Systems and methods for bone fracture repair

Abstract

A fracture repair system using a tension / compression locking configuration is described herein. In some embodiments, the fracture repair system includes one or more bone anchors, one or more locking elements configured to be nested within the one or more bone anchors, and one or more flexible tension members configured to interact with the bone anchors and the locking elements to securely hold fractured bone pieces in place for healing while also creating a tension band construct that prevents the bone pieces from being displaced by forces that tend to pull the bone pieces apart.

Description

[0001] Cross-references to related applications

[0002] This application is an international application claiming priority interests in U.S. Provisional Application No. 63 / 599,795, filed November 16, 2023, and U.S. Provisional Application No. 63 / 601,128, filed November 20, 2023, pursuant to 35 USC § 119(e), the entire disclosures of which are incorporated herein by reference as if fully set forth herein. Technical Field

[0003] This disclosure generally relates to soft tissue-to-bone and bone-to-bone repair and reconstruction, and more specifically to systems and methods for repairing fractured bones using multiple bone anchors and one or more tension members to fix the repair structure. Background Technology

[0004] Current tension band repair techniques require the use of stainless steel wire or suture tape. As seen in patellar fractures, wire has a high revision rate. The use of wire leads to numerous revisions due to implant-related symptoms. Recent techniques using tape as an alternative to stainless steel wire require surgeons to tie knots. Several challenges of this technique include knot failure and the need to maintain tension at the repair site while tying the knots.

[0005] Patellar fractures typically account for 1% of all bone fractures, with approximately 350,000 to 400,000 repair surgeries performed annually. The revision rate is high due to hardware-related issues. Poorly healed fractures can also lead to arthritis, necessitating resurfacing arthroplasty. The novel technique disclosed in this paper optimizes repair outcomes by allowing for precise tensioning, avoiding the use of metal hardware for tension band repair, and minimizing loosening that could lead to separation of the fracture site. Summary of the Invention

[0006] This disclosure introduces a novel technique for performing repairs (i.e., tension band constructs) that allows for knot-free repair. In addition to fracture repair, this technique can be used for soft tissue-to-bone and bone-to-bone repairs. Although illustrated and described herein in the context of patellar fractures, it should be understood that the fracture repair system disclosed herein can be used to repair soft tissue and / or fractured bone in any suitable anatomical location of the body, including but not limited to the patella, ankle, medial malleolus, olecranon, etc.

[0007] Once installed, the fracture repair system of this disclosure is used to reduce fractures and maintain compression of the fractured bone for healing. As an example, reduction is maintained by: a) tension generated within the system; b) a locking interface; and c) a reaction force generated by an annular tension member, which, based on its interaction with the locking element, counteracts forces attempting to separate the fracture, specifically by increasing the tension within the system. These features will resist any forces attempting to pull and separate the repaired bone fragments. Using this novel technology, surgeons will be able to generate tension within the system and perform tension band repair on the fractured bone. Once assembled, the tension member can slide in one direction, allowing the surgeon to eliminate any slack in the system (and / or increase tension), and once maximum tension is reached, the system will lock and repair in a knot-free manner.

[0008] By way of example only, the various embodiments disclosed herein illustrate repairs performed in a cross-shaped manner, but repairs can also be implemented with a single screw and locking element configuration, while the tension member is secured at the locking interface.

[0009] In some embodiments, the fracture repair system described herein includes at least one bone anchor, at least one locking element, and at least one flexible tension member configured to interact with the bone anchor and the locking element to securely hold the fractured bone fragment in place for healing, while also creating a tension band structure that prevents the bone fragment from shifting due to forces that tend to pull the bone fragment apart.

[0010] In some embodiments, the bone anchor has a head at its proximal end, an elongated rod extending distally from the head, and an internal cavity or through-channel extending along the length of the rod and having a proximal opening within the head and a distal opening at the distal end of the rod. In some embodiments, the head further includes a proximal recess comprising a drive feature configured to engage with a drive tool. In some embodiments, the head may also include one or more grooves formed in its outer surface to facilitate insertion of the head into bone. In some embodiments, the rod comprises a cylindrical member having a smooth outer surface portion and a threaded outer surface portion. In some embodiments, the threaded outer surface portion is located at or near the distal end of the rod, and the smooth outer surface portion is located near the head. In some embodiments, the bone anchor may have a fully threaded rod. By way of example only, the threaded outer surface portion is configured to insert into and obtain gripping within a bone fragment (e.g., a fractured distal bone fragment) to hold the distal and proximal bone fragments together. In some embodiments, the head further includes a circumferential mating surface, which may be a tapered or concave surface positioned within a proximal recess and surrounding the proximal opening of the through-channel. In some embodiments, the circumferential mating surface serves as a first locking surface that mates with a distal engagement surface of the locking element and / or a concave cutout positioned within the distal engagement surface of the locking element (e.g., a second locking surface) to form one or more "pinch points" that secure the tension member between them, thereby locking the fracture repair system under tension. As an example, the bone anchor can be provided in any suitable length. In some embodiments, the bone anchor may have a rod without a head, and the "pinch points" may be formed at the proximal end of the headless rod, for example, at the proximal opening of the through-channel or at a location within the through-channel.

[0011] In some embodiments, the locking element has a proximal head and a distal extension extending longitudinally from the proximal head. In some embodiments, the locking element is configured such that the size and shape of the distal extension are designed to extend into the through-channel of the bone anchor, while the head is received within the proximal recess.

[0012] In some embodiments, the proximal head includes an internal cavity and a plurality of orifices formed in the head, which serve as inlets and outlets for the tension member to pass through during assembly and tensioning of the fracture repair system. For example, in some embodiments, the head may have a pair of proximal orifices and transverse orifices positioned on opposite sides of the head. In some embodiments, the proximal head has a bottom or distal portion including a distal engagement surface that may be convex or conical and may or may not include a concave incision positioned within the distal engagement surface. In some embodiments, the distal engagement surface and / or the concave incision serves as a second locking surface that engages with a circumferential mating surface of the bone anchor (e.g., a first locking surface) to form one or more "pinch points" that hold the tension member between them, thereby locking the fracture repair system under tension. As an example, the concave incision provides space for the tension member to pass between the bone anchor and the plug insert, while remaining held and locked within the concave incision when the system is finally tightened. In some embodiments, the proximal head may include one or more smooth concave lateral recesses located near the lateral orifice, the one or more smooth concave lateral recesses being configured to provide clearance for the tension member during use. In some embodiments, the proximal head may include one or more smooth concave proximal surfaces positioned near the proximal orifice, the one or more smooth concave proximal surfaces being configured to provide a smooth contact surface for the tension member as it passes through the head during use.

[0013] In some embodiments, the distal extension includes an elongated body having an elongated oval shape and includes a pair of opposing long sides and a pair of opposing short sides. In some embodiments, the short sides are curved and configured to contact or engage the inner wall of the through-channel of the bone anchor to prevent the plug insert from wobbling during engagement with the bone anchor. In some embodiments, the long sides are flat or planar and are included to provide travel space for the tension member within the through-channel. In some embodiments, the long sides have a convex curvature. In some embodiments, the long sides have a concave curvature.

[0014] In some embodiments, the distal extension may include an open mating groove that is open to one of the curved sides. In some embodiments, the open mating groove may include an angled proximal surface (to form the open groove) angled to the proximal side of one of the curved sides, a hook-shaped end, and a smooth circular surface configured to reduce the effect of friction on the tension member as it moves within the open mating groove during assembly and / or tightening.

[0015] As used throughout this disclosure, a tension member is defined as having an annular portion (or “annular end”) and a pair of free ends. As an example, the annular portion is defined as the part of the tension member that ultimately engages with (and “surrounds”) the mating groove of the locking element. The free ends are the actual ends of the tension member.

[0016] As an example, the fracture repair system of this disclosure can be assembled and used in several configurations to achieve the same goal, namely, to form a tension band repair structure capable of locking the repair site in a knotless manner under tension.

[0017] In some embodiments, an example of the assembly and use of a fracture repair system includes a pair of bone anchors, a single locking element with an open mating slot, and a single tension member. As a first step, the user (e.g., a surgeon) positions the bone anchors through the fractured bone (e.g., the patella). At this point, the locking element is not attached to either bone anchor. In some embodiments, the locking element and tension member are connected by passing the free end of the tension member distally through the proximal and transverse orifices of the locking element, such that the free end is positioned distal to the locking element and an annular portion is formed proximally to the head.

[0018] Once the locking element and tension member are engaged, the locking element is positioned near the proximal head of the first bone anchor. At this point, the free end can shuttle from the proximal end of the bone anchor to the distal end. The annular portion then shuttles proximally across the anterior surface of the bone from the proximal head of the locking element to the distal end of the second bone anchor, then proximally across the second bone anchor, across the anterior surface of the bone (e.g., in a cross or "X" pattern) to the distal end of the first bone anchor, and proximally across the first bone anchor to the locking element located proximal to the head of the bone anchor. The annular portion is then engaged with the locking element by inserting it into an open mating groove. Once this engagement is established, the user can begin tightening the system by pulling the free end of the tension member and / or the portion of the tension member that moves from the distal end and across the bone to the proximal end of the second bone anchor. This causes the locking element to translate distally to pull the locking element into the through-channel of the first bone anchor. In some embodiments, this can also be achieved by manually pushing the locking element distally. Once the locking element is placed in the bone anchor, the tension member can be tensioned by pulling the free ends one by one or simultaneously along the distal direction. This eliminates slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned "pinch point" between the distal engagement surface and / or concave recess of the locking element and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0019] In some embodiments, another example of the assembly and use of a fracture repair system includes a pair of bone anchors, two locking elements with open mating slots, and two tension members. As a first step, the user (e.g., a surgeon) positions the bone anchors through the fractured bone (e.g., the patella). At this point, the locking elements are not attached to either bone anchor. In some embodiments, the locking elements and tension members are connected by passing the free end of the tension member distally through the proximal and transverse orifices of the respective locking elements, such that the free end is positioned distal to the locking element and an annular portion is formed proximally to the head.

[0020] Once the locking element and tension member are engaged, the locking element is positioned near the proximal heads of the first and second bone anchors. At this point, the free end can shuttle from the proximal end of the bone anchor to the distal end of the corresponding bone anchor. The annular portion then shuttles proximally across the bone surface from the proximal head of the corresponding locking element to the distal end of the opposing bone anchor, and is engaged with the locking element by inserting the annular portion into the corresponding open mating slot. Once these connections are established, the user can begin tightening the system by pulling the free end of the tension member and / or the portion of the tension member that moves from the distal end across the bone to the proximal end of the opposing bone anchor. This causes the locking element to translate distally to pull it into the bone anchor. In some embodiments, this can also be achieved by manually pushing the locking element distally. Once the locking element is in place in the corresponding bone anchor, the tension member can be tensioned by pulling the free ends distally, one at a time or simultaneously. This eliminates any slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned "pinch point" between the distal engagement surface of the locking element and / or the concave recess and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0021] In some embodiments, another example of the assembly and use of a fracture repair system includes a single bone anchor, a single locking element with an open mating slot, and a single tension member. As a first step, the user (e.g., a surgeon) positions the bone anchor through the fractured bone (e.g., the patella) and forms a bone tunnel across the fracture near the bone anchor. At this point, the locking element is not attached to the bone anchor. In some embodiments, the locking element and tension member are connected by passing the free end of the tension member distally through the proximal and transverse orifices of the locking element, such that the free end is positioned distal to the locking element and an annular portion is formed proximally to the head.

[0022] Once the locking element and tension member are engaged, the locking element is positioned near the proximal head of the bone anchor. At this point, the free end can shuttle from the proximal end of the bone anchor to the distal end. The annular portion then shuttles proximally across the anterior surface of the bone from the proximal head of the locking element to the distal opening of the bone tunnel, then through the bone tunnel, across the anterior surface of the bone (e.g., in a cross or "X" pattern) to the distal end of the bone anchor, and then proximally across the bone anchor to the locking element located proximal to the head of the bone anchor. The annular portion is then engaged with the locking element by inserting it into an open mating groove. Once this engagement is established, the user can begin tightening the system by pulling the free end of the tension member and / or the portion of the tension member that moves distally and across the bone to the proximal opening of the bone tunnel. This causes the locking element to translate distally to pull it into the through-channel of the first bone anchor. In some embodiments, this can also be achieved by manually pushing the locking element distally. Once the locking element is placed in the bone anchor, the tension member can be tensioned by pulling the free ends one by one or simultaneously along the distal direction. This eliminates slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned "pinch point" between the distal engagement surface and / or concave recess of the locking element and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0023] In some embodiments, another example of the assembly and use of a fracture repair system includes a pair of bone anchors, a single locking element with a closed mating groove, and a single tension member. In some embodiments, the same integral assembly can be achieved by guiding the free end of the tension member through the bone anchors (as an alternative to the aforementioned guided annular end). As a first step, the user (e.g., a surgeon) positions the pair of bone anchors through the fractured bone. At this time, the locking element is not engaged to either bone anchor. In some embodiments, the locking element and the tension member are engaged by first passing the tension member through the closed mating groove and allowing the tension member to be in place, such that the free end is positioned distal to the locking element and the annular portion is formed within the closed mating groove.

[0024] Once the locking element and tension member are coupled (or provided pre-coupled), the locking element is positioned near the proximal head of the first bone anchor. At this point, the free end can shuttle from the proximal end of the first bone anchor to its distal end. The free end then shuttles distally through the second bone anchor from its distal end to its proximal end on the anterior surface of the bone. Once the free end exits the distal opening of the second bone anchor, it then shuttles distally through the second bone anchor. Assembly continues by positioning the free end of the tension member distal to the first bone anchor through the proximal and transverse orifices of the locking element and through the first bone anchor.

