CN117881348A - Knotless orthopedic stabilization systems and related methods - Google Patents
Knotless orthopedic stabilization systems and related methods Download PDFInfo
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Abstract
Orthopedic button assemblies are described that are capable of performing soft tissue repair or bone repair using methods for securing sutures or fasteners in a knotless manner. The orthopedic button assembly of the present disclosure is designed to perform locking independent of additional components. The orthopedic button assembly of the present disclosure includes the ability to optimally tension the repair by pulling the tensionable fastener (e.g., suture) in the tensioning direction, and the ability to prevent the tensionable fastener from sliding in the opposite direction by capturing the tensionable fastener in a manner such that pulling the tensionable fastener in a direction opposite to the tensioning direction (e.g., if the attached tissue or bone tries to "pull" away from the button assembly under tension) actually increases the tension, resulting in a tighter locking interface, thereby increasing the safety of the repair.
Description
Cross Reference to Related Applications
This application is an international patent application filed according to the Patent Cooperation Treaty (PCT) and claims the benefit of priority from the following applications: U.S. provisional patent application Ser. No. 63/194,436, entitled "Knotless, self-locking Suture Button and Related Methods for Tissue Repair (Knotless Self-locking suture button for tissue repair and related methods)" filed on month 5, 28 of 2021, U.S. provisional patent application Ser. No. 663/254,136, entitled "Knotless Orthopedic Stabilization System and Related Methods (Knotless orthopedic stabilization system and related methods)" filed on month 10 of 2021, and U.S. provisional patent application Ser. No. 63/293,738, entitled "Knotless Orthopedic Stabilization System and Related Methods (Knotless orthopedic stabilization system and related methods)" filed on month 24 of 2021, the complete disclosures of which are hereby expressly incorporated by reference as if fully set forth herein.
Technical Field
The present disclosure relates generally to surgical repair of bone or soft tissue, and more particularly to knotless repair of bone or soft tissue using sutures and button assemblies.
Background
Bone suspension devices, such as button sewing assemblies, for stabilizing bone and tissue are known in the art. Current devices fasten bone and soft tissue by locking the suture in place with auxiliary fixation elements such as knots, screws, pins, hooks or staples, etc. In these procedures, after drilling through the bone, a suture is passed through the hole and secured distally of the hole. The bone and/or tissue is then pulled closer and an auxiliary fixation element (e.g., a knot) is applied proximal to the assembly to maintain tension. For example, tying knots to hold the suture tight is relatively difficult and may result in some loss of tension when tying knots are completed and the knot mechanism (whether a tool or a finger) releases its grip on the suture. As a result, the loops of the knot may rebound or relax one or more millimeters before tightening the assembly, and then create a tension significantly less than originally intended.
Generally, similar repairs involve devices that require auxiliary fixation elements such as knots and/or fixation hardware (e.g., screws, hooks, pins, staples, etc.) to hold the repair in place after the tensionable fastener is tightened. These devices do not have a self-locking mechanism to accomplish repair. While these techniques may be effective in repairing, certain devices may fail, including but not limited to: (a) failure of the auxiliary fixation element, (b) failure of the soft tissue junction at the knot-tying site, (c) delayed emergence of the implant, possibly requiring a second surgery for repair, and (d) complex suturing techniques near the blood vessel and nerve, which if injured at the time of fixation, may lead to short-term or long-term complications.
Knotless systems exist that employ various mechanisms for length adjustment and locking. In most cases, to obtain better ease of use, either the strength of the structure (measured by tension to failure) or its stability (measured by tension loss) is sacrificed.
Disclosure of Invention
The present disclosure describes knotless stabilization systems having a base member (e.g., button, plate, etc.) and a locking element associated with a tensionable fixture (e.g., surgical suture, strap, etc.), which may be for surgical repair of bone or soft tissue. The knotless stabilization systems of the present disclosure may be used to stabilize, fix, and/or repair bone or soft tissue using a tensionable fastener. In some embodiments, the knotless stabilization system may have a built-in locking mechanism such that the device is self-locking. In some embodiments, the knotless stabilization system may be coupled with a tensionable fastener (e.g., suture/tape) that is tensioned to secure, fix, or tension bone, soft tissue, or another member to effect repair.
The knotless stabilization systems of the present disclosure provide the ability to perform soft tissue repair or bone repair using methods for fastening sutures or tensionable fasteners in a knotless manner. The knotless stabilization systems of the present disclosure are designed in a manner that does not rely on additional components to perform locking. The knotless stabilization systems of the present disclosure include the ability to optimally tension the repair by pulling the tensionable fastener (e.g., suture) in a tensioning (e.g., proximal) direction and to prevent the tensionable fastener from sliding in the opposite (e.g., distal) direction by capturing the tensionable fastener in a manner such that pulling the tensionable fastener in a direction opposite to the tensioning direction (e.g., if the attached tissue or bone attempts to "pull" away from the button suture assembly under tension) actually increases the tension, resulting in a tighter locking interface, thereby improving the safety of the repair.
In some embodiments, the present disclosure includes methods of repairing bone or soft tissue using sutures that interact with self-locking buttons.
In some embodiments, the knotless stabilization systems of the present disclosure include the ability to perform repair by eliminating the need to use auxiliary fixation elements such as knots and/or fixation hardware (e.g., screws, hooks, pins, staples, etc.) to hold the repair in place after the tensionable fixation is tensioned, thereby preventing complications associated with failure of the auxiliary fixation elements.
In some embodiments, the knotless stabilization systems and related methods of the present disclosure make surgery safer by eliminating the need to use invasive surgical instruments (e.g., needles) through small incisions and tie knots around important anatomical structures, which may result in inadvertent damage.
In some embodiments, the knotless stabilization systems of the present disclosure include the ability to directly tension tissue. The resulting tension may also help to maintain the fixation as described above.
Due to the self-locking design, the knotless stabilization systems described herein and related methods of use will make bone and/or soft tissue repair safer, faster, cheaper, more reliable, and simpler.
The unique repair methods disclosed herein allow a surgeon to fix soft tissue or bone using a self-locking fixation assembly. This repair method also teaches a technique of attaching a tensionable fastener or fiber for repairing torn tissue (e.g., tendons) to a self-locking fastening assembly, and a technique of tensioning the repair using knotless, self-locking interactions, without the use of a backup device or fastening technique.
For purposes of disclosure, for example only, bicep tendon repair is used in the methods of the repair techniques described herein, however, the repair methods may be used in any number of tissue repair procedures.
In some embodiments, the knotless stabilization systems disclosed herein may be provided to a surgeon in an assembled state to initiate repair (e.g., utilizing a base component, a locking element, and one or more shuttle components associated with the base component and the locking element). For example, a knotless stabilization system may have a base member and a locking element. In some embodiments, the shuttle members may be connected later. In some embodiments, the shuttle member may have an annular end or capture mechanism to connect with a tensionable fastener for repairing a tendon. This technique may require that each of those tensionable fastener ends be passed through the capture end of the shuttle member.
In some embodiments, the tensionable fastener is first secured to the tissue (e.g., tendon) to be repaired and then loaded into the capture end of the shuttle member. The free end of the shuttle member is pulled in a proximal (or pulling) direction. Pulling in the proximal direction will be accompanied by the tensionable fastener passing through the base member. Finally, the shuttle member will be removed and the tensionable fastener attached to the tissue to be repaired will pass through the fastening assembly.
Pulling on the tensionable fastener will tighten the prosthesis and pull the tendon adjacent the fixation assembly to the desired repair site, for example by reducing the distance between the tendon and the fixation assembly. Tension can be adjusted according to the preference of the surgeon and then the tensionable fastener locked in place relative to the fixation assembly. The locking occurs at a locking interface or "pinch point" where the tensionable fastener is captured between mating surfaces of the base member and the locking element. Pulling the tensionable fastener in the proximal direction will create a tension that can be changed or increased by additional pulling in the same direction. Once the knotless stabilization system is in its locked state, the tensionable fastener, fixation assembly, and repaired tissue will maintain their locked state by a combination of compression, friction, and tension. Repair is thus completed without the need for additional screws or knots.
If the tendon is pulled away from the repair site, it will transmit tension through the tensionable fastener, thereby locking the structure tighter by pulling the locking element closer to the base member. This will clamp the tensionable fastener tighter and prevent the tendon from coming out of repair.
In some embodiments, the knotless orthopedic stabilization systems described herein include a locking assembly including a base member and a locking element and a tensionable fastener (e.g., surgical suture, tape, fiber, etc.). In some embodiments, the base member includes a central recess sized and configured to receive the locking element therein when the locking assembly is assembled. In some embodiments, the base member and the locking element have complementary surfaces that form a locking interface to capture and retain the tensionable mount under tension to lock the assembly in place.
In some embodiments, the locking assembly may be coupled with a tensionable fastener (e.g., surgical suture, tape, fiber, etc.) that attaches to tissue, bone, or other member to lock the tensionable fastener under tension during a surgical procedure. For example, in bicep repair, one end of the tensionable fastener (e.g., the "attachment end") may be first attached to or otherwise associated with the torn muscle or other tissue, then subsequently coupled with the locking assembly (e.g., by passing the free end of the tensionable fastener through the locking assembly or accompanying the free end of the tensionable fastener, as described herein), and then the locking assembly may be advanced through a surgical channel formed through the bone. Once the locking assembly is secured on the opposite side of the bone, the surgeon may apply a desired amount of tension to the tensionable fastener in the direction of the attached tissue to position and secure the tissue in the desired location, such as by reducing the distance between the attached tissue and the locking assembly. For example, the locking assembly is a self-locking assembly that does not require secondary securement (e.g., knots, securing hardware, etc.) to ensure tension in the tensionable fastener. In general, the tensionable fastener is threaded or concomitantly threaded through the locking assembly by entering the locking assembly from one side (e.g., bottom or proximal) thereof, looping or "U-turning" around a crossbar or fulcrum element of the locking element, passing through a locking interface (described below) of the locking assembly, and exiting the locking assembly on the same side (e.g., bottom or proximal) as the portal. Looping or "U-turns" of the tensionable fastener provides a number of advantages over existing button stitch assemblies, including but not limited to: (i) Maintaining the base member and the locking element in alignment and in a compressed state, which maintains tension in the tension element; (ii) Increasing tension in the construct in response to the attached tissue being pulled away from the assembly; and (iii) maintaining compression in the lock interface.
Optionally, in any embodiment, the locking assembly may be provided with an auxiliary locking element to provide additional secure interaction between the locking element and the base member, for example to ensure that the locking element remains engaged with the base member during re-tensioning of the tensionable member when necessary, preventing the locking element from rocking or other movement within the central recess to prevent the tensionable fixture from loosening. For example only, the secondary locking element may include any physical mechanism that provides a secure interaction between the base member and the locking element, including but not limited to press fit engagement, snap fit engagement, friction fit engagement, and the like.
In some embodiments, the locking element includes one or more proximal extensions extending proximally from a bottom surface of the locking element. For example, when the locking assembly is in the locked state, the proximal extension is sized and configured to be received within the lateral opening of the base member in a snug, flush, and/or nested manner such that a surface area of the proximal extension engages a surface area of a peripheral wall of the lateral opening. This engagement of the surface regions stabilizes the locking element relative to the base member, for example, preventing rocking or other movement that may result in relaxation of tension applied to the tensionable fastener after the knotless stabilization system has been locked and the surgical procedure is completed.
Optionally, in any embodiment, the knotless stabilization system includes an unlocking feature to unlock the locking assembly, thereby enabling re-tensioning of the tensionable fastener after initial tensioning and locking is complete. In some embodiments, the unlocking feature comprises an unlocking component or tool that can engage and displace the base member and/or locking element relative to the base member to create a space or distance or space that allows the tensionable fastener to relax and then re-tension if desired. The relaxed state will allow the tensionable fastener to maneuver and slide to re-tension. Once the desired tension is reached, the unlocking component or tool is pulled back, removed, or otherwise disengaged from the base member and/or locking element. As the tensioned tensionable mount pulls the locking element in the proximal direction, the gap obtained by the unlocking tool will disappear and the tensionable mount will again be clamped between the locking element and the base member. Merely by way of example, the unlocking tool or component may include any tool or component suitable or capable of overcoming tension in the tensionable fastener to create a temporary separation between the locking element and the base member, including but not limited to threaded members, snap-fit trigger controlled pushers/extenders, pliers-like clamps, and the like.
In some embodiments, the unlocking feature may include a deflectable member that is movable from a first position in which the locking assembly is in the locked configuration to a second position in which the locking assembly is in the unlocked configuration, thereby enabling re-tensioning of the tensionable fastener.
For example, the present disclosure describes a unique technique for allowing a tensionable fastener to be easily passed through a multi-component fixation assembly (e.g., locking assembly) for connecting soft tissue or any other tissue to an anchoring device. In some embodiments, the assembly device of the present disclosure includes the ability to shuttle a tensionable fixture through a multi-component assembly. In some embodiments, the assembly device of the present disclosure includes the ability to pass a tensionable mount or tensionable mount between multiple base components or fixation parts such that the tensionable mount is positioned at a locking interface of the multiple fixation parts. The assembly holder technique describes a unique mechanism for fastening a tensionable fastener for securing tissue without the need for knotting. The tensionable fastener also prevents it from being damaged and/or broken when it passes through the locking interface of the multi-component fastening assembly. In some embodiments, the assembly device allows for release of pressure on the tensionable fastener during assembly with the multi-component fastening assembly by reducing friction at the locking interface of the multi-component assembly. This allows the user to pass the tensionable fastener through the assembly device in a seamless manner and then disengage the assembly device to couple the tensionable fastener with the multi-component fastening assembly to complete the repair.
By way of example only, according to some embodiments, described herein are insertion instruments or fin devices that may be used to implant an anchoring device (e.g., a fixation assembly) for soft tissue bone or any other tissue repair. For example, insertion instruments are designed to perform a variety of functions to aid in the repair process. The fin device of the present disclosure is unique in that it allows a user to load an anchor device or fixation assembly onto the fin device, which will keep the anchor device or fixation assembly in tension to help easily pass through a bone tunnel. When the proper position is reached, the surgeon or user will use the release feature to reduce tension in the construct and flip the anchor or fixation assembly to the correct position.
In some embodiments, the fixation assemblies of the present disclosure are designed for use with fracture plate applications, and are particularly useful where the fracture is fixed near an articular surface. In some embodiments, the angle (e.g., tilt angle or curvature) of the articular surface may vary depending on the anatomical location. For example, accurate repositioning of the articular surface without any further damage to the articular surface due to hardware placement is critical to the patient's therapeutic effect. The presently described knotless fixation assemblies may have the ability to work with fracture plate systems, including but not limited to (and by way of example only) fracture plates used near articular surfaces (e.g., distal and radial fractures around the ankle or e.g., shoulder) or non-articular locations. In some embodiments, the knotless fixation assembly may be introduced through a hole in the bone flap using a guide hole, and the fixation assembly may be shuttled through the fracture site using a shuttle. Upon reaching the cortical outer side of the distal end of the fracture site, the fixation assembly may be tightened to effect reduction by changing the shape, changing orientation (e.g., longitudinal to horizontal), and/or expanding in size of the distal end. Tensioning of the tensionable fastener (e.g., suture, tape, wire, or other) will create compression at the fracture site. The small guide holes created for device shuttle will allow the device to be positioned close to the articular surface. Tensioning will reduce the fracture to be compressed at the fracture site and allow the locking member to lock into the fixation plate. This will reduce the risk of non-healing, malformed healing hardware complications and repeated surgery. It will also prevent the surgeon from making multiple incisions to place additional hardware to effect repair.
Rebuilding soft tissue and bone envelope is critical for a well-functioning repair, especially when it is located around joints where muscles and tendons assist in the range of motion. For example, the present disclosure describes a fracture plate that uses one or more tensionable fasteners (e.g., surgical sutures, straps, wires, or others) to connect soft tissue and bone through the fracture plate in a knotless manner. For example only, the bone flap is similar to the base member described above in that the bone flap provides one compression surface in the locking interface and the locking element secured to the plate by the tensionable fastener provides the other compression surface in the locking interface.
As a complement to the embodiments described below, the present disclosure describes the following embodiments.
Embodiment 1 is a knotless fixation assembly operable to secure tissue to tissue, bone, or other member, the knotless fixation assembly comprising: a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore; a locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a central opening extending between the proximal side and the distal side, a first lateral opening extending between the proximal side and the distal side and positioned adjacent the central opening, the first lateral opening being separated from the central opening by a bridging member, the locking element having a second compression surface adjacent the central opening, the locking element having a first proximal extension protruding proximally from the proximal side; and a tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element between the first and second compression surfaces; wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance; wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastening assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces; and wherein the first proximal extension is sized and configured to nest within the first throughbore when the knotless fixation assembly is in the second state to prevent relative movement between the locking element and the base member when the assembly is in the second state.
Embodiment 2 is the knotless fixation assembly of embodiment 1, wherein the attachment end of the tensionable fixation is movable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
Embodiment 3 is the knotless fixation assembly of embodiment 1 or 2, wherein the base member further comprises a recess positioned within the distal-facing surface, the recess configured to receive the locking element therein.
Embodiment 4 is the knotless fixation assembly of any one of embodiments 1-3, wherein the first through-hole is positioned within the recess.
Embodiment 5 is the knotless fastening assembly of any of embodiments 1-4, wherein the first through-hole has an inner peripheral wall having a first surface area.
Embodiment 6 is the knotless fixation assembly of any of embodiments 1-5, wherein the first proximal extension has a peripheral wall having a second surface area.
Embodiment 7 is the knotless fixation assembly of any one of embodiments 1-6, wherein the first surface region and the second surface region are flush engaged with one another when the knotless fixation system is in the second state.
