Apparatus and method for joint repair

A bolster system having a first bolster device, a second bolster device, and an adjustable tether that includes a one-way pre-tied slideable adjustment knot. The adjustment knot is at a first position prior to insertion of the first bolster device into a passageway in one or more bones. The second bolster device includes a body portion having an outer portion that is sized to be received in the passageway and/or in an aperture of a bone plate. The body portion also includes a channel that is sized to accommodate recessed and/or embedded placement of the pre-tied slideable adjustment knot. The second bolster device can also include an oversized plate portion that abuts against a cortex of a bone or a wall of a bone plate. The second bolster device can also include a threaded member or retention tab that lockingly secures the second bolster device to a bone plate.

BACKGROUND

Embodiments of the present invention generally relate to joint repair. More particularly, but not exclusively, embodiments of the present invention relate to an adjustable apparatus that at least assists in maintaining tension on a one or more bones during joint repair and/or healing.

Reconstructive surgery can be utilized to repair damaged and/or unstable sprains, among other injuries. For example, in at least certain instances, reconstructive surgery can be utilized to repair damage to the distal tibiofibular joint, including but not limited to damage associated with certain high ankle sprains and/or breaks and fractures of the fibula and tibia, among repairs to other joints. Such surgeries can seek to establish/re-establish the correct apposition, placement, and/or separation of the fibula relative to the tibia, or vice versa. Further, such reconstructive surgery can also seek to re-establish the integrity of the fibula and tibia, as well as re-establish axial, rotational and transitional forces. A common procedure for repairing certain types of injuries to the distal tibiofibular joint is syndemosis screw fixation. During syndemosis screw fixation, at least two fixation screws are driven into drilled holes in the bone(s) of a patient. Such screws are typically also driven through holes in a bone plate that abuts, or is generally positioned adjacent to, an outer surface of the patient's bone. Yet, such drilling and screw implantation can cause damage to the bone(s) and/or weaken portions of the bone. Further, after several weeks or months of recovery, such hardware is typically removed from the patient, which typically involves the patient undergoing a subsequent or additional procedure.

SUMMARY

Certain embodiments of the present invention provide an apparatus that includes an adjustable tether having a pre-tied knot slideably displaceable in one direction from a first axial position to a second axial position. The apparatus also includes a first bolster device that is coupled to the adjustable tether, the first bolster device having a width and a length that are each sized to accommodate passage of the first bolster device through a passageway in a first orientation of the first bolster device, and which are sized to prevent passage through the passageway when the first bolster device is in a second orientation. Further, the pre-tied knot is tied prior to insertion of the first bolster device into the passageway. The apparatus also includes a second bolster device coupled to the adjustable tether, the second bolster device being positioned between the pre-tied knot and the first bolster device. The second bolster device includes a channel that extends through at least a portion of the second bolster device, the channel being sized to receive replacement of the pre-tied knot. Further, an axial distance between the pre-tied knot and the first bolster device is reduced by slideable displacement of the pre-tied knot from the first axial position to the second axial position.

Additionally, certain embodiments of the present invention provide an apparatus comprising a first bolster device and a second bolster device, the second bolster device having a plate portion and a body portion, the body portion including a channel that extends through the plate portion. The apparatus can further include an adjustable tether that extends through one or more apertures of the first bolster device and the body portion of the second bolster device. The adjustable tether includes a pre-tied slideable locking knot that is embedded within the second bolster device. The pre-tied slideable locking knot is displaceable from at least a first position to a second position along the adjustable tether. Additionally, the adjustable tether can have a first length between the first and second bolster devices when the pre-tied slideable locking knot is at the first position and a second length when the pre-tied slideable locking knot is at the second position, the second length being smaller than the first length. Additionally, the pre-tied slideable locking knot is at the first position prior to insertion of the first bolster device into the formed passageway.

Further, certain embodiments include is a method that includes forming, with at least a drill bit, a passageway through one or more bones and disconnecting the drill bit from a drill. Further, a lead suture is coupled to the disconnected drill bit, the lead suture also being coupled to a first bolster device that is coupled to a second bolster device by an adjustable tether that has a pre-tied knot that is embedded at a first position along the adjustable tether within the second bolster device. The lead suture and the first bolster device are displaced through the passageway, via displacement of the drill bit. After displacing the first bolster device through the passageway, the pre-tied knot is slid along the adjustable tether from the first position to a second position, with a length of the adjustable tether between the first bolster device and the pre-tied knot being reduced as the pre-tied knot is slid from the position to the second position.

The foregoing summary, as well as the following detailed description of certain embodiments of the present invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings certain embodiments. It should be understood, however, that the present invention is not limited to the arrangements and instrumentalities shown in the attached drawings.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

Certain terminology is used in the foregoing description for convenience and is not intended to be limiting. Words such as “upper,” “lower,” “top,” “bottom,” “first,” and “second” designate directions in the drawings to which reference is made. This terminology includes the words specifically noted above, derivatives thereof, and the words of similar import. Additionally, the words “a” and “one” are defined as including one or more of the referenced item unless specifically noted. The phrase “at least one of” followed by a list of two or more items, such as “A, B or C,” means any individual one of A, B or C, as well as any combination thereof.

