BACKGROUND OF THE INVENTION Certain bone fractures in the human body are inherently unstable and require additional measures to fix and stabilize the bone other than external immobilization with a cast, a splint, or the like. For instance, the bones of the facial area have such requirements as these bones comprise integral parts of the skull, are relatively small, and may include complex curves and varying thicknesses. External immobilization by a cast or the like is impractical here since the use of the eyes, nose, or mouth may be impeded. In addition, the shape of the skull means that the fractured bone will not be supported on the back side thereof by the external immobilization means. Thus, there exists a need for an internal device for effectively stabilizing fractures of fragile and complex bones in the facial region.

Where external immobilization of a facial bone fracture is impractical, surgical fixation of the fracture is often required. This is an invasive procedure which dictates that incisions be made in the skin to expose the underlying fracture and associated bone structure. However, for aesthetic reasons, incisions in the facial region are undesirable due to the resulting scarring as the incision heals. An alternative procedure to the incision in proximity to the fracture is to perform a bicoronal incision, which encompasses making an incision above the hairline and "peeling"the skin and other tissue down off the face in order to expose the underlying facial bone structure. The fracture may then be fixed and the skin

replaced. However, this procedure carries the risk of damage to facial nerves, possible unwanted scarring, and pain and discomfort during the healing process.

Thus, there exists a need for a device for fixing a facial fracture which may be applied to the bone with minimal incisions or disturbance to the skin or other tissue.

Further, surgical fixation of a bone fracture is sometimes made with a plate, usually comprised of titanium or other biocompatible metallic or nonmetallic material, which is placed across the fracture and attached to the affected bone at both ends with screws, nails, staples, or the like. A plate may be used, for example, to fix mandibular fractures. However, a plate generally requires a large incision in the skin for insertion and application thereof, may be cumbersome to affix to the fractured bone, and may be unsuited to certain applications where the bone is small or has a complex shape. In addition, where the fractured bone is thin and/or otherwise fragile, drilling or otherwise forming holes in the bone to engage the fasteners securing the plate thereto may further weaken the already fractured bone. Thus, there exists a further need for a device for fixing facial bone fractures wherein the device is preferably adaptable to bones having complex shapes and varying sizes and may be fastened thereto without screws, nails, staples, or the like.

Further, when a plate is used to fix the fractured bone, the plate may often only be applied to the outer surface of the bone since access to the back side thereof for forming the necessary holes or for applying the necessary fasteners may be restricted. Such a situation may be encountered, for instance, with a fracture of the zygomatic arch wherein the outward side is readily accessible, but the inward side is not. If the plate is only attached to one side of the bone, support is provided to the fracture only on the accessible outer side of the bone. In addition, if the bone is small and/or fragile and a less-than-optimum number of fasteners is used to secure the plate on either side of the fracture, the fractured bone sections may not be securely fixed and may still be able to move relative to each other. Using fasteners to secure the plate may further carry the limitations as previously described. Thus, there exists a need for a device for fixing facial bone fractures which is capable of rigidly supporting the fractured bone from more than one side thereof without requiring fasteners to secure the device to the bone.

The plate is typically a solid member which has limited openings therein to accommodate the necessary fasteners, thereby restricting blood flow to and around the fracture necessary to promote the healing thereof. Further, a typical metal plate is also generally not bioabsorbable, which may make it unsuited for use in children where the bone has not fully developed and is still growing since the plate cannot adapt to growth changes in the bone. Bioabsorbable materials may be desirable in areas that may carry a refracture risk and may also tend to reduce the risk of infection. Thus, there exists a need for a device for fixing facial bone fractures wherein the device may be comprised of a bioabsorbable material. Preferably, the device will also have significant open area to allow circulation about the fracture to promote the healing thereof while also having the desired structural properties for securely fixing the fracture.

An example of a bone fracture fixing device is shown in U. S. Patent No. to Smith, which discloses a fracture clamp comprising a pair of plates pivotally connected along a longitudinal edge by a simple hinge disposed outwardly of the enclosed area defined by the plates. Longitudinally spaced fingers project from the edge of each plate opposite the hinged edge and are curved toward the similar fingers projecting from the other plate to form cylindrical rings with the free ends thereof slightly spaced apart when the clamp is in a closed position. The clamp is configured in this manner such that the hinge and adjacent parts of the plate are offset from the bone to permit free circulation through the periosteum longitudinally of the bone. The plates are retained in a compressive position adjacent the side walls of the bone portions by operation of a sliding key, a pivoting cam, or a coiled spring mechanism along the hinge.

