Distal screw cluster for intramedullary tibial nail

Abstract

A tibial nail comprises an elongate body having a proximal end zone, a distal end zone and an intermediate zone extending therebetween along a central axis, at least one proximal fixation hole located in the proximal end zone for receiving a proximal fixation element, and a distal fixation hole cluster located in the distal end zone for receiving a plurality of distal fixation elements, wherein the distal fixation hole cluster includes multiple fixation holes extending at different trajectories and at different axial levels, wherein the elongate body is configured to be inserted into an intramedullary canal of a tibia bone to stabilize a distal tibial fracture.

Description

DISTAL SCREW CLUSTER FOR INTRAMEDULLARY TIBIAL NAILCLAIM OF PRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 702,538, filed on October 2, 2024, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0002] The present disclosure is generally directed to, but not by way of limitation, systems, devices and methods for performing medical procedures, such as long bone fracture fixation procedures. More specifically, but not by way of limitation, the present disclosure is directed to clusters, patterns and trajectories of fixation holes for intramedullary nails used to provide internal fixation of a long bone, such as a tibia bone.BACKGROUND

[0003] Sometimes long bones of the human body, such as the femur, tibia and humerus, can become fractured due to trauma. It can be desirable to repair the long bone by setting, e.g., immobilizing, the fractured pieces of the bone to permit healing. One area of the body that presents challenges is the ankle due to, for example, the presence of small bones, e.g., the talus, and the potential presence of small bone fragments on the tibia. Various known procedures for repairing an ankle joint include total ankle arthroplasty (TAA) and ankle fusion. Such procedures can involve implanting various implants including prostheses, plates and nails to facilitate healing. In some instances, however, extreme distal tibial fractures can be difficult to repair due to the presence of small bone fragments at the joint interface.

[0004] One manner of repairing distal tibial fractures can include the use of an intramedullary nail. Intramedullary nails can be used to align and stabilize fractures of a tibia by inserting the nail into the intramedullary canal of the tibia to extend across one or more fracture lines of the tibia. Fasteners, such as screws or other fixation devices, can be inserted into exterior cortical bone surfaces of the tibia and into bores within the intramedullary nail to immobilize the intramedullary nail. Fasteners can be positioned on opposing sides of thefracture to secure the opposing portions of the fractured tibia together. In some configurations, the opposing fasteners can be arranged to apply compression to the bone fragments to facilitate healing. One potential problem with conventional intramedullary nail systems is the occurrence of micromotion where slight movement of the bone fragments occurs due to imperfect alignment of the bone fragments, thereby delaying or preventing the healing process.

[0005] Examples of intramedullary nails are described in Pat. No. US 10,869,701 B2 to Van Dyke et al., titled “Joint Compression Instrumentation and Methods”; Pat. No. US 9,452,056 B2 to Early et al ., titled “Implants for Fixation of the Distal Tibia”; and Pub. No. US 2012 / 0330313 Al to Grady et al., titled “Intramedullary Nail Technology.”OVERVIEW

[0006] The present inventors have recognized, among other things, that problems to be solved in tibial intramedullary nails is the placement of fixation holes along the length of the tibial nail. Fixation holes are placed at various locations along the tibial nail in order to provide adequate fixation with intact bone and / or bone fragments on either side of the fracture location. However, these fixation holes are not always located in good positions for every bone fragment pattern. In particular, these fixation holes are typically located some distance away from the distal-most tip of the intramedullary nail. Such placement of the fixation holes is not useful in setting tibial fractures of or at the extreme distal end portion of the tibia. For example, sometimes the distal end of the tibia is fractured into fragments or pieces that are too small to receive a fastener. Thus, it is sometimes desirable, if not necessary, to use a tibial intramedullary nail that extends from the tibia into the ankle joint, e.g., into one or both of the talus and the calcaneus. However, such placement of the nail fuses the tibia bone with one or both of the talus and calcaneus bones of the ankle joint, limiting mobility and generating discomfort for the recipient of the nail.

[0007] The present subject matter can provide solutions to these and other problems, such as by providing a tibial intramedullary nail that includes a distal fixation hole cluster that provides a plurality of options for setting distal tibial bone fragments. The present inventors have recognized that some small bone fragments can receive a fastener, but only if the trajectory of the fastener is such that a sufficient amount of the fastener engages the bone fragment to provideadequate fixation. The distal fixation hole cluster can be located at the extreme distal end of the tibial nail. The distal fixation hole clusters of the present disclosure can include fixation holes at a plurality of different superior-inferior levels in close proximity to the distal end of the nail to increase stability. The distal fixation hole clusters can include fixation holes at different angles and rotational positions relative to the superior-inferior axis to provide precise placement of fixation elements and improved purchase with bone matter. As such, the distal fixation hole clusters of the present disclosure can provide a surgeon with options for finding a fastener trajectory that can locate and set small bone fragments at the distal end portion of a tibia bone.

