BACKGROUND

[0007]

[0003] Oral examination, dental treatments, and / or maintaining proper oral hygiene in challenged or uncooperative subjects, especially those with special needs, is often difficult.

[0008]

[0004] Mouth props such as a dental gag or a bite block generally assist in maintaining the mouth open wide and steady during a dental examination and / or an oral surgical procedure. Mouth props can also be employed to assist in reducing fatigue due to the mouth staying open during long dental procedures and reducing the likelihood of accidental closing of the mouth during administration of oral care. Additional embodiments can include maintaining the mouth open during procedures where the subject (e.g., patient) is sedated.

[0009]

[0005] The description above is presented as a general overview of related art in this field and should not be construed as an admission that any of the information it contains constitutes prior art against the present patent application.

[0010] BRIEF DESCRIPTION OF THE DRAWINGS

[0011]

[0006] In the following description, for purposes of explanation and not limitation, details and descriptions are set forth to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments that depart from these details and descriptions.

[0012]

[0007] In the following description, the figures referenced herein illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. For simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity of presentation.

[0013]

[0008] Furthermore, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. References to previously presented elements are implied without necessarily further citing the drawing or description in which they appear. The number of elements shown in the Figures should by no means be construed as limiting and is for illustrative purposes only. The figures are listed below.

[0014]

[0009] Fig. 1 is a schematic illustration of apparatus for use with an oral cavity of a subject, in accordance with some embodiments.

[0015]

[0010] Figs. 2A-2C are views of the apparatus for use with the oral cavity of the subject shown in Fig. 1, in accordance with some embodiments.[Oil] Fig. 3A is a schematic illustration of the apparatus for use with the oral cavity of the subject, in accordance with some embodiments.

[0016]

[0012] Fig. 3B is a schematic illustration of a cross section of the apparatus of Fig. 3A, in accordance with some embodiments.

[0017]

[0013] Fig. 4A is a schematic illustration of the apparatus for use with the oral cavity of the subject, in accordance with some embodiments.

[0018]

[0014] Fig. 4B is a schematic illustration of a cross section of the apparatus of Fig. 4A, in accordance with some embodiments.

[0019]

[0015] Figs. 5A-5B, Figs. 6A-6C are schematic illustrations of the apparatus for use with the oral cavity of the subject, being used in the oral cavity to open the oral cavity of the subject, in accordance with some embodiments.

[0020]

[0016] Figs. 7A-7B, and Figs. 8A-8B are schematic illustrations of apparatus for use with an oral cavity of a subject, in accordance with additional embodiments.

[0021]

[0017] Figs. 9A-9C are schematic illustrations of longitudinal elements of the apparatus shown in Figs. 7A-7B, and Figs.

[0022] 8A-8B, in accordance with some embodiments.

[0023]

[0018] Figs. 10A-10C are schematic illustrations of the apparatus for use with the oral cavity of the subject shown in Fig.

[0024] 1, in accordance with some embodiments.

[0025]

[0019] Figs. 11A-11B are schematic illustrations of the apparatus for use with the oral cavity of the subject shown in Fig.

[0026] 10A-10C, in accordance with some embodiments.

[0027]

[0020] Figs. 12A and 12B are schematic side-view illustrations of the apparatus for use with the oral cavity of the subject shown in Fig. 10A-10C, in accordance with some embodiments.

[0028]

[0021] Figs. 13A and 13B are schematic top-view and cross-sectional view, respectively, of the illustrations of the apparatus for use with the oral cavity of the subject shown in Fig. 10A- IOC, in accordance with some embodiments.

[0029]

[0022] Figs. 14A and 14B are schematic top-view and isometric view, respectively, of the illustrations of the apparatus for use with the oral cavity of the subject shown in Fig. 10A-10C, when the closing-band is open in accordance with some embodiments.

[0030]

[0023] Figs. 15A and 15B are schematic front-view and top views, respectively, of the illustrations of the apparatus for use with the oral cavity of the subject shown in Figs. 10A- IOC, when the closing-band is open and with further detail of the biting-wedge in accordance with some embodiments.

[0031]

[0024] Figs. 16A and 16B are schematic isometric views of the illustrations of a distal phalange element of the apparatus for use with the oral cavity of the subject shown in Figs. 10A- IOC, in accordance with some embodiments.

[0032]

[0025] Figs. 17A-17C are schematic top-view and bottom view, respectively, of a distal phalange element of the illustrations of the apparatus for use with the oral cavity of the subject shown in Figs. 10A- IOC, in accordance with some embodiments.

[0026] Figs. 18A-18D are schematic side, bottom, top and front views, respectively, of a distal phalange element of the illustrations of the apparatus for use with the oral cavity of the subject shown in Fig. 10A, 10B and IOC, in accordance with some embodiments.

[0033]

[0027] Figs. 19A-19C are schematic side views of embodiments of a distal phalange element of the illustrations of the apparatus for use with the oral cavity of the subject shown in Fig. 10A, 10B and IOC, in accordance with some embodiments.

[0034]

[0028] Figs. 20 is a schematic view of a distal phalange element of the illustrations of the apparatus for use with the oral cavity of the subject shown in Figs. 10A- IOC, in accordance with some embodiments.

[0035]

[0029] Fig. 21A is a schematic isometric view of another embodiment of the apparatus.

[0036]

[0030] Fig. 21B is a schematic back view of the embodiment shown in Fig.21A.

[0037] DETAILED DESCRIPTION

[0038]

[0031] In accordance with some embodiments, apparatuses and methods, and uses thereof, are disclosed for engagement with an oral cavity of a subject. In some examples, apparatuses and methods are provided for (e.g., forcefully) opening the oral cavity of the subject from a closed state to an open state and / or for maintaining the oral cavity in the open state. In some examples, the apparatuses and methods are provided for maintaining an oral cavity, forcefully or voluntarily opened by the subject, in an open state. Apparatuses and methods may be configured to prevent injury of the subject and / or of a user of the apparatus during, e.g., opening of the oral cavity, oral examination, oral medication delivery, actions of oral hygiene, and / or the like.

[0039]

[0032] The term "user" may herein refer to any type of caregiver of the subject, for example, e.g., a parent, a physician, a dentist, an occupational therapist, a dental hygienist, a tutor, paramedic, educational staff member, special education teacher, and / or any type of medical staff member. The above examples should by no means be construed in a limiting manner, additional users may be referred to for the employment of the apparatus.

[0040]

[0033] The term "subject" may herein refer to a subject with assistive or special needs, which may include, but not limited to, an infant, a disabled subject, uncooperative subject and / or any subject, who may be challenged in the execution of opening and / or maintaining open the oral cavity. Namely, any subject exhibiting difficulty in opening and maintaining the mouth in an open state during an oral examination, and / or an oral medical, and / or dental treatment, e.g., to maintain proper oral hygiene. The term "subject" may refer to a human subject and / or to an animal.

[0041]

[0034] In some scenarios, the apparatus and methods may be used and practiced by a user seeking to provide oral care to the subject.

[0042]

[0035] Oral care may be provided by the user to a subject that requires assistance, wherein the assistance may comprise the initial opening of the oral cavity from a closed state and maintaining the oral cavity in the open state during administration of the oral care.

[0043]

[0036] Forsome embodiments, the apparatus may be configured forthe employment within the oral cavity of the subject may be adapted or configured to be coupled with a finger of the user, which may be advanced, wedged or inserted into the oral cavity of the subject.

[0037] The terms "advancing", "wedging", and "inserting" in the context of accessing the oral cavity, as well as grammatical variations thereof, may herein be used interchangeably.

[0044]

[0038] In some embodiments, the apparatus may comprise a protective cover for receiving the finger of the user, and a projection extending laterally and, optionally, distally in axial finger direction, from the protective cover. A "projection" may herein also be referred to as "projection".

[0045]

[0039] In some embodiments, the apparatus may be configured such when operably coupled with a finger, the projection may extend about laterally in a direction which is orthogonal to a finger's longitudinal axis and corresponds to a flexing direction towards the palm. Accordingly, when the apparatus is operably engaged with the user, the projection may project in a palmar direction of the user's hand.

[0046]

[0040] In some embodiments, the protective cover may be configured such that when operably coupled with a finger, the projection may also extend distally (with respect to the user's hand) in a direction which is about in alignment with the finger's longitudinal axis. Accordingly, the projection may also extend in a "pointing direction".

[0047]

[0041] The projection may be at least partially wedged ortapered in the palmarand / or distal direction. In some examples, the projection may have a constant width or thickness in radial / ulnar or palmar direction.

[0048]

[0042] For some embodiments, the protective cover may be configured to at least partially surround the finger of the user such that the finger of the user is protected by the protective cover when (e.g., forcefully) advanced or inserted into the oral cavity of the subject's teeth (mandibular and maxillary teeth) onto the finger of the user. The term "teeth" as used herein may refer to primary teeth, adult teeth, implants, and / or dentures. In some scenarios, apparatus may also be employed for opening a mouth that is toothless.

[0049]

[0043] In an embodiment, the protective cover may comprise a flexible and / or rigid finger sheath, and / or a sleeve, shaped and sized to (e.g., snugly) receive a finger (also: digit) of the user. The protective cover may provide protection from biting of the finger by the subject when the finger is inserted into the oral cavity of the subject. In some examples, the apparatus may include scale armor.

[0050]

[0044] In some embodiments, the protective cover may comprise a rigid or at least partially rigid structure configured to be coupled with the user's finger, which is adapted to cover one or more of a user's finger phalanges (e.g., distal, intermediate, and / or proximal phalanges) for protecting the user's phalange(s), and to allow (e.g. forcefully) the opening of the subject's oral cavity.

[0051]

[0045] In some examples, the protective cover may comprise one or more linkage which are articulated with each other by a coupling mechanism (e.g., a hinge) for facilitating movement between various parts of the protective cover that is operably engaged with the finger, e.g., for facilitating advancing and / or maneuvering the finger covered by the protective cover between and / or into the oral cavity. Each linkage may be configured to receive a different phalange of the same finger.

[0052]

[0046] In some embodiments, the protective cover may be assembled from at least two phalange-engaging parts, which may be coupled with each other by a corresponding articulating mechanism, e.g., at a coupling point of a pivoting axis.

[0053]

[0047] In some embodiments, a projection may extend laterally from the protective cover. The projection may comprise a wedged portion or segment. The projection may be shaped and sized to be (e.g., forcefully) wedged or pushed betweenat least one tooth of an upper dental arch of the subject, and at least one tooth of a lower dental arch of the subject when the oral cavity is in a closed state, to facilitate accessing of the subject's oral cavity. Pushing and / or advancing (e.g. forcefully) a portion of the projection between the at least one tooth of the upper dental arch and at least one tooth of the lower dental arches may separate the upper dental arch from the lower dental arch. At least a portion of the projection may have a tapering (e.g., wedged) configuration. The expression "dental arch" as used herein may refer to a complete or incomplete or partial dental arch.

[0054]

[0048] Separation teeth may cause an initial opening of the oral cavity which may be followed by further opening of the oral cavity facilitated by inserting the cover-protected finger between the upper and lower dental arches. Thus, the apparatus may maintain the opening of the oral cavity during administration of oral care to the subject.

[0055]

[0049] In accordance with some examples, an alternative and / or additional apparatus for use with an oral cavity of the subject may be provided.

[0056]

[0050] In some examples, the apparatus may comprise an oral cavity opening tool which may be configured to open the oral cavity from a closed state to an open state and to maintain the oral cavity in the open state during application of oral care to the subject. Although the oral cavity opening tool may be configured to be advanced into the oral cavity of the subject, it may be operated and controlled by a user from outside of the oral cavity, for example, generally without requiring insertion of a hand of the user into the oral cavity of the subject.