FIGS. 1A, 1B, and 2illustrate side perspective views of at least a portion of a bolster system100according to an embodiment of the present invention. As illustrated, the bolster system100can include a first bolster device102, a second bolster device104, and an adjustable tether106.FIGS. 1A, 1B, and 2further depict a lead suture108coupled to the first bolster device102. The first and second bolster devices102,104can be constructed from a variety of different materials including, for example, stainless steel, plastic and titanium, among other suitable materials. As discussed below in greater detail, the adjustable tether106can comprise a wire, fiber or suture110, among other items or devices, that passes around, through, and/or about at least a portion of the first and second bolster devices102,104so as form an adjustable tether106therebetween that is operably coupled to the first and second bolster devices102,104. Further, as shown in at leastFIGS. 1B and 2, the first bolster device102can be positioned at a first end112of the adjustable tether106, while the second bolster device104can be positioned at or around a second, opposite end114of the adjustable tether106.

As illustrated in at leastFIG. 1B, and as discussed below in greater detail, the adjustable tether106can include a pre-tied slideable locking knot116at or around the second end114of the adjustable tether106. Moreover, according to the illustrated embodiment, the slideable locking knot116can be positioned at an end of the tether106adjacent to the second bolster device104. The pre-tied slideable locking knot116can be structured for use in adjusting a length of the adjustable tether106between the first and second bolster devices102,104and/or to secure relative positions of the first and second bolster devices102,104so that the bolster system100at least provides tension on a fibula and tibia bones128a,128b(FIG. 15B). Further, according to certain embodiments, the slideable locking knot116can be a one-way locking knot, and more specifically a knot that can shorten, but not expand, at least the distance of the locking knot116from the first bolster device102relative to the adjustable tether106. A variety of different types of knots can be used as the pre-tied slideable locking knot116including, but not limited to, a woven, fast fix, square, and cow hitch knot, among other suitable types and styles of knots.

As illustrated inFIG. 1B, according to certain embodiments, the pre-tied slideable locking knot116can comprise lockingly intertwined portions of one or more sutures110of the adjustable tether106that extend away from the second bolster device104. Further, according to the illustrated embodiment, the pre-tied slideable locking knot116is formed prior to implantation of at least a portion of the bolster system100into one or more bones of a patient. For example,FIG. 1Bprovides an indication of the routing of portions of the suture110about itself or other sutures110in a manner that can form the pre-tied slideable locking knot116prior to implantation of the bolster system100into a patient. Additionally, as discussed below, the pre-tied slideable locking knot116can be formed in a manner that allows the pre-tied slideable locking knot116to be displaced along at least a portion of the adjustable tether106, at least after a portion of the bolster system100has routed through a passageway in a bone128a,128bof a patient in a manner that can facilitate or enhance the ability of the bolster system100to exert compressive tension against one or more of the patient's bones128a,128b.

Additionally, according to certain embodiments, the tether106can extend from the second bolster device106to first bolster device102, where a portion of the tether106can wrap or extend around a portion of the first bolster device102, and return to the second bolster device104, where a portion of the tether106can wrap or extend around a portion of the second bolster device104. According to certain embodiments, this process can be repeated one or more additional times in a manner that accommodates multiple portions or loops of the tether106being wound and/or extending between the first and second bolster devices102,104. Further, opposing ends of the tether106can extend from the second bolster device104such that at least a portion of the tether106forms the slideable locking knot116.

FIGS. 3A and 3Billustrate front and side cross-sectional views, respectively, of an exemplary embodiment of a first bolster device102. As illustrated, the first bolster device102can include a body portion118that extends between first and second ends120,122along a central axis124. Further, according to the illustrated embodiment, the first bolster device102can have a first length or height in a direction that is relatively or generally parallel to the central axis124(as indicated by the “L1” direction inFIG. 3A) that is longer than a second length or width of the first bolster device102in a direction that is arranged generally perpendicular to the central axis124(as indicated by the “L2” direction inFIG. 3B). For example, according to certain embodiments, the first bolster device102can have a variety of shapes including, for example, rectangular, trapezoidal, oval, or triangular, among other suitable shapes and sizes. As discussed below in greater detail, according to certain embodiments, such a configuration can permit the first bolster device102to be manipulated to a first orientation in which the first bolster device102can pass through a passageway126in one or more bones128a,128b(FIGS. 15A and 15B) that has a size that is similar or greater than the second length or width of the first bolster device102, but which is less than the first length of the first bolster device102. Upon removal from the passageway126, the first bolster device102can be placed in a second orientation in which the first bolster device102is positioned in a manner that utilizes the larger first length of the first bolster device102to prevent re-entry of the first bolster device102into the passageway126.

According to the illustrated embodiment, the first bolster device102includes one or more tether apertures130a,130bthat extend between the front side131aand the back side131bof the first bolster device102along an aperture axis133that can be arranged generally perpendicular to the central axis124of the first bolster device102. The tether apertures130a,130bare sized to at least received one or more passages of portions of the suture(s)110of the adjustable tether106. For example, according to the illustrated embodiment, the first bolster device102includes a first tether aperture130aand a second tether aperture130a, the first and second tether apertures130a,130bbeing separated from one another by a bridge portion134of the first bolster device102. According to such embodiment, at least a portion of the suture110can extend in a first direction generally away from the second bolster device104through one of the first and second tether apertures130a,130bof the first bolster device102, and subsequently pass through the other of the first and second tether apertures130a,130bin a second, opposite direction generally toward the second bolster device104. Such passages of the suture110through the first and second tether apertures130a,130bcan be repeated one or more times. Additionally, according to certain embodiments, at least a portion of the suture110can also be wrapped through the first and second tether apertures130a,130band around the bridge portion134of the first bolster device102. Alternatively, according to other embodiments, the sutures110can pass through one of the first and second tether apertures130a,130bbefore returning back toward the second bolster device104. Further, according to certain embodiments, the adjustable tether106can comprise separate sutures110that each extend through separate ones of the tether apertures130a,130b, and which are joined together by the pre-tied slideable locking knot116.

