Mechanically operative intermaxillary (IMF) clip and its applicator for achieving dental occlusion

Abstract

Embodiments of the present invention provides an innovative system of mechanically operative Intermaxillary (IMF) clip and its applicator for achieving dental occlusion. The revolutionary design of the system including the Intermaxillary (IMF) clips and its applicator makes use of the embrasure spaces for mechanically locking with teeth. These are teeth specific IMF clips and are numbered accordingly. The application is instant using its applicator and could be applied and removed even by untrained person owing to simple mechanics.

Description

[0001] “MECHANICALLY OPERATIVE INTERMAXILLARY (IMF) CLIP AND ITS APPLICATOR FOR ACHIEVING DENTAL OCCLUSION”

[0002] FIELD OF INVENTION

[0003] The present invention generally relates to dental occlusion methods and appliances. More particularly, the present invention relates to an Intermaxillary (IMF) or Maxillo-Mandibular fixation (MMF) appliance that operates mechanically to achieve dental occlusion.

[0004] BACKGROUND OF INVENTION

[0005] Dental malocclusion can result from maxillofacial injuries resulting in facial bone fractures, surgical osteotomies as in orthognathic surgery, access osteotomies as in pathology resection & its reconstruction and acute Temporomandibular joint dislocation. Even though the etiology is multifactorial, correction and preservation of the dental occlusion to pre-traumatic state is of high significance. The occlusal contacts and dental alignment act as chief guide in establishing the maxillomandibular relation to the stomatognathic system and cranium.

[0006] Various methodology of achieving and preservation of the pre-injury occlusion in the form of Intermaxillary (IMF) or Maxillo-Mandibular fixation (MMF) include use of various types of arch bars, intermaxillary bone fixation screws, rapid IMF system, bonded IMF system, bonded dental brackets, direct interdental wiring, metal cap splints, acrylic splints, Ivy loops, Leonard buttons, Gottingen quick arch bar, Dimac wire and Pearl steel wire based on the indication. However, the utilization of the above methods requires high clinical experience and has a steep learning curve. The common problems in the existing methodology may include: needle stick or penetrating injury to the operator, increasing the chance of transmission of blood borne diseases; long operating time; poor periodontal status; poor oral hygiene; traumatic ulcers in oral mucosa; unaesthetic appearance; screw loosening or dislodgement; risk of aspiration; loss of tooth vitality; altered thermal response in teeth; bad breath and difficulty in application.

[0007] As mentioned above, one of the common teeth borne appliances and methods for achieving dental occlusion includes using Arch bars. However, arch bars may have certain drawbacks such as: a) Require fastening devices such as wires that are passed around neck of each tooth, b) It is a cumbersome procedure that has a traumatic psychological effect on the patients, c) The same manoeuvre increases the operating time and need for increased quantity and duration of anaesthesia, d) The open interdental contacts make it difficult for its application, e) Poor oral hygiene due to presence of increased retention areas, f) Traumatic ulcers in oral mucosa in postoperative period due to sharp cleats and fastening wires, g) Application of sectional arch bars as required in small, fractured segments is difficult, h) At least two fastening wires are required to fix arch bar segment along with teeth, i) Unaesthetic appeal among patients who wear such appliance, j) Gingival overgrowth and secondary infections are not very uncommon with usage of arch bars. Lastly, using arch bars requires clinical practice for application by operator.

[0008] A common bone borne appliance and method to achieve dental occlusion may include using Intermaxillary fixation screws. However, Intermaxillary fixation screws may also have certain drawbacks or mandatory pre-operative requirements such as: a) Traumatic procedure and increased operating time, b) Preoperative investigations such as plain X-rays or CT / CBCT scan required to analyze ideal position for screw placement, to analyze the root morphology and spacing, c) Increased risk of thermal necrosis to bone and overlying mucosa, d) Chance of screw loosening in post operative period, e) Chance of mucosal overgrowth over the screws in perioperative period, f) Increased chance of iatrogenic tooth root damage, resulting loss of tooth vitality, root fracture and altered thermal response necessitating its extraction in post operative period, g) Increased chance of infection owing to its transmucosal application into bone, h) Chance of occurrence of posterior open bite in cases of screws being placed only in anterior portion of jaws, i) Increased chance of damage to vital structures such as arteries, veins and nerves that run along upper and lower jaws. Lastly, using Intermaxillary fixation screws may produce obliteration of anatomical spaces such as maxillary sinuses, inferior alveolar nerve canal and nasopalatine nerve canal.