[0008] In an example, a tibial nail can comprises an elongate body having a proximal end zone, a distal end zone and an intermediate zone extending therebetween along a central axis, at least one proximal fixation hole located in the proximal end zone for receiving a proximal fixation element, and a distal fixation hole cluster located in the distal end zone for receiving a plurality of distal fixation elements, wherein the distal fixation hole cluster includes multiple fixation holes extending at different trajectories and at different axial levels, wherein the elongate body is configured to be inserted into an intramedullary canal of a tibia bone to stabilize a distal tibial fracture.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. l is a side view of an intramedullary nail of the present disclosure having a distal fixation hole cluster.

[0010] FIG. 2 is a perspective view of the intramedullary nail of FIG. 1 having fasteners inserted therein.

[0011] FIG. 3 is a front view of a tibia bone having an intramedullary nail of the present disclosure inserted therein.

[0012] FIG. 4 is a close-up, side view of a proximal end of an intramedullary nail of the present disclosure showing a proximal fixation hole cluster.

[0013] FIG. 5 is a close-up, side view of a distal end of an intramedullary nail showing a distal fixation hole cluster of the present disclosure.

[0014] FIG. 6A is a front view of a distal end of an intramedullary nail of the present disclosure including fasteners inserted into a distal fixation hole cluster to show different longitudinal angles of the fixation holes.

[0015] FIG. 6B is a cross-sectional view of the distal fixation hole cluster of FIG. 6A with the fasteners removed.

[0016] FIG. 7A is a side view of a distal end of an intramedullary nail of the present disclosure including fasteners inserted into a distal fixation hole cluster to show different longitudinal levels of the fixation holes.

[0017] FIG. 7B is a cross-sectional view of the distal fixation hole cluster of FIG. 7A with the fasteners removed.

[0018] FIG. 8 is a bottom view of an intramedullary nail of the present disclosure showing fasteners inserted into a distal fixation hole cluster to show the rotational orientation of the fixation holes.DETAILED DESCRIPTION

[0019] FIG. 1 is a side view of intramedullary nail 100 of the present disclosure having distal fixation hole cluster 102. Intramedullary nail 100 can comprise elongate shaft 104 having proximal zone 106, distal zone 108 and intermediate zone 110. Proximal zone 106 can include proximal fixation hole cluster 112. Distal zone 108 can comprise distal fixation hole cluster 102. Intramedullary nail 100 can extend along central axis AA. Central axis AA can be centered along intermediate zone 110.

[0020] Elongate shaft 104 can be circular in cross-section, but can have other cross-sectional profiles, such as oval, elliptical, hexagonal, octagonal, square and the like. Elongate shaft 104 can have the same cross-sectional profile from proximal-most end tip 114 to distal-most end tip 116. However, in other examples, elongate shaft 104 can have different cross-sectional shapes. In examples, elongate shaft 104 can be tapered from proximal-most end tip 114 to distal-most end tip 116. In examples, elongate shaft 104 can be tapered between proximal zone 106 and distal zonel08. In examples, proximal zone 106 can be cylindrical, intermediate zone 110 can be tapered and distal zone 108 can be tapered.

[0021] In examples, elongate shaft 104 can be of solid construction. As such, proximal zone 106, distal zone 108 and intermediate zone 110 can be monolithic with each other. In examples, elongate shaft 104 can include an internal lumen extending therethrough. In examples, intermediate zone 110 can be solid, and proximal zone 106 and distal zone 108 can include blind-end bores. Elongate shaft 104 can comprise a body fabricated from biocompatible material, such as steel, stainless steel, titanium, titanium alloys and others.

[0022] Elongate shaft 104 can be configured for insertion into a tibial bone. As such, elongate shaft 104 can be shaped or contoured to match the anatomical shape of a tibial bone or to facilitate insertion therein. In examples, proximal zone 106 can extend along axis AX and can be angled in the anterior direction relative to intermediate zone 110 at angle al. In examples angle al can be in the rage of approximately four degrees to twenty degrees. In examples angle al can be approximately nine degrees. In examples, distal zone 108 can extend along local axis AB and can be angled in the anterior direction relative to intermediate zone 110 at angle a2. In examples angle a2 can be in the rage of approximately two degrees to ten degrees. In examples angle a2 can be approximately three degrees.

[0023] Proximal fixation hole cluster 112 of proximal zone 106 can include fixation hole 118, fixation hole 120, fixation hole 122 and slot 124, as discussed in greater detail with reference to FIG. 4. Distal fixation hole cluster 102 of distal zone 108 can include fixation hole 126A through fixation hole 126E, as discussed in greater detail with reference to FIG. 5 through FIG. 8. In examples, fixation hole 118 through fixation hole 122 and fixation hole 126A through fixation hole 126E can comprise through bores having smooth internal surfaces to allow fasteners to pass therethrough and allow sliding therebetween. In examples, fixation hole 118 through fixation hole 122 and fixation hole 126A through fixation hole 126E can comprise threaded bores having grooved or threaded internal surfaces to allow mating fasteners to threadedly engage therein.