Embodiment 8 is the knotless fixation assembly of any one of embodiments 1-7, wherein the tensionable fastener passes through the base member and locking element such that the tensionable fastener passes distally from the attachment end through the first through-hole and the first lateral opening, loops around the bridging member and then passes proximally through the central opening and the first through-hole between first and second compression surfaces.
Embodiment 9 is the knotless fixation assembly of any of embodiments 1-8, wherein the base member further comprises a second throughbore extending between the proximal-facing surface and the distal-facing surface, and a third compression surface adjacent to the second throughbore.
Embodiment 10 is the knotless fixation assembly of any one of embodiments 1-9, wherein the locking element further comprises a second lateral opening extending between the proximal and distal sides and positioned opposite the first lateral opening adjacent the central opening, the second lateral opening being separated from the central opening by a second bridging member, the locking element having a fourth compression surface adjacent the central opening and a second proximal extension protruding proximally from the proximal side, the second proximal extension being sized and configured to nest within the second throughbore when the knotless fixation assembly is in the second state.
Embodiment 11 is the knotless fixation assembly of any one of embodiments 1-10, further comprising a second tensionable fastener configured to interact with the base member and the locking element, the second tensionable fastener having an attachment end configured to attach to tissue, bone, or other member and a free end configured to be manipulated by a user, the second tensionable fastener passing through the base member and locking element between the third compression surface and fourth compression surface.
Embodiment 12 is the knotless fixation assembly of any of embodiments 1-11, further comprising an unlocking element configured to facilitate transition of the assembly from the second state to the first state upon engagement by a user.
Embodiment 13 is the knotless fixation assembly of any one of embodiments 1-12, wherein the unlocking element comprises a tool engagement feature configured to engage with an unlocking tool.
Embodiment 14 is the knotless fixation assembly of any of embodiments 1 to 13, wherein the unlocking element comprises a threaded opening in the locking element.
Embodiment 15 is the knotless fixation assembly of any one of embodiments 1-14, wherein the unlocking tool comprises a threaded shaft configured to engage the threaded opening and having a distal tip configured to engage a bearing surface of the base member, wherein actuation of the threaded shaft causes the distal tip to rotate against the bearing surface, and the locking element is disengaged from the base member, thereby transitioning the assembly from the second state to the first state.
Embodiment 16 is the knotless fixation assembly of any of embodiments 1-15, wherein the unlocking element comprises at least one cutout region positioned on at least one end of the locking element, the at least one cutout region having a bearing surface.
Embodiment 17 is the knotless fixation assembly of any one of embodiments 1-16, wherein the unlocking means comprises an engagement member configured to engage the bearing surface of the locking element and operable to disengage the locking element from the base member, thereby transitioning the assembly from the second state to the first state.
Embodiment 18 is a knotless fixation assembly operable to secure tissue to tissue, bone, or other member, the knotless fixation assembly comprising: a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore; a locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a central opening extending between the proximal side and the distal side, a first lateral opening extending between the proximal side and the distal side and positioned adjacent the central opening, the first lateral opening being separated from the central opening by a bridging member, the locking element having a second compression surface adjacent the central opening; and a tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element such that the tensionable fixture passes distally from the attachment end through the first through hole and the first lateral opening, loops around the bridging member, and then proximally through the central opening and the first lateral opening between the first and second compression surfaces; wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance; wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastener assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces.
Embodiment 19 is the knotless fixation assembly of embodiment 18, wherein the attachment end is movable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
Embodiment 20 is the knotless fixation assembly of embodiments 18 or 19, wherein the base member further comprises a recess positioned within the distal-facing surface, the recess configured to receive the locking element therein.
Embodiment 21 is the knotless fixation assembly of any one of embodiments 18-20, wherein the first through-hole is positioned within the recess.
Embodiment 22 is the knotless fixation assembly of any one of embodiments 18-21, wherein the locking element comprises a proximal extension extending proximally from the first lateral opening, the proximal extension configured to nest within the first throughbore when the knotless fixation assembly is in the second state.
Embodiment 23 is a knotless fixation assembly operable to secure tissue to tissue, bone, or other member, the knotless fixation assembly comprising: a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore; a locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a first opening extending between the proximal side and the distal side, a second opening extending between the proximal side and the distal side and positioned adjacent to the first opening, the second opening being separated from the first opening by a bridging member, the locking element having a second compression surface adjacent to the first opening; and a tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element such that the tensionable fixture loops distally from the attachment end through the base member and the second opening, around the bridging member, and then proximally through the first opening and the first through-hole between the first compression surface and the second compression surface; wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance; wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastener assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces.
Embodiment 24 is the knotless fixation assembly of embodiment 23, wherein the base member further comprises a second through hole extending between the proximal-facing surface and the distal-facing surface and positioned adjacent to the first through hole, and the tensionable fastener passes distally through the base member through the second through hole.
Embodiment 25 is the knotless fastening assembly of embodiments 23 or 24, wherein the second through-hole extends laterally to a longitudinal end of the base member.
Embodiment 26 is the knotless fixation assembly of any of embodiments 23-25, wherein the second opening extends laterally to a longitudinal end of the locking element.
Embodiment 27 is the knotless fixation assembly of any one of embodiments 23-26, wherein the attachment end of the tensionable fastener is movable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
Embodiment 28 is the knotless fixation assembly of any one of embodiments 23-27, wherein the base member further comprises a recess positioned within the distal-facing surface, the recess configured to receive the locking element therein.
Embodiment 29 is the knotless fixation assembly of any of embodiments 23-28, wherein the first through-hole is positioned within the recess.
Drawings
Many advantages of the present disclosure will be apparent to one of ordinary skill in the art upon reading the specification in light of the accompanying drawing figures, wherein like reference numerals are applied to like elements, and wherein:
FIG. l is a perspective view of an example of a knotless orthopedic stabilization system in accordance with some embodiments;
FIG. 2 is a perspective view of an example of a locking assembly forming part of the knotless orthopedic stabilization system of FIG. 1 in accordance with some embodiments;
FIG. 3 is a top plan view of the locking assembly of FIG. 2 according to some embodiments;
FIG. 4 is a bottom plan view of the locking assembly of FIG. 2 according to some embodiments;
fig. 5-6 are exploded perspective views of the locking assembly of fig. 2 according to some embodiments.
FIG. 7 is a perspective view of an example of a base member forming part of the locking assembly of FIG. 2, according to some embodiments;
FIG. 8 is a top plan view of the base member of FIG. 7 according to some embodiments;
FIG. 9 is a bottom plan view of the base member of FIG. 7 according to some embodiments;
FIG. 10 is a perspective view of an example of a locking element forming part of the locking assembly of FIG. 2, according to some embodiments;
FIG. 11 is a top plan view of the locking element of FIG. 10 according to some embodiments;
FIG. 12 is a bottom plan view of the locking element of FIG. 10 according to some embodiments;
FIG. 13 is a side plan view of the locking element of FIG. 10 according to some embodiments;
FIG. 14 is an end plan view of the locking element of FIG. 10 according to some embodiments;
FIG. 15 is a cross-sectional view of the locking assembly of FIG. 2, taken along line A-A of FIG. 3, according to some embodiments;
FIG. 16 is a perspective view of the knotless orthopedic stabilization system of FIG. 1 including the locking assembly of FIG. 2, a shuttle member, and a tensionable fastener attached to tissue to be repaired, in accordance with some embodiments;
FIG. 17 is a perspective view of the knotless orthopedic stabilization system of FIG. 16 in which a tensionable fastener passes through a locking assembly, in accordance with some embodiments;
fig. 18-19 are side cross-sectional views of the knotless orthopedic stabilization system of fig. 17 in accordance with some embodiments in which a tensionable fastener is threaded therethrough;
fig. 20 is a perspective view of another example of a locking assembly configured for use with a flexible tensionable fastener as part of a knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments.
FIG. 21 is a top plan view of the locking assembly of FIG. 20, according to some embodiments;
FIG. 22 is an exploded perspective view of the locking assembly of FIG. 20, according to some embodiments;
FIG. 23 is a top plan view of a base member forming part of the locking assembly of FIG. 20, according to some embodiments;
FIG. 24 is a bottom perspective view of the base member of FIG. 23, according to some embodiments;
FIG. 25 is a top plan view of a locking element forming part of the locking assembly of FIG. 20, according to some embodiments;
FIG. 26 is a bottom perspective view of the locking element of FIG. 25, according to some embodiments;
FIG. 27 is a side cross-sectional view of the locking assembly of FIG. 20, taken along line CC of FIG. 21, illustrating an exemplary use of the knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 28 is a perspective view of another example of a locking assembly configured for use with a flexible tensionable fastener as part of the knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 29 is a top plan view of the locking assembly of FIG. 28;
FIG. 30 is an exploded perspective view of the locking assembly of FIG. 28;
FIG. 31 is a side cross-sectional view of the locking assembly of FIG. 28, taken along line D-D of FIG. 29, showing an exemplary use of the knotless fixed orthopaedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 32 is a perspective view of another example of a locking assembly configured for use with a flexible tensionable fastener as part of a knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 33 is a side cross-sectional view of the locking assembly of FIG. 32, taken along line E-E of FIG. 32, showing an exemplary use of the knotless fixed orthopaedic stabilization system disclosed herein, in accordance with some embodiments;
fig. 34 is a perspective view of another example of a locking assembly configured for use with a flexible tensionable fastener as part of the knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments.
FIG. 35 is a top plan view of a base member forming part of the locking assembly of FIG. 34;
FIG. 36 is a perspective view of a locking element forming part of the locking assembly of FIG. 34;
FIG. 37 is a side cross-sectional view of the locking assembly of FIG. 34, taken along line F-F of FIG. 34, illustrating an exemplary use of the knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 38 is a perspective view of another example of a locking assembly configured for use with a flexible tensionable fastener as part of a knotless orthopedic stabilization system disclosed herein, in accordance with some embodiments;
FIG. 39 is a top plan view of the locking assembly of FIG. 38 according to some embodiments;
FIG. 40 is a bottom plan view of the locking assembly of FIG. 38 according to some embodiments;
41-42 are exploded perspective views of the locking assembly of FIG. 38 according to some embodiments;
FIG. 43 is a perspective view of an example of a base member forming part of the locking assembly of FIG. 38, according to some embodiments;
FIG. 44 is a top plan view of the base member of FIG. 43 according to some embodiments;
FIG. 45 is a perspective view of an example of a locking element forming part of the locking assembly of FIG. 38, according to some embodiments;
FIG. 46 is a bottom perspective view of the locking element of FIG. 45, according to some embodiments;
FIG. 47 is a top plan view of the locking element of FIG. 38 according to some embodiments;
FIG. 48 is a side cross-sectional view of the locking assembly of FIG. 38, taken along line G-G of FIG. 39, with the tensionable fastener passing therethrough and the assembly in an unlocked state, according to some embodiments;
FIG. 49 is a side cross-sectional view of the locking assembly of FIG. 38, taken along line G-G of FIG. 39, with the tensionable fastener passing therethrough and the assembly in a locked state, according to some embodiments;
FIG. 50 is a perspective view of an example of a locking assembly and unlocking tool, with the locking assembly in a locked state, according to some embodiments;
FIG. 51 is a side plan view of the locking assembly and unlocking tool of FIG. 50, with the unlocking tool engaged with the locking assembly and the locking assembly in a locked state, according to some embodiments;
FIG. 52 is a side cross-sectional view of the locking assembly and unlocking tool of FIG. 50, with the unlocking tool engaged with the locking assembly and the locking assembly in a locked state, according to some embodiments;
FIG. 53 is a side cross-sectional view of the locking assembly and unlocking tool of FIG. 50, with the unlocking tool engaged with the locking assembly and the locking assembly in an unlocked state, according to some embodiments;
FIG. 54 is a side plan view of the locking assembly and unlocking tool of FIG. 50, with the unlocking tool engaged with the locking assembly and the locking assembly in an unlocked state, according to some embodiments;
FIG. 55 is a perspective view of another example of a locking assembly having deflectable unlocking elements forming part of the knotless orthopedic stabilization system of FIG. 1, shown in a locked state, in accordance with some embodiments;
FIG. 56 is a bottom perspective view of the locking assembly of FIG. 55 in a locked state according to some embodiments;
FIG. 57 is a top plan view of the locking assembly of FIG. 55 in a locked state, showing an example of a clamping member, according to some embodiments;
FIG. 58 is a top plan view of the locking assembly of FIG. 55 in an unlocked state according to some embodiments;
59-60 are top plan views of the locking assembly of FIG. 55 in an unlocked state coupled with a tensionable mount according to some embodiments;
FIGS. 61-62 are top plan views of the locking assembly of FIG. 55 in a locked state coupled with a tensionable mount according to some embodiments;
FIG. 63 is a block diagram of an example of the locking assembly of FIG. 55 used in carpal-palm (CMC) arthroplasty in accordance with some embodiments;
FIG. 64 is a top plan view of another example of a locking assembly having deflectable unlocking elements forming part of the knotless orthopedic stabilization system of FIG. 1, shown in a locked state, in accordance with some embodiments;
FIG. 65 is a perspective view of another example of a locking assembly having deflectable unlocking elements forming part of the knotless orthopedic stabilization system of FIG. 1, shown in a locked state, in accordance with some embodiments;
FIG. 66 is a bottom perspective view of the locking assembly of FIG. 65 according to some embodiments;
FIG. 67 is an exploded perspective view of the locking assembly of FIG. 65, according to some embodiments;
FIG. 68 is a perspective view of an example of an assembly device configured for use with a multi-component fixation device, according to some embodiments;
FIG. 69 is a side cross-sectional view of the assembled device of FIG. 68, according to some embodiments;
FIG. 70 is an end plan view of the assembled device of FIG. 68 according to some embodiments;
FIG. 71 is an end cross-sectional view of the assembled device of FIG. 68, according to some embodiments;
FIG. 72 is a perspective view of the assembly device of FIG. 68 coupled with the locking assembly of FIG. 2, according to some embodiments;
FIG. 73 is an end plan view of the assembly device of FIG. 68 coupled with the locking assembly of FIG. 2, according to some embodiments;
FIG. 74 is a side cross-sectional view of the assembled device of FIG. 68 coupled with the locking assembly of FIG. 2, according to some embodiments;
FIG. 75 is an end cross-sectional view of the assembly device of FIG. 68 coupled with the locking assembly of FIG. 2, according to some embodiments;
76-77 are front perspective cross-sectional views of the assembly device of FIG. 68 coupled with the locking assembly of FIG. 2, showing an exemplary technique of using the assembly device with a tensionable fastener passing through the locking assembly, according to some embodiments;
78-80 are perspective views of examples of insertion instruments or fin devices that may be used to implant an anchoring device for soft tissue bone or any other tissue repair according to some embodiments;
FIG. 81 is a perspective view of a distal end of the insertion instrument of FIG. 78 coupled with an anchor device, according to some embodiments;
FIG. 82 is a side plan view of a distal end of the insertion instrument of FIG. 78 coupled with an anchor device, wherein an outer shaft of the insertion instrument is shown transparent, according to some embodiments;
FIG. 83 is a block diagram of an anchoring device coupled to a locking assembly through a bone tunnel by a tensionable fastener after placement with the insertion device of FIG. 78, according to some embodiments;
FIG. 84 is a perspective view of an example of a fracture repair plate having a knotless self-locking fixation assembly, in accordance with some embodiments;
FIG. 85 is an exploded perspective view of the fracture repair plate of FIG. 84, according to some embodiments;
FIG. 86 is another exploded perspective view of the fracture repair plate of FIG. 84, according to some embodiments;
FIG. 87 is a side plan view of the fracture repair plate of FIG. 84 in use, according to some embodiments;
FIG. 88 is a plan view of the assembled device of FIG. 68 for use with the fracture repair plate of FIG. 84, according to some embodiments; and
fig. 89 is a block diagram illustrating an example of an articular prosthesis coupled with a knotless fixation assembly to secure soft tissue in accordance with some embodiments.
Detailed Description
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The knotless orthopedic stabilization systems and related methods disclosed herein possess a variety of inventive features and components, both alone and in combination, that provide for patent protection.
Fig. 1-19 illustrate an example of a knotless orthopedic stabilization system 10 in accordance with one embodiment of the present disclosure. By way of example only, the knotless orthopedic stabilization system 10 includes a locking assembly 11 and a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the locking assembly 11 including a base member 12 and a locking element 14. The base member 12 includes a central recess 28, the central recess 28 being sized and configured to receive the locking element 14 therein when the locking assembly 11 is assembled. As will be explained in further detail herein, the base member 12 and the locking element 14 have complementary surfaces that form a locking interface to capture and retain the tensionable fastener 16 under tension, thereby locking the assembly in place.
