Maxillomandibular fixation instruments and implants

Abstract

A fastener deployment system including a fastener and a tool. The fastener including a plurality of side surfaces and an end surface abutting each side surface of the plurality of side surfaces. Each side surface of the plurality of side surfaces being curved. The tool including a shaft and a gripping portion extending from the shaft, the gripping portion including a plurality of internally facing surfaces that define an opening in the gripping portion. Wherein when the gripping portion of the holding instrument is advanced over the head of the fastener, each internally facing surface of the plurality of internally facing surfaces has a contour that complements a respective side surface of the plurality of side surfaces.

Description

MAXILLOMANDIBULAR FIXATION INSTRUMENTS AND IMPLANTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of the filing date of U.S. Provisional Application No. 63 / 693,608, filed September 11, 2024, entitled Maxillomandibular Fixation Instruments And Implants, the disclosure of which is hereby incorporated herein by reference.BACKGROUND

[0002] When bone in a facial region of the skull is fractured due to trauma or deteriorated due to disease, treatment may involve the implantation of one or more bars and / or fasteners. For instance, trauma to the jaw, such as a jaw fracture, may require implantation of a bar and / or fasteners onto the maxilla and / or mandible to promote recovery and / or restore function of the jaw.

[0003] However, successful implantation of a bar or fastener may be difficult due to the importance of proper implant placement and the need to efficiently complete the procedure. Specifically, the nerves and teeth around the jaw bones must be properly accounted for and the implant placement itself must be performed so as to promote sufficient healing.BRIEF SUMMARY

[0004] The present disclosure includes various implants and tools for use in maxillomandibular fixation procedures in the craniomaxillofacial region of a patient.

[0005] In accordance with an aspect of the present disclosure, a fastener includes a head and a shaft extending from the head. The shaft includes a proximal portion and a distal portion, the proximal portion separating the head from the distal portion. The proximal portion includes a first threaded surface and the distal portion includes a second threaded surface different from the first threaded surface. When the fastener secures a bone plate to a bone, the fastener may be rotated to bring the fastener partially out of the bone while a portion of the bone plate is held on the first threaded surface, thereby causing the bone plate to move away from a surface of the bone while remaining engaged to the first threaded surface of the fastener.

[0006] In accordance with another aspect of the present disclosure, a system for a maxillomandibular repair may include a bone plate including an elongate bar with a plurality of loops spaced apart along a length of the elongate bar, and a fastener including a head and a shaft extending from the head, the shaft including a proximal portion and a distal portion, the proximal portion separating the head from the distal portion. The proximal portion includes a first threaded surface and the distal portion includes a second threaded surface different from the first threaded surface. When the fastener is passed through a loop of the plurality of loops and secures the bone plate to a bone, the fastener may be rotated to bring the fastener partially out of the bone while a portion of the bone plate is held on the first threaded surface, thereby causing the bone plate tomove away from a surface of the bone while remaining engaged to the first threaded surface of the fastener.

[0007] In accordance with another aspect of the present disclosure, a bone plate may include an elongate bar including a plurality of loops spaced apart along a length of the elongate bar, each loop of the plurality of loops having an oblong shape, and a plurality of hooks extending from the elongate bar. The plurality of hooks being arranged such that each loop of the plurality of loops is complemented by a hook of the plurality of hooks.

[0008] In other embodiments of this aspect, each hook of the plurality of hooks that complements a respective loop of the plurality of loops may extend from the elongate bar at a center of the respective loop. The elongate bar and the plurality of hooks may be formed monolithically. At least two loops of the plurality of loops may have different sizes.

[0009] In accordance with another aspect of the present disclosure, a fastener may include a head portion and a shaft portion extending from the head portion. The head portion includes a circumferential outer surface flaring outward toward the shaft portion, the outer surface being configured to be received in a tool with a complementary shape such that the fastener is held within the tool.

[0010] In other embodiments of this aspect, the circumferential outer surface may be a hexagonal prism that flares outward toward the shaft portion. The circumferential outer surface may be spaced apart from a free end portion of the head portion. The head portion may further comprise a neck, and the free end portion flares outward toward the shaft portion at the same angle as the circumferential outer surface.

[0011] In accordance with another aspect of the present disclosure, a fastener may include a head portion and a shaft portion extending from the head portion. The head portion includes a central subportion spaced apart from a free end of the head portion, the central subportion having a uniform cross-sectional shape over part of a length of the central subportion and having an increasing cross-sectional shape toward a shaft-facing end of the central subportion. The length is measured along an elongate dimension of the fastener.

[0012] In other embodiments of this aspect, the cross-sectional shape of the central subportion may be rectangular with beveled corners. A cross-sectional shape shaft-facing end of the central subportion may be circular.

[0013] In accordance with another aspect of the present disclosure, a holding tool may include an elongate portion and an engagement portion at a distal end of the elongate portion. The engagement portion including a cavity extending into the engagement portion from a distal end of the engagement portion and a pair of arms. Each arm of the pair of arms extending distally toward respective free ends of the arms, the pair of arms being biased such that the free ends of the armsare closer together than bases of the arms. The engagement portion further including a fastener including a head and a shaft extending therefrom. The head being shaped such that when the fastener is received in the cavity, each arm of the pair of arms is pushed outward away from a centerline of the holding tool such that the fastener is held by the holding tool.

[0014] In other embodiments of this aspect, the engagement portion of the holding tool may include a recessed surface adjacent to the distal end of the engagement portion that is sized to receive a central portion of the head of the fastener. The central portion of the head of the fastener may be hexagonal in cross-section. The head may include a free end portion that pushes each arm of the pair of arms outward, the free end portion being separated from the shaft of the fastener by the central portion.

[0015] In accordance with another aspect of the present disclosure, a fastener may include a head including an end portion, a central portion and a neck portion separating the end portion and the central portion. The central portion having a first pair of outer surfaces parallel to each other and a second pair of outer surfaces parallel to each other, each outer surface of the first pair of outer surfaces being separated from the other outer surface of the first pair of outer surfaces by the outer surfaces of the second pair of outer surfaces; and a shaft extending from the head.

[0016] In other embodiments of this aspect, the neck portion may have a smaller outer cross- sectional dimension than the central portion and the end portion and is cylindrical in shape.

[0017] In accordance with another aspect of the present disclosure, a fastener deployment system may include a fastener including a head including a plurality of side surfaces and an end surface abutting each side surface of the plurality of side surfaces, each side surface of the plurality of side surfaces being curved and a shank extending from the head, and a holding instrument including a shaft and a gripping portion. The gripping portion extending from the shaft, the gripping portion including a plurality of internally facing surfaces that define an opening in the gripping portion. When the gripping portion of the holding instrument is advanced over the head of the fastener, each internally facing surface of the plurality of internally facing surfaces has a contour that complements a respective side surface of the plurality of side surfaces.

[0018] In other embodiments of this aspect, each internally facing surface of the plurality of internally facing surfaces may have a first radius of curvature and each side surface of the plurality of side surfaces has the first radius of curvature. The gripping portion may further include a plurality of prongs extending distally from an end of the opening in the gripping portion. Each side surface of the plurality of side surfaces may include a concave surface portion.

[0019] In accordance with another aspect of the present disclosure, a fastener may include a head including a plurality of side surfaces and an end surface abutting each side surface of the plurality of side surfaces. Each side surface of the plurality of side surfaces being radially spaced from acentral longitudinal axis of the fastener and including a first peripheral surface portion and a second peripheral surface portion. The fastener further including a concave surface portion extending from the end surface, the concave surface portion being in between the first peripheral surface portion and the second peripheral surface portion, and a shank extending from the head, an overall width of each side surface of the plurality of side surfaces extends from a side of the first peripheral surface portion to a side of the second peripheral surface portion, and a width of the concave surface portion is a majority of the overall width.

[0020] In other embodiments of this aspect, the concave surface portion of each side surface of the plurality of side surfaces may include a base portion that flares outward toward the shank. For each side surface of the plurality of side surfaces, the concave surface portion may define an opening therethrough. The fastener may further include a collar portion between the head and the shank, the collar portion has a maximum diameter that is greater than a maximum diameter of the shank and that is greater than a maximum outer dimension of the head. The shank may include a first portion and a second portion in between the first portion and the head, the first portion having a first minimum diameter and the second portion having a second minimum diameter less than the first minimum diameter. The first portion and the second portion each may include a threaded surface. The threaded surface of the first portion may have a crest with a larger cross-sectional thickness than a root of the threaded surface of the second portion and a smaller cross-sectional thickness than a crest of the threaded surface of the second portion. The shank may include a first portion and a second portion in between the first portion and the collar portion, the first portion having a threaded surface and the second portion having a smooth cylindrical surface. A maximum diameter along the first portion of the shank may be less than a minimum diameter along the second portion of the shank.

[0021] In accordance with another aspect of the present disclosure, a holding instrument configured to hold a fastener, the holding instrument may include a shaft; and a gripping portion extending from the shaft, the gripping portion including a base including an end surface remote from the shaft; and a plurality of internally facing surfaces that define an opening in the gripping portion, each internally facing surface of the plurality of internally facing surfaces having a convex shape, the end surface defines a distal end of the opening.

[0022] In other embodiments of this aspect, the gripping portion may further include a plurality of prongs extending from the end surface. Each prong of the plurality of prongs may have a convex shaped inward facing surface commensurate with the convex shape of the plurality of internally facing surfaces. The holding instrument may further include a plurality of externally facing surfaces opposite the plurality of internally facing surfaces. A space may be defined through a portion of one of the plurality of externally facing surfaces such that the one of the plurality ofextemally facing surfaces is in fluid communication with the opening. The space may extend from the end surface to a curve-shaped closed end.

[0023] In accordance with another aspect of the present disclosure, an implant configured for securement to a bone includes a bar including a plurality of links along a longitudinal axis of the bar, each link of the plurality of links including a body defining an elongate aperture. A first elongate aperture defined in a first link of the plurality of links is longer than a second elongate aperture defined in a second link of the plurality of links. Each link of the plurality of links is separated from other links of the plurality of links by a segment of the bar. The implant further including a plurality of hooks extending from the bar, each hook of the plurality of hooks being spaced apart from other hooks of the plurality of hooks along a length of the bar.

[0024] In other embodiments of this aspect, each link of the plurality of links may include only one elongate aperture. A first hook of the plurality of hooks and a second hook of the plurality of hooks each may extend from the bar in a first direction orthogonal to a length direction of the bar, the first hook extending from the bar at a first location opposite the first link and the second hook extending from the bar at a second location opposite the second link. A distance of the first hook from a center of the first link may be less than a distance of the second hook from a center of the second link. Each hook of the plurality of hooks may include a thickness that is the same as a cross-sectional of the plurality of links.

[0025] In accordance with another aspect of the present disclosure, a method of implant fixation of a fastener in a patient may include, coupling a fastener onto a tool by engaging a head of the fastener in an opening at a distal end of the tool, the head of the fastener including a plurality of side surfaces and an end surface, at least one side surface of the plurality of side surfaces including a first peripheral surface portion, a second peripheral surface portion, and a concave surface portion extending from the end surface and being in between the first peripheral surface portion and the second peripheral surface portion, the tool including a plurality of internally facing surfaces that define the opening, at least one of the internally facing surfaces having a contour that complements the concave surface portion of the fastener. The method further includes securing the fastener onto a first bone using the tool.

[0026] In other embodiments of this aspect, the step of securing the fastener onto the first bone using the tool includes rotating the tool such that at least one of the internally facing surfaces having the contour that complements the concave surface portion of the fastener is held fixed to the concave surface portion of the fastener to cause the fastener to rotate with the tool. The tool may resist pull out from the fastener when rotating the tool due to engagement members extending from the distal end of the tool being angled inward at a steeper angle than the concave surface portions of the fastener.

