Electric orthopaedic tensioner and using method thereof

Abstract

Systems and methods related to orthopedic tensioners for knee joints. The tensioner is electrically powered and operates in a force control mode and a displacement control mode. A control system controls the tensioner in the force control mode to apply a force to the knee joint until a predetermined force is reached. The control system captures, from the tensioner, a plurality of force-displacement data pairs resulting from the force applied by the tensioner in the force control mode. Control of the tensioner is switched from the force control mode to the displacement control mode to perform a stretch test in which displacement of the tensioner is progressively reduced according to displacement from the plurality of force-displacement data pairs, the knee joint can reach an acceptable fully extended position during the extension test or after the completion of the extension test until the knee joint is able to reach an acceptable fully extended position during the extension test or after the completion of the extension test.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and all benefits to U.S. Provisional Patent Application No. 63 / 524,241, filed June 30, 2023, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Knee replacement surgery involves replacing the joint surfaces of the knee to restore function. An important part of a successful knee replacement involves assessing the soft tissues or ligaments of the knee joint to ensure proper joint stability, laxity, stiffness, and / or range of motion. To date, many surgeons still prefer to use traditional manual methods and devices to assess the knee ligaments.

[0004] One known device for assessing the knee joint is a knee spreader, which has one or more upper paddles for engaging the femur and a lower paddle for engaging the tibia. The paddles move apart to provide measurements related to the force or spacing between the joints. However, conventional spreaders have several drawbacks.

[0005] Conventional retractors have limited adjustability. For example, a conventional retractor may be "universal" and not configured to accommodate the various sizes of bones in the knee joint. To accommodate larger bones, these types of retractors would require a large size, increasing the difficulty of inserting the retractor into the knee joint. Some conventional retractor configurations are limited to assessing only the left or right knee, rather than both. For example, some conventional retractors include a curved paddle to avoid collision with the patellar tendon. However, the curved paddle may not be removable and is therefore designed to bypass the patellar tendon for use only in the left or right knee. To bypass the patellar tendon in both knees, some conventional designs require removing the curved paddle and replacing it with a different set of (conversely curved) paddles. Replacing these components prolongs the assessment process (during which the patient is under anesthesia) and increases complexity and cost.

[0006] Conventional retractors carry a risk of slipping off the knee joint during assessment. Slippage can potentially damage the knee, lead to inaccurate measurements, and cause inconvenience to the surgeon. This problem is particularly pronounced in intermediate resection workflows where the tibia is removed before assessment. The rigid, poorly adjustable configuration of conventional retractors limits the paddle plate's contact coverage with the corresponding bone, thus increasing the susceptibility to slippage. Alternatively, conventional retractors require invasively securing the lower paddle plate to the plane of the resected tibia to reduce slippage. Securing the lower paddle plate to the resected tibia adds an additional surgical step and trauma to the bone.

[0007] Conventional spreaders are not optimized for cleaning or disinfection. Some spreaders include exposed components such as springs, actuators, or measuring devices that require thorough disinfection and are easily damaged during the process. Disassembling the spreader components for cleaning or other purposes may be time-consuming. Disinfected components are at risk of malfunction or wear.

[0008] Most conventional retractors are not electric and cannot take advantage of computer-aided techniques such as surgical navigation and / or clinical applications. Therefore, surgeons often have to rely on their subjective knowledge and skills to predict the condition of the joint ligaments. In turn, using a conventional retractor may result in suboptimal joint assessment and surgical outcomes. A particularly challenging part of the knee assessment process involves determining the optimal degree of knee relaxation required to achieve full extension. Retracting the knee to 0 degrees (full extension) is likely to produce inaccurate measurements due to posterior capsule tension. To assess knee stretch in full extension, surgeons typically use a trial-and-error process where the surgeon inserts a manual retractor in a moderately flexed position and uses educated guesswork to set the retractor's stretch. The knee is then moved toward full extension. If full extension is not achieved, the surgeon must reset the retractor's stretch and repeat the assessment. This process prolongs the assessment, produces suboptimal results, and is inconvenient for the surgeon. Summary of the Invention

[0009] The present invention is presented in a simplified form, with the following detailed description of selected concepts. The present invention is not intended to limit the scope of the claimed subject matter, nor to define the key or essential features of the claimed subject matter.