By way of example only, fig. 2-6 illustrate an example of a locking assembly 11 forming part of the knotless orthopedic stabilization system 10 described herein, in accordance with some embodiments. In some embodiments, the locking assembly 11 may be coupled with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the tensionable fastener 16 being attached to tissue, bone, or other member to lock the tensionable fastener 16 under tension during a surgical procedure. For example, in bicep repair, one end (e.g., an "attachment end") of tensionable fastener 16 may be first attached to or otherwise associated with a torn muscle or other tissue, and then subsequently coupled with locking assembly 11 (e.g., by threading or concomitantly threading a free end of tensionable fastener 16 through locking assembly 11, as described herein), and then may be advanced through a surgical channel formed through the bone. Once the locking assembly 11 is secured on the opposite side of the bone, the surgeon may apply a desired amount of tension to the tensionable fastener 16 in the direction of the attached tissue to position and secure the tissue in the desired location, such as by reducing the distance between the attached tissue and the locking assembly 11. For example, the locking assembly 11 is a self-locking assembly that does not require secondary securement (e.g., knots, securing hardware, etc.) to ensure tension in the tensionable fastener 16. Typically, tensionable fastener 16 is threaded or concomitantly threaded through locking assembly 11 by entering locking assembly 11 from one side (e.g., bottom or proximal) of locking assembly 11, looping or forming a "U-turn" around a crossbar or fulcrum element of locking element 14, passing through a locking interface (described below) of locking assembly 11, and exiting locking assembly 11 on the same side (e.g., bottom or proximal) as the portal. Looping or "U-turns" of the tensionable fastener 16 provides a number of advantages over existing button stitch assemblies, including, but not limited to: (i) Maintaining the base member 12 and locking element 14 aligned and in compression maintains tension in the tensioning element 16; (ii) Increasing tension in the construct in response to the attached tissue being pulled away from the assembly; and (iii) maintaining compression in the locking interface.
By way of example only, fig. 7-9 illustrate one example of a base member 12 forming part of the locking assembly 11 described herein, according to one embodiment. In some embodiments, the base member 12 may have a generally rectangular shape having a first end 18, a second end 20, a pair of long sides 22, and a longitudinal axis L extending therethrough 1 . For example, in some implementationsIn embodiments, the base member 12 can have a first or bottom surface 24 configured to interface with tissue, bone, or other members and a second or top surface 26 opposite the bottom surface 24. The top surface 26 includes a central recess 28 that is sized and shaped to complement the size and shape of the locking element 14 such that the locking element 14 fits snugly within the recess 28 when assembled.
In some embodiments, the base member 12 may further include a central structure 30 and a pair of lateral openings 32 positioned within the central recess 28, with one lateral opening 32 positioned on each side of the central structure 30. The central structure 30 includes a proximally facing surface 34 and a pair of smooth and/or rounded outer side surfaces 36 positioned on either side of the proximally facing surface 34 and each facing in the direction of the respective lateral opening 32. In some embodiments, the lateral surface 36 may be angled or tapered from a first height at the intersection with the proximally facing surface 34 to a second height within the central recess 28, for example, at or near the intersection with the lateral opening 32. In some embodiments, the outer side surface 36 may extend at least partially over the lateral opening 32. In some embodiments, the outer side surface 36 is a compression surface configured to cooperate with the inner side surface 70 of the locking element 14 (e.g., as a "locking interface") to capture or clamp the tensionable fastener 16 therebetween (e.g., forming a "pinch point") when the locking assembly 11 is tensioned during use. In some embodiments, the central structure 30 includes a transverse linear beam along a transverse axis T 1 Extending through the central recess 28 between the lateral openings 32. In some embodiments, the central structure 30 may have a non-linear shape, thereby creating one or both of the outer side surfaces 36 having a concave and/or convex shape. In some embodiments, the outside surface 36 may have any combination of linear, convex, and/or concave orientations.
In some embodiments, the base member 12 may have a generally rectangular shape. In some embodiments, the base member 12 may have any suitable shape including, but not limited to, rectangular, circular, oblong, oval, elliptical, or polygonal. In some embodiments, the base member 12 may be sized and configured to be inserted through a surgical channel (e.g., having a proximal opening and a distal opening) formed in bone, tissue, and/or other anatomical structures, and thereafter pivoted, rotated, or otherwise manipulated to extend through the distal opening of the surgical channel without being pulled back through the channel. In some embodiments, the base member 12 may also include a rounded and/or smooth peripheral surface 38 to minimize the profile of the base member 12 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the first end 18 comprises a forward end as the base member 12 is advanced through a channel formed in bone, tissue, or other anatomical structure. In some embodiments, the first end or front end 18 has a smooth, rounded, and/or tapered front surface 40 configured to minimize the profile of the first end or front end 18 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the first end or front end 18 further includes one or more longitudinal recesses 42, the longitudinal recesses 42 being sized and configured to receive at least a portion of the tensionable fastener 16 therein during advancement of the base member 12 through the surgical channel to reduce the profile of the tensionable fastener 16 exposed to the surgical channel, thereby protecting the surgical channel and the tensionable fastener 16 from damage during implantation.
In some embodiments, the distal and/or proximal openings of the lateral openings 32 include smooth, angled, tapered, and/or rounded edge surfaces 44 to reduce wear on the tension members 16 during use.
By way of example only, fig. 10-14 illustrate one example of a locking element 14 forming part of an orthopedic locking assembly 11 described herein, according to one embodiment. For example, the locking element 14 has a size and shape that is complementary to the size and shape of the central recess 28 of the base member 12 such that the locking element 14 fits tightly within the central recess 28 when assembled. In some embodiments, the locking element 14 may have a generally rectangular shape (e.g., with rounded ends) having a first end 50, a second end 52, a pair of long sides 54, a bottom surface 56, and a top surface 58, and extending therethroughThe longitudinal axis L of (a) 2 . In some embodiments, bottom surface 56 is configured to engage with central recess 28 of base member 12. In some embodiments, the locking element 14 further includes a central opening 60 and a pair of lateral openings 62 extending through the locking element 14 between the bottom surface 56 and the top surface 58. The central opening 60 and the lateral opening 62 are separated by a bridge or crossbar 64 or similar structure that can serve as a fulcrum for the tensionable fastener 16. In some embodiments, the crossbar 64 may have one or more rounded, curved, and/or smooth upper surfaces 66 to minimize friction or other forces applied by the crossbar to the tensionable fastener 16 during use.
In some embodiments, bottom surface 56 includes a central recess 68 formed around central opening 60. For example, the central recess 68 may have a size and shape that is complementary to the size and shape of the central structure 30 of the base member 12 such that the central structure 30 fits tightly within the central recess 68 of the locking element 14 when assembled. In some embodiments, central recess 68 includes a pair of smooth, tapered, and/or rounded and/or curved inner side surfaces 70 that form the boundaries of central recess 68. For example, the inner side surface 70 is tapered or curved inwardly (or medially) toward the central opening 60. In some embodiments, the medial surface 70 extends at least partially over the lateral opening 32 of the base member 12. In some embodiments, the inner side surface 70 is a compression surface configured to cooperate with the outer side surface 36 of the base member 12 to capture or sandwich the tensionable fastener 16 when the tensionable fastener 16 is tensioned during use. In some embodiments, central recess 68 may have a non-linear shape, resulting in one or both of medial surfaces 70 having a concave and/or convex shape. In some embodiments, the medial surface 70 may have any combination of linear, convex, and/or concave orientations. In any embodiment, the inner side surface 70 has a shape that is complementary to the outer side surface 36 of the base member 12 such that a combined compression on the tensionable fastener 16 is maintained.
In some embodiments, the locking element 14 may also include a rounded and/or smooth peripheral surface 72 to minimize the profile of the locking element 14 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the peripheral edge surface 74 of the central opening 60 includes smooth, angled, tapered, and/or rounded edge surfaces to reduce wear on the tension members 16 during use. In some embodiments, the distal and/or proximal openings of the lateral openings 62 include smooth, angled, tapered, and/or rounded edge surfaces 76 to reduce wear on the tension members 16 during use.
As explained herein, the knotless stabilization system 10 is a self-locking system in which tension applied to the tensionable fastener 16 will ensure that the locking element 14 is aligned within the base member 12 while also locking the assembly together due to the interaction of the tensionable fastener 16 with the locking interface (i.e., the outside surface 36 of the base member 12 and the inside surface 70 of the locking element 14). Optionally, in any embodiment, the locking assembly 11 may be provided with an auxiliary locking element to provide additional secure interaction between the locking element 14 and the base member 12, for example to ensure that the locking element 14 remains engaged with the base member 12 during re-tensioning of the tensionable fixture 16 when necessary, and to prevent rocking or other movement of the locking element 14 within the central recess 28 to prevent loosening of the tensionable fixture 16. By way of example only, secondary locking "locking element" may include any physical mechanism that provides a secure interaction between base member 12 and locking element 14, including but not limited to a press fit engagement, a snap fit engagement, a friction fit engagement, and the like.
For example, fig. 15 illustrates one example of a secondary locking element according to some embodiments. For example only, the locking element 14 may further include one or more elongated flanges 78 positioned along the long side 54, for example, near the intersection with the bottom surface 56, and configured to engage with a corresponding elongated flange or overhang 46 extending from the top surface 26 of the base member 12 at least partially above the central recess 28 to form a secondary locking element and ensure that the locking element 14 remains within the base member 12. In some embodiments, the elongate flange 78 may further include an inwardly facing angled, tapered or curved surface 80, the surface 80 configured to interface with the corresponding inwardly facing angled, tapered or curved surface 48 of the overhang 46 to enable proper alignment of the locking element 14 within the central recess 28 when the locking element 14 is engaged with the base member 12 and to facilitate passage of the elongate flange 78 beyond the overhang 46 into the central recess 28. As shown in the embodiment of fig. 14, once the elongate flange 78 of the locking element 14 passes over the overhang 46 of the central recess 28, the overhang 46 provides a physical barrier that prevents the locking element 14 from disengaging from the central recess 28 without additional force being applied by a user (e.g., using a removal tool).
In some embodiments, the central opening 60 of the locking element 14 is positioned such that, when assembled with the base member 12, the central opening 60 is positioned above the central structure 30 of the base member 12 or aligned with the central structure 30 of the base member 12. In some embodiments, the lateral opening 62 of the locking element 14 is positioned such that, when assembled with the base member 12, the lateral opening 62 of the locking element 14 is positioned above the lateral opening 32 of the base member 12 or aligned with the lateral opening 32 of the base member 12.
In some embodiments, the lateral opening 32 of the base member 12 and the lateral opening 62 of the locking element 14 are different sizes. In some embodiments, the lateral opening 32 of the button is larger than the lateral opening 62 of the locking element 14 to enable the lateral compression surfaces 36, 70 to extend at least partially over the lateral opening 32.
For example, fig. 16-19 illustrate several steps of a method of using the orthopedic locking assembly 11 of the present disclosure to fix or repair bone and/or tissue, according to some embodiments. In some embodiments, the shuttle member 82 may be used to assist the tensionable fastener 16 through the base member 12 and the locking element 14, as shown by way of example only in fig. 16-17. In some embodiments, the shuttle member 82 may have a free end 84 and a catch end 86. For example, the capture end 86 is configured to capture the tensionable fastener 16 or engage with the tensionable fastener 16 such that the shuttle member 82 may pass through the locking assembly 11 with the tensionable fastener 16. For example, the capture end 86 may have any capture mechanism suitable for maintaining coupling with the tensionable fastener 16 while concomitantly passing the tensionable fastener 16 through the locking assembly 11, including but not limited to (and by way of example) loops, adhesives, tear-off couplings, and the like.
In some embodiments, the shuttle member 82 may be coupled with the locking assembly 11 by: (i) Advancing the free end 84 in a distal direction (e.g., from the bottom surface 24 toward the top surface 26) through one of the lateral openings 32 of the base member 12; (ii) Causing the free end 84 to be advanced further through the corresponding aligned lateral opening 62 of the locking element 14; (iii) Pushing the free end 84 inwardly about the crossbar 64 (e.g., toward the central opening 60); (iv) Advancing the free end 84 proximally (e.g., from the top surface 58 toward the bottom surface 56 of the locking element 14 such that the shuttle member 82 and by extension the tensionable fastener 16 around the crossbar 64) makes a "U-turn" through the central opening 60 of the locking element 14; and (v) pushing the free end 84 proximally through the same lateral opening 32 through which it was first pushed, such that the free end 84 and the catch end 86 are located on the same side of the locking assembly 11, i.e., proximally (e.g., "below" the bottom surface 24 of the base member 12).
In some embodiments, the locking assembly 11 may be provided with a shuttle member 82 that is pre-threaded through the locking assembly 11 as described above. In some embodiments, the shuttle member 82 may be provided separately and pass through the locking assembly 11 during use or immediately prior to use.
In some embodiments, one end of tensionable fastener 16 is configured to be secured to tissue, bone, or other member and then passed concomitantly through locking assembly 11 by shuttle member 82. In the embodiment shown in the figures, the tensionable fastener 16 is attached to tissue 2 (e.g., tendon, muscle, or bone) and coupled to bone 4 using the locking assembly 11 and tensionable fastener 16 of the present disclosure. Referring again to fig. 16, one end of the tensionable fastener 16 is attached to the tendon 2 and the other end of the tensionable fastener is coupled with the capture end 86 of the shuttle member 82 (e.g., through the annular capture end 86). This step may be repeated to pass another tensionable fastener 16 through the second set of lateral openings 32, 62 of the locking assembly 11. For example, the second tensionable fastener 16 can be coupled to another tissue portion (e.g., to repair torn tissue)Or to the same tissue segment as the first tensionable fastener 16 (e.g., to secure tissue to bone). Preferably, tensionable fastener 16 is coupled to tissue, bone, or other component prior to coupling to locking assembly 11. Once the tensionable fastener 16 is coupled to the catch end 86 of the shuttle member 82, the free end 84 may be in the proximal direction D 1 (or "pull direction") is pulled, which in turn causes the shuttle member 82 and, by extension, the tensionable fastener 16 to be pulled through the locking assembly 11, as described above. Once the shuttle member 82 is pulled completely through the locking assembly 11, the result is that the tensionable fastener 16 will accompany the passage through the locking assembly 11 in the same manner as the shuttle member 82 described above, with the tensionable fastener 16 making a "U-turn" about the crossbar 64 and with both ends of the tensionable fastener 16 (e.g., the loose end and the end coupled with tissue, bone or other member) on the same (e.g., proximal) side of the locking assembly 11, as shown by way of example only in fig. 17-20. Shuttle member 82 may then be separated from tensionable fastener 16 and removed from the surgical field, leaving only tensionable fastener 16 a) coupled to tissue, bone, or other member and b) threaded through locking assembly 11 such that the loose end of tensionable fastener 16 is on the same side (e.g., proximal) of locking assembly 11 as the coupled end.
At this time, by passing along the direction D 2 Pulling the tendon close to the locking assembly 11 to the desired position for repair, in direction D 1 Pulling the loose end of the tensionable fastener 16 (proximally) will tension the prosthesis. For example only, the tension in the tensionable fastener 16 may be adjusted according to the preference of the surgeon. For example, the locking assembly 11 is a self-locking assembly, wherein locking occurs at a locking interface between the outside surface 36 of the base member 12 and the inside surface 70 of the locking element 14, creating a "pinch point" in which the tensionable fastener 16 is captured and securely held between the outside surface 36 of the base member 12 and the inside surface 70 of the locking element 14. For example, in direction D 1 Pulling will create a tension that can be changed or increased by pulling further in the same direction. Once the locking assembly 11 is in its locked state, the tensionable fastener 16, locking assembly 11 and tissue 2 will be compressed, rubbed and pulledThe combination of extensions maintains its locked state. Repair is thus completed without the need for additional screws or knots.
If the tendon attempts to pull away from the repair site (e.g., in direction D 1 ) It will transmit tension through the tensionable fastener 16 and it will further lock the assembly 11 by pulling the base member 12 and the locking element 14 towards each other. This is because the tensionable fastener 16 is captured and securely held at the locking interface (e.g., at the "pinch point") between the outer side surface 36 of the base member 12 and the inner side surface 70 of the locking element 14, and the tensionable fastener 16 loops around the crossbar 64 or makes a "U-turn" around the crossbar 64 (which may act as a fulcrum in some embodiments), thus the proximal force exerted by the tissue 2 is in the proximal direction D 1 Pulling away from the locking assembly 11 will in turn cause the tensionable fastener 16 to exert a proximal force on the crossbar 64 and thus on the locking element 14, which increases the compression of the tensionable fastener 16 at the locking interface. This will tightly clamp the tensionable fastener 16 and prevent the tendon 2 from moving out of the repaired condition, for example.
In some embodiments, the base member 12 and/or the locking element 14 may be made of metal, polymer, fiber, or any other material that is or may be used to create a fixed post. In some embodiments, the shuttle member 82 and/or tensionable fastener 16 may be made of a polymer, polyester, UHMWPE, nitinol, tape, or any other material that may be or is commonly used to secure tissue for repair.
By way of example only, the tissue referred to herein may be any soft tissue, tendon, muscle, graft, bone or support material that requires fixation or stabilization. The technique of repairing the tendon using the fiber may be Mattress, krakow or any other technique preferred by the surgeon.
Fig. 20-27 illustrate another example of a knotless orthopedic stabilization system 10 in accordance with an embodiment of the present disclosure. By way of example only, the knotless orthopedic stabilization system 10 of the present embodiment includes a locking assembly 110 and a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the locking assembly 110 including a base member 112 and a locking element 114. The base member 112 includes a central recess 128, the central recess 128 being sized and configured to receive the locking element 114 therein when the locking assembly 110 is assembled. As will be explained in further detail herein, the base member 112 and the locking element 114 have complementary surfaces that form a locking interface to capture and hold the tensionable fastener 16 under tension, thereby locking the assembly in place.