According to certain embodiments, the first bolster device102can also include one or more lead suture apertures132that extend between the front side131aand the back side131bof the first bolster device102along an aperture axis136that can be generally arranged perpendicular to the central axis124of the first bolster device102. The lead suture apertures132can be sized to at least accommodate the passage of a lead suture108(FIG. 1A) that can be used in the displacement of the first bolster device102through a passageway126in one or more bones128a,128b, as discussed in greater detail below. According to the illustrated embodiment, the first bolster device102is depicted as having two lead suture apertures132. However, according to certain embodiments, the lead suture108may extend through only one of the lead suture apertures132. Additionally, according to certain embodiments, the first bolster device102can have only one lead suture aperture132through which the lead suture108extends. Further, the lead suture aperture132may, or may not, be configured as an aperture that is separate from the tether apertures130a,130bsuch that lead suture108and the suture110of the adjustable tether106do, or do not, extend through the same aperture. Further, whileFIGS. 1A and 2illustrate the lead suture apertures132positioned outside of the tether apertures130a,130b, according to other embodiments, the tether apertures130a,130bcan be positioned outside of the lead suture apertures132such that the tether apertures130a,130bare separated from each other by one or more of the lead suture apertures132.

FIGS. 4A and 4Billustrate front and top perspective views, respectively, of an exemplary embodiment of a second bolster device104. According to the depicted embodiment, the second bolster device104includes a wall138having an inner portion140, an outer portion142, a first end144, and a second end146. According to certain embodiments, the wall138extends from the first end144to the second end146of the wall138of the second bolster device104along a central axis148. Further, at least a portion of the wall138is configured to provide a generally elongated body portion150. The body portion150can have a variety of different shapes and sizes, such as, for example, having an oval, square, rectangular, or other non-circular cross-sectional shapes, among other suitable shapes. According to the illustrated embodiment, the body portion150is generally cylindrical such that the second bolster device104can have a plug shape. Further, the body portion150can be sized such that at least a portion of the body portion150extends into a passageway126formed in a bone(s)128a,128band/or through an aperture152in a bone plate154(FIGS. 10A and 10B), as discussed in greater detail below.

According to certain embodiments, the wall138can also include a tapered portion156in which the wall138outwardly extends from the elongated body portion150to a plate portion158at the first end144of the wall138. For example, in the illustrated embodiment, the wall138can have a size such as, for example, a diameter, along the elongated body portion150of the second bolster device104that is smaller than a corresponding size, such as a diameter of the plate portion158at the first end144of the wall138. According to certain embodiments, at least a portion of the outer portion142of the wall138along the tapered portion156and/or plate portion158can be sized to prevent the entire second bolster device104from being pushed or pulled into the passageway126in one or more bones128a,128band/or through an aperture152in a bone plate154. For example, at least the plate portion158can have a size that abuts against an adjacent portion of bone or an inner wall of an aperture152in a bone plate154while at least a portion of the body portion150extends into the passageway126and/or through the aperture in the bone plate154. Further, the second bolster device104can be sized to prevent the second bolster device104, such as the first end of the second bolster device104, from extending beyond an outer surface153of the bone plate154when the second bolster device104is operably positioned in the aperture152of the bone plate154.

Additionally, according to certain embodiments, at least a portion of the elongated body portion150can be provided with a shape and/or size that assists in the positioning of at least a portion of the body portion150of the second bolster device104in the passageway126in a bone(s)128a,128band/or through an aperture152of a bone plate154. For example, as shown in at leastFIG. 4A, according to certain embodiments, the elongated body portion150can decrease in size as the wall138approaches the second end146of the wall138of the second bolster device104. For example, according to certain embodiments, the elongated body portion150can taper inwardly and/or have a chamfer or curvature as the wall138approaches the second end146, as shown in at leastFIG. 4A.

The first end144of the wall138of the second bolster device104can include an inlet145in communication with a channel147that extends within a portion of the second bolster device104along the central axis148. For example, according to certain embodiments, the channel147can extend from the inlet145to an opposite base portion162of the channel147. Further, the inlet145and the base portion162can be separated from each other by a distance that provides the channel147with a depth that can accommodate the recessed insertion or embedding of the pre-tied slideable locking knot116of the adjustable tether106into/in the channel147, as discussed in greater detail below. More specifically, the depth of the channel147can allow the pre-tied slideable locking knot116to be placed in the channel147in a manner that prevents the pre-tied slideable locking knot116from extending beyond the inlet145, and thereby be recessed or embedded in the channel147below at least a portion of the plate portion158of the second bolster device104.

According to certain embodiments, the second bolster device104can include one or more tether openings164and/or recesses166that are in communication with the channel147. While certain embodiments the second bolster device104illustrated herein are depicted as having two tether openings164, the number of tether openings164can vary, including, but not limited to, having a single tether opening164or three or more tether openings164. According to the embodiment illustrated inFIGS. 4A and 4B, recesses166on opposing sides of the wall138can generally extend upwardly from the second end146of the second bolster device104to a tether opening164in the body portion150of the wall138. Moreover, the recesses166may be positioned so as to extend from at least a portion of the second end146of the second bolster device104to different or opposing sides of the channel147. Further, the recesses166can extend into the wall138at a depth that may permit the adjustable tether106to be recessed in the recess166such that adjustable tether106does not outwardly protrude from the recess166beyond the outer portion142of the wall138. Alternatively, the recesses166can have a depth to accommodate portions of the adjustable tether being compressed into the recesses166when the body portion150is positioned in a passageway126. Thus, according to certain embodiments, at least when the bolster system100is operably implanted in a patient, the portion of the adjustable tether106positioned along and/or within the recesses166can generally be arranged flush with or recessed below adjacent outer portions142of the wall138so that the recessed portions of the adjustable tether106are not in a position that interferes with the placement of at least a portion of the second bolster device104in the passageway of a bone128a,128band/or an aperture152a home plate154.