[0025] Once the assembly is established, the user can begin tightening the system by pulling the free end of the tension member. This causes the locking element to translate distally into the first bone anchor. This can also be achieved by manually pushing the locking element distally. Once the locking element is in the bone anchor, the tension member can be tensioned by pulling the free ends and / or the annular portion disengaged from the distal end of the first bone anchor, one at a time (e.g., sequentially) or simultaneously, distally. This eliminates any slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned “pinch point” between the distal engagement surface and / or concave notch of the locking element and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0026] In some embodiments, another example of the assembly and use of a fracture repair system includes a pair of bone anchors, a pair of locking elements with closed mating slots, and a pair of tension members. As a first step, the user (e.g., a surgeon) positions the pair of bone anchors through the fractured bone. At this point, the locking elements are not engaged with either bone anchor. In some embodiments, the locking elements and tension members are engaged by first passing the tension member through the closed mating slot of the respective locking element and allowing the tension member to be in place, such that the free end is positioned distal to the locking element and an annular portion is formed within the closed mating slot.

[0027] Once the locking element and tension member are connected, the locking element is positioned near the proximal head of the bone anchor. At this point, the free end can shuttle distally through the bone anchor. The free end then passes from the distal end of its corresponding bone anchor to the proximal end of the opposing locking element on the anterior surface of the bone, and then shuttles through the head of the locking element and the corresponding bone anchor, such that the free end extends distally from the corresponding bone anchor.

[0028] Once the assembly is established, the user can begin tightening the system by pulling the free end of the tension member. This causes the locking element to translate distally into its corresponding bone anchor. This can also be achieved by manually pushing the locking element distally. Once the locking element is in the bone anchor, the tension member can be tensioned by pulling the free ends and / or the annular portion disengaged from the distal end of the first bone anchor, one at a time or simultaneously, distally. This eliminates any slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned “pinch point” between the distal engagement surface and / or concave notch of the locking element and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0029] In some embodiments, another example of the assembly and use of a fracture repair system includes a single bone anchor, a single locking element with a closed mating groove, and a single tension member. As a first step, the user (e.g., a surgeon) positions the single bone anchor through the fractured bone, forming a bone tunnel across the fracture near the bone anchor. At this point, the locking element is not attached to the bone anchor. In some embodiments, the locking element and tension member are connected by first passing the tension member through the closed mating groove and allowing the tension member to be in place, such that the free end is positioned distal to the locking element and an annular portion is formed within the closed mating groove.

[0030] Once the locking element and tension member are coupled (or provided pre-coupled), the locking element is positioned near the proximal head of the bone anchor. At this point, the free end can shuttle from the proximal end of the bone anchor to the distal end. The free end then passes through the proximal opening of the bone tunnel on the anterior surface of the bone from the distal end of the bone anchor, and then shuttles distally through the bone tunnel. Once the free end exits the distal opening of the bone tunnel, it then passes through the locking element on the anterior surface of the bone (e.g., in a cross or "X" pattern). Assembly continues by passing the free end of the tension member through the proximal and transverse orifices of the locking element and through the bone anchor, so that the free end is distal to the bone anchor.

[0031] Once the assembly is established, the user can begin tightening the system by pulling the free end of the tension member and / or the annular component disengaging from the distal end of the bone anchor. This causes the locking element to translate distally into the bone anchor. This can also be achieved by manually pushing the locking element distally. Once the locking element is in place in the bone anchor, the tension member can be tensioned by pulling the free ends distally one by one (e.g., sequentially) or simultaneously. This eliminates any slack in the system, further pulling the head of the locking element into the proximal recess of the head of the bone anchor, thereby creating the aforementioned “pinch point” between the distal engagement surface and / or concave notch of the locking element and the circumferential mating surface of the bone anchor, where the tension member is secured between them. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart.

[0032] In some embodiments, several examples of the assembly and use of the fracture repair system are almost identical to the closed-loop mating example presented above, except that locking of the tension member occurs between the tapered outer surface of the locking element and the tapered inner surface of the bone anchor with a through-channel. As an example, locking under tension occurs through a wedging interaction rather than a pinching point interaction.

[0033] In any of the described embodiments, locking is maintained by tension generated in the configuration and by the annular portion of the tension member (which engages in an open mating slot), which continues to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. If the user wishes to adjust the tension or if revision surgery is deemed necessary, the locking element can be released by passing a reaction suture (e.g., through a transverse orifice) and pulling the locking element proximally. In some embodiments, the reaction suture may be pre-loaded in the locking element. In some embodiments, the reaction suture may be guided through the transverse orifice before the system is finally tensioned.

[0034] As a supplement to the embodiments described below, this disclosure describes the following embodiments.

[0035] Example 1 is a fracture repair system comprising: a flexible tension member having a first free end and a second free end, and a flexible body extending between the first free end and the second free end; the flexible tension member being oriented in an assembly configuration to have an annular end and an open end, the annular end including a U-shaped portion of the flexible body, and the open end including the first free end and the second free end of the flexible tension member; a first bone anchor and a second bone anchor configured for implantation in bone, each of the first bone anchor and the second bone anchor having an anchor head located at a proximal end, and an anchor head between the anchor head and the distal end. The anchor head includes a slender rod extending longitudinally through the slender shaft and a through-channel having a proximal opening at the proximal end and a distal opening at the distal end. The proximal recess includes a circumferential mating surface positioned within the proximal recess. A locking element has a proximal head and an elongated extension extending distally from the proximal head. The proximal head includes a proximal opening, a pair of lateral openings, and a distal mating surface. The elongated extension includes a mating groove formed therein and is configured to secure the annular end of the flexible tension member. A first assembly configuration wherein the locking element is associated with the first bone anchor, and the annular end of the flexible tension member is positioned within the... In a first assembly configuration, the open end of the flexible tension member is positioned distal to the distal end of the first bone anchor, and the flexible body extends through the proximal opening of the locking element, the lateral opening of the locking element, and the through-channel of the first bone anchor; and in a second assembly configuration, the elongated extension of the locking element extends into the through-channel of the first bone anchor, the annular end of the flexible tension member is secured by the mating groove of the locking element, the open end of the flexible tension member is positioned distal to the distal end of the first bone anchor, and the flexible body passes through the circumferential mating surface of the first bone anchor and the distal mating surface of the locking element. The through-channels extending through the first bone anchor, the through-channels of the second bone anchor, and the proximal and lateral openings of the locking element are connected between the mating surfaces; wherein the open end of the flexible tension member is configured to be pulled taut along the distal direction, thereby generating tension in the flexible tension member, the tension causing the locking element to translate distally relative to the first bone anchor and causing the fracture repair system to switch from an unlocked state that allows movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, wherein the locked state is maintained by compression and friction applied to the flexible tension member between the mating surface of the first bone anchor and the engaging surface of the locking element.

[0036] Example 2 is a fracture repair system of Example 1, wherein the proximal head of the locking element is configured to be embedded within the anchor head.

[0037] Example 3 is a fracture repair system of Example 1 or 2, wherein the distal engagement surface of the locking element includes at least one concave recess.

[0038] Example 4 is a fracture repair system of any one of Examples 1 to 3, wherein the second assembly configuration further includes the flexible body extending distally from the annular end through the through-channel of the first bone anchor, then obliquely extending to the proximal end of the second bone anchor, then distally through the through-channel of the second bone anchor, then obliquely extending to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the transverse opening of the locking element, and the through-channel of the first bone anchor.

[0039] Example 5 is a fracture repair system of any one of Examples 1 to 4, wherein the rods of the first bone anchor and the second bone anchor have an outer surface, the outer surface including a threaded portion and a non-threaded portion.

[0040] Example 6 is a fracture repair system of any one of Examples 1 to 5, wherein the locking element further includes at least one smooth curved surface adjacent to the mating groove.

[0041] Example 7 is a fracture repair system of any one of Examples 1 to 6, wherein the docking groove is an open docking groove.

[0042] Example 8 is a fracture repair system of any one of Examples 1 to 7, wherein the docking groove has a hook-shaped configuration.

[0043] Example 9 is a fracture repair system of any one of Examples 1 to 8, wherein the mating groove extends to the distal end of the elongated extension.

[0044] Example 10 is a fracture repair system of any one of Examples 1 to 9, wherein the elongated extension is sized and configured to fit snugly within the through-channel of the first bone anchor to prevent the locking element from pivoting when the elongated extension is positioned within the through-channel of the first bone anchor.

[0045] Example 11 is a fracture repair system comprising: a flexible tension member having a first free end and a second free end, and a flexible body extending between the first free end and the second free end, the flexible tension member being oriented in an assembly configuration to have an annular end and an open end, the annular end including a U-shaped portion of the flexible body, and the open end including the first free end and the second free end of the flexible tension member; and a bone anchor configured for implantation in bone, the bone anchor having an anchor head located at a proximal end, an elongated rod extending between the anchor head and the distal end, and a longitudinally extending portion through the bone. A slender shaft having a proximal opening at its proximal end and a distal opening at its distal end, a through channel, the anchor head including a proximal recess including a circumferential mating surface positioned within the proximal recess; a locking element having a proximal head and an elongated extension extending distally from the proximal head, the proximal head including a proximal opening, a pair of lateral openings, and a distal mating surface, the elongated extension including a mating groove formed therein and configured to secure the annular end of the flexible tension member; a first assembly configuration wherein the locking element is associated with the bone anchor, and the annular end of the flexible tension member is positioned proximal to the locking element. The open end of the flexible tension member is positioned distal to the distal end of the bone anchor, and the flexible body extends through the proximal opening of the locking element, the lateral opening of the locking element, and the through-channel of the bone anchor; and in a second assembly configuration, wherein the elongated extension of the locking element extends into the through-channel of the bone anchor, the annular end of the flexible tension member is secured by the mating groove of the locking element, the open end of the flexible tension member is positioned distal to the distal end of the bone anchor, and the flexible body extends between the circumferential mating surface of the bone anchor and the distal engaging surface of the locking element. The through-channel extending through the bone anchor, the bone tunnel formed in the fracture bone to be repaired, and the proximal opening and the transverse opening of the locking element; wherein the open end of the flexible tension member is configured to be pulled taut along the distal direction, thereby generating tension in the flexible tension member, the tension causing the locking element to translate distally relative to the bone anchor and causing the fracture repair system to switch from an unlocked state that allows movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, wherein the locked state is maintained by compression and friction applied to the flexible tension member between the mating surface of the bone anchor and the engaging surface of the locking element.

[0046] Example 12 is a fracture repair system of Example 11, wherein the proximal head of the locking element is configured to be embedded within the anchor head.

[0047] Example 13 is a fracture repair system of Example 11 or 12, wherein the distal engagement surface of the locking element includes at least one concave recess.

[0048] Example 14 is a fracture repair system of any one of Examples 11 to 13, wherein the second assembly configuration further includes the flexible body extending distally from the annular end through the through-channel of the first bone anchor, then obliquely extending to the proximal opening of the bone tunnel, then distally through the bone tunnel, then obliquely extending to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the transverse opening of the locking element, and the through-channel of the bone anchor.

[0049] Example 15 is a fracture repair system of any one of Examples 11 to 14, wherein the rod of the bone anchor has an outer surface, the outer surface including a threaded portion and a non-threaded portion.

[0050] Example 16 is a fracture repair system of any one of Examples 11 to 15, wherein the locking element further includes at least one smooth curved surface adjacent to the mating groove.

[0051] Example 17 is a fracture repair system of any one of Examples 11 to 16, wherein the docking groove is an open docking groove.

[0052] Example 18 is a fracture repair system of any one of Examples 11 to 17, wherein the docking groove has a hook-shaped configuration.

[0053] Example 19 is a fracture repair system of any one of Examples 11 to 8, wherein the mating groove extends to the distal end of the elongated extension.

[0054] Example 20 is a fracture repair system of any one of Examples 11 to 19, wherein the elongated extension is sized and configured to fit snugly within the through-channel of the bone anchor to prevent pivoting of the locking element when the elongated extension is positioned within the through-channel of the bone anchor. Attached Figure Description

[0055] Many advantages of this disclosure will be apparent to those skilled in the art upon reading this specification and in conjunction with the accompanying drawings, wherein the same reference numerals apply to the same elements, and wherein:

[0056] Figure 1This is a front view of an example fracture repair system of the present disclosure according to some embodiments, specifically illustrating a first configuration including a pair of bone anchors, a single locking element and a single tension member;

[0057] Figure 2 According to some embodiments Figure 1 A frontal sectional view of a fracture repair system;

[0058] Figure 3 It is formed according to some embodiments Figure 1 A frontal plan view of an example of a bone anchor, which is part of a fracture repair system;

[0059] Figure 4 According to some embodiments Figure 3 A frontal sectional view of the bone anchor;

[0060] Figure 5 According to some embodiments Figure 3 A perspective view of the bone anchor;

[0061] Figure 6 According to some embodiments Figure 4 Top view of the bone anchor;

[0062] Figures 7 to 8 It is formed according to some embodiments Figure 1 A perspective view of an example of a locking element, which is part of a fracture repair system;

[0063] Figure 9 According to some embodiments Figure 7 Side plan view of the locking element;

[0064] Figure 10 According to some embodiments Figure 7 Front view of the locking element;

[0065] Figure 11 According to some embodiments Figure 7 Top view of the locking element;

[0066] Figure 12 The description is based on some embodiments. Figure 1 A flowchart of an example method for a fracture repair system;

[0067] Figures 13 to 21 Examples according to some embodiments are illustrated. Figure 12 The flowchart depicts the use of Figure 1 Several steps in the method of fracture repair system;

[0068] Figure 22 According to some embodiments Figure 1A frontal view of the fracture repair system, specifically illustrating a second configuration including a pair of bone anchors, a pair of locking elements, and a pair of tension members;

[0069] Figure 23 According to some embodiments Figure 22 A frontal sectional view of a fracture repair system;

