Methods of long bone repair utilizing continuous compression implants

The present disclosure is directed to a method of surgical repair utilizing a continuous compression staple for an orthopedic injury site having a long bone fracture defining a fracture boundary between a first bone fragment and a second bone fragment. The method can include the steps of aligning the fragments, applying a temporary compressive force to the aligned fragments, inserting a compression staple in a tensioned state into the first and second bone fragments such that it traverses the fracture boundary, releasing tension in the compression staple such that the staple exerts a continuous compressive force to the first and second bone fragments, and securing a neutralization implant to the long bone. The disclosure further includes kits and systems for performing the disclosed surgical methods.

FIELD OF THE DISCLOSURE

The present disclosure is directed to methods of surgical repair of a fracture in a long bone utilizing a surgical construct including at least one compression stable and a neutralization implant.

BACKGROUND

Current methods for repair of fractures in long bones rely upon the use of lag screws, compression plates, or articulated tensioning devices to provide the necessary alignment and compression of the adjoining bone fragments. Lag screws (also referred to as “interfragmentary compression screws”) can fail to gain purchase, and therefore proper compression, where there is a lack of sufficient cortical bone, such as in the diaphyseal region where the bone shaft is narrowest, or where there is poor cortical bone density, such as in the case of osteoporotic bone. Compression plates often require precise contouring to be effective and can additionally suffer from poor purchase of the bone screws securing the plate. Articulated tensioning devices are complex tool systems that are difficult to use correctly and require substantial amount of time to set the bone fragments as well as surgical space to be utilized effectively. Moreover, all three methods suffer from the same problem in that they only provide static compression to the fracture repair area. Once the screws are secured into the bone, the compression force does not become any greater; and, in certain cases, over time the compression force can drop to a level where malunion or non-union of the bone fragments occurs.

FIGS.1A-Billustrate a problem associated with current long bone fracture repair techniques.FIGS.1A-Bare x-rays of an oblique diaphyseal fracture of the ulna of a 69-year-old woman. This fracture was initially repaired using a lag screw and a neutralization plate (also known as a stabilization plate or a bridge plate). The x-rays shown here were taken 6 weeks after surgical repair. As can be seen, the lag screw did not secure the adjacent bone fragments and failed to provide proper compression at the fracture site, which caused non-union of the bone fragments, and additionally caused the neutralization plate to break. Whether due to poor bone density at the fracture site, or an insufficient amount of cortical bone for the screw to gain purchase, the fact remains that the lag screw compression technique did not provide complete osteosynthesis to the ulna. Ultimately, this type of failed static compression technique requires an additional surgery to repair.

SUMMARY

The present inventor has identified a need in the surgical arts for improving the repair of fractured long bones that reduces the problems associated with static compression fixation in long bones as well as reducing dependence on the quality and quantity of cortical bone at the long bone repair site. The present inventor has surprisingly found that the use of continuous compression staples as a replacement to existing static compression methods provides unexpected and superior results.

Accordingly, the present disclosure is directed to methods of surgical repair of a long bone utilizing a surgical construct including at least one compression staple and a neutralization implant; the method including the steps of:

identifying an orthopedic injury site having a fracture of a long bone, the fracture defining a fracture boundary between a first bone fragment and a second bone fragment of the long bone;

aligning the first bone fragment and the second bone fragment to contact one another along at least a portion of the fracture boundary in anatomically correct position;

applying a temporary compressive force to the first and second bone fragments;

during the application of the temporary compressive force, inserting at least one compression staple into the first and second bone fragments such that the at least one compression staple traverses the fracture boundary, where the at least one compression staple is inserted in a first tensioned state;

releasing tension in the at least one compression staple such that the staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments;

securing a neutralization implant to the long bone, the neutralization implant defining one or more apertures configured to receive a bone fastener, by applying the bone fastener through the one or more apertures and the long bone; and,

removing the temporary compressive force.

According to another embodiment, the step of inserting the at least one compression staple includes inserting the at least one compression staple such the compression staple traverses the fracture boundary in a direction substantially normal to the fracture boundary. According to a further embodiment, the step of inserting the at least one compression staple includes inserting the at least one compression staple such that the at least one compression staple traverses the fracture boundary in a direction substantially parallel to the temporary compressive force.