[0027] In accordance with another aspect of the present disclosure, a method of implant fixation, the method may include securing a first bar onto a first bone, the first bar including a plurality of links along a longitudinal axis of the first bar, each link of the plurality of links defining an elongate aperture, a first elongate aperture defined in a first link of the plurality of links and a second elongate aperture defined in a second link of the plurality of links, the second elongate aperture is different than the first elongate aperture. The method further includes placing a first fastener through the first link to anchor the first fastener to the first bone. The method further includes placing a second fastener through the second link to anchor the second fastener to the first bone.

[0028] In other embodiments of this aspect, the method may further include prior to placing the first fastener through the first link, determining a bone location under the first elongate aperture for placement of the first fastener, the first elongate aperture having a length that is at least twice a diameter of a head of the first fastener. The method may further include placing a third fastener through a first link of a second bar to anchor the third fastener to a second bone, placing a fourth fastener through a second link of the second bar to anchor the fourth fastener to the second bone, and coupling the second bar to the first bar with a wire.

[0029] In accordance with another aspect of the present disclosure, a multi-purpose tool includes a base, a first arm extending from the base, and a second arm extending from the base. The base having a tip with an elongate shape configured be received in an elongate opening of an implant. The first arm having a first tine, a second tine spaced apart from the first tine by a space, and a first protrusion extending from a surface of the first arm. The second arm spaced apart from the first arm. The second arm defining an aperture therethrough, and the second arm including a second protrusion extending from a surface of the second arm. The first arm and the second arm are biased such that in a neutral state, a first distance separates the first arm and the second arm. When the first arm and the second arm are closed together such that a second distance less than the first distance separates the first arm and the second arm, the aperture receives the first protrusion and the space receives the second protrusion. The first tine and the second tine are positionable against soft tissue of a patient to separate an implant surface from the soft tissue.

[0030] In other embodiments of this aspect, the first aperture of the multi-purpose tool may have a different shape from the second aperture. The elongate shape of the tip may include opposing parallel surfaces separated by convex curved surfaces. The first arm may further include a central arm extending from a surface of the first arm and the second arm includes a central aperture extending from a surface of the second arm, the central aperture configured to receive the central arm such that the central arm is engaged to the first arm, thereby locking the first arm to the second arm. The central arm may be operatively connected to a biasing member to maintain the lockingof the first arm to the second arm when the central aperture receives the central arm. The central arm may be operatively connected to a biasing member to maintain the locking of the first arm to the second arm when the central aperture receives the central arm. The first protrusion may be closer to the base than the second protrusion. The first tine and the second tine may extend to respective free ends such that the space is open on one lateral side.BRIEF DESCRIPTION OF THE DRAWINGS

[0031] A more complete appreciation of the subject matter of the present disclosure and of the various advantages thereof can be realized by reference to the following detailed description in which reference is made to the accompanying drawings in which:

[0032] FIG. 1A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0033] FIG. IB is a cross-sectional view of the fastener of FIG. 1A taken along line IB- IB of FIG. IF.

[0034] FIG. 1C is a side view of the fastener of FIG. 1 A.

[0035] FIG. ID is a cross-sectional view of a head portion of the fastener of FIG. 1A taken along line 1B-1B of FIG. IF.

[0036] FIG. IE is a cross-sectional view of a shaft portion of the fastener of FIG. 1A taken along line lE-lE of FIG. IB.

[0037] FIG. IF is a top view of the head portion of the fastener of FIG. 1 A.

[0038] FIG. 1G is a cross-sectional view of a shank portion of the fastener of FIG. 1A taken along line IG-lG of FIG. 1C.

[0039] FIG. 2A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0040] FIG. 2B is a cross-sectional view of the fastener of FIG. 2A taken along line 2B-2B of FIG. 2C.

[0041] FIG. 2C is a side view of the fastener of FIG. 2A.

[0042] FIG. 2D is an enlarged view of the area 2D in FIG. 2B.

[0043] FIG. 2E is a cross-sectional view of a head portion of the fastener of FIG. 2A taken along line 2B-2B of FIG. 2C.

[0044] FIG. 2F is a top view of a head portion of the fastener of FIG. 2A.

[0045] FIG. 3A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0046] FIG. 3B is a cross-sectional view of a shaft portion of the fastener of FIG. 3A taken along line 3B-3B of FIG. 3C.

[0047] FIG. 3C is a cross-sectional view of the fastener of FIG. 3A taken along line 3C-3C of FIG. 3E.

[0048] FIG. 3D is a top view of the fastener of FIG. 3A.

[0049] FIG. 3E is a side view of the fastener of FIG. 3A.

[0050] FIG. 4A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0051] FIG. 4B is a cross-sectional view of the fastener of FIG. 4A taken along line 4B-4B of FIG. 4C.

[0052] FIG. 4C is a cross-sectional view of the fastener of FIG. 4A taken along line 4C-4C of FIG. 4E.

[0053] FIG. 4D is a top view of the fastener of FIG. 4A.

[0054] FIG. 4E is a side view of the fastener of FIG. 4A.

[0055] FIG. 5A is a perspective view of a tool according to one embodiment of the present disclosure.

[0056] FIG. 5B is a perspective view of the tool of FIG. 5A.

[0057] FIG. 5C is a cross-sectional view of the tool of FIG. 5A taken along line 5C-5C of FIG. 5E.

[0058] FIG. 5D is a cross-sectional view of the tool of FIG. 5A taken along line 5C-5C of FIG. 5E.

[0059] FIG. 5E is a top view of the tool of FIG. 5 A.

[0060] FIG. 6A is a side view of a fastener inserted into biological matter according to one embodiment of the present disclosure.

[0061] FIG. 6B is a side view of the fastener of FIG. 6A.

[0062] FIG. 6C is a cross-sectional view of the fastener of FIG. 6A taken along line 6C-6C of FIG. 6B.

[0063] FIG. 6D is a cross-sectional view of a head portion of the fastener of FIG. 6A taken along line 6C-6C of FIG. 6B.

[0064] FIG. 6E is a top view of the fastener of FIG. 6A.

[0065] FIG. 7A is a side view of a fastener with threads hidden according to one embodiment of the present disclosure.

[0066] FIG. 7B is a side view of the fastener of FIG. 7A.

[0067] FIG. 8 is a side view of a fastener according to one embodiment of the present disclosure.

[0068] FIG. 9 is a side view of a fastener according to one embodiment of the present disclosure.

[0069] FIG. 10A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0070] FIG. 10B is a side view of the fastener of FIG. 10A.

[0071] FIG. 10C is a cross-sectional view of the fastener of FIG. 10A taken along line 10C- 10C of FIG. 10D.

[0072] FIG. 10D is a top view of the fastener of FIG. 10A.

[0073] FIG. 10E is a cross-sectional view of a shaft portion of the fastener of FIG. 10A taken along line 10E-10E of FIG. 10A.

[0074] FIG. 11 is a side view of a fastener according to one embodiment of the present disclosure.

[0075] FIG. 12 is a side view of a fastener according to one embodiment of the present disclosure.

[0076] FIG. 13A is a side view of a tool according to one embodiment of the present disclosure.

[0077] FIG. 13B is a perspective view of a head portion of the tool of FIG. 13A.

[0078] FIG. 13C is a cross-sectional view of the head portion of the tool of FIG. 13A taken along line 13E-13E of FIG. 13F.

[0079] FIG. 13D is a side view of the head portion of the tool of FIG. 13A.

[0080] FIG. 13E is a cross-sectional view of the head portion of the tool of FIG. 13A.

[0081] FIG. 13F is a top view of the head portion of the tool of FIG. 13A.

[0082] FIG. 13G is a perspective view of the head portion of the tool of FIG. 13A.

[0083] FIG. 14A is a perspective view of the tool of FIG. 13A coupled to the fastener of FIG. 10A.

[0084] FIG. 14B is a cross-sectional view of the tool of FIG. 13A coupled to the fastener of FIG. 10A.

[0085] FIG. 15A is a side view of a tool according to one embodiment of the present disclosure.

[0086] FIG. 15B is a side view of a head portion of the tool of FIG. 15A.

[0087] FIG. 15C is a top view of the head portion of the tool of FIG. 15A.

[0088] FIG. 16A is a perspective view of a tool according to one embodiment of the present disclosure.

[0089] FIG. 16B is a perspective view of a head portion of the tool of FIG. 16A.

[0090] FIG. 16C is a side view of the head portion of the tool of FIG. 16A.

[0091] FIG. 16D is a top view of the head portion of the tool of FIG. 16D.

[0092] FIG. 17A is a side view of a tool according to one embodiment of the present disclosure.

[0093] FIG. 17B is a top view of the tool of FIG. 17A.

[0094] FIG. 18 illustrates a perspective view of the tool of FIGs. 16A-D coupled to the fastener of FIGs. 12A-D.

[0095] FIG. 19A is a front view of a bar according to one embodiment of the present disclosure.

[0096] FIG. 19B is a perspective view of the bar of FIG. 19A.

[0097] FIG. 19C is a cross-sectional side view of the bar of FIG. 19A taken along line 19C-19C of FIG. 19A.

[0098] FIG. 20A is a front view of a bar according to one embodiment of the present disclosure.

[0099] FIG. 20B is a perspective view of the bar of FIG. 20A.

[0100] FIG. 20C is a cross-sectional side view of the bar of FIG. 20A taken along line 20C-20C of FIG. 20A.

[0101] FIG. 21 A is a front view of a bar according to one embodiment of the present disclosure.

[0102] FIG. 21B is a cross-sectional side view of the bar of FIG. 21A taken along line 21B-21B of FIG. 21A.

[0103] FIG. 22A is a front view of a bar according to one embodiment of the present disclosure.

[0104] FIG. 22B is a perspective view of the bar of FIG. 22A.

[0105] FIG. 22C is a cross-sectional side view of the bar of FIG. 22A taken along line 22B-22B of FIG. 22A.

[0106] FIG. 23A is a front view of a bar according to one embodiment of the present disclosure.

[0107] FIG. 23B is a perspective view of the bar of FIG. 23A.

[0108] FIG. 23C is a cross-sectional side view of the bar of FIG. 23A taken along line 23B-23B of FIG. 23A.

[0109] FIG. 24A is a front view of a bar according to one embodiment of the present disclosure.

[0110] FIG. 24B is a perspective view of the bar of FIG. 24A.

[0111] FIG. 24C is a cross-sectional side view of the bar of FIG. 24A taken along line 24B-24B of FIG. 24A.

[0112] FIG. 25A is a front view of a bar according to one embodiment of the present disclosure.

[0113] FIG. 25B is a perspective view of the bar of FIG. 25A.

[0114] FIG. 25C is a cross-sectional side view of the bar of FIG. 25A taken along line 25B-25B of FIG. 25A.

[0115] FIG. 26 is a perspective view of a bar according to one embodiment of the present disclosure.

[0116] FIG. 27A is a front view of a fixation system according to one embodiment of the present disclosure.

[0117] FIG. 27B is a front view of a fixation system according to one embodiment of the present disclosure.

[0118] FIG. 28A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0119] FIG. 28B is a cross-sectional view of the fastener of FIG. 28A taken along line 28B-28B of FIG. 28D.

[0120] FIG. 28C is a side view of the fastener of FIG. 28A.

[0121] FIG. 28D is a top view of the fastener of FIG. 28A.

[0122] FIG. 29A is a perspective view of a fastener according to one embodiment of the present disclosure.

[0123] FIG. 29B is a perspective view of a fastener according to one embodiment of the present disclosure.

[0124] FIG. 29C is a perspective view of a fastener according to one embodiment of the present disclosure.

[0125] FIG. 29D is a perspective view of a fastener according to one embodiment of the present disclosure.

[0126] FIG. 29E is a perspective view of a head portion of the fastener of FIG. 29A.

[0127] FIG. 29F is an enlarged view of the area of 29F in FIG. 29E.

[0128] FIG. 30A is a perspective view of a tool according to one embodiment of the present disclosure.

[0129] FIG. 30B is a perspective view of a portion of the tool of FIG. 30A.