[0070] Figure 24 The description is based on some embodiments. Figure 22 A flowchart of an example method for a fracture repair system;

[0071] Figures 25 to 32 Examples according to some embodiments are illustrated. Figure 24 The flowchart depicts the use of Figure 1 Several steps in the method of fracture repair system;

[0072] Figure 33 This is a front view of an example of another fracture repair system according to some embodiments, specifically illustrating a first configuration including a pair of bone anchors, a single locking element, and a single tension member;

[0073] Figure 34 According to some embodiments Figure 12 A frontal sectional view of a fracture repair system;

[0074] Figure 35 It is formed according to some embodiments Figure 33 A frontal plan view of an example of a bone anchor, which is part of a fracture repair system;

[0075] Figure 36 According to some embodiments Figure 35 A frontal sectional view of the bone anchor;

[0076] Figure 37 According to some embodiments Figure 35 Top view of the bone anchor;

[0077] Figures 38 to 39 It is formed according to some embodiments Figure 33 A perspective view of an example of a locking element, which is part of a fracture repair system;

[0078] Figure 40 According to some embodiments Figure 38 Side plan view of the locking element;

[0079] Figure 41 According to some embodiments Figure 38 Front view of the locking element;

[0080] Figure 42 According to some embodiments Figure 38 Top view of the locking element;

[0081] Figure 43 The description is based on some embodiments. Figure 33 A flowchart of an example method for a fracture repair system;

[0082] Figure 44 According to some embodiments Figure 33 A perspective sectional view of a fracture repair system;

[0083] Figure 45 According to some embodiments Figure 33 A frontal view of the fracture repair system, specifically illustrating a second configuration including a pair of bone anchors, a pair of locking elements, and a pair of tension members;

[0084] Figure 46 According to some embodiments Figure 45 A frontal sectional view of a fracture repair system;

[0085] Figure 47 The description is based on some embodiments. Figure 45 A flowchart of an example method for a fracture repair system;

[0086] Figure 48 According to some embodiments Figure 45 A perspective sectional view of a fracture repair system;

[0087] Figure 49 This is a front view of an example of another fracture repair system according to some embodiments;

[0088] Figure 50 According to some embodiments Figure 49 A frontal sectional view of a fracture repair system;

[0089] Figure 51 According to some embodiments Figure 49 A fracture repair system is shown in a frontal sectional view for fracture repair.

[0090] Figure 52 According to some embodiments Figure 49 The fracture repair system is shown in a perspective sectional view for fracture repair;

[0091] Figure 53 It is formed according to some embodiments Figure 49 A frontal view of a bone anchor, part of a fracture repair system;

[0092] Figure 54 According to some embodiments Figure 53 A frontal sectional view of the bone anchor;

[0093] Figure 55 It is formed according to some embodiments Figure 49 A perspective view of the locking element, which is part of the fracture repair system;

[0094] Figure 56 The description is based on some embodiments. Figure 49 A flowchart of an example method for a fracture repair system;

[0095] Figure 57 It is formed according to some embodiments Figure 1 A plan view of an example tension member, which is part of a fracture repair system;

[0096] Figure 58 According to some embodiments Figure 57 A plan view of the tension member, specifically showing the orientation including the annular end and a pair of free ends;

[0097] Figure 59 According to some embodiments Figure 1 A frontal view of the fracture repair system, specifically illustrating a third configuration including a single bone anchor, a locking element, and a tension member;

[0098] Figure 60 According to some embodiments Figure 60 A frontal sectional view of a fracture repair system;

[0099] Figure 61 The description is based on some embodiments. Figure 59 A flowchart of an example method for a fracture repair system; and

[0100] Figures 62 to 66 Examples according to some embodiments are illustrated. Figure 61 The flowchart depicts the use of Figure 1 Several steps in the method of fracture repair system. Detailed Implementation

[0101] The following describes exemplary embodiments of the invention. For clarity, not all features of actual implementations are described in this specification. It should be understood, of course, that in the development of any such actual embodiment, many implementation-specific decisions must be made to achieve the developer's specific goals, such as compliance with system-related and business-related constraints, which will vary from implementation to implementation. Furthermore, it should be understood that while such development work may be complex and time-consuming, it is still routine work for those skilled in the art who benefit from this disclosure. The fracture repair system and related methods disclosed herein have a number of inventive features and components, which, individually or in combination, are worthy of patent protection.

[0102] Figures 1 to 2 An example of a fracture repair system 10 using a tension / compression locking configuration according to some embodiments is illustrated. Although illustrated and described herein in connection with a patellar fracture, it should be understood that the fracture repair system 10 can be used to repair soft tissue and / or fractured bone in any suitable anatomical location of the body, including but not limited to the patella, ankle, medial malleolus, olecranon, etc. In some embodiments, the fracture repair system 10 includes at least one bone anchor 12, at least one locking element 14, and at least one flexible tension member 16 configured to interact with the bone anchor 12 and the locking element 14 to firmly hold the fractured bone fragment in place for healing, while also creating a tension band structure that prevents displacement of the bone fragment due to forces that tend to pull the bone fragment apart.

[0103] Figures 3 to 6An example of a bone anchor 12 forming part of a fracture repair system 10 according to some embodiments is illustrated. In some embodiments, the bone anchor 12 has a head 20 at a proximal end, an elongated rod 22 extending distally from the head 20, and an internal cavity or through-channel 24 extending along the length of the rod 22 and having a proximal opening 26 within the head 20 and a distal opening 28 at the distal end of the rod 22. In some embodiments, the head 20 further includes a proximal recess 30 including a drive feature 32 configured to engage with a drive tool. In some embodiments, the head may also include one or more grooves 33 formed in an outer surface to facilitate insertion of the head into bone. In some embodiments, the rod includes a cylindrical member having a smooth outer surface portion 34 and a threaded outer surface portion 36. In some embodiments, the threaded outer surface portion 36 is located at or near the distal end of the rod 22, and the smooth outer surface portion 34 is located near the head 20. In some embodiments, the bone anchor 12 may have a fully threaded rod 22. By way of example only, the threaded outer surface portion 36 is configured to insert into and obtain grip within a bone fragment (e.g., the distal fragment of a fracture) to hold the distal and proximal fragments together. In some embodiments, the head 20 also includes a circumferential mating surface 38, which may be a tapered or concave surface positioned within a proximal recess 30 and surrounding a proximal opening 26 of the rod through-channel 24. In some embodiments, the circumferential mating surface 38 serves as a first locking surface that mates with the distal engagement surface 52 of the locking element 14 and / or a concave cutout 54 (e.g., a second locking surface) positioned within the distal engagement surface 52 of the locking element to form one or more "pinch points" that secure the tension member 16 between them, thereby locking the fracture repair system 10 under tension. By way of example, the bone anchor 12 may be provided in any suitable length. In some embodiments, the bone anchor 12 may have a rod 22 without a head, and a "pinch point" may be formed at the proximal end of the headless rod 22, for example, at the proximal opening of the through channel 24 or at a location within the through channel 24.

[0104] Figures 7 to 11 An example of a locking element 14 forming part of a fracture repair system 10 according to some embodiments is illustrated. By way of example only, the locking element 14 has a proximal head 40 and a distal extension 42 extending longitudinally from the proximal head 40. In some embodiments, the locking element 14 is configured such that the size and configuration of the distal extension 42 are designed to extend into the through-channel 24 of the bone anchor 12, while the head 40 is received within the proximal recess 30.

[0105] In some embodiments, the proximal head 40 includes an internal cavity 44 and a plurality of orifices formed in the head 40, which serve as inlets and outlets for the tension member 16 to pass through during assembly and tensioning of the fracture repair system 10. For example, in some embodiments, the head 40 may have a proximal orifice 46 and a pair of transverse orifices 48 positioned on opposite sides of the head 40. In some embodiments, the proximal head has a bottom or distal portion 50, which includes a distal engagement surface 52, which may be convex or conical, and may or may not include a concave cutout 54 positioned within the distal engagement surface 52. In some embodiments, the distal engagement surface 52 and / or the concave cutout 54 serve as a second locking surface that engages with a circumferential mating surface 38 of the bone anchor 12 (e.g., a first locking surface) to form one or more "pinch points" that hold the tension member 16 between them, thereby locking the fracture repair system 10 under tension. As an example, the concave incision 54 provides space for the tension member 16 to pass between the bone anchor 12 and the plug insert 14, while remaining secured and locked within the concave incision 54 when the system 10 is finally tightened. In some embodiments, the proximal head 40 may include one or more smooth concave lateral recesses 62 positioned near the transverse orifice 48, which are configured to provide clearance for the tension member 16 during use. In some embodiments, the proximal head 40 may include one or more smooth concave proximal surfaces 64 positioned near the proximal orifice 46, which are configured to provide a smooth contact surface for the tension member 16 as it passes through the head 40 during use.

[0106] In some embodiments, the distal extension 42 includes an elongated body 56 having an elongated oval shape and including a pair of opposing long sides 58 and a pair of opposing short sides 60. In some embodiments, the short sides 60 are curved and configured to contact or engage the inner wall of the through-channel 24 of the bone anchor 12 to prevent the plug insert 14 from wobbling when engaged with the bone anchor 12. In some embodiments, the long sides 58 are flat or planar and are included to provide travel space for the tension member 16 within the through-channel 24. In some embodiments, the long sides 58 have a convex curvature. In some embodiments, the long sides 58 have a concave curvature.

[0107] In some embodiments, the distal extension 42 may include an open mating groove 66 that opens to one of the curved sides 60. In some embodiments, the open mating groove 66 may include an angled proximal surface 68 (to form an open groove) angled to the proximal side of one of the curved sides 60, a hook-shaped end 70, and a smooth circular surface 72 that abuts the open mating groove 66 on both sides and is configured to reduce the effects of friction and / or shear on the tension member 16 as it moves within the open mating groove 66 during assembly and / or tightening.

[0108] Figure 12 This is a flowchart illustrating the steps of an example method 80 for repairing a fracture using the fracture repair system 10 described herein. By way of example only, method 80 is described in conjunction with repairing a fractured bone 2 (e.g., the patella) having a first fracture segment 4 and a second fracture segment 6, the first and second fracture segments being separated from each other by a fracture 8, further referenced to... Figures 13 to 21 In this example embodiment, the fracture repair system 10 includes a pair of bone anchors 12, 12', a single locking element 14, and a single tension member 16. As used throughout this disclosure, the tension member 16 is defined as having an annular portion (or “annular end”) 74 and a pair of free ends 76. As an example, the annular portion 74 is defined as the portion of the tension member 16 that ultimately engages (and “wraps” around) the mating groove 66 of the locking element 14. The free ends 76 are the actual ends of the tension member 16.

[0109] In some embodiments, the first step 82 of the method 80 for repairing a fracture is to implant or otherwise position a pair of bone anchors (e.g., a first bone anchor 12 and a second bone anchor 12') through the fractured bone (e.g., the patella) using a preferred, known technique for implanting bone anchors 12. For example, the bone anchors 12, 12' may be inserted such that the distal ends of the threaded outer surface portions 36, 36' of the bone anchors 12, 12', including the rods 22, 22', are positioned in the first fracture segment 4, and the heads 20, 20' at the proximal ends of the bone anchors 12, 12' are positioned within the second fracture segment 6, for example as... Figure 13 As shown. At this time, the locking element 14 is not connected to either bone anchor 12, 12'.

[0110] In some embodiments, the second step 84 of the method 80 for repairing a fracture is to attach the tension member 16 to the locking element 14 such that the annular end 74 is positioned proximally to the locking element 14 and the free end 76 is positioned distally to the locking element 14. As an example, the locking element 14 and the tension member 16 can be attached by first passing the free end 76 of the tension member 16 distally through the proximal orifice 46 of the locking element 14, then passing one free end 76 distally through each transverse orifice 48, and continuing to advance the free end 76 distally along the corresponding long side 58 of the distal extension 42. This results in the tension member 16 being attached to the locking element 14 such that the free end 76 is positioned distally to the locking element 14 and the annular portion 74 is formed proximally to the head 40. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the locking element 14 may be pre-attached to the tension member 16. In some embodiments, the locking element 14 and the tension member 16 are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76 of the tension member 16 through the locking element 14 as described above. In some embodiments, once the locking element 14 and the tension member 16 are connected (or provided in a pre-connected form), the next step 86 of the fracture repair method 80 is to position the locking element 14 near the proximal head 20 of the first bone anchor 12.

[0111] In some embodiments, the next step 88 in the method 80 for repairing a fracture is to shuttle the free end 76 of the tension member 16 from the proximal end of the bone anchor 12 to the distal end of the bone anchor 12 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 26 of the passage channel 24 and exits from the distal opening 28 of the passage channel 24, as an example only. Figure 13 As shown.

[0112] The user can then focus on the annular portion 74 located proximal to the head 40 of the locking element 14. In some embodiments, the next step 90 of the method 80 for repairing a fracture is to pass the annular portion 74 across the anterior surface of the fractured bone 2 from the proximal head 40 of the locking element 14 toward the distal end of the second bone anchor 12', as an example. Figure 14 As shown. In some embodiments, the next step 92 of the method 80 for repairing a fracture is to sew the annular portion 74 proximally through the distal opening 28' of the passage 24' of the second bone anchor 12' to the proximal opening 26' of the passage 24' of the second bone anchor 12', as an example. Figure 15As shown. In some embodiments, once the annular portion 74 exits the proximal opening 26' of the second bone anchor 12', the next step 94 of the method 80 for repairing the fracture is to pass the annular portion 74 through the distal opening 28 of the through-channel 24 of the first bone anchor 12 on the anterior surface of the bone (e.g., in a cross or "X" pattern), as an example only. Figure 16 As shown. In some embodiments, the next step 96 of the method 80 for repairing a fracture is to shuttle the annular end 74 of the tension member 16 proximally through the through-channel 24 of the first bone anchor 12, from the distal opening 28 through the proximal opening 26 to the locking element 14 located proximal to the proximal opening 26, as an example. Figure 17 As shown. In some embodiments, the next step 98 of the method 80 for repairing a fracture is to connect the annular end 74 of the tension member 16 to the locking element 14 by inserting the annular portion 74 into the open mating groove 66 of the locking element 14, as an example. Figure 18 As shown.