[0057]

[0051] In some examples, the oral cavity opening tool may comprise an upper and a lower opposing longitudinal member, wherein each may be shaped to define at a distal end of the longitudinal members, an extension section extending laterally from the longitudinal members. The upper and lower longitudinal members may be disposed on both sides of a central axis, and each may be movable between a closed position and an open position.

[0058]

[0052] In some embodiments, the oral cavity opening tool may further comprise an actuator mechanism coupled to the upper and lower opposing longitudinal members, which may be configured to move the upper and lower longitudinal members with respect to each other, between the open and closed positions.

[0059]

[0053] In the closed position, the upper longitudinal member may be mounted onto the lower longitudinal member, such that the extension sections of both longitudinal members have a total thickness that is equal or less than, e.g., 3 mm, or e.g., less than 2mm. Consequently, when in the closed position of the longitudinal members, the extension sections may be shaped and sized adapted to be wedged between a tooth of an upper dental arch of the subject and a tooth of a lower dental arch of the subject, in the example scenario when the oral cavity is in a closed state. Subsequently, while wedged between the teeth, the actuator mechanism may cause separation of the upper and lower longitudinal members into the open position of the longitudinal members, thereby forcing separation between the tooth of the upper dental arch from the tooth of the lower dental arch, to initiate opening of the oral cavity.

[0060]

[0054] In some embodiments, the apparatus may be configured for the employment with an oral cavity of a subject, and comprise:

[0061]

[0055] a protective cover configured to at least partially surround a finger of a user;

[0062]

[0056] a projection extending laterally from the protective cover with shape and size adapted to be wedged between one or more teeth of an upper dental arch of the subject, and one or more teeth of a lower dental arch of the subject such as to separate the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch.

[0057] In some embodiments, the thickness of the projection may be equal or less than, e.g., 2 mm.

[0063]

[0058] In some examples, the projection may include a first end (e.g., base of a wedge) coupled to the protective cover, and a second end extending away from the protective cover, and the projection may be, in some examples, shaped such that the second end is tapered with respect to the first end. In some examples, the projection may have at least one groove configured to function as a stopper for form-fittingly preventing teeth from biting onto the projection surface from sliding on the projection away from the finger, in a direction which is opposite the direction of advancement. In some examples, a projection may comprise upper and lower grooves incorporated in the corresponding upper and lower projection surfaces.

[0064]

[0059] In some examples, the projection, in dorsal viewing direction, may have a triangular cross section.

[0065]

[0060] In some examples, the projection is conically shaped, e.g., in axial phalange direction.

[0066]

[0061] In some examples, the second end of the projection may have a thickness that is, for example, equal or less than, 5 mm, 4 mm, less than 2 mm, less than 1 mm.

[0067]

[0062] In some examples, a ratio between the thickness of the first end of the projection and thickness of the second end of the projection may be at least 3:1.

[0068]

[0063] In some examples, a ratio between the thickness of the first end of the projection and a thickness of the second end of the projection may be at least 5:1.

[0069]

[0064] In some examples, the protective cover includes a sheath may be configured to at least partially surround the finger.

[0070]

[0065] In some examples, the protective cover may include a sheath configured to fully surround the finger.

[0071]

[0066] In some examples, the protective cover may include a flexible protective cover.

[0072]

[0067] In some examples, the protective cover may be configured for insertion between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch when the protective cover may be at least partially surrounding the finger, and subsequent to the projection being wedged between the tooth of the upper dental arch, and the tooth of the lower dental arch so as to maintain the oral cavity in an open state thereof.

[0073]

[0068] In some examples, the projection may extend laterally from the protective cover in a palmar direction with respect to the protective cover when the projection is wedged between the tooth of the upper dental arch and the tooth of the lower dental arch in a lingual direction.

[0074]

[0069] In some examples, the protective cover may further include one or more annular structures.

[0075]

[0070] In some examples, the protective cover may include an inner layer and an outer layer, and the one or more annular structures may be arranged between the inner layer and the outer layer of the protective cover, e.g., for strengthening the structure of the protective cover.

[0076]

[0071] In some examples, the protective cover may further include at least one mechanical energy storage element (e.g., a spring).

[0077]

[0072] In some examples, the protective cover may include an inner layer and an outer layer, and the at least one mechanical energy storage element may be arranged between the inner layer and the outer layer.

[0073] Therefore, in accordance with some embodiments, a method for opening an oral cavity of a subject may comprise:

[0078]

[0074] Inserting (e.g., forcefully), and / or advancing (e.g., forcefully) a protective cover covering a finger into the oral cavity in a lingual direction, wherein the finger may be at least partially surrounded by the protective cover comprising a projection extending laterally from the protective cover, for example in the palmar, or lingual direction;

[0079]

[0075] wedging at least a section of the projection between one or more teeth of an upper dental arch of the subject, and one or more teeth of a lower dental arch of the subject; and

[0080]

[0076] separating the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch by wedging the at least a section of the projection.

[0081]

[0077] In some examples, wedging the at least section of the projection may include wedging the entire projection between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch.

[0082]

[0078] In some examples, the method may further include wedging the finger between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch, subsequently to wedging the at least section of the projection.

[0083]

[0079] In some examples, wedging the at least section of the projection between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch may include wedging the projection in a lingual direction with respect to the protective cover.

[0084]

[0080] In some examples, the second end of the projection may have a thickness that is equal or less than, e.g., 2 mm.

[0085]

[0081] In some embodiments, the apparatus may be configured for engagement with an oral cavity of a subject. The apparatus may comprise:

[0086]

[0082] an oral cavity opening tool comprising:

[0087]

[0083] an upper longitudinal member shaped to define at a distal end of the upper longitudinal member an extension section extending laterally from the upper longitudinal member;

[0088]

[0084] a lower longitudinal member opposing the upper longitudinal member, and shaped to define at a distal end of the lower longitudinal member an extension section extending laterally from the lower longitudinal member;

[0089]

[0085] the upper and lower longitudinal members being disposed on both sides of a central axis, and each being movable between a closed position and an open position, such that:

[0090]

[0086] in the closed position of the longitudinal members the extension sections are shaped and sized to be wedged between one or more teeth of an upper dental arch of the subject and one or more teeth of a lower dental arch of the subject, and;

[0091]

[0087] in the open position of the longitudinal members the extension sections are configured to separate the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch, to open the oral cavity of the subject, and; an actuator mechanism coupled to the upper and lower opposing longitudinal members and configured to move the upper and lower longitudinal members between the open and closed positions of the longitudinal members.

[0092]

[0088] In some examples, the extension sections of the upper and lower opposing longitudinal members may have a total thickness that is equal or less than, e.g., 3 mm.

[0089] In some examples, oral cavity opening tool may further include a flexible biocompatible covering, which may be configured to cover the upper and lower longitudinal members.

[0093]

[0090] In some examples, the apparatus may further include a handle at a proximal section of the apparatus.

[0094]

[0091] In some examples, the extension sections may be configured to extend laterally from the upper and lower opposing longitudinal members in a lingual direction with respect to the longitudinal members, while the extension sections may be wedged between the one or more teeth of the upper dental arch and the one or more teeth of the lower dental arch.

[0095]

[0092] Alternatively, and additionally, in some embodiments, apparatus configured for the employment within an oral cavity of a subject, the apparatus may further comprise:

[0096]

[0093] an elongated body configured to be advanced into the oral cavity of the subject; and

[0097]

[0094] a projection extending laterally from the elongated body and having a thickness equal or less than, e.g., 3 mm, the projection may be configured to be wedged between one or more teeth of an upper dental arch of the subject, and one or more teeth of a lower dental arch of the subject such as to separate the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch.

[0098]

[0095] In some examples, the projection extending laterally from the elongated body may have a thickness equal or less than, e.g., 2 mm.

[0099]

[0096] Reference is first made to Figs.l-4B, showing apparatus 20, and to Figs.7A-8B showing apparatus 120, in accordance with some embodiments. Apparatus 20 and apparatus 120 may be both configured for employment within the oral cavity (i.e., a mouth) of a subject by being inserted into the oral cavity.

[0100]

[0097] The terms "mouth" and "oral cavity" may refer to the general anatomical site of interest, wherein the apparatus may be inserted into. The terms "mouth" and "oral cavity" may be used interchangeably herein.

[0101]

[0098] Apparatus 20 and apparatus 120 may comprise mouth opening assisting devices for opening the mouth of the subject. Apparatus 20 and apparatus 120 may be both configured to open the mouth of the subject from a closed state of the mouth to an open state of the mouth, and to maintain the mouth in the open state following the initial opening.

[0102]

[0099] The term "closed state" of a mouth as used herein may refer to a situation where the lower jaw, e.g. Mandible, comprising the lower dental arch of the subject may be generally in proximity to or engage with the upper jaw, e.g. Maxilla, comprising the upper dental arch of the subject, preventing access to the subject's oral cavity.

[0103]

[0100] The term "bite force" and / or "bite pressure" may refer to the amount of force generated by the muscles and bones of the upper and lower jaw when the subject oral cavity is brought into a closed state, e.g. when the subject bites.

[0104]

[0101] In some embodiments, apparatus 20 and apparatus 120 may assist the user with the opening of the oral cavity of a subject, for example, an infant, a disabled subject, and / or an uncooperative or challenged subject, to allow access to the oral cavity of the subject to provide oral care, e.g., to maintain proper oral hygiene.

[0105]

[0102] Apparatus 20 and apparatus 120 may assist in the opening of the mouth and allowing access to the oral cavity of the subject during an oral examination and / or dental treatments.

[0103] Apparatus 20 and apparatus 120 may be used in accordance with some examples by a user, who may be a caregiver, providing oral care to the subject. Accordingly, apparatus 20 and apparatus 120 may be configured for home use and / orfor use in a medical settingsuch as a clinic, an educational facility, a rehabilitation facility, a treatment center, and / or a children's care center.

[0106]

[0104] Apparatus 20 and apparatus 120 may be configured for the opening of the mouth of the subject, and maintaining the mouth in an open state, in a safe manner for both the treated subject and the user. Moreover, apparatus 20 and apparatus 120 may be configured to open the mouth of the subject in a gentle and dignified manner while reducing potential risk to the user, which may be caused by the subject suddenly shutting the mouth closed (e.g., biting).

[0107]

[0105] The adjectives "gentle and dignified" used for describing the mode at which the opening of the subject mouth may be achieved, may further refer to the employment of the apparatus by the user with minimal or comparatively reduced force required to open and maintain open the oral cavity of the subject,

[0108]

[0106] Reference is now made to Fig. 1 which is a schematic illustration of apparatus 20. In accordance with some embodiments of the present invention, apparatus 20 may comprise a protective cover 22 and a projection 24 extending laterally from protective cover 22.

[0109]

[0107] Protective cover 22 may be configured for at least partially surround finger 10 of the user. Otherwise, protective cover 22 may partially or fully surround finger 10.

[0110]

[0108] Protective cover 22 may further comprise a flexible, or semi-rigid finger sheath and / or sleeve, which may be shaped and sized adapted to receive finger 10 of the user.

[0111]

[0109] In some embodiments, protective cover 22 may have an inner and an outer surface 42 and 44 (inner surface 42 and outer surface 44 are shown in Fig. 2B), open end 32 and closed end 34, and an elongate tubular body defining an axial lumen 38 between open and closed ends 32 and 34.

[0112]

[0110] In some embodiment, finger 10 may be inserted into protective cover 22 through an opening 30 positioned at open end 32.

[0113]

[0111] Further reference is made to Fig. 1, wherein in some embodiments, protective cover 22 may fully encase finger 10 such that finger 10 may fit snuggly into protective cover 22.