[0024] Distal fixation hole cluster 102 can be located completely on distal zone 108. Distal fixation hole cluster 102 can be located distal of the juncture between distal zone 108 and intermediate zone 110. That is, all of fixation hole 126A through fixation hole 126E can be located between distal-most end tip 116 and where distal zone 108 joins to intermediate zone110. In particular, distal fixation hole cluster 102 can be located within a short distance of distal- most end tip 116, as discussed with reference to distance D2 in FIG. 5.

[0025] FIG. 2 is a perspective view of intramedullary nail 100 of FIG. 1 having fasteners inserted therein. For example, proximal fixation hole cluster 112 can comprise fastener 130, fastener 132 and fastener 134, and distal fixation hole cluster 102 can comprise fastener 136A. Fasteners for proximal fixation hole cluster 112 and distal fixation hole cluster 102 can comprise any suitable type of fixation device or element, such as screws, pins, bolts, rivets, anchors and the like. Fasteners for proximal fixation hole cluster 112 and distal fixation hole cluster 102 can be fabricated of any suitable material, such as biocompatible materials including steel, stainless steel, titanium, titanium alloys and others. Fasteners of proximal fixation hole cluster 112 can be arranged in any suitable manner to provide fixation with a proximal portion of a tibia bone, as shown in FIG. 3. As described herein, fasteners of distal fixation hole cluster 102 can be arranged to provide fixation with an extreme distal portion of a tibia bone. In particular, fasteners inserted into distal fixation hole cluster 102 can be located at different superior-inferior levels, different angles and different rotations to provide adequate purchase in bone material, particularly small bone fragments, while minimizing interference with soft tissue, e.g., nerves, of the bone. Note, the side of intramedullary nail 100 that fastener 136A and fastener 136E are inserted into can be reversed for left-side and right-side limbs.

[0026] FIG. 3 is a front view of tibia bone 150 having intramedullary nail 100 of the present disclosure inserted therein. Tibia bone 150 can extend from head 152 having medial and lateral condyles for engaging with a femur at proximal end 154 to inferior articular surface 156 for engaging with talus 158 at distal end 160. Proximal fixation hole cluster 112 can be located within or near head 152. Proximal fixation hole cluster 112 can be provided with fastener 130, fastener 132 and fastener 134. Distal fixation hole cluster 102 can be located proximate to inferior articular surface 156. Distal fixation hole cluster 102 can be provided with fastener 136A, fastener 136B, fastener 136C, fastener 136D and fastener 136E. As shown, the fasteners can include shanks that can be inserted through the cortical bone wall of tibia bone 150 and heads attached to the shanks that engage an exterior of the cortical bone wall of tibia bone 150.

[0027] As discussed herein, it can be desirable to position distal fixation hole cluster 102 in close proximity to distal-most end tip 116 in order to allow one or more fasteners inserted thereinto gain adequate purchase with one or more bone fragments at the extreme distal end portion of tibia bone 150. However, due to the varying lengths of tibia bones of different people, the distance DI from inferior articular surface 156 and distal-most end tip 116 can vary in practice. Intramedullary nail 100 of the present disclosure can be configured in different sizes, e.g., different lengths and / or different diameters. A surgeon can select an instance of intramedullary nail 100 having a suitable length to position distal-most end tip 116 close to inferior articular surface 156 without penetrating therethrough. Thus, intramedullary nail 100 can be manufactured in sets having a plurality of different lengths. In examples, the lengths of intramedullary nail 100 can come in different lengths at intervals in the range of approximately one millimeter to approximately fifteen millimeters. In examples, intramedullary nail 100 can come in approximately one-millimeter increments, five-millimeter increments or ten-millimeter increments to ensure one size of intramedullary nail 100 will come close to inferior articular surface 156.

[0028] Once intramedullary nail 100 is implanted, distal-most end tip 116 can be located distance DI from inferior articular surface 156. Note, distance DI is not necessarily shown to scale in FIG. 3. In examples, it can be desirable for distance DI to be in the range of approximately one millimeter to approximately two millimeters. However, as mentioned, in practice, distance DI can vary based on the length of intramedullary nail 100 selected and the length of the tibial bone of the specific patient. In each case, it can be desirable for the surgeon to select an intramedullary nail size to allow for the placement of distal fixation hole cluster 102 close to inferior articular surface 156, particularly in the case of tibial fractures having small sized bone fragments at or near inferior articular surface 156. As such, it can be desirable to place one or more fixation holes extremely close to distal-most end tip 116 of intramedullary nail 100. All of fixation holes 126A through fixation hole 126E of distal fixation hole cluster 102 can be located within a small distance, D2 (FIG. 5), from distal-most end tip 116 to provide flexibility for inserting fasteners into distal end 160 of tibia bone 150 in multiple different patterns.