[0113] In some embodiments, once the connection has been established, the next step 100 in the method 80 for repairing the fracture is to tighten the system 10 by pulling the free end 76 of the tension member 16 located distal to the distal opening 28 of the through-channel 24 of the first bone anchor 12. Alternatively or additionally, the system 10 can be tightened by pulling a portion 17 of the tension member 16 that exits from the distal opening 28 and crosses the bone to the proximal end of the second bone anchor 12'. This allows the locking element 14 to translate seamlessly while preventing the tension member 16 from converging within the through-channel 24. This pulling force causes the locking element 14 to translate distally into the through-channel 24 of the first bone anchor 12. This can also be achieved, or alternatively, by manually pushing the locking element 14 distally into the first bone anchor 12.

[0114] In some embodiments, once the locking element 14 is placed in the bone anchor 12, the next step 102 in the method 80 for repairing a fracture is to lock the repair site under tension. To achieve this, the user first applies the desired amount of tension to the tension member 16 by pulling the free end 76, which is located distally from the distal end of the first bone anchor 12. As an example, the free ends can be tensioned one at a time or simultaneously. This eliminates slack in the system 10, further pulling the head 40 of the locking element 14 into the proximal recess 30 of the head 20 of the bone anchor 12, and creating the aforementioned “pinch point” 78 between the distal engagement surface 52 and / or concave cutout 54 of the locking element 14 and the circumferential mating surface 38 of the bone anchor 12, where the tension member 16 is secured between them, as an example. Figure 19As shown. This locking produces a knotless compression lock of the tension member 16 under tension, thereby converting the fracture fixation system 10 from an unlocked state to a locked state, wherein the locked state is maintained by compression and friction applied to the flexible tension member 16 between the mating surface 38 of the bone anchor 12 and the engaging surface 52 of the locking element 14. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces cause an increase in tension in the tension member 16, which in turn causes additional pulling of the annular end 74 against the locking element 14, which only further tightens the lock. In some embodiments, the next step 104 of the method 80 for repairing the fracture is, optionally, to remove excess tension member material once the desired tension has been applied and final tightening of the system 10 has occurred, as exemplified by... Figures 20 to 21 As shown.

[0115] As an example, locking is maintained by the tension generated in the fracture repair system 10 and the annular portion 74 of the tension member 16 engaging in the open docking slot 66, which continues to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the locking element 14 can be released by passing a reaction suture (e.g., or other unlocking tool) through the transverse opening 48 and pulling the locking element 14 proximally. In some embodiments, the reaction suture or other unlocking tool may be pre-loaded in the locking element 14. In some embodiments, the reaction suture or other unlocking tool may be guided through the transverse opening 48 before the system 10 is finally tensioned.

[0116] In some embodiments, the fracture repair system 10 may use two different bone anchors 12 (e.g., a first bone anchor 12 and a second bone anchor 12'), two different locking elements 14 (e.g., a first locking element 14 and a second locking element 14'), and two different tension members 16 (e.g., a first tension member 16 and a second tension member 16') to achieve tension band fracture repair, as exemplified by... Figures 22 to 23 As shown. Figure 24 This is a flowchart illustrating the steps of an exemplary method 110 for repairing a fracture using a fracture repair system 10 as described herein, having two tension members 16, 16' and two locking elements 14, 14'. As an example, the hardware (e.g., bone anchors 12, 12', locking elements 14, 14', and tension members 16, 16') is characterized as described above. As an example, method 110 is described in conjunction with repairing a fractured bone 2 (e.g., the patella) having a first fracture segment 4 and a second fracture segment 6, which are separated from each other by a fracture 8, further referenced to... Figures 25 to 32 .

[0117] In some embodiments, the first step 112 of the method 80 for repairing a fracture is to implant or otherwise position a pair of bone anchors (e.g., a first bone anchor 12 and a second bone anchor 12') through the fractured bone (e.g., the patella) using a preferred, known technique for implanting bone anchors 12. For example, the bone anchors 12, 12' may be inserted such that the distal ends of the threaded outer surface portions 36, 36' of the bone anchors 12, 12', including the rods 22, 22', are positioned in the first fracture segment 4, and the heads 20, 20' at the proximal ends of the bone anchors 12, 12' are positioned within the second fracture segment 6, for example as... Figure 25 As shown. At this time, locking elements 14, 14' are not connected to either bone anchor 12, 12'.

[0118] In some embodiments, the second step 114 of the fracture repair method 110 is to connect the first tension member 16 to the first locking element 14 such that the annular end 74 of the first tension member 16 is positioned proximally to the first locking element 14 and the free end 76 of the first tension member 16 is positioned distally to the first locking element 14. As an example, the first locking element 14 and the first tension member 16 can be connected by first passing the free end 76 of the first tension member 16 distally through the proximal orifice 46 of the first locking element 14, then passing one free end 76 distally through each transverse orifice 48, and continuing to advance the free end 76 distally along the corresponding long side 58 of the distal extension 42. This results in the first tension member 16 being connected to the first locking element 14 such that the free end 76 is positioned distally to the first locking element 14 and the annular portion 74 is formed proximally to the head 40. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the first locking element 14 may be pre-connected to the first tension member 16. In some embodiments, the first locking element 14 and the first tension member 16 are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76 of the first tension member 16 through the first locking element 14 as described above. In some embodiments, once the first locking element 14 and the first tension member 16 are connected (or provided in a pre-connected form), the next step 116 of the method 110 for repairing a fracture is to position the first locking element 14 near the proximal head 20 of the first bone anchor 12.

[0119] In some embodiments, the next step 118 in the method 110 for repairing a fracture is to connect the second tension member 16' to the second locking element 14' such that the annular end 74' of the second tension member 16' is positioned proximally to the second locking element 14' and the free end 76' of the second tension member 16' is positioned distally to the second locking element 14'. As an example, the second locking element 14' and the second tension member 16' can be connected by first passing the free end 76' of the second tension member 16' through the proximal orifice 46' of the second locking element 14' in a distal direction, then passing one free end 76' distally through each transverse orifice 48', and continuing to advance the free end 76' distally along the corresponding long side 58' of the distal extension 42'. This results in the second tension member 16' being connected to the second locking element 14' such that the free end 76' is positioned distally to the second locking element 14' and the annular portion 74' is formed proximally to the head 40'. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the second locking element 14' may be pre-connected to the second tension member 16'. In some embodiments, the second locking element 14' and the second tension member 16' are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76' of the second tension member 16' through the second locking element 14' as described above. In some embodiments, once the second locking element 14' and the second tension member 16' are connected (or provided in a pre-connected form), the next step 120 of the fracture repair method 110 is to position the second locking element 14' near the proximal head 20' of the second bone anchor 12'.

[0120] In some embodiments, the next step 122 in the method 110 for repairing a fracture is to shuttle the free end 76 of the first tension member 16 from the proximal end of the first bone anchor 12 to the distal end of the first bone anchor 12 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 26 of the passage channel 24 and exits from the distal opening 28 of the passage channel 24, as an example only. Figure 25 As shown.

[0121] The user can then focus on the annular portion 74 located proximal to the head 40 of the first locking element 14. In some embodiments, the next step 124 of the method 110 for repairing a fracture is to pass the annular portion 74 across the anterior surface of the fractured bone 2 from the proximal head 40 of the first locking element 14 toward the distal end of the second bone anchor 12', as an example. Figure 26As shown. In some embodiments, the next step 126 of the method 110 for repairing a fracture is to shuttle the annular portion 74 proximally through the distal opening 28' of the passage 24' of the second bone anchor 12' to the proximal opening 26' of the passage 24' of the second bone anchor 12'. In some embodiments, once the annular portion 74 leaves the proximal opening 26' of the second bone anchor 12', the next step 128 of the method 110 for repairing a fracture is to connect the annular end 74 of the first tension member 16 to the second locking element 14' by inserting the annular portion 74 into the open mating groove 66' of the second locking element 14', as an example. Figure 28 As shown.

[0122] In some embodiments, the next step 130 in the method 110 for repairing a fracture is to shuttle the free end 76' of the second tension member 16' from the proximal end of the second bone anchor 12' to the distal end of the second bone anchor 12' by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76' passes through the proximal opening 26' of the passage channel 24' and exits from the distal opening 28' of the passage channel 24', as an example only. Figure 25 As shown.

[0123] The user can then focus on the annular portion 74' located proximal to the head 40' of the second locking element 14. In some embodiments, the next step 132 of the method 110 for repairing a fracture is to pass the annular portion 74' across the anterior surface of the fractured bone 2 from the proximal head 40' of the second locking element 14' toward the distal end of the first bone anchor 12, as an example. Figure 27 As shown. In some embodiments, the next step 134 of the method 110 for repairing a fracture is to shuttle the annular portion 74' proximally through the distal opening 28 of the passage 24 of the first bone anchor 12 to the proximal opening 26 of the passage 24 of the first bone anchor 12. In some embodiments, once the annular portion 74' leaves the proximal opening 26 of the first bone anchor 12, the next step 136 of the method 110 for repairing a fracture is to connect the annular end 74' of the second tension member 16' to the first locking element 14 by inserting the annular portion 74' into the open mating groove 66 of the first locking element 14, as an example. Figure 29 As shown.

[0124] It should be noted that the various steps described herein relating to the in situ assembly of the fracture repair system 10 can be performed in any reasonable order. For example, in some embodiments, the steps described above for coupling the first tension member 16 to the second locking element 14' can be performed as a set before the steps required to coupling the second tension member 16' to the first locking element 14. In some embodiments, the various steps can be performed such that the coupling occurs substantially simultaneously (e.g., as...). Figures 25 to 29(as shown) rather than occurring sequentially (as described).

[0125] In some embodiments, once these connections have been established, the next step 138 in the method 110 for repairing a fracture is to tighten the system 10 by pulling the free end 76' of the first tension member 16 located distal to the distal opening 28 of the passage 24 of the first bone anchor 12. This pull causes the second locking element 14' to translate distally into the passage 24' of the second bone anchor 12'. Alternatively or additionally, the system 10 can be tightened by pulling a portion 17 of the tension member that exits from the distal opening 28' of the second bone anchor 12' and traverses the bone to the proximal end of the first tension member 16. This allows for seamless translation of the second locking element 14' while preventing the tension member 16 from converging within the passage 24'. This can also be achieved, or alternatively, by manually pushing the second locking element 14' distally into the second bone anchor 12'. Similarly, the next step 140 in the fracture repair method 110 is to tighten the system 10 by pulling the free end 76' of the second tension member 16' located distal to the distal opening 28' of the through-channel 24' of the second bone anchor 12'. This pulling force causes the first locking element 14 to translate distally into the through-channel 24 of the first bone anchor 12. Alternatively or additionally, the system 10 can be tightened by pulling the tension member portion 17', which is a portion of the second tension member 16' that exits from the distal opening 28' and crosses the bone to the proximal end of the second bone anchor 12'. This allows the first locking element 14 to translate seamlessly while preventing the tension member 16' from converging within the through-channel 24. This can also be achieved, or alternatively, by manually pushing the first locking element 14 distally into the first bone anchor 12.

[0126] In some embodiments, once the locking elements 14, 14' are placed in the bone anchors 12, 12', the next step 142 in the method 110 for repairing fractures is to lock the repair site under tension. To achieve this, the user first applies the desired amount of tension to the tension members 16, 16' by pulling the free ends 76, 76' that are displaced from the distal ends of the bone anchors 12, 12' in a distal direction. As an example, the free ends 76, 76' can be tensioned one at a time or simultaneously. This eliminates slack in the system 10, further pulling the heads 40, 40' of the locking elements 14, 14' into the proximal recesses 30, 30' of the heads 20, 20' of the bone anchors 12, 12', and creating the aforementioned "pinch points" 78, 78' between the distal engagement surfaces 52 and / or concave cutouts 54 of the locking elements 14, 14' and the circumferential mating surfaces 38 of the bone anchors 12, 12', where the tension members 16, 16' are secured between them, as an example. Figure 30As shown. This locking produces a knotless compression lock of the tension members 16, 16' under tension, thereby converting the fracture fixation system 10 from an unlocked state to a locked state, wherein the locked state is maintained by compression and friction applied to the flexible tension members 16, 16' between the mating surfaces 38 of the bone anchors 12, 12' and the engaging surfaces 52 of the locking elements 14, 14'. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces cause an increase in tension in the tension members 16, 16', which in turn causes additional pulling of the annular ends 74, 74' onto the locking elements 14, 14', which only further tightens the lock. In some embodiments, the next step 144 of the method 110 for repairing the fracture is, optionally, to remove excess tension member material once the desired tension has been applied and final tightening of the system 10 has occurred, as exemplified by Figures 31 to 32 As shown.

[0127] As an example, locking is maintained by the tension generated in the fracture repair system 10 and the annular portions 74, 74' of the tension members 16, 16' engaging with the open mating slots 66, 66', which continue to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the locking elements 14, 14' can be released by pulling the locking elements 14, 14' proximally through the transverse openings 48, 48'. In some embodiments, the reaction sutures or other unlocking tools may be pre-loaded in the locking elements 14, 14'. In some embodiments, the reaction sutures or other unlocking tools may be guided through the transverse openings 48, 48' before the system 10 is finally tensioned.