[0114]

[0112] Protective cover 22 may comprise a flexible, biocompatible material, for example, an elastomer, which may be suitable for the insertion of the apparatus into the oral cavity of the subject.

[0115]

[0113] Furthermore, protective cover 22 selected material may assist with protection of finger 10 from potential injury, for example, a penetration injury which may be caused by the teeth of the subject cutting into finger 10.

[0116]

[0114] In some embodiments, protective cover 22 selected material may be configured for exhibiting desired mechanical properties suited for apparatus 20 functionality, for example, selecting a material which may exhibit strength, which may withstand exerted bite force and / or pressure generated by the jaws and inflicted upon the apparatus, when the mouth may be in the closed state.

[0117]

[0115] Protective cover 22 may protect the teeth of the subject when the finger of the user is inserted into the mouth of the subject. In particular when the material of protective cover 22 is, e.g., an elastomeric material.

[0116] As shown in Fig. 1, projection 24 projects laterally from protective cover 22 and may be shaped and sized configured (also: adapted) to be wedged between one or more teeth of the upper dental arch, and one or more teeth of the lower dental arch.

[0118]

[0117] Therefore, the separation of the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch may be attained, resulting in distancing between the one or more teeth of the upper dental arch from the one or more teeth of the lower dental arch.

[0119]

[0118] Projection 24 may have a first end 26, which may be coupled to protective cover 22, and a second end 28, which may be extending away from protective cover 22. In some examples, a portion of projection 24 may taper in direction from first end 26 to second end 28.

[0120]

[0119] In some embodiments, projection 24 may have a thickness that is equal or less than, e.g., 2 mm. in some examples, at least one section of projection 24 may be the first to contact and / or to be wedged between the teeth of the upper and lower dental arches may have a thickness that is equal or less than, e.g., 2 mm.

[0121]

[0120] In some examples, projection 24 may have a constant thickness along its entire cross section. Alternatively, projection 24 may be shaped such that second end 28 is tapered with respect to first end 26, wherein the ratio between the thickness of first end 26 and the thickness of second end 28 may be more than 3:1, and / or more than 5:1.

[0122]

[0121] As shown in Fig. 1, in some examples, projection 24 may be shaped to define a wedge having a triangular cross section with a wider first end 26, which may be tapered towards a narrow second end 28 along an incline 27.

[0123]

[0122] In some embodiments, projection 24 may be shaped to define a conical projection having, e.g., a tip section.

[0124]

[0123] In some embodiments, the thickness of projection 24, which may be the minimal thickness of second end 28, may facilitate the wedging of projection 24 between the teeth of the upper and lower dental arches adapted to separate the teeth and initiate the opening of the mouth of the subject.

[0125]

[0124] In some embodiments, narrow second end 28 may be first wedged between the teeth followed by the remainder of projection 24, which may cause further separation between the teeth of the upper and lower dental arches.

[0126]

[0125] Optionally, finger 10, covered by protective cover 22 may be positioned between the upper and lower dental arches to further open the mouth and maintain the mouth in an open position for the desired extent and duration.

[0127]

[0126] In some embodiments, protective cover 22 further comprises a suction tube coupling element (not shown) which may be configured to removably couple a suction tube to protective cover 22 for evacuating excessive moisture and / or saliva from the oral cavity during administration of oral care to the subject by the user during use of apparatus 20.

[0128]

[0127] In some embodiments, the suction tube may comprise, for example, a dental saliva ejector and / or a dental surgical aspirator, a distal section which may be coupled to protective cover 22 via the suction tube coupling element, while a proximal section thereof may be coupled to a suction source.

[0129]

[0128] In some embodiments, the suction tube coupling element may comprise a mechanical coupling element such as a clip. Alternatively, the suction tube coupling element may be shaped to define a loop for insertion therethrough of the suction tube.

[0129] In some embodiments, the suction tube coupling element may be disposed in the vicinity of open end 32 of protective cover 22, e.g., attached to opening 30. Alternatively, the suction tube coupling element may be disposed anywhere along protective cover 22.

[0130]

[0130] Reference is now made to Figs. 2A, 2B and 2C, which are schematic illustrations of various views of apparatus 20 in accordance with some embodiments. Fig. 2A shows apparatus 20 with a side view of projection 24. Fig. 2B shows a top view of apparatus 20, showing opening 30 through which finger 10 enters apparatus 20, and lumen 38 into which finger 10 is inserted. Finally, Fig. 2C shows apparatus 20 with a front view of projection 24.

[0131]

[0131] Reference is now made to Figs.3A-3B and 4A-4B, which are schematic illustrations of apparatus 20, in accordance with some embodiments. Figs. 3A and 4A show side views of the apparatus in accordance with respective embodiments, wherein Figs.3B and 4B show corresponding cross-sectional views.

[0132]

[0132] As described hereinabove, in some embodiments, the protective cover 22 may comprise a flexible protective cover facilitating easy and safe maneuvering of finger 10 of the user within the mouth of the subject.

[0133]

[0133] The adjectives "easy and safe" describing the maneuvering modes of finger 10, when coupled with apparatus 20, and when inserted within the subject oral cavity, may refer to the little or no physical confinement of finger 10 coupled with apparatus 20, when maneuvering in translations and / or rotation. For example, when inserted into the protective cover 22, finger 10 may be able to bend, flex and move naturally.

[0134]

[0134] For example, finger 10 may be able to bend, flex and move naturally allowing finger 10 phalange to bend and / or flex about the radial axis, in the palmer direction, exhibiting extension and / or flexing maneuvers of finger 10. Finger 10 may also rotate about the distal axis.

[0135]

[0135] In some embodiments, in addition to being composed of, e.g., an elastomeric deformable material, the protective cover 22 may comprise additional protective components, which may also be flexibility-enabling, such as rings 40 (shown in Figs. 3A-3B), or spring 50 (shown in Figs. 4A-4B).

[0136]

[0136] In some embodiments, the protective components, e.g., annular structures 40 and / or spring 50 may provide protection to the user's finger 10 from sudden closing of the mouth (e.g., biting), when the finger 10 may be disposed in protective cover 22 and inserted into the mouth of the subject.

[0137]

[0137] Further reference is now made to Fig. 3A, wherein Fig. 3A is a cut-out view of apparatus 20, which may comprise a plurality of (e.g., three or more) rings 40 in accordance with some embodiments.

[0138]

[0138] In addition, further reference is now made to Fig. 3B, wherein Fig.3B is a view of a cross section of apparatus 20 may comprise one or more rings 40, e.g., metallic rings arranged in protective cover 22 adapted to provide segmentation of the protective cover 22 in a manner that generally corresponds to a human finger.

[0139]

[0139] In some embodiments, the rings may provide protection from biting of finger 10, while enabling bendability and / or flexibility of protective cover 22. Moreover, rings 40 may allow for generally natural maneuverability of finger 10 when inserted into protective cover 22.

[0140]

[0140] In addition, rings 40 may be disposed between an inner (e.g., elastomeric) layer 46 of protective cover 22 and outer (e.g., elastomeric) layer 48 of protective cover 22 and may not penetrate through to the inner lumen 38 defined by the protective cover 22. Accordingly, as described above, rings 40 may provide protection to the user's finger 10.

[0141] Reference is now made to Figs. 4A-4B, wherein apparatus 20 may comprise a spring 50, which may be disposed between an inner layer 46 and an outer layer 48. Spring 50 may provide protection to finger 10 from biting while allowing bendability and / or flexibility of protective cover 22. For example, protective cover 22 may be able to bend, flex and move naturally allowing protective cover 22 to bend and / or flex about the radial axis, in the palmer direction, exhibiting extension and / or flexing maneuvers of protective cover 22. Protective cover 22 may rotate about the distal axis.

[0141]

[0142] Further reference is now made to Fig. 4A, wherein Fig.4A is a cut-out view of apparatus 20, which may comprise a spring 50 in accordance with some embodiments.

[0142]

[0143] Further reference is now made to Fig.4B, wherein Fig.4B is a schematic illustration of a cross section of apparatus 20 comprising spring 50 which may allow for generally natural maneuverability of finger 10 when inserted into protective cover 22, while providing protection to the user's finger.

[0143]

[0144] Reference is now made to Figs.5A-5B and Figs.6A-6C, which are schematic illustrations of apparatus 20 configured for being employed within the oral cavity with the purpose of opening the oral cavity of the subject, in accordance with some embodiment.

[0144]

[0145] Moreover, as described hereinabove apparatus 20 may be configured for employment by a finger of user 100 for opening the oral cavity of subject 200 with the aim of providing oral care to subject 200.

[0145]

[0146] Further reference is now made to Figs. 5A-5B, which are front views of subject 200 showing apparatus 20 being used by finger 10 of user 100.

[0146]

[0147] Further reference is now made to Figs. 6A-6C, which are side views showing apparatus 20 being used by finger 10 of user 100 to open the oral cavity of subject 200.

[0147]

[0148] In some embodiments, finger 10 may be first inserted into the protective cover 22. Subsequently, once finger 10 is positioned inside protective cover 22, user 100 may advance finger 10 into the oral cavity of subject 200, through upper lip 82U and lower lip 82L, wherein the projection 24 may be oriented towards teeth of the subject.

[0148]

[0149] in some examples, while being advanced to a desired location along the dental arches of subject 200, the projection 24 may be oriented in any direction, which may be convenient for user 100 and / or subject 200.

[0149]

[0150] The term "convenient" may refer to the ease of use by user 100, wherein little to no constraints may be experienced on user maneuvers of the apparatus within the oral cavity. Furthermore, the term "convenient" may refer to subject 200 physical and / or emotional sensations due to the insertion of the apparatus into the subject's oral cavity.

[0150]

[0151] Moreover, once the desired location is reached, finger 10 may be adjusted (e.g., rotated) such that second end 28 of projection 24 may be oriented towards the teeth of the subject, which may be separated by projection 24.

[0151]

[0152] Finally, projection 24 may be then wedged between one or more teeth 80U of the upper dental arch and one or more teeth 80L of lower dental arch of subject 200, which may cause the separation of the upper and lower dental arches to achieve the purpose of opening of the oral cavity.

[0152]

[0153] As shown in Figs. 5A-5B, 6A- 6C, in some examples, finger 10 may be advanced through lips 82U and 82L into the oral cavity parallel to the lower and upper dental arches along the inner cheek, while, optionally, having second end 28 of projection 24 oriented towards the dental arches.

[0154] Subsequently, the projection 24 may then be wedged between the teeth of the upper and lower dental arches in a lingual direction, which may further be adapted to separate the teeth by initiating the opening of the oral cavity.

[0153]

[0155] Further reference is now made to Fig.5A and 5B, wherein second end 28 may be the first section of projection 24 to be wedged between teeth 80U and 80L.

[0154]

[0156] In some embodiments, as described hereinabove, second end 28 of projection 24 may have a relatively small thickness that may facilitate the insertion of second end 28 between 80U and 80L, when the mouth is in a closed state.

[0155]

[0157] In some embodiments, the thickness of second end 28 may be equal or less than, e.g., 2 mm.

[0156]

[0158] Furthermore, the wedging of the second end 28 of projection 24 between teeth 80U and 80L may cause initial separation of the upper and lower dental arches.

[0157]

[0159] Following the second end 28, a remainder of the projection 24 may be wedged between teeth 80U and 80L to gradually and / or continuously increase the separation of the upper and lower dental arches to further open the mouth of subject 200.

[0158]

[0160] In some examples, the adjective "gradually" may refer to the temporal change, which may take place over a period of time in small, incremental steps.

[0159]

[0161] For example, the gradual insertion of apparatus 20 into the oral cavity of a subject may refer to the incremental progression in time, of the apparatus 20 within the oral cavity of the subject.