[0009] Another common tooth borne appliances and methods for achieving dental occlusion includes using Direct interdental wiring appliances. Even direct interdental wiring appliances ought to have certain drawbacks including a) Making use of fastening stainless steel wires which are traumatic and increases the risk of prick injury and disease transmission, b) Small cross section of the wires providing reduced retention due to less surface area, c) Some of the interdental wiring techniques are dependent on factors such as the amount of interdental space available and tight contact points. In long term, interdental wiring may loosen. Additionally, Intermaxillary fixation has to repeated even if one of the wires fails, since mouth opening is mandatory for correction and reapplication. Some more common appliances in tooth borne applications, including Orthodontic bracket, bonded, acrylic and prefabricated appliances. Similar to other tooth borne appliances, these brackets too have some drawbacks, such as: a) Bonded appliances require acid etching of enamel resulting in demineralisation and white patch formation post removal, b) Acrylic and any form of prefabricated appliance is laborious to fabricate and requires fabrication of the dental teeth models, c) Chance of dislodgement and mechanical failure are not very uncommon.

[0010] Therefore, there exists a need for an appliance to achieve dental occlusion, that is simple in design, can operate mechanically, is non-invasive and does not require a high clinical experience and a steep learning curve to operate, instead can be operated by an unexpert or common person too, who does not have in depth clinical experience.

[0011] OBJECTIVES OF INVENTION

[0012] An object of the present invention is to construct an IMF clip having minimalistic construction that establishes proper dental occlusion. Another objective of the present invention is to develop tooth specific IMF clips applicator as a system or individually having minimally invasion that brace the natural anatomy of the teeth without obliterating the adjacent periodontal structures, a method of construction and uses thereof.

[0013] SUMMARY OF THE INVENTION

[0014] In an embodiment of the present invention discloses an Intermaxillary (IMF) clip comprising a body; a capstan head with the cross-head receptacle is designed and fixed in front of the body of the IMF clip; at least two shoulders each of which carries at least one prong respectively at its front one end; at least two arms at the back of the body of the IMF clip and the arms at their ends have safety tips; numbered accordingly with quadrant number on to the right of capstan head and on to the left describing the tooth number wherein the IMF clip is self-retaining clip and that helps it to adhere to the neck of the teeth mechanically. The capstan head and the cross-head receptacle engages the clip to an IMF clip applicator and prevents it from slipping at the time of activation and application of the IMF clip to teeth. The capstan head receives one or more intermaxillary fixation wires around it. Between every pair of the shoulder and its prong, the body has the capstan head with the cross-head receptacle. The shoulders and the prongs are projecting outwards facing the opposite of the teeth when the IMF clip is applied on a tooth along the embrasure spaces of teeth. The prongs prevent the slippage of engaged IMF wire onto the clip. Each arm extends beyond each shoulder, from the rear of the body, facing the teeth when the IMF clip is applied on a tooth.

[0015] In another embodiment of the present invention, the IMF clip and applicator shall be fabricated in metals like titanium, aluminium, stainless steel and alloys including Ni-Ti giving high strength resin and polymer or of mixed composition of materials.

[0016] In another embodiment of the present invention, the IMF clip can be constructed by machining process, CNC or SLS / SLM , Lathe cut or injection molded etc.

[0017] In another embodiment of the present invention discloses a system comprising IMF clips and IMF clip applicator wherein the IMF clip applicator comprises a handle, a guide shaft and a chief drive shaft are attached on its distal end (head) with respect to the proximal end (tail) usually held by the operator; the chief drive shaft has a cross head driver provided at the end of its opposite portion; a trigger of the applicator slides over the chief drive shaft; a stopper on the opposite end of the chief drive shaft; the trigger has a slider towards its top end and on its front end above the stopper carries at least two special prong holders; each of the prong holders has a prong sleeve at its end; a closed coil spring and at least one lock holes at each of the prong holders to help it spring loaded. The cross-head driver engages with the cross-head receptacle of the capstan head of the IMF clip for providing utmost stability. The chief drive shaft has another portion that is spring loaded on the rear of the trigger for rebounding the trigger. The closed coil spring provides a degree of freedom to the distance between the two prong sleeves to engage with clips of various sizes.

[0018] In another embodiment of the present invention discloses a method of using the IMF clip as claimed in claim 1, comprising the steps of: i. the gums along the teeth bearing region are anaesthetised with topical anaesthetic agent in the form of spray or jelly or local site injections; ii. following anaesthesia from step i, each IMF clips are provided with two prongs designed to emerge along the adjacent embrasure spaces which are selected for application on alternate teeth; iii. an applicator is then held firmly in a power grip, with the index finger positioned to engage the trigger; iv. a clip is engaged to the applicator by aligning its prongs with the prong sleeves of the holder, manually adjusting the distance between the sleeves to ensure a proper fit; v. once the prongs are securely seated in the sleeves from step iv, the trigger is pressed to engage the capstan head of the IMF clip with the crosshead receptacle of the main drive shaft, marking full engagement of the clip to the applicator; vi. with the clip engaged from step v, further pressure on the trigger activates the IMF clip, causing its arms to open wide; vii. at this stage, the clip is ready for placement into the interdental spaces between the teeth; viii. apical pressure is applied to the applicator handle, directing the safety tips of the clip toward the targeted interdental spaces; ix. as pressure is maintained from step viii, the clip slips into the space and engages the teeth; x. once the clip is in position from step ix, the trigger is released, and the spring mechanism assists in retracting the drive shaft from the capstan head, causing the applicator to withdraw automatically; xi. the IMF clip is then released from the prong holders by moving the applicator away from the clip shoulders freeing the sleeves and completing the application of the clip to the designated tooth.