According to the illustrated embodiment, a tether opening164can extend through opposing sides of the wall138along an axis168that is arranged generally perpendicular to the central axis148of the second bolster device104. According to certain embodiments, the tether opening164may be formed by an intersection of the channel147with the recesses166, and can also define the location of the base portion162. For example, according to the embodiment shown inFIGS. 4A and 4B, the tether opening164can be positioned such that one or more sutures110of the adjustable tether106can extend in a direction that is generally directed away from the first bolster device102along one of two recesses166in the sidewall138before extending across a bridge portion178at the base portion162of the channel147, and subsequently extend along the other of the two recesses166in the sidewall138in a direction that is generally directed toward the first bolster device102. Thus, according to such an embodiment, the wall138can have a thickness between the base portion162of the channel147and the second end146that can accommodate forces exerted on the bridge portion178of the second bolster device104by the adjustable tether106.

FIGS. 5A-5Cillustrate front, top, and side cross-sectional views, respectively, of an exemplary embodiment of a second bolster device104′. As illustrated inFIGS. 5A-5C, according to the illustrated embodiment, a pair of opposing recesses166′ extend upwardly generally from the second end146′ of the wall138′ to an area at or around the tapered portion156′ of the wall138′. Additionally, at least a portion of the recesses166′ extend to a depth in the wall138′ that exposes a portion of the channel147′, or otherwise allows the recesses166′ to be positioned in communication with the channel147′. Further, the recesses166′ and/or base portion162′ of the channel147′ can have a rounded or chamfered shape so as to prevent the adjustable tether106′ from transitioning from the recesses166′ to the bridge portion178at the base portion162′ along a corner or sharp edge.

FIGS. 6A-6Dillustrate front and top views, respectively, of an exemplary embodiment of a second bolster device104″. As illustrated inFIGS. 6A-6C, the plate portion158″ can extend from the body portion150″ in a direction that is arranged generally perpendicular to the channel147″ and/or the body portion150″. Further, the plate portion158″ can have an oversized and/or generally elongated shape. For example, according to certain embodiments, the plate portion158″ can have a length along a first axis160(which is shown as shared by line6D-6D inFIG. 6B) of the plate portion158″ arranged generally perpendicular to the central axis148″ that is at least equal to, if not longer, than a length or width along a second axis160(which is shown as shared by line6C-6C inFIG. 6B) that extends in a direction arranged generally perpendicular to the first axis160. For example, according to certain embodiments, the plate portion158″ can have a length along the first axis160that is at least about 1 to around 3 times larger, and more particularly about 1.1 to about 1.5 times larger, than the length of the plate portion158″ along a second axis160. Additionally, according to certain embodiments the length of the plate portion158″ along the first axis160can be approximately one-half inch (½″) while the length of the plate portion158″ along a second axis160can be approximately three eighths of an inch (⅜″).

The elongated shape of the plate portion158″, and moreover the elongated shape of the plate portion158″ along at least the first axis160, can, in at least certain circumstances, eliminate the need, whether actual or perceived, for the inclusion of a bone plate154(FIG. 8). Further, by eliminating the use of a bone plate154in at least certain circumstances, the step of drilling holes into bone128a,128band implanting screws into those drilled holes to secure the bone plate154to bone128acan also be eliminated, as well as the associated risks and damage such holes and screws can present to the bone128a. Further, such an elongated shape can provide a relatively wide area for the plate portion158″ to abut and/or press against the adjacent bone128a. Moreover, by providing a large area in which the plate portion158″ abuts against the bone128a, forces exerted onto the bone128aby the plate portion158″ can be distributed over a larger area. By distributing the forces exerted onto the bone128aby the plate portion158″ over a larger area, the plate portion158″ of the present design can have a decreased likelihood of breaking through the cortex of the bone128a.

According to the embodiment depicted inFIGS. 6A-6D, the length of the plate portion158″ along the first axis160can be around the same or greater than the overall length of the second bolster device104″ along the central axis148″. For example, according to certain embodiments, the length of the plate portion158″ along the first axis160can be approximately 1.1 to approximately 3 times greater than the overall length of the second bolster device104″ along the central axis148″. As another example, the length of the plate portion158″ along the first axis160can be approximately one-half inch (½″), which can be approximately 1.5 to 2 times larger than the overall length of the second bolster device104″ from a top surface170of the plate portion158″ to the second end146″ of the wall138″.

According to certain embodiments, the plate portion158″ can be curved in at least one direction. The location, orientation, degree, and number of curvatures can be based on a variety of different factors, including the ability of at least a portion of the bottom surface172of the plate portion158″ to be shaped to generally conform to the shape and/or size of the portion of the bone128aagainst which at least a portion of the bottom surface172can abut. For example, according to the illustrated embodiment, the plate portion158″, including the top and bottom surfaces170,172, can be curved between first and second sidewalls174a,174bthat are on opposite sides of the first axis160. According to such an embodiment, the apex of the curvature can extend around the first axis160. Further, such a curvature along the bottom surface172of the plate portion158″ can, in at least certain embodiments, facilitate the ability of the bottom surface172of the plate portion158″ to be positioned in relatively flush contact with a fibular cortex.