[0160]

[0162] In some examples, the term "continuously" may refer to spatial change, which may progress steadily without stops and / or gaps.

[0161]

[0163] For example, the continuous insertion of apparatus 20 into the oral cavity of a subject may refer to the steady progression of the positioning of apparatus 20 within the oral cavity of the subject.

[0162]

[0164] For illustrative purposes only and for further clarity the adjectives "gradually" and "continuously" may be used interchangeably and may refer to spatiotemporal changes.

[0163]

[0165] In some embodiments, when the first end 26 of projection 24 is positioned and advanced between teeth 80U and 80L, separation between teeth 80U and 80L may be increased due to the greater dimensions, e.g. thickness, of first end 26 relative to the second end 28.

[0164]

[0166] In some embodiment, the varying thickness of projection 24 (i.e., increasing from end 28 to end 26), may facilitate a gradual and / or continues and / or controllable opening of the mouth, by advancing projection 24 in palmar direction of the subject's oral cavity. The direction of (e.g., forceful) advancement of the projection may be in direction that corresponds to a tapering direction of a wedge segment.

[0165]

[0167] In some embodiments, by maintaining projection 24 between teeth 80U and 80L, apparatus 20 may maintain the opening of the oral cavity during administration of oral care to subject 200 by user 100.

[0166]

[0168] Further reference is now made to Fig.6C, wherein in some examples, succeeding the initial opening of the oral cavity by projection 24, additional opening of the oral cavity may be facilitated by the insertion of cover-protected finger 10 between the upper and lower dental arches.

[0169] In some examples, when finger 10 is inserted between the upper and lower dental arches, finger 10, which may be incased within the protective cover 22, may further be bent in a lingual direction, and / or maneuvered in any other direction.

[0167]

[0170] In some embodiments, finger 10 may be held between the teeth during administration of oral care to subject 200 by user 100, which may be executed in a plurality of example scenarios, including daily brushing of the subject's teeth, a dental procedure, and / or a medical procedure (e.g., intubation). The above example scenario should by no means be construed in a limiting manner.

[0168]

[0171] Further reference is now made to Figs.5A-5B and Figs.6A-6C, wherein the insertion of apparatus 20 between the side teeth of the subject is shown for illustration purposes only and should by no means be construed in a limiting manner.

[0169]

[0172] Further emphasis may be drawn, wherein apparatus 20 may be configured for insertion between the upper and lower dental arches at any location along the dental arches.

[0170]

[0173] In some examples, wherein the subject may lack at least one tooth and / or may be missing the entirety of teeth, nonetheless, projection 24 may be wedged between the upper and lower gums of the subject. Thus, apparatus 20 may still open the mouth of the subject by separating the gums of the subject, irrespectively of the subject's tooth condition.

[0171]

[0174] Reference is now made to Figs.7A-7B and 8A-8B, which are schematic illustrations of apparatus 120 for use with an oral cavity of a subject, in accordance with some embodiments.

[0172]

[0175] In some examples, apparatus 120 may comprise an oral cavity opening tool, which may be configured to open the oral cavity from a closed state to a partially or fully open state and to maintain the oral cavity in the open state during application of oral care to the subject.

[0173]

[0176] In some examples, apparatus 120 may be configured for the advancement into the oral cavity of the subject, generally, without requiring the insertion of a hand and / or finger of the user into the mouth of the subject.

[0174]

[0177] In some examples, apparatus 120 may be operated and controlled by the user from outside of the oral cavity, thereby being suitable for cases in which the insertion of a hand into the oral cavity causes discomfort or inconvenience to the user and / or the treated subject.

[0175]

[0178] In some embodiments, apparatus 120 may comprise an upper and a lower longitudinal member, 122U and 122L respectively, wherein each member may have a proximal section 132 and a distal section 134.

[0176]

[0179] In some embodiments, the adjective "distal" may refer to a location or projection portion which may be engage first into the subject's oral cavity. Correspondingly, the adjective "proximal" may refer to a direction or location, which may engage with the oral cavity of the subject subsequent to the engagement of a distal portion.

[0177]

[0180] In some embodiments, upper and lower longitudinal members 122U and 122L may be each shaped to define at distal section 134, an extension section 124U and 124L respectively, which may be further extending laterally, e.g., substantially perpendicularly, from the longitudinal members, 122U and 122L.

[0178]

[0181] In addition, the upper and lower longitudinal members ,122U and 122L respectively, may be disposed on both sides of a central axis A0, wherein each member may be movable between a closed position and an open position, as shown in Fig.7Aand in Fig.7B.

[0182] Further reference is now made to Fig.7A, wherein the closed position is exemplified, in such an example scenario, the upper longitudinal member 122U may be mounted onto the lower longitudinal member 122L. Thus, extension sections 124U and 124L of both longitudinal members may have a total thickness equal or less than, e.g., 3 mm, or e.g., less than 2 mm.

[0179]

[0183] Generally, within the closed position, upper longitudinal member 122U may be mounted onto lower longitudinal member 122L, wherein extension sections 124U and 124L of both longitudinal members may have a total thickness which may be relatively small (e.g., up to 3 mm or up to 2 mm).

[0180]

[0184] Consequently, when in the closed position, the extension sections 124U and 124L shape and size may be adapted to be wedged between a tooth of an upper dental arch of the subject and a tooth of a lower dental arch of the subject.

[0181]

[0185] In some examples, once wedged between the teeth, longitudinal members, 122U and 122L, may be moved to the open position, wherein extension sections 124U and 124L may be separated from each other, in turn, forcing separation between the teeth of the upper dental arch from the tooth of the lower dental arch. Therefore, achieving the opening of the oral cavity.

[0182]

[0186] In some examples, a degree of separation of longitudinal members 122U and 122L may be controlled by the user. In addition, the consequent degree of the mouth opening, may be by proxy controlled by the user.

[0183]

[0187] In some examples, longitudinal members 122U and 122L may comprise metallic longitudinal members, which may be covered by a flexible biocompatible material, e.g., elastomeric material. For example, longitudinal members 122U and 122L may be inserted into an (e.g., elastomeric) sleeve 180, shown in Fig.7A.

[0184]

[0188] In some embodiment, (e.g., elastomeric) sleeve 180 may provide a soft protective layer relative to the rigidity of the longitudinal members and the subject's teeth.

[0185]

[0189] Further reference is now made to Figs.8A-B, wherein apparatus 120 may comprise an actuator mechanism 140, which may cause the separation of the upper and lower longitudinal members 122U and 122L, achieving an open state of the oral cavity.

[0186]

[0190] Thereby, the actuator mechanism may force the separation between the teeth of the upper dental arch from the tooth of the lower dental arch, to initiate the opening of the oral cavity. As described hereinabove, apparatus 120 is operated and controlled by the user from outside of the oral cavity.

[0187]

[0191] Furthermore, apparatus 120 may comprise a proximal section 132, which may generally remain outside of the oral cavity of the subject and may be further controlled by the user. A distal section 134 may comprise longitudinal members 122U and 122L, which may be inserted into the oral cavity. The actuator mechanism 140 is operated by the user through handle 130, which is held by the user.

[0188]

[0192] Additional reference is now made to Figs.8A-8B, in some examples, the longitudinal members 122U and 122L may pass through a pivot 141. In some examples, when handle 130 is pressed inwardly in the direction indicated by arrows A3 and A4, longitudinal members 122U and 122L pivot about pivot 141 and spring outwardly in the direction indicated by arrows Al and A2.

[0193] Consequently, when handle 130 is pressed, a resulting movement of the upper and lower longitudinal members 122U and 122L may be propagated, wherein the upper and lower longitudinal members may move outwardly and be pushed apart.

[0189]

[0194] As described hereinabove, when the upper and lower longitudinal members 122U and 122L are separated when wedged between teeth of the upper and lower dental arches, an opening of the mouth may be achieved.

[0190]

[0195] In some examples (not shown), the actuator may include a ratchet mechanism, which may be disposed within the handle and may be configured for maintaining upper and lower longitudinal members 122U and 122L separated, resulting in an open state of the subject oral cavity.

[0191]

[0196] In some examples, the handle may comprise a release button 138, shown in Figs.7A-7B, for releasing the ratchet mechanism, wherein the release of the ratchet mechanism may allow the upper and lower longitudinal members 122U and 122L to close such that they may be removed from the subject's mouth.

[0192]

[0197] Further emphasis is made to release button 138, which may be configured for releasing any incorporated mechanism adapted to keep upper and lower longitudinal members 122U and 122L in an open state and allows the longitudinal members to close such that apparatus 120 may be removed from the subject's mouth.

[0193]

[0198] It is to be understood that for subjects without teeth, extension portions 124U and 122L are wedged between the upper and lower gums of the subject, and apparatus 120 opens the mouth of the subject by separating the gums of the subject.

[0194]

[0199] In some examples, wherein the subject may lack at least one tooth and / or may be missing the entirety of teeth, nonetheless, extension sections 124U and 122L may be wedged between the upper and lower gums of the subject. Thus, apparatus 120 may still open the mouth of the subject by separating the gums of the subject, irrespectively of the subject's teeth condition.

[0195]

[0200] In some embodiments, apparatus 120 may further comprise a suction tube coupling element (not shown) configured for removably coupling a suction tube to one or both of upper and lower longitudinal members 122U and 122L for evacuating excessive moisture and / or saliva from the oral cavity during administration of oral care to the subject by the user during use of apparatus 120.

[0196]

[0201] In some embodiments, for example, the suction tube may comprise a dental saliva ejector and / or a dental surgical aspirator, a distal section of which is coupled to upper and / or lower longitudinal members 122U and 122L via the suction tube coupling element, while a proximal section thereof is coupled to a suction source.

[0197]

[0202] In some examples, the suction tube coupling element may comprise a mechanical coupling element such as a clip. Alternatively, the suction tube coupling element may be shaped to define a loop for insertion therethrough of the suction tube.

[0198]

[0203] In some embodiments, the suction tube coupling element may be disposed in the vicinity of proximal section 132 of upper and / or lower longitudinal members 122U and 122L. Alternatively, the suction tube coupling element is disposed anywhere along longitudinal members 122U and 122L.

[0204] Reference is now made to Figs. 9A, 9B, and 9C, which are schematic illustrations of upper and lower longitudinal members 122U and 122L, in accordance with some examples, the upper and lower longitudinal members 122U and 122L may be shaped to define curved longitudinal members.

[0199]

[0205] Further reference is now made to Fig.9A, wherein the extension sections 124U and 124L extend from distal section 134 of upper and lower longitudinal members 122U and 122L, respectively.

[0200]

[0206] Alternatively, as shown in Figs. 9B-C, only one of longitudinal members 122L or 124 (e.g., lower longitudinal members 122L) may be shaped to define extension section 124. In such a manner, the thickness of the section first wedged between the teeth, may be further minimized relative to each one of upper and lower longitudinal members 122U and 122, which may have an extension section 124.

[0201]

[0207] As shown in Figs. 9B-9C, for such embodiments, the longitudinal members, which do not define the extension section (e.g., upper longitudinal members 122U in the example shown in Figs. 9B-9C) may be shaped to define a tapered distal section 134 for fitting onto the longitudinal members, which do define the extension section (e.g., lower longitudinal members 122L in the example shown in Figs.9B-9C). The tapered end is configured to facilitate insertion of the distal end in between the teeth, as described hereinabove.

[0202]

[0208] Reference is now made to Figs. 10A-10C, which are schematic illustrations of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In accordance with some embodiments, apparatus 150, which is an alternative embodiment of the previously presented apparatus 20 and 120, is herein disclosed.