[0019] Multiple clips are engaged as per the requirement for the scenario and is ready for intermaxillary fixation.

[0020] After the need for IMF is accomplished, the IMF wires are cut, or the elastics are removed. The applicator is again engaged to the clip in similar fashion as described earlier. The trigger is activated again such that the arms open and the whole system is pulled apart. The action disengages the IMF clip from the teeth. The IMF clip is then retrieved from the applicator.

[0021] The IMF shall be achieved through rubber elastics or various sizes of stainless -steel wires. The IMF shall be applied making use of the capstan head or the prongs over shoulder based on the scenario.

[0022] The use of the IMF clip is for establishing proper dental occlusion. And the use of the system is for bracing the natural anatomy of the teeth without obliterating the adjacent periodontal structures.

[0023] BRIEF DESCRIPTION OF DRAWINGS

[0024] FIGs. 1-7 illustrate an exemplary representative of an Intermaxillary (IMF) clip showing its parts, in which FIGs. 1-7 shows a back view, a bottom view, a front view, an isometric view, a right side view, a left side view and a top view respectively of the Intermaxillary (IMF) clip, according to an embodiment of the invention;

[0025] FIGs. 8-9 illustrate an exemplary representative of a front view and an isometric view of 28 tooth specific IMF clips respectively, in accordance with an embodiment of the invention; FIG. 10 illustrates an exemplary representative of a back view of 14 upper jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0026] FIG. 11 illustrates an exemplary representative of a back view of 14 lower jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0027] FIG. 12 illustrates an exemplary representative of a top view of 14 upper jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0028] FIG. 13 illustrates an exemplary representative of a top view of 14 lower jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0029] FIG. 14 illustrates an exemplary representative of a bottom view of 14 upper jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0030] FIG. 15 illustrates an exemplary representative of a bottom view of 14 lower jaw tooth specific IMF clips, in accordance with an embodiment of the invention;

[0031] FIGs. 16-21 illustrate an exemplary representative of an IMF clips applicator showing its parts, in which FIGs. 16-21 shows a left side view, a right side view, a top view, a bottom view, a front view, and a back view, respectively of the IMF clips applicator, according to an embodiment of the invention;

[0032] FIGs. 22-23 illustrate an exemplary representative of an IMF clips applicator, in which FIGs. 22- 23 shows a right side view, a left side view respectively of the IMF clips applicator, according to an embodiment of the invention;

[0033] FIG. 24 illustrates an exemplary representation of a top view of the IMF clips applicator holding the IMF clip according to an embodiment of the invention; FIG. 25 illustrates an exemplary representation of a top view of the IMF clips applicator engaging the IMF clip, according to an embodiment of the invention;

[0034] FIG. 26 illustrates an exemplary representation of a top view of the IMF clips applicator engaging the IMF clip n active position, according to an embodiment of the invention;

[0035] FIGs. 27 and 27A illustrate an exemplary representation of a front view of a dental model with teeth showing IMF clips in respective position, according to an embodiment of the invention;

[0036] FIGs. 28 and 28A illustrate an exemplary representation of a right-side view of a dental model with teeth showing IMF clips in respective position, according to an embodiment of the invention;

[0037] FIGs. 29 and 29A illustrate an exemplary representation of a left-side view of a dental model with teeth showing IMF clips in respective position, according to an embodiment of the invention;

[0038] FIGs. 30-32 illustrate exemplary representations of a front view, a right-side view, and an isometric view of a dental model with teeth showing IMF clips in respective position and IMF applied with stainless steel wires, according to an embodiment of the invention;

[0039] FIG. 33 illustrates exemplary representations of a cross sectional view in coronal plane of a representative IMF clip along with respective tooth showing self-retaining mechanism owing to its shape, engaging teeth below the greatest curvature, according to an embodiment of the invention; and

[0040] FIG. 34 illustrates exemplary representations of a cross sectional view in axial plane of a representative IMF clip along with respective tooth showing self-retaining mechanism owing to its shape, encircling %th of the tooth surpassing the greatest curvature of tooth, according to an embodiment of the invention.

[0041] DETAILED DESCRIPTION This patent describes the subject matter of the invention with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. The principles described herein may be embodied in many different forms.

[0042] Illustrative embodiments of the invention now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the invention are shown. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

[0043] The present invention provides an innovative system of mechanically operative Intermaxillary (IMF) clip and its applicator for achieving dental occlusion. The revolutionary design of the system including the Intermaxillary (IMF) clips and its applicator makes use of the embrasure spaces for mechanically locking with teeth. These are teeth specific IMF clips and are numbered accordingly. The application is instant using its applicator and could be applied and removed even by untrained person owing to simple mechanics. The novel IMF system has been developed to overcome the existing drawbacks and improve the ease of application along with aesthetically appealing form.