[0029] FIG. 4 is a close-up, side view of proximal zone 106 of intramedullary nail 100 of the present disclosure showing proximal fixation hole cluster 112. Proximal fixation hole cluster 112 can comprise fixation hole 118, fixation hole 120, fixation hole 122 and slot 124. Fixationhole 118, fixation hole 120, fixation hole 122 and slot 124 can be configured to receive fixation elements, such as threaded screws, to attach intramedullary nail 100 to tibia bone 150. Proximal fixation hole cluster 112 can comprise any suitable pattern for attaching fasteners to proximal zone 106 of intramedullary nail 100. In examples, proximal-most end tip 114 can include a bore, such as a blind end bore, that intersects one or more of fixation hole 118, fixation hole 120, fixation hole 122 and slot 124 to allow a vertical, locking fastener to push down on a fastener inserted into one of fixation hole 118, fixation hole 120, fixation hole 122 and slot 124. In examples, proximal zone 106 of intramedullary nail 100 can include CoreLock Technology commercially available from Zimmer Biomet. In examples, proximal zone 106 of intramedullary nail 100 can include fixation features described in Pat. No. US 9,320,551 B2 to Frank et al., titled “Lockable Intramedullary Fixation Device,” the entire contents of which are hereby incorporated by this reference.

[0030] FIG. 5 is a close-up, side view of distal zone 108 of intramedullary nail 100 showing distal fixation hole cluster 102 of the present disclosure. Distal fixation hole cluster 102 of distal zone 108 can include fixation hole 126A through fixation hole 126E, as discussed in greater detail with reference to FIG. 6 A through FIG. 8.

[0031] Distal zone 108 can extend along local axis AB. As discussed with reference to FIG. 1, distal zone 108 can be angled at angle a2 relative to central axis AA of intermediate zone 110. Local axis AB can comprise the central axis of distal zone 108.

[0032] The proximal-most hole of distal fixation hole cluster 102, fixation hole 126A, can be located distance D2 from distal-most end tip 116. In the illustrated example, distance D2 can extend from distal-most end tip 116 to the center of fixation hole 126A. In examples, distance D2 can be in the range of approximately thirty millimeters to approximately thirty-five millimeters. In examples, distance D2 can be approximately thirty-four millimeters from distal- most end tip 116. In examples, distance D2 can be approximately thirty -two and one-half millimeters. In other examples, distance D2 can comprise a length adequate to encompass the entirety of all of fixation hole 126A through fixation hole 126E, specifically, to the proximal side of fixation hole 126A.

[0033] The distal-most hole of distal fixation hole cluster 102, fixation hole 126E, can be located distance D6 from distal -most end tip 116. As discussed herein, it can be desirable toplace fixation hole 126E close to distal-most end tip 116 to allow for fixation of bone fragments proximate to inferior articular surface 156 (FIG. 3), such as peri -articular fragments, without having to extend intramedullary nail 100 into the ankle joint. As such, it can be desirable to place one or more fixation holes extremely close to distal-most end tip 116 of intramedullary nail 100 without sacrificing the ability of the material of intramedullary nail 100 to remain rigid and hold the fastener within the distal most fixation hole in a fixed manner. For example, if fixation hole 126E were placed too close to distal-most end tip 116, the material of intramedullary nail 100 might flex under stress, such as when fasteners are used to lock-down intramedullary nail 100 with bone matter. However, in examples, the thickness of material along the sides of fixation hole 126E can be reinforced to allow the bottom of fixation hole 126E to penetrate through distal -most end tip 116. In examples, the length between the bottom of fixation hole 126E and distal-most end tip 116 can be approximately one-half the size of the diameter of fixation hole 126E. In examples, fixation holes of the present disclosure can be approximately five millimeters in diameter.

[0034] As discussed below, each of fixation hole 126A, fixation hole 126B, fixation hole 126C, fixation hole 126D and fixation hole 126E can be spaced axially along axis AB, rotated horizontally relative to axis AB and angled vertically relative to axis AB to provide a distal fixation hole cluster that provides options for purchasing bone matter near inferior articular surface 156 without interfering with soft tissue, such as neurovascular structure in the anterior compartment of the tibia. In particular, the fixation holes of distal fixation hole cluster 102 can be spaced, rotated and angled to allow a surgeon to select a fastener trajectory that can penetrate small bone fragments near inferior articular surface 156 with adequate bone engagement.

[0035] FIG. 6A is a front or anterior view of a distal end of intramedullary nail 100 showing distal fixation hole cluster 102 of the present disclosure including fastener 136A through fastener 136E inserted therein. FIG. 6B is a cross-sectional view of distal fixation hole cluster 102 of FIG. 6A with the fasteners removed. FIG. 6A and FIG. 6B are discussed concurrently. Note, the side of intramedullary nail 100 that fastener 136A and fastener 136E are inserted into are reversed in FIG. 6A from what is shown in FIG. 3.

[0036] Fixation hole 126A can extend along central axis AC. Fixation hole 126A and central axis AC can extend perpendicular to axis AB. Fixation hole 126A can extend in the medial- lateral direction.