The inlet of the second bolster device104″ can extend through the plate portion158″ such that at least a portion of the adjustable tether106can at least initially extend outside of the channel147″ and beyond the plate portion158″ through the inlet145″. Further, in the illustrated embodiment, the plate portion158″ can include a chamfered or inclined inner wall176that can facilitate the passage of at least a portion of the adjustable tether106such as, for example, the pre-tied slideable locking knot116, into the channel147″. Further, the body portion150″ of the second bolster device104″ shown in at leastFIGS. 6A, 6C and 6Dcan be configured similar to any of the body portions150,150′ shown inFIGS. 4A-5C, or can have a variety of other shaped body portions.

FIGS. 7A-7Cillustrate another exemplary embodiment of a second bolster device104ahaving one or more retention tabs105that outwardly project from the outer portion142of the wall138. The retention tabs105can have a variety of shapes and sizes. For example, according to the illustrated embodiment, as shown inFIG. 7A, the retention tab105has a generally planar profile and outwardly extends from the wall138in a direction that is arranged perpendicular to the central axis148,148′,148″ (FIGS. 4A, 5C and 6C). Further, as shown inFIGS. 7B and 7C, according to certain embodiments, the retention tab105can have a generally round or curved shape. However, it should be understood that the retention tab105can have a variety of other shapes or profiles.

The retention tab105is positioned and shaped to engage one or more locking lobes or teeth200in an aperture152of a bone plate154(FIGS. 8A and 8B) in a manner that may assist in retaining the second bolster device104ain locking engagement with the locking teeth200. For example, according to certain embodiments, the retention tab(s)105may be sized to engage a side of the locking tooth/teeth200that faces toward the bone of the patient. Moreover, the retention tab105can be positioned and sized relative to at least the locking teeth200such as when the second bolster device104ais rotated into an aperture of the bone plate154, the retention tab105can be rotated to a position below the superior plate surface such that the retention tab105is generally positioned between the bone and the adjacent locking tooth/teeth200. For example, according to certain embodiments, the retention tab105can be sized to be at displaced through a space or gap between adjacent locking teeth200as the second bolster device104ais rotated relative to the aperture152so that the retention tab105is positioned beneath at least one locking tooth200.

With the retention tab105at such a position, the locking tooth200may be positioned to engage with the retention tab105in a manner in which the locking tooth/teeth200provides an interference or barrier against at least subsequent axial displacement of the second bolster device104aout of the associated aperture152. Such engagement between the retention tab105and the one or more locking lobes or teeth200in the aperture152of the bone plate154can, for example, at least assist in retaining the second bolster device104ain a position relative to at least the bone plate154, including, for example, in instances where the tension on the fractured bones that is provided by use of the bone plate154and associated bone screws changes. For example, in at least certain instances in which tension used to hold a position of bones or fractures is reduced, engagement between the retention tab105and the one or more locking lobes or teeth200can at least assist in preventing the second bolster device104afrom being displaced away from, or at least partially popping out of, the bone plate154. Additionally, the retention tab105and/or locking tooth/teeth200may be positioned such that the retention tab105is in pressing engagement with the locking tooth/teeth200, or another force is asserted between the retention tab105and locking tooth/teeth200that prevents at least rotational displacement of the second bolster device104arelative to the bone plate154. For example, according to the embodiment illustrated inFIGS. 7A-7C, the retention tab105is positioned at a distance below the plate portion158at the first end144of the second bolster device104aat a location in which the tab engages at least a portion of one or more of the locking teeth200. For example, the retention tab105can be positioned about 0.015 millimeters (mm) to about 0.020 millimeters (mm) below the proximately adjacent bottom surface of the plate portion158of the second bolster device104a.

Additionally the retention tab105can outwardly extend to a distance that is greater than a similar outward distance of other relatively adjacent portions of the plate portion158. For example, according to certain embodiments, the tab portion105can outwardly extend approximately 0.09 millimeters (mm) further than the corresponding outward distance of the proximately adjacent portion of the plate portion158. Further, to at least facilitate such locking engagement, at least one of the retention tabs105and the locking tooth/teeth200can be configured to be deformed, deflected, or otherwise bent when in a pressed engagement with the other of the retention tab105and the locking tooth/teeth200. For example, according to certain embodiments, the retention tab105can have a thickness of approximately 0.020 millimeters (mm).

FIG. 8illustrates a side view of an exemplary embodiment of a second bolster device104bhaving a threaded member107. According to the illustrated embodiment, the threaded member107is configured as an external thread structured to engage one or more of the locking teeth200of the bone plate154in a manner that at least assists in maintaining the second bolster device104bin locking engagement with the bone plate154. Moreover, the thread member107can engage one or more of the locking teeth200of the bone plate154in a manner that at least resists removal of the second bolster device104bfrom the bone plate154. For example, according to the illustrated embodiment, at least a portion of the previously discussed plate portion158can include, or be replaced by, the threaded member107. As the second bolster device104bis rotated within the aperture152of the bone plate154and axially displaced toward the bone, at least a portion of the threaded member107may pass through a gap or space between adjacent locking teeth200of the bone plate154and proceed to a position in which at least a portion of the threaded member107below the superior surface of the bone plate154and between at least one locking tooth200and the bone. With at least a portion of the threaded member107positioned below at least one locking tooth200, the locking tooth/teeth200provides an interference or barrier against at least subsequent axial displacement of the second bolster device104bout of the associated aperture152. Additionally, at least a portion of the threaded member107and/or locking tooth/teeth200may be positioned such that the threaded member107is in pressing engagement with the locking tooth/teeth200, or another force is provided between the threaded member107and locking tooth/teeth200, that prevents at least rotational displacement of the second bolster device104brelative to the bone plate154.

