Abstract: The present disclosure relates to a system and method of knee ligament balancing for knee replacement procedures. The disclosure provides a system of components to implant to achieve ligament balancing. In addition, instruments and methods are provided to achieve the desired balance of the ligaments before final fixation.

Abstract: A method of evaluating soft tissue of a human joint which includes two or more bones and ligaments, wherein the ligaments are under anatomical tension to connect the bones together, creating a load-bearing articulating joint, the method includes: inserting into the joint a tensioner-balancer that includes a means of controlling a distraction force; providing an electronic receiving device; moving the joint through at least a portion of its range of motion; while moving the joint, controlling the distraction force, and collecting displacement and distraction load data of the bones; processing the collected data to produce a digital geometric model of the joint, wherein the model includes: ligament displacement data along a range of flexion angles and ligament load data along a range of flexion angles; and storing the digital geometric model for further use.

Abstract: A method of evaluating a human joint including bones and ligaments under anatomical tension to connect the bones. The method includes: defining a primary datum oriented and fixed in six degrees of freedom; defining at least one secondary datum having fixed origins relative to one of the bones of the joint and relative to a tracking device affixed to the bone; providing an electronic receiving device; while moving the bones of the joint relative to each other, using the electronic receiving device to collect data from the at least one tracking device, wherein the data includes information describing the position and movement in six degrees of freedom of the at least one secondary datum relative to the primary datum to produce a digital geometric model of at least a portion of the joint; and storing the digital geometric model for further use.

Abstract: An anchor for anchoring tensile members to bone includes: a housing extending along a central axis, with a hollow interior; a collet in the hollow interior having a central bore for accepting tensile members and an exterior surface, the collet being configured to swage around and against tensile members; a sleeve having a peripheral wall defining interior and exterior surfaces, the sleeve disposed in the housing's hollow interior axially adjacent to the collet, and movable parallel to the central axis between first and second positions; and wherein at least one of the collet exterior surface and the sleeve interior surface is tapered and the sleeve and the collet are arranged so movement of the sleeve from the first position to the second position causes the sleeve interior surface to bear against the collet exterior surface, causing the collet to swage radially inwards around and against one or more tensile members.

Abstract: An anchor for anchoring tensile members to bone includes: a housing extending along a central axis, with a hollow interior; a collet in the hollow interior having a central bore for accepting tensile members and an exterior surface, the collet being configured to swage around and against tensile members; a sleeve having a peripheral wall defining interior and exterior surfaces, the sleeve disposed in the housing's hollow interior axially adjacent to the collet, and movable parallel to the central axis between first and second positions; and wherein at least one of the collet exterior surface and the sleeve interior surface is tapered and the sleeve and the collet are arranged so movement of the sleeve from the first position to the second position causes the sleeve interior surface to bear against the collet exterior surface, causing the collet to swage radially inwards around and against one or more tensile members.

Abstract: A knee gap tensioning apparatus includes: a baseplate, a top plate, and a linkage operable to move the top plate relative to the bottom plate between retracted and extended positions, the linkage including: a first toggle linkage, including a lower link and an upper link; a second toggle linkage, including a lower link and an upper link; a connector linkage interconnecting the first and second toggle linkages; wherein the links comprise parallel pivot axes and the linkage is configured so as to produce linear movement of the top plate relative to the base plate, in response to a rotational movement of one or more of the links; and wherein the linkage includes an input shaft coupled to the linkage and configured to accept a rotary input about an axis parallel to the parallel pivot axes of the links of the linkage.

Abstract: An anchor for anchoring tensile members to bone includes: a housing having a hollow interior; a collet in the interior of the housing, having a central bore for accepting tensile members therethrough and an exterior surface, wherein the collet is configured to be swaged around the tensile members; a sleeve having opposed interior and exterior surfaces, the sleeve disposed in the hollow interior of the housing and positioned adjacent to the collet, so as to be movable between first and second positions; wherein at least one of the exterior surface of the collet and the interior surface of the sleeve is tapered and the sleeve and the collet are arranged such that movement of the sleeve from the first position to the second position will cause the collet to swage radially inwards around the tensile members; and a flange element, wherein the housing is pivotally mounted to the flange element.