[0130] FIG. 30C is a perspective view of a portion of the tool of FIG. 30A.

[0131] FIG. 30D is a side view of the tool of FIG. 30A.

[0132] FIG. 30E is a top view of a second arm of the tool of FIG. 30A.

[0133] FIG. 30F is an enlarged view of the area 30F in FIG. 30E.

[0134] FIG. 30G is a top view of a first arm of the tool of FIG. 30A.

[0135] FIG. 30H is an enlarged view of the area of 30H in FIG. 30G.

[0136] FIG. 31A illustrates a step in a method of preparing a bar for placement on a patient according to an embodiment of the present disclosure.

[0137] FIG. 3 IB illustrates a step in a method of preparing a bar for placement on a patient according to an embodiment of the present disclosure.

[0138] FIG. 32 is a flowchart illustrating a method for utilizing a tool and a fastener according to the present disclosure.

[0139] FIG. 33 is a flowchart illustrating a method for implanting a bar according to the present disclosure.DETAILED DESCRIPTION

[0140] In describing the embodiments of the present disclosure, specific terminology may be used for the sake of clarity. However, the present disclosure is not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents, which operate in a similar manner to accomplish a similar purpose.

[0141] As used herein, the terms “about,” “generally,” and “substantially” are intended to mean that slight deviations from absolute are included within the scope of the term so modified. To aid the Patent Office and any readers of any patent issued on this application in interpreting the claims appended hereto, Applicant notes that it does not intend any of the appended claims or claim elements to invoke 35 U.S.C. § 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.

[0142] In one aspect, the present disclosure relates to fasteners used for maxillary-mandibular fixation ("MMF”). Examples of such fasteners are shown in FIGs. 1A-4E. In another aspect, the present disclosure relates to tools useable to drive such fasteners, e.g., for anchoring such fasteners to bone. Examples of such tools are shown in FIGs. 5A-5E, 13A-G, and 15A-17B. Details of the aforementioned fasteners and tools are provided below.

[0143] It should be appreciated that the implants and tools as described herein are not limited to such uses and may also be employed for use in other repair or reconstructive surgeries.

[0144] FIGs. 1A-1G are various views of a fastener 100 according to an embodiment of the present disclosure. The fastener 100 is configured to be coupled with various other components for maxillomandibular fixation. Fastener 100 includes head portion 120 adjacent a first end 110, a shaft portion 180 adjacent a second end 190 and extending from head portion 120, a shank portion 150 between head portion 120 and shaft portion 180. Head portion 120 includes parts that are cuboid and cylindrical, shank portion 150 is substantially cuboid, and shaft portion 180 is cylindrical and conical. Head portion 120 includes head 122 with a cuboid shape, interface 124 defined on and within head 122, and neck 123 with a cylindrical shape extending from head 122 towards shank portion 150. Neck 123 is configured to receive wire thereon. Interface 124 of head 122 is configured to receive an end of a driving tool such that fastener 100 may be rotated and advanced such as into a patient. Specifically, interface 124 includes a plurality of depressions on a face of head 122 forming a X-shape such that crossing depressions are perpendicular to each other as shown in FIG. IF. Shaft portion 180 includes a threaded surface along a cylindrical and conical length, having a crest 181 and root 182, cutting edges 183A-B, and a tip 191. Cutting edges 183A-B are non-threaded surface portions that, when fastener 100 is inserted and driven, are configured to remove material away from a hole and provide self-tapping characteristics such that fastener 100 may be secured without a pre-tapped or pilot hole.

[0145] Shank portion 150 includes a cuboid shape having a plurality of faces. Specifically, shank portion 150 includes a plurality of surfaces portions 127 A-D and apertures 121A-D each defined on respective surface portions 127 A-D. Apertures 121A-D are configured to receive wire therein. In some embodiments, wire is configured to pass through some of the apertures 121A-D, for instance, aperture 121A and aperture 121C. In another embodiment, wire is configured to passthrough all of the apertures 121A-D. In yet a further embodiment, wire is configured to pass through none of the apertures 121A-D. In yet an even further embodiment, wire is configured to wrap around neck 123. As shown, fastener 100 has four surface portions 127A-D and four apertures 121A-D however, it should be appreciated that the fastener may have any amount of apertures 121A-D and surface portions 127 A-D.

[0146] With continued reference to shank portion 150, shank portion 150 includes a first portion 151 adjacent neck 123, a third portion 153 adjacent shaft portion 180, and a second portion 152 between first portion 151 and third portion 153. In an embodiment, first portion 151 includes a cross-sectional dimension greater than a cross-sectional dimension of neck 123 and third portion 153 but less than a cross-sectional dimension of second portion 152. Put another way, first portion151 forms a cuboid shape of shank portion 150, second portion 152 defines a collar flaring out from the cuboid shape of first portion 151 at a base of first portion 151. An edge of second portion152 may be circular or have a similar shape, and may represent a maximum diameter along a length of fastener 100. Third portion 153 has a cylindrical shape.

[0147] In another embodiment, a fastener is as shown in FIGs. 2A-F. FIGs. 2A-F are various views of a fastener 200 according to an embodiment of the present disclosure. Fastener 200 includes some features similar to those of fastener 100, and therefore, like elements are referred to with like numerals but within the 200-series of numerals. For example, fastener 200 includes a head portion 220, a shank portion 250 extending from head portion 220, and a shaft portion 280 extending from shank portion 250. However, fastener 200 includes a shank portion 250 different from the shank portion in fastener 100. Specifically, shank portion 250 includes a first collar portion 251 adjacent a neck 223 and a second collar portion 253 adjacent first collar portion 251. According to an embodiment, first collar portion 251 has an octagonal prism shape, and second collar portion 253 has a cylindrical shape. In some embodiments, first collar portion 251 includes surface portions configured to mate with a corresponding tool, such as but not limited to, tool 500 in FIGs. 5A-E. In an embodiment, first collar portion 251 includes eight surface portions. Of these, four surface portions are corner surface portions and four are face surface portions longer than the comer surface portions such that first collar portion 251 is an octagonal prism.

[0148] In another embodiment, a fastener is as shown in FIGs. 3A-E. FIGs. 3A-E are various views of a fastener 300 according to an embodiment of the present disclosure. Fastener 300 includes some features similar to those of fastener 200, and therefore, like elements are referred to with like numerals but within the 300-series of numerals. For example, fastener 300 includes a head portion 320, a shank portion 350 extending from the head portion 320, and a shaft portion 380 extending from shank portion 350. However, fastener 300 includes a head portion 320 and a shank portion 350 different from the shank portion 250 and head portion 220 in fastener 200. Forinstance, head portion 320 includes a head 322 without an interface as well as a plurality of side surface portions 326A-F in a hexagonal-like shape. First collar portion 351 includes a hexagonal prism with a tapering surface decreasing in a direction from the second end 390 to first end 310. Second collar portion 353 includes a cylindrical shape. In an embodiment, head 322 is semispherical having six planar side surface portions 326A-F.

[0149] In another embodiment, a fastener is as shown in FIGs. 4A-E. FIGs. 4A-E are various views of a fastener 400 according to an embodiment of the present disclosure. Fastener 400 includes some features similar to those of fastener 200, and therefore, like elements are referred to with like numerals but within the 400-series of numerals. For example, fastener 400 includes a head portion 420, a shank portion 450 extending from head portion 420, and a shaft portion 480 extending from shank portion 450. However, fastener 400 includes a head portion 420 and shank portion 450 different from shank portion 250 and head portion 220 in fastener 200. For instance, head 422 has smooth side surface portions and first collar portion 451 has twelve side surface portions. Put another way, head 422 is semispherical and first collar portion 451 is an dodecagonal prism.

[0150] In another embodiment, an instrument, also referred to as a tool 500, is shown in FIGs. 5A-5E. FIGs. 5A-5E are various views of tool 500. Tool 500 includes ahead portion 520 adjacent a first end of the tool and a shaft portion 550 extending from the head portion 520. Head portion 520 is cylindrical with a hollow center. Shaft portion 550 is also cylindrical. Shaft portion 550 includes a first collar portion 551, a first recessed portion 552, and a third collar portion 553. Head portion 520 includes a channel 524 defined by a hexagonal inner wall that extends along a length of head portion 520 towards shaft portion 550. Head portion 520 further includes a plurality of deformable surface portions 529 A-B extending from a portion of head portion 520 adjacent shaft portion 550 to respective free ends within opposing side cavities in the head portion. Specifically, deformable surface portions 529 A-B extend from one end of the opposing side cavities along an elongate direction of tool 500 toward a free end of head portion 520. Each deformable surface portion 529A_B has a thickness and is positioned such that when a fastener head is received in channel 524, the deformable surface portions 529A-B may provide an interference fit. Specifically, deformable surface portions 529A-B are configured to deform when channel 524 receives a fastener therein. Each deformable surface portion 529 A-B has an elongate dimension oriented along a length direction of the tool 500 and may have a constant width and thickness along its length. It should be appreciated that head portion 520 may include a differently shaped channel 524. For instance, rather than a hexagonal channel, tool 500 may include an octagonally shaped channel to receive a fastener with a shape complementary to such channel. In one embodiment, tool 500 is configured to be utilized with fasteners 100-400.

[0151] In another embodiment, a fastener is as shown in FIGs. 6A-F. FIGs. 6A-F are various views of a fastener 600 according to an embodiment of the present disclosure. Fastener 400 includes some features similar to those of fastener 100, and therefore, like elements are referred to with like numerals but within the 600-series of numerals. For example, fastener 600 includes a head portion 620, a shank portion 650 extending from head portion 620, and a shaft portion 680 extending from shank portion 650. However, fastener 600 includes a head portion 620 and a shank portion 650 different from respective head portion 120 and shank portion 150 in fastener 100. For instance, head portion 620 includes a plurality of apertures 621 A-D on neck 623. Moreover, shank portion 650 includes a first collar portion 651, a second collar portion 652, a third collar portion 653, and a fourth collar portion 654. First collar portion 651 has a cylindrical shape, third collar portion has a cylindrical shape with a cross-sectional dimension less than first collar portion 651, second collar portion 652 has a frustoconical shape tapering from first collar portion 651 to third collar portion 653, and fourth collar portion 654 has a cylindrical surface adjacent a threaded surface of shaft portion 680, the cross-sectional dimension of fourth collar portion 654 being less than third collar portion 653. Moreover, each of first collar portion 651, second collar portion 652, and third collar portion 653, have a cross-sectional dimension greater than a root of shaft portion 680.

[0152] Fastener 600, like fasteners 100-400, is configured to be inserted into a patient and in some instances, specifically into the maxilla or mandible of a patient. As shown in FIG. 6A, fastener 600 is implanted in a patient such that shaft portion 680 is within cancellous bone 643, fourth collar portion 654 is within cortical bone 642, and third collar portion 653 is within soft tissue 641. It should be appreciated that FIG. 6A shows one example of fastener 600 placement in the patient, and in other instances, fastener 600 may be further or less inserted into a patient. Second collar portion 652 is configured to reduce tissue irritation and adapt to different tissue thickness of a patient. Specifically, second collar portion 652 displaces soft tissue 641 surrounding fastener 600 rather than compressing the soft tissue 641 towards cortical bone 642. This is advantageous as fasteners without second collar portion 652 cause greater irritation by compressing soft tissue 641. Third collar portion 653 is configured to provide tactile feedback to an operator when bone is reached during insertion of fastener 600. Specifically, a shoulder 655 of third collar portion 653 adjacent fourth collar portion 654 includes a surface transverse to third collar portion 653 and fourth collar portion 654 such that the operator receives tactile feedback when shoulder 655 contacts bone (such as cortical bone 642). Put another way, shoulder 655 is a face of third collar portion 653 such that as shoulder 655 advances through biological matter, a change in density between soft tissue 641 and cortical bone 642 is felt by the operator since a greater force is required to advance the fastener 600 through cortical bone 642 than soft tissue 641. Moreover, third collarportion 653 includes a smooth cylindrical surface that causes minimal tissue irritation when advanced through tissue, as shown in FIG. 6A, for example, and is designed such that it helps to protect the gingiva. This characteristic of fastener 600 is advantageous as some fasteners without a smooth cylindrical surface may irritate or damage the gingiva and other biological matter such that use of a fastener for maxillomandibular fixation causes unwanted complications. For instance, fasteners without the smooth cylindrical surface, such as fasteners with a helical thread positioned through the gingiva when implanted would cause more irritation than a smooth cylindrical surface of a fastener configured to be positioned through the gingiva when implanted.