In some embodiments, the orthopedic locking assembly 110 can be coupled with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the tensionable fastener 16 being attached to tissue, bone, or other member to lock the tensionable fastener 16 under tension during a surgical procedure. For example, in bicep repair, one end (e.g., an "attachment end") of tensionable fastener 16 may be first attached to or otherwise associated with a torn muscle or other tissue, and then subsequently coupled with locking assembly 110 (e.g., by threading a free end of tensionable fastener 16 or concomitantly through locking assembly 110, as described herein), and then may be advanced through a surgical channel formed through the bone. Once the locking assembly 110 is secured on the opposite side of the bone, the surgeon may apply a desired amount of tension to the tensionable fastener 16 by pulling the free end of the tensionable fastener 16 in the direction of the attached tissue to position and secure the tissue in the desired location. For example, the locking assembly 110 is a self-locking assembly that does not require secondary securement (e.g., knots, securing hardware, etc.) to ensure tension in the tensionable fastener 16. Typically, tensionable fastener 16 passes through or accompanies locking assembly 110 by entering assembly 110 (and also through the open end described below) from one side (e.g., bottom or proximal) of locking assembly 110, looping or making a "U-turn" around a crossbar or fulcrum element of locking element 114, passing through a locking interface (described below) of locking assembly 110, and exiting locking assembly 110 on the same side (e.g., bottom or proximal) as the portal. Looping or "U-turns" of the tensionable fastener 16 provides a number of advantages over existing button assemblies, including, but not limited to: (i) Maintaining the base member 112 and locking element 114 aligned and in a compressed state maintaining tension in the tensioning element 16; (ii) Increasing tension in the construct in response to the attached tissue being pulled away from the assembly; and (iii) maintaining compression in the locking interface.
23-24 illustrate one example of a base member 112 forming part of the locking assembly 110 described herein, according to one embodiment. In some embodiments, the base member 112 may have a generally rectangular shape having a first end 118, a second end 120, a pair of long sides 122, and a longitudinal axis L extending therethrough 1 . For example, in some embodiments, the base member 112 may have a first or bottom surface 124 configured to interface with tissue, bone, or other members and a second or top surface 126 opposite the bottom surface 124. The top surface 126 includes a central recess 128, the size and shape of the central recess 128 being complementary to the size and shape of the locking element 114 such that the locking element 114 fits snugly within the recess 128 when assembled.
In some embodiments, the base member 112 may further include a first opening 130 formed within the central recess 128 proximate the first end 118 and a second opening 132 formed at least partially within the central recess 128 and extending along the longitudinal axis L to the second side 120. Notably, in this exemplary embodiment, the second opening 132 opens into the second end 120, which may enable a faster and more efficient coupling of the locking assembly 110 and the tensionable fastener 16. By way of example, the first opening 130 includes a smooth, angled, tapered, and/or rounded edge surface 134 at the intersection with the central recess 128 to reduce wear on the tension member 16 during use. In some embodiments, the inner portion 136 of the edge surface 134 includes a compression surface configured to cooperate with the outer portion 170 of the edge surface 168 of the locking element 114 (e.g., as a "locking interface") to capture or clamp the tensionable fastener 16 therebetween (e.g., form a "pinch point") when the locking assembly 110 is tensioned during use.
In some embodiments, the base member 112 may have a generally rectangular shape. In some embodiments, the base member 112 may have any suitable shape including, but not limited to, rectangular, circular, oblong, oval, elliptical, or polygonal. In some embodiments, the base member 112 may be sized and configured to be inserted through a surgical channel (e.g., having a proximal opening and a distal opening) formed in bone, tissue, and/or other anatomical structures, and thereafter pivoted, rotated, or otherwise manipulated to extend through the distal opening of the surgical channel without being pulled back through the channel. In some embodiments, the base member 112 may also include a rounded and/or smooth peripheral surface 138 to minimize the profile of the base member 112 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the first end 118 includes a front end as the base member 112 is advanced through a channel formed in bone, tissue, or other anatomical structure. In some embodiments, the first end or front end 118 has a smooth, rounded, and/or tapered front surface 140, which front surface 140 is configured to minimize the profile of the first end or front end 118 and potentially reduce trauma to surrounding tissue during and after implantation. Although not shown in the figures, in some embodiments, the first or front end 118 further includes one or more longitudinal recesses sized and configured to receive at least a portion of the tensionable fastener 16 therein during advancement of the base member 112 through the surgical channel to reduce the profile of the tensionable fastener 16 exposed to the surgical channel, thereby protecting the surgical channel and tensionable fastener 16 from damage during implantation.
By way of example only, fig. 25-26 illustrate one example of a locking element 114 forming part of the orthopedic locking assembly 110 described herein, according to one embodiment. For example, the locking element 114 has a size and shape that is complementary to the size and shape of the central recess 128 of the base member 112 such that the locking element 114 fits tightly within the central recess 128 when assembled. In some embodiments, the locking element 114 may have a generally rectangular shape (e.g., with rounded ends) having a first end 150, a second end 152, a pair of long sides 154, a bottom surface 156, a top surface 158, and a longitudinal axis L extending therethrough. In some embodiments, the bottom surface 156 is configured to interface with the central recess 128 of the base member 112. In some embodiments, the locking element 114 further comprises: a first opening 160, the first opening 160 positioned proximate the first end 150 and extending through the stationary member 114 between the lock bottom surface 156 and the top surface 158; and a second opening 162 positioned adjacent the second end 152 and extending to the second end 152 such that the second end 152 includes an open end complementary to the open second end 120 of the base member 112. The first opening 160 and the second opening 162 are separated by a bridge or rail 164 or similar structure that may serve as a fulcrum for the tensionable fastener 16. In some embodiments, the rail 164 may have one or more rounded, curved, angled, and/or smooth upper surfaces 166 to minimize friction or other forces applied by the rail to the tensionable fastener 16 during use.
For example, the first opening 160 includes a smooth, angled, tapered, and/or rounded edge surface 168 at the intersection with the central recess bottom surface 156 to reduce wear on the tension member 16 during use. In some embodiments, the outer portion 170 of the edge surface 168 (e.g., the portion of the edge surface 168 proximate the first end 150) includes a compression surface configured to cooperate with the inner portion 136 of the edge surface 134 of the base member 112 (e.g., as a "locking interface") to capture or clamp the tensionable fastener 16 therebetween (e.g., to form a "pinch point") when the locking assembly 110 is tensioned during use.
In some embodiments, the locking element 114 may also include a rounded and/or smooth peripheral surface 172 to minimize the profile of the locking element 114 and potentially reduce trauma to surrounding tissue during and after implantation.
As explained herein, the knotless stabilization system 10 is a self-locking system in which tension applied to the tensionable fastener 16 will ensure that the locking element 114 is aligned within the base member 112 while also locking the assembly together due to the interaction of the tensionable fastener 16 with the locking interface (i.e., the inner portion 136 of the rounded edge surface 134 of the base member 112 and the outer portion 170 of the edge surface 168 of the locking element 114 described above). In some embodiments, the locking assembly 110 may be provided with an auxiliary locking element (e.g., similar to the auxiliary locking element described above with respect to the locking assembly 11) to provide additional secure interaction between the locking element 114 and the base member 112, e.g., to ensure that the locking element 114 remains engaged with the base member 112 during re-tensioning of the tensionable fixture 16, if desired. For example only, the secondary locking element may include any physical mechanism that provides a secure interaction between the base member 112 and the locking element 114, including but not limited to a press fit engagement, a snap fit engagement, a friction fit engagement, and the like.
For example only, the locking element 114 may further include one or more elongated flanges 178 positioned along the long side 154 near the intersection with the bottom surface 156 and configured to engage with corresponding elongated flanges or overhangs 146 extending from the top surface 126 of the base member 112 at least partially above the central recess 128 to form a secondary locking element and ensure that the locking element 114 remains within the base member 112. In some embodiments, the elongate flange 178 may also include an inwardly facing angled, tapered or curved surface 180, the surface 180 configured to interface with a corresponding inwardly facing angled, tapered or curved surface 148 of the overhang 146 to enable proper alignment of the locking element 114 within the central recess 128 when the locking element 114 is engaged with the base member 112 and to facilitate passage of the elongate flange 178 beyond the overhang 146 and into the central recess 128. For example, once the elongate flange 178 of the locking element 114 passes over the overhang 146 of the central recess 128, the overhang 146 provides a physical barrier that prevents the locking element 114 from disengaging from the central recess 128 without additional force being applied by a user (e.g., using a removal tool).
As an example, fig. 27 illustrates a tensionable fastener 16 associated with a locking assembly 110 according to some embodiments. Although not shown, in some embodiments, the tensionable fastener 16 may be accompanied by a locking assembly 110 using a shuttle member 82 in a similar manner as the locking assembly 11 described above.
In some embodiments, tensionable fastener 16 may be coupled with locking assembly 110 by: (i) Advancing the free end of tensionable fastener 16 in a distal direction (e.g., from bottom surface 124 toward top surface 126) (e.g., optionally using shuttle member 82 as described above) through second opening 132 of base member 112, or alternatively, sliding tensionable fastener 16 laterally into second opening 132 via open end 120 such that the attached tissue is located on the proximal or bottom side of base member 112 and the free end of tensionable fastener 16 extends distally through second opening 132 (and second opening 162 of locking element 114); (ii) Advancing tensionable fastener 16 inwardly about crossbar 164; (iii) Urging tensionable fastener 16 proximally (e.g., from top surface 158 toward bottom surface 156 of locking element 114 such that tensionable fastener 16 makes a "U-turn" about crossbar 164) through first opening 160 of locking element 114; (iv) The tensionable fastener 16 is advanced proximally through the first opening 130 of the base member 112 such that the tensionable fastener passes through the locking interface (e.g., between the inner portion 136 of the edge surface 134 of the base member and the outer portion 170 of the edge surface 168 of the first opening 160 of the locking assembly 114), and the free and attached ends of the tensionable fastener 16 are located on the same side of the locking assembly 110, i.e., proximally (e.g., "below" the bottom surface 124 of the base member 112).
In some embodiments, the locking assembly 11 may be provided with a shuttle member (e.g., the shuttle member 82 described above) that pre-passes through the locking assembly 110, as described above with respect to the locking assembly 11. The shuttle member 82 may be provided separately and pass through the locking assembly 110 during use or immediately prior to use.
With continued reference to fig. 27, in some embodiments, one end of the tensionable fastener 16 is configured to be secured to tissue, bone, or other member and then passed concomitantly with the locking assembly 110 by a shuttle member (not shown). In the embodiment shown in fig. 27, the tensionable fastener 16 is attached to soft tissue 2 (e.g., muscle, tendon, etc.) and coupled to bone 4 using the locking assembly 110 and tensionable fastener 16 of the present disclosure. For example, the method demonstrates repair of soft tissue (e.g., biceps tendons). In some embodiments, one or more tensionable fasteners 16 are used to repair the torn bicep tendon. The surgeon may use suturing techniques according to his preferences. In some embodiments, multiple tensionable fasteners 16 may be used with the locking assembly 110 (and/or any of the button assemblies described herein) to achieve tissue repair. One or more tensionable fasteners 16 attached to the tissue to be repaired (e.g., bicep tendon) would be connected to the locking assembly 110. The locking assembly 110 will allow fixation of the bicep tendon, tensioning of the bicep repair and will self lock and maintain tension after repair is completed.
By way of example only, a surgical channel or tunnel is drilled through the radius tuberosity. Next, one end or "attached end" of the tensionable fastener 16 is attached to the tissue 2 and the other end or "free end" of the tensionable fastener is shuttled through the locking assembly 110 as described herein. In some embodiments, additional tensionable fixtures 16 may be coupled to another tissue portion (e.g., to repair torn tissue), or to the same tissue segment as first tensionable fixture 16 (e.g., to secure tissue to bone). Preferably, tensionable fastener 16 is coupled to tissue, bone, or other component prior to coupling to locking assembly 110.
The locking assembly 110 with associated suture 16 is then passed through the tunnel (e.g., using the insertion device 710 of fig. 78-80 as described below) in an orientation with the longitudinal axis L generally parallel to the longitudinal axis of the tunnel, and then rotated such that the longitudinal axis L of the locking assembly 110 is generally perpendicular to the tunnel and the locking assembly 110 sits on the distal cortex (e.g., radius) of the bone 4. In this orientation, the bottom surface 124 of the base member 112 will rest on the bone 4 (e.g., distal cortex of the radius), which is the loose end of the tensionable fastener 16 and the tissue to be repaired.
Tensionable fastener 16, which is withdrawn proximally through first opening 130 and extends away from bottom surface 124 of base member 112, may be in direction D 1 Pulled to pass along direction D 2 Pulling the tendon closer to the locking assembly 11 to the desired location for repair (e.g., thereby reducing the distance between the tendon and the base member 112) creates tension in the repair, including but not limited to docking in a tunnel (e.g., for example). For example only, the tension in the tensionable fastener 16 may be adjusted according to the preference of the surgeon. Once the biceps tendon 2 reaches the desired tension, for example, the locking is completed. This locking is caused by capturing the tensionable fastener 16 in the locking interface between the base member 112 and the locking element 114, as described above. This allows when the surgeon is in the allowed direction D 1 The tensioning fixture 16 slides when tensioning is performed thereon, but prevents the suture from sliding in the opposite direction, which could lead to slack when repairing. For example, in direction D 1 Pulling will create a tension that can be changed or increased by pulling further in the same direction. Once the locking assembly 110 is in its locked state, the tensionable fastener 16, locking assembly 110 and tissue 2 will maintain their locked state by a combination of compression, friction and tension. Repair is thus completed without the need for additional screws or knots.
If the tendon 2 (or tissue, bone or other member) is attempted to be pulled away from the repair site (e.g., in direction D 1 ) It will transmit tension through the tensionable fastener 16 and it will further lock the assembly 110 by pulling the base member 112 and the locking element 114 toward each other. This is because the tensionable fastener 16 is captured and secured at the locking interface between the base member 112 and the locking element 114 (e.g., at the "pinch point"), and the tensionable fastener 16 loops around the crossbar 164 (which may act as a fulcrum in some embodiments) and thus is looped by the locking element in the proximal direction D 1 The proximal force exerted by tissue 2 pulled away from locking assembly 110 will in turn cause tensionable fastener 16 to exert a proximal force on crossbar 164 and thus locking element 114, which increases the compression on tensionable fastener 16 at the locking interface. This will tightly clamp the tensionable fastener 16 and prevent the tendon 2 from moving out of the repaired condition, for example.
Fig. 28-31 illustrate another example of a locking assembly 210 forming part of a knotless orthopedic stabilization system 10 in accordance with an embodiment of the present disclosure. For example only, the locking assembly 210 includes a base member 212 and a locking element 214, the locking element 214 being configured to engage a tensionable fastener 16 (e.g., a surgical suture, a strap, a fiber, etc.). The base member 212 includes a central recess 228, the central recess 228 being sized and configured to receive the locking element 214 therein when the locking assembly 210 is assembled. As will be explained in further detail herein and similar to the embodiments described above, the base member 212 and locking element 214 have complementary surfaces that form a locking interface to capture and hold the tensionable fastener 16 under tension, thereby locking the assembly in place.
In some embodiments, the orthopedic locking assembly 210 can be coupled with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the tensionable fastener 16 being attached to tissue, bone, or other member to lock the tensionable fastener 16 under tension during a surgical procedure, as described above with respect to other embodiments. For example, in bicep repair, one end (e.g., an "attachment end") of tensionable fastener 16 may be first attached to or otherwise associated with a torn muscle or other tissue, and then subsequently coupled with locking assembly 210 (e.g., by passing or accompanying the free end of tensionable fastener 16 through locking assembly 210, as described herein), and then locking assembly 210 may be advanced through a surgical channel formed through the bone. Once the locking assembly 210 is secured on the opposite side of the bone, the surgeon may apply a desired amount of tension to the tensionable fastener 16 by pulling the free end of the tensionable fastener 16 in the direction of the attached tissue to position and secure the tissue in the desired location. For example, the locking assembly 210 is a self-locking assembly that does not require secondary securement (e.g., knots, securing hardware, etc.) to ensure tension in the tensionable fastener 16. Typically, tensionable fastener 16 passes through or accompanies locking assembly 210 by entering assembly 210 (and also through the open end described below) from one side (e.g., bottom or proximal) of locking assembly 210, looping or "U-turning" around a crossbar or fulcrum element of locking element 214, passing through a locking interface (described below) of locking assembly 210, and exiting locking assembly 210 on the same side (e.g., bottom or proximal) as the portal. Looping or "U-turns" of the tensionable fastener 16 provides a number of advantages over existing button assemblies, including, but not limited to: (i) Maintaining the base member 212 and locking element 214 aligned and in a compressed state maintaining tension in the tensioning element 16; (ii) Increasing tension in the construct in response to the attached tissue being pulled away from the assembly; and (iii) maintaining compression in the locking interface.
By way of example only, base member 212 is similar to base members 12 and 112 described above and may include any of the features described herein with respect to any other base member embodiments, even if not specifically described. In some embodiments, the base member 212 may have a generally rectangular shape with a first end 218, a second end 220, a pair of long sides 222, and a longitudinal axis extending therethrough. For example, in some embodiments, the base member 212 may have a first or bottom surface 224 configured to interface with tissue, bone, or other members and a second or top surface 226 opposite the bottom surface 224. In some embodiments, the top surface 226 includes a central recess 228 that is sized and shaped to complement the size and shape of the locking element 214 such that the locking element 214 fits snugly within the recess 228 when assembled.
In some embodiments, the base member 212 may include a pair of outer openings 230 formed within the central recess 228, with one outer opening 230 located near the first end 218 and the other outer opening 230 located near the second end 220, and a pair of inner openings 232 located between the outer openings 230. Notably, in this exemplary embodiment, each outboard opening 230 extends to one of the long sides 222 of the base member 212, which may enable a faster and more efficient coupling of the locking assembly 210 and the tensionable fastener 16. The outer openings 230 may extend to the same long side 222 or to opposite long sides 222. For example, the medial opening 232 extends through the base member 212 from the central recess 228 to the bottom surface 224. In some embodiments, the inboard openings 232 each have a smooth, angled, tapered, and/or rounded edge surface 234 at the intersection with the central recess 228 to reduce wear on the tension member 16 during use. In some embodiments, edge surface 234 includes a compression surface configured to cooperate with edge surface 268 of locking element 214 (e.g., as a "locking interface") to capture or clamp tensionable fastener 16 therebetween (e.g., form a "pinch point") when locking assembly 210 is tensioned during use.