[0128] Figures 33 to 34 An example of another fracture repair system 210 using a tension locking configuration according to some embodiments is illustrated. Although illustrated and described herein in connection with patellar fractures, it should be understood that the fracture repair system 210 can be used to repair soft tissue and / or fractured bone in any suitable anatomical location of the body, including but not limited to the patella, ankle, medial malleolus, olecranon, etc. In some embodiments, the fracture repair system 210 includes at least two bone anchors 212, at least one locking element 214, and a flexible tension member 16 configured to interact with the bone anchors 212 and the locking element 214 to firmly hold the fractured bone fragment in place for healing, while also creating a tension band structure that prevents the bone fragment from shifting due to forces that tend to pull the bone fragment apart.

[0129] Figures 35 to 37An example of a bone anchor 212 forming part of a fracture repair system 210 according to some embodiments is illustrated. In some embodiments, the bone anchor 212 has a head 220 at a proximal end, an elongated rod 222 extending distally from the head 220, and an internal cavity or through-channel 224 extending along the length of the rod 222 and having a proximal opening 226 within the head 220 and a distal opening 228 at the distal end of the rod 222. In some embodiments, the head 220 further includes a proximal recess 230 including a drive feature 32 configured to engage with a drive tool. In some embodiments, the rod includes a cylindrical member having a smooth outer surface portion 234 and a threaded outer surface portion 236. In some embodiments, the threaded outer surface portion 236 is located at or near the distal end of the rod 222, and the smooth outer surface portion 234 is located near the head 220. In some embodiments, the bone anchor 212 may have a fully threaded rod 222. By way of example only, the threaded outer surface portion 236 is configured to insert into and obtain grip within a bone fragment (e.g., the distal fragment of a fracture) to hold the distal and proximal fragments together. In some embodiments, the head 220 also includes a circumferential mating surface 238, which may be a tapered or concave surface positioned within a proximal recess 30 and surrounding a proximal opening 226 of the rod through-channel 224. In some embodiments, the circumferential mating surface 238 serves as a “first locking surface” and mates with the distal engagement surface 252 of the locking element 214 and / or a concave cutout 254 positioned within the distal engagement surface 252 of the locking element (e.g., a “second locking surface”) to form a “pinch point” that secures the tension member 16 between them, thereby locking the fracture repair system 210 under tension. By way of example, the bone anchor 212 may be provided in any suitable length. In some embodiments, the bone anchor 212 may have a rod 222 without a head, and a "pinch point" may be formed at the proximal end of the headless rod 222, for example, at the proximal opening of the through channel 224 or at a location within the through channel 224.

[0130] Figures 7 to 11 An example of a locking element 214 forming part of a fracture repair system 210 according to some embodiments is illustrated. By way of example only, the locking element 214 has a proximal head 240 and a distal extension 242 extending longitudinally from the proximal head 240. In some embodiments, the locking element 214 is configured such that the size and configuration of the distal extension 242 are designed to extend into the through-channel 224 of the bone anchor 212, while the head 240 is received within a proximal recess 230.

[0131] In some embodiments, the proximal head 240 includes an internal cavity 244 and a plurality of orifices formed in the head 240, which serve as inlets and outlets for the tension member 16 to pass through during assembly and tensioning of the fracture repair system 210. For example, in some embodiments, the head 240 may have a proximal orifice 246 and a pair of transverse orifices 248 located on opposite sides of the head 240. In some embodiments, the proximal head has a bottom or distal portion 250 that includes a distal engagement surface 252, which may be convex or conical, and may or may not include a concave incision 254 positioned within the distal engagement surface 252. In some embodiments, the distal engagement surface 252 and / or the concave incision 254 mate with a circumferential mating surface 238 of the bone anchor 212 to form a “pinch point” that holds the tension member 16 between them, thereby locking the fracture repair system 210 under tension. As an example, the concave incision 254 provides space for the tension member 216 to pass between the bone anchor 212 and the plug insert 214, while remaining secured and locked within the concave incision 254 when the system 210 finally tightens.

[0132] In some embodiments, the distal extension 242 includes an elongated body 256 having an elongated oval shape and including a pair of opposing long sides 258 and a pair of opposing short sides 260. In some embodiments, the short sides 260 are curved and configured to contact or engage the inner wall of the through-channel 224 of the bone anchor 212 to prevent the plug insert 214 from wobbling when engaged with the bone anchor 212. In some embodiments, the long sides 258 are flat or planar and are included to provide travel space for the tension member 16 within the through-channel 224. In some embodiments, the long sides 258 have a convex curvature. In some embodiments, the long sides 258 have a concave curvature.

[0133] In some embodiments, the distal extension 242 may include one or more mating grooves configured to receive the tension member 16 therein. In some embodiments, the one or more mating grooves may include closed mating grooves 262 formed as transverse channels through the long side 258 of the distal extension 242. In some embodiments, the closed mating groove 262 may have a smooth, rounded edge 264 to reduce the effect of friction on the tension member 16 as it moves within the closed mating groove 262 during assembly and / or tightening. In some embodiments, the one or more mating grooves may include open mating grooves 266 that open to one of the curved sides 260. In some embodiments, the open mating groove 266 may include an angled proximal surface 268 (to form an open groove) angled proximally to one of the curved sides 260, a hook-shaped end 270, and a smooth, rounded surface 272 configured to reduce the effect of friction on the tension member 16 as it moves within the open mating groove 266 during assembly and / or tightening. In some embodiments, the distal extension 242 may include one or more open mating grooves and no closed mating grooves. In some embodiments, the distal extension 242 may include one or more closed mating slots and no open mating slots.

[0134] In some embodiments, the same integral assembly can be achieved by guiding the free end 76 of the tension member 16 through the bone anchor 12 instead of guiding the annular end 74 as described above. As an example, Figure 43 This is a flowchart illustrating the steps of an example method 280 for repairing a fracture using the fracture repair system 210 described herein. By way of example only, method 280 is described in conjunction with repairing a fractured bone 2 (e.g., the patella) having a first fracture segment 4 and a second fracture segment 6, the first and second fracture segments being separated from each other by a fracture 8, further referenced to... Figure 44 In this example embodiment, the fracture repair system 210 includes a pair of bone anchors 212, 212', a single locking element 214, and a single tension member 216.

[0135] In some embodiments, the first step in the method 280 for repairing a fracture is to implant or otherwise position a pair of bone anchors (e.g., a first bone anchor 212 and a second bone anchor 212') through the fractured bone (e.g., the patella) using a preferred, known technique for implanting bone anchors 212. For example, the bone anchors 212, 212' may be inserted such that the distal end of the threaded outer surface portion 236 of the bone anchors 212, 212', including the rod 222, is driven into the first fracture segment, and the head 220 at the proximal end of the bone anchors 212, 212' is positioned within the second fracture segment. In this case, the locking element 214 is not engaged with either bone anchor 212, 212'.

[0136] In some embodiments, the second step 284 of the method 280 for repairing a fracture is to engage the tension member 16 to the locking element 214 such that the annular end 74 passes through the closed mating groove 262 of the locking element 214 and the free end 76 is positioned distally to the locking element 214. As an example, the locking element 214 and the tension member 16 can be engaged by first passing the tension member 16 through the closed mating groove 262 and allowing the tension member 16 to be in place such that one free end 76 of the tension member 16 is positioned along either long side 258 of the distal extension 242. This results in an engagement where the free end 76 is positioned distally to the locking element 214 and the annular portion 74 is positioned within the closed mating groove 262. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the locking element 214 may be pre-engaged with the tension member 16. In some embodiments, the locking element 214 and the tension member 16 are provided as separate, un-pre-engaged components, and the user (or assistant, etc.) must then pass the free end 76 of the tension member 16 through the locking element 214 as described above. In some embodiments, once the locking element 214 and the tension member 16 are coupled (or provided in the form of pre-coupled connection), the next step 288 of the method 280 for repairing fractures is to position the locking element 214 near the proximal head 220 of the first bone anchor 212.

[0137] In some embodiments, the next step 288 in the method 280 for repairing a fracture is to shuttle the free end 76 of the tension member 16 from the proximal end of the bone anchor 212 to the distal end of the bone anchor 212 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 226 of the passage channel 224 and exits from the distal opening 228 of the passage channel 224.

[0138] In some embodiments, the next step 290 of the method 280 for repairing a fracture is to pass the free end 76 on the anterior surface of the patella from the distal end of the first bone anchor 212 to the proximal end of the second bone anchor 212'. In some embodiments, the next step 292 of the method 280 for repairing a fracture is to shuttle the free end 76 through the proximal opening 226' of the passage 224' of the second bone anchor 212' to the distal opening 228' of the passage 224' of the second bone anchor 212'. In some embodiments, once the free end 76 exits the distal opening 228' of the second bone anchor 212', the next step 294 of the method 280 for repairing a fracture is to pass the free end 76 on the anterior surface of the bone (e.g., in a cross or "X" pattern) to the proximal opening 246 of the locking element 214. In some embodiments, the next step 296 of the fracture repair method 280 is to shuttle the free end 76 of the tension member 16 through the proximal opening 246 of the locking element 214 in a distal direction, then pass one free end 76 distally through each transverse opening 248, and continue to advance the free end 76 distally along the corresponding long side 258 of the distal extension 242. In some embodiments, the next step 298 of the fracture repair method 280 is to shuttle the free end 76 through the through-channel 224 of the first bone anchor 212, from the proximal opening 226 through the distal opening 228, such that the free end 76 is positioned distal to the distal opening 228, as an example. Figure 44 As shown.

[0139] In some embodiments, once the assembly has been established, the next step 300 in the method 280 for repairing the fracture is to tighten the system 210 by pulling the free end 76 of the tension member 16 located distal to the distal opening 228 of the through-channel 224 of the first bone anchor 212. This pulling force causes the locking element 214 to translate distally to pull the locking element 214 into the through-channel 224 of the first bone anchor 212. Alternatively or additionally, the system 210 can be tightened by pulling the tension member portion 17, which is a portion of the tension member 16 that exits from the distal opening 228 and crosses the bone to the proximal end of the second bone anchor 212'. This allows the locking element 214 to translate seamlessly while preventing the tension member 16 from converging within the through-channel 224. This can also be achieved, or alternatively, by manually pushing the locking element 214 distally.

[0140] In some embodiments, once the locking element 214 is placed in the bone anchor 212, the next step 302 in the method 380 for repairing a fracture is to lock the repair site under tension. To achieve this, the user first applies a desired amount of tension to the tension member 16 by pulling the free end 76 and / or portions of the tension member 16 that are displaced from the distal end of the first bone anchor 212, either individually (e.g., sequentially) or simultaneously, in a distal direction. This eliminates slack in the system 210, further pulling the head 240 of the locking element 214 into the proximal recess 230 of the head 220 of the bone anchor 212, thereby creating the aforementioned “pinch point” 78 between the distal engagement surface 252 and / or concave cutout 254 of the locking element 214 and the circumferential mating surface 238 of the bone anchor 212, where the tension member 16 is secured between them. This locking creates a knotless compression lock of the tension member 16 under tension, thereby converting the fracture fixation system 210 from an unlocked state to a locked state, wherein the locked state is maintained by compression and friction applied to the flexible tension member 16 between the mating surface 238 of the bone anchor 212 and the engaging surface 252 of the locking element 214. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces cause an increase in tension in the tension member 16, which in turn causes additional pulling of the annular end 74 against the locking element 214, which only further tightens the lock. In some embodiments, the next step 304 of the method 380 for repairing the fracture is, optionally, to remove excess tension member material once the desired tension has been applied and final tightening of the system 310 has occurred.

[0141] As an example, the locking is maintained by the tension generated in the fracture repair system 210 and the annular portion 74 in the closed docking groove 262 of the tension member 16, which continues to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the locking element 214 can be released by passing a reaction suture (e.g., or other unlocking tool) through the transverse opening 248 and pulling the locking element 214 proximally. In some embodiments, the reaction suture or other unlocking tool may be pre-loaded in the locking element 214. In some embodiments, the reaction suture or other unlocking tool may be guided through the transverse opening 248 before the system 210 is finally tensioned.

[0142] In some embodiments, the fracture repair system 210 may use two different bone anchors 212 (e.g., a first bone anchor 212 and a second bone anchor 212'), two different locking elements 214 (e.g., a first locking element 214 and a second locking element 214'), and two different tension members 16 (e.g., a first tension member 16 and a second tension member 16') to achieve tension band fracture repair, as exemplified by... Figures 45 to 46 As shown. Figure 47 This is a flowchart illustrating the steps of an exemplary method 310 for repairing a fracture using a fracture repair system 210 as described herein, having two tension members 16, 16' and two locking elements 214, 214'. As an example, the hardware (e.g., bone anchors 212, 212', locking elements 214, 214', and tension members 16, 16') is characterized as described above. As an example, method 310 is described in conjunction with repairing a fractured bone 2 (e.g., the patella) having a first fracture segment 4 and a second fracture segment 6, which are separated from each other by a fracture 8, further referenced to... Figure 48 .

[0143] In some embodiments, the first step 312 of the method 310 for repairing a fracture is to implant or otherwise position a pair of bone anchors (e.g., a first bone anchor 312 and a second bone anchor 312') through the fractured bone (e.g., the patella) using a preferred, known technique for implanting bone anchors 312. For example, the bone anchors 312, 312' may be inserted such that the distal end of the threaded outer surface portion 336 of the bone anchor 312, 312', including the rod 322, is positioned in the first fracture segment 4, and the head 320 at the proximal end of the bone anchor 312, 312' is positioned within the second fracture segment 6. In this case, locking elements 314, 314' are not engaged with either bone anchor 312, 312'.