[0153] In another embodiment, a fastener is as shown in FIGs. 7A-B. FIGs. 7A is a side view of a fastener 700 according to an embodiment of the present disclosure. Fastener 700 includes some features similar to those of fastener 600, and therefore, like elements are referred to with like numerals but within the 700-series of numerals. For example, fastener 700 includes a head portion 720, a shank portion 750 extending from the head portion 720, and a shaft portion 780 extending from the shank portion 750. Although not visible in FIG. 7A, shaft portion 780 includes threads extending helically along its surface over a majority of its length as shown in FIG. 7B. Turning to additional details of fastener 700, head portion 720 and a shaft portion 780 include differences relative to the head portion 620 and shaft portion 680 in fastener 600. For instance, shaft portion780 includes a first shaft portion 781, a second shaft portion 782, a third shaft portion 783, a fourth shaft portion 784, and a fifth shaft portion 785. First shaft portion 781 is adjacent fourth collar portion 754. Second shaft portion 782 includes a surface that flares outward from first shaft portion781 to third shaft portion 783. Third shaft portion 783 includes a diameter greater than a diameter of first shaft portion 781. Fourth shaft portion 784 includes a tapering surface between third shaft portion 783 and fifth shaft portion 785. Fifth shaft portion 785 is adjacent second end 790 and includes a tapering surface. As described immediately above, fastener 700 includes a shaft portion 780 having a varying diameter along its length such that a crest of a threaded surface on shaft portion 780 is located at a varying distance from longitudinal axis 701. The variation of crest and root position along shaft portion 780 is configured to provide insertion of fastener 700 into a patient with a lesser amount of torque than a fastener with a non-varying threaded surface diameter. Specifically, the larger diameter of third shaft portion 783 with respect to the other shaft portions closer to the head (e.g., first shaft portion 781) reduces the friction forces on those other shaft portions having a smaller diameter than third shaft portion 783 and thus, reduces the required torque to drive the screw.

[0154] In another embodiment, a fastener isas shown in FIG. 8. FIG. 8 is a side view of a fastener 800 according to an embodiment of the present disclosure. Fastener 800 includes some features similar to those of fastener 600, and therefore, like elements are referred to with like numerals butwithin the 800-series of numerals. For example, fastener 800 includes a head portion 820, a shank portion 850 extending from head portion 820, and a shaft portion 880 extending from shank portion 850. However, fastener 800 includes a shank portion 850 different from shank portion 650 in fastener 600. For instance, first collar portion 851 is longer in a length direction of the fastener 800 relative to an overall length of the fastener 800 than first collar portion 651 of fastener 600. Moreover, shoulder 855 is longer in the length direction of the fastener 800 than shoulder 655.

[0155] In another embodiment, a fastener is as shown in FIG. 9. FIG. 9 is a side view of a fastener 900 according to an embodiment of the present disclosure. Fastener 900 includes some features similar to those of fastener 800, and therefore, like elements are referred to with like numerals but within the 900-series of numerals. For example, fastener 900 includes a head portion 920, a shank portion 950 extending from head portion 920, and a shaft portion 980 extending from shank portion 950. However, fastener 900 includes a shank portion 950 different from shank portion 850 in fastener 800. For instance, second collar portion 952 has a greater angle between first collar portion 951 and third collar portion 953 than an angle of second collar portion 852. Moreover, shoulder 955 is shorter in a length direction of the fastener 900 relative to an overall length of the fastener 900 than shoulder 855 of fastener 800.

[0156] In another embodiment, a fastener is as shown in FIGs. 10A-F. Fastener 1000 includes some features similar to those of fastener 600, and therefore like elements are referred to with like numerals but within 1000-series of numerals. For example, fastener 1000 includes a head portion 1020, a shank portion 1050 extending from head portion 1020, and a shaft portion 1080 extending from shank portion 1050. However, fastener 1000 also includes a head portion 1020 and a shank portion 1050 different from head portion 620 and shank portion 650 in fastener 600. For instance, head portion 1020 adjacent first end 1010 includes a plurality of peripheral surface portions 1026A-D parallel with a longitudinal axis 1001 of fastener 1000. As shown in FIGs. 10A and 10E, each peripheral surface portion 1026A-D defines a convex surface. In some embodiments, peripheral surface portions 1026A-D may extend transverse with longitudinal axis 1001. Separating pairs of peripheral surface portions from among the peripheral surface portions 1026A- D are concave surface portions 1027 A-D. Further, extending through the head portion 1020 from respective concave surface portions 1027 A-D are a plurality of apertures 1021A-D. Put another way, each aperture and concave surface portion is positioned between two peripheral surface portions. Specifically, aperture 1021A and concave surface portion 1027A are between peripheral surface portion 1026A and peripheral surface portion 1026B. Moreover, each aperture of apertures 1021A-D are defined through a respective concave surface portions 1027 A-D. Specifically, aperture 1021A is defined through a central portion of concave surface portion 1027A. Further, each aperture 1021A-D extends from one concave surface portion to an opposing concave surfaceportion, e.g., aperture 1021A extends from concave surface portion 1027A to concave surface portion 1027C. According to an embodiment, concave surface portions 1027 A-D are concave relative to a plane bifurcating fastener 1000, where the plane does not intersect the surface portion(s) at issue. For example, where a plane bifurcating fastener 1000 passes through concave surface portions 1027B, 1027D, concave surface portions 1027A, 1027C are concave relative to that plane. Further, each concave surface portion may be concave in only one direction, i.e., across a width of the head, such that along a length direction, a line along the surface may be linear, as shown in FIGs. 10A and 10E, for example. As described in greater detail elsewhere in the present application, fastener 1000 as shown in FIGs.lOA-lOF is configured to be received by a tool, such as tool 1300 shown in FIGs. 13A-E.

[0157] With continued reference to head portion 1020 of fastener 1000, head portion 1020 further includes edge surface portions 1025 A-D adjacent respective peripheral surface portions 1026A- D. Specifically, edge surface portions 1025A-D are adjacent peripheral surface portions 1026A- D further along the longitudinal axis 1001 towards second end 1090. Edge surface portions 1025A-D include a scallop-type surface that is recessed relative to adjacent surfaces of the head such as the peripheral surface portions 1026A-D.

[0158] Shank portion 1050 of fastener 1000 includes a first collar portion 1051, a second collar portion 1052, and a third collar portion 1053. In an embodiment, first collar portion 1051 and second collar portion 1052 form a frustoconical shape and third collar portion 1053 forms a cylindrical shape. In a further embodiment, first collar portion 1051 has a larger cross-sectional dimension than second collar portion 1052 and third collar portion 1053. Put another way, a diameter of first collar portion 1051 centered along longitudinal axis 1001 is greater than a diameter measured the same as second collar portion 1052 or third collar portion 1053. In an embodiment, first collar portion 1051 and second collar portion 1052 are configured to reduce tissue irritation and adapt to different tissue thicknesses because of the varying diameter of second collar portion 1052. In a further embodiment, second collar portion 1052 is configured to provide feedback that bone has been reached when fastener 1000 is inserted into a patient. Shank portion 1050 is coupled to shaft portion 1080 along a direction of the longitudinal axis 1001 opposite a direction towards head portion 1020.

[0159] Shaft portion 1080 extends from shank portion 1050 to second end 1090 and includes a threaded surface having a crest 1081 and a root 1082 and cutting edges 1083A-B. In an embodiment, shaft portion 1080 has a non-tapering surface. In a further embodiment, shaft portion 1080 has a non-tapering surface along a majority of its length.

[0160] In another embodiment, a fastener is as shown in FIG. 11. FIG. 11 is a side view of a fastener 1100 according to an embodiment of the present disclosure. Fastener 1100 includes somefeatures similar to those of fastener 1000, and therefore, like elements are referred to with like numerals but within the 1100-series of numerals. For example, fastener 1100 includes a head portion 1120, a shank portion 1150 extending from the head portion 1120, and a shaft portion 1180 extending from the shank portion 1150. However, fastener 1100 includes a head portion 1120 different from head portion 1020. For instance, concave surface portions 1127A-D between peripheral surface portions 1126A-D include a different concave surface than concave surface portions 1027 A-D. Specifically, an edge of concave surface portions 1127 A-D adjacent respective apertures 1121 A-D form a parabolic shape with an apex remote from a free end of head portion 1120.

[0161] In another embodiment, a fastener is as shown in FIG. 12. FIG. 12 is a side view of a fastener 1200 according to an embodiment of the present disclosure. Fastener 1200 includes some features similar to those of fastener 1100, and therefore, like elements are referred to with like numerals but within the 1200-series of numerals. For example, fastener 1200 includes a head portion 1220, a shank portion 1250 extending from head portion 1220, and a shaft portion 1280 extending from shank portion 1250. However, fastener 1200 includes a shaft portion 1280 different from shaft portion 1180. For instance, fastener 1200 includes differently sized and shaped diameters on shaft portion 1280 like fastener 700.

[0162] Fasteners 100-400 and 600-1200 may include elements that are interchangeable with respect to other fastener embodiments, such as other fasteners within this group. As a non-limiting example, head portion 120 may be used with shank portion 650 and shaft portion 1280. As another non-limiting example, third shaft portion 783 having a larger diameter than other shaft portions of fastener 700 may be used with any other elements of fasteners 100-400, 600, and 800-1200. Moreover, the fasteners may optionally include dimensions within the below ranges. It should be appreciated that while dimensions of fastener 1000 are described, such dimensions may also be applicable to fasteners 100-400, 600-900, and 1100-1200. A length of fastener 1000 along longitudinal axis 1001 from first end 1010 to second end 1090 may be in a range from 6.0mm to 18.0mm, for example. In some instances, that length of fastener 1000 may be 13.0mm, 13.5mm, 14.0mm, or more precise intervals therebetween. A length of shaft 1080 from second end 1090 to third collar portion 1053 along longitudinal axis 1001 may be in a range from 3.0mm to 15.0mm. In some instances, that length of fastener 1000 may be 8.0mm, 9.0mm or 10.0mm. A diameter of apertures 1021A-D may be in a range from 0.5mm to 3.0mm. In some instances, that diameter may be 0.5mm, 1.0mm, or 1.5mm. First collar portion 1051 may have a maximum diameter in a range from 2.0mm to 6.0mm. In some instances, the maximum diameter may be 3.0mm, 4.0mm, or 5.0mm. Third collar portion 1053 may have a maximum diameter in a range from 1.0mm to 4.0mm. In some instances, the maximum diameter may be 1.0mm, 1.5mm, or 2.0mm. Root 1082may have a maximum diameter in a range from 0.5mm to 3.0mm. In some instances, such maximum diameter may be 1.0mm, 1.5mmor 2.0mm. Crest 1081 may have a maximum diameter in a range from 0.5mm to 3.0mm. In some instances, the maximum diameter may be 1.0mm, 1.5mm, or 2.0mm.. Peripheral surface portions 1026A-D may have a radius in a range from 0.25mm to 2.0mm. In some instances, the radius may be 0.25mm, 0.5mm, or 0.75mm. Concave surface portions 1027 A-D may have a radius in a range from 0.25mm to 4.0mm. In some instances, the radius may be 1.5mm, 2.0mm, or 2.5mm. Shaft portion 1080 adjacent second end 1090 may have a maximum diameter in a range from 0.2mm to 2.0mm. In some instances, the maximum diameter may be 0.4mm, 0.6mm, or 0.8mm.