For example, the locking element 214 has a size and shape that is complementary to the size and shape of the central recess 228 of the base member 212 such that the locking element 214 fits tightly within the central recess 228 when assembled. In some embodiments, locking element 214 may have a generally rectangular shape with a first end 250, a second end 252, a pair of long sides 254, a bottom surface 256, a top surface 258, and a longitudinal axis extending therethrough. In some embodiments, the bottom surface 256 is configured to interface with the central recess 228 of the base member 212. In some embodiments, locking element 214 further includes a central opening 260 extending through locking element 214 between bottom surface 256 and top surface 258, and a pair of outer openings 262, the pair of outer openings 262 being positioned adjacent first end 250 and second end 252, respectively, and extending through locking element 214 between bottom surface 256 and top surface 258 and to one of the long sides 254 of the locking element. The outer openings 262 may extend to the same long side 254 or to opposite long sides 254, but in either case, the outer openings 262 are complementary to the outer openings 230 of the base member 212. The central opening 260 and the outer openings 262 are separated by a bridge or crossbar 264 or similar structure that can serve as a fulcrum for the tensionable fastener 16. In some embodiments, the crossbar 264 may have one or more rounded, curved, angled, and/or smooth upper surfaces 266 to minimize friction or other forces applied by the crossbar to the tensionable fastener 16 during use.
For example, the central opening 260 includes a smooth, angled, tapered, and/or rounded edge surface 268 at the intersection with the bottom surface 256 to reduce wear on the tension member 16 during use. In some embodiments, the edge surface 268 includes a compression surface configured to cooperate with the edge surface 234 of the base member 212 (e.g., as a "locking interface") to capture or clamp the tensionable fastener 16 therebetween (e.g., forming a "pinch point") when the locking assembly 210 is tensioned during use.
As explained herein, the knotless stabilization system 10 is a self-locking system in which tension applied to the tensionable fastener 16 will ensure that the locking element 214 is aligned within the base member 212 while also locking the assembly together due to the interaction of the tensionable fastener 16 with the locking interface.
As an example, fig. 31 illustrates a tensionable fastener 16 associated with a locking assembly 210 according to some embodiments. Although not shown, in some embodiments, tensionable fastener 16 may be accompanied by a locking assembly 210 using shuttle member 82 in a similar manner as locking assembly 11 described above.
In some embodiments, tensionable fastener 16 may be coupled with locking assembly 210 by: (i) Advancing (e.g., optionally using shuttle member 82 as described above) the free end of tensionable fastener 16 in a distal direction (e.g., from bottom surface 224 toward top surface 226) through lateral opening 232 of base member 212, or alternatively, sliding tensionable fastener 16 laterally into lateral opening 232 via the open side such that the adhering tissue is on the proximal or bottom side of base member 212 and the free end of tensionable fastener 16 extends distally through lateral opening 232 (and outer opening 262 of locking element 214); (ii) Advancing tensionable fastener 16 inwardly about crossbar 264; (iii) Urging tensionable fastener 16 proximally (e.g., from top surface 258 toward bottom surface 256 of locking element 214 such that tensionable fastener 16 makes a "U-turn" about crossbar 264) through central opening 260 of locking element 214; and (iv) urging tensionable fastener 16 proximally through inner side opening 232 of base member 212 such that the tensionable fastener passes through the locking interface (e.g., between edge surface 234 of base member 212 and edge surface 268 of central opening 260 of locking element 214) and the free and attached ends of tensionable fastener 16 are located on the same side of locking assembly 210, i.e., proximally (e.g., "below" bottom surface 224 of base member 212).
For example, the locking assembly 210 may be used in the same or similar tissue repair methods described herein in connection with other locking assembly embodiments.
Fig. 32-33 illustrate another example of a locking assembly 310 forming part of a knotless orthopedic stabilization system 10 in accordance with an embodiment of the present disclosure. By way of example only, the locking assembly 310 is similar in structure and function to the locking assemblies 11, 110, and 210 described above, and may include any of the features described herein with respect to any other locking assembly, even if not specifically described. For example only, the locking assembly 310 includes a base member 312 and a locking element 314, as well as a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.). The base member 312 includes a central recess 328, the central recess 328 being sized and configured to receive the locking element 314 therein when the orthopedic button assembly 310 is assembled. Similar to the embodiments described above, the base member 312 and locking element 314 have complementary surfaces that form a locking interface to capture and hold the tensionable fastener 16 under tension, thereby locking the assembly in place. For example only, the base member 312 has four through holes 318 extending through the central recess 328. The locking element 314 has two through holes 320 in line with the outer buttons. Similar to the previously described embodiments, to couple the tensionable fastener 16 to the button assembly, one end of the tensionable fastener 16 is attached to the soft tissue 2 and the other end of the tensionable fastener 16 passes through holes 320, 318 in the locking element 314 and the base member 312, respectively. The tensionable fastener 16 will then make a 'U-turn' towards the respective end of the base member 312 and pass through the remaining through-hole 318 (lateral or outer through-hole) of the base member 312, through the locking interface between the base member 312 and the locking element 314, the locking interface comprising the lateral end 322 of the locking element 314 and the lateral end 324 of the central recess 328. Pulling on the tensionable fastener 16 in the direction of the soft tissue will cause the repair to tension. Releasing the tension will put the device in a locked state. This configuration may be used either intra-osseously or distally of the cortex to complete the repair. For example only, the locking assembly 310 of the current embodiment may be performed with the locking element 314 in contact with bone or any stabilizing member (e.g., plate, etc.), as shown in fig. 33, or alternatively, with the base member 312 in contact with bone or any other stabilizing member, e.g., as shown and described in the previously described embodiments.
Fig. 34-37 illustrate another example of a locking assembly 410 according to one embodiment of the present disclosure. For example only, the locking element 414 is located within the central recess 428 of the base member 412. The base member 412 has one opening 418 and the locking element 414 has two openings 420 separated by a bridge 422. By way of example only in fig. 37, a tensionable fastener 16 attached to or for soft tissue repair may form a single loop or multiple loops by passing between a single opening 418 in base member 412 and two openings 420 in locking element 414. The free end of tensionable fastener 16 passes through a locking interface comprising lateral end 424 of locking element 414 and lateral end 426 of central recess 428 by passing through single opening 418 of base member 412 and eventually exiting locking assembly 410 between base member 412 and locking element 414. Pulling on the free end of the tensionable fastener 16 will tighten the prosthesis. Once the tension is released, the repair is maintained by the lock between the base member 412 and the locking element 414. The locking interface may have different shapes. In some embodiments, the locking assembly 410 may be used with two additional holes in the base member 412 for the additional tensionable fastener 16 to exit through the locking interface.
Figures 38-49 illustrate an example of a locking assembly 910 including a base member 912 and a locking element 914 for use with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.) as part of a knotless orthopedic fixation system 10, according to some embodiments. By way of example only, the base member 912 includes a central recess 928, the central recess 928 being sized and configured to receive the locking element 914 therein when the locking assembly 910 is assembled. As will be explained in further detail herein, the base member 912 and the locking element 914 have complementary surfaces that form a locking interface to capture and hold the tensionable fastener 16 under tension, thereby locking the assembly in place. Notably, the locking assembly 910 differs from other locking assembly embodiments disclosed herein in that the locking assembly 910 includes an anti-shake feature and an unlocking tool engagement feature. By way of example only, the anti-shake features described herein include a proximal extension 982 on the locking element 914, the proximal extension 982 extending into a lateral opening 932 of the base member 912 when the locking assembly 910 is in the locked state. For example only, the unlocking tool engagement features described herein include a pair of end openings 940 on the base member 912 and lateral cutouts 944 and engagement surfaces 945 on the locking element 914 that are configured to engage with an unlocking tool so that the unlocking tool can be manipulated to physically unlock the locking assembly by forcing the locking element 914 distally away from the base member 912 such that the tensionable mount is again moveable relative to the base member 912.
By way of example only, fig. 38-42 illustrate an example of a locking assembly 910 forming part of the knotless orthopedic stabilization system 10 described herein, in accordance with some embodiments. In some embodiments, the locking assembly 910 may be coupled with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the tensionable fastener 16 being attached to tissue, bone, or other member to lock the tensionable fastener 16 under tension during a surgical procedure. For example, in bicep repair, one end (e.g., an "attachment end") of tensionable fastener 16 may be first attached to or otherwise associated with a torn muscle or other tissue, then subsequently coupled with locking assembly 910 (e.g., by passing or accompanying the free end of tensionable fastener 16 through locking assembly 910, as described herein), and then locking assembly 910 may be advanced through a surgical channel formed through the bone. Once the locking assembly 910 is secured on the opposite side of the bone, the surgeon may apply a desired amount of tension to the tensionable fastener 16 in the direction of the attached tissue to position and secure the tissue in the desired location, such as by reducing the distance between the attached tissue and the locking assembly 910. For example, the locking assembly 910 is a self-locking assembly that does not require secondary securement (e.g., knots, securing hardware, etc.) to ensure tension in the tensionable fastener 16. Typically, tensionable fastener 16 passes through or accompanies locking assembly 910 by entering locking assembly 910 from one side (e.g., bottom or proximal) of locking assembly 910, looping or making a "U-turn" around a crossbar or fulcrum element of locking element 914, passing through a locking interface (described below) of locking assembly 910, and exiting locking assembly 910 on the same side (e.g., bottom or proximal) as the portal. Looping or "U-turns" of the tensionable fastener 16 provides a number of advantages over existing button stitch assemblies, including, but not limited to: (i) Maintaining the base member 912 and locking element 914 aligned and in compression maintains tension in the tensioning element 16; (ii) Increasing tension in the construct in response to the attached tissue being pulled away from the assembly; and (iii) maintaining compression in the locking interface.
43-44 illustrate one example of a base member 912 forming part of a locking assembly 910 described herein, according to one embodiment. In some embodiments, the base member 912 may have a generally rectangular shape with a first end 918, a second end 920, a pair of long sides 922, and a longitudinal axis L extending therethrough. For example, in some embodiments, the base member 912 may have a first or bottom surface 924 configured to interface with tissue, bone, or other members and a second or top surface 926 opposite the bottom surface 924. In some embodiments, the top surface 926 includes a central recess 928 that is sized and shaped to complement the size and shape of the locking element 914 such that the locking element 914 fits snugly within the recess 928 when assembled.
In some embodiments, the base member 912 may further include a central structure 930 and a pair of lateral openings 932 positioned within the central recess 928, with one lateral opening 932 positioned on each side of the central structure 930. The central structure 930 includes a proximally facing surface 934 and a pair of smooth and/or rounded outer side surfaces 936 positioned on either side of the proximally facing surface 934 and each facing in the direction of the respective lateral opening 932. In some embodiments, the lateral surface 936 may be angled or tapered from a first height at the intersection with the proximal facing surface 934 to a second height within the central recess 928, e.g., at or near the intersection with the lateral opening 932. In some embodiments, the lateral surface 936 may extend at least partially over the lateral opening 932. In some embodiments, the outside surface 936 is a compression surface configured to cooperate with the inside surface 970 of the locking element 914 (e.g., as a "locking interface") to capture or clamp the tensionable fastener 16 therebetween (e.g., forming a "pinch point") when the locking assembly 910 is tensioned during use. In some embodiments, the central structure 930 includes a transverse linear beam that extends along the transverse axis T through the central recess 928 between the lateral openings 932. In some embodiments, the central structure 930 may have a non-linear shape, resulting in one or both of the outer side surfaces 936 having a concave and/or convex shape. In some embodiments, the exterior side surface 936 may have any combination of linear, convex, and/or concave orientations.
For example, the lateral opening 932 extends completely through the base member 910 between the central recess 928 and the bottom surface 924. In some embodiments, the lateral opening 932 has a peripheral wall 933 that extends around the perimeter of the lateral opening 932. In some embodiments, the peripheral wall 933 extends perpendicularly (e.g., perpendicular to a plane defined by the bottom surface 924) through the base member 910. For example only, the lateral opening 932 has a rounded rectangular cross-section, however, the lateral opening 932 may have any cross-sectional shape suitable for receiving the tensionable fastener 16 therethrough.
In some embodiments, the base member 912 may have a generally rectangular shape. In some embodiments, the base member 912 may have any suitable shape, including, but not limited to, rectangular, circular, oblong, oval, elliptical, or polygonal. In some embodiments, the base member 912 may be sized and configured to be inserted through a surgical channel (e.g., having a proximal opening and a distal opening) formed in bone, tissue, and/or other anatomical structures, and thereafter pivoted, rotated, or otherwise manipulated to extend through the distal opening of the surgical channel without being pulled back through the channel. In some embodiments, the base member 912 may also include a rounded and/or smooth peripheral surface 938 to minimize the profile of the base member 12 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the first end 918 and the second end 920 are identically formed, such that either end may include a front end as the base member 912 is advanced through a channel formed in bone, tissue, or other anatomical structure. In some embodiments, the first end 918 and the second end 920 each have an end opening 940, the end openings 940 extending into the central recess 928 and configured to receive an engagement portion of an unlocking tool (not shown) therein. In some embodiments, each of the first end 918 and the second end 920 further includes a lateral cutout 942, the lateral cutout 942 configured to provide space for an unlocking tool when the unlocking tool is engaged with the end opening 940.
By way of example only, fig. 45-47 illustrate one example of a locking element 914 forming part of the locking assembly 910 described herein, according to one embodiment. For example, the locking element 914 has a size and shape that is complementary to the size and shape of the central recess 928 of the base member 912 such that the locking element 914 fits tightly within the central recess 928 when assembled. In some embodiments, the locking element 914 may have a generally rectangular shape (e.g., with rounded ends) having a first end 950, a second end 952, a pair of long sides 954, a bottom surface 956 and a top surface 958, and a longitudinal axis L extending therethrough. In some embodiments, the bottom surface 956 is configured to interface with the central recess 928 of the base member 912. In some embodiments, the locking element 914 further includes a central opening 960 and a pair of lateral openings 962 extending through the locking element 914 between the bottom surface 956 and the top surface 958. The central opening 960 and the lateral openings 962 are separated by a bridge or rail 964 or similar structure that may serve as a fulcrum for the tensionable fastener 16. In some embodiments, the rail 964 may have one or more rounded, curved, and/or smooth upper surfaces 966 to minimize friction or other forces applied by the rail to the tensionable fastener 16 during use.
In some embodiments, the bottom surface 956 includes a central recess 968 formed around the central opening 960. For example, the central recess 968 may have a size and shape that is complementary to the size and shape of the base member 912 such that the central structure 930 fits tightly within the central recess 968 of the locking element 914 when assembled. In some embodiments, the central recess 968 includes a pair of smooth, tapered, and/or rounded and/or curved inner side surfaces 970 that form the boundaries of the central recess 968. For example, the inner side surface 970 is inwardly tapered or curved (or medially) toward the central opening 960. In some embodiments, the inner side surface 970 extends at least partially over the outer side opening 932 of the base member 912. In some embodiments, the inner side surface 970 is a compression surface configured to cooperate with the outer side surface 936 of the base member 912 to capture or clamp the tensionable fastener 16 therebetween when the tensionable fastener 16 is tensioned during use. In some embodiments, the central recess 968 may have a non-linear shape, resulting in one or both of the inboard surfaces 970 having a concave and/or convex shape. In some embodiments, medial surface 970 may have any combination of linear, convex, and/or concave orientations. In any embodiment, the inside surface 970 has a shape that is complementary to the outside surface 936 of the base member 912 such that a combined compression on the tensionable mount 16 is maintained.
In some embodiments, the first end 950 and the second end 954 each further include a lateral cutout 944, the lateral cutout 944 being configured to receive an engagement portion of an unlocking tool (not shown) therein. In some embodiments, the lateral cutout 944 further includes an engagement surface 945, the engagement surface 945 configured to engage and receive a distal force applied by an unlocking tool to cause separation between the locking element 914 and the base member 912 to unlock the assembly 910 and enable movement of the tensionable fastener 16 to re-tension.
In some embodiments, the locking element 914 may also include a rounded and/or smooth peripheral surface 972 to minimize the profile of the locking element 914 and potentially reduce trauma to surrounding tissue during and after implantation. In some embodiments, the peripheral edge surface 974 of the central opening 960 includes a smooth, angled, tapered, and/or rounded edge surface to reduce wear on the tension member 16 during use. In some embodiments, the distal and/or proximal openings of the lateral openings 62 include smooth, angled, tapered, and/or rounded edge surfaces 976 to reduce wear on the tension member 16 during use.
In some embodiments, the locking element 914 includes a pair of proximal extensions 982 extending proximally from the bottom surface 956. For example, the proximal extension 982 comprises a vertical extension of the lateral opening 962, wherein the proximal extension 982982 has a peripheral inner wall 984, the peripheral inner wall 984 comprising a seamless extension of the inner peripheral boundary of the lateral opening 962. In some embodiments, proximal extension 982 has a medial opening 986 configured to enable tensionable fastener 16 to pass proximally from lateral opening 962. In some embodiments, the proximal extension 982 has a peripheral outer wall 988, the peripheral outer wall 988 being sized and configured to be snugly, flush, and/or nestably received within the lateral opening 932 of the base member 912 when the locking assembly 912 is in the locked state (see, e.g., fig. 49) such that a surface area of the proximal extension 982 engages a surface area of the peripheral wall 933 of the lateral opening 932. This engagement of the surface regions stabilizes the locking element 914 relative to the base member 912, for example, preventing rocking or other movement that may result in tension applied to the tensionable fastener 16 loosening after the knotless stabilization system 10 has been locked and the surgical procedure is completed.