Additionally, similar to the engagement between the retention tab105and the one or more locking lobes or teeth200in the aperture152of the bone plate154, the engagement between the threaded member107and the one or more locking lobes or teeth200in the aperture152can also at least assist in retaining the second bolster device104bin position relative to at least the bone plate154including, for example, in instances in which the tension on the fractured bones that is provided by the use of the bone plate154and associated bone screw changes. For example, engagement between the threaded member107and the one or more locking lobes or teeth200can at least assist in preventing the second bolster device104bfrom being displaced away from, or at least partially popping out of, the bone plate154.

As shown inFIGS. 7A-8, according to certain embodiments, the second bolster device104a,104bcan also include one or more driver surfaces109that are shaped to facilitate engagement between the second bolster device104a,104band a driver300(FIGS. 15C and 15D). For example, according to the illustrated embodiments, the driver surfaces109can be positioned to form one or more recesses111in second bolster device104a,104bthat can each receive an arm302a,302bof the driver300. According to the exemplary embodiment shown inFIGS. 15C and 15D, the arms302a,302bof the driver300can extend from a shaft304that is coupled to a handle306. The arms302a,302bcan be separated from each other by a gap308. The gap308and/or recesses111may be sized to accommodate at least a portion of the arms302a,302bbeing received in a corresponding recess111. Further, the gap308can extend along a length of the shaft304so as to accommodate at least a portion of the tether110of the bolster system100being received within the gap while the driver300is operably engaged with the second bolster device104a,104b. With the driver300is operably engaged with the second bolster device104a,104b, and with the arms302a,302beach positioned in a recess111of the second bolster device104a,104b, a user may rotate the driver306such as by gripping the handle306. Depending on the direction of rotation, such rotation of the driver300will be translated to the second bolster device104a,104bvia the arms302a,302bengaging one or more of the driver surfaces109. Further, such rotation of the second bolster device104a,104bcan, when the second bolster device104a,104bis being inserted into an aperture152of the bone plate154(FIG. 15C), facilitate the retention tab105or threaded member107being rotated to a position in which the retention tab105or threaded member107is positioned between one or more locking teeth200and an adjacent bone128a, thereby at least assisting in locking the position of the second bolster device104a,104brelative to the bone plate154, as discussed in detail above.

While the retention tab105, the threaded member107, the driver surfaces109, and the recesses111are discussed and illustrated in connection with certain exemplary second bolster devices104a,104b, such features can also be incorporated into other bolster devices including, for example, the second bolster devices104,104′,104″ illustrated inFIGS. 1A-6D, among other devices. Similarly, the features discussed herein with respect to the second bolster devices104,104′,104″ illustrated inFIGS. 1A-6Dcan be incorporated into the second bolster devices104a,104bshown inFIGS. 7A-8, among other devices.

Additionally, the second bolster device104,104′,104″,104a,104bcan be secured within the bone plate154at a variety of different angles while still being recessed within at least the bone plate154. Such variability can provide a degree of patient-to-patient variability. For example, according to certain embodiments, the second bolster device104,104′,104″,104a,104bcan have a size and/or shape that can accommodate the second bolster device104,104′,104″,104a,104bhaving up to 15 degrees of freedom relative to at least the aperture152of the bone plate154. Further, the number of locking teeth200for an aperture152can vary and can include, for example, five or six locking teeth200, among other numbers of locking teeth200.

FIG. 9illustrates an example of a second bolster device104″ secured to an adjustable tether106prior to implantation in a patient. As shown, the pre-tied slideable locking knot116is positioned or embedded within the channel147″ such that the pre-tied slideable locking knot116is positioned adjacent to the bridge portion178of the second bolster device104at the base portion162of the channel147″. Accordingly, as previously discussed, the channel147″ can have one or more sizes such as, for example, a diameter and depth that accommodate placement of the pre-tied slideable locking knot116in the channel147″. Additionally, the channel147″ can also have a depth that prevents ends180of the adjustable tether106that extend from beyond the pre-tied slideable locking knot116from extending beyond the inlet145of the second bolster device104,104′,104″ when the bolster system100is implanted in a patient. Moreover, at least a portion of the ends180of the adjustable tether106can be removed or cut when the bolster system100is operably positioned or secured to a patient. Thus, the channel147″ can have a depth that permits the remaining portions of the cut ends180that extend from the pre-tied slideable locking knot116from extending outside of the channel147″, thereby at least attempting to prevent the ends180from engaging the patient in a manner that can result in irritation to the patient.

FIG. 11illustrates a drill bit182for use with the bolster system100. According to certain embodiments, the drill bit182can include a first section184aand a second section184b, the first section184ahaving a size such as, for example, a diameter that is larger than a corresponding size of the second section184b. According to the illustrated embodiment, the first section184acan extend from a first end186of the drill bit182and can include at least the cutting edge and flutes of the drill bit182. For example, according to certain embodiments, the first section184aof the drill bit182can provide the cutting surface and flute for a 3.5 millimeter drill bit. Further, according to certain embodiments, the first section184acan include a first shank portion188aand the second portion184bcan include a second shank portion188b, with the first shank portion188ahaving an outer size that is larger than a corresponding outer size of the second shank portion188b. The portion of the second shank portion188bthat is in proximity to the second end190of the drill bit182can include an eyelet192that extends through at least a portion of, or extends from, the second shank portion188b. For example, the eyelet192can extend from the second shank portion188band have an outer size such as, for example, a diameter which is smaller than a corresponding size of the second shank portion188b. The eyelet192is configured to provide an opening through which the lead suture108can extend in a manner that can accommodate the lead suture being coupled to the drill bit182. For example, the lead suture108can be tied to itself such that the lead suture108forms a generally continuous loop that extends through the eyelet192, as well as through one or more tether apertures130a,130bin the first bolster device102.