However, the device disclosed by the Smith'440 patent is not comprised of a unitary piece of material, but has a freely pivoting hinge disposed along one edge of the plates. Having the freely pivoting hinge thus theredisposed requires that an additional element is required to maintain the clamp in either an open or a closed position. The additional element, such as a slide key, a pivoting cam, or a coiled spring, results in a more complex device which may be cumbersome to manipulate and apply to the fractured bone segment. Further, the'440 patent discloses that the device is preferably comprised of a silver-plated steel and further contemplates that

the device be removed from the patient's body following healing of the fracture.

Thus, the device may be difficult to manufacture since plating of the complex hinge and locking mechanism structures are required. In addition, the contemplated removal of the device following healing of the bone may contribute to additional pain and discomfort to the patient due to the invasiveness of the removal process.

Thus, there exists a need for a device capable of effectively internally stabilizing bone fractures, more particularly, fractures of fragile and complex bones in the facial region. In order to minimize scarring of the skin as well as pain and discomfort to the patient, it would be desirable for the device to be applicable to the fractured bone through a minimal incision in the skin. In addition, the device should be adaptable to bones having complex shapes and varying sizes, wherein the device may be fastened about the fractured bone without the use of screws, nails, staples, or other fasteners. Preferably, the device should rigidly secure and support the fractured bone about a substantial portion of the surface area thereof. Still further, the device should be comprised of a biocompatible material. In some instances, it may be desirable that the device is additionally comprised of a bioabsorbable material. The device should also be simply constructed and capable of being scaled to accommodate various sizes and segments of bones, while allowing free circulation about the fractured area to promote healing thereof.

SUMMARY OF THE INVENTION The above and other needs are met by the present invention which, in a preferred embodiment, provides a clip comprising a pair of opposed, spaced apart legs spanned along corresponding edges by a bridge member, wherein the legs further define opposing concave faces for engaging the fractured bone segment.

The clip preferably includes grips coupled thereto and adapted to apply the clip to the fractured bone segment. In one embodiment, the clip may be elastically deformable wherein it is flexed from its original position to be positioned about the bone segment and then released thereat such that the elastic force returning the clip to its original position secures the clip about the bone. In an alternate embodiment,

the clip may be plastically deformable wherein it is placed about the fractured bone segment and then plastically deformed to surround and secure the bone.

The edges of the legs opposite the bridge member may be provided with a plurality of tines, which may also be pointed, to assist in gripping the bone and securing the clip thereto. The clip is preferably comprised of a biocompatible material which may be non-metallic, polymeric, or metallic. In a preferred embodiment, the clip is adapted for endoscopic insertion and application to the fractured bone segment. Further, the bridge member preferably defines at least one opening therethrough disposed intermediate the legs in order to promote free circulation and effective healing of the fracture. The clip may also be further secured to the bone by fasteners passing therethrough.

A preferred embodiment of the present invention comprises a kit having an application tool and at least one bone fracture fixation clip corresponding in size thereto. The application tool is further configured in accordance with the particular arrangement of the clip. In one embodiment of the present invention, the application tool is configured to engage the grips and to deform the elastic bridge member from an original position such that the clip may be positioned about the bone segment. Once positioned about the fracture, the application tool releases the grips and the clip is secured to the bone segment by the elastic force of the bridge member. In an alternate embodiment of the present invention, a plastically deformable clip is positioned about the bone segment and the application tool then used to plastically deform or crimp the clip about the bone segment. In a preferred embodiment of the present invention, the clip is sized to be endoscopically insertable and applicable to the bone segment, wherein the application tool is accordingly configured to correspond thereto.

Thus, the bone fracture fixation clip according to preferred embodiments of the present invention is capable of effectively internally stabilizing bone fractures and is applicable to any bone. However, and more particularly, the clip is useful for application to fractures of fragile and complex bones in the facial region. The clip may be configured to be endoscopically inserted and applied to the bone fracture through a minimal incision in order to minimize scarring of the skin as well as pain and discomfort to the patient as a result of, for example, a bicoronal

incision. In addition, the clip may be configured for bones having complex shapes and varying sizes and can be fastened about the fractured bone without the use of screws, nails, staples, or other fasteners. Since the clip may be crimped about the bone or applied such that the elasticity of the clip secures it to the bone, rigid support may be provided to the fractured bone about a substantial portion of the accessible surface area thereof. Still further, the clip is comprised of a biocompatible material and, in some instances, the material may also be bioabsorbable. The clip is simply constructed from a unitary piece of the material and may be scaled to accommodate various sizes and segments of bones. At least one opening in the bridge member of the clip further allows free circulation about the fractured area to promote healing thereof.