[0010] According to a first aspect, a tensioner is provided, the tensioner being electrically powered, and wherein the tensioner is configured to operate in a force control mode to apply a force to an anatomical joint until a predetermined force is reached; capture a plurality of force-displacement data pairs generated due to the force applied by the tensioner in the force control mode; and operate in a displacement control mode wherein the displacement of the tensioner is progressively reduced based on the displacement from the plurality of force-displacement data pairs.

[0011] According to a second aspect, a method of operating a tensioner, the tensioner being electrically powered, the method comprising: operating the tensioner in a force control mode to apply a force to an anatomical joint until a predetermined force is reached; capturing a plurality of force-displacement data pairs generated by the force applied by the tensioner in the force control mode; and operating the tensioner in a displacement control mode by progressively decreasing the displacement of the tensioner based on the displacement from the plurality of force-displacement data pairs.

[0012] According to a third aspect, a surgical system is provided, the surgical system being configured to evaluate an anatomical joint, the surgical system comprising: a tensioner, the tensioner being electrically powered and configured to operate in a force control mode and a displacement control mode; and a control system configured to control the tensioner and configured to: control the tensioner in the force control mode to apply a force to the anatomical joint until a predetermined force is reached; capture from the tensioner a plurality of force-displacement data pairs generated due to the force applied by the tensioner in the force control mode; and control the tensioner in the displacement control mode, wherein the displacement of the tensioner is progressively reduced according to the displacement from the plurality of force-displacement data pairs.

[0013] According to a fourth aspect, a method is provided for evaluating an anatomical joint using a surgical system, the surgical system comprising: a tensioner, the tensioner being electrically powered and configured to operate in a force control mode and a displacement control mode; and a control system configured to control the tensioner, the method comprising: controlling the tensioner in the force control mode via the control system to apply a force to the anatomical joint until a predetermined force is reached; capturing, via the control system, a plurality of force-displacement data pairs generated by the force applied by the tensioner in the force control mode; and controlling the tensioner in the displacement control mode via the control system by progressively decreasing the displacement of the tensioner based on the displacement from the plurality of force-displacement data pairs.

[0014] According to a fifth aspect, a surgical system is provided, the surgical system being configured to evaluate a knee joint, the surgical system comprising: a tensioner, the tensioner being electrically powered and configured to operate in a force control mode and a displacement control mode; and a control system configured to control the tensioner and configured to: control the tensioner in the force control mode to apply a force to the knee joint until a predetermined force is reached; capture from the tensioner a plurality of force-displacement data pairs generated due to the force applied by the tensioner in the force control mode; and control the tensioner to switch from the force control mode to the displacement control mode, and control the tensioner in the displacement control mode to perform an extension test, wherein the displacement of the tensioner is progressively reduced according to the displacement from the plurality of force-displacement data pairs until the knee joint is able to reach an acceptable full extension posture during or after the extension test.

[0015] According to a sixth aspect, a method for evaluating a knee joint using a surgical system is provided, the surgical system comprising: a tensioner, the tensioner being electrically powered and configured to operate in a force control mode and a displacement control mode; and a control system configured to control the tensioner, the method comprising: controlling the tensioner in the force control mode via the control system to apply a force to the knee joint until a predetermined force is reached; capturing multiple force-displacement data pairs generated by the force applied by the tensioner in the force control mode via the control system; and controlling the tensioner via the control system to switch from the force control mode to the displacement control mode, and controlling the tensioner in the displacement control mode to perform an extension test by progressively decreasing the displacement of the tensioner according to the displacement from the multiple force-displacement data pairs until the knee joint is able to reach an acceptable fully extended posture during or after the extension test.