[0044] Referring to FIGs. 1-7 that illustrate an exemplary representation of an Intermaxillary (IMF) clip 100 showing its parts, each individual IMF clip 100 includes one or more of the following components: (102) a body; (104) a capstan head; (106) a pair of arms; (108) a pair of prongs; (110) a pair of shoulders; (112) a cross head receptacle; (114) a tooth number; (116) a quadrant number; (118) safety tips.

[0045] Referring to FIGs. 1-7, an IMF clip 100 has a revolutionary tooth specific design that is a selfretaining clip and that helps it to adhere to the neck of the teeth mechanically. It conforms to natural anatomy of the teeth. The IMF clip 100 consists of the body (102), and in front of the body of the IMF clip 100, the capstan head (104) with the cross-head receptacle (112) is designed and fixed at the body (102). The capstan head (104) with the cross-head receptacle (112) faces the opposite of the teeth, when the IMF clip 100 is applied on a tooth, and faces towards an IMF clip applicator when the IMF clip 100 engages with the applicator. The function of the capstan head (104) and the cross-head receptacle (112) is to engage the clip 100 to an IMF clip applicator (which is described later) and to prevent it from slipping at the time of activation and application of the IMF clip 100 to teeth. In an embodiment, the capstan head (104) also functions to receive one or more intermaxillary fixation wires around it.

[0046] The clip 100 further consists of at least two shoulders (110), each of which carries at least one prong (108) respectively at its front one end. The shoulders (110) and the prongs (108) are designed in front of the body 102, as the capstan head (104) with the cross-head receptacle (112), in which each shoulder (110) and its prong (108) is designed and fixed at one side end of the capstan head (104). Thus, between every pair of the shoulder (110) and its prong (108), the body 102 has the capstan head (104) with the cross-head receptacle (112). The shoulders (110) and the prongs (108) are projecting outwards, facing the opposite of the teeth when the IMF clip 100 is applied on a tooth, along the embrasure spaces of teeth. The prongs (108) chiefly help in engagement of the clip 100 with the IMF clip applicator through the prong sleeves (described later) of the IMF clip applicator.

[0047] In an embodiment, the function of the shoulder (110) is to receive the intermaxillary fixation (IMF) wire around it. In this embodiment, another function of the prongs (108) can be to prevent the slippage of engaged IMF wire onto the clip 100.

[0048] Further, beyond the shoulders (110), at the back of the body 102 of the IMF clip 100, there are at least two arms (106), each arm 106 extending beyond each shoulder 110, from the rear of the body 102, facing the teeth when the IMF clip 100 is applied on a tooth. The arms 106 functions to extend mechanically around the designated teeth. The arms (106) at their ends have specially designed safety tips (118) to prevent penetration injury to both operator and the patient.

[0049] Each IMF clip 100 can be designed being tooth specific and is numbered accordingly. The number on to the right of capstan head (104) describes the quadrant (116) and on to the left describes the tooth number (114). The SAFE - IMF system consists of 28 tooth specific IMF clips 100 that shall be applied with a special IMF clip applicator, which is described as below, and removed by the same. For example, FIGs. 8-9 illustrate an exemplary representation of the front view 200 and the isometric view 300 of 28 tooth specific IMF clips respectively. FIG. 10 illustrates an exemplary representation of the back view 400 of 14 upper jaw tooth specific IMF clips, whereas FIG. 11 illustrates an exemplary representation of a back view 500 of 14 lower jaw tooth specific IMF clips.

[0050] FIG. 12 illustrates an exemplary representation of the top view 600 of 14 upper jaw tooth specific IMF clips, whereas FIG. 13 illustrates an exemplary representation of a top view 700 of 14 lower jaw tooth specific IMF clips. Lastly, FIG. 14 illustrates an exemplary representation of a bottom view 800 of 14 upper jaw tooth specific IMF clips, and FIG. 15 illustrates an exemplary representation of a bottom view 900 of 14 lower jaw tooth specific IMF clips.

[0051] Referring to FIGs. 16-23, the IMF clip applicator 1000 is a handheld device with power grip ergonomic design. It consists of a handle (1002), to be held by an operator, onto which a guide shaft (1004) and a chief drive shaft (1006) are attached on its distal end (head) with respect to the proximal end (tail) usually held by the operator. In an embodiment, the guide shaft (1004) and the chief drive shaft (1006) are fixedly attached to the handle 1002.