According to one embodiment, the step of applying temporary compressive force creates a shear force at the fracture boundary configured to force translation of the first and second bone fragments relative to each other in the direction of the shear force, where the continuous compressive force of the at least one compression staple applies a net compression force across the fracture boundary that is substantially normal to the direction of shear force, and where the net compressive force is greater than the shear force.

According to yet another embodiment, the step of applying temporary compressive force creates a shear force at the fracture boundary configured to force translation of the first and second bone fragments relative to each other in the direction of the shear force, and the methods can further include:

prior to inserting the at least one compression staple, applying a buttress plate to the first and second bone fragments such that the buttress plate traverses the fracture boundary, and

securing the buttress plate to only one of the first or second bone fragments such that the other of the first or second bone fragments is not secured to the buttress plate;

where the buttress plate is configured to inhibit the translation of the first and second bone fragments in the direction of the shear force.

According to still other embodiments, the at least one compression staple includes a first compression staple and a second compression staple and the step of inserting at least one compression staple and the step of releasing tension in the at the least one compression staple includes:

inserting the first compression staple into the first and second bone fragments such that the first compression staple traverses the fracture boundary, where the first compression staple is inserted in a first tensioned state;

releasing tension in the first compression staple such that the first compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments;

inserting the second compression staple into the first and second bone fragments such that the second compression staple traverses the fracture boundary, where the second compression staple is inserted in a first tensioned state; and

releasing tension in the second compression staple such that the second compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments.

According to further embodiments utilizing the first and second compression staples, the step of inserting the second compression staple includes inserting the second compression staple such that the second compression staple traverses the fracture boundary in a direction substantially normal to the fracture boundary. In additional embodiments, the second compression staple is inserted in a direction substantially parallel to the temporary compressive force.

According to additional embodiments, the continuous compressive force of the first and second compression staples exerts a combined net compression force applied across the fracture boundary that is substantially normal to the direction of shear force. According to further embodiments, the net compressive force is greater than the shear force.

According to certain embodiments of the present disclosure, the long bone fracture includes at least a first fracture boundary and second fracture boundary such that the fracture boundary between the first bone fragment and the second bone fragment is the first fracture boundary and the fracture boundary between a third bone fragment and either the first bone fragment or the second bone fragment, or both, is the second fracture boundary. In embodiments including at least a first and second fracture boundary, the at least one compression staple includes at least a first compression staple and a second compression staple, where the first compressions staple is the at least one compression staple that is inserted at the fracture boundary between the first and second bone fragments. The methods can therefore further include:

aligning the third bone fragment to contact either of the first bone fragment or the second bone fragment, or both, along at least a portion of the second fracture boundary in anatomically correct position;

applying a temporary compressive force to the third bone fragment and either of the first bone fragment or the second bone fragment, or both;

during the application of the temporary compressive force to the third bone fragment, inserting the second compression staple into the third bone fragment such that the second compression staple traverses the second fracture boundary, wherein the second compression staple is inserted in a first tensioned state; and,

releasing tension in the second compression staple such that the second compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the third bone fragment and either of the first bone fragment or the second bone fragment, or both.

According to certain additional embodiments, the method can further include inserting the second compression staple such the second compression staple traverses the second fracture boundary in a direction substantially normal to the second fracture boundary; or additionally, inserting the second compression staple such the second compression staple traverses the second fracture boundary in a direction substantially parallel to the temporary compressive force to the third bone fragment. In embodiments where the temporary compressive force applied to the third bone fragment generates a shear force at the second fracture boundary, the method can further include inserting the second compression staple such that it traverses the second fracture boundary in a direction substantially normal to the direction of shear force.

According to further embodiments where the temporary compressive force applied to the third bone fragment generates a shear force at the second fracture boundary, the method can include:

prior to inserting the second compression staple, applying a buttress plate to the third bone fragment and either of the first bone fragment or the second bone fragment such that the buttress plate traverses the second fracture boundary, and

securing the buttress plate to only one of the third bone fragment or the first or second bone fragments such that the other of the third bone fragment or the first or second bone fragments is not secured to the buttress plate;

where the buttress plate is configured to inhibit movement of the third bone fragment in a direction of the shear force.