[0144] In some embodiments, the second step 314 of the fracture repair method 310 involves coupling the first tension member 16 to the first locking element 214 such that the annular end 74 passes through the closed mating groove 262 of the first locking element 214 and the free end 76 is positioned distally to the first locking element 214. As an example, the first locking element 214 and the first tension member 16 can be coupled by first passing the first tension member 16 through the closed mating groove 262 and allowing the first tension member 16 to be in place such that a free end 76 of the first tension member 16 is positioned along either long side 258 of the distal extension 242. This results in a coupling where the free end 76 is distal to the first locking element 214 and the annular portion 74 is within the closed mating groove 262. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the first locking element 214 may be pre-coupled to the first tension member 16. In some embodiments, the first locking element 214 and the first tension member 16 are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76 of the first tension member 16 through the first locking element 214 as described above. In some embodiments, once the first locking element 214 and the first tension member 16 are connected (or provided in a pre-connected form), the next step 316 of the fracture repair method 310 is to position the first locking element 214 near the proximal head 220 of the first bone anchor 212.

[0145] In some embodiments, the next step 318 in the method 310 for repairing a fracture is to engage the second tension member 16' to the second locking element 214' such that the annular end 74' passes through the closed mating groove 262' of the second locking element 214' and the free end 76' is positioned distally to the second locking element 214'. As an example, the second locking element 214' and the second tension member 16' can be engaged by first passing the second tension member 16' through the closed mating groove 262' and allowing the second tension member 16' to be in place such that one free end 76' of the second tension member 16' is positioned along either long side 258' of the distal extension 242'. This results in an engagement where the free end 76' is positioned distally to the second locking element 214' and the annular portion 74' is positioned within the closed mating groove 262'. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the second locking element 214' may be pre-engaged with the second tension member 16'. In some embodiments, the second locking element 214' and the second tension member 16' are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76' of the second tension member 16' through the second locking element 214' as described above. In some embodiments, once the second locking element 214' and the second tension member 16' are connected (or provided in a pre-connected form), the next step 320 of the fracture repair method 310 is to position the second locking element 214' near the proximal head 220' of the second bone anchor 212'.

[0146] In some embodiments, the next step 322 of the method 310 for repairing a fracture is to shuttle the free end 76 of the first tension member 16 from the proximal end of the first bone anchor 212 to the distal end of the first bone anchor 212 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 226 of the passage channel 224 and exits from the distal opening 228 of the passage channel 224. In some embodiments, the next step 324 of the method 310 for repairing a fracture is to pass the free end 76 of the first tension member 16 from the distal end of the first bone anchor 212 onto the anterior surface of the patella through the proximal opening 246' of the second locking element 214'. In some embodiments, the next step 326 of the fracture repair method 310 is to shuttle the free end 76 of the first tension member 16 through the proximal opening 246' of the second locking element 214' in a distal direction, then pass one free end 76 distally through each transverse opening 248', and continue to advance the free end 76 distally along the corresponding long side 258' of the distal extension 242'. In some embodiments, the next step 328 of the fracture repair method 310 is to shuttle the free end 76 through the proximal opening 226' of the through-channel 224' of the second bone anchor 212' to the distal opening 228' of the through-channel 224' of the second bone anchor 212', such that the free end 76 of the first tension member 16 is positioned distal to the distal opening 228' of the second bone anchor 212', for example as follows: Figure 48 As shown.

[0147] In some embodiments, the next step 330 of the method 310 for repairing a fracture is to shuttle the free end 76' of the second tension member 16' from the proximal end of the second bone anchor 212' to the distal end of the second bone anchor 212' by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76' passes through the proximal opening 226' of the passage channel 224' and exits from the distal opening 228' of the passage channel 224'. In some embodiments, the next step 332 of the method 310 for repairing a fracture is to pass the free end 76' of the second tension member 16' from the distal end of the second bone anchor 212' onto the anterior surface of the patella to the proximal opening 246 of the first locking element 214. In some embodiments, the next step 334 of the fracture repair method 310 is to shuttle the free end 76' of the second tension member 16' through the proximal opening 246 of the first locking element 214 in a distal direction, then pass one free end 76' distally through each transverse opening 248, and continue to advance the free end 76' distally along the corresponding long side 258 of the distal extension 242. In some embodiments, the next step 336 of the fracture repair method 310 is to shuttle the free end 76' through the proximal opening 226 of the through-channel 224 of the first bone anchor 212 to the distal opening 228 of the through-channel 224 of the first bone anchor 212, such that the free end 76' of the second tension member 16' is positioned distal to the distal opening 228 of the first bone anchor 212, for example, as shown in the figure. Figure 48 As shown.

[0148] It should be noted that the various steps described herein related to the in-situ assembly of the fracture repair system 210 can be performed in any reasonable order. For example, in some embodiments, the steps described above for coupling the first tension member 16 to the second locking element 214' can be performed as a set before performing the steps required to coupling the second tension member 16' to the first locking element 214. In some embodiments, the various steps can be performed such that the coupling occurs substantially simultaneously rather than sequentially.

[0149] In some embodiments, once these connections have been established, the next step 338 in the method 310 for repairing a fracture is to tighten the system 210 by pulling the free end 76 of the first tension member 16 located distal to the distal opening 228' of the passage 224' of the second bone anchor 212'. This pull causes the first locking element 214 to translate distally into the passage 224 of the first bone anchor 212. Alternatively or additionally, the system 210 can be tightened by pulling a portion 17 of the tension member that exits from the distal opening 228' of the first bone anchor 212 and traverses the bone to the proximal end of the first tension member 16 of the second bone anchor 212'. This allows for seamless translation of the first locking element 214 while preventing the tension member 16 from converging within the passage 224. This can also be achieved, or alternatively, by manually pushing the first locking element 214 distally into the first bone anchor 212. Similarly, the next step 340 in the fracture repair method 310 is to tighten the system 210 by pulling the free end 76' of the second tension member 16' located distal to the distal opening 228 of the through-channel 224 of the first bone anchor 212. This pulling force causes the second locking element 214' to translate distally into the through-channel 224' of the second bone anchor 212'. Alternatively or additionally, the system 210 can be tightened by pulling a portion 17' of the tension member that exits from the distal opening 228' of the second bone anchor 212' and crosses the bone to the proximal end of the first bone anchor 212. This allows for seamless translation of the second locking element 214' while preventing the tension member 16 from converging within the through-channel 224'. This can also be achieved, or alternatively, by manually pushing the second locking element 214 distally into the second bone anchor 212.

[0150] In some embodiments, once the locking elements 214, 214' are placed in the bone anchors 212, 212', the next step 342 in the fracture repair method 310 is to lock the repair site under tension. To achieve this, the user first applies the desired amount of tension to the tension members 16, 16' by pulling the free ends 76, 76' that are located distally from the distal ends of the bone anchors 212, 212'. As an example, the free ends 76, 76' can be tensioned one at a time or simultaneously. This will eliminate slack in system 210, further pulling the heads 240, 240' of locking elements 214, 214' into the proximal recesses 230, 230' of the heads 220, 220' of bone anchors 212, 212', and creating the aforementioned "pinch points" 78, 78' between the distal engagement surfaces 252 and / or concave cutouts 254 of locking elements 214, 214' and the circumferential mating surfaces 238 of bone anchors 212, 212', where tension members 16, 16' are secured between them, as exemplified by Figure 48As shown. This locking produces a knotless compression lock of the tension members 16, 16' under tension, thereby converting the fracture fixation system 210 from an unlocked state to a locked state, wherein the locked state is maintained by compression and friction applied to the flexible tension members 16, 16' between the mating surfaces 238 of the bone anchors 212, 212' and the engaging surfaces 252 of the locking elements 214, 214'. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces cause an increase in tension in the tension members 16, 16', which in turn causes additional pulling of the annular ends 74, 74' against the locking elements 214, 214', which only further tightens the lock. In some embodiments, the next step 344 of the method 310 for repairing the fracture is, optionally, to remove excess tension member material once the desired tension has been applied and final tightening of the system 310 has occurred.

[0151] As an example, locking is maintained by the tension generated in the fracture repair system 210 and the annular portions 74, 74' in the closed docking slots 262, 262' of the tension members 16, 16', which continue to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the locking elements 14, 14' can be released by passing a reaction suture (e.g., or other unlocking tool) through the transverse openings 248, 248' and pulling the locking elements 214, 214' proximally. In some embodiments, the reaction suture or other unlocking tool may be pre-loaded in the locking elements 214, 214'. In some embodiments, the reaction suture or other unlocking tool may be guided through the transverse openings 248, 248' before the system 210 is finally tensioned.

[0152] Figures 49 to 55 An example of a fracture repair system 410 using a conical locking configuration according to some embodiments is illustrated. Although illustrated and described herein in connection with patellar fractures, it should be understood that the fracture repair system 410 can be used to repair fractures in any suitable anatomical location of the body, including but not limited to the patella, ankle, etc. In some embodiments, the fracture repair system 410 includes at least two bone anchors 412, 412', two locking elements 414, 414', and two flexible tension members 16, 16', which are configured to interact with the bone anchors 412, 412' and the locking elements 414, 414' to firmly hold the fractured bone fragment in place for healing, while also creating a tension band structure that prevents the bone fragment from shifting due to forces that tend to pull the bone fragment apart. In some embodiments, the fracture repair system 410 may include only one locking element 414 and a flexible tension member 16, as referenced above. Figures 1 to 2 As shown and described. As an example, instead of the "pinch point" mentioned above, locking in this embodiment occurs through a wedging interaction between the locking element 414 and the inner surface of the bone anchor 412, as will be described below.

[0153] Figures 53 to 54 An example of a bone anchor 412 (or bone anchor 412', which is identical to bone anchor 412) forming part of a fracture repair system 410 according to some embodiments is illustrated. By way of example only, the bone anchor 412 has a head 420 at its proximal end, an elongated rod 422 extending distally from the head 420, and an internal cavity or through-channel 424 extending along the length of the rod 422 and having a proximal opening 426 within the head 420 and a distal opening 428 at the distal end of the rod 422. In some embodiments, the head 420 further includes a lip 430. In some embodiments, the rod comprises a cylindrical member having a smooth outer surface portion 434 and a threaded outer surface portion 436. In some embodiments, the threaded outer surface portion 436 is located at or near the distal end of the rod 422, and the smooth outer surface portion 434 is located near the head 420. By way of example only, the threaded outer surface portion 436 is configured to insert into and obtain gripping within a bone fragment (e.g., a fractured distal bone fragment) to hold the distal and proximal bone fragments together. In some embodiments, the bone anchor 412 may have a fully threaded rod 422.

[0154] In some embodiments, the through-channel 424 includes a proximal portion 438, a distal portion 442, and an intermediate portion 446. The proximal portion includes a cylindrical inner surface 440 having a first diameter, the distal portion includes a cylindrical inner surface 444 having a second diameter smaller than the first diameter, and the intermediate portion is positioned between the proximal and distal portions 442 and includes a tapered inner surface 448 having a diameter that decreases from proximal to distal. In some embodiments, the tapered inner surface 448 is sized and configured to interact with the tapered outer surface 454 of the locking element 414 to provide an elongated surface area that contacts the tension member 16 during locking of the fracture repair system 410, thereby wedging the tension member 16 between the locking element 414 and the tapered inner surface 448 of the bone anchor 412.

[0155] Figure 55An example of a locking element 414 forming part of a fracture repair system 410 according to some embodiments is illustrated. By way of example only, the locking element 414 includes a single body having a proximal portion 450, a distal portion 452, and a tapered outer surface 454. In some embodiments, the locking element 414 is configured such that the size and configuration of the single-body locking element 414 are designed to fit within the middle portion 446 of the through-channel 424 of the bone anchor 412 during tightening of the system 410.

[0156] In some embodiments, the proximal portion 450 includes an internal cavity 460 and a plurality of orifices formed in the proximal portion 450, which serve as inlets and outlets for the tension member 416 to pass through during assembly and tensioning of the fracture repair system 410. For example, in some embodiments, the proximal portion 450 may have a proximal orifice 458 and a pair of transverse orifices 460 positioned on opposite sides of the locking element 414. In some embodiments, the distal portion 452 has a mating groove 462, which may be open or closed. In some embodiments, the tapered outer surface 454 engages with the tapered inner surface 448 of the bone anchor 412 to form a locking mechanism that uses a combination of tension locking (via the tension member) and interference fit (via the interaction of the tapered components described herein) to secure the tension member 16 between them, thereby locking the structure under tension.

[0157] Figure 56 This is a flowchart illustrating the steps of an exemplary method 510 for repairing a fracture using a fracture repair system 410 as described herein, having two bone anchors 412, 412', two tension members 16, 16', and two locking elements 414, 414'. As an example, method 510 is described in conjunction with repairing a fractured bone 2 (e.g., the patella) having a first fracture segment 4 and a second fracture segment 6, the first and second fracture segments being separated from each other by a fracture 8, further referenced to... Figures 51 to 52 Although described herein as a repair using two locking elements 414, 414' and two tension members 16, 16', the fracture repair system 410 of the currently described embodiment can be configured to perform tension band repair using only one locking element 414 and one tension member 16, with the method steps performed as described above for a similarly arranged construction. Furthermore, although shown and described herein as having a closed mating groove, in some embodiments, the locking elements 414, 414' may have an open locking groove, enabling the use of assembly techniques in which the annular ends of the tension members 16, 16' shuttle through the bone anchors 412, 412' as described above.

[0158] In some embodiments, the first step 512 of the method 510 for repairing a fracture is to implant or otherwise position a pair of bone anchors (e.g., a first bone anchor 512 and a second bone anchor 512') through the fractured bone (e.g., the patella) using a preferred, known technique for implanting bone anchors 512. For example, the bone anchors 512, 512' may be inserted such that the distal end of the threaded outer surface portion 536 of the bone anchor 512, 512', including the rod 522, is positioned in the first fracture segment 4, and the head 520 at the proximal end of the bone anchor 512, 512' is positioned within the second fracture segment 6. In this case, locking elements 514, 514' are not engaged with either bone anchor 512, 512'.