Thus, in some embodiments, the proximal extension 982 has an outer peripheral shape that is complementary to the inner peripheral shape of the lateral opening 932 of the base member 912. In some embodiments, the proximal extension 982 has an outer peripheral dimension that is complementary to an inner peripheral dimension of the lateral opening 932 of the base member 912. In some embodiments, when the locking assembly 910 is in the locked state, a surface area of the peripheral wall 933 of the lateral opening 932 is engaged with a surface area of the circumferential outer wall 988 on at least one side of the proximal extension 982. In some embodiments, when the locking assembly 910 is in the locked state, a surface area of the peripheral wall 933 of the lateral opening 932 is engaged with a surface area of the peripheral outer wall 988 on at least two sides of the proximal extension 982. In some embodiments, when the locking assembly 910 is in the locked state, a surface area of the peripheral wall 933 of the lateral opening 932 is engaged with a surface area of the peripheral outer wall 988 on at least three sides of the proximal extension 982. In some embodiments, when the locking assembly 910 is in the locked state, the surface areas of the peripheral wall 933 of the lateral opening 932 are engaged with the surface areas of the peripheral outer wall 988 on four sides of the proximal extension 982.
As explained herein, the knotless stabilization system 10 is a self-locking system in which tension applied to the tensionable fastener 16 will ensure that the locking element 914 is aligned within the base member 912 while also locking the assembly together due to the interaction of the tensionable fastener 16 with the locking interface (i.e., the outside surface 936 of the base member 912 and the inside surface 970 of the locking element 914). In some embodiments, the locking assembly 910 may be provided with an auxiliary locking element to provide additional secure interaction between the locking element 914 and the base member 912, for example to ensure that the locking element 914 remains engaged with the base member 912 during re-tensioning of the tensionable fastener 16 if desired, and to prevent rocking or other movement of the locking element 914 within the central recess 928, thereby preventing loosening of the tensionable fastener 16. For example only, the secondary locking element may include any physical mechanism that provides a secure interaction between the base member 912 and the locking element 914, including but not limited to a press fit engagement, a snap fit engagement, a friction fit engagement, and the like.
For example only, the locking element 914 may further include one or more elongated flanges 978 positioned near the first and second ends 918, 920 near the intersection with the bottom surface 956 and configured to engage with a corresponding elongated flange or overhang 946 extending from the top surface 926 of the base member 912 at least partially above the central recess 928 to form a second locking element and ensure that the locking element 914 remains within the base member 912 when the locking assembly 910 is in an unlocked state (e.g., when the tensionable fastener 16 is free to move for adjustment or re-tensioning). In some embodiments, the elongated flange 978 may further include an inwardly facing angled, tapered or curved surface 980, the surface 980 being configured to engage with a corresponding inwardly facing angled, tapered or curved surface 948 of the overhang 946 to enable proper alignment of the locking element 914 within the central recess 928 when the locking element 914 is engaged with the base member 912, and to facilitate passage of the elongated flange 978 over the overhang 946 and into the central recess 928. As shown in the embodiment of fig. 38, once the elongated flange 978 of the locking element 914 passes over the overhang 946 of the central recess 928, the overhang 946 provides a physical barrier that prevents the locking element 914 from disengaging the central recess 928 without additional force being applied by a user (e.g., using a removal tool).
In some embodiments, the central opening 960 of the locking element 914 is positioned such that, when assembled with the base member 912, the central opening 960 is positioned over the central structure 930 of the base member 912 or aligned with the central structure 930 of the base member 912. In some embodiments, the lateral opening 962 of the locking element 914 is positioned such that, when assembled with the base member 912, the lateral opening 962 of the locking element 914 is positioned over the lateral opening 932 of the base member 912 or aligned with the lateral opening 932 of the base member 912.
48-49 illustrate several steps of a method for securing or repairing bone and/or tissue using the locking assembly 910 of the present disclosure, according to some embodiments. In some embodiments, a shuttle member may be used to assist the tensionable fastener 16 through the base member 912 and the locking element 914, as described above with respect to the other embodiments.
In some embodiments, tensionable fastener 16 may be coupled with locking assembly 910 by: (i) Advancing the free end (e.g., coupled with a shuttle member as described above) in a distal direction (e.g., from the bottom surface 924 toward the top surface 926) through one of the lateral openings 932 of the base member 912; (ii) Further advancing the free ends through the respective aligned lateral openings 962 of the locking element 914; (iii) Pushing the free ends inwardly (e.g., toward the central opening 960) around the rails 964; (iv) Advancing the free end proximally (e.g., from the top surface 958 toward the bottom surface 956 of the locking element 914 such that the tensionable fastener 16 makes a "U-turn" around the crossbar 964) through the central opening 960 of the locking element 914; and (v) pushing the free end proximally through the same lateral opening 932 through which it was first pushed such that the free end and the attached end of tensionable fastener 16 are on the same side of locking assembly 910, i.e., proximally (e.g., "below" bottom surface 924 of base member 912).
In some embodiments, the locking assembly 910 may be provided with a shuttle member that is pre-threaded through the locking assembly 910, as described above with respect to other embodiments. In some embodiments, the shuttle member may be provided separately and pass through the locking assembly 910 during or immediately prior to use.
In some embodiments, one end of tensionable fastener 16 is configured to be secured to tissue, bone, or other member, and then passed by shuttle member concomitantly with locking assembly 910. In the embodiment shown in the figures, the tensionable fastener 16 is attached to tissue 2 (e.g., tendon, muscle, or bone) and coupled to bone 4 using the locking assembly 910 and tensionable fastener 16 of the present disclosure. 48-49, one end of the tensionable fastener 16 is attached to the tendon 2 and the other end of the tensionable fastener has been passed through the locking assembly 910 as described above. For example, the second tensionable fastener 16 may be coupled to another tissue portion (e.g., to repair torn tissue), or to the same tissue segment as the first tensionable fastener 16 (e.g., to secure tissue to bone). Preferably, tensionable fastener 16 is coupled to tissue, bone, or other component prior to coupling with locking assembly 910.
At this time, by passing along the direction D 2 Tendon 2, which is close to locking assembly 910, is pulled to the desired position for repair, in direction D 1 Pulling the loose end of the tensionable fastener 16 (proximally) will tension the prosthesis. For example only, the tension in the tensionable fastener 16 may be adjusted according to the preference of the surgeon. For example, the locking assembly 910 is a self-locking assembly in which locking occurs at a locking interface between the outside surface 936 of the base member 912 and the inside surface 970 of the locking element 914, creating a "pinch point" in which the tensionable fastener 16 is captured and securely held between the outside surface 936 of the base member 912 and the inside surface 970 of the locking element 914. For example, in direction D 1 Pulling will create a tension that can be changed or increased by pulling further in the same direction. Once locking assembly 910 is in its locked state, tensionable fastener 16, locking assembly 910 and tissue 2 will maintain their locked state by a combination of compression, friction and tension. In this way, the repair is completed,no additional screws or knots are required.
If the tendon attempts to pull away from the repair site (e.g., in direction D 1 ) It will transmit tension through the tensionable fastener 16 and it will further lock the assembly 910 by pulling the base member 912 and the locking element 914 toward each other. This is because the tensionable fastener 16 is captured and secured at the locking interface (e.g., at the "pinch point") between the outer side surface 936 of the base member 912 and the inner side surface 970 of the locking element 914, and the tensionable fastener 16 loops or "U-turns" around the crossbar 964 (which may act as a fulcrum in some embodiments), and thus the proximal force exerted by the tissue 2 is in the proximal direction D 1 Pulling away from the locking assembly 910 will in turn cause the tensionable fastener 16 to exert a proximal force on the rail 964 and thus on the locking element 914, which increases the compression on the tensionable fastener 16 at the locking interface. This will tightly clamp the tensionable fastener 16 and prevent the tendon 2 from moving out of the repaired condition, for example.
Several embodiments of the locking assembly described herein (e.g., locking assembly 11, 110, 210, 310, 410, 910) are shown and described as specific embodiments of the overall concept and are not limited by the specific combinations of features of the various embodiments depicted. Thus, any locking assembly described herein may include any feature described with respect to any other locking assembly, even if not specifically described in combination. Further, the various locking assemblies are not limited to the particular number of through holes or openings shown, or the number of tensionable fasteners 16. Optionally, in any embodiment, the specific size and shape of the various features may be different than shown in the figures. Optionally, in any embodiment, the number of compression surfaces or locking interfaces may be different than shown.
Optionally, in any embodiment, the knotless stabilization system 10 includes an unlocking feature to unlock the locking assembly 11 (or any alternative embodiment thereof) to enable re-tensioning of the tensionable fastener 16 after initial tensioning and locking is complete. In addition to the previous figures, referring also to fig. 50-54, in some embodiments, the unlocking feature includes an unlocking feature or tool 90 that can engage the base member 12 and/or the locking element 14 and displace the locking element 14 relative to the base member 12 to create a space or distance or interval that allows the tensionable fastener 16 to relax and then re-tension if desired. The relaxed state will allow the tensionable fastener to maneuver and slide to re-tension. Once the desired tension is reached, the unlocking component or tool 90 is pulled back, removed, or otherwise disengaged from the base member 12 and/or locking element 14. As the tensioned tensionable fastener 16 pulls the locking element 14 in the proximal direction, the gap obtained by the unlocking tool 90 will disappear and the tensionable fastener 16 will again be sandwiched between the locking element 14 and the base member 12, as described above.
Unlocking tool or component 90 may comprise any tool or component suitable or capable of overcoming tension in tensionable mount 16 to create a temporary separation between locking element 14 and base member 12, including but not limited to threaded members, snap-fit trigger controlled pushers/extenders, pliers-like clamps, and the like. By way of example only, fig. 50-54 illustrate one example of an unlocking tool 90 according to some embodiments. For example, unlocking tool 90 includes a threaded portion 92 and a distal end 94. In this embodiment, the locking element 14 includes a threaded bore 96, the threaded bore 96 having a thread form that is complementary to the thread form of the threaded portion 92 such that the threaded portion 92 is in threaded engagement with the threaded bore 96. In this embodiment, the base member 12 has an engagement surface 98 that provides a contact surface for the distal end 94 of the unlocking tool 90. For example, fig. 50-52 illustrate the locking assembly 11 in a locked position (not shown with the tensionable fastener 16) wherein the unlocking tool 90 is aligned with the threaded bore 96 and then advanced into the threaded bore 96 (e.g., by rotating the threaded portion 92 of the bonding tool 90 of the present embodiment in an advancing direction) until the distal end 94 contacts the bonding surface 98. Once distal end 94 contacts engagement surface 98, further rotation in the forward direction will cause locking element 14 to translate distally along threaded portion 92, thereby creating a separation between locking element 14 and base member 12, as shown by way of example only in FIGS. 53-54. Once separation is achieved, the tensionable fastener may be adjusted as described above, and the locking assembly 11 may be locked again by removal or separation of the unlocking tool 90.
In some embodiments, as described herein, the locking assembly 11 may include an auxiliary locking element in addition to the unlocking features described herein to prevent the locking element 14 from separating from the base member 12 during the re-tensioning process.
In some embodiments, the unlocking feature may include a deflectable member that is movable from a first position in which the locking assembly 11 is in the locked configuration to a second position in which the locking assembly 11 is in the unlocked configuration, thereby enabling re-tensioning of the tensionable fastener 16. By way of example only, fig. 55-67 illustrate an example of a locking assembly 510 having a deflectable member 528 that can unlock the locking assembly 510 to re-tension the tensionable fastener 16, according to some embodiments. For example only, the locking assembly 510 may have a base member 512 and a locking element 514. In some embodiments, the locking assembly 510 may be coupled with a tensionable fastener 16 (e.g., surgical suture, tape, fiber, etc.), the tensionable fastener 16 being attached to tissue, bone, or other member to lock the tensionable fastener 16 under tension during a surgical procedure. In some embodiments, the locking element 514 is movable relative to the base member 512 between a locked state (e.g., fig. 55-57) and an unlocked state (e.g., fig. 58). For example, tensioning of the tensionable fastener 16 may occur while the locking assembly 510 is in the unlocked state, and then the locking assembly 510 may be transitioned to the locked state to secure the tensionable fastener 16 in a desired position under a desired tension. In some embodiments, the locking assembly 510 includes an unlocking feature to enable re-tensioning of the tensionable fastener 16 after initial tensioning and locking is complete. In some embodiments, the unlocking feature includes a deflectable member that biases the locking element 514 in the locked state, but is deflectable to enable the locking element 512 to translate to the unlocked state. In some embodiments, the deflectable member is part of the button 512, disposed on the button 512, or attached to the button 512. In some embodiments, the deflectable member is part of the locking element 514, disposed on the locking element 514, or attached to the locking element 514 (see, e.g., fig. 65-67).
For example, in some embodiments, the base member 512 may have a first or bottom surface 518 configured to interface with tissue, bone, or other members and a second or top surface 520 opposite the bottom surface 518. In some embodiments, the top surface 520 includes an elongated central recess 522, the central recess 522 having a generally planar translation surface or bottom surface 524 and a size and shape that enables the locking element 514 to translate linearly within the recess 522 when assembled.
In some embodiments, base member 512 may further include a central opening 526 formed through bottom surface 524 and a deflectable member 528 positioned at one end of elongated recess 522. In some embodiments, the intersection between the central opening 526 and the bottom surface 524 of the elongated recess 522 includes a smooth and/or rounded edge surface 530. In some embodiments, the edge surface 530 is a compression surface configured to cooperate with the edge surface 540 of the locking element 514 to capture or clamp the tensionable fastener 16 therebetween (e.g., form a "pinch point") when the locking assembly 510 is tightened during use.
In some embodiments, the base member 512 may have a generally rectangular shape. In some embodiments, base member 512 may have any suitable shape including, but not limited to, rectangular, circular, oblong, oval, elliptical, or polygonal. In some embodiments, the base member 512 may be sized and configured to be inserted through a channel formed in bone and thereafter pivoted, rotated, or otherwise manipulated to extend over the channel without being pulled back through the channel. In some embodiments, the top surface 520 may also include a rounded and/or smooth peripheral surface 532 to minimize the profile of the base member 512 and potentially reduce trauma to surrounding tissue during and after implantation.
For example, the locking element 514 has a width dimension and shape that is complementary to the width and shape of the elongated recess 522 of the base member 512 such that the locking element 514 is translatable within the recess 522 when assembled. For example, in some embodiments, the locking element 514 may have a first or bottom surface 534 configured to engage a bottom surface 524 of the elongate recess 522 of the base member 512 and a second or top surface 536 opposite the bottom surface 534. In some embodiments, the locking element 514 further includes a central opening 538 extending through the locking element 514 between the bottom surface 534 and the top surface 536. In some embodiments, the intersection between the central opening 538 and the top surface 534 of the locking element 514 includes a smooth and/or rounded edge surface 540. In some embodiments, the edge surface 540 is a compression surface configured to cooperate with the edge surface 530 of the base member 512 to capture or clamp the tensionable fastener 16 therebetween (e.g., form a "pinch point") when the locking assembly 510 is tightened during use.
In some embodiments, the locking assembly 510 may include a retaining feature to prevent the locking element 514 from separating from the base member 512 while allowing the locking element 514 to translate within the elongated recess 522. In some embodiments, the retention feature may include one or more overhangs of the top surface 520 of the button that extend over the elongated recess 522. In some embodiments, the retention features may include one or more rails 533 extending from either or both side and/or bottom surfaces 534 of the locking element 514 and into complementary elongated slots 535 formed in the side walls and/or bottom surface 524 of the elongated recess 522, as shown by way of example only in fig. 67. In some embodiments, the retention features may include one or more rails extending from one or both side walls and/or bottom surfaces 524 of the elongate recess 522 into complementary elongate slots formed in the side and/or bottom surfaces 534 of the locking element 514.
In some embodiments, the base member 512 further includes a deflectable member 528, the deflectable member 528 being positioned at one end of the elongated recess 522 and having deflectable, flexible, and/or spring-like features. Deflectable member 528 interacts with locking element 514 to create a locked and unlocked position. For example, deflectable member 528 is spring loaded and biases locking element 514 in the locked position by exerting a directional force on locking element 514. To achieve the unlocked position, this directional force must be overcome, for example, using clamping member 542 (e.g., fig. 57), and clamping member 542 will exert a counter-directional force on locking element 514 and cause flexible member 528 to temporarily deflect. In some embodiments, in the unlocked position, the central opening 538 of the locking element 514 is positioned such that, when assembled with the base member 512, the central opening 538 of the locking element 514 is positioned at least partially over the central opening 526 of the base member 512 or aligned with the central opening 526 of the base member 512, as shown by way of example only in fig. 58. This positioning enables movement of the tensionable fastener 16 to increase and/or relax the tension in the tensionable fastener 16. For example, when the tension is insufficient, the operator can change the state of the locking assembly 510 from the locked position to the unlocked position by using the clamping member 542 to increase the overlap between the central opening 538 of the locking element 514 and the central opening 526 of the button 512. Similarly, when tensionable fastener 16 is over-tensioned, clamping member 542 may be used to create an unlocked state to relax the tension in tensionable fastener 16, and then lock tensionable fastener 16 by releasing clamping member 542 when the desired tension is reached. In some embodiments, the clamping member 542 may be modified to be a pulling member to achieve at least partial alignment or overlap of the central opening 538 of the locking element 514 with the central opening 526 of the button 512.