According to additional embodiments of the present disclosure, a method of surgical repair of a long bone utilizing a surgical construct is described including at least one continuous compression staple and a buttress plate is described, the method including the steps of:

identifying an orthopedic injury site having a fracture of a long bone, the fracture defining a fracture boundary between a first bone fragment and a second bone fragment of the long bone;

aligning the first bone fragment and the second bone fragment to contact one another along at least a portion of the fracture boundary in anatomically correct position;

applying a temporary compressive force to the first and second bone fragments such that a shear force is created the fracture boundary configured to force translation of the first and second bone fragments relative to each other in the direction of the shear force;

during the application of the temporary compressive force, applying a buttress plate to the first and second bone fragments such that the buttress plate traverses the fracture boundary, and securing the buttress plate to only one of the first or second bone fragments such that the other of the first or second bone fragments is not secured to the buttress plate, wherein the buttress plate is configured to inhibit the translation of the first and second bone fragments in the direction of the shear force;

during the application of the temporary compressive force inserting at least one compression staple into the first and second bone fragments such that the at least one compression staple traverses the fracture boundary, wherein the at least one compression staple is inserted in a first tensioned state;

releasing tension in the at least one compression staple such that the staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments; and,

removing the temporary compressive force.

According to further embodiments of the present disclosure, a kit for use in the surgical repair of a long bone fracture is described including:

at least one compression staple configured to traverse a fracture boundary in a long bone between a first bone fragment and a second bone fragment; and,

at least one neutralization implant.

In certain embodiments, the kit can additionally include at least one buttress plate.

According to still further embodiments of the present disclosure, a surgical construct system for use in the surgical repair of a long bone fracture is described including:

at least one compression staple configured to traverse a fracture boundary in a long bone between a first bone fragment and a second bone fragment;

at least one buttress plate configured to traverse the fracture boundary and,

a neutralization implant.

DETAILED DESCRIPTION

For the purpose of this application, terminology and definitions related to long bones and the types of fractures occurring in long bones is derived from the AO Classification that can be found in “Fracture and Dislocation Classification Compendium” J Orthop Trauma Volume 32, Number 1 Supplement, January 2018, which is hereby incorporated by reference in its entirety.

As used herein, the term “long bone” is limited to the humerus, radius, ulna, femur, tibia, and fibula of mammals.

According to the present disclosure, methods of surgical repair are described including the steps of:

identifying an orthopedic injury site having a fracture of a long bone, the fracture defining a fracture boundary between a first bone fragment and a second bone fragment of the long bone;

aligning the first bone fragment and the second bone fragment to contact one another along at least a portion of the fracture boundary in anatomically correct position;

applying a temporary compressive force to the first and second bone fragments;

during the application of the temporary compressive force, inserting at least one compression staple into the first and second bone fragments such that the at least one compression staple traverses the fracture boundary, where the at least one compression staple is inserted in a first tensioned state;

releasing tension in the at least one compression staple such that the staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments;

securing a neutralization implant to the long bone, the neutralization implant defining one or more apertures configured to receive a bone fastener, by applying the bone fastener through the one or more apertures and the long bone; and,

removing the temporary compressive force.