FIG. 12illustrates use of an exemplary drill guide194to guide the location of drilling by the drill bit182through one or more bones128a,128bin connection with forming a passageway126through the bone(s)128a,128b. According to the illustrated embodiment, prior to drilling of the passageway126, the bone plate154(shown inFIGS. 10A and 10B) can be secured to an exterior surface of a bone128athrough the insertion of one or more fixation devices196, such as screws, through apertures152in the bone plate154and into drilled holes in the bore128a. According to such embodiment, as previously discussed, the bolster system100, including at least certain embodiments of the second bolster device104,104′,104a,104b, among others, can be received within an aperture152in the bone plate154. However, according to other embodiments, the bolster system100can be utilized in a patient without the inclusion of a bone plate154.

The drill guide194can be configured to be used with, or without, a separate drill clamp, and can be positioned along the bone(s)128a,128bat a location in which drill bit182, when operably coupled to the drill guide194, will drill or otherwise form the passageway126along a pre-determined trajectory and/or at pre-determined location within the bone(s)128a,128b. The drill bit182can also be, if not already, coupled to a drill (not shown) such that operation of the drill rotates the drill bit182in a manner in which the drill bit182can cut into the bone(s)128a,128bto form the passageway126. ReferencingFIG. 12, according to the illustrated embodiment, the drill bit182can be operated by operation of the drill to cut through the four cortices of the fibula128aand tibia128b

The passageway126can be provided with a variety of different shapes and/or sizes. For example, according to certain embodiments, the passageway126can generally have a circular cross-sectional shape that is provided by the drill bit182. According to other embodiments, the size and/or shape of the passageway126can be altered via the use of one or more other cutting or shaping instruments or components. For example,FIGS. 13A and 13Billustrate a cutting guide that can be used with at least the drill bit182bto provide the passageway126in the bone128a,128bwith a non-round cross-sectional shape such as, for example, an oval shape. For example, according to certain embodiments, the cutting guide can include a first drill bit182a(FIG. 13A) that has a vertical slot198and which is used to drill a first hole in the bone128a,128bthat has a generally circular cross-sectional shape. A second drill bit182b(FIG. 13B) can then be positioned to extend along the slot198of the first drill bit182aas the second drill bit182bremoves additional bone material from the bone(s)128a,128bat a location that at least extends from one side of the hole that was formed in the bone(s)128a,128bby the first drill bit182a. The combination of holes formed by the first and second drill bits182a,182bcan thereby form a passageway126having a generally elongated and/or oval shape. Such non-round shapes can be particularly suited for forming holes which are large enough to accommodate the insertion of at least a portion of the body portion150,150′,150″ of the second bolster device104,104′,104″, but which are also constrained by the size of the aperture152of a bone plate154such as, for example, at a location between locking teeth200in the aperture152of the bone plate154(FIGS. 10A and 10B). Alternatively, rather than utilizing first and second drill bits182a,182b, a s ingle drill bit having a short cutting surface and flat surfaces that can fit between the locking teeth200in the aperture152of the bone plate154can be used.

FIGS. 14A and 14Billustrate another shaping apparatus202structured to form a cross-sectional shape and/or size of a passageway through one or more bones128a,128b. According to such embodiments, the shaping apparatus202includes a drill bit182″ that drills through the cortices of one or more of the bones128a,128b. The shaping apparatus202can further include a chisel204that can slide over the drill bit182″ or otherwise be displaced with the drill bit182″, and through the hole formed by the drill bit182″. According to such an embodiment, after the drill bit182″ has established a hole through the bones128a,128b, the chisel204can pass along or with the drill bit182″ and through the aperture152in the bone plate154. For example, according to certain embodiments, the chisel204, which can have an ovular cross-sectional shape, can be displaced along the drill bit182″ in a direction that is generally tangential to locking teeth200in the aperture152of the bone plate154. According to such an embodiment, the drill bit182″ can guide displacement of the chisel204through the hole formed by the drill bit182″ as the chisel204is tapped with an impact device such as, for example, a hammer or another impact device, and thereby forming a generally oval, or non-round, shaped passageway126.

With the passageway formed, the drill bit182,182a,182b,182″ can be de-coupled from the drill, thereby exposing the eyelet192. The lead suture108, which can already be coupled to the first bolster device102, can then be coupled to the drill bit182,182a,182b,182″ such that, as the drill bit182,182a,182b,182″ is pulled through the passageway126, at least a portion of the lead suture108can also pass through the passageway126. Referring toFIG. 13, with the lead suture108exposed through one side of the passageway126, the first bolster device102can be oriented, if not already, at a first orientation so that the first bolster device102is oriented to pass into a first side206aof and through the passageway126. The first bolster device102can then be displaced through the passageway126by a pulling force on the drill bit182,182a,182b,182″ and/or the lead suture108. When the first bolster device102passes out of a second side206bof the passageway126, the first bolster device102can be manipulated to, if not already, in a second orientation that can abut the back side131bof the first bolster device102against a bone128bin a manner that prevents the return passage of the first bolster device102through the passageway, sa shown inFIG. 14.