Abstract: A knee gap tensioning apparatus includes: a tensioner-balancer, including: a baseplate; a top plate; and a linkage operable to move the top plate relative to the bottom plate between retracted and extended positions in response to application of an actuating force, the linkage including: a first toggle linkage, including: a lower link having a first end pivotally connected to the baseplate; an upper link having a first end pivotally connected to the top plate, wherein second ends of the first and second links are pivotally connected to each other; a second toggle linkage, including: a lower link having a first end pivotally connected to the baseplate; an upper link having a first end pivotally connected to the top plate, wherein second ends of the first and second links are pivotally connected to each other; and a connector linkage interconnecting the first and second toggle linkages.

Abstract: A knee gap tensioning apparatus includes: a tensioner-balancer, including: a baseplate; a top plate; and a linkage operable to move the top plate relative to the bottom plate between retracted and extended positions in response to application of an actuating force, the linkage including: a first toggle linkage, including: a lower link having a first end pivotally connected to the baseplate; an upper link having a first end pivotally connected to the top plate, wherein second ends of the first and second links are pivotally connected to each other; a second toggle linkage, including: a lower link having a first end pivotally connected to the baseplate; an upper link having a first end pivotally connected to the top plate, wherein second ends of the first and second links are pivotally connected to each other; and a connector linkage interconnecting the first and second toggle linkages.

Abstract: A method of evaluating soft tissue of a human joint which includes two or more bones and ligaments, wherein the ligaments are under anatomical tension to connect the bones together, creating a load-bearing articulating joint, the method includes: inserting into the joint a tensioner-balancer that includes a means of controlling a distraction force; providing an electronic receiving device; moving the joint through at least a portion of its range of motion; while moving the joint, controlling the distraction force, and collecting displacement and distraction load data of the bones; processing the collected data to produce a digital geometric model of the joint, wherein the model includes: ligament displacement data along a range of flexion angles and ligament load data along a range of flexion angles; and storing the digital geometric model for further use.

Abstract: A method of evaluating a human joint including bones and ligaments under anatomical tension to connect the bones. The method includes: defining a primary datum oriented and fixed in six degrees of freedom; defining at least one secondary datum having fixed origins relative to one of the bones of the joint and relative to a tracking device affixed to the bone; providing an electronic receiving device; associating continuous position and orientation of the at least one secondary datums with respect to the primary datum; while moving the joint, using the electronic receiving device to collect data from the at least one tracking device, wherein the data includes information describing the position and movement in six degrees of freedom of the at least one secondary datum to produce a digital geometric model of at least a portion of the joint; and storing the digital geometric model for further use.

Abstract: A method of evaluating a human knee joint which includes a femur bone, a tibia bone, a patella bone, a patellar tendon, and ligaments, wherein the ligaments and patellar tendon are under anatomical tension to connect the femur and tibia together, creating a load-bearing articulating joint, the method including: inserting into the knee joint a gap balancer that includes a tibial interface surface, an opposed femoral interface surface, and at least one force sensor, the method including: providing an electronic receiving device; moving the knee joint through at least a portion of its range of motion; while moving the knee joint, using the electronic receiving device to collect data from the at least one force sensor; processing the collected data to produce a digital geometric model of at least a portion of the knee joint; and storing the digital geometric model for further use.

Abstract: A method of evaluating a human knee joint which includes a femur bone, a tibia bone, a patella bone, a patellar tendon, and ligaments, wherein the ligaments and patellar tendon are under anatomical tension to connect the femur and tibia together, creating a load-bearing articulating joint, the method including: inserting into the knee joint a gap balancer that includes a tibial interface surface, an opposed femoral interface surface, and at least one force sensor, the method including: providing an electronic receiving device; moving the knee joint through at least a portion of its range of motion; while moving the knee joint, using the electronic receiving device to collect data from the at least one force sensor; processing the collected data to produce a digital geometric model of at least a portion of the knee joint; and storing the digital geometric model for further use.