[0037] Fixation hole 126B can extend along central axis AD, as can be seen more clearly in FIG. 7B. Fixation hole 126B and central axis AD can extend perpendicular to axis AB. Fixation hole 126B can extend in the anterior-posterior direction. Fixation hole 126B can be orthogonal to fixation hole 126A.

[0038] Fixation hole 126C can extend along central axis AE. Fixation hole 126C and central axis AE can be angled from vertical. Fixation hole 126C can have an anterior-superior to posterior-inferior trajectory. Furthermore, fixation hole 126C can have a lateral -to-medial trajectory. Fixation hole 126C can be oblique to fixation hole 126A and fixation hole 126B. Fixation hole 126C and central axis AE can extend relative to axis AB at angle a3. In examples, angle a3 can be in the range of approximately eighteen degrees to approximately twenty-two degrees. In examples, angle a3 can be approximately twenty degrees.

[0039] Fixation hole 126D can extend along central axis AF. Fixation hole 126D and central axis AF can be angled from vertical. Fixation hole 126D can have an anterior-superior to posterior-inferior trajectory. Furthermore, fixation hole 126D can have a medial-to-lateral trajectory. Fixation hole 126C can be oblique to fixation hole 126A and fixation hole 126B. Fixation hole 126D and central axis AF can extend relative to axis AB at angle a4. In examples, angle a4 can be in the range of approximately eighteen degrees to approximately twenty-two degrees. In examples, angle a4 can be approximately twenty degrees.

[0040] Fixation hole 126E can extend along central axis AG. Fixation hole 126E and central axis AG can extend perpendicular to axis AB. Fixation hole 126E can extend in the medial lateral-direction. Fixation hole 126B can be parallel to fixation hole 126A and orthogonal to fixation hole 126B.

[0041] The angling of fixation hole 126C and fixation hole 126D as shown in FIG. 6B can allow fastener 136C and fastener 136D to project downward or distally to reach distal fragments of tibia bone 150 (FIG. 3). Fixation hole 126C and fixation hole 126D can comprise coronally or obliquely angled fixation holes.

[0042] FIG. 6A and FIG. 6B show particular angular orientations relative to vertical of fixation hole 126 A to fixation hole 126E. However, in examples, fixation holes of distal fixation hole cluster 102 through can be arranged at other vertical angles. In examples, fixation hole 126A and fixation hole 126E can comprise posterior-anterior or inferior-superior holes.

[0043] FIG. 7A is a side view of a distal end of intramedullary nail 100 showing distal fixation hole cluster 102 of the present disclosure including fastener 136A through fastener 136E inserted therein. FIG. 7B is a cross-sectional view of distal fixation hole cluster 102 of FIG. 7A with the fasteners removed. FIG. 7A and FIG. 7B are discussed concurrently.

[0044] As discussed with reference to FIG. 5, the proximal-most hole, fixation hole 126A, can be located distance D2 from distal -most end tip 116. Distance D2 can extend from distal- most end tip 116 to the center of fixation hole 126A.

[0045] Fixation hole 126B can be located distance D3 from distal-most end tip 116. In examples, D3 can be in the range of approximately twenty-five millimeters to approximately twenty-nine millimeters. In examples, distance D3 can be approximately twenty-eight millimeters. In examples, distance D3 can be approximately twenty-seven millimeters. Distance D3 can extend from distal-most end tip 116 to the center of fixation hole 126B.

[0046] Fixation hole 126C can be located distance D4 from distal-most end tip 116. In examples, D4 can be in the range of approximately twenty millimeters to approximately sixteen millimeters. In examples, distance D4 can be approximately nineteen millimeters. In examples, distance D4 can be approximately eighteen millimeters. Distance D4 can extend from distal- most end tip 116 to the center of fixation hole 126C at the median height of fixation hole 126C.

[0047] Fixation hole 126D can be located distance D5 from distal-most end tip 116. In examples, D5 can be in the range of approximately fourteen millimeters to approximately ten millimeters. In examples, distance D5 can be approximately thirteen millimeters. In examples, distance D5 can be approximately twelve millimeters. Distance D5 can extend from distal-most end tip 116 to the center of fixation hole 126D at the median height of fixation hole 126D.

[0048] The distal-most hole, fixation hole 126E, can be located distance D6 from distal-most end tip 116. In examples, D6 can be in the range of approximately one millimeter to approximately seven millimeters. In examples, distance D6 can be approximately five and one-half millimeters. In examples, distance D6 can be approximately four and one-half millimeters. Distance D6 can extend from distal-most end tip 116 to the center of fixation hole 126E.