BRIEF DESCRIPTION OF THE DRAWINGS Some of the advantages of the present invention having been stated, others will appear as the description proceeds, when considered in conjunction with the accompanying drawings in which: FIGS. lA and 1B are perspective views of a preferred embodiment of the bone fracture fixation clip according to the present invention wherein the bridge member of the clip is elastically deformable and the elastic force thereof secures the clip about the fracture.

FIGS. 2A and 2B are perspective views of an alternate embodiment of the bone fracture fixation clip according to the present invention wherein the clip is plastically deformable and is secured about the fracture by crimping the free ends of the spaced apart legs.

FIG. 3 is a perspective view of an alternate embodiment of the bone fracture fixation clip according to the present invention wherein the clip is plastically deformable and the bridge member defines a plurality of holes therethrough for facilitating circulation about the fracture, wherein some of the holes may further accommodate fasteners for further securing the clip to the bone.

FIG. 4 is a perspective view of an alternate embodiment of the bone fracture fixation clip according to the present invention wherein the clip is plastically deformable and the bridge member defines a plurality of holes of

different sizes therethrough for facilitating circulation about the fracture, wherein some of the holes may further accommodate fasteners for further securing the clip to the bone.

DETAILED DESCRIPTION OF THE INVENTION The present invention now will be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Like numbers refer to like elements throughout.

FIGS. 1A and 1B disclose an embodiment of a bone fracture fixation clip, indicated generally by the numeral 10, which includes the features of the present invention. The bone fracture fixation clip 10 comprises a pair of opposed, spaced apart legs 20, a bridge member 30, and grips 40. The clip 10 is used for securing and stabilizing bone fractures and is applicable to any bone. However, and more particularly, the clip 10 is useful for application to fractures of the fragile and complex bones in the facial region. The clip 10 is also readily implemented in the case of facial fractures where minimal incisions in the skin and other facial tissue are desirable and access to the fractured bone is limited.

As shown in FIGS. 1A and 1B, the clip 10 generally comprises a pair of opposed, spaced apart legs 20, with a bridge member 30 spanning corresponding edges of the legs to thereby generally define the clip 10 which is further positionable about a fractured bone segment. The legs 20 also define opposing concave faces 25 for engaging the bone segment received within the clip 10. In addition, the clip 10 includes a pair of grips 40 coupled to the clip 10 and adapted to apply the clip 10 to the bone segment such that the opposing concave faces 25 cooperate with the bridge member 30 to secure and stabilize the fractured bone.

Preferably, the clip 10 is comprised of a unitary piece of material. Further, the clip 10 may be comprised of either a metallic or a nonmetallic biocompatible material where, for example, titanium is an applicable metallic material. In the

facial region, titanium is preferably used from the mandible on downward and typically provided in a thickness of between about 0.2 and about 0.3 inches.

Alternatively, the clip 10 may be formed of either a metallic or nonmetallic biocompatible material. Preferably the biocompatible material is also a bioabsorbable material. A preferred bioabsorbable material is a non-reinforced, non-oriented lactide and glycolide copolymer composition. These copolymers may be made from about 70-85% m lactide moieties and from about 15-30% m glycolide moieties. An example of such material is LactoSorb, available from Walter Lorenz Surgical, Inc. of Jacksonville, Florida. An alternate bioabsorbable material is a deisomer of polylactic acid 70% and lactic acid 30%, available from Bionix Corp. of Finland. When applied in the facial region, bioabsorbable materials are preferred for fractures in the mid-face region on upward.

Biocompatible materials may tend to reduce infection risks and particularly useful for application to fractures in growing children, to fractures in the hands, and where the fractured area carries a risk of subsequent refracture.

As further shown in FIGS. 1A and 1B, the clip 10 may further include a plurality of spaced apart tines 50 disposed along the edges of the legs 20 opposite the bridge member 30 to assist the clip 10 in gripping the bone. In some instances, the tines 50 may be pointed to aid the tines 50 in gripping the bone. In this embodiment, the bridge member 30 is elastically deformable. Accordingly, the grips 40 are disposed on either side of the bridge member 30 such that forcing the grips 40 together elastically deforms the bridge member 30 and spreads the legs 20 apart from a rest position. With the legs 20 separated, the clip 10 can be positioned about the fracture such that the fracture is located at approximately the longitudinal midpoint of the clip 10. Once the clip 10 is positioned about the bone, the grips 40 are released. The elastically deformable bridge member 30 then returns to its undeformed shape, thus causing the legs 20 to converge about the bone such that the opposing faces 25 provide the necessary support to the fracture with the tines 50 gripping the bone.