[0203]

[0209] As shown in Figs. 10A-10C, in some embodiments, apparatus 150 may comprise one or more elements. Alternatively, apparatus 150 may comprise a distal phalange element 151 and an intermediate phalange element 152, wherein finger 10, shown in Fig.l, may be operably covered by apparatus 150, which may be assembled by the distal and intermediate phalange-engaging and / or (e.g., partially) phalange-covering elements.

[0204]

[0210] In some embodiments of apparatus 150, a distal phalange element 151 and an intermediate phalange element 152 may be coupled with each other by a linking mechanism 153, wherein linking mechanism 153 may comprise for example, snap-fit joints, living hinges, press-fit connections, threaded fasteners, dovetail joints, bayonet fitting, and / or riveting. The above examples should by no means be construed in a limiting manner, additional linking mechanisms may be applicable to attain the linking functionality.

[0205]

[0211] In some embodiments of apparatus 150, the phalange part of finger 10 (not shown) may be positioned within distal phalange element 151 and the intermediate phalange part of finger 10 (not shown) may be positioned within intermediate phalange element 152, which may enable the coupling of finger 10 to apparatus 150.

[0206]

[0212] In some embodiments, the coupling of finger 10 to apparatus 150 may be secured, for example, by strapping the intermediate phalange part of finger 10 with intermediate phalange element 152, wherein the strapping may comprise a band 160 adapted for strapping apparatus 150. In some examples, apparatus 150 may comprise a coupling arrangement configured to secure the apparatus, for example, with, the user's hand, wrist, forearm, and / or the like.

[0207]

[0213] In some embodiments, the strapping of the intermediate phalange part of finger 10 with intermediate phalange element 152 may further comprise: a cam buckle, straps, magnetic straps, elastic bungee strap, Velcro strap, twist lockstraps and / or snap buckle straps. The above examples should by no means be construed in a limiting manner, additional securing methods may be applicable to attain the coupling functionality.

[0208]

[0214] Reference is now made to Figs. 10B, which is a schematic illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments of apparatus 150, a distal phalange element 151 and an intermediate phalange element 152 may be pivotally coupled with each other, e.g., by a linking mechanism 153, as seen in Fig.lOA, wherein the linking mechanism 153 may comprise, for example, a snap to fit mechanism, which may link the distal phalange element 151 comprising an elongated segment 154 into a corresponding hole segment 155 within the intermediate phalange element 152.

[0209]

[0215] In some embodiments of apparatus 150, an intermediate phalange element 152 and a proximal phalange element (not shown) may be pivotally coupled with each other by a linking mechanism, similar to linking mechanism 153.

[0210]

[0216] Alternatively, and additionally, in some embodiments (not shown), a first linking mechanism may pivotally couple the distal phalange element with intermediate phalange element and / or a second linking mechanism may pivotally couple the intermediate phalange element with proximal phalange element.

[0211]

[0217] Accordingly, apparatus 150 may comprise a distal phalange element 151, an intermediate phalange element 152, and / or a proximal phalange element (not shown), wherein finger 10, shown in Fig.l, may be operably covered by apparatus 150, which may be assembled by the distal, intermediate, and proximal phalange elements.

[0212]

[0218] Furthermore, distal phalange part of finger 10 (not shown) may be positioned within distal phalange element 151, intermediate phalange part of finger 10 (not shown) may be positioned within intermediate phalange element 152, and the proximal phalange part of finger 10 (not shown) may be positioned within the proximal phalange element (not shown), which may enable the coupling of finger 10 to apparatus 150.

[0213]

[0219] In some embodiments, a local cartesian coordinate system (LCS) of the apparatus, is presented for illustrative purposes only, the intermediate phalange element 152 may longitudinally extend, for example, in the X direction of the LCS. The height of intermediate phalange element 152 may extend, for example, in the Z-direction. The LCS may herein be referred to as a reference for various dimensions illustrative of the apparatus. Negative Z direction may herein also be referred to as Palmar direction.

[0214]

[0220] In some embodiments, linking mechanism 153 may function as a hinge allowing for the unconstraint maneuver of the user finger phalanges within the oral cavity of the subject. More specifically, linking mechanism 153 may facilitate the rotation about the Y' axis where distal phalange element 151 may have an angle of rotation with respect to intermediate phalange element 152.

[0215]

[0221] Furthermore, linking mechanism 153 may maintain the connecting functionality, while being configured for the allowance of the movement of the distal phalange element 151 relative to intermediate phalange element 152.

[0216]

[0222] Alternatively, and additionally, in some embodiments (not shown), a linking mechanism may facilitate the rotation of the intermediate phalange element relative to the proximal phalange element about a rotation axis (not shown).

[0217]

[0223] Furthermore, the linking mechanism may maintain the connecting functionality, while being configured for the allowance of the relative movement of the intermediate phalange element and the proximal phalange element.

[0224] Alternatively, and additionally, in some embodiments (not shown), a first and second linking mechanisms may function as hinges allowing for the pivoting of the user's finger phalanges relative to each other.

[0218]

[0225] For illustrative purposes only, from herein, embodiments of the present invention may refer to embodiments which comprise only one linking mechanism 153, wherein the linking mechanism is being configured for the allowance of the relative movement of distal phalange element 151 and intermediate phalange element 152. This should by no means be construed in a limiting manner.

[0219]

[0226] In some embodiments, band 160, which may be made, e.g., of an elastomer, may comprise at least one positioning hole 161, an elongated segment 162 of the intermediate phalange element 152 and a fixing segment 163 of the intermediate phalange element 152.

[0220]

[0227] In some embodiment, the band may comprise of a different material, which may be biocompatible.

[0221]

[0228] In some embodiments, the elongated segment 162 of the intermediate phalange element 152 may be adapted as a placeholder configured to be housed within the positioning hole 161.

[0222]

[0229] In some embodiments, the fixing segment 163 of the intermediate phalange element 152 may be adapted to fix the band 160 to the body of the intermediate phalange element 152.

[0223]

[0230] In some embodiments, the fixing of the band 160 to the fixing segment 163 may be achieved for example by heat stacking, adhesive bonding, ultrasonic welding, etc. The mentioned examples should by no means be construed in a limiting manner, additional fixing methods may be applicable to attain the fixing of band 160 to the fixing segment 163, including frictional and / or form-fitting coupling by employing corresponding fasteners.

[0224]

[0231] Reference is now made to Figs. 10C, which is a schematic illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments, apparatus 150 may comprise a wedge segment 170 configured for the functionality of opening the oral cavity by wedging the finger between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch.

[0225]

[0232] With reference to previously disclosed Fig.l to Fig.6C, the wedge segment 170 of apparatus 150, may be synonym related to the projection 24 extending laterally from the protective cover 22 of apparatus 20, wherein the purpose and desired functionality of both the wedge 170 and the projection 24 may be related.

[0226]

[0233] In some embodiments, the wedging of the upper and lower dental arch may be achieved by the insertion of the cover-protected finger between the upper and lower dental arches, which may maintain its placement between the upper and lower dental arches by pressure exerted from the one or more teeth on the cover-protected finger.

[0227]

[0234] In some embodiments, the wedge segment 170 may comprise at least one groove 171 along the segment whose function is to prevent the teeth from sliding along the wedge segment 170 and may further assist in drainage of accumulated excess moisture and / or salvia within the oral cavity.

[0228]

[0235] Reference is now made to Figs. 11A, which is a schematic illustration of the apparatus 150 configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments, apparatus 150 may comprise a distal phalange element 151 with at least one hole 157 and an intermediate phalange element 152 with at least one hole 158 configured for receiving filler material, which may be different from distal phalange element 151 and the intermediate phalange element 152 material.

[0236] At least part or the entirety of apparatus may comprise a protective cover. At least some of parts of the apparatus may be configured to withstand bite forces to protect a user's finger. At least some parts of the apparatus may comprise suitable materials to withstand bite forces (e.g., synthetic fibers, hard plastics, and metals).

[0229]

[0237] At least some parts of the apparatus may be configured to protect the patient's tissue. At least some parts of the apparatus may, for example, comprise suitable coatings.

[0230]

[0238] At least some parts of the apparatus may be configured to protect the user's finger (e.g., have suitable hardness to withstand bite forces) and configured to protect the patient's tissue (e.g., have suitable softness, and / or smoothness). For example, a phalange element may comprise a comparatively hard base material (e.g., metal) covered with a comparatively soft material (e.g., silicon).

[0231]

[0239] In some embodiments, the filler material may be adapted for greater friction with respect to distal phalange element 151 and intermediate phalange element 152 material, which may facilitate improved grip of apparatus 150 when inserted for the opening of the oral cavity.

[0232]

[0240] The term "filler material" may be further referring to at least one selected region upon apparatus 150, for example selected regions may comprise at least one hole of the distal phalange element 157 and at least one hole of the intermediate phalange element 158, wherein the selected region may comprise anti-slippage structure and / or anti-slippage material.

[0233]

[0241] The term "anti-slippage structure" may refer to protrusions and / or grooves, which may increase friction in axial finger direction with the purpose of decreasing likelihood of slippage of finger out of the protective cover and / or slippage of the obtained position of apparatus 150 with the oral cavity of the subject.

[0234]

[0242] The term "anti-slippage material" may refer to material which exhibit mechanical properties promoting the stable positioning of apparatus 150 with the subject oral cavity, for example hydrophobic materials, elastomeric material, material with surface roughness supporting enhanced friction, and / or the like.

[0235]

[0243] In some examples, the anti-slippage material and structure may be implemented as fillers within a receiving hole 157 and 158. Alternatively, the anti-slippage material and structure may be implemented at least one selected region upon apparatus 150.

[0236]

[0244] Reference is now made to Figs. 11B, which is a schematic illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments, the distal phalange element 151 may comprise a distal phalange protective cover 159, which may further comprise a hole 156 configured for receiving filler material, which may be different from the distal phalange protective cover 159 material.

[0237]

[0245] In some embodiments, distal phalange protective cover 159 may comprise of a material different form distal phalange element 151 material, wherein the protective cover 159 material may exhibit different mechanical properties, for example yield strength, ultimate strength, module young, ext.

[0238]

[0246] In some embodiments, the filler material of hole 156, may facilitate improved grip of apparatus 150 when inserted for the opening of the oral cavity.

[0239]

[0247] In some embodiments, the filler material of hole 156 and distal phalange protective cover 159 material may be the same material. Otherwise, the material may differ.

[0248] In some embodiments, the filler material of hole 156 and the distal phalange protective cover 159 material may exhibit the same surface roughness. Otherwise, the surface roughness may differ.

[0240]

[0249] Further reference is made to Fig.llA and Fig.llB, wherein intermediate phalange element 152 may extend n the X direction, and distal phalange element 151 may extend in the X' direction, when the linking mechanism 153 may facilitate the rotation about the Y' axis.

[0241]

[0250] In some embodiments, band 160 extends with the length Lin the Y axis when open and adapted to strap and cover the intermediate phalange of finger 10, when coupled to with apparatus 150.

[0242]

[0251] Reference is now made to Figs. 12A, which is a schematic side-view illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C, in accordance with some examples. For illustrative purposes only, line A-A is made clear indicating a later referenced cross-section view.

[0243]

[0252] Reference is now made to Figs. 12B, which is a schematic side-view illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C, in accordance with some examples , wherein the length of the intermediate phalange element 152 may extend n the X direction, corresponding to the distal direction, and the height may extend in the Z direction, corresponding to the palmar direction.

[0244]

[0253] Distal phalange element 151 may extend in the X' direction, when the linking mechanism 153 may facilitate the rotation about the Y' axis, and the height may extend in the Z' direction.

[0245]

[0254] Reference is now made to Figs. 13A, which is a schematic top-view illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments, band 160 may have a width of LI extending at the X direction.

[0246]

[0255] Additionally, and alternatively, band 160 may have a width of L2, which is wider relative to DI, extending at the X direction.