[0052] The chief drive shaft 1006 has a cross head driver (1008) provided at the end of its opposite portion 1006A to get engaged with the cross head receptacle 112 of the capstan head (104) of the IMF clip 100, providing utmost stability. The trigger (1010) of the applicator 1000 slides over the chief drive shaft 1006. A portion of the chief drive shaft 1006 on the rear of the trigger 1010 is spring (1006B) loaded for rebounding of the trigger (1010). While portion 1006A of the chief drive shaft 1006 on the front of the trigger 1010 may or may not be spring loaded. The chief drive shaft spring (1006B) action is opposed by a stopper (1012) which is equipped on the opposite end of the chief drive shaft 1006, beyond the trigger 1010, in which the stopper 1012 keeps the trigger’s 1010 position within a required range. The trigger 1010 has a slider (1014) towards its top end, such that it engages with the guide shaft 1004 to make the movement of the guide shaft 1004 unidirectional. The guide shaft 1004 if required shall also be spring loaded, in an embodiment.

[0053] The trigger 1010 on its front end, above the stopper 1012, carries at least two special prong holders (1016). Each of the prong holders 1016 has a prong sleeve (1018) at its end which engages with the prongs (108) of the IMF clip 100. A closed coil spring (1020) helps the prong holder 1016 to be in a designated position to help it engage with IMF clip 100. The closed coil spring (1020) in the applicator 1000 provides necessary tension to hold and engage with the prongs (108) of the IMF clip 100. Also, the closed coil spring (1020) provides a degree of freedom to the distance between the two prong sleeves 1018 to engage with clips of various sizes. Further, the applicator 1000 also includes a required number of lock holes (1022) at each of the prong holders 1016 to help it spring loaded.

[0054] The IMF clips 100 are designed conforming to individual tooth anatomy at its neck near the gums. All the tooth constricts at the neck in both antero-posterior and mesio-distal dimensions. This principle has been applied in designing the IMF clips 100 that makes it self-retaining (FIGs. 33- 34). The IMF clips 100 engage the tooth below the greatest curvature of the teeth (2004) in coronal plane and encircles 3 / 4th of the tooth surpassing the greatest curvature of tooth in axial plane (2006). Narrowest curvature of the teeth (2004) in coronal plane being represented as 2004A in FIG. 33. Greatest diameter of tooth in axial plane being represented as 2008 in FIG. 34. It may be apparent to a person of ordinary skill in the art, that the clip 100 may encircle less than or more than 3 / 4th of the tooth, depending on the requirement for dental occlusion and design of clips 100, without deviating from the meaning and scope of the present invention.

[0055] The cross section of the arms 106 of the clips 100 are grossly semi-circular with a tapered (2002) design to conform with the specific anatomy of the specific tooth it engages with. In an embodiment, the body 102 and arms 106 of the clips 100 shall also be made circular, ellipsoid & other geometric forms for better adaptability to the anatomy of the teeth. The self-retaining feature is also promoted by the flexibility of the clips 100. Upon activation of the clip 100 with its applicator 1000 (FIG. 26), the body 102 of the clip 100 flexes while the arms 106 open. The open arms 106 are ready to engage with the teeth when a pressure is applied through the handle 1002 of the applicator 1000 using the trigger 1010. On release of the trigger 1010, the clip 100, owing to its flexibility, grips over the cervical tooth region near gums.

[0056] The clips 100 may be made of various materials such as including and not limited to stainless steel, Nickel, titanium, Resin and Polymer etc. The IMF clips 100 may also be made available in multiple sizes such as small, medium, large and extra-large based on the size of teeth of an individual for which it is to be used.

[0057] It may be apparent to a person of ordinary skill in the art, that the geometric modification of the all the above-mentioned parts of the clip 100 and the applicator 1000 is possible for improvement in the design at the time of manufacturing, without deviating from the meaning and scope of the present invention.

[0058] Further, in an exemplary operation, referring to FIGs. 24-26, the application of the IMF clips 100 shall be done under local anaesthesia. The gums along the teeth bearing region are anaesthetised with topical anaesthetic agent in the form of spray or jelly or local site injections. Since each IMF clips 100 is provided with at least two prongs 108 that emerge along the adjacent embrasure spaces, the IMF clip 100 is applied on alternate teeth.

[0059] The applicator 1000 is held in hand in a power grip and the trigger 1010 is engaged with, for example, the index finger. The clip 100 chosen is engaged primarily to the applicator 1000, engaging the prong sleeves 1018 of the applicator 1000 with the prongs 108 of the clip 100, by adjusting the distance between the sleeves 1018 manually [FIG. 24], Once the clip 100 is engaged through its prongs 108, the trigger 1010 is pressed, the chief drive shaft 1006 drives ahead to engage the cross-head driver (1008) of the chief drive shaft 1006 with the cross-head receptacle 112 of the capstan head 104 of the IMF clip 100 [FIG. 25], This step marks the complete engagement of the IMF clip 100 with the applicator 1000. Once engaged to the applicator 1000, the IMF clip 100 is activated by pressing the trigger 1010 further, such that the arms 106 of the clip 100 open wide apart [FIG. 26], Once the arms 106 are open, the IMF clip 100 is ready to be inserted into the interdental spaces present between the teeth. Apical pressure is applied to the applicator handle 1002 with the safety tips 118 of IMF clip 100 directed towards the interdental spaces. The clip 100 slips into the space and engages the teeth. Once engaged, the trigger 1010 is released. The spring 1006B assists in retraction of the drive shaft 1000 from the capstan head 104 (mechanically, the applicator 1000 is retracted owing to the spring action 1006B). Finally, the IMF clip 100 is released from the prong holders 1016 of the applicator 1000, by freeing it from the prong sleeves 1018 by moving the applicator 1000 away from the shoulders 110 of the clip 100. This step concludes the IMF clip 100 being applied to the designated tooth. Multiple IMF clips 100 are engaged as per the requirement for the scenario and is ready for intermaxillary fixation.