[0016] According to a seventh aspect, an orthopedic tensioner is provided, comprising: a body; an upper paddle plate movable relative to the body and configured to engage a first bone of an anatomical joint; a lower paddle plate coupled to the body and configured to engage a second bone of the anatomical joint; a drive assembly disposed within the body and including an electric motor and a displacement mechanism coupled between the electric motor and the upper paddle plate, wherein the electric motor is configured to move the displacement mechanism to linearly displace the upper paddle plate relative to the lower paddle plate; and a sensor configured to sense a force applied to the upper paddle plate, wherein the sensor is located in the displacement mechanism.

[0017] According to an eighth aspect, an orthopedic tensioner is provided, comprising: a body; an upper paddle plate movable relative to the body and configured to engage a first bone of an anatomical joint; a lower paddle plate coupled to the body and configured to engage a second bone of the anatomical joint; a drive assembly coupled to the body and including an electric motor and a displacement mechanism coupled between the electric motor and one or both of the upper and lower paddle plates, wherein the electric motor is configured to move the displacement mechanism to linearly displace the upper and / or lower paddle plates relative to each other; and a sensor configured to sense a force applied to one or both of the upper and lower paddle plates, wherein the sensor is configured to move in response to movement of the displacement mechanism.

[0018] According to a ninth aspect, an orthopedic tensioner is provided, comprising: a first body; a first set of paddles coupled to the first body, the first set of paddles including a first upper paddle movable relative to the first body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second body separate from the first body; a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a retainer configured to hold the first body and the second body relative to each other, wherein the first body is configured to rotate within the retainer to achieve rotational adjustment of the first set of paddles, and wherein the second body is configured to rotate within the retainer to achieve rotational adjustment of the second set of paddles; and wherein a locking mechanism is coupled to the retainer and configured to be actuated to rotatably lock one or both of the first body and the second body relative to the retainer.

[0019] According to a tenth aspect, a retainer for an orthopedic tensioner is provided, the retainer defining a first sleeve configured to receive a first body of the tensioner, and a second sleeve configured to receive a second body of the tensioner, wherein the retainer allows the first body to rotate within the first sleeve to achieve rotational adjustment of a first set of paddles, and allows the second body to rotate within the second sleeve to achieve rotational adjustment of a second set of paddles, wherein a locking mechanism is coupled to the retainer and configured to rotatably lock one or more of the first body and the second body relative to the retainer.

[0020] According to an eleventh aspect, an orthopedic tensioner is provided, comprising: a first body; a first set of paddles coupled to the first body, the first set of paddles including a first upper paddle movable relative to the first body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second body separate from the first body; a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a connecting portion coupled between the first body and the second body, the connecting portion including one or more joints configured to enable adjustment of the first body and the second body to enable adjustment of the first set of paddles and the second set of paddles; wherein a locking mechanism is coupled to the connecting portion and configured to be actuated to lock the one or more joints to lock the first body and the second body relative to each other.

[0021] According to a twelfth aspect, a retainer for an orthopedic tensioner is provided, the retainer defining a first sleeve configured to receive a first body of the tensioner, and a second sleeve configured to receive a second body of the tensioner, wherein the retainer includes a connecting portion coupled between the first sleeve and the second sleeve, the connecting portion including one or more connectors configured to enable adjustment of the first body and the second body to enable adjustment of a first set of paddles and a second set of paddles; wherein a locking mechanism is coupled to the connecting portion and configured to be actuated to lock the one or more connectors to lock the first body and the second body relative to each other.

[0022] According to a thirteenth aspect, an assembly is provided for evaluating an anatomical joint including a first bone and a second bone, the assembly comprising: an orthopedic tensioner including a lower paddle plate and an upper paddle plate and a drive assembly configured to move the upper paddle plate relative to the lower paddle plate; and an auxiliary paddle plate configured to be inserted between the upper paddle plate and the lower paddle plate and captured by the upper paddle plate and the lower paddle plate, wherein the auxiliary paddle plate includes a distal portion extending beyond the distal end of each of the upper paddle plate and the lower paddle plate after the auxiliary paddle plate is captured, wherein the distal portion is configured to contact the first bone and the second bone of the anatomical joint.