[0159] In some embodiments, the second step 514 of the fracture repair method 510 is to attach the first tension member 16 to the first locking element 414 such that the annular end 74 passes through the closed mating groove 462 of the first locking element 414 and the free end 76 is positioned distal to the first locking element 414. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the first locking element 414 may be pre-attached to the first tension member 16. In some embodiments, the first locking element 414 and the first tension member 16 are provided as separate, unattached components, and the user (or assistant, etc.) must then pass the free end 76 of the first tension member 16 through the first locking element 414 as described above. In some embodiments, once the first locking element 414 and the first tension member 16 are attached (or provided pre-attached), the next step 516 of the fracture repair method 510 is to position the first locking element 414 near the proximal head 420 of the first bone anchor 412.

[0160] In some embodiments, the next step 518 in the method 510 for repairing a fracture is to attach the second tension member 16' to the second locking element 414' such that the annular end 74' passes through the closed mating groove 462' of the second locking element 414' and the free end 76' is positioned distal to the second locking element 414'. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the second locking element 414' may be pre-attached to the second tension member 16'. In some embodiments, the second locking element 414' and the second tension member 16' are provided as separate, unattached components, and the user (or assistant, etc.) must then pass the free end 76' of the second tension member 16' through the second locking element 414' as described above. In some embodiments, once the second locking element 414' and the second tension member 16' are attached (or provided pre-attached), the next step 520 in the method 510 for repairing a fracture is to position the second locking element 414' near the proximal head 420' of the second bone anchor 412'.

[0161] In some embodiments, the next step 522 of the method 510 for repairing a fracture is to shuttle the free end 76 of the first tension member 16 from the proximal end of the first bone anchor 412 to the distal end of the first bone anchor 412 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 426 of the passage channel 424 and exits from the distal opening 428 of the passage channel 424. In some embodiments, the next step 524 of the method 510 for repairing a fracture is to pass the free end 76 of the first tension member 16 from the distal end of the first bone anchor 412 onto the anterior surface of the patella through the proximal opening 458' of the second locking element 414'. In some embodiments, the next step 526 of the fracture repair method 510 is to shuttle the free end 76 of the first tension member 16 distally through the proximal opening 458' of the second locking element 414', then pass one free end 76 distally through each transverse opening 460', and continue to advance the free end 76 distally along the tapered outer surface 454' of the second locking element 414'. In some embodiments, the next step 528 of the fracture repair method 510 is to shuttle the free end 76 through the proximal opening 426' of the through-channel 424' of the second bone anchor 412' to the distal opening 428' of the through-channel 424' of the second bone anchor 412', such that the free end 76 of the first tension member 16 is positioned distal to the distal opening 428' of the second bone anchor 412', for example as follows: Figures 51 to 52 As shown.

[0162] In some embodiments, the next step 530 of the method 510 for repairing a fracture is to shuttle the free end 76' of the second tension member 16' from the proximal end of the second bone anchor 412' to the distal end of the second bone anchor 412' by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76' passes through the proximal opening 426' of the passage channel 424' and exits from the distal opening 428' of the passage channel 424'. In some embodiments, the next step 532 of the method 510 for repairing a fracture is to pass the free end 76' of the second tension member 16' from the distal end of the second bone anchor 412' onto the anterior surface of the patella to the proximal opening 458 of the first locking element 414. In some embodiments, the next step 534 of the fracture repair method 510 is to shuttle the free end 76' of the second tension member 16' through the proximal opening 458 of the first locking element 414 in a distal direction, then pass one free end 76' distally through each transverse opening 460, and continue to advance the free end 76' distally along the tapered outer surface 454 of the first locking element 414. In some embodiments, the next step 536 of the fracture repair method 510 is to shuttle the free end 76' through the proximal opening 426 of the through-channel 424 of the first bone anchor 412 to the distal opening 428 of the through-channel 424 of the first bone anchor 412, such that the free end 76' of the second tension member 16' is positioned distal to the distal opening 428 of the first bone anchor 412, as an example... Figures 51 to 52 As shown.

[0163] It should be noted that the various steps described herein related to the in-situ assembly of the fracture repair system 510 can be performed in any reasonable order. For example, in some embodiments, the steps described above for coupling the first tension member 16 to the second locking element 414' can be performed as a set before performing the steps required to coupling the second tension member 16' to the first locking element 414. In some embodiments, the various steps can be performed such that the coupling occurs substantially simultaneously rather than sequentially.

[0164] In some embodiments, once these connections have been established, the next step 538 in the method 510 for repairing a fracture is to tighten the system 510 by pulling the free end 76 of the first tension member 16 located distal to the distal opening 428' of the passage 424' of the second bone anchor 412'. This pull causes the first locking element 414 to translate distally into the passage 424 of the first bone anchor 412. Alternatively or additionally, the system 410 can be tightened by pulling a portion 17 of the tension member that exits from the distal opening 428 of the first bone anchor 412 and traverses the bone to the proximal end of the first tension member 16 to the second bone anchor 412'. This allows for seamless translation of the first locking element 414 while preventing the tension member 16 from converging within the passage 424. This can also be achieved, or alternatively, by manually pushing the first locking element 414 distally into the first bone anchor 412. Similarly, the next step 540 in the fracture repair method 510 is to tighten the system 410 by pulling the free end 76' of the second tension member 16' located distal to the distal opening 428 of the through-channel 424 of the first bone anchor 412. This pulling force causes the second locking element 414' to translate distally into the through-channel 424' of the second bone anchor 412'. Alternatively or additionally, the system 410 can be tightened by pulling a portion 17' of the tension member that exits from the distal opening 428' of the second bone anchor 412' and crosses the bone to the proximal end of the first bone anchor 412. This allows for seamless translation of the second locking element 414' while preventing the tension member 16 from converging within the through-channel 424'. This can also be achieved, or alternatively, by manually pushing the second locking element 414' distally into the second bone anchor 412'.

[0165] In some embodiments, once the locking elements 414, 414' are placed in the bone anchors 212, 212', the next step 542 in the fracture repair method 510 is to lock the repair site under tension. To achieve this, the user first applies the desired amount of tension to the tension members 16, 16' by pulling the free ends 76, 76' that are distal to the bone anchors 412, 412' in a distal direction. As an example, the free ends 76, 76' can be tensioned one at a time or simultaneously. This eliminates slack in the system 210, further pulling the first locking element 414 and the second locking element 414' into the middle portion 446 of the through-channel 424 of the respective bone anchors 412, 412', and wedging the tension members 16, 16' between the tapered outer surface 454 of the locking elements 414, 414' and the tapered inner surface 440 of the bone anchors 412, 412', respectively. This wedging creates a knotless locking of the tension members 16, 16' under tension, thereby converting the fracture fixation system 210 from an unlocked state to a locked state, wherein the locked state is maintained by pressure and friction applied to the flexible tension members 16, 16' between the mating surfaces 238 of the bone anchors 212, 212' and the engaging surfaces 252 of the locking elements 214, 214'. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces increase the tension in the tension members 16, 16', which in turn leads to additional pulling of the annular ends 74, 74' against the locking elements 414, 414', which only further tightens the lock.

[0166] As an example, locking is maintained by the tension generated in the fracture repair system 410 and the annular portions 76, 76' in the mating slots 462, 462' of the tension members 16, 16', which continue to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the first locking element 414 and / or the second locking element 414' can be released by passing a reaction suture (e.g., through the transverse orifice 460 and pulling the first locking element 414 and / or the second locking element 414' proximally. In some embodiments, the reaction suture may be pre-loaded in the locking elements 414, 414'. In some embodiments, the reaction suture may be guided through the transverse orifice 460 before the system 410 is finally tensioned.

[0167] In some embodiments, the fracture repair system 10 may use a single bone anchor 12, locking element 14, and tension member 16 to achieve tension band fracture repair, as exemplified by... Figures 59 to 60 As shown. Figure 61This is a flowchart illustrating the steps of an example method 150 for repairing a fracture using a fracture repair system 10 having a single bone anchor 12, locking element 14, and tension member 16 as described herein. As an example, the characteristics of the hardware (e.g., bone anchor 12, locking element 14, and tension member 16) are as specifically referenced above. Figures 3 to 11 The described components have the same characteristics. As an example, method 150 is described in conjunction with repairing a fractured bone 2 (e.g., the patella), which has a first fracture segment 4 and a second fracture segment 6, the first and second fracture segments being separated from each other by a fracture 8, further referenced. Figures 62 to 66 .

[0168] In some embodiments, the first step 152 of the method 150 for repairing a fracture is to implant or otherwise position the bone anchor 12 through the fractured bone (e.g., the patella) using a preferred, known technique for implanting a bone anchor 12. For example, the bone anchor 12 may be inserted such that the distal end of the threaded outer surface portion 36 of the bone anchor 12, including the rod 22, is positioned in the first fracture segment 4, and the head 20 at the proximal end of the bone anchor 12 is positioned within the second fracture segment 6, for example as... Figure 62 As shown. At this time, the locking element 14 is not connected to the bone anchor 12. In addition, a bone tunnel 3 is formed in the bone 2 near the bone anchor 12, which extends across the fracture 8, wherein a distal opening 7 is formed in the first bone segment 4 and a proximal opening 5 is formed in the second bone segment 6.

[0169] In some embodiments, the second step 154 ​​of the fracture repair method 150 is to connect the tension member 16 to the locking element 14 such that the annular end 74 is positioned proximally to the locking element 14 and the free end 76 is positioned distally to the locking element 14. As an example, the locking element 14 and the tension member 16 can be connected by first passing the free end 76 of the tension member 16 distally through the proximal orifice 46 of the locking element 14, then passing one free end 76 distally through each transverse orifice 48, and continuing to advance the free end 76 distally along the corresponding long side 58 of the distal extension 42. This results in the tension member 16 being connected to the locking element 14 such that the free end 76 is positioned distally to the locking element 14 and the annular portion 74 is formed proximally to the head 40. In some embodiments, to facilitate a reduction in the number of steps for the surgeon, the locking element 14 may be pre-connected to the tension member 16. In some embodiments, the locking element 14 and the tension member 16 are provided as separate, unconnected components, and the user (or assistant, etc.) must then pass the free end 76 of the tension member 16 through the locking element 14 as described above. In some embodiments, once the locking element 14 and the tension member 16 are connected (or provided in a pre-connected form), the next step 156 of the fracture repair method 80 is to position the locking element 14 near the proximal head 20 of the bone anchor 12.

[0170] In some embodiments, the next step 158 in the method 150 for repairing a fracture is to shuttle the free end 76 of the tension member 16 from the proximal end of the bone anchor 12 to the distal end of the bone anchor 12 by hand or using a shuttle device (e.g., a nickel-titanium alloy shuttle or a suture shuttle), so that the free end 76 passes through the proximal opening 26 of the passage channel 24 and exits from the distal opening 28 of the passage channel 24, as an example only. Figure 62 As shown.

[0171] The user can then focus on the annular portion 74 located proximal to the head 40 of the locking element 14. In some embodiments, the next step 160 of the method 150 for repairing a fracture is to pass the annular portion 74 across the anterior surface of the fractured bone 2 from the proximal head 40 of the locking element 14 toward the distal opening 7 of the bone tunnel 3. In some embodiments, the next step 162 of the method 150 for repairing a fracture is to shuttle the annular portion 74 proximally through the bone tunnel 3 to the proximal opening 5 of the bone tunnel 3. In some embodiments, once the annular portion 74 leaves the proximal opening 5 of the bone tunnel 3, the next step 164 of the method 150 for repairing a fracture is to pass the annular portion 74 across the anterior surface of the bone 2 (e.g., in a cross or “X” pattern) toward the distal opening 28 of the passageway 24 of the first bone anchor 12, as an example only. Figure 63 As shown. In some embodiments, the next step 166 of the method 150 for repairing a fracture is to shuttle the annular end 74 of the tension member 16 proximally through the through-channel 24 of the first bone anchor 12, from the distal opening 28 through the proximal opening 26 to the locking element 14 located proximal to the proximal opening 26, as an example. Figure 64 As shown. In some embodiments, the next step 168 of the method 150 for repairing a fracture is to connect the annular end 74 of the tension member 16 to the locking element 14 by inserting the annular portion 74 into the open mating groove 66 of the locking element 14, as an example. Figure 64 As shown.

[0172] In some embodiments, once the connection has been established, the next step 170 in the fracture repair method 150 is to tighten the system 10 by pulling the free end 76 of the tension member 16 located distal to the distal opening 28 of the through-channel 24 of the first bone anchor 12. Alternatively or additionally, the system 10 can be tightened by pulling a portion 17 of the tension member 16 that exits from the distal opening 28 and crosses the proximal opening 5 of the bone-to-anchor tunnel 3. This allows the locking element 14 to translate seamlessly while preventing the tension member 16 from converging within the through-channel 24. This pulling force causes the locking element 14 to translate distally into the through-channel 24 of the first bone anchor 12. This can also be achieved, or alternatively, by manually pushing the locking element 14 distally into the first bone anchor 12.

[0173] In some embodiments, once the locking element 14 is placed in the bone anchor 12, the next step 172 in the fracture repair method 150 is to lock the repair site under tension. To achieve this, the user first applies the desired amount of tension to the tension member 16 by pulling the free end 76, which is located distally from the distal end of the first bone anchor 12. As an example, the free ends can be tensioned one at a time or simultaneously. This eliminates slack in the system 10, further pulling the head 40 of the locking element 14 into the proximal recess 30 of the head 20 of the bone anchor 12, and creating the aforementioned “pinch point” 78 between the distal engagement surface 52 and / or concave cutout 54 of the locking element 14 and the circumferential mating surface 38 of the bone anchor 12, where the tension member 16 is secured between them, as an example. Figure 65 As shown. This locking produces a knotless compression lock of the tension member 16 under tension, thereby converting the fracture fixation system 10 from an unlocked state to a locked state, wherein the locked state is maintained by compression and friction applied to the flexible tension member 16 between the mating surface 38 of the bone anchor 12 and the engaging surface 52 of the locking element 14. This creates a tension band structure that prevents fracture displacement caused by forces that tend to pull the fracture fragments apart, as these reaction forces cause an increase in tension in the tension member 16, which in turn causes additional pulling of the annular end 74 against the locking element 14, which only further tightens the lock. In some embodiments, the next step 104 of the method 80 for repairing the fracture is, optionally, to remove excess tension member material once the desired tension has been applied and final tightening of the system 10 has occurred, as exemplified by... Figure 66 As shown.