[0060] FIGs. 27 and 27A illustrate an exemplary representation of a front view 3000 of a dental model with teeth showing IMF clips in respective position, whereas FIGs. 28 and 28A illustrate an exemplary representation of a right-side view 4000 of a dental model with teeth showing IMF clips in respective position, and FIGs. 29 and 29A illustrate an exemplary representation of a left-side view 6000 of a dental model with teeth showing IMF clips in respective position. In all these figures, an IMF clip 100 is engaged in position 3002, at an upper jaw 3004 and a lower jaw 3006, showing teeth 3008.

[0061] In an embodiment, as shown in the FIGs. 30-32, showing the front view 6000, the right-side view 7000, and the isometric view 8000 of a dental model with teeth showing IMF clips 100 in respective position and IMF applied with stainless steel wires 6002, according to an embodiment of the invention. The IMF may further be achieved through rubber elastics or various sizes of stainless-steel wires 6002. The IMF wires 6002 may be applied making use of the capstan head 104 or the prongs 108 over shoulder 112 based on the scenario.

[0062] After the need for IMF is accomplished, the IMF wires 6002 are cut, or the elastics are removed. The applicator 1000 is again engaged to the clip 100 in similar fashion as described earlier. The trigger 1010 is activated again such that the arms 106 open and the whole system is pulled apart. The action disengages the IMF clip 100 from the teeth. The IMF clip 100 is then retrieved from the applicator 1000.

[0063] Application:

[0064] The application of the current innovation extends into treating maxillomandibular fractures in the form of conservative or non-operative management providing intermaxillary fixation. The system of the IMF clips 100 can also be used in establishing temporary occlusion in cases of orthognathic surgery, access osteotomies for pathologic resection and reconstruction of mandible. Acute temporomandibular joint dislocation shall also be treated with the present system by providing intermittent maxillomandibular fixation. The system has unique advantage of its use in cases with restricted mouth opening such as temporomandibular joint ankylosis.

[0065] In overall, the present invention is aimed at revolutionizing the method of intermaxillary or maxillomandibular fixation owing to its novelty.

[0066] Primarily, the application of the IMF clips and its applicator is in establishing the dental occlusion to pre-traumatic state and maintaining the same either in intermittent or long term. Also, the IMF system shall be used in treating maxillomandibular fractures conservatively or non-operatively by providing immobilisation of the jaws. Additionally, the IMF system shall be used in re-establishing the dental occlusal status of the individual in cases such as functional treatment of mandibular condyle fracture, guidance in pre-operative and perioperative period of temporomandibular joint ankylosis release and replacement surgeries.

[0067] Further, the IMF system may also be used in achieving maxillomandibular relation in cases of orthognathic surgery, access osteotomies in pathologic resection & reconstruction and facial asymmetry corrective surgeries.

[0068] Furthermore, the IMF system may be used in treatment of acute Temporomandibular joint dislocation by assisting in traction of jaws together and establishing proper dental relation. Additionally, the IMF system may also be used in treatment of Temporomandibular joint subluxation by providing intermittent immobilisation of the jaws. Thus advantageously, the present system of IMF clips and its applicator aids in maintaining oral hygiene, reducing operating time drastically and reducing the risk of penetrating injury to the operator. Owing to the design and nature of the IMF clips being mechanically operative along with its easy-to-use applicator, the application process is much easier than the ones conventionally present to fix dental occlusions. Further, because the IMF clips are not too much pain rendering and also aesthetically better than the conventional appliances, the IMF clips have improved patient psychosocial status and acceptance for the procedure. The system also has economic and cost- effective design. Many more advantages of the present invention are:

[0069] Avoidance of use of adjuvant fasteners to retain the IMF system. Safety design protecting operator from prick injuries. Atraumatic and minimally invasive method of application and retrieval. Reduced surgical steps in achieving intermaxillary fixation. Simplistic design helps maintain oral hygiene, preserve periodontal health and prevent soft tissue injury in the patients. Single tooth intermaxillary fixation is possible (partially edentulous jaws). Reduced chance of dental trauma in terms of root perforation and altered thermal response (sensitivity). Both patient and operator friendly. Tooth specific design with numbering makes it a unique IMF system. Simple mechanical resistance of the IMF clips is provided by anatomic form of teeth. Clips available in various sizes based on the individual teeth size. Novel mass personalisation technology. Minimum hardware in oral cavity of the individual. Special applicator specific to applying the IMF clips. Applicator provides directional guidance in controlling the degree of freedom of IMF clips while applying. IMF clips are less conspicuous in design. Minimal retention areas for debris and food accumulation providing improved oral hygiene. Safety tip design prevents formation of traumatic ulcers in the post operative period. Sectional IMF with teeth specific clips that are easy to apply even in posterior teeth. Each IMF clip is applied are independent of adjacent clips. With minimalistic and less invasive design, reduced chances of gingival overgrowth and secondary infections. Can be applied even by untrained professionals. Tooth borne appliance obviating need for any radiological investigations. No chance of thermal necrosis owing to its clip-on mechanical design. Less chance of loosening secondary to self-retaining mechanical design. Tooth borne appliance that does not cause iatrogenic tooth injury. The IMF clips available even second molars of jaws make it easier for application and prevents development of open bite. Does not cause damage to arteries, nerves and veins along the jaws. Does not obliterate any anatomical spaces. Larger cross-sectional area conforming to the anatomy of individual tooth offers greater resistance form. Application does not mandate mouth opening and hence less chance for re-do procedures as individual clips shall be changed at any given point of time. No chemical tooth preparation required for its application. No requirement of laboratory work and fabrication of dental models. Less chance of mechanical failure owing to its single component design.

[0070] It is intended that the disclosure and examples be considered exemplary only. The IMF clips system disclosed herein may be employed for various other applications as would be appreciated by one skilled in the art. The references to devices and structures used here are intended to be applied or extended to the larger scope and should not be construed as restricting the scope and practice of the present invention.

[0071] While certain embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the present disclosure. Indeed, the novel methods, devices, and systems described herein may be embodied in a variety of other forms. Furthermore, various omissions, substitutions, and changes in the form of the methods, devices, and systems described herein may be made without departing from the present disclosure.

[0072] The present invention aims to address several limitations of conventional clinical and laboratory procedures by introducing an innovative instrument designed for ease of application and a gradual learning curve, thereby supporting maxillofacial surgeons, plastic surgeons, otolaryngologists, oncosurgeons, and dentists in establishing dental occlusion. It significantly reduces intra-operative time and minimize the number of surgical instruments required during procedures. The invention also focuses on enhancing patient outcomes by maintaining good oral hygiene and aesthetics, while simultaneously ensuring operator safety by eliminating risks such as needle stick injuries and the transmission of blood-borne diseases. Additionally, the instrument is designed to be ergonomic and minimalistic, helping to preserve the individual's periodontal health and reduce the likelihood of dental trauma, including tooth root perforation, loss of vitality, and altered thermal responses. Another major goal is the development of intermaxillary fixation (IMF) clips that can function either independently or as a system, adaptable to various dental arch conditions, including partially edentulous states. These clips are intended to eliminate the need for traumatic fastening methods like wires and screws, offering a minimally invasive and atraumatic alternative that protects the periodontium, mucosa, and bone structures of the upper and lower jaws. The IMF (Intermaxillary Fixation) clips and the applicator are specifically used to restore and maintain dental occlusion to its pre-traumatic state, either intermittently or over a long-term period of 3 to 6 weeks. This system is employed solely for conservative or non-operative treatment of maxillomandibular fractures by immobilizing the jaws — initially using elastics for 24-48 hours followed by wiring, which is removed after 4-6 weeks if occlusion is stable. The IMF system also plays a crucial role in re-establishing occlusal status in cases such as functional treatment of mandibular condyle fractures and in the perioperative management of temporomandibular joint ankylosis surgeries, using guiding elastics for 3-4 weeks. In orthognathic and reconstructive surgeries, IMF clips are applied intraoperatively to achieve maxillomandibular relation. Furthermore, the system is used solely in treating acute TMJ dislocations through elastic traction to gradually restore occlusion and in TMJ subluxations via intermittent jaw immobilization with wiring over a 4-week period.

Claims

We claim:

1. An Intermaxillary (IMF) clip comprising a body (102); a capstan head (104) with the crosshead receptacle (112) is designed and fixed in front of the body of the IMF clip; at least two shoulders (110) each of which carries at least one prong (108) respectively at its front one end; at least two arms (106) at the back of the body of the IMF clip and the arms at their ends have safety tips (118); numbered accordingly with quadrant number (116) on to the right of capstan head and on to the left describes the tooth number (114) wherein the IMF clip is self-retaining clip and that helps it to adhere to the neck of the teeth mechanically.

2. The IMF clip as claimed in claim 1, wherein the capstan head (104) and the cross-head receptacle (112) engages the clip to an IMF clip applicator and prevents it from slipping at the time of activation and application of the IMF clip to teeth.