FIG.2shows a schematic representation of a completed surgical procedure according to exemplary methods of the present disclosure including repair of a long bone4utilizing a surgical construct including at least one continuous compression staple20and a neutralization implant50. As shown, long bone4(here, the humerus) has a transverse fracture in the diaphyseal region of the humeral shaft, the fracture defining a fracture boundary41between a first bone fragment31and a second bone fragment32. The compression staple20has been inserted into the first bone fragment31and the second bone fragment32and traverses the fracture boundary41. The compression staple20applies a continuous compressive force to the first31and second32bone fragments to keep them in contact and anatomical alignment, which promotes proper bone healing of the humerus4. Neutralization implant50has been secured to the long bone4to protect and maintain the integrity of the humerus during fracture healing. The neutralization implant50(as the name implies) neutralizes bending, rotational, and axial forces along long bone4to provide relative stability and to permit correct length, alignment, and rotation in the bone as the fracture heals. Exemplary classes of neutralization implants50can include intramedullary nails and bone plates configured for use with long bones, such as e.g., locking plates or bridge plates. In a preferred embodiment, the neutralization implant50does not facilitate or otherwise influence healing at the fracture site, and therefore preferably excludes implants such as lag screws and compression plates. In this exemplary embodiment, the neutralization implant50is a locking bone plate including one or more apertures56configured to receive a bone fastener52so as to secure the implant50to the long bone4and is fixed to each of the first31and second32bone fragments without compromising or otherwise interacting with fracture boundary41.

According to the present disclosure, and with reference toFIGS.3A-3E, methods of surgical repair are described that include the step of identifying an orthopedic injury site of a long bone4(as shown inFIGS.3A-E, a tibia) that includes a fracture suitable for repair utilizing at least one continuous compression staple. While there are numerous types of long bone fractures and methods of characterizing fracture patterns,FIGS.3A-Eprovide, for the purpose of example, categories of certain fractures that are suitable for surgical repair according to the present disclosure and are for the purpose of illustration only.

FIGS.3A-Care representative of what are known in the AO classification as simple fractures consisting of a single fracture defining two bone segments of the long bone.FIG.3Ais a transverse fracture defining a fracture boundary41between first bone fragment31and second bone fragment32. According to the AO classification, a transverse fracture is defined as a fracture having an angle relative to the short axis of the long bone4of between 0 and 30 degrees.FIG.3Bis an oblique fracture defining a fracture boundary41between first bone fragment31and second bone fragment32. According to the AO classification, an oblique fracture is defined as a fracture having an angle relative to the short axis of the long bone4of greater than 30 degrees.FIG.3Cis a spiral fracture defining a fracture boundary41between first bone fragment31and second bone fragment32. Spiral fractures typically have a fracture boundary41that spirals along the long axis of the bone and are accompanied by sharp or pointed edges.

FIGS.3D-Eare representative of more complex long bone fractures.FIG.3D-2Eare representative of what are known in the AO classification as complex fractures where there is a lack of contact between the bone fragments including the ends (proximal, distal) of the long bone4.FIG.3Dis a segmental fracture defining a first fracture boundary41between first bone fragment31and second bone fragment32and a second fracture boundary42between second bone fragment32and third bone fragment33. As shown, the main proximal bone fragment31has no means of directly contacting the main distal bone fragment33. Certain other segmental fractures (not shown) can be classified in the AO classification as wedge fractures (an intermediate fracture classification), where there is still a potential point of contact available between the main proximal and distal bone segments. Wedge fractures are considered suitable for surgical repair according to methods of the present disclosure. Returning toFIG.3D, as shown, both first41and second42fracture boundary of the segmental fracture define substantially transverse fracture patterns; however, it should be appreciated that either or both fracture boundaries can assume different fracture patterns, such as e.g., oblique or spiral.FIG.3Eis known as a comminuted (i.e., multi-fragmentary) fracture. Comminuted fractures include a category of some of the most severe long bone fractures. They define a fracture including at least a first31, second32, and third33bone fragment, and where the fracture boundaries defining the bone fragments can intersect. Comminuted fracture boundaries can include fracture patterns that are transverse, oblique, or spiral. As shown inFIG.3E, the fractured long bone4includes five bone fragments (31,32,33,34, and35) defining up to five fracture boundaries (41,42,43,44, and45).

Thus, according to embodiments of the present invention, the fracture of the long bone can include, traverse, oblique, spiral, segmental (including wedge), and comminuted, as well as combinations thereof. According to further embodiments, the fracture of the long bone can include certain regions of the long bone including the diaphyseal, metaphyseal, articular, and malleolar regions, as well as combinations thereof.