[0023] According to a fourteenth aspect, a method is provided using an assembly for evaluating an anatomical joint including a first bone and a second bone, the assembly comprising: an orthopedic tensioner including a lower paddle plate and an upper paddle plate and a drive assembly for moving the upper paddle plate relative to the lower paddle plate; and an auxiliary paddle plate including a distal portion, the method comprising: inserting the auxiliary paddle plate between the upper paddle plate and the lower paddle plate; controlling the orthopedic tensioner to move the upper paddle plate toward the lower paddle plate while the auxiliary paddle plate is inserted between the upper paddle plate and the lower paddle plate; capturing the auxiliary paddle plate between the upper paddle plate and the lower paddle plate such that the distal portion of the auxiliary paddle plate extends beyond the distal ends of each of the upper paddle plate and the lower paddle plate; and using the distal portion of the auxiliary paddle plate to contact the first bone and the second bone of the anatomical joint.

[0024] According to a fifteenth aspect, an auxiliary paddleboard is provided for use with an orthopedic tensioner to evaluate an anatomical joint including a first bone and a second bone, the orthopedic tensioner including a lower paddleboard and an upper paddleboard and a drive assembly for moving the upper paddleboard relative to the lower paddleboard, wherein the auxiliary paddleboard includes: a body configured to be inserted between the upper paddleboard and the lower paddleboard of the orthopedic tensioner and captured by the upper paddleboard and the lower paddleboard; and a distal portion coupled to the body and configured to extend beyond the distal end of each of the upper paddleboard and the lower paddleboard, wherein the distal portion is configured to contact the first bone and the second bone of the anatomical joint.

[0025] According to the sixteenth aspect, an auxiliary paddleboard configured for use with an orthopedic tensioner is provided, wherein the auxiliary paddleboard comprises: a body; a distal portion coupled to the body and configured to contact unresected surfaces of a first and second bone of an anatomical joint; and a pivot disposed on the body and / or coupled to the distal portion.

[0026] According to a seventeenth aspect, an orthopedic tensioner is provided, comprising: a body; an upper paddle plate coupled to the body and configured to engage a first bone of an anatomical joint; a lower paddle plate coupled to the body and configured to engage a second bone of the anatomical joint; and a load cell configured to sense a force applied to one of the upper or lower paddle plates, wherein the load cell is incorporated into the one of the upper or lower paddle plates.

[0027] According to the eighteenth aspect, a paddle for an orthopedic tensioner is provided, the paddle comprising: a paddle base configured to be removably attached to the orthopedic tensioner; a paddle surface extending from the base and configured to engage the bone of the anatomical joint; and a load cell configured to sense a force applied to the paddle, wherein the load cell is incorporated into the paddle base or the paddle surface.

[0028] According to a nineteenth aspect, an orthopedic tensioner assembly is provided, comprising: a first body; a first set of paddles coupled to the first body, the first set of paddles including a first upper paddle movable relative to the first body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second body coupled to the first body; a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a spacer configured to be coupled to a paddle in the first set of paddles or the second set of paddles.

[0029] According to a twentieth aspect, a surgical system configured to assess a knee joint is provided, the surgical system comprising: a tensioner including a body supporting a first paddle and a second paddle configured to interact with the knee joint; a sensing system configured to sense: a force applied to at least one of the first paddle and the second paddle, and / or a displacement between the first paddle and the second paddle; and a control system coupled to the tensioner, the control system configured to: obtain sensed values ​​of the force and / or the displacement from the sensing system; use the sensed values ​​to predict the deflection of one or both of the first paddle and the second paddle; and update the sensed values ​​based on the predicted deflection.

[0030] Computer-implemented methods and / or computer program products (or non-transitory computer-readable media) are provided for operating or being configured to operate any aspect of any surgical system, tensioner, component, or paddleboard.