[0247]

[0256] In some embodiments of band 160, the band width may vary gradually and / or abruptly, wherein the wider L2 section of the band may facilitate an extended protection cover of the intermediate phalange of finger 10, when strapped by band 160 into the intermediate phalange element 152.

[0248]

[0257] Reference is now made to Figs. 13B, which is a schematic cross-section A-A illustration of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C, in accordance with some examples , the linking mechanism 153 may comprise, for example, a rivet R, which may not allow the two elements of the apparatus to separate. In addition, the rivet R may be adapted as a hinge, a Mowing for the flexible maneuver of finger 10, when coupled with apparatus 150.

[0249]

[0258] Reference is now made to Figs. 14A and 14B, which are bottom and isometric schematic illustrations of the apparatus, respectively, configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C.

[0250]

[0259] In some embodiments of apparatus 150 may comprise a wedge segment 170, which may extend with a length of W2 at the X direction, corresponding to the distal and / or proximal direction, and a maximum width of W1 at the base of the wedge segment 170 in the Y direction, corresponding to the radial and / or ulnar direction.

[0260] In some examples, width W1 and length W2 may lie in a coronal plane. Alternatively, width W1 and length W2 may reside in different planes.

[0251]

[0261] The referenced "W2" length may be interchangeably referred to as the centerline and / or symmetry line of the wedge segment 170. The referenced "Wl" width may be interchangeably referenced as midway transition line of the wedge segment 170.

[0252]

[0262] Reference is now made to Figs. 15A and 15B, which are front and top schematic illustrations of the apparatus, respectively, configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C. In some embodiments, apparatus 150 may comprise a wedge segment 170, with a base with the width of Wl.

[0253]

[0263] For illustrative purposes sections of the wedge segment 170 may be referenced for further disclosure of apparatus structure and functionality. The wedge segment 170 sections may comprise, for example, an upper section 170U, a bottom section 170B, a right section 170R and a left section 170L.

[0254]

[0264] Reference is now made to Figs. 16A and 16B, which are isometric schematic illustrations of the apparatus 150 for use with the oral cavity of the subject shown in Fig.l, As shown, some embodiments of apparatus 150 may comprise a wedge segment 170 with an upper section 170U, a bottom section 170B, a right section 170R and a left section 170L, and wherein a transitional area 172 may be incorporated allowing for the continuous transition between the wedge segment 170 and the main body distal phalange element 151M.

[0255]

[0265] In some embodiments, wedge segment 170 may be configured to convert force applied Ftby finger 10, for example in the Z direction, into a perpendicular force exerted F2in both positive and negative Y directions. Consequently, enabling the user to split, lift, hold the subject's oral cavity in an open state.

[0256]

[0266] In some examples, the force applied Ftby finger 10 in the Z direction may correspond to the force applied Ftby finger 10 in palmar direction relative to the finger and in the lingual direction relative to the hand. The resultant perpendicular force exerted F2in both positive and negative Y directions may correspond to the radial and ulnar direction relative to finger 10.

[0257]

[0267] In some embodiments, the applied force Ftdriven by the user finger 10 coupled with apparatus 151 may be (e.g., forcefully) advanced or inserted into the oral cavity of the subject's teeth resulting the resultant force F2.

[0258]

[0268] In some embodiments, the applied force Ftmay be exerted upon a section of contact between apparatus 151 and the oral cavity of a subject, wherein the section of contact may initially be 170B, which may comprise a narrow edge, e.g., an apex.

[0259]

[0269] Moreover, the resultant force F2from the interaction of sections 170R and 170L with the subject's oral cavity, may be exerted. Consequently, enabling the user to split, lift, hold the subject's oral cavity in an open state.

[0260]

[0270] In some embodiments, the transition between the wedge segment 170 and main body distal phalange element 151M may comprise, for example, flush transition, smooth transition, phased transition, abrupt transition, binary transition, etc. The above examples should by no means be construed in a limiting manner, additional transition types may be applicable.

[0261]

[0271] The term "transition" may refer to a change between a first part of apparatus 151 , for example the wedge segment 170, and a second, different part, for example the main body distal phalange element 151M. the "transition" may compriseat least one mechanical property of the material make-up of the part, at least one defining geometry feature the part, at least one pattern formation, for example grooves patterns, ext.

[0262]

[0272] In some embodiments, the term "binary transition" may refer to a dual-state transition, for example, the transition is between two distinct surface roughness of the same material, two distinct engraved patterns, ext.

[0263]

[0273] Further reference is now made to Fig.l6A, wherein an additional embodiment of the distal phalange element 151 is made clear with reference to Fig.lOA, wherein the linking mechanism 153 may comprise for example a snap to fit mechanism, which may link the distal phalange element 151 comprising an elongated segment 154 into a corresponding hole segment 155 within the intermediate phalange element 152.

[0264]

[0274] In the current, Fig.l6A, embodiment the linking mechanism 153 may comprise for example a riveting mechanism, which may link the distal phalange element 151 comprising a hole segment 154A into a, not shown, corresponding hole segment 155A within the intermediate phalange element 152.

[0265]

[0275] Further reference is now made to Fig.l6B, wherein an additional embodiment of the distal phalange element 151 is made clear with reference to Fig. 11B, wherein a distal phalange protective cover 159, which may further comprise a hole 156 configured for receiving filler material, may be incorporated within the distal phalange element 151.

[0266]

[0276] In the current, Fig.l6B, embodiment the distal phalange element 151 may comprise a uniform protective cover 159, without incorporating a hole configured to receive a filler material.

[0267]

[0277] In some embodiments, distal phalange element 151 material may be different from distal phalange protective cover 159 material. Alternatively, the distal phalange element 151 material may be of the same material of the distal phalange protective cover 159 material.

[0268]

[0278] Reference is now made to Figs. 17A, 17B and 17C, which are top, bottom and bottom with enlargement illustrations of the apparatus, respectively, which may be configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C.

[0269]

[0279] In some embodiments, apparatus 150 may comprise a distal phalange element 151 with a wedge segment 170, which may extend with a length of W2 in the X direction, and a maximum width of W1 at the base of the wedge segment 170 in the Y direction.

[0270]

[0280] Wedge segment 170 may have an initial connecting edge P2, wherein the main body of the distal phalange element 151M may be merged with the wedge segment 170. In addition, an edge of the wedge segment Pl, which may be descriptive of the tip of the distal phalange element 151, may be denoted.

[0271]

[0281] Further reference in now made to Fig.l7A, wherein the distal phalange element 151 may comprise a receiving inner opening diameter of DI configured to facilitate the distal phalange of finger 10 within the main body of distal phalange element 151M, when coupled with distal phalange element 151 of apparatus 150.

[0272]

[0282] Further reference is now made to Fig.l7B, wherein wedge segment 170, which may extend with a length of W2 in the X direction, according to some embodiments, the wedge may extend beyond the edge of the wedge segment Pl.

[0273] Consequently, lengthening the tip of the distal phalange element 151M.

[0274]

[0283] In some embodiments, the lengthening of the wedge W2 may provide a gradual transition of force, which may be advantageous when precision and control are required. In addition, the extended length of the wedge W2 may reduce theresultant force F2per unit area exerted on the subject's oral cavity. Thus, facilitating balance and control during (e.g., forcefully) advancement and / or insertion of apparatus 151 into the oral cavity of the subject.

[0275]

[0284] Additionally, and alternatively, in some embodiments, a shortening of the length of the wedge W2 may concentrate the resultant force F2over a smaller area, which may facilitate a faster opening of the oral cavity of the subject due to increase of feree per unit area exerted on the subject's oral cavity.

[0276]

[0285] In some embodiments, the length of the wedge W2 may be determined to establish an exerted resultant force F2per unit area, which may overcome bite force and / or pressure generated by the jaws and inflicted upon apparatus 151, when the mouth may be in the closed state.

[0277]

[0286] In some embodiments, the contour of the wedge connecting P2 and Pl may define the section of contact, which may be the first part of apparatus 151 contacting the subject's teeth when (e.g., forcefully) advancing and / or inserting the wedge segment between the subject's teeth.

[0278]

[0287] In some embodiments, the contour of the wedge connecting P2 and Pl, may be a straight line, for example the line of length W2. Alternatively, the contour line may exhibit non-straight lines.

[0279]

[0288] In some embodiments, the gradient along the contour of the wedge connecting P2 and Pl, which may facilitate a narrow constant edge, e.g., an apex, and / or an edge adapt to facilitate elevation change of the edge with respect to the Z direction.

[0280]

[0289] In some embodiments, P2 and Pl may be points which may geometrically define the contour of the wedge comprising a narrow edge, e.g., an apex. Alternatively, P2 and Pl may be lines. Thus, geometrically defining a strip of the wedge edge, which may comprise constant width when Pl and P2 are equivalent in length. Otherwise, the width of the strip may vary.

[0281]

[0290] In some embodiments, the wedge geometry may comprise a divergence and convergence sections of the wedge segment 170 along the longitudinal axis, namely, along the X direction.

[0282]

[0291] In some embodiments, the maximum width of W1 at the base of the wedge segment 170 in the Y direction may define a midway line, e.g. a midway transition line, wherein the wedge expands from P2 toward the midway line Wl, comprising the divergence section of wedge segment 170, and contracts from midway line Wl up to Pl, comprising the convergence section of wedge 170.

[0283]

[0292] In some embodiments, the divergence section of the wedge 170, wherein the wedge expands from P2 toward midway line Wl, may comprise the outward symmetrical divergence, which may form an expanding profile. The divergence section cross-sectional area gradually increases as it extends towards midway line Wl.

[0284]

[0293] Alternatively, the wedge expands from P2 toward midway line Wl may comprise an outward asymmetrical divergence, which may form an asymmetrically expanding profile.

[0285]

[0294] In some embodiments, the expanding geometry allows for the resultant force F2to be distributed across a larger area of the subject's oral cavity.

[0286]

[0295] The comparatively wide distribution of the resultant force F2may reduce the pressure applied at the contact oral cavity surface. Furthermore, the divergence section may provide stability and control, when operable by user, as thebroader area of contact may engage the material comprising the apparatus, with less probability of slipping and / or misalignment.

[0287]

[0296] In some embodiments, the expending of wedge length W2 may ensure that wedge segment 170 may be adapted to enable the user to split, lift and / or hold the subject's oral cavity in an open state with wider distribution of the resultant force F2along the wedge length W2, facilitating a gradual, continuous, and / or controlled (e.g. forceful) advancement and / or insertion of the wedge segment 170 between the subject's teeth.

[0288]

[0297] The phrase "distribution of the resultant force F2" may imply the division of the resultant force F2across the length of the wedge segment 170, wherein at each point along the length of the wedge segment 170 a local resultant force may be referenced to for purpose of further illustration.

[0289]

[0298] In some embodiments, midway line Wl, e.g., midway transition line, may be the line of maximum width of wedge segment 170. The midway line may facilitate the transition between the divergence and the convergence sections, wherein the trend of the distributed resultant force F2acting on wedge segment 170 may shift from a decreasing magnitude of the local resultant force when approaching midway line Wl to increasing magnitude of the local resultant force when approaching Pl.

[0290]

[0299] In some embodiments, midway line Wl may facilitate the stability of wedge segment 170 upon the (e.g., forceful) advancement and / or insertion of wedge segment 170 between the subject's teeth, wherein the of the forces exerted on either side of the wedge may be balanced.

[0291]

[0300] In some embodiments, the convergence section of wedge 170, wherein the wedge contracts from midway line Wl toward the tip of wedge Pl, may comprise the inward symmetrical convergence, which may form a contacting profile. The convergence section cross-sectional area gradually reduces as it contracts from midway line Wl towards the tip of the wage at Pl.