3. The IMF clip as claimed in claim 1, wherein the capstan head (104) receives one or more intermaxillary fixation wires around it.

4. The IMF clip as claimed in claim 1, wherein between every pair of the shoulder (110) and its prong (108), the body (102) has the capstan head with the cross-head receptacle (112).

5. The IMF clip as claimed in claim 1, wherein the shoulders (110) and the prongs (108) are projecting outwards facing the opposite of the teeth when the IMF clip is applied on a tooth along the embrasure spaces of teeth.

6. The IMF clip as claimed in claim 1, wherein the prongs (108) prevent the slippage of engaged IMF wire onto the clip.

7. The IMF clip as claimed in claim 1 , wherein each arm (106) extends beyond each shoulder (110), from the rear of the body (102), facing the teeth when the IMF clip is applied on a tooth.

8. The IMF clip as claimed in claim 1, wherein the IMF clip and applicator shall be fabricated in metals like titanium, aluminium, stainless steel and alloys including Ni-Ti giving high strength resin and polymer or of mixed composition of materials.

9. The IMF clip as claimed in claim 1 , wherein the IMF clip can be constructed by machining process, CNC or SLS / SLM , lathe cut or injection molded etc.

10. A system comprises IMF clips (100) and IMF clip applicator (1000) wherein the IMF clip applicator comprising a handle (1002), a guide shaft (1004) and a chief drive shaft (1006) are attached on its distal end (head) with respect to the proximal end (tail) usually held by the operator; the chief drive shaft (1006) has a cross head driver (1008) provided at the end of its opposite portion (1006A); a trigger (1010) of the applicator slides over the chief drive shaft; a stopper (1012) on the opposite end of the chief drive shaft; the trigger has a slider (1014) towards its top end and on its front end above the stopper carries at least two special prong holders (1016); each of the prong holders has a prong sleeve (1018) at its end; a closed coil spring (1020) and at least one lock holes (1022) at each of the prong holders (1016) to help it spring loaded.

11. The system as claimed in claim 8, wherein the cross-head driver (1008) engages with the cross-head receptacle (112) of the capstan head (104) of the IMF clip (100) for providing utmost stability.

12. The system as claimed in claim 8, wherein the chief drive shaft (1006) has another portion that is spring (1006B) loaded on the rear of the trigger (1010) for rebounding the trigger.

13. The system as claimed in claim 8, wherein the closed coil spring (1020) provides a degree of freedom to the distance between the two prong sleeves (1018) to engage with clips of various sizes.

14. A method of using the IMF clip as claimed in claim 1, comprising the steps of:i. the gums along the teeth bearing region are anaesthetised with topical anaesthetic agent in the form of spray or jelly or local site injections; ii. following anaesthesia from step i, each IMF clips are provided with two prongs designed to emerge along the adjacent embrasure spaces which are selected for application on alternate teeth; iii. an applicator is then held firmly in a power grip, with the index finger positioned to engage the trigger; iv. a clip is engaged to the applicator by aligning its prongs with the prong sleeves of the holder, manually adjusting the distance between the sleeves to ensure a proper fit; v. once the prongs are securely seated in the sleeves from step iv, the trigger is pressed to engage the capstan head of the IMF clip with the crosshead receptacle of the main drive shaft, marking full engagement of the clip to the applicator; vi. with the clip engaged from step v, further pressure on the trigger activates the IMF clip, causing its arms to open wide; vii. at this stage, the clip is ready for placement into the interdental spaces between the teeth; viii. apical pressure is applied to the applicator handle, directing the safety tips of the clip toward the targeted interdental spaces; ix. as pressure is maintained from step viii, the clip slips into the space and engages the teeth; x. once the clip is in position from step ix, the trigger is released, and the spring mechanism assists in retracting the drive shaft from the capstan head, causing the applicator to withdraw automatically; xi. the IMF clip is then released from the prong holders by moving the applicator away from the clip shoulders freeing the sleeves and completing the application of the clip to the designated tooth.

15. The method of usage as claimed in claim 14, wherein multiple IMF clips are engaged as per the requirement for the scenario and is ready for intermaxillary fixation.

16. The method of usage as claimed in claim 14, wherein after the need for IMF clip is accomplished, the IMF wires are cut, or the elastics are removed. The applicator is again engaged to the clip in similar fashion as described earlier. The trigger is activated again such that the arms open and the whole system is pulled apart. The action disengages the IMF clip from the teeth. The IMF clip is then retrieved from the applicator.

17. The method of usage as claimed in claim 14, wherein the IMF clip shall be achieved through rubber elastics or various sizes of stainless-steel wires. The IMF shall be applied making use of the capstan head or the prongs over shoulder based on the scenario.

18. Use of the IMF clip as claimed in claim 1 for establishing proper dental occlusion.

19. Use of the system as claimed in claim 10 for bracing the natural anatomy of the teeth without obliterating the adjacent periodontal structures. 1

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