[0163] In another embodiment, a tool 1300 is as shown in FIGs. 13A-G. FIGs. 13A-G are various views of tool 1300 according to an embodiment of the present disclosure. Tool 1300 includes a gripping portion, otherwise referred to as an engagement portion 1320 adjacent first end 1310 coupled to a shaft portion 1350 extending from engagement portion 1320 to second end 1390. Engagement portion 1320 includes prongs, otherwise referred to as engagement members 1321 A- D each having a respective flat surface portion 1324 A-D on an interior surface facing opening 1330 of engagement portion 1320. Adjacent flat surface portions 1324A-D are respective contours, otherwise referred to as convex surface portions 1327 A-D that are partially on respective engagement members 1321A-D and partially within interior surface facing opening 1330 of engagement portion 1320, extending continuously therebetween, as shown in FIG. 13B. Each convex surface portion 1327 A-D is configured to engage with a respective concave surface portion 1027 A-D of fastener 1000. Convex surface portions 1327 A-D may have partial cylindrical surfaces but may instead have any other surface that provides gripping and securement with a fastener. For instance, if a fastener were to have convex surface portions the tool 1300 may have concave surface portions configured to correspond to the fasteners surface portions. It should be appreciated that corresponding surfaces of concave surface portions 1024A-D and convex surface portions 1327 A-D provide a secure attachment for fastener 1000, as shown in FIGs. 14A-B, as well as for additional torque when driving fastener 1000 into a patient. It should be appreciated that tool 1300 may also be used with other fasteners such as, but not limited to, fasteners 1100, 1200. Moreover, in an embodiment, the angle of a length direction of engagement members 1321A-D with respect to a central longitudinal axis 1301 of tool 1300 is different from the angle of a base surface portion of the head, otherwise referred to as lower head surfaces 1028 A-D along a length direction of the fastener 1000 with respect to the central longitudinal axis 1001 of fastener 1000 such that tool 1300 is restrained from pullout from fastener 1000 due to the friction fit between engagement members 1321A-D and lower head surfaces 1028A-D when tool 1300 is engaged with fastener 1000. Put another way, the slope of engagement members 1321A-D alongthe longitudinal axis 1301 is slightly different than the slope of the lower head surfaces 1028 A-D along the longitudinal axis 1001 such that fastener 1000 is wedged within tool 1300.

[0164] With continued reference to tool 1300, engagement portion 1320 further includes concave surface portions 1329A-D adjacent respective convex surface portions 1327 A-D. For instance, concave surface portion 1329A is between convex surface portions 1327A and 1327D. Like convex surface portions 1327 A-D, concave surface portions 1329 A-D are configured to correspond to a surface of a fastener such as fastener 1000. Specifically, concave surface portions 1329A-D correspond to peripheral surface portions 1026A-D. The inclusion of alternating concave and convex surfaces 1327A-D, 1329A-D on the interior surface facing opening 1330 of the engagement end of tool 1300 and complementary surfaces on the fastener head is advantageous because when the fastener is received in the receiving part of the tool 1300, torque may be transmitted from the tool 1300 to the fastener without slippage of a rotational constraint between the tool 1300 and the fastener. In this manner, decoupling of the fastener from the tool 1300 is prevented such that an operator can insert the fastener onto the tool and perform an operation with decreased risk of complications (e.g., fastener falling inside patient, fastener falling on contaminated ground, etc.). Further, the distal end of tool 1300 is also advantageous in that having an inner cavity defined in part by convex surface portions 1327 A-D along with engagement members 1321 A-D extending from an end wall at an end of the cavity allows for partial visibility of the fastener head when a fastener is received in tool 1300, e.g., when fastener 1000 is received in tool 1300. This aids a user in evaluating whether the fastener is properly engaged by the tool 1300.

[0165] With continued reference to tool 1300, shaft portion 1350 includes a first shaft portion 1351, a first recessed portion 1352, a second shaft portion 1353, a second recessed portion 1354, a third shaft portion 1355, and a third recessed portion 1356. First shaft portion 1351 is between engagement portion 1320 and first recessed portion 1352. Second shaft portion 1353 is between first recessed portion 1352 and second recessed portion 1354. Third shaft portion 1355 is between second recessed portion 1354 and third recessed portion 1356. Third recessed portion 1356 may include features for coupling to a handle or other component for use with tool 1300.

[0166] FIGs. 14A-B show fastener 1000 coupled to tool 1300. Specifically, head portion 1020 is received by engagement portion 1320 such that concave surface portions 1027 A-D mate with convex surface portions 1327 A-D.

[0167] In another embodiment, a tool is as shown in FIGs. 15A-C. FIGs. 15A-C are various views of a tool 1500 according to an embodiment of the present disclosure. Tool 1500 includes some features similar to those of tool 1300, and therefore, like elements are referred to with like numerals but within the 1500-series of numerals. For example, tool 1500 includes an engagementportion 1520 and a shaft portion 1550 extending from the engagement portion 1520.. However, tool 1500 includes a engagement portion 1520 different from tool 1300. Specifically, tool 1500 does not include engagement members 1321A-D. Rather, tool 1500 includes a flat end face, as shown in FIGs. 15B and 15C, with an opening defined therein. Further, the opening is defined by a plurality of convex surface portions 1527 A-D having a similar shape and features as convex surface portions 1327 A-D. A profile of an outer surface of engagement portion 1520 may be rectangular, as shown in FIG. 15C.

[0168] In another embodiment, a tool is as shown in FIGs. 16A-D. FIGs. 16A-D are various views of a tool 1600 according to an embodiment of the present disclosure. Tool 1600 includes some features similar to those of tool 1500, and therefore, like elements are referred to with like numerals but within the 1600-series of numerals. For example, tool 1600 includes an engagement portion 1620 and a shaft portion 1650 extending from the engagement portion 1620. However, tool 1600 includes a different engagement portion 1620. Specifically, tool 1600 includes a space, otherwise referred to as U-shaped apertures 1628A-B on two faces 1626A, 1626C of engagement portion 1620 adjacent surface portions 1621A-D. In variations, tool 1600 may include four U- shaped apertures.

[0169] In another embodiment, a tool is as shown in FIGs. 17A-B. FIGs. 17A-B are various view of a tool 1700 according to an embodiment of the present disclosure. Tool 1700 includes some features similar to those of tool 1600, and therefore, like elements are referred to with like numerals but within the 1700-series of numerals. However, tool 1700 includes a different engagement portion 1720 than tool 1600. Specifically, head portion includes two convex surface portions 1727 A-B defining the opening in the engagement portion 1720 rather than four.

[0170] FIG. 18 shows fastener 1200 coupled with tool 1600. Specifically, head portion 1220 is received by engagement portion 1620 such that concave surface portions 1227 A-D mate with convex surface portions 1627 A-D. Moreover, a second end 1290 of fastener 1200 is positioned further away from second end 1690 of tool 1600 than first end 1210 of fastener 1200. It should be appreciated that apertures 1628A-B of tool 1600, as well as apertures 1728A-B of tool 1700, provide improved visibility of head portion 1220 of fastener 1200 (as well as any other fastener) and the gingiva during insertion. For instance, apertures 1628 A-B of tool 1600 provide for visibility of apertures 1221A-D such that apertures 1221A-D of a first fastener 1200 may be aligned with apertures 1221A-D of other fasteners 1200.

[0171] In another aspect, the present disclosure relates to hybrid maxilla-mandibular fixation (HMMF) systems. Embodiments may include one or more bars, one or more fasteners, or one or more bars and fasteners. In any one embodiment, a system or kit may include one or more wiresused with a pair of bars. Example configurations are shown from FIGs. 19 A through 29E and are described below.

[0172] In one embodiment, a plate, also referred to as a bar is as shown in FIGs. 19A-C. FIGs. 19A-C are various views of bar 1900 according to an embodiment of the present disclosure. In some embodiments, bar 1900 is configured for hybrid maxillomandibular fixation. In some embodiments, bar 1900 is monolithically formed. Bar 1900 includes a plurality of links 1920 extending from first end 1910 to second end 1990. Each link of the plurality of links 1920 includes a body from among a plurality of bodies 1940, and each body has an aperture from among a respective plurality of apertures 1930 defined therethrough. Each link 1920 further includes a hook from among a plurality of hooks 1950 extending along a central point of bodies 1940. Each link 1920 is joined by a segment, otherwise referred to as a connecting member 1960. Connecting member 1960 is narrower than each link of the plurality of links 1920 in a length direction. Further, each space between adjacent links from among the plurality of links 1920 defines a cavity 1980. Put another way, each connecting member 1960 connects two adjacent links 1920 and each cavity 1980 is spaced between two adjacent links 1920. as shown, bodies 1940 have an ovular toroid shape. And, bodies 1940 and apertures 1930 are elongated in a length direction of the bar 1900, i.e., along a direction extending between first end 1910 and second end 1990. The shape of the bodies is advantageous as each fastener can be inserted at a desired location within one of the apertures. In some instances, one or more fasteners may be inserted at an angle that deviates from a perpendicular orientation relative to bar 1900. In an embodiment, links 1920 are each the same size and shape. Aperture 1930 includes a first surface 1931 and a second surface 1932. In an embodiment, second surface 1932 includes a tapering surface and first surface 1931 includes a cylindrical surface configured to be received by circumferential groove 2888, 2988 of respective fasteners 2800, 2900. Hook 1950 includes a shaft portion 1951 and a curved portion 1952. Shaft portion 1951 includes an elongated shaft having a rectangular prism shape and curved portion 1952 extending from shaft portion 1951 such that an end part of curved portion 1952 is spaced apart from and generally parallel to a portion of bar 1900 that includes bodies 1940. Specifically curved portion 1952 extends from shaft portion 1951 and curves to form a J-shape. According to an embodiment, a fastener is configured to be inserted through aperture 1930 and a wire is configured to be passed around hook 1950. As a non-limiting example, a screw can be inserted into aperture 1930 and a wire can be tied and looped around hook 1950. Moreover, body 1940 includes a first portion 1941 on a side of aperture 1930 opposite hook 1950 and a second portion 1942 opposite first portion 1941 adjacent hook 1950. As shown in FIG. 19C, aperture 1930 includes a tapered opening such that a first face of body 1940 has a smaller opening than a second face of body 1940 opposite the first face. According to an embodiment, each hook 1950 extendsfrom a central location on a respective body 1940, i.e., at a halfway point along a length direction of the body 1940. In some alternative embodiments, one or more hook 1950 can extend from connecting members 1960 or at a non-central portion of body 1940.

[0173] In another embodiment, a bar is as shown in FIGs. 20A-C. FIGs. 20A-C are various views of bar 2000 according to an embodiment of the present disclosure. Bar 2000 includes some features similar to those of bar 1900, and therefore like elements are referred to with like numerals but within the 2000-series of numerals. For example, bar 2000 includes a plurality of links 2020 each having bodies 2040 with apertures 2030 defined therethrough and connected by connecting members 2060. Additionally, bar 2000 includes cavities 2080 spaced between bodies 2040 as well as hooks 2050 each positioned on a respective link 2020. However, unlike bar 1900, bar 2000 includes seven links 2020..