Abstract: The present invention provides a technique for percutaneous intramedullary fixation. A protective outer sheath is provided for internal fixation of the proximal tibia. Additionally, a unique intramedullary plate is provided that is adapted for percutaneous insertion into the intramedullary canal of a long bone. A plate holder is also provided that may be utilized through the outer sheath to drive and position a fixation plate within the intramedullary canal.

Abstract: A crimp cap apparatus includes: a crimp sleeve having a peripheral wall defining an exterior surface and an interior passage sized to receive a tensile member having a predetermined outer diameter, the crimp sleeve being configured such that it can be crimped around the tensile member by an application of mechanical force which reduces its dimensions from a first size to a second, smaller size; and a cap having a bottom surface, a convex top surface, a central bore extending from the bottom surface to the top surface for receiving the crimp sleeve, wherein the cap includes a clamping structure disposed in the central bore and configured to permit elastic deflection in response to being pressed over the crimp sleeve the crimp sleeve and apply a clamping force there-to to secure the cap in place.

Abstract: A method for imparting tension across a human knee joint which includes a femur bone, a tibia bone, a patella bone, a patellar tendon, and ligaments, wherein the ligaments and patellar tendon are under anatomical tension to connect the femur and tibia together, creating a load-bearing articulating joint. The method includes: providing a tensioning device, including: a baseplate; a top plate; and a linkage interconnecting the baseplate and the top plate and operable to move the tensioning device between retracted and extended positions, wherein the top plate is pivotally connected to the linkage so as to be able to freely pivot about a pivot axis; positioning the tensioning device between the femur and the tibia; applying an actuating force to the linkage to move the tensioning device towards the extended position, so as to impart a controlled separating force driving the femur and tibia apart to extend the ligaments.

Abstract: A method of evaluating a human knee joint, includes: cutting away a proximal portion of the tibia; inserting the gap tensioner between the tibia and the femur; extending the gap tensioner urging the tibia and the femur apart and applying tension to the medial and lateral collateral ligaments; associating at least two tracking markers with the knee joint; providing an electronic receiving device operable to determine a position and orientation of each of the tracking markers relative to the electronic receiving device; moving the knee joint through at least a portion of its range of motion; while moving the knee joint, using the electronic receiving device to collect position data from the tracking markers; processing the collected position data to produce a geometric model of at least a portion of the knee joint; and computing one or more tool paths passing through the knee joint.

Abstract: A clamp for anchoring tensile members includes: a collet having a peripheral wall defining a central bore for accepting tensile members therethrough and an exterior surface, wherein the collet is configured to be swaged around the tensile members, and includes an array of longitudinal grooves defining webs configured to collapse inward in response to external compressive force; a sleeve having a peripheral wall defining interior and exterior surfaces, the sleeve positioned axially adjacent to the collet, so as to be movable parallel to a mutual central axis of the sleeve and the collet, between first and second positions; and wherein the sleeve and the collet are arranged such that movement of the sleeve from the first position to the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around the tensile members.

Abstract: A clamp for anchoring tensile members includes: a collet having a peripheral wall defining a central bore for accepting tensile members therethrough and an exterior surface, wherein the collet is configured to be swaged around the tensile members, and includes an array of longitudinal grooves defining webs configured to collapse inward in response to external compressive force; a sleeve having a peripheral wall defining interior and exterior surfaces, the sleeve positioned axially adjacent to the collet, so as to be movable parallel to a mutual central axis of the sleeve and the collet, between first and second positions; and wherein the sleeve and the collet are arranged such that movement of the sleeve from the first position to the second position will cause the interior surface of the sleeve to bear against the exterior surface of the collet, causing the collet to swage radially inwards around the tensile members.

Abstract: The present disclosure relates to a system and method of knee ligament balancing for knee replacement procedures. The disclosure provides a system of components to implant to achieve ligament balancing. In addition, instruments and methods are provided to achieve the desired balance of the ligaments before final fixation.