[0049] The vertical stacking of fixation hole 126A through fixation hole 126E along axis AB as shown in FIG. 8 can be configured to allow a bone fastener to enter into a bone fragment at a level appropriate to enter a bone fragment to obtain purchase with bone matter of a bone fragment, e.g., at a center of a bone fragment. The smaller the bone fragment, the lower the fixation hole can be. Likewise, the angling of two of the middle, stacked fixation holes, e.g., fixation hole 126C and fixation hole 126D, can allow for entry into intermediate sized bone fragments at intervals closer than the stacked vertical height of each fixation hole, e.g., D2 - D6, particularly toward posterior portions of the tibia. In other words, fixation hole 126C and fixation hole 126D can be angled downward to reach smaller bone fragments close to distal-most end tip 116 than are at the exact heights of D4 and D5.

[0050] FIG. 7A and FIG. 7B show a particular top-to-bottom order of fixation hole 126A to fixation hole 126E. However, in examples, fixation holes of distal fixation hole cluster 102 through can be arranged in other top-to-bottom orders. For example, fixation hole 126B can be moved from the second from the top hole to the second from the bottom hole, with fixation hole 126C and fixation hole 126D moving up accordingly.

[0051] FIG. 8 is a bottom or inferior view of intramedullary nail 100 showing distal fixation hole cluster 102 of the present disclosure including fastener 136A through fastener 136E inserted therein. FIG. 8 shows a view parallel to the plane of distal -most end tip 116. As such, axis AB (FIG. 5) extends perpendicularly into the plane of FIG. 8. FIG. 8 shows axis AC through axis AG for fastener 136A through fastener 136E, respectively. As such, axis AC through axis AG are shown at rotational angles relative to axis AB of distal zone 108. Fixation hole 126C and fixation hole 126D can comprise sagittally angled fixation holes.

[0052] Axis AD can extend in the anterior-posterior direction. Axis AD can be parallel to and coincident with the sagittal plane.

[0053] Axis AC and axis AG can extend in the medial-lateral direction. Axis AC and axis AG can be parallel to and coincident with the coronal plane. Axis AC and axis AG can be perpendicular to the sagittal plane.

[0054] Axis AE can be angled relative to the sagittal plane. Axis AE can extend relative to the sagittal plane angle a5. In examples, angle a5 can be in the range of approximately thirty degrees to approximately forty degrees. In examples, angle a5 can be approximately thirty-five degrees.

[0055] Axis AF can be angled relative to the sagittal plane. Axis AF can extend relative to the sagittal plane angle a6. In examples, angle u.6 can be in the range of approximately thirty degrees to approximately forty degrees. In examples, angle a6 can be approximately thirty-five degrees.

[0056] The angling of fixation hole 126C and fixation hole 126D as shown in FIG. 8 can be configured to extend into the medial and lateral portions of tibia bone 150 (FIG. 3) away from the medial-lateral midline to converge in the posterior portion of tibia bone 150 thereby leaving the anterior portion of tibia bone 150 and neurovascular structure of the anterior compartment of tibia bone 150 uncontacted and unharmed.

[0057] FIG. 8 shows particular angular orientations relative to a horizontal plane of fixation hole 126A to fixation hole 126E. However, in examples, fixation holes of distal fixation hole cluster 102 through can be arranged at other horizontal orientations. In examples, fixation hole 126A and fixation hole 126E can comprise anterior-posterior holes, and fixation hole 126B can comprise a medial-lateral hole.

[0058] The present disclosure describes intramedullary nails for treating distal tibial fractures, particularly those involving small bone fragments near the ankle joint. Some of the features and benefits of the present disclosure include:

[0059] 1. Distal Fixation Hole Cluster: A distal fixation hole cluster can be located at the extreme distal end of the tibial nail. The distal fixation hole cluster can comprise multiple fixation holes in close proximity to the distal end tip. The distal fixation hole cluster can allow for fixation of small bone fragments near the inferior articular surface of a tibial bone without extending the nail into the ankle joint.

[0060] 2 Flexible Fixation Options: The intramedullary nails of the present disclosure can include distal fixation holes at different superior-inferior levels. The distal fixation holes can be positioned at various angles and rotational positions relative to the superior-inferior axis. Thisarrangement can provide surgeons with multiple options for fastener trajectories to locate and set small bone fragments.

[0061] 3. Improved Stability: The multiple fixation holes at different levels can also increase stability in the distal portion of the nail.

[0062] 4. Precise Placement: The multiple fixation holes and varied angles and positions of the fixation holes can allow for improved purchase with bone matter. These features can help in setting extremely distal tibial fractures that may be difficult to repair due to small bone fragments at the joint interface.

[0063] 5. Anatomical Considerations: The intramedullary nail and the fixation holes of the distal fixation hole cluster are designed to avoid intersecting soft tissue, such as nerves and tendons of the tibial bone. The proximal and distal zones of the intramedullary nail can be angled relative to the intermediate zone of the intramedullary nail to facilitate insertion and proper positioning.

[0001] 6 Customizable Length: The intramedullary nails of the present disclosure can be manufactured in different lengths to accommodate varying patient anatomies, e.g., different lengths of tibia bones. This can allow surgeons to select a size that positions the distal fixation hole cluster close to the inferior articular surface without penetrating it.