According to the present disclosure, methods of surgical repair are described that include the step of aligning the first bone fragment and the second bone fragment to contact one another along at least a portion of the fracture boundary in anatomically correct position.FIGS.4A-Dshow exemplary alignments of first31and second32bone fragments at fracture boundary41of the long bone4.FIGS.4A-Bshow the reduction and anatomical alignment of a transverse fracture of the tibia in the diaphyseal region.FIGS.4C-Dshow the reduction and anatomical alignment of a spiral fracture of the tibia in the diaphyseal region.

It should be appreciated that surgical techniques and procedures can vary among orthopedic surgeons in the case of complex fractures. With respect to multi-fragment long bone fractures, depending on a particular surgeon's preference for the sequence in which the reduction and repair of the collective bone fragments will occur, the numbering convention employed in the present disclosure with respect to bone fragments and fracture boundaries (i.e., a first bone fragment31or a first fracture boundary41) is not meant to signify the order in which long bone4is actually repaired, but is merely for identification purposes. In other words, where multi-fragmentary fractures are described herein, it is equally within the scope of the disclosure that a second32and third33bone fragment are aligned or repaired before or after a first31and second32, or a first31and third33bone fragment are aligned and repaired.

According to the present disclosure, and with reference toFIG.5, methods of surgical repair are described that include the step of applying temporary compressive force to the first31and second32bone fragments. According to certain embodiments, the application of temporary compressive force can occur simultaneously with the previously described step of aligning. Alternatively, the step of applying temporary compressive force can occur after the step of aligning. As an example, one suitable tool16for applying temporary compressive force to the first31and second32bone fragments at the fracture boundary41is bone reduction forceps16. As shown inFIG.4, a pair of forceps16are applying temporary compression to first31and second32bone fragments across fracture boundary41.

According to the present disclosure, and with reference toFIGS.6-8, methods of surgical repair are described that include, during the application of temporary compressive force, the step of inserting at least one compression staple20into the first31and second32bone fragments such that the at least one compression staple20traverses the fracture boundary41.

According to certain embodiments, the at least one compression staple20defines a bridge21having a first end22and a second end23, the bridge20defining a bridge length20L extending between the first end22and a second end23. Additionally, the at least one compression staple20defines a first leg24and a second leg25, where the first leg24extends from the first end22of the bridge21to a first distal tip26and defines a first leg height24h, and the second leg25extends from the second end23of the bridge21to a second distal tip27and defines a second leg height25h. In certain embodiments, the bridge has a bridge length in the range of about 15 mm to about 25 mm. In further embodiments, the at least one compression staple20can further include a third leg28and fourth leg29, wherein the third28and fourth29legs each extend from the bridge21between the first leg24and second leg25and in substantially the same direction as the first24and second25legs.

Preferably, the at least one compression staple20is inserted in a first tensioned state20t. According to certain embodiments, compression staple20is made from a shape memory material such as a shape memory alloy. A preferred shape memory alloy is nitinol, which is an approximately 50%/50% titanium-nickel metal alloy. Due to the shape-memory properties, compression staple20can be mechanically or thermally deformed from its original configuration and return to its original state upon removal of the deformation force. According to the methods of surgical repair described herein, the deformation force can be a tensioning force. Referring toFIGS.6A, compression staple20is shown in a tensioned state20t, where the legs of the staple have been deformed by tension to approximate right angles with respect to the bridge of the staple. Referring toFIG.6B, compression staple20is shown in a compressed state20cwhere the legs of the staple have returned to their original configuration upon removal of the tensioning force and exert a continuous compressive force (arrows indicating relative movement and compression). Referring toFIG.7, an exemplary staple insertion tool18is shown, with a compression staple20affixed in the tensioned state20t. Referring toFIG.8, insertion tool18is shown inserting a tensioned staple20t(not shown) into first31and second32bone fragments across fracture41of long bone4during the application of temporary compressive force by a pair of bone reduction forceps16. Once inserting of compression staple20tis complete, it can be released from insertion tool18, and upon release from insertion tool18, tension in the compression staple20is likewise removed, causing compression staple20tto transition from a tensioned state to a compressed state20cthat exerts a continuous compressive force to first31and second32bone fragments across fracture boundary42.