[0174] As an example, locking is maintained by the tension generated in the fracture repair system 10 and the annular portion 74 of the tension member 16 engaging in the open docking slot 66, which continues to assist in preventing any separation of the fracture by providing a reaction force in the opposite direction. In some embodiments, if the user wishes to adjust the tension or if revision surgery is proven necessary, the locking element 14 can be released by passing a reaction suture (e.g., or other unlocking tool) through the transverse opening 48 and pulling the locking element 14 proximally. In some embodiments, the reaction suture or other unlocking tool may be pre-loaded in the locking element 14. In some embodiments, the reaction suture or other unlocking tool may be guided through the transverse opening 48 before the system 10 is finally tensioned.

[0175] Figures 57 to 58 Examples of tension member 16 according to some embodiments of the present disclosure are illustrated. As described throughout this document, tension member 16 is an elongated flexible member having a first end and a second end 76, which are referred to herein as “free ends” 76, as exemplified by... Figure 57 As shown. In certain orientations of the tension member 16, an "annular end" 74 is created and distinguished from the "free end" 76. As used throughout this document, the "annular end" 74 is not the actual end of the tension member 16, because these actual ends are the "free ends" 76. Rather, the "annular end" 74 is created during the assembly of the fracture fixation system 10 (and / or fracture fixation system 210 and / or fracture fixation system 410) when the tension member 16 is oriented around an object or component, and / or makes a U-turn around an object or component, and / or folds in half and / or folds itself into two orientations where the "free ends" 76 are at one end of the orientation and the U-turn portion or the "annular end" 74 is at the other end of the orientation, as exemplified by... Figure 58 As shown. As an example, this orientation can be generated during the fracture repair procedure by a surgeon or operating room personnel when assembling the tension member 16 with the locking element 14 (and / or locking element 214 and / or locking element 414) in situ, or during pre-assembly at some point before the surgical procedure. In some embodiments, the tension member 16 may be made of polyester, polyethylene, nickel-titanium alloy, or any suitable material. In some embodiments, the tension member 16 may be a surgical suture, band, strap, or any suitable tensionable component. In some embodiments, the tension member 16 may be round, flat, or a combination of round and flat.

[0176] Optionally, in any embodiment, the bone anchors described herein (e.g., bone anchors 12, 12', 212, 212', 412, 412') may be partially threaded, fully threaded, or completely unthreaded. Optionally, in any embodiment, the bone anchors described herein may be headed or headless. Optionally, in any embodiment, the bone anchors described herein may be made of any suitable medical-grade metal or polymer, including but not limited to (by example only) titanium, stainless steel, cobalt-chromium alloys, polyetheretherketone (PEEK), polyetherketoneketone (PEKK), etc.

[0177] Optionally, in any embodiment, the distal extension 42 may include one or more open mating slots and no closed mating slots. Alternatively, in any embodiment, the distal extension 42 may include one or more closed mating slots and no open mating slots.

[0178] As an example, this method of repairing patellar fractures using an anchoring system and tensioning member can also be performed using a finger-cot design, metal, PEEK, or similar device. This similar device could be a button that serves as a base member for organizing sutures onto the base member using a finger-cot technique or finger-cot method, which may include sutures woven in a manner that they cross or have a fibrous sheath surrounding or adjacent to the tensioning suture. As an example, once the configuration is tensioned by pulling the tensioning member or free suture, the loop size can be reduced, thereby eliminating all slack in the configuration and providing a tension band effect for fixation of the patellar fracture. The looped end can be delivered in a cross-shaped manner through a through-channel within the screw, ultimately connecting to the base member or a component of the base member or a component of the screw. This provides the user with an anchor point to form some form of closed loop that can be internally tensioned or reduced to eliminate slack in the system and then act as a barrier against any fracture traction. The base member can be positioned adjacent to or along the body of the screw, and may or may not have a press-fit design. The loop can start from the desired maximum length in the ring, and then be reduced by decreasing the size of the ring, which can be achieved by pulling the tension member, which can be achieved by pulling the tension member of the finger sleeve structure.

[0179] As used herein, the terms “proximal” and “distal” are defined by the positioning of the head end of the bone anchor relative to the opposing end of the bone anchor. For example, “proximal end” is defined as the end of the bone anchor 12 with the anchor head 20, and “distal end” is defined as the end of the bone anchor 12 opposite to the end with the anchor head 20, regardless of the orientation of the bone anchor 12 during use. “Proximal direction” can be defined as the direction from the distal end to the proximal end (and further) along a longitudinal axis extending through the proximal and distal ends. Similarly, “distal direction” can be defined as the direction from the proximal end to the distal end (and further) along a longitudinal axis extending through the proximal and distal ends. The term “proximal” can be defined as “along the proximal direction.” The term “distal” can be defined as “along the distal direction.”

[0180] The term “connection” is defined as a link, but is not necessarily a direct link or a mechanical link. When used in conjunction with the term “comprising” in the claims and / or specification, the use of the words “a” or “an” can mean “one”, but also implies “one or more” or “at least one.” The term “about” typically means ±5% of the stated value. The term “or” as used in the claims is used to mean “and / or” unless explicitly indicated as referring only to alternatives or that the alternatives are mutually exclusive, although this disclosure supports the definition of referring only to alternatives and “and / or.”

[0181] The terms “comprise” (and any form of “comprise”, such as “comprises” and “comprising”), “have” (and any form of “have”, such as “has” and “having”), “include” (and any form of “include”, such as “includes” and “including”), and “contain” (and any form of “contain”, such as “contains” and “containing”) are open-ended connecting verbs. Therefore, a method or apparatus that “comprises,” “has,” “includes,” or “contains” one or more steps or elements has, but is not limited to, having only that one or more steps or elements. Similarly, a method or apparatus that “comprises,” “has,” “includes,” or “contains” one or more features has, but is not limited to, having only that one or more features. Furthermore, a device or structure constructed in a certain way is at least constructed in that way, but may also be constructed in ways not listed.

[0182] Any feature or attribute of the above embodiments and variations can be combined with any other feature and attribute of the above embodiments and variations as needed. It will also be apparent from the foregoing disclosure and the detailed description of certain preferred embodiments that various modifications, additions, and other alternative embodiments are possible without departing from the true scope and spirit. The embodiments discussed have been chosen and described to provide the best illustration of the principles of this disclosure and its practical application, thereby enabling those skilled in the art to use the methods and apparatus described herein in various embodiments with various modifications suitable for the intended particular purpose. All such modifications and variations are within the scope of this disclosure when interpreted according to the scope to which they are fairly, legally, and impartially conferred.

Claims

1. A fracture repair system, the fracture repair system comprising: A flexible tension member having a first free end and a second free end, and a flexible body extending between the first free end and the second free end, the flexible tension member being oriented in an assembly configuration to have an annular end and an open end, the annular end including a U-shaped portion of the flexible body, and the open end including the first free end and the second free end of the flexible tension member; A first bone anchor and a second bone anchor, configured for implantation in bone, each of the first bone anchor and the second bone anchor having an anchor head at a proximal end, an elongated rod extending between the anchor head and a distal end, and a through-channel extending longitudinally through the elongated rod and having a proximal opening at the proximal end and a distal opening at the distal end, the anchor head including a proximal recess including a circumferential mating surface positioned within the proximal recess; A locking element having a proximal head and an elongated extension extending distally from the proximal head, the proximal head including a proximal opening, a pair of lateral openings and a distal engagement surface, the elongated extension including a mating groove formed therein and configured to secure the annular end of the flexible tension member. A first assembly configuration wherein the locking element is associated with the first bone anchor, the annular end of the flexible tension member is positioned proximally to the locking element, the open end of the flexible tension member is positioned distally to the distal end of the first bone anchor, and the flexible body extends through the proximal opening of the locking element, the lateral opening of the locking element, and the through-channel of the first bone anchor. and A second assembly configuration wherein the elongated extension of the locking element extends into the through-channel of the first bone anchor, the annular end of the flexible tension member is secured by the mating groove of the locking element, the open end of the flexible tension member is positioned distal to the distal end of the first bone anchor, and the flexible body extends through the through-channel of the first bone anchor, the through-channel of the second bone anchor, and the proximal opening and the lateral opening of the locking element before passing between the circumferential mating surface of the first bone anchor and the distal engaging surface of the locking element; The open end of the flexible tension member is configured to be stretched along the distal direction, thereby generating tension in the flexible tension member, which causes the locking element to translate distally relative to the first bone anchor and to change the fracture repair system from an unlocked state that allows movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, wherein the locked state is maintained by pressure and friction applied to the flexible tension member between the mating surface of the first bone anchor and the engaging surface of the locking element.

2. The fracture repair system of claim 1, wherein the proximal head of the locking element is configured to be embedded within the anchor head.

3. The fracture repair system of claim 1, wherein the distal engagement surface of the locking element includes at least one concave recess.

4. The system of claim 1, wherein the second assembly configuration further comprises the flexible body extending distally from the annular end through the through-channel of the first bone anchor, then obliquely extending to the proximal end of the second bone anchor, then distally through the through-channel of the second bone anchor, then obliquely extending to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the lateral opening of the locking element, and the through-channel of the first bone anchor.

5. The fracture repair system of claim 1, wherein the rod of the first bone anchor and the second bone anchor has an outer surface, the outer surface including a threaded portion and a non-threaded portion.

6. The fracture repair system of claim 1, wherein the locking element further comprises at least one smooth curved surface adjacent to the mating groove.

7. The fracture repair system according to claim 1, wherein the docking groove is an open docking groove.

8. The fracture repair system according to claim 1, wherein the docking groove has a hook-shaped configuration.

9. The fracture repair system of claim 1, wherein the mating groove extends to the distal end of the elongated extension.

10. The fracture repair system of claim 1, wherein the elongated extension is sized and configured to fit snugly within the through-channel of the first bone anchor to prevent pivoting of the locking element when the elongated extension is positioned within the through-channel of the first bone anchor.

11. A fracture repair system, the fracture repair system comprising: A flexible tension member having a first free end and a second free end, and a flexible body extending between the first free end and the second free end, the flexible tension member being oriented in an assembly configuration to have an annular end and an open end, the annular end including a U-shaped portion of the flexible body, and the open end including the first free end and the second free end of the flexible tension member; A bone anchor configured for implantation in bone, the bone anchor having an anchor head at a proximal end, an elongated rod extending between the anchor head and a distal end, and a through-channel extending longitudinally through the elongated rod and having a proximal opening at the proximal end and a distal opening at the distal end, the anchor head including a proximal recess, the proximal recess including a circumferential mating surface positioned within the proximal recess; A locking element having a proximal head and an elongated extension extending distally from the proximal head, the proximal head including a proximal opening, a pair of lateral openings and a distal engagement surface, the elongated extension including a mating groove formed therein and configured to secure the annular end of the flexible tension member. A first assembly configuration wherein the locking element is associated with the bone anchor, the annular end of the flexible tension member is positioned proximally to the locking element, the open end of the flexible tension member is positioned distally to the distal end of the bone anchor, and the flexible body extends through the proximal opening of the locking element, the lateral opening of the locking element, and the through-channel of the bone anchor. and The second assembly configuration, wherein the elongated extension of the locking element extends into the through-channel of the bone anchor, the annular end of the flexible tension member is secured by the mating groove of the locking element, the open end of the flexible tension member is positioned distal to the distal end of the bone anchor, and the flexible body extends through the through-channel of the bone anchor, the bone tunnel formed in the fracture bone to be repaired, and the proximal opening and the transverse opening of the locking element before passing between the circumferential mating surface of the bone anchor and the distal engagement surface of the locking element; The open end of the flexible tension member is configured to be pulled taut along the distal direction, thereby generating tension in the flexible tension member, which causes the locking element to translate distally relative to the bone anchor and to change the fracture repair system from an unlocked state that allows movement of the flexible tension member to a locked state that prohibits movement of the flexible tension member, wherein the locked state is maintained by pressure and friction applied to the flexible tension member between the mating surface of the bone anchor and the engaging surface of the locking element.

12. The fracture repair system of claim 11, wherein the proximal head of the locking element is configured to be fitted into the anchor head.

13. The fracture repair system of claim 11, wherein the distal engagement surface of the locking element includes at least one concave recess.

14. The fracture repair system of claim 11, wherein the second assembly configuration further comprises the flexible body extending distally from the annular end through the through-channel of the first bone anchor, then obliquely extending to the proximal opening of the bone tunnel, then distally through the bone tunnel, then obliquely extending to the proximal head of the locking element, and then distally through the proximal opening of the locking element, the transverse opening of the locking element, and the through-channel of the bone anchor.

15. The fracture repair system of claim 11, wherein the rod of the bone anchor has an outer surface, the outer surface including a threaded portion and a non-threaded portion.

16. The fracture repair system of claim 11, wherein the locking element further comprises at least one smooth curved surface adjacent to the mating groove.

17. The fracture repair system of claim 11, wherein the docking groove is an open docking groove.

18. The fracture repair system of claim 11, wherein the docking groove has a hook-shaped configuration.

19. The fracture repair system of claim 11, wherein the mating groove extends to the distal end of the elongated extension.

20. The fracture repair system of claim 11, wherein the elongated extension is sized and configured to fit snugly within the through-channel of the bone anchor to prevent pivoting of the locking element when the elongated extension is positioned within the through-channel of the bone anchor.

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