A corresponding application tool 60 may be used to engage the grips 40 and install the clip 10 about the bone segment. In one embodiment, the application tool 60 may be used to apply the clip 10 through an open incision in the vicinity of

the fracture. Alternatively, both the clip 10 and the application tool 60 may be sized such that the application tool 60 can carry the clip 10 through a small incision in an endoscopic procedure and is also used to apply the clip 10 about the fractured bone segment. Endoscopic application of the clip 10 may be desirable, for instance, in a case of a fracture to a zygomatic arch wherein access to the bone structure is limited and conventional surgical fixation of the fracture would involve significant incisions in the skin. In a preferred embodiment of the present invention, the application tool 60 and at least one clip 10 comprise a kit for applying bone fracture fixation clips about fractured bone segments, wherein clips may be provided in different shapes and sizes to be adaptable to various bone configurations.

FIGS. 2A and 2B disclose an alternate embodiment of a bone fracture fixation clip according to the present invention, indicated generally by the numeral 10'. The clip 10'comprises a pair of opposed spaced apart legs 20'defining a pair of opposing faces 25'for engaging the bone. The legs 20'are connected along a longitudinal edge by a bridge member 30'. The edges of the legs 20'opposite the bridge member 30'may further include a plurality of spaced apart tines 50'. The tines 50'may be further pointed to assist the tines 50'in gripping the bone. The clip 10'is preferably made of a unitary piece of either a metallic or nonmetallic biocompatible material, wherein titanium is an example of a metallic biocompatible material. In some instances, the clip 10'may be further comprised of either a metallic or nonmetallic biocompatible material which is also a bioabsorbable material.

As shown in FIGS. 2A and 2B, the clip 10'is preferably plastically deformable. The clip 10'is thus configured such that it is positionable about the fractured bone segment wherein the opposing faces 25'and the bridge member 30' abut the bone segment with the fracture disposed at approximately the longitudinal midpoint of the clip 10'. A pair of grips 40'are individually disposed on the outward surfaces of the legs 20'to assist in positioning the clip 10'about the bone segment. Once positioned, the tined edges of the legs 20'are plastically deformed such that the tined edges are wrapped or crimped about the bone segment to secure and stabilize the fracture therein.

A corresponding application tool 60'may be used to engage the grips 40' and crimp the clip 10'about the bone segment. In one embodiment, the application tool 60'may be used to apply and crimp the clip 10'through an open incision in the vicinity of the fracture. Alternatively, both the clip 10'and the application tool 60'may be sized such that the application tool 60'can carry the clip 10'through a small incision in an endoscopic procedure and can also be used to crimp the clip 10'about the fractured bone segment. In a preferred embodiment of the present invention, the application tool 60'and at least one clip 10'comprise a kit for applying bone fracture fixation clips about fractured bone segments, wherein clips may be provided in different shapes and sizes to be adaptable to various bone configurations.

FIGS. 3 and 4 disclose alternate embodiments of a bone fracture fixation clip according to the present invention. As shown in FIG. 3, the plastically deformable clip 10"may be configured to be applicable to bone segments having complex curvature by having the length of one of the legs 20"different from the other. Further, in some instances, the legs 20"may be arcuately shaped where necessary to conform to the bone structure. Accordingly, the bridge member 30" is configured to connect and provide a transition between the legs 20". The bridge member 30"may also define a plurality of holes 55 therein. The holes 55 permit free circulation about the fractured bone segment to promote healing thereof. The holes 55 may also allow fasteners to be passed therethrough and into the bone segments on either side of the fracture in order to secure the clip 10"to the bone, thereby providing an alternate or additional means of further stabilizing the fracture using the clip 10". The clip 10"may comprise either a metallic or nonmetallic unitary piece of a biocompatible material which may also be, in some instances, a bioabsorbable material. In addition, the clip 10"is preferably applied such that the fracture is disposed at about the longitudinal midpoint of the clip 10".

FIG. 4 shows an alternate embodiment of a bone fracture fixation clip 10"'which is also preferably plastically deformable. In this embodiment of the present invention, the bridge member 30"'defines a plurality of holes of varying sizes.

For example, the bridge member 30"'may define a main hole 55"extending over a substantial portion thereof. Along the remaining portions of the bridge member

30"', there may be further defined a plurality of smaller holes 55"'suitable for fasteners to pass therethrough and into the adjacent bone segment. The fasteners provide an alternate or an additional means of securing the clip 10"'to the bone on either side of the fracture. As with other embodiments of the present invention as described herein, an application tool (not shown) may be provided with the clips for installation thereof about the fractured bone segment, thereby comprising a kit for applying a bone fracture fixation clip. The clip and the application tool may also be configured for application of the clip through a direct incision or via an endoscopic procedure.

Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings.

Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.