As previously mentioned, according to certain embodiments, the pre-tied slideable locking knot116can be formed at least before the lead suture108and/or first bolster device102enters the passageway126. Additionally, according to certain embodiments, the pre-tied slideable locking knot116can be pre-formed such as that the pre-tied slideable locking knot116is, and remains, embedded in the second bolster device104,104′,104″ including, for example, embedded in the second bolster device104,104′,104″ prior to the first bolster device102entering into the passageway126. Thus, when the first bolster device102is positioned and oriented for operable abutment against a portion of the adjacent bone128b, one or more ends180of the adjustable tether106can be pulled so as to at least axially displace the pre-tied slideable locking knot116from a first position to a second position so that the bolster system100exerts tension on the fibula and tibia in a manner that can at least assist in the repair of the tibiofibular joint. Further, according to certain embodiments in which the pre-tied slideable locking knot116is embedded in the second bolster device104,104′,104″, such displacement of the pre-tied slideable locking knot116can be relative to the adjustable tether106, as the pre-tied slideable locking knot116can generally be at a relatively static position relative to the second bolster device104,104′,104″ and/or subjected to minimal axial displacement generally in a direction the along the central axis148,148′,148″ within the second bolster device104,104′,104″.

Alternatively, according to certain embodiments, when tightened, the pre-tied slideable locking knot116can be axially displaced from a first position at which the pre-tied slideable locking knot116, or a portion of the pre-tied slideable locking knot116, is positioned outside of the second bolster device104,104′,104″, to a second position in which the pre-tied slideable locking knot116is recessed inside of the second bolster device104,104′,104″. Additionally, according to certain embodiments, the second bolster device104,104′,104″ can be positioned such that at least a portion of the second bolster device104,104′,104″ extends into the passageway126and/or aperture152of the bone plate154prior to displacement of the pre-tied slideable locking knot116from the first position to the second position. Further, when at the second position, the pre-tied slideable locking knot116can be positioned or embedded in the channel147,147′,147″ of the second bolster device104,104′,104″ at a location in which the pre-tied slideable locking knot116abuts against or is otherwise in close proximity to the bridge portion178at the base of the channel147,147′,147″ of the second bolster device104,104′,104″. Further, the pre-tied slideable locking knot116is configured to prevent the pre-tied slideable locking knot116from returning from the second position to the first position along the adjustable tether106so as to at least assist the bolster system100in maintaining tension on fibula and tibia.

While the preceding examples and figures are discussed with respect to syndemosis repairs, it should be understood that the bolster system100can be utilized for repairs to a variety of other joints and/or bones. For example, as illustrated byFIGS. 16A-16C, the bolster system100can extend through adjacent metacarpal bones208a,208bof a wrist or band210. According to the illustrated example, a passageway can be drilled or otherwise formed through the first and second metacarpal bones108a,208bthat is sized to accommodate the passage of a first bolster device102when the first bolster device102is in a first orientation. Again, the adjustable tether106can be operably secured to the first device102prior to insertion of the first device102into the drilled or otherwise formed passageway in the first and second metacarpal bones208a,208b. Further, the second bolster device104″′ can be operably secured to the adjustable tether106by the pre-tied slideable locking knot116prior to insertion of the first bolster device102into the first and second metacarpal bones208a,208b. Moreover, according to certain embodiments, the pre-tied slideable locking knot116can be formed such that the pre-tied slideable locking knot116is embedded within the second bolster device102, wherein the pre-tied slideable locking knot116can remain at least before, during, and after the first bolster device102has been inserted into and through the passageway in the first and second metacarpal bones208a,208b, as well as before and during the displacement of the pre-tied slideable locking knot116from the first position to the second position relative to at least the adjustable tether106. Accordingly, similar to the previously discussed examples, upon exiting the passageway of the first metacarpal bone208a, the first bolster device102can be manipulated to a second position that prevents the first bolster device102from passing back through the passageway. With the first bolster device102in the second position, the first and/or second ends112,114of the adjustable tether106can be pulled, thereby reducing a length of the adjustable tether106that extends between at least the pre-tied slideable locking knot116and the first bolster device102, and thereby displacing the slideable locking knot116from the first position to the second position relative to at least the adjustable tether106.

FIGS. 17A and 17Billustrate an additional, non-limiting use of the bolster system100in the repair of joints and/or bones. Moreover, as shown inFIGS. 17A and 17B, the bolster system100can also be used in association with the repair of a shoulder such as, for example, repair of acromioclavicular (AC) joints212. As shown, in at least certain situations, implantation of the bolster system100can include passing the first bolster device102at a first orientation through a passageway drilled or otherwise formed in the clavicle214and the acromion216. With the first bolster device102extending out of the passageway and beyond the acromion216, the first bolster device102can be manipulated to a second orientation that prevents the first bolster device102from passing back through the passageway. While a variety of different shaped and sized first bolster devices102can be used with the bolster system100, according to certain embodiments, relatively small bolster devices102may be used such as, for example, bolster devices102having a width of about 3.5 millimeters (mm). The first and/or second ends112,114of the adjustable tether106can be pulled, thereby reducing a length of the adjustable tether106that extends between at least the pre-tied slideable locking knot116and the first bolster device102, and thereby displacing the slideable locking knot116from the first position to the second position relative to at least the adjustable tether106such that pre-tied slideable locking knot116is tightened at the second position. Moreover, the first and/or second ends112,114of the adjustable tether106can be pulled such that the pre-tied slideable locking knot116is tightened in a manner that prevents the length of the adjustable tether106between the first bolster device102and at least the pre-tied slideable locking knot116and/or the second bolster device104″″ from subsequently increasing.

Furthermore it should be understood that while the use of the word preferable, preferably, or preferred in the description above indicates that feature so described can be more desirable, it nonetheless may not be necessary and any embodiment lacking the same may be contemplated as within the scope of the invention, that scope being defined by the claims that follow. In reading the claims it is intended that when words such as “a,” “an,” “at least one” and “at least a portion” are used, there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. Further, when the language “at least a portion” and/or “a portion” is used the item may include a portion and/or the entire item unless specifically stated to the contrary.