According to certain embodiments, and with reference toFIG.9the step of inserting the compression staple20is such that compression staple20traverses fracture boundary41in a direction substantially normal to fracture boundary41. According to certain additional embodiments, the step of inserting the compression staple20is such that compression staple20traverses fracture boundary41in a direction substantially parallel to the temporary compressive force.

With reference toFIGS.10-11, according to certain embodiments, the application of temporary compressive force C to the first31and second32bone fragments of long bone4can create a shear force S at fracture boundary41that is configured to force translation of the first31and second32bone fragments relative to each other in the direction of the shear force S. In other words, due to the presence of shear force created by the compression, slippage or an over rotation of one bone fragment relative to the other can occur that can result in a misalignment of the long bone and an impairment to the proper healing of the bone. For example, oblique, spiral, segmental (including wedge), and comminuted fractures can all include a fracture boundary (or multiple fracture boundaries) that, upon application of a temporary compression force may cause bone fragments to slip out of alignment. This is primarily due to the orientation of the angle between the bone fragments at the fracture boundary where a steeper angle between the bone fragments increases the transmission of shear forces upon compression

FIG.10Ashows the application of temporary compressive force C to an oblique fracture in the diaphyseal region of a tibia4that can create a shear force S. In certain embodiments, and with reference toFIG.10B, the continuous compressive force of the at least one compression staple20applies a net compressive force across fracture boundary41that is substantially normal to the direction of shear force S, and the net compressive force neutralizes, or otherwise cancels out the shear force S.

With reference toFIG.11A, according to certain additional embodiments, the methods describe herein can further include:

prior to inserting the at least one compression staple, applying a buttress plate to the first and second bone fragments such that the buttress plate traverses the fracture boundary, and,

securing the buttress plate with fastener to only one of the first or second bone fragments such that the other of the first or second bone fragments is not secured to the buttress plate;

where the buttress plate is configured to inhibit the translation of the first and second bone fragments in the direction of the shear force.

In these embodiments, and as shown inFIG.11A, buttress plate67functions as a mechanical stop. As shown, tibia4has an oblique fracture boundary41in the diaphyseal region that is being subjected to temporary compression C that results in shear force S generated at fracture boundary41. In this case, shear force S is forcing translation of first bone fragment31downwards and to the right, and second bone fragment32upwards and to the left. Buttress plate67is applied to tibia4such that it traverses fracture boundary41and is secured with a fastener52(for example with a bone screw) to second bone fragment32. Buttress plate67therefore resists the ability of first31and second32bone fragments to translate in the direction of shear and stabilizes the alignment of tibia4in anatomically correct configuration. As shown inFIG.11B, compression staple20can then be applied as previously described. In the particular example shown inFIG.11B, compression staple20is inserted in a direction substantially parallel to the compressive force C. The benefit of buttress plate67is that it gives more freedom to the surgeon as to placement and orientation of compression staple20at fracture boundary41because the effects of shear force S no longer need to be taken into account in determining where or how to insert compression staple20. For example, compression staple20could be inserted in a direction substantially normal to fracture boundary41, if desired.

According to still other embodiments of the present disclosure, a fracture boundary may require more than one compression staple to be inserted to provide appropriate compression to first and second bone fragments. In such embodiments, the at least one compression staple includes a first compression staple and a second compression staple and the step of inserting at least one compression staple and the step of releasing tension in the at the least one compression staple includes:

inserting the first compression staple into the first and second bone fragments such that the first compression staple traverses the fracture boundary, where the first compression staple is inserted in a first tensioned state;

releasing tension in the first compression staple such that the first compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments;

inserting the second compression staple into the first and second bone fragments such that the second compression staple traverses the fracture boundary, where the second compression staple is inserted in a first tensioned state; and

releasing tension in the second compression staple such that the second compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the first and second bone fragments.