59-62, the unlocked state or "position X" is when the central opening 538 of the locking element 514 and the central opening 526 of the base member 512 are at least partially aligned or otherwise overlap. The locked state or "position Y" is when the central opening 538 of the locking element 514 and the central opening 526 of the base member 512 are misaligned (very slight overlap to accommodate the width/diameter of the tensionable fastener 16 without allowing the tensionable fastener to move). In some embodiments, position X is achieved by using clamping member 542 to exert a force on locking element 514 in a reverse direction, thereby causing temporary deflection of flexible member 528 (as shown, by way of example only, in fig. 57). In some embodiments, position Y is achieved by: clamping member 542 is released to enable deflectable member 528 to yield to its direction bias and move back in the direction of its original position, thereby creating a locked position in which tensionable fastener 16 is locked between edge surface 530 of base member 512 and edge surface 540 of locking element 514 (e.g., at a "pinch point").
In some embodiments, the position X (or unlocked state) of the locking assembly 510 will also allow the tensionable fastener 16 to be tensioned or moved (e.g., further tensioned or relaxed) in both directions, which is a key element in adjusting tension in an over-or under-tensioned state. The position Y of the locking assembly 510 will lock the tensionable fastener 16, as described herein, and ensure the desired tension therein. In some embodiments, the deflectable member is part of the base member 512, disposed on the base member 512, or attached to the base member 512, as shown in the examples in fig. 55-64. In some embodiments, the deflectable member is part of the locking element 514, is disposed on the locking element 514, or is attached to the locking element 514, as shown in the examples in fig. 65-67. In either case, deflectable member 528 allows the position of locking element 514 to be temporarily changed to create an unlocked state (e.g., position X), which allows tensioning or releasing the repair. In some embodiments, a similar condition may be created by a spring-like feature 528 (shown only as an example in fig. 64) provided on the base member 512 and/or the locking element 514 or by additional components to allow the creation of an unlocked position X to tighten or loosen the repair structure.
For example, the base member 512 and/or the locking element 514 may be made of polymer, PEEK, resorbable or non-resorbable components, metal (e.g., titanium, stainless steel, cobalt chrome, etc.), or similar materials used in the industry. Tensionable fastener 16 may be used in a looped or non-looped orientation. The tensionable fastener 16 may be made of a polymer, a tape-suture, or any other material component for increasing or decreasing tension in the repair structure. The looped or non-looped portion of tensionable fastener 16 may be attached to tissue, bone, graft, or other component (e.g., sheet metal, anchor, etc.) to which it is anchored or to which repair is desired.
By creating an unlocked state using a clamping member or similar mechanism to allow the surgeon to increase or decrease tension, the uniqueness of this novel design will minimize the incidence of failure due to suboptimal tension, reducing surgical time, as the surgeon does not have to tie and re-tie to achieve the desired tension. Uniqueness refers to creating a locked and unlocked position with the aid of a member that creates an unlocked state by clamping or pulling or any mechanism that can create an unlocked state. Deflectable member 528, as described herein by way of example, will temporarily change position due to clamping member 542 as described herein and then attempt to move back to its original position, thereby establishing a locked condition.
Examples: carpal-metacarpal (CMC) joint replacement
With additional reference to fig. 63, one embodiment method of using the locking assembly 510 of the present disclosure will now be described in the context of a carpal-palm (CMC) arthroplasty procedure. However, this is strictly an example of a repair method, and the use of the apparatus is not limited to the specific embodiments described. After the trapezium bone is resected, a surgical tunnel is created by drilling generally aligned holes in the first and second metacarpals. Tensionable anchors disposed in an annular orientation shuttle through holes formed in the first metacarpal bone and the second metacarpal bone. Once the looped end of the tensionable fastener is retracted from the distal cortex of the second metacarpal bone, the open button or anchor 544 can, for example, act as a bridge and the tensionable fastener can bypass it as shown in fig. 63. Once the open button with the looped tensionable fastener therearound is secured to the distal cortex of the second metacarpal bone, the locking assembly 510 is then clamped to the unlocked state (e.g., position X) using the clamping member 542 or any other member that manipulates the locking assembly 510 to position X. The gripping feature 542 creates a temporary deflection of the flexible member 528 and will allow the tensionable fastener to slide to increase the tension in the fiber and pulling on the tensionable fastener will reduce the distance between the two base members or locking assemblies 510 and the member attached to the looped end. If at this point the surgeon feels the repair in an overstretched state, which may limit the patient's ability to use the hand, the surgeon may bring the locking assembly 510 from position Y (locked state) back to position X (unlocked state). This will allow the surgeon to increase the distance between the member attached to the looped end and the locking assembly 510. Once the new position is confirmed and tension is desired, releasing the clamping member will return the button assembly to position Y, which is the locked state. Position Y will now ensure repair under this new optimal tension.
Component holding device
Fig. 68-77 illustrate examples of assembly devices 610 and techniques configured for use with a multi-component fixation device (e.g., the locking assembly 11 described above) according to some embodiments. Although shown and described herein by way of example in connection with the above-described locking assembly 11, it should be understood that the assembly device 610 may be modified for use with other multi-component fixation devices, including, but not limited to (and by way of example only) the locking assembly 110, the locking assembly 210, the locking assembly 310, the locking assembly 410, the locking assembly 910 (as described above), or the fracture/soft tissue repair plate 810 (see, e.g., fig. 88) described below.
For example, the present disclosure describes a unique technique for allowing a tensionable fastener to be easily passed through a multi-component fixation assembly (e.g., locking assembly 11) for connecting soft tissue or any other tissue to an anchoring device. In some embodiments, the assembly device 610 of the present disclosure includes the ability to pass the tensionable fastener 16 through a multi-component assembly. In some embodiments, the assembly device 610 of the present disclosure includes the ability to pass a tensionable mount or tensionable mount between multiple base components or securing members such that the tensionable mount is positioned at a locking interface of the multiple securing members. The assembly holder technique describes a unique mechanism for fastening a tensionable fastener for securing tissue without the need for knotting. The tensionable fastener also prevents it from being damaged and/or broken when it passes through the locking interface of the multi-component fastening assembly. In some embodiments, the assembly device 610 allows for release of pressure on the tensionable fastener during assembly with the multi-component fastening assembly by reducing friction at the locking interface of the multi-component assembly. This allows the user to pass the tensionable fastener through the assembly apparatus 610 in a seamless manner and then disengage the assembly apparatus 610 to couple the tensionable fastener with the multi-component fastening assembly to complete the repair.
By way of example only, the component holder may be made of metal, polyetheretherketone (PEEK), polymer, or other materials commonly used in the industry for manufacturing such parts. The tensionable fastener or suture may be made of PEEK, stainless steel, nitinol wire, tape, polyester, or other similar material for capturing soft tissue or other tissue to be secured during repair.
By way of example only, the multi-component fixation assembly or similar anchoring system may be made of PEEK, metal, polymer, plastic, or other materials that may be used to make the product. The number of multi-component assemblies and multiple anchor systems used may be variable. The passage of the tensionable fastener through assembly device 610 may be accomplished directly or by means of a suture noose or other shuttle member. The unloader or shuttle assist may be made of metal, polyetheretherketone, polymer, or other similar materials. It basically describes a method of creating engagement between a tensionable fastener and a self-locking button or similar anchoring device. This mechanism involves creating a feature that will eliminate the pressure created at the locking interface as the suture shuttles, allowing the suture to pass easily and be tensioned during subsequent repair. Once the locking surface is engaged, it will allow the restoration to be pulled in one direction and prevent the suture from sliding or the restoration from loosening when the fiber is pulled in the opposite direction.
The preferred embodiments described herein are merely examples of one way to achieve such repair using a multi-part fixation assembly and an assembly retention device. Similar embodiments may be created using the principles described herein to relieve pressure on the locking interface while shuttling the suture or tensionable fastener.
Referring to fig. 68-75, in some embodiments, the assembly device 610 includes a body 612, the body 612 may include separable first and second body portions 612a, 612b that are held together by, for example, an outer sleeve 614. Body 612 also includes a proximal portion 616 and a distal portion 618. In some embodiments, the proximal portion 616 is a solid portion, or alternatively, the proximal portions of the first and second body portions 612a, 612b mate flush with one another. The proximal portion 616 may also include a central lumen 620 extending longitudinally (e.g., along a central longitudinal axis extending through the assembly device 610) through the body 612 between the proximal and distal portions. In some embodiments, the central lumen 620 has a proximal opening 622 and opens distally to a working gap 624, as described below.
In some embodiments, the distal portion 618 includes a working gap or recess 624 formed along the central longitudinal axis and extending along a plane parallel to the central longitudinal axis. In some embodiments, working gap 624 is formed by a space separating distal portion 618 of first body portion 612a and distal portion 618 of second body portion 612b. In some embodiments, working gap 624 provides space for manipulating one or more tensionable fixtures, shuttles, and/or other instruments that may be used during the assembly process. In some embodiments, the distal portion 618 includes a transverse channel 626 that extends through the first and second body portions 612a, 612b and is configured to receive a shuttle assist (e.g., a cross pin) 628 therethrough, the shuttle assist 628 in turn extending through the working gap 624.
In some embodiments, distal portion 618 further comprises: a first component recess 630 configured to retain a first component of the multi-component fixation assembly (e.g., the base member 12 of the locking assembly 11 described above) within the working gap 624; and a second component recess 630 configured to retain a second component of the multi-component fixation assembly (e.g., the locking element 14 of the locking assembly 11 described above) within the working gap 624. In some embodiments, the first component recess 630 and the second component recess 632 are vertically spaced apart (e.g., longitudinally spaced in a proximal-distal direction) to ensure that the locking interfaces of the first and second components (e.g., the outer side surface 36 of the base member 12 and the inner side surface 70 of the locking element 14 described above) remain separated from each other in the first position during the shuttling of the tensionable fastener 16 to reduce or eliminate damage to the tensionable fastener 16 during coupling with a multi-component fastening assembly (e.g., the locking assembly 11). In some embodiments, the first and second component recesses 630, 632 are not completely separate, but are still able to retain the component with some vertical spacing therebetween with the projection forcing the component into the unlocked position.
76-77, a repair method is described by way of example only in which tensionable fastener 16 is used to attach to tissue being repaired. In some embodiments, a first end of each of the two (or more) tensionable fixtures 16 is secured to the tissue to be repaired, while a second end (e.g., free end) of the tensionable fixtures 16 is each coupled with a capture end 86 of two different shuttle members 82 (e.g., shuttle lines, etc.). For example, the shuttle member 82 is coupled with the assembly device 610 in the same manner as described above with respect to the shuttle member 82 coupled with the locking assembly 11, except that the components of the locking assembly 11 are held by the assembly device 610 (e.g., the base member 12 is held in the first component recess 630 and the locking element 14 is held in the second component recess 632), and the shuttle member 82 is also looped around the shuttle assist or cross pin 628 at the apex of the assembly such that the shuttle member 82 (and subsequent tensionable fastener 16) is not damaged by friction of the locking interface components (e.g., the outside surface 36 of the base member 12 and the inside surface 70 of the locking element 14 as described above) during manipulation through the assembly.
For example only, the free end 84 of the shuttle member 82 may be pulled in a distal direction, which causes the tensionable fastener 16 to shuttle through the assembly apparatus 610, whereby the tensionable fastener 16 first traverses the base member 12, then the locking element 14, then makes a U-turn about the shuttle assist 628, then passes between the locking element 14 and the base member 12 as it passes through the locking interface between the base member 12 and the locking element 14. As described above, the longitudinal spacing between the first and second components (e.g., base member 12 and locking element 14) ensures that there is little or no resistance or friction that prevents tensionable fastener 16 from easily passing through locking assembly 11. For example only, the shuttle assist 628 may include a simple rod, pin, or any other mechanism that enables unloading to occur at the locking interface while shuttling. In some embodiments, once the tensionable fastener 16 passes through or is coupled with the multi-component fastening assembly (e.g., locking assembly 11), the assembly device 610 is disassembled, allowing the first and second components to transition between a first position in which the first and second components are longitudinally separated, and a second position in which the first and second components engage one another, thereby restoring a locking interface that allows unidirectional tensioning and locking (e.g., by compression and friction) once tensioning has been completed (e.g., as described above). When the tissue or tensionable fastener 16 is pulled in the opposite direction, the locking interface will prevent or resist loosening, which in turn will prevent repair failure. For example only, the mechanism may allow repair in a knotless manner.
Fin/interposer
Fig. 78-83 illustrate examples of insertion instruments or fin devices 710 that may be used to implant an anchoring device for soft tissue bone or any other tissue repair, according to some embodiments. For example, the insertion instrument 710 is designed to perform a variety of functions to aid in the repair process. For example, the fin device 710 may be configured for use with any number of securing components, including, but not limited to, the locking components 10, 110, 210, 310, 410, 910 described above and/or the locking components described in commonly owned U.S. patent No. 11,109,855 ("the' 855 patent"), entitled "Knotless Orthopedic Stabilization System (knotless orthopedic stabilization system)" issued on month 9, 2021, the entire contents of which are incorporated by reference as if fully set forth herein.
Current devices for assisting such repair perform only one function, namely transporting the anchoring device through the bone tunnel. The fin device 710 of the present disclosure is unique in that it allows a user to load an anchor device onto the fin device, which will keep the anchor device in tension to help easily pass through a bone tunnel. When the proper position is reached, the surgeon or user will use the release feature to reduce tension in the structure and flip the anchoring device to the correct position.
For example, a spring-like mechanism may be used to maintain tension that can hold the structure under tension until the surgeon or user is ready to invert the device. The device will help simplify surgical repair by transporting the anchoring device through the bone tunnel and preventing the tensionable fastener used or connected to the anchoring device from bunching up. Once the slider or loading feature is engaged, it will trigger a decrease in structural tension and the pushing feature within the flipper may be actuated to advance and unload the anchor device, which may then be pulled taut to complete the repair after the flipper device 710 has been disengaged.
For example, any or all of the components of fin device 710 may be made of metal, plastic, polymer using different manufacturing processes, such as machining, molding, 3D printing, or other materials and manufacturing processes currently used in the industry.
In some embodiments, an anchor 712 (e.g., base member 12, anchor plate, or the like) is loaded on fin device 710, fin device 710 having a capture end 714 to retain anchor 712. In some embodiments, the capture end 714 may also have additional features or cutouts 716 to allow positioning of the tensionable fastener 16. For example only, fin device 710 has a shaft 718, shaft 718 facilitating transport of anchoring device 712 to a desired location through a bone tunnel. The anchoring device 712 is coupled to the capture end 714, and a tensionable mount is connected to the device 712. The tensionable fastener 16 is connected at an opposite end to another component 720 (e.g., the locking element 14 described above). The second component 720 may be positioned in the device pouch 722 prior to insertion. This position is maintained by a feature on the fin or slider 724 that holds the second member 720 under tension. Once the bone tunnel is formed, the anchoring device 712 may be tunneled to its desired location so that the repair may be completed. Once the anchoring device 712 is transported, the sled 724 in this embodiment is pushed distally to release tension in the flexible fasteners 16. This will also allow rod pusher 726 to push on anchoring device 712 to flip anchoring device 712. When the operator pushes the slider to release tension in the suture structure, it will increase the tension in the spring-loaded structure 728. The self-tensioning mechanism of the flipper 710, which is spring loaded, has a tendency to be in its non-stretched position in its rest state (e.g., fig. 79), and the slider is pushed downward to feed the second button device 720 into the device pocket 722 (e.g., fig. 78) to maintain tension in the suture as the spring loaded feature will have a tendency to return to the rest position, which in turn will eliminate any slack in the tensionable fastener 16. The push rod 726 passes through a cannula in the fin device 710. The slider 724, when pushed distally, will cause the pusher bar 726 to flip over the anchoring device 712 to engage the anchoring feature. The device may be modified in different embodiments whereby the flipping occurs by moving the parts in opposite directions or loading the spring or spring-like tensionable feature in different positions. The spring-loaded mechanism may be an actual spring or a material that may change the elastic properties, such as nitinol, and perform the same function.
Self-locking design bone folded plate
Fig. 84-89 illustrate examples of fracture repair plates 810 having a self-locking design according to some embodiments.
In some embodiments, the present disclosure relates to knotless fixation assemblies useful for surgical repair of bone or soft tissue. In some embodiments, the knotless fixation assemblies disclosed herein include a base member, a locking element, and one or more tensionable fasteners, such as surgical sutures, bands, and/or wires, that can be used to stabilize, fix, and/or repair bone or soft tissue. In some embodiments, the fixation assembly may have a built-in locking mechanism or require an auxiliary locking element, and the tensionable fixation may be used to fasten, fix, and/or tension bone, soft tissue, or another component to achieve the same desired result. In some embodiments, the locking mechanism may secure the tensionable fastener in a knotless manner. In some embodiments, the user may use knots in addition to (or separate from) the knotless locking mechanisms described herein to provide secondary locking.
In general, fracture repair involves the use of plates and screws for repair. While these techniques are effective for fracture repair, a portion of the population fails for reasons including, but not limited to, subsidence of the fracture, insufficient capture of fracture fragments resulting in loss of reduction and protrusion of the implant into the joint space requiring repeated surgery. By way of example only, a typical fracture plate has holes for screw channels and fracture fixation. The challenge faced by existing systems is that the screw cannot capture the bone fragments attached to the tendon because there is insufficient thread to penetrate the bone fragments, and the bone may be damaged by breaking into pieces even when in use. In addition, other methods are used to repair soft tissue and bone to the plate, i.e., using sutures that pass through the soft tissue or bone, and then attaching the sutures to the bone by passing through holes in the plate and fastening by tying knots. A further problem is that the surgeon must use complex knotting techniques or drill additional holes in the remainder of the good bone to pass the suture through the tunnel. Failure may occur due to loosening of the knot, fracture through additional holes, soft tissue failure, or screw failure to capture bone fragments.