[0002] One of the main benefits of the present disclosure is the ability of the intramedullary nails to address the challenge of fixing extremely distal tibial fractures without the need to extend the nail into the ankle joint. This approach can potentially reduce complications associated with ankle fusion while still providing adequate fixation for small bone fragments near the ankle joint. The multiple fixation options offered by the distal hole cluster of the present disclosure give surgeons flexibility in treating various fracture patterns, potentially improving patient outcomes in cases where conventional intramedullary nails may be less effective. Although described with respect to a tibia bone, the fixation holes clusters of the present application can be used in intramedullary nails for other long bones, such as a femur.Examples

[0003] Example 1 is a tibial nail comprising: an elongate body having a proximal end zone, a distal end zone and an intermediate zone extending therebetween along a central axis; at leastone proximal fixation hole located in the proximal end zone for receiving a proximal fixation element; and a distal fixation hole cluster located in the distal end zone for receiving a plurality of distal fixation elements, wherein the distal fixation hole cluster includes multiple fixation holes extending at different trajectories and at different axial levels; wherein the elongate body is configured to be inserted into an intramedullary canal of a tibia bone to stabilize a distal tibial fracture.

[0004] In Example 2, the subject matter of Example 1 optionally includes wherein the distal end zone comprises a length starting from a distal-most end tip of the tibial nail extending to encompass the distal fixation hole cluster.

[0005] In Example 3, the subject matter of Example 2 optionally includes wherein the distal end zone comprises a length starting from the distal-most end tip of the tibial nail extending to a center of a proximal-most distal fixation hole.

[0006] In Example 4, the subject matter of any one or more of Examples 2-3 optionally include wherein a distal-most fixation hole of the distal fixation hole cluster has a center located approximately 4.5 millimeters from the distal-most end tip of the tibial nail.In Example 5, the subject matter of any one or more of Examples 3-4 optionally include wherein the distal end zone comprises a length in a range of approximately 28.5 millimeters to approximately 36.5 millimeters starting from the distal-most end tip of the tibial nail.

[0007] In Example 6, the subject matter of Example 5 optionally includes wherein the distal end zone comprises a length of 32.5 millimeters starting from the distal-most end tip of the tibial nail.

[0008] In Example 7, the subject matter of any one or more of Examples 2-6 optionally include wherein the distal fixation hole cluster comprises five distal fixation holes.

[0009] In Example 8, the subject matter of Example 7 optionally includes wherein the distal fixation hole cluster comprises more than one oblique fixation hole angled relative to the central axis.

[0010] In Example 9, the subject matter of Example 8 optionally includes wherein the distal fixation hole cluster comprises two oblique fixation holes, wherein each of the two oblique fixation holes is angled relative to the central axis at an angle in a range of approximately eighteen degrees to approximately twenty-two degrees.

[0011] In Example 10, the subject matter of Example 9 optionally includes wherein each of the two oblique fixation holes is angled relative to the central axis at an angle of twenty degrees.

[0012] In Example 11, the subject matter of any one or more of Examples 7-10 optionally include wherein the distal fixation hole cluster comprises two coronal fixation holes extending in a medial -lateral direction.

[0013] In Example 12, the subject matter of Example 11 optionally includes wherein one of the two coronal fixation holes is a distal-most fixation hole of the distal fixation hole cluster.

[0014] In Example 13, the subject matter of any one or more of Examples 11-12 optionally include wherein one of the two coronal fixation holes is a proximal-most fixation hole of the distal fixation hole cluster.

[0015] In Example 14, the subject matter of any one or more of Examples 7-13 optionally include wherein the distal fixation hole cluster comprises a sagittal fixation hole extending in an anterior-posterior direction.

[0016] In Example 15, the subject matter of any one or more of Examples 7-14 optionally include wherein the distal fixation hole cluster comprises two sagittally angled fixation holes.

[0017] In Example 16, the subject matter of Example 15 optionally includes wherein each of the two sagittally angled fixation holes is angled relative to a sagittal plane in a range of approximately thirty degrees to approximately forty degrees.

[0018] In Example 17, the subject matter of Example 16 optionally includes wherein each of the two sagittally angled fixation holes is angled relative to the sagittal plane at an angle of thirty -five degrees.

[0019] In Example 18, the subject matter of any one or more of Examples 7-17 optionally include wherein a center of a first distal fixation hole is located 4.5 millimeters from the distal- most end tip of the tibial nail, a center of a second distal fixation hole is located 12 millimeters from the distal -most end tip of the tibial nail, a center of a third distal fixation hole is located 18 millimeters from the distal-most end tip of the tibial nail, a center of a fourth distal fixation hole is located 27 millimeters from the distal-most end tip of the tibial nail, and a center of a fifth distal fixation hole is located 32.5 millimeters from the distal-most end tip of the tibial nail.