Referring toFIGS.12A-B, a comminuted fracture of the right distal tibia of a male is shown, classified according to the AO Classification as a 43C3, which includes multifragmentary fractures of the metaphyseal and articular regions of the distal tibia. This fracture is commonly known as a Pilon fracture.FIG.12Ais a pre-operative CT scan of a distal portion of the fractured tibia4showing first31and second32bone fragments defining a spiral fracture boundary41.FIG.12Bis an enlarged photograph of the region identified inFIG.12Awith the dashed box B. As shown inFIG.12B, compression is being applied to tibia4with forceps16to align first31and second32bone fragments in anatomical position. First compression staple20a, and a second compression staple20bhave been inserted into first31and second32bone fragments traversing fracture boundary41. First compression staple20ahas been inserted such that it traverses fracture boundary41in a direction substantially normal to fracture boundary41. Second compression staple20bhas been inserted such that it traverses fracture boundary41in a direction substantially parallel to the temporary compressive force.

The fracture boundary41in the region shown inFIGS.12A-Bis in a spiral fracture configuration and as such the alignment and compression of first31and second32bone fragments can, in certain embodiments, generate shear force along portions of fracture boundary41. In this exemplary surgical procedure, and as shown inFIG.12B, buttress plate67has been applied to first31and second32bone fragments traversing fracture boundary41and secured to first bone fragment31with a fastener52(such as in the manner previously described above with the use of a bone screw). It should be appreciated however, that in alternative embodiments, first20aand second20bcompression staples can be inserted such that the continuous compressive force of the first20aand second20bcompression staples exerts a combined net compressive force applied across fracture boundary41that is substantially normal to the direction of shear force. In such embodiments, a surgeon can forgo the use of buttress plate67if desired because the continuous compression staples20a,20bhave neutralized the shear force to an extent to eliminate translation of first31and second32bone fragments.

As previously described (with respect toFIGS.3D-E), and with reference toFIGS.13A-C, certain long bone fractures can include more than two fragments, for example, segmental (including wedge) and comminuted fractures can include at least three bone fragments, such that there can be a first31, second32, and third33bone fragment. It therefore follows that these multifragmentary fractures will further include more than one fracture boundary, such as a first fracture boundary41and a second fracture boundary42. It should be appreciated that depending upon the severity of the long bone fracture, there can be several bone fragments, for example anywhere from three bone fragments to ten bone fragments at a single long bone fracture site. Likewise, it should be appreciated that as the number of bone fragments at a long bone fracture site increase, the number of fracture boundaries will also increase, most often in proportional relationship to the number of bone fragments, but in certain cases, especially comminuted fractures, there can exist more fracture boundaries than bone fragments because the size and shape of the bone fragments and their respective orientation to one another for alignment and reduction purposes.

According to embodiments of the present disclosure, multifragmentary fractures includes at least a first fracture boundary and a second fracture boundary such that the fracture boundary between the first bone fragment and the second bone fragment is the first fracture boundary and a fracture boundary between a third bone fragment and either of the first bone fragment or the second bone fragment, or both, defines the second fracture boundary. Furthermore, the at least one compression staple includes at least a first compression staple and a second compression staple such the first compression staple is the compression staple inserted at the first fracture boundary. The method of surgical repair, according to these embodiments, can therefore further include the steps of:

aligning the third bone fragment to contact either of the first bone fragment or the second bone fragment, or both, along at least a portion of the second fracture boundary in anatomically correct position;

applying a temporary compressive force to the third bone fragment and either of the first bone fragment or the second bone fragment, or both;

during the application of the temporary compressive force to the third bone fragment, inserting the second compression staple into the third bone fragment such that the second compression staple traverses the second fracture boundary, wherein the second compression staple is inserted in a first tensioned state; and,

releasing tension in the second compression staple such that the second compression staple transitions from the first tensioned state to a second compressed state that exerts a continuous compressive force to the third bone fragment and either of the first bone fragment or the second bone fragment, or both.

FIGS.13A-Cshow an exemplary illustration of the above surgical steps for a segmental fracture of tibia4. Here, first31and second32bone fragments define a first fracture boundary41, and a second fracture boundary42can be defined between second32and third33bone fragments. It should be appreciated, as previously detailed, that second fracture boundary42can be defined between third bone fragment33, and either of first31or second32bone fragments, depending upon the orientation of the respective bone fragments at the fracture site.