[0174] In another embodiment, a bar is as shown in FIGs. 21A-B. FIGs. 21A-B are various views of bar 2100 according to an embodiment of the present disclosure. Bar 2100 includes some features similar to those of bar 1900, and therefore like elements are referred to with similar numerals within 2100-series of numerals. For example, bar 2100 includes a plurality of links 2120 each having bodies 2140 with apertures 2130 defined therethrough and connected by connecting members 2160. Additionally, bar 2100 includes cavities 2180 spaced between adjacent links from among the plurality of links 2120 as well as hooks 2150, where each hook 2150 is positioned on a respective link 2120. However, unlike bars 1900, 2000, bar 2100 includes links with different sizes. Specifically, bar 2100 includes a plurality of first links 2120A and a smaller second link 2120B. The plurality of first links 2120A is divisible into a first subset 2121 and a third subset 2123 of bar 2100 adjacent first end 2110 and second end 2190 respectively. Second link 2120B is positioned in a central region 2122 between first and third subsets 2121, 2123. First link 2120A includes an aperture 2130A and a body 2140A differently sized than an aperture 2130B and a body 2140B of second link 2120B. It should be further appreciated that body 2140B and aperture 2130B may be positioned centrally along bar 2100 or in any other position. For instance, body 2140B and aperture 2130B may be closer to first end 2110 or closer to second end 2190. Furthermore, the amount of differently sized bodies and apertures may vary. As a non-limiting example, bar 2100 can include four bodies and apertures of a first size and five bodies and apertures of a second size. In other embodiments, the configuration of differently sized bodies and apertures can be any other combination or quantity. For instance, differently sized bodies and apertures can alternate, be continuous for a portion of the length of bar 2100, be randomized, or include any combination thereof, and the like. The size of body 2140B and aperture 2130B can be a smaller or larger variation of bodies 2140A and apertures 2130A.

[0175] In another embodiment, a bar is as shown in FIGs. 22A-C. FIGs. 22A-C are various views of bar 2200 according to an embodiment of the present disclosure. Bar 2200 includes some features similar to those of bar 1900, and therefore like elements are referred to with like numerals but within the 2200-series of numerals. For example, bar 2200 includes a plurality of links 2220 each having bodies 2240 with apertures 2230 defined therethrough and connected by connecting members 2260. Additionally, bar 2200 includes cavities 2280 spaced between adjacent links from among the plurality of links 2220 as well as hooks 2250 each positioned on a respective link 2220 extending from a center point of body 2240. Specifically, connecting members 2260 are narrower than the plurality of links such that the space between each link defines cavity 2280. Bar 2200 further includes first links 2220A and second links 2220B with differing sizes. However, unlike bar 2100, bar 2200 includes three second links 2220B positioned with second subset 2222. Moreover, three first links 2220A are positioned at each of first subset 2221 and third subset 2223. As with bars 1900-2100, the configuration of bar 2200 may be altered such that positioning, amount, and size of links are changed.

[0176] In another embodiment, a bar is as shown in FIGs. 23A-C. FIGs. 23A-C are various views of bar 2300 according to an embodiment of the present disclosure. Bar 2300 includes some features similar to those of bar 1900, and therefore like elements are referred to with like numerals within 2300-series of numerals. For example, bar 2300 includes a plurality of links 2320A-B each having bodies 2340A-B with apertures 2330A-B defined therethrough and connected by connecting members 2360. Additionally, bar 2300 includes cavities 2380 spaced between adjacent links from among the plurality of links 2320 A-B as well as hooks 2350 each positioned on a respective link 2320A-B and extending from a body 2340A-B. Specifically, connecting members 2360 are narrower than the plurality of links 2320A-B such that the space between each link 2320A-B defines cavity 2380. However, unlike bar 2200, hooks 2350 extend from central locations on respective bodies 2340A, 2340B as well as portions off-center from body 2340A, 2340B. Bar 2300 further includes first links 2320 A and second links 2320B with differing sizes. However, unlike bars 2100, 2200, bar 2300 includes three second links 2320B positioned with second subset 2322. Moreover, three first links 2320A are located in both a first subset 2321 and in a third subset 2323. As with bars 1900-2200, the configuration of bar 2300 may be altered such that positioning, amount, and size of links are changed. However, unlike bars 1900-2200, bar 2300 includes some links having bodies with multiple hooks extending therefrom. For instance, a first link 2320A adjacent first end 2310 includes a first hook 2350A and a second hook 2350B. Some first links, such as a first link in first subset 2321 third closest to first end 2310, include one hook 2350A. Moreover, some hooks 2350 may be positioned central to a respective body or off- centered. For instance, hook 2350B is positioned off-center from a center point of aperture 2330Aof first link 2320A closest to first end 2310. In contrast, a hook 2350A extends centrally from body 2340B of the center-most second link 2320B in second subset 2322.

[0177] In another embodiment, a bar is as shown in FIGs. 24A-C. FIGs. 24A-C are various views of bar 2400 according to an embodiment of the present disclosure. Bar 2400 includes some features similar to those of bars 1900-2300, and therefore like elements are referred to with similar numerals within 2400-series of numerals. For example, bar 2400 includes a plurality of links 2420A-B each having bodies 2440A-B with apertures 2430A-B defined therethrough and connected by connecting members 2460. Additionally, bar 2400 defines cavities 2480\ between adjacent bodies 2440A-B and also includes hooks 2450. Some hooks 2450 extend from a center point of bodies 2440 and some extend from a center point of connecting members 2460. Bar 2400 further includes first links 2420A and second links 2420B with differing sizes. However, unlike bars 1900-2300, bar 2400 includes hooks 2450 extending from connecting members 2460. Moreover, each connecting member 2460 has a length proportionate to a length of a link, unlike some of the other bars contemplated in the present disclosure, where a length of the connecting members is much less than a length of the links. The inclusion of connecting members 2460 promotes ease of bending the bar 2400 due to the reduced amount of material in the connecting members compared to the links. By rendering bending easier, the risk of post-operative irritation is reduced. As with bars 1900-2300, the configuration of bar 2400 may be altered in variations such that positioning, quantity, and size of the links are different from those of bar 2400 as shown.

[0178] In another embodiment, a bar is as shown in FIGs. 25A-C. Bar 2500 includes some features similar to those of bar 2400, and therefore like elements are referred to with like numerals but within the 2500-series of numerals. Bar 2500 includes first links 2520A each having a body 2540A and an aperture 2530A, second links 2520B each having a body 2540B and an aperture 2530B, and third link 2520C each having a body 2540C and an aperture 2530C. In an embodiment, each of first links 2520A, second links 2520B, and third links 2520C are differently sized. Specifically, first links 2520A are larger than second links 2520B and smaller than third links 2520C. A first subset 2521 and a third subset 2523 each include first, second, and third links therein. Specifically, first subset 2521 includes first link 2520A adjacent first end 2510, a second link 2520B closer to second end 2590 than first link 2520A, and a third link 2520C closer to second end 2590 than first link 2520A and second link 2520B. Second subset 2522 includes a single first link 2520A. Furthermore, bar 2500 includes cavities 2580 spaced between adjacent bodies 2540, connecting members 2560 with varying lengths, and hooks 2550 extending from a center point of each body 2540 and from a center point of some of the connecting members 2560, as shown in FIGs. 25A- B. For instance, at first subset 2521, the first link 2520A and second link 2520B are between a first cavity 2580A and connected by connecting member 2560A. With continued reference to firstsubset 2521, second link 2520B and third link 2520C are between a second cavity 2580B and connected by a connecting member 2560B, each larger than respective cavity 2580A and connecting member 2560A. Between first subset 2521 and second subset 2522, third link 2520C and first link 2520A are between a cavity 2580C and connected by connecting member 2560C. In an embodiment, cavity 2580B and connecting member 2560B are larger than cavity 2580A and connecting member 2560A but smaller than cavity 2580C and connecting member 2560C, respectively.

[0179] In another embodiment, a bar is as shown in FIG. 26. FIG. 26 shows a perspective view of bar 2600 according to an embodiment of the present disclosure. Bar 2600 includes some features similar to those of bar 1900, and therefore, like elements are referred to with like numerals but within the 2600-series of numerals. Bar 2600 includes connecting members 2660A and 2660B with differing sizes with respect to each other. Each of connecting members 2660A and 2660B has a convex edge opposite an edge connected to a hook 2650. The convex edges of connecting members 2660A-B provide such connecting members an increased in-plane bending stiffness. Bar 2600 includes hooks 2650 that extend from central locations on bodies 2640A-B and connecting members 2660A, 2660B, as shown in FIG. 26.

[0180] It should be appreciated that bars 1900-2600 can be adjusted, bent, and / or partially cut. For instance, an individual link may be cut to remove potential irritation. As a non-limiting example, links positioned adjacent the patient’s frenum may be removed to reduce irritation. It should be further appreciated that the shaft portions of the hooks of bars 1900-2600 have the same cross-sectional thickness as respective links, as shown in e.g., FIG. 19C. The flat profile of the shaft portion of the hooks with respect to the links is configured to reduce tissue irritation such as at the buccal mucosa. Moreover, elements of bars 1900-2600 may be interchangeable such that a bar may include some elements of, for example, bar 1900 and bar 2500. Additionally, dimensions of the bars may be similar. While reference to bar 1900 is made, it should be appreciated that such reference is made for the sake of brevity and that the described range of dimensions may apply to bars 2000-2600 as well. The bar 1900 includes a first length between first end 1910 and second end 1990, and the length may be in a range from 80.0mm to 140.0mm. In some instances, the first length may be 110.0mm, 115.0mm, or 120.0mm. A second length is measured between an end of hook 1950 to an end of body 1940 perpendicular to the first length, the second length being in a range from 5mm to 12.0mm. In some instances, second length may be 8.0mm, 8.5mm, or 9.0mm. A third length is measured between ends of connecting members 1960 perpendicular to first length, third length being in a range from 1.0mm to 4.0mm. In some instances, third length may be 1.5mm, 1.7mm, or 2.0mm. Fourth length is a distance measured between ends of hook 1950 parallel to first length, fourth length being in a range from 1.0mm to 4.0mm. In some instances,fourth length is 2.3mm, 2.5mm, or 2.7mm. Fifth length is a distance between two ends of one aperture 1930 perpendicular to first length, fifth length being a range from 1.0mm to 4.0mm. In some instances, length may be 2.5mm, 2.6mm, or 2.7mm. Sixth length is measured between two ends of one body 1940 perpendicular to first length, sixth length being a range from 3.5mm to 7.0mm. In some instances, sixth length may be 5.0mm, 6.0mm, or 7.0mm. Eighth length is measured between two ends of one body 1940 perpendicular to sixth length and parallel to first length, eighth length being in a range from 6mm to 18mm. In some instances, eighth length may be 11.0mm, 12.0mm, or 13.0mm. Seventh length is measured between two ends of one aperture 1930 perpendicular to fifth length and parallel to first length, seventh length being in a range from 7.0mm to 9.0mm. In some instances, seventh length may be 8.0mm, 8.5m, or 9.0mm.

[0181] With continued reference to bar 1900, bar 1900 includes a thickness perpendicular to first length. The thickness may be in a range from 0.25mm to 1.5mm. In some instances, the thickness may be 0.5mm, 1.0mm, or 1.5mm. Apertures 1930 include a tapering angle from two ends of bar 1900 perpendicular to first length. The angle may be in a range from 30 degrees to 90 degrees. In some instances, the angle may be 55 degrees, 60 degrees, and 65 degrees.

[0182] It should be appreciated that a cross-sectional thickness of each link of bars 1900-2600 may be the same cross-sectional thickness of each hook. Moreover, it should be appreciated that in some embodiments, at least some apertures of bars 1900-2600 may have a length that is at least twice a diameter of a head of a fastener such as fasteners 2800, 2900.

[0183] In some embodiments, an HMMF system may include two bars and wire. These embodiments may also optionally include one or more fasteners, such as those described below, e.g., fastener 2800. Other systems may include two bars and one or more fasteners without wire. FIGs. 27A-B show front views according to one bar and wire system embodiment of the present disclosure. FIG. 27A shows two bars 1900 opposite each other having wire 2710 attached thereon. Specifically, wire 2710 is wrapped around a plurality of hooks from each bar 1900 such that the two bars 1900 are coupled together. As shown, three wires 2710 couple two bars 1900 together. However, it should be appreciated that any amount of wires 2710 as well as any arrangement of wires 2710 may be utilized. For instance, FIG. 27A depicts wires 2710 contacting three hooks of each bar 1900 in a rectangular configuration. However, wires 2710 can be utilized to define other shapes and utilize a different number of hooks. For instance, wire 2710 can contact four hooks on a first bar 1900 and can contact two hooks on a second bar 1900 in a trapezoidal shape. Furthermore, it should be appreciated that any combination of bars 1900-2600 may be utilized in these arrangements. For instance, as shown in FIG. 27B, bar 1900 is coupled to bar 2200.