[0020] In Example 19, the subject matter of Example 18 optionally includes wherein: the first distal fixation hole extends in a medial -lateral direction; the second distal fixation holeextends in an anterior-posterior direction; the third distal fixation hole extends along an anterior- superior to posterior-inferior trajectory; the fourth distal fixation hole extends along an anterior- superior to posterior-inferior trajectory; and the fifth distal fixation hole extends in a medial- lateral direction.

[0021] In Example 20, the subject matter of any one or more of Examples 5-19 optionally include wherein the distal end zone is angled relative to the intermediate zone.

[0022] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.Various Notes

[0023] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventor also contemplates examples in which only those elements shown or described are provided. Moreover, the present inventor also contemplates examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0024] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.

[0025] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in aclaim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0026] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

THE CLAIMED INVENTION IS:

1. A tibial nail comprising: an elongate body having a proximal end zone, a distal end zone and an intermediate zone extending therebetween along a central axis; at least one proximal fixation hole located in the proximal end zone for receiving a proximal fixation element; and a distal fixation hole cluster located in the distal end zone for receiving a plurality of distal fixation elements, wherein the distal fixation hole cluster includes multiple fixation holes extending at different trajectories and at different axial levels; wherein the elongate body is configured to be inserted into an intramedullary canal of a tibia bone to stabilize a distal tibial fracture.

2. The tibial nail of claim 1, wherein the distal end zone comprises a length starting from a distal-most end tip of the tibial nail extending to encompass the distal fixation hole cluster.

3. The tibial nail of claim 2, wherein the distal end zone comprises a length starting from the distal-most end tip of the tibial nail extending to a center of a proximal-most distal fixation hole.

4. The tibial nail of any one of claim 2 and claim 3, wherein a distal-most fixation hole of the distal fixation hole cluster has a center located approximately 4.5 millimeters from the distal- most end tip of the tibial nail.

5. The tibial nail of any one of claim 3 through claim 4, wherein the distal end zone comprises a length in a range of approximately 28.5 millimeters to approximately 36.5 millimeters starting from the distal-most end tip of the tibial nail.

6. The tibial nail of claim 5, wherein the distal end zone comprises a length of 32.5 millimeters starting from the distal-most end tip of the tibial nail.

7. The tibial nail of any one of claim 2 through claim 4, wherein the distal fixation hole cluster comprises five distal fixation holes.

8. The tibial nail of any one of claim 2 through claim 4, wherein the distal fixation hole cluster comprises more than one oblique fixation hole angled relative to the central axis.

9. The tibial nail of claim 8, wherein the distal fixation hole cluster comprises two oblique fixation holes, wherein each of the two oblique fixation holes is angled relative to the central axis at an angle in a range of approximately eighteen degrees to approximately twenty-two degrees.

10. The tibial nail of claim 9, wherein each of the two oblique fixation holes is angled relative to the central axis at an angle of twenty degrees.

11. The tibial nail of any one of claim 2 through claim 4, wherein the distal fixation hole cluster comprises two coronal fixation holes extending in a medial-lateral direction.

12. The tibial nail of claim 11, wherein one of the two coronal fixation holes is a distal-most fixation hole of the distal fixation hole cluster.

13. The tibial nail of claim 11, wherein one of the two coronal fixation holes is a proximal- most fixation hole of the distal fixation hole cluster.

14. The tibial nail of any one of claim 2 through claim 4, wherein the distal fixation hole cluster comprises a sagittal fixation hole extending in an anterior-posterior direction.

15. The tibial nail of any one of claim 2 through claim 4, wherein the distal fixation hole cluster comprises two sagittally angled fixation holes.

16. The tibial nail of claim 15, wherein each of the two sagittally angled fixation holes is angled relative to a sagittal plane in a range of approximately thirty degrees to approximately forty degrees.

17. The tibial nail of claim 16, wherein each of the two sagittally angled fixation holes is angled relative to the sagittal plane at an angle of thirty-five degrees.

18. The tibial nail of any one of claim 2 through claim 4, wherein: a center of a first distal fixation hole is located 4.5 millimeters from the distal-most end tip of the tibial nail; a center of a second distal fixation hole is located 12 millimeters from the distal -most end tip of the tibial nail; a center of a third distal fixation hole is located 18 millimeters from the distal-most end tip of the tibial nail; a center of a fourth distal fixation hole is located 27 millimeters from the distal-most end tip of the tibial nail; and a center of a fifth distal fixation hole is located 32.5 millimeters from the distal-most end tip of the tibial nail.

19. The tibial nail of claim 18, wherein: the first distal fixation hole extends in a medial-lateral direction; the second distal fixation hole extends in an anterior-posterior direction; the third distal fixation hole extends along an anterior-superior to posterior-inferior trajectory; the fourth distal fixation hole extends along an anterior-superior to posterior-inferior trajectory; and the fifth distal fixation hole extends in a medial -lateral direction.

20. The tibial nail of claim 5, wherein the distal end zone is angled relative to the intermediate zone.

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