FIG.13Ais a representation of the unrepaired segmental fracture previously shown inFIG.3D.FIG.13Bshows the segmental fracture after first31and second32bone fragments have been aligned at fracture boundary41and first compression staple20ahas been inserted to traverse fracture boundary41according to the embodiments previously described above.FIG.13Cshows the alignment of third bone fragment33with second bone fragment32at second fracture boundary42and second compression staple20bhas been inserted so as to traverse second fracture boundary42.

As shown inFIG.13C, second compression staple20bhas been inserted in a direction substantially normal to second fracture boundary42. According to another embodiment, second compression staple20bcan be inserted such that it traverses second fracture boundary42in a direction substantially parallel to the temporary compressive force. This can be accomplished in the same manner as previously described above.

According to additional embodiments, the application of temporary compressive force to third bone fragment33can generate a shear force at second fracture boundary42, in the same manner as previously described above with respect to the generation of shear force at fracture boundary41.

According to embodiments of the present disclosure, after completing the steps including the insertion and releasing of tension of the at least one compression staple, the method of surgical repair can include the step of securing a neutralization implant to the long bone, where the neutralization implant defines one or more apertures configured to receive a bone fastener. Such a securing can be done, according to certain embodiments, by applying the bone fastener through the one or more apertures and the long bone such that the fastener secured the neutralization implant to the long bone. In certain embodiments, the neutralization implant can include a bone plate, such as a bridge plate or locking plate, but preferably excludes compression bone plates. In certain other embodiments, the neutralization implant can include an intramedullary nail. It should be appreciated that more than one neutralization implant can be utilized in the surgical constructs and methods described herein, such that multiple bone plates or bone plates in combination with an intramedullary nail can be secured to the long bone.

Referring toFIG.14, neutralization implant50(in this case a bone plate) is shown being secured to long bone4with fasteners52(obstructed by fastener insertion tool) being through apertures56into long bone4. As can be seen, compression staple has already been inserted into long bone4. Temporary compression is being applied to long bone4with bone reduction forceps16. Depending on the type of long bone fracture and the type of neutralization implant being applied to the long bone, the removal of the temporary compressive force can occur prior to, or subsequent to, the securing of the neutralization implant.

According to further embodiments of the present disclosure, a kit for use in the surgical repair of a long bone fracture is described including:

at least one compression staple configured to traverse a fracture boundary in a long bone between a first bone fragment and a second bone fragment; and,

at least one neutralization implant.

In certain embodiments, the kit can additionally include at least one buttress plate. In additional embodiments, the at least one compression staple defines a bridge length extending between the first end and a second, wherein the bridge length is in the range of about 15 mm to about 35 mm. In further embodiments, the first and second leg lengths are each in the range of about 15 mm to about 25 mm. In still further embodiments, the at least one compression staple includes a third leg and a fourth leg, wherein the third leg and fourth leg each extend from the bridge between the first and second legs and in a direction substantially the same as the first leg and second leg.

In certain embodiments, the neutralization implant is a bone plate. In additional embodiments, the neutralization implant is an intramedullary nail.

In certain embodiments, the at least one compression staple of the kit can include one compression staple, two compression staples, three compression staples, up to and including ten compression staples.

According to still further embodiments of the present disclosure, a surgical construct system for use in the surgical repair of a long bone fracture described including:

at least one compression staple configured to traverse a fracture boundary in a long bone between a first bone fragment and a second bone fragment;

at least one buttress plate configured to traverse the fracture boundary and,

a neutralization implant.

In additional embodiments, the at least one compression staple defines a bridge length extending between the first end and a second, wherein the bridge length is in the range of about 15 mm to about 35 mm. In further embodiments, the first and second leg lengths are each in the range of about 15 mm to about 25 mm. In still further embodiments, the at least one compression staple includes a third leg and a fourth leg, wherein the third leg and fourth leg each extend from the bridge between the first and second legs and in a direction substantially the same as the first leg and second leg.

In certain embodiments, the neutralization implant is a bone plate. In additional embodiments, the neutralization implant is an intramedullary nail.