The above-described problems may result in healing of deformities, disunion, multiple subsequent visits to make additional fixation and/or hardware removal or surgery to address the complexity of hardware. The present disclosure solves the problems of the prior art methods by describing a method of repair and use of a knotless fixation assembly that includes a tensionable fixation that may be used for soft tissue and bone repair, and specifically across a fracture site to achieve compression, reduction, and fracture healing.
The presently disclosed knotless fixation assemblies may provide the ability to perform soft tissue repair, bone repair, or fixation methods for securing sutures or other tensionable fasteners in a knotless manner. In some embodiments, the securing assembly of the present disclosure is designed to perform locking independent of the second component. In some embodiments, the securing assembly includes a locking feature that maintains the ability of the optimally tensioned repair by pulling the tensionable fastener in the tensioning direction and preventing the tensionable fastener from sliding in the opposite direction, thereby providing safety for the repair.
In some embodiments, the fixation assemblies of the present disclosure are designed for use with fracture plate applications, and are particularly useful where the fracture is fixed near an articular surface. In some embodiments, the angle (e.g., tilt angle or curvature) of the articular surface may vary depending on the anatomical location. For example, accurate repositioning of the articular surface without any further damage to the articular surface due to hardware placement is critical to the patient's therapeutic effect. The presently described knotless fixation assemblies may have the ability to work with fracture plate systems including, but not limited to (and by way of example only) fracture plates used near articular surfaces, such as fractures of the distal end and around the radius, ankle, or shoulder, or also fractures of non-articular locations. In some embodiments, the knotless fixation assembly may be introduced through a hole in the bone flap using a guide hole, and the fixation assembly may be shuttled through the fracture site using a shuttle. Upon reaching the cortical outer side of the distal end of the fracture site, the fixation assembly may be tightened to effect reduction by changing the shape, changing orientation (e.g., longitudinal to horizontal), and/or expanding the size of the distal end. Tensioning of the tensionable fastener (e.g., suture, tape, wire, or other) will create compression on the fracture site. The small guide holes created for device shuttle will allow the device to be positioned close to the articular surface. Tensioning will reduce the fracture to be compressed at the fracture site and allow the locking member to lock into the fixation plate. This will reduce the risk of non-healing, malformed healing hardware complications and repeated surgery. It will also prevent the surgeon from making multiple incisions to place additional hardware to effect repair.
Reconstructing the soft tissue 812 and bone envelope is critical for a well-functioning repair, especially when it is located around joints where muscles and tendons assist in the range of motion. For example, the bone flap 810 of the present disclosure uses one or more tensionable fasteners 16 (e.g., surgical sutures, straps, wires, or the like) to connect the soft tissue 812 and the bone 4 in a knotless manner through the bone flap 810. By way of example only, the fracture plate 810 is similar to the base members 12, 112, 212, 312, 412, 912 described above in that the bone flap 810 provides one of the compression surfaces in the locking interface and the locking element is secured to the plate by the tensionable fastener 16 providing the other compression surface in the locking interface.
In some embodiments, the fracture plate 810 includes one or more holes 814, the holes 814 configured for screw passage using locking elements 816, 818, 822, 823 that form a locking interface 820 with the plate 810 and/or repair of soft tissue 812 with the plate 810 in a knotless manner (e.g., similar to the soft tissue fixation techniques described above). By way of example only, the plate 810 shown and described herein illustrates various interactions with different embodiments of locking elements, including, but not limited to, locking element 816 (e.g., similar to the locking element shown and described in the' 855 patent, which optionally may be used with anchor 832), locking element 818 (e.g., which optionally may be used with anchor 832), locking element 822 (e.g., configured to be used with one tensionable fastener 16), and locking element 823 (e.g., similar to locking element 822, but configured to be used with two tensionable fasteners 16). The fracture plate 810 shown by way of example only in the drawings is an example only and need not necessarily include each type of locking element shown.
In some embodiments, the plate 810, along with the locking elements 816, 818, 822, or 823, may assist in tensioning the soft tissue 812.
For example only, the locking interface 820 created by the interaction between the plate 810 and the various locking elements 816, 818, 822, 823 includes interactions between one or more compression surfaces on the plate 810 that interact with one or more complementary compression surfaces on the locking elements to create a "pinch point" that captures the tensionable mount 16 as the tensionable mount 16 is tensioned in the direction of tension.
In some embodiments, a similar mechanism may be used for a total joint prosthesis 826 or a partial joint prosthesis (see, e.g., fig. 89), wherein soft tissue (e.g., tendons) 812 may be connected to the prosthesis directly through the prosthesis 826 or using allografts or using a mechanism in which the prosthesis connects a mechanism with a locking interface 820 to bone, which mechanism may assist in soft tissue tensioning and locking once connected to the locking element 822 (or locking elements 816, 818, or 823).
In some embodiments, the present disclosure describes a fracture plate 810 or prosthesis 826 that may be used to repair bone 4 and/or tissue 812, as shown by way of example only in fig. 87. In some embodiments, the plate includes one or more holes 814, the holes 814 configured for passage of screws configured to obtain support within bone as part of fracture repair. In some embodiments, the plate 810 includes an opening toward the center and/or periphery of the plate that has a compression surface forming part of the locking interface 820 or that can be used as a compression surface forming part of the locking interface 820 when engaged with the locking elements 816, 818, 822, 823 or mating devices, such as any of the securing assemblies 11, 110, 210, 310, 410, 510, 910 disclosed herein and/or the securing assemblies described in the' 855 patent. This will allow the tensionable fastener 16 attached to the soft tissue 812 to pass through the hole 814 for soft tissue or bone repair, then the tensionable fastener 16 shuttles through the locking elements 816, 818, 822, 823 having mating or compression surfaces with the plate forming locking interface 820, allowing tensioning in one direction, and locking when pulled in the opposite direction to prevent loosening or repair failure. In some embodiments, the tensionable fastener 16 passes through the aperture 814 and loops around the locking elements 816, 818, 822, 823 in a U-shaped manner, then attaches to the soft tissue 812 and passes proximally through the plate 810 again through the outlet channel 834, which outlet channel 834 may be a separate outlet aperture 834 (shown in fig. 85-86 by way of example only) adjacent to the aperture 814, or alternatively may include a slot, groove, channel or other passageway proximate to the aperture 814. Importantly, the outlet channel 834 guides the tensionable fastener 16 to the locking interface 820 to ensure that the tensionable fastener 16 is knot-free once the desired tension is applied.
In some embodiments, there may be a plurality of holes 814 and/or locking interface surfaces 820 that may be used to repair a plurality of soft tissues or bones or small pieces of bone to a bone flap or directly to a bone. In some embodiments, the fracture plate 810 has a surface that can create a friction or compression lock of the tensionable fastener 16 to secure soft tissue or bone repair.
In some embodiments, the same hole 814 that includes a locking interface surface 820 for soft tissue repair and mating with a locking element (816 or 818 or 822 or 823) may also be used to receive screw 830.
In some embodiments, the fracture plate 810 may have a screw locking the tensionable fixation for securing soft tissue by creating a friction compression mechanism with the tensionable fixation 16.
In some embodiments, the shape of the plate may be variable. In some embodiments, the number of tensionable fixtures 16 may be based on the design configuration, and the tensionable fixtures may be tensioned in the proximal or distal direction, but there may be one direction that allows tensioning and pulling in the opposite direction to be blocked by the locking interface. Furthermore, although the number of tensionable fixtures 16 may be variable, the plate 810 should be provided with an outlet channel 834 for each end of each tensionable fixture 16 used.
The above-described embodiments help provide knotless repair, providing the operator with the ability to tighten. The fracture plate 810 of the present disclosure will provide a more modular system that provides superior repair.
In some embodiments, the fracture plate 810 includes the use of an anchoring device 832 on the distal cortex of the bone to which the plate 810 is attached, tensioning performed by pulling the suture in the proximal direction, and locking is created by the interaction of the plate and locking interface 820 against the first half (proximal half) of the locking element (816, 818, 822, 823).
For example, the fracture plate 810 system and repair method disclosed herein possess many features over prior art systems, including but not limited to (and by way of example only):
a. the bone flap 810 itself provides a locking interface 820 for the locking element and/or the anchoring device.
b. The bone flap 810 can form a locking interface 820 with the locking element and/or the anchoring device.
c. The bone flap 810 may perform repair in a knotless manner by providing a surface with a locking interface 820 and will lock the tensionable fastener 16.
d. The bone flap 810 may have a dual function and may be used with a locking element to lock the tensionable fastener 16 or may also be used to pass through the screw 830.
e. Bone flap 810 may allow for bi-directional tensioning, with one direction being proximal or one direction being distal.
f. The bone flap 810 may have a version of soft tissue repair secured by a locking element or device having a locking interface 820 with the plate 810.
g. The bone flap 810 may be repaired in a knotless manner by providing a surface with a locking interface 820, which locking interface 820 will then lock with the other fixation elements. This allows the tensionable fastener 16 to be tightened by using compression and friction.
The foregoing detailed description is presented to enable any person skilled in the art to make and use the button stitch assembly described herein. For purposes of explanation, specific details are set forth in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one skilled in the art that these specific details are not required in order to practice the methods described herein. The description of specific applications is provided as representative examples only. Various modifications to the preferred embodiment will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments and applications without departing from the scope of the disclosure. The present disclosure is not intended to be limited to the embodiments shown, but is to be accorded the widest scope possible consistent with the principles and features disclosed herein. All such modifications and variations are within the scope of the invention as determined by any and all claims from this disclosure when interpreted in accordance with the breadth to which they are fairly, legally and equitably entitled.
Claims (29)
1. A knotless fixation assembly operable to secure tissue to tissue, bone or other member, the knotless fixation assembly comprising:
a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore;
a locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a central opening extending between the proximal side and the distal side, a first lateral opening extending between the proximal side and the distal side and positioned adjacent the central opening, the first lateral opening being separated from the central opening by a bridging member, the locking element having a second compression surface adjacent the central opening, the locking element having a first proximal extension protruding proximally from the proximal side; and
a tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element between the first and second compression surfaces;
Wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance;
wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastening assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces; and is also provided with
Wherein the first proximal extension is sized and configured to nest within the first throughbore when the knotless fixation assembly is in the second state to prevent relative movement between the locking element and the base member when the assembly is in the second state.
2. The knotless fixation assembly of claim 1, wherein an attachment end of the tensionable fastener is moveable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
3. The knotless fixation assembly of claim 1, wherein the base member further comprises a recess positioned within the distally-facing surface, the recess configured to receive the locking element therein.
4. The knotless fixation assembly of claim 3, wherein the first through-hole is positioned within the recess.
5. The knotless fastening assembly of claim 1, wherein the first through-hole has an inner peripheral wall having a first surface area.
6. The knotless fixation assembly of claim 5, wherein the first proximal extension has a peripheral wall having a second surface area.
7. The knotless fixation assembly of claim 6, wherein the first surface region and the second surface region are flush engaged with one another when the knotless fixation system is in the second state.
8. The knotless fixation assembly of claim 1, wherein the tensionable fastener passes through the base member and locking element such that the tensionable fastener passes distally from the attachment end through the first through-hole and the first lateral opening, loops around the bridging member and then passes proximally through the central opening and the first through-hole between first and second compression surfaces.
9. The knotless fixation assembly of claim 1, wherein the base member further comprises a second throughbore extending between the proximally-facing surface and the distally-facing surface, and a third compression surface adjacent the second throughbore.
10. The knotless fixation assembly of claim 9, wherein the locking element further comprises a second lateral opening extending between the proximal and distal sides and positioned opposite the first lateral opening adjacent the central opening, the second lateral opening being separated from the central opening by a second bridging member, the locking element having a fourth compression surface adjacent the central opening and a second proximal extension protruding proximally from the proximal side, the second proximal extension being sized and configured to nest within the second throughbore when the knotless fixation assembly is in the second state.
11. The knotless fixation assembly of claim 10, further comprising a second tensionable fastener configured to interact with the base member and the locking element, the second tensionable fastener having an attachment end configured to attach to tissue, bone, or other member and a free end configured to be manipulated by a user, the second tensionable fastener passing through the base member and locking element between the third compression surface and fourth compression surface.
12. The knotless fixation assembly of claim 1, further comprising an unlocking element configured to facilitate transition of the assembly from the second state to the first state upon engagement by a user.
13. The knotless securing assembly of claim 12, wherein the unlocking element comprises a tool engagement feature configured to engage with an unlocking tool.
14. The knotless fixation assembly of claim 13, wherein the unlocking element comprises a threaded opening in the locking element.
15. The knotless fixation assembly of claim 14, wherein the unlocking tool comprises a threaded shaft configured to engage the threaded opening and having a distal tip configured to engage a bearing surface of the base member, wherein actuation of the threaded shaft causes the distal tip to rotate against the bearing surface and the locking element to disengage from the base member, thereby transitioning the assembly from the second state to the first state.
16. The knotless fixation assembly of claim 13, wherein the unlocking element comprises at least one cutout region positioned on at least one end of the locking element, the at least one cutout region having a bearing surface.
17. The knotless securing assembly of claim 16, wherein the unlocking means comprises an engagement member configured to engage the bearing surface of the locking element and operable to disengage the locking element from the base member to transition the assembly from the second state to the first state.
18. A knotless fixation assembly operable to secure tissue to tissue, bone or other member, the knotless fixation assembly comprising:
a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore;
a locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a central opening extending between the proximal side and the distal side, a first lateral opening extending between the proximal side and the distal side and positioned adjacent the central opening, the first lateral opening being separated from the central opening by a bridging member, the locking element having a second compression surface adjacent the central opening; and
A tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element such that the tensionable fixture passes distally from the attachment end through the first through hole and the first lateral opening, loops around the bridging member, and then passes proximally through the central opening and the first lateral opening between the first and second compression surfaces;
wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance;
wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastener assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces.
19. The knotless fixation assembly of claim 18, wherein the attachment end is movable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
20. The knotless fixation assembly of claim 18, wherein the base member further comprises a recess positioned within the distally-facing surface, the recess configured to receive the locking element therein.
21. The knotless fixation assembly of claim 19, wherein the first through-hole is positioned within the recess.
22. The knotless fixation assembly of claim 18, wherein the locking element comprises a proximal extension extending proximally from the first lateral opening, the proximal extension configured to nest within the first through-hole when the knotless fixation assembly is in the second state.
23. A knotless fixation assembly operable to secure tissue to tissue, bone or other member, the knotless fixation assembly comprising:
a base member having a proximally facing engagement surface configured to mate or secure to tissue, bone, or other member, a distally facing surface opposite the proximally facing surface, a first through bore extending between the proximally facing surface and the distally facing surface, and a first compression surface adjacent the first through bore;
A locking element configured to mate with the base member, the locking element having a proximal side, a distal side opposite the proximal side, a first opening extending between the proximal side and the distal side, a second opening extending between the proximal side and the distal side and positioned adjacent to the first opening, the second opening being separated from the first opening by a bridging member, the locking element having a second compression surface adjacent to the first opening; and
a tensionable fixture configured to interact with the base member and the locking element, the tensionable fixture having an attachment end configured to attach to tissue, bone or other member and a free end configured to be manipulated by a user, the tensionable fixture passing through the base member and locking element such that the tensionable fixture loops distally from the attachment end through the base member and the second opening, around the bridging member, and then proximally through the first opening and the first through-hole between the first and second compression surfaces;
wherein the knotless fixation assembly comprises a first state defining a first distance between the base member and the locking element and a second state defining a second distance between the base member and the locking element, the second distance being less than the first distance;
Wherein the free end of the tensionable fastener is configured to be tensioned in a proximal direction when the attachment end is mated with a first tissue and the base member is mated with a second tissue, bone or other member, thereby creating tension in the tensionable fastener causing the knotless fastener assembly to transition from the first state to the second state, wherein the second state is maintained by compression and friction applied to the tensionable fastener between the first and second compression surfaces.
24. The knotless fixation assembly of claim 23, wherein the base member further comprises a second through-hole extending between the proximally-facing surface and the distally-facing surface and positioned adjacent to the first through-hole, and the tensionable fastener passes distally through the base member through the second through-hole.
25. The knotless securing assembly of claim 24, wherein the second through-hole extends laterally to a longitudinal end of the base member.
26. The knotless fixation assembly of claim 25, wherein the second opening extends laterally to a longitudinal end of the locking element.
27. The knotless fixation assembly of claim 23, wherein an attachment end of the tensionable fastener is moveable in a distal direction but prevented from moving in the proximal direction when the knotless fixation assembly is in the second state.
28. The knotless fixation assembly of claim 23, wherein the base member further comprises a recess positioned within the distally-facing surface, the recess configured to receive the locking element therein.
29. The knotless fastening assembly of claim 28, wherein the first through-hole is positioned within the recess.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US63/194,436 | 2021-05-28 | ||
| US63/254,136 | 2021-10-10 | ||
| US202163293738P | 2021-12-24 | 2021-12-24 | |
| US63/293,738 | 2021-12-24 | ||
| PCT/US2022/031479 WO2022251721A1 (en) | 2021-05-28 | 2022-05-28 | Knotless orthopedic stabilization system and related methods |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117881348A true CN117881348A (en) | 2024-04-12 |
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ID=90590537
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202280038553.9A Pending CN117881348A (en) | 2021-05-28 | 2022-05-28 | Knotless orthopedic stabilization systems and related methods |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117881348A (en) |
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2022
- 2022-05-28 CN CN202280038553.9A patent/CN117881348A/en active Pending
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