[0184] In another embodiment, a fastener is as shown in FIGs. 28A-D. FIGs. 28A-D are various views of fastener 2800 according to an embodiment of the present disclosure. Fastener 2800includes a head portion 2820 adjacent a first end 2810 and a shaft portion 2880 coupled to head portion 2820 extending to a second end 2890. Head portion 2820 tapers from first end 2810 to shaft portion 2880 and shaft portion 2880 has a central portion with a constant diameter and a tapering portion at tip 2891. A surface of the fastener 2800 is threaded in head portion 2820 and shaft portion 2880. The threaded surface of head portion 2820 includes a first root 2882 and first crest 2881 larger than a second root 2884 and a second crest 2883 of the threaded surface of the shaft portion 2880. In some embodiments, including that shown in FIGs.28A-D, head portion 2820 may include a double lead thread. In such an arrangement, the pitch of the threaded surface of the head portion 2820 is less than a pitch of the threaded surface of the shaft portion 2880. Further, a lead of the threaded surface of the head portion 2820 is greater than a lead of the threaded surface of the shaft portion 2880. Moreover, head portion 2820 includes a circumferential groove 2888 (i.e., defining a circle and not helical) between the threaded surface and a drive end 2822 of the head. Circumferential groove 2888 is configured to provide tactile feedback when fastener 2800 is inserted into a bar and functions to set the fastener position relative to a bar or plate once the bar or plate is received in circumferential groove 2888, i.e., as a form of locking. Moreover, circumferential groove 2888 allows a bar to lock, i.e., snap into circumferential groove 2888 such that excessive torquing is prevented. This is advantageous as fasteners without circumferential groove 2888 inserted into a bar may allow for excessive torque such that deformation of the bar would occur. In an embodiment, circumferential groove 2888 is configured to snap into a portion of a surface of an aperture, such as aperture surface 1931. Head portion 2820 includes an interface 2824, like interface 124, shaped like an X (or plus) configured to receive a tool tip. Fastener 2800 is configured to be inserted into a bar for hybrid maxillomandibular fixation such as bars 1900-2600. Specifically, fastener 2800 is configured to be inserted into an aperture of a link of a bar such as aperture 1930.

[0185] In another embodiment, a fastener is as shown in FIGs. 29A-F. FIGs. 29A-D are perspective views of a fastener 2900 according to an embodiment of the present disclosure. Moreover, FIGs. 29A-D each show slight variations of fastener 2900. Fastener 2900 includes some features similar to those of fastener 2800, and therefore, like elements are referred to with like numerals but within the 2900-series of numerals. For example, fastener 2900 includes a head portion 2920, a shaft portion 2980 extending from the head portion 2920. However, fastener 2900 includes a head portion 2920 different from fastener 2800. Fastener 2900 includes a variety of different thread surface portions 2989A-D adjacent a head portion 2920. Moreover, each fastener 2900 includes a collar portion 2953A-D.

[0186] With continued reference to fastener 2900, FIG. 29E shows a circumferential groove 2988 of fastener 2900 adjacent head 2922. Circumferential groove 2988 is configured to lock fastener2900 in place when inserted into a system such as bars 1900-2600. In an embodiment, circumferential groove 2988 is configured to cause fastener 2900 to be rotated while secured via circumferential groove 2988 as circumferential groove 2988 includes a circular groove rather than a helical groove such as the threaded surface of the head portion 2920.

[0187] In another embodiment, a tool is as shown in FIGs. 30A-H. FIGs. 30A-H are various views of a tool 3000 configured to engage with interact with bars, such as bars 1900-2600. Tool 3000 includes a first arm 3021 and a second arm 3026 each extending towards first end 3010. As shown in FIG. 30A, the respective first and second arms are biased in a spaced apart configuration such that if they are compressed toward each other and released, they will return to their spaced apart configuration. First arm 3021 includes a first tine 3022, a second tine 3023 spaced apart from first tine 3022, an aperture 3024, and a protrusion 3025. With reference to FIG. 30H, first arm 3021 forms a substantially rectangular prism with each of first tine 3022 and second tine 3023 forming smaller rectangular prisms adjacent first end 3010. Protrusion 3025 is a rectangular prism boss extending from a surface of the first arm distinct from first tine 3022 and second tine 3023 and extending in a direction transverse, e.g., perpendicular to first and second tines 3022, 3023. Aperture 3024 includes a substantially U-shaped opening having a plurality of tapering edges. With reference to FIG. 30F, second arm 3026 includes a body 3028, aperture 3027 defined through body 3028, and a protrusion 3029 extending from body 3028. Second arm forms a substantially heptagonal prism with protrusion 3029 being a rectangular prism boss extending from a surface of second arm 3026. As shown in FIG. 30C, protrusion 3029 is configured to be received by aperture 3024 of first arm 3021 to engage the arms via a friction fit. And, as shown in FIG. 30B, aperture 3027 forms a rectangular opening and is configured to be received by protrusion 3025. As noted above, first arm 3021 and second arm 3026 are flexible and are biased in an open position such that a compressive force is required to attach first arm 3021 with second arm 3026 adjacent first end 3010.

[0188] Tool 3000 further includes a central arm 3051 extending from first arm 3021. Central arm 3051 is configured to be received by a central aperture 3056 of second arm 3026. Specifically, central arm 3051 extends from first arm 3021 and includes a raised elongated surface, aperture 3056 includes a corresponding hole configured to receive and secure central arm 3051. In an embodiment, central arm 3051 is secured by a spring locking mechanism. In a further embodiment, central arm 3051 is disengaged with central aperture 3056 by actuating a tip of central arm 3051 such that the spring locking mechanism is unlocked, e.g., by pushing tip of central arm 3051 while it is in the locked position. Receipt of central arm 3051 in aperture 3056 provides a lock to hold the arms in a closed position, e.g., when ends of the arms are holding a bar, for example. At second end 3090, first arm 3021 and second arm 3026 extend from base 3081.In some arrangements, base 3081 may be a portion of first arm 3021 that is engaged with second arm 3026. A tip 3082 extends from base 3081 and has a shape configured to correspond to the apertures of the bars, such as bars 1900-2600. In this manner, tip 3082 received in an aperture of a link in a bar may have a close interference-type fit, allowing for tool 3000 to be used to bend the bar. Specifically, insertion of tip 3082 into an aperture allows for individual links to be bent with respect to a length of the bars between first and second ends of the bar. As a non-limiting example, tip 3082 is inserted into aperture 2530A of third subset 2523 such that link 2520A may be bent transverse to a length between first end 2510 and second end 2590. According to an embodiment, tip 3082 is an oval-shaped protrusion commensurate with an oval shaped aperture in a link. In some embodiments, tip 3082 may include a protrusion having another shape that is configured to correspond to the aperture or apertures of a bar such that the bar may be bent.

[0189] It is to be understood that various components discussed herein, including but not limited to, fasteners 100-400, 600-1200, 2800-2900, tools 500, 1300, 1500-1700, 3000, and bars 1900- 2600, can be constructed of various materials for use in the human body. For instance, it is contemplated to construct the various components of metallic materials, such as titanium or stainless steel. Moreover, the fasteners can be a resorbable material.

[0190] In yet another aspect, the present disclosure relates to a kit. In some embodiments, a kit may include one or more fasteners, such as fasteners 100-400, 600-1200, 2800-2900, or any other fastener contemplated in the disclosure. In some embodiments, a kit may include one or more tools, such as tools 500, 1300, 1500-1700, 3000, or any other tool contemplated in the disclosure. In some embodiments, a kit may include on or more bars, such as bar 1900-2600 or any other bar contemplated in the disclosure. In some embodiments, the kit may include one or more wires. In some embodiments, the kit may be provided with one or more of and / or all of the above-noted components disassembled such that assembly is required by the surgeon upon receipt in the manner described throughout the disclosure. Alternatively, some or all of the pieces noted above may be provided already assembled in the kit, thereby reducing or eliminating the need for assembly by the surgeon. In some examples, the kit may be provided with an instruction manual. In other examples, the kit may include packaging. Packaging may be used to enclose each component of the kit individually and / or to enclose two or more components of the kit.

[0191] In another aspect, the present disclosure relates to a method of implanting a fastener into a patient utilizing a tool. Specifically, maxillomandibular fixation (MMF) of a fastener into a facial bone of the patient. FIG. 32 is a flowchart illustrating a method for utilizing a tool and a fastener according to some embodiments. The method S3200 may be performed with fasteners 100-400, 600-1000, or other fasteners as contemplated by the present disclosure. Moreover, the methodS3200 may be further performed with tools 500, 1300, 1500-1700, , or other tools as contemplated by the present disclosure.

[0192] At step S3210, pre-operative procedures are performed. For instance, it may be determined that damage or deterioration to bone in the cranio-maxillofacial region of the patient is identified, and an assessment is made as to whether such bone is suitable for repair using the fastener and tool. It should be appreciated that in some examples, the fastener and tool may be utilized in an operation where no surgery is necessitated (e.g. , cadaver for research purposes, etc.). Accordingly, an operator may determine that such fastener and tool may be utilized such that they are obtained in preparation for operation. Other pre-operative procedures may include anesthetizing the patient, consulting the patient, sterilizing the fastener and tool.

[0193] At step S3220, the fastener is coupled to the tool. In an embodiment, the head of the fastener is coupled to the head of the tool such that the shank and shaft of the fastener are positioned opposite a shaft of the tool. Accordingly, the tool and fastener are secured such that the fastener and tool may be moved around without the fastener being easily detached. Moreover, the fastener and tool are coupled such that the fastener is configured to receive a torque from the tool. The design of the tool and fastener may be such that they may mate with each other and form a strong interlocking connection.

[0194] As a non-limiting example, fastener 1000 is coupled to tool 1300. The convex surface portions 1327 A-D of tool 1300 are configured to correspond with the concave surface portions 1027 A-D of fastener 1000. Additionally, concave surface portions 1329A-D of tool 1300 are configured to correspond with peripheral surface portions 1026A-D of fastener 1000. The corresponding surface portions of the fastener with respect to the tool allows the fastener, when inserted into the tool, to have a torque transferred from the tool to the fastener. Moreover, the surface portions of fastener 1000 and tool 1300 are each differently sloped along respective longitudinal axes such that fastener 1000 is restrained within tool 1300 and prevented from easily being decoupled. These features are advantageous as fastener 1000 can be driven by tool 1300 while being restrained such that an operator can more efficiently and safely perform an operation.

[0195] At step 3230, the fastener is inserted into the patient. When inserted, the fastener is configured to be positioned within the patient such as biological matter adjacent the maxilla and / or the mandible. In an embodiment, the tool is also inserted into the patient.

[0196] At step S3240, the tool is actuated such that the fastener is secured into the patient. Specifically, the tool maybe rotated about its longitudinal axis such that the head of the tool contacts the head of the fastener and translates the rotational force to the fastener. A tip of the fastener is configured to contact and pierce tissue or bone of the patient such that the fastener is driven into the patient. The fastener may include a variety of surfaces configured to providesupport against irritation of tissue and bone as well as tactile sensation to the operator through the fastener and the tool. As a non-limiting example, fastener 1000 includes third collar portion 1053 having a surface configured to provide support against irritation of tissue and bone. At step S3250, the tool is removed from the fastener. According to an embodiment, the tool may be removed from a secured or partially secured fastener in a patient. In an embodiment, the tool is removed from the fastener by back and forth movement. The process is then repeated to secure additional fasteners to other locations on the maxilla and / or mandible until all planned fasteners are implanted in the patient.