[0292]

[0301] Alternatively, the wedge contracts from midway line Wl toward the tip of the wedge Pl, which may comprise the outward asymmetrical divergence, and may, consequently, form an asymmetrically contracting profile.

[0293]

[0302] In some embodiments, wedge segment 170 may be a symmetric wedge segment with evenly tapered sides, which may provide balanced distribution of the resultant force adapted to facilitate a straight and / or controlled motion when (e.g., forcefully) advancing and / or inserting wedge segment 170 between the subject's teeth.

[0294]

[0303] Alternatively, wedge segment 170 may be an asymmetric wedge, wherein one side is steeper or longer relative to the other, which may provide an uneven distribution of the resultant force adapted to facilitate a costume redirection user experience when (e.g. forcefully) advancing and / or inserting wedge segment 170 between the subject's teeth.

[0295]

[0304] In some embodiments, focusing the applied force into a progressively smaller region may amplify the force per unit area, allowing the wedge to penetrate and / or exert pressure more efficiently, e.g. requiring less force for initiating the insertion of the wedge segment 170 between the teeth of a subject for further splitting, lifting and / or holding the oral cavity of a subject in an open state.

[0296]

[0305] Further reference is now made to Fig. 17C, wherein the angle of the convergence section a and the angle of the divergence section are shown for illustration purposes only.

[0306] In some embodiments, the angle of the convergence section a and the angle of the divergence section may be a narrow angle, for example an angle under 45 degrees, wherein the wedge may be configured to produce higher mechanical advantage by concentrating the resultant force into a smaller contact area.

[0297]

[0307] Conversely, the angle of the convergence section a and the angle of the divergence section 0 may be a wide angle, for example an angle above 90 degrees, wherein a wider-angle wedge may distribute the resultant force over a larger area.

[0298]

[0308] In some embodiments, wedge segment 170 may comprise a plurality of grooves 171 on the surface of a wedge, which may facilitate patterns of functional channels configured to enhance its performance by enhancing the wedge's grip, stability, force distribution, friction management, and / or saliva disposal.

[0299]

[0309] In some embodiments, grooves 171 may comprise, for example, U shaped, V shaped, W shaped, and / or rectangular channel, which may vary in width, length, depth, orientation, spacing, and / or pattern.

[0300]

[0310] In some embodiments, the grooves width G1 may comprise even and / or uneven width between neighboring grooves.

[0301]

[0311] In some embodiments, the center line grooves G2 may overlap the center line of the wedge segment W2, which may be further configured for grater friction management across the line of first contact, e.g., the center line. Thus, the center line grooves G2 may be tightly spaced. Alternatively, center line grooves G2 may be spaced differently relative to the spacing G3 between neighboring grooves.

[0302]

[0312] In some embodiments, a spacing G3 between neighboring grooves may comprise even and / or uneven spacing. Alternatively, and additionally, spacing G3 between neighboring grooves may comprise randomized spacing or customized spacing.

[0303]

[0313] In some embodiments, the pattern of the grooves may comprise linear parallel grooves, crisscross grooves, radial grooves, spiral or helical grooves, concentric grooves.

[0304]

[0314] In some embodiments, grooves 171 patterns may align with the direction of the applied force Ft, which may further guide the (e.g., forceful) advancement of the wedge smoothly between the teeth of the subject. Otherwise, the groove patterns may be misaligned.

[0305]

[0315] In some embodiments, the arrangement of the patterned grooves may increase the surface area in contact with the subject's teeth, which may improve the grip and reduce the likelihood of slippage.

[0306]

[0316] The arrangement of the patterned grooves may channel excess moisture and / or salvia from the subject's oral cavity away from the contact point with the wedge segment 170, which may prevent clogging and / or maintain consistent contact with the subject's teeth.

[0307]

[0317] Reference is now made to Fig.l8A, 18B, 18C and 18D, which are side, bottom, top and front illustrations, respectively, of the apparatus configured for user employment within the oral cavity of the subject, as shown in previous figures, Fig.l to Fig.9C.

[0308]

[0318] As previously referenced in Fig.lOA, the linking mechanism 153 may comprise for example a snap to fit mechanism, which may link the distal phalange element 151 comprising an elongated segment 154 into a, not shown, corresponding hole segment 155 within the intermediate phalange element 152.

[0319] Further reference is made to Fig.l8C, wherein the distal phalange element 151 may comprise a receiving inner opening diameter of DI configured to receive at least the distal phalange of finger 10 within the main body of distal phalange element 151M, when coupled with distal phalange element 151 of apparatus 150. And an outer diameter D2 of main body of distal phalange element 151M.

[0309]

[0320] In some embodiments, the difference between inner DI and outer D2 diameter may vary along the circumference of the distal phalange element 151, which may be adapted for thicker protection in region of interest.

[0310]

[0321] The term "region of interest" may refer to any section of the apparatus 150, wherein a desired mechanical property is designated to suite the functionality of the said region, for example regions where enhanced friction is in need, regions where greater protection from deformation is needed, ext.

[0311]

[0322] Emphasis is now made, to distinguish previously coined terms "mouth" and "oral cavity", which were referenced to a general anatomical site of interest, wherein the apparatus may be inserted into. While the term "region of interest" may refer to a section of the apparatus 150, the wording "site of interest" may refer to anatomical sections within the oral cavity of a subject.

[0312]

[0323] Reference is now made to Figs. 19A, 19B and 19C, which are side illustrations, wherein embodiments of the distal phalange element 151 are presented.

[0313]

[0324] Further reference is now made to Fig.l9A, wherein the distal phalange element 151 with an upper section 170U of the wedge segment 170 may comprise a raised wedge head 173A, which facilitates the transitions from the upper section 170U of the wedge segment 170 to the main body of distal phalange element 151M.

[0314]

[0325] The distal phalange element 151 with an upper section 170U of the wedge segment 170 may comprise no continuous transition 172Afrom the wedge head 173A to the main body of distal phalange element 151M.

[0315]

[0326] Further reference is now made to Fig.l9B, wherein the distal phalange element 151 with an upper section 170U of the wedge segment 170 may comprise a flattened wedge head 173B, which facilitates the smooth transitions from the upper section 170U of the wedge segment 170 to the main body of distal phalange element 151M.

[0316]

[0327] Distal phalange element 151 with an upper section 170U of the wedge segment 170 may comprise narrow continuous transition 172B from the wedge head 173B to the main body of distal phalange element 151M.

[0317]

[0328] Further reference is now made to Fig.l9C, wherein the distal phalange element 151 with an upper section 170U of wedge segment 170 may comprise a flattened wedge head with added grooves 173C, which facilitates the smooth transitions from the upper section 170U of the wedge segment 170 to the main body of distal phalange element 151M and allows for grater friction between to the apparatus 150 to the oral cavity, consequently enabling positioning control of the apparatus 150 within the oral cavity.

[0318]

[0329] Distal phalange element 151 with an upper section 170U of wedge segment 170 may comprise continuous transition 172C from wedge head 173C to the main body of distal phalange element 151M.

[0319]

[0330] In some embodiments, wedge segment 170 may comprise, for example, a raised wedge head, flattened wedge head, sunk wedge head. The above examples should by no means be construed in a limiting manner, additional wedge head geometry may be applicable to facilitate the transition from the upper section 170U of wedge segment 170 to the main body of distal phalange element 151M.

[0331] Reference is now made to Fig. 20, wherein an embodiment of the distal phalange element 151 is shown to exemplify the functionality of the wedge segment 170.

[0320]

[0332] In some embodiments, wedge segment 170 may be configured for opening the oral cavity by wedging the finger between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch, wherein the initial connecting edge P2 may be thinner relative to a wider end of wedge segment Pl.

[0321]

[0333] In some embodiments, the distal phalange element 151 may be separately referenced by element portion, for example, as shown in Fig.20, portion A, B and C, wherein portion A may comprise and / or overlap with part of section 170B, portion B may comprise and / or overlap with part of section 170B and / or section 170L, and portion C may comprise and / or overlap with part of section 170L.

[0322]

[0334] In some embodiments, the wedge segment 170 (or corresponding wedge portion(s)) may be configured to form a blade shape with a variable slope, which allows gradual penetration between the jaws, specifically between the one or more teeth of the upper dental arch, and the one or more teeth of the lower dental arch, while gradually opening the oral cavity as a result of the pressure of the wedge, from portion A to portion B initially, and to portion C subsequently.

[0323]

[0335] In some embodiments, apparatus 150 opening of the oral cavity may be achieved by inserting in a continuous rotary movement apparatus 150, wherein portion A may initiate the contact of the sharp blade shaped of section 170B, portion B may widen the initial opening by rotating wedge segment 170 such that the blade shape of section 170L may be brought into contact, finally, portion C facilitates the positioning of section 170L.

[0324]

[0336] In some embodiments, while the teeth sit on portion C the desired degree of opening may have been achieved.

[0325]

[0337] Fig. 21A is a schematic isometric view of another embodiment of the apparatus.

[0326]

[0338] Fig. 21B is a schematic back view of the embodiment shown in Fig.21A.

[0327]

[0339] Additional examples:

[0328]

[0340] Embodiments pertain to an apparatus configured, when operably engaged with a user, for employment by the user within an oral cavity of a subject having a complete or incomplete lower dental arch and a complete or incomplete upper dental arch.

[0329]

[0341] In some embodiments, the apparatus comprises a protective cover having an axial phalange extension direction and which is configured to at least partially cover a finger of the user such to protect the finger from biting force applied by the subject; and a projection that is wedge-shaped and extends laterally, in palmar direction, from the protective cover, and terminates in a distal edge of the projection.

[0330]

[0342] In some embodiments, the projection is shaped and sized to be pushed by the user between the upper dental arch and the lower dental arch to separate the dental arches from each other to facilitate accessing the oral cavity of the subject.

[0331]

[0343] In some embodiments, the projection comprises a first wedge portion having a first base portion.

[0332]

[0344] In some embodiments, a width of the first base portion diverges distally in the axial phalange direction from a first narrow width to a wide width.

[0333]

[0345] In some embodiments, the projection engaging with the user's finger also extends distally as a second wedge portion in axial direction of the phalange of the user.

[0346] In some embodiments, the second wedge portion has a second base portion, and the width of the second base portion converges from the wide width to a second narrow width.

[0334]

[0347] In some embodiments, the projection has a third wedge portion having a third base portion, and the width of the third base portion further converges from the second narrow width to a third narrow width.

[0335]

[0348] In some embodiments, the third wedge portion of the projection extends in a dorsal direction.

[0336]

[0349] In some embodiments, both faces of the wedge-shaped projection are curved inwardly (e.g., curved towards each other). In some embodiments, one face is inwardly curved, and one outwardly curved. In some embodiments, both faces are outwardly curved (i.e., away from each other). In some examples, one or both faces are not curved (e.g. have a planar shape or are not curved). In some examples, or one or both faces are partially curved and partially non-curved.

[0337]

[0350] In some embodiments, the projection comprises at least one groove configured to prevent teeth engaging with the projection from sliding along the projection.

[0338]

[0351] In some embodiments, the protective cover is at least partially flexible and / or comprises a plurality of rigid and / or partially flexible phalange-engaging elements which are coupled with each other to enable the flexing of at least two different phalanges of a same finger relative to each other.

[0339]

[0352] In some embodiments, the plurality of rigid and / or partially flexible phalange-engaging elements are pivotally coupled with each other.

[0340]

[0353] In some embodiments, the projection comprises a first end coupled with the protective cover, and a second end extending away from the protective cover.

[0341]

[0354] In some embodiments, the projection is shaped such that the second end is tapered with respect to the first end.