[0197] At step S3260, once all fasteners are in place, wire is coupled onto the fasteners. Specifically, wire, such as wire 2710, may be inserted through an aperture of each fastener, tied around a neck of each fastener, or both. As a non-limiting example, a wire may be inserted through apertures 1121 A and 1121C of fastener 1100 and then around neck 1123. Steps S3210-3250 may be repeated so that the wire may be used to provide secured engagement between or among multiple fasteners. Moreover, multiple wires may be used with multiple fasteners such that a first group of fasteners may have a first wire secured between or among the first group of fasteners and a second group of fasteners may have a second wire, different than the first wire, secured between or among the second group of fasteners. In some embodiments, wires may overlap multiple groups of fasteners.

[0198] In another aspect, the present disclosure relates to a method of implanting a bar into a patient. Specifically, hybrid maxillomandibular fixation of a bar onto a maxilla or mandible of the patient. FIG. 33 is a flowchart illustrating a method for utilizing a bar according to some embodiments. The method S3300 may be performed with bars 1900-2600, or other bars as contemplated by the present disclosure. Moreover, the method S3300 may be further performed with fasteners 2800-2900, or other fasteners as contemplated by the present disclosure and tool 3000.

[0199] At step S3310, pre-operative procedures are performed. For instance, it may be determined that damage or deterioration of bone in the cranio-maxillofacial region of the patient is identified, and an assessment is made as to whether such bone is suitable for repair using the bar. It should be appreciated that in some examples, the bar may be utilized in an operation where no surgery is necessitated (e.g., cadaver for research purposes, etc.). Accordingly, an operator may determine that such bar may be utilized such that it is obtained in preparation for operation. Other preoperative procedures may include planning for the specific size and structure of the bar(s) and / or fasteners, anesthetizing the patient, consulting the patient, and / or sterilizing the bar, fasteners, and tool.

[0200] At step S3320, a portion of the bar is positioned adjacent a bone of the patient. Tool 3000 may be used to hold a bar and bring it to the implantation location. Specifically, the bar is inserted into the patient and is positioned on the bone. In an embodiment, the bone may include bone such as the maxilla and / or the mandible. In an embodiment, a portion of the bar is positioned adjacent the bone such that the portion of the bar adjacent the bone is configured to be secured to the bone. In an embodiment, the bar is secured to the bone by a fastener. It should be appreciated that the bar may be bent, such that the bar matches the geometry of a patient’s bone. Prior to commencing the placement of fasteners, a spacer is used to space the bar from the gingiva or other soft tissue. The spacer may be placed adjacent to bone such that a cavity of the spacer allows a fastener to be inserted therethrough. The placement of the spacer ensures that the bar is elevated from the bone and / or gingiva after insertion of fasteners to reduce irritation and damage to bone and / or gingiva. As a non-limiting example, tool 3000 can be used as a spacer such that as a bar is inserted into a patient, tool 3000 is placed between the bar and the bone and / or gingiva. Specifically, tool 3000 can be placed such that aperture 3024 between first and second tines 3022, 3023 of first arm 3021 is positioned coaxial with a point along an aperture of the bar as shown in FIG. 31 A. It should be appreciated that tool 3000 may also be used to hold and position the bar to a desired location as shown in FIG. 3 IB. Moreover, tool 3000 can be used to bend the bar to conform to a geometry of a patient’ s bone.

[0201] At step S3330, a fastener is inserted through a portion of the bar adjacent a bone. Specifically, the fastener is inserted through an aperture of a link of the bar. A placement location for the fastener may be established based on an analysis of bone integrity under the bar. E.g., a location within an aperture of the bar that will provide greater bone purchase than other locations within the aperture. The fastener is then driven through the bone such that the fastener couples the bar to the bone, thereby securing the bar to the patient. It should be appreciated that one or more fasteners may be inserted into and one or more apertures of the bar such that the bar is secured to the patient at different points on the bone. The process may be repeated for the other of the maxilla or mandible using a second bar after securement of the first bar. In some embodiments, a spacer may be used when the fastener is inserted through the portion of the bar adjacent to a bone. For instance, tool 3000 as shown in FIG. 31A may be positioned between the bar and the gingiva and / or bone such that the fastener can be inserted through both an aperture of the bar and aperture 3024 of tool 3000. In some instances, tool 3000 can be as shown in FIG. 3 IB such that a fastener is inserted through an aperture of the bar while tool 3000 spaces the bar from bone and / or gingiva adjacent to the aperture the fastener is being inserted through.

[0202] At step S3340, a wire is coupled onto the bar or a pair of opposing bars. In an embodiment wire can include wire 2710. The wire can be coupled around a plurality of hooks of the bar or toone single hook of the bar. The wires can be coupled to the bar by various loops, knots, or other securing techniques. Moreover, multiple wires can be coupled to the bar, for instance, as shown in FIGs. 27A-B. When the wire is coupled onto the pair of opposing bars, the wire and first and second bars are configured to promote healing of a patient’ s jaw as it provides a compressive force between the maxilla and mandible.

[0203] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present disclosure as defined by the appended claims.

Claims

IN THE CLAIMS1. A fastener deployment system comprising: a fastener comprising: a head including a plurality of side surfaces and an end surface abutting each side surface of the plurality of side surfaces, each side surface of the plurality of side surfaces being curved; and a shank extending from the head, and a holding instrument comprising: a shaft; and a gripping portion extending from the shaft, the gripping portion including a plurality of internally facing surfaces that define an opening in the gripping portion, wherein when the gripping portion of the holding instrument is advanced over the head of the fastener, each internally facing surface of the plurality of internally facing surfaces has a contour that complements a respective side surface of the plurality of side surfaces.

2. The fastener deployment system of claim 1, wherein each internally facing surface of the plurality of internally facing surfaces has a first radius of curvature and each side surface of the plurality of side surfaces has the first radius of curvature.

3. The fastener deployment system of claim 1 , wherein the gripping portion further comprises a plurality of prongs extending distally from an end of the opening in the gripping portion.

4. The fastener deployment system of claim 1, wherein each side surface of the plurality of side surfaces includes a concave surface portion.

5. A fastener comprising: a head including a plurality of side surfaces and an end surface abutting each side surface of the plurality of side surfaces, each side surface of the plurality of side surfaces being radially spaced from a central longitudinal axis of the fastener and comprising: a first peripheral surface portion and a second peripheral surface portion; and a concave surface portion extending from the end surface, the concave surface portion being in between the first peripheral surface portion and the second peripheral surface portion, and a shank extending from the head,wherein an overall width of each side surface of the plurality of side surfaces extends from a side of the first peripheral surface portion to a side of the second peripheral surface portion, and a width of the concave surface portion is a majority of the overall width.

6. The fastener of claim 5, wherein the concave surface portion of each side surface of the plurality of side surfaces includes a base portion that flares outward toward the shank.

7. The fastener of claim 5, wherein for each side surface of the plurality of side surfaces, the concave surface portion defines an opening therethrough.

8. The fastener of claim 5 , further comprising a collar portion between the head and the shank, wherein the collar portion has a maximum diameter that is greater than a maximum diameter of the shank and that is greater than a maximum outer dimension of the head.

9. The fastener of claim 5, wherein the shank includes a first portion and a second portion in between the first portion and the head, the first portion having a first minimum diameter and the second portion having a second minimum diameter less than the first minimum diameter.

10. The fastener of claim 9, wherein the first portion and the second portion each include a threaded surface.

11. The fastener of claim 10, wherein the threaded surface of the first portion has a crest with a larger cross-sectional thickness than a root of the threaded surface of the second portion and a smaller cross-sectional thickness than a crest of the threaded surface of the second portion.

12. The fastener of claim 8, wherein the shank includes a first portion and a second portion in between the first portion and the collar portion, the first portion having a threaded surface and the second portion having a smooth cylindrical surface.

13. The fastener of claim 12, wherein a maximum diameter along the first portion of the shank is less than a minimum diameter along the second portion of the shank.

14. A holding instrument configured to hold a fastener, the holding instrument comprising: a shaft; and a gripping portion extending from the shaft, the gripping portion comprising:a base including an end surface remote from the shaft; and a plurality of internally facing surfaces that define an opening in the gripping portion, each internally facing surface of the plurality of internally facing surfaces having a convex shape, wherein the end surface defines a distal end of the opening.

15. The holding instrument of claim 14, wherein the gripping portion further comprises a plurality of prongs extending from the end surface.

16. The holding instrument of claim 15, wherein each prong of the plurality of prongs has a convex shaped inward facing surface commensurate with the convex shape of the plurality of internally facing surfaces.

17. The holding instrument of claim 14, wherein the holding instrument further comprises a plurality of externally facing surfaces opposite the plurality of internally facing surfaces, and wherein a space is defined through a portion of one of the plurality of externally facing surfaces such that the one of the plurality of externally facing surfaces is in fluid communication with the opening.

18. The holding instrument of claim 17, wherein the space extends from the end surface to a curve- shaped closed end.

19. An implant configured for securement to a bone comprising: a bar including a plurality of links along a longitudinal axis of the bar, each link of the plurality of links including a body defining an elongate aperture, wherein a first elongate aperture defined in a first link of the plurality of links is longer than a second elongate aperture defined in a second link of the plurality of links, wherein each link of the plurality of links is separated from other links of the plurality of links by a segment of the bar; and a plurality of hooks extending from the bar, each hook of the plurality of hooks being spaced apart from other hooks of the plurality of hooks along a length of the bar.

20. The implant of claim 19, wherein each link of the plurality of links includes only one elongate aperture.

21. The implant of claim 19, wherein a first hook of the plurality of hooks and a second hook of the plurality of hooks each extend from the bar in a first direction orthogonal to a length direction of the bar, the first hook extending from the bar at a first location opposite the first link and the second hook extending from the bar at a second location opposite the second link.

22. The implant of claim 21, wherein a distance of the first hook from a center of the first link is less than a distance of the second hook from a center of the second link.

23. The implant of claim 19, wherein each hook of the plurality of hooks has a thickness that is the same as a thickness of the plurality of links.

24. A method of fixation of a fastener in a patient, the method comprising: coupling a fastener onto a tool by engaging a head of the fastener in an opening at a distal end of the tool, the head of the fastener including a plurality of side surfaces and an end surface, at least one side surface of the plurality of side surfaces including a first peripheral surface portion, a second peripheral surface portion, and a concave surface portion extending from the end surface and being in between the first peripheral surface portion and the second peripheral surface portion, the tool comprising a plurality of internally facing surfaces that define the opening, at least one of the internally facing surfaces having a contour that complements the concave surface portion of the fastener; and securing the fastener onto a first bone of the patient by rotating the tool with the fastener coupled to the tool.

25. The method of claim 24, wherein the step of securing the fastener onto the first bone using the tool includes rotating the tool such that at least one of the internally facing surfaces having the contour that complements the concave surface portion of the fastener is held fixed to the concave surface portion of the fastener to cause the fastener to rotate with the tool.

26. The method of claim 24, wherein the tool resists pull out from the fastener when rotating the tool due to engagement members extending from the distal end of the tool being angled inward at a steeper angle than a base surface portion of the head of the fastener.

27. A method of implant fixation, the method comprising: securing a first bar onto a first bone, the first bar comprising a plurality of links along a longitudinal axis of the first bar, each link of the plurality of links defining an elongate aperture,a first elongate aperture defined in a first link of the plurality of links and a second elongate aperture defined in a second link of the plurality of links, wherein the second elongate aperture is different than the first elongate aperture; placing a first fastener through the first link to anchor the first fastener to the first bone; and placing a second fastener through the second link to anchor the second fastener to the first bone.

28. The method of claim 27, the method further comprising: prior to placing the first fastener through the first link, determining a bone location under the first elongate aperture for placement of the first fastener, wherein the first elongate aperture has a length that is at least twice a diameter of a head of the first fastener.

29. The method of claim 27, the method further comprising: placing a third fastener through a first link of a second bar to anchor the third fastener to a second bone; placing a fourth fastener through a second link of the second bar to anchor the fourth fastener to the second bone; and coupling the second bar to the first bar with a wire.

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