[0342]

[0355] In some embodiments, the projection has a triangular cross section, when viewed from a direction that is orthogonal to both the lateral extension direction and the axial phalange direction.

[0343]

[0356] In some embodiments, a ratio between a thickness of the first end of the projection and a thickness of the second end of the projection is at least 3:1.

[0344]

[0357] In some embodiments, a ratio between a thickness of the first end of the projection and a thickness of the second end of the projection is at least 5:1.

[0345]

[0358] In some embodiments, the projection has a constant thickness in palmar direction.

[0346]

[0359] In some embodiments, the protective cover comprises a sheath configured to at least partially surround the finger.

[0347]

[0360] In some embodiments, the protective cover comprises a sheath configured to fully surround the finger.

[0348]

[0361] In some embodiments, the protective cover comprises a flexible protective cover.

[0349]

[0362] In some embodiments, when operably engaged with the user, the protective cover is configured for insertion between the one or more teeth of the upper dental arch and the at least one tooth of the lower dental arch so as to maintain the oral cavity in an open state.

[0350]

[0363] In some embodiments, wherein when operably engaged with the user, the projection, when placed for insertion into the oral cavity of the subject, extends laterally from the protective cover in a lingual direction of the subject.

[0351]

[0364] In some embodiments, the protective cover further comprises at least one reinforcement structure.

[0365] In some embodiments, the at least one reinforcement structure is an annular structure having a center that about coincides with the corresponding longitudinal axis of a phalange-engaging element of the protective cover.

[0352]

[0366] In some embodiments, the protective cover comprises an inner layer and an outer layer, and wherein the reinforcement structure is disposed between the inner layer and the outer layer and / or at the inner surface of the inner layer and / or at the external surface of the outer layer.

[0353]

[0367] In some embodiments, the protective cover comprises at least one mechanical energy storage element.

[0354]

[0368] In some embodiments, the protective cover comprises an inner layer and an outer layer, and wherein the at least one mechanical storage element is disposed between the inner layer and the outer layer.

[0355]

[0369] Embodiments pertain to an apparatus configured, when operably engaged with a user, for employment by the user within an oral cavity of a subject having a lower dental arch and an upper dental arch, the apparatus comprising:

[0356]

[0370] a protective cover having an axial phalange extension direction and which is configured to at least partially cover a finger of the user such to protect the finger from biting force applied by the subject; and

[0357]

[0371] a projection extending laterally from the protective cover and shaped and sized to be pushed by the user between the upper dental arch and the lower dental arch such to separate the dental arches from each other to facilitate accessing the oral cavity of the subject.

[0358]

[0372] In some embodiments, the projection engaging with the user's finger extends distally in axial direction of the distal phalange of the user.

[0359]

[0373] Embodiments pertain to a method for opening an oral cavity of a nonhuman animal having an upper dental arch and a lower dental arch.

[0360]

[0374] In embodiments, the method comprises:

[0361]

[0375] operably engaging a protective cover with a finger of a user, the protective cover comprising a projection extending laterally from the protective cover;

[0362]

[0376] advancing, by the finger, the projection between the upper dental arch and the lower dental arch for distancing the dental arch and the lower dental arch from each other.

[0363]

[0377] It should be understood that where the claims or specification refer to "a" or "an" element and / or feature, such reference is not to be construed as there being only one of that element. Hence, reference to "an element" or "at least one element" for instance may also encompass "one or more elements".

[0364]

[0378] Unless otherwise specified, terms such as, for example, 'about1, 'substantially', and / or 'close1with respect to a magnitude or a numerical value may imply to be within an inclusive range of -10% to +10% of the respective magnitude or value.

[0365]

[0379] It is important to note that the method is not limited to those diagrams or to the corresponding descriptions. For example, the method may include additional or even fewer processes or operations in comparison to what is described herein. In addition, embodiments of the method are not necessarily limited to the chronological order as illustrated and described herein.

[0366]

[0380] "Coupled with" means indirectly or directly "coupled with".

[0367]

[0381] It should be noted that the term "item" as used herein refers to any physically tangible, individually distinguishableunit of packaged or unpackaged good or goods. Positional terms such as "upper", "lower" "right", "left", "bottom", "below", "lowered", "low", "top", "above", "elevated", "high", "vertical" and "horizontal" as well as grammatical variations thereof as may be used herein do not necessarily indicate that, for example, a "bottom" component is below a "top" component, or that a component that is "below" is indeed "below" another component or that a component that is "above" is indeed "above" another component as such directions, components or both may be flipped, rotated, moved in space, placed in a diagonal orientation or position, placed horizontally or vertically, or similarly modified. Accordingly, it will be appreciated that the terms "bottom", "below", "top" and "above" may be used herein for exemplary purposes only, to illustrate the relative positioning or placement of certain components, to indicate a first and a second component or to do both.

[0368]

[0382] Unless otherwise stated or applicable, the use of the expression "and / or" between the last two members of a list of options for selection indicates that a selection of one or more of the listed options is appropriate and may be made, and may be used interchangeably with the expressions "at least one of the following", "any one of the following" or "one or more of the following", followed by a listing of the various options.

[0369]

[0383] As used herein, the phrase "A,B,C, or any combination of the aforesaid" should be interpreted as meaning all of the following: (i) A or B or C or any combination of A, B, and C, (ii) at least one of A, B, and C; and (iii) A, and / or B and / or C. This concept is illustrated for three elements (i.e., A,B,C), but extends to fewer and greater numbers of elements (e.g., A, B, C, D, etc.).

[0370] [1] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments or example, may also be provided in any combination with a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, example and / or option, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment, example, or option of the invention. Certain features described in the context of various embodiments, examples and / or options are not to be considered essential features of those embodiments, unless the embodiment, example and / or option is inoperative without those elements. Any feature disclosed herein can be disclaimed, alone or in any combination.

[0371]

[0384] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as, for example, from 1 to 6 should be considered to have specifically disclosed subranges such as, for example, from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0372]

[0385] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging / ranges between" a first indicate number and a second indicate number and "ranging / ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0373]

[0386] While the invention has been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention, but rather as exemplifications of some of the embodiments.

[0387] While certain features of the described implementations have been illustrated as described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It should be understood that they have been presented by way of example only, not limitation, and various changes in form and details may be made. Any portion of the apparatus and / or methods described herein may be combined in any combination, except mutually exclusive combinations. The implementations described herein can include various combinations and / or subcombinations of the functions, components and / orfeatures of the different implementations and embodiments described.

Claims

CLAIMSWhat is claimed is:

1. An apparatus configured, when operably engaged with a user, for employment by the user within an oral cavity of a subject having a complete or incomplete lower dental arch, and a complete or incomplete upper dental arch, the apparatus comprising:a protective cover having an axial phalange extension direction and which is configured to at least partially cover a finger of the user such to protect the finger from biting force applied by the subject; anda projection that is wedge-shaped and extends laterally, in palmar direction, from the protective cover, and terminates in a distal edge of the projection,wherein the projection is shaped and sized to be pushed by the user between the upper dental arch and the lower dental arch such to separate the dental arches from each other to facilitate accessing the oral cavity of the subject, the projection comprising a first wedge portion having a first base portion,wherein a width of the first base portion diverges distally in the axial phalange direction from a first narrow width to a wide width.

2. The apparatus of claim 1, wherein the projection engaging with the user's finger also extends distally as a second wedge portion in axial direction of the phalange of the user.

3. The apparatus of claim 2, wherein the second wedge portion has a second base portion, andwherein the width of the second base portion converges from the wide width to a second narrow width.

4. The apparatus of claim 3, wherein the projection has a third wedge portion having a third base portion, and wherein the width of the third base portion further converges from the second narrow width to a third narrow width.

5. The apparatus of claim 4, wherein the third wedge portion of the projection extends in a dorsal direction.

6. The apparatus of any one or more of the preceding claims, wherein a face or the faces of the wedge-shaped projection are inwardly-curved, in direction of the base.

7. The apparatus of any one or more of the preceding claims, wherein the projection further comprises at least one groove configured to prevent teeth engaging with the projection from sliding along the projection.

8. The apparatus of any one or more of the previous claims, wherein the protective cover is at least partially flexible and / or comprises a plurality of rigid and / or partially flexible phalange-engaging elements which are coupled with each other to enable the flexing of at least two different phalanges of a same finger relative to each other.

9. The apparatus of claim 8, wherein the plurality of rigid and / or partially flexible phalange-engaging elements are pivotally coupled with each other.

10. The apparatus of any one or more of the previous claims, wherein the projection comprises a first end coupled with the protective cover, and a second end extending away from the protective cover.

11. The apparatus of any one or more of the previous claims, wherein the projection is shaped such that the second end is tapered with respect to the first end.

12. The apparatus according to any one or more of the preceding claims, wherein the projection has a triangular cross section, when viewed from a direction that is orthogonal to both the lateral extension direction and the axial phalange direction.

13. The apparatus according to any one or more of the preceding claims, wherein a ratio between a thickness of the first end of the projection and a thickness of the second end of the projection is at least 3:1.

14. The apparatus according to any one or more of the preceding claims, wherein a ratio between a thickness of the first end of the projection and a thickness of the second end of the projection is at least 5:1.

15. The apparatus according to any one or more of the preceding claims, wherein the projection has a constant thickness in palmar direction.

16. The apparatus according to any one or more of the preceding claims, wherein the protective cover comprises a sheath configured to at least partially surround the finger.

17. The apparatus according to any one or more of the preceding claims, wherein the protective cover comprises a sheath configured to fully surround the finger.

18. The apparatus of any one or more of the preceding claims, wherein the protective cover comprises a flexible protective cover.

19. The apparatus of any one or more of the preceding claims, when operably engaged with the user, the protective cover is configured for insertion between the one or more tooth of the upper dental arch and the at least one tooth of the lower dental arch so as to maintain the oral cavity in an open state.

20. The apparatus of any one or more of the preceding claims, wherein when operably engaged with the user, the projection, when placed for insertion into the oral cavity of the subject, extends laterally from the protective cover in a lingual direction of the subject.

21. The apparatus of any one or more of the preceding claims, wherein the protective cover further comprises at least one reinforcement structure.

22. The apparatus of claim 21, wherein the at least one reinforcement structure is an annular structure having a center that about coincides with the corresponding longitudinal axis of a phalange-engaging element of the protective cover.

23. The apparatus according to claim 21 and / or claim 22, wherein the protective cover comprises an inner layer and an outer layer, and wherein the reinforcement structure is disposed between the inner layer and the outer layer and / or at the inner surface of the inner layer and / or at the external surface of the outer layer.

24. The apparatus of any one or more of the preceding claims, wherein the protective cover further comprises at least one mechanical energy storage element.

25. The apparatus of claim 24, wherein the protective cover comprises an inner layer and an outer layer, and wherein the at least one mechanical storage element is disposed between the inner layer and the outer layer.

26. An apparatus configured, when operably engaged with a user, for employment by the user within an oral cavity of a subject having a lower dental arch and an upper dental arch, the apparatus comprising:a protective cover having an axial phalange extension direction and which is configured to at least partially cover a finger of the user such to protect the finger from biting force applied by the subject; anda projection extending laterally from the protective cover and shaped and sized to be pushed by the user between the upper dental arch and the lower dental arch such to separate the dental arches from each other to facilitate accessing the oral cavity of the subject.

27. The apparatus of claim 26, wherein the projection engaging with the user's finger extends distally in axial direction of the distal phalange of the user.

28. A method for opening an oral cavity of a nonhuman animal having an upper dental arch and a lower dental arch, wherein the method comprises:operably engaging a protective cover with a finger of a user, the protective cover comprising a projection extending laterally from the protective cover;advancing, by the finger, the projection between the upper dental arch and the lower dental arch for distancing the dental arch and the lower dental arch from each other.

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