[0031] Any aspect of the above can be combined, in whole or in part, with any other aspect. Any aspect of the above can be combined, in whole or in part, with any of the following implementations:

[0032] The control system can be configured to control the tensioner in the force control mode to apply a force to the knee joint until the predetermined force is reached when the current pose of the knee joint is in a first acceptable flexion pose. The knee joint includes a femur and a tibia, and the surgical system may include a locator and a display device, wherein the control system may: track the pose of the femur and the tibia via the locator; control the display device to provide visual guidance to help position the current pose of the knee joint in the first acceptable flexion pose; capture the current pose of the knee joint relative to the first acceptable flexion pose via the locator; and / or control the display device to provide visual confirmation in response to the current pose of the knee joint being in the first acceptable flexion pose. The first acceptable flexion pose may be a value between 2 and 15 degrees of knee flexion, such as 10 degrees. The control system may control the display device to provide a visual representation of the current pose of the knee joint based on the pose of the femur and the tibia tracked by the locator. The control system can measure the knee joint gap based on the pose of the femur and the tibia tracked by the locator. The control system can capture the current pose of the knee joint relative to the acceptable full extension pose via the locator, and / or control the display device to provide visual confirmation in response to the current pose of the knee joint being in the acceptable full extension pose. The acceptable full extension pose can be a knee flexion value from 0 to 2 degrees, such as 0 degrees. The control system can generate a lookup table based on the plurality of force-displacement data pairs captured from the tensioner, and / or perform the extension test based on the displacement from the lookup table. The control system can capture a target displacement of the tensioner at the time when the predetermined force is reached, the target displacement indicating the target gap of the knee joint. Before performing the extension test, the control system can control the tensioner in the displacement control mode by progressively decreasing the displacement of the tensioner from the target displacement to position the tensioner at the target displacement and / or perform the extension test. The control system can perform the extension test by automatically and progressively reducing the displacement of the tensioner and optionally based on the displacement from the plurality of force-displacement data pairs. The tensioner may include user control inputs, such as control buttons or sliders. The control system can perform the extension test by progressively reducing the displacement of the tensioner in response to the user control inputs and optionally based on the displacement from the plurality of force-displacement data pairs. During or after the extension test, the control system may identify a first force-displacement data pair that enables the knee joint to achieve the acceptable fully extended posture.After the extension test is completed, the control system can control the tensioner to switch from the displacement control mode to the force control mode, and optionally control the tensioner in the force control mode to apply a second predetermined force to the knee joint when the knee joint is in a second acceptable flexion position. The control system can control the tensioner in the force control mode to apply a second predetermined force to the knee joint when the knee joint is in a second acceptable flexion position. The control system can control the display device to provide visual guidance to help position the current posture of the knee joint into the second acceptable flexion position, and / or capture the current posture of the knee joint relative to the second acceptable flexion position, and / or control the display device to provide visual confirmation in response to the current posture of the knee joint being in the second acceptable flexion position. The second acceptable flexion position can be a knee flexion value from 80 degrees to 105 degrees, such as 90 degrees. The control system can obtain the second predetermined force from the force from the first force-displacement data pair that enables the knee joint to reach the acceptable full extension posture. The control system may obtain the second predetermined force from one of the following: a predetermined joint balance force, a force based on surgeon preference, a force obtained from statistical data, or a force from any force-displacement data pair. While the knee joint is in the second acceptable flexion position, and during or after the application of the second predetermined force to the knee joint, the control system may capture the second force-displacement data pair from the tensioner. The control system may determine parameters of the knee joint based on the first force-displacement data pair that brings the knee joint to the acceptable full extension position and based on the second force-displacement data pair identified when the knee joint is in the second acceptable flexion position. These parameters may be relaxation parameters, such as the relaxation of the medial and lateral compartments of the knee joint. The knee joint may include a femur having a medial condyle and a lateral condyle, and a tibia, wherein the tensioner further includes: a medial upper paddle plate and a lateral upper paddle plate, and at least one lower paddle plate, the medial upper paddle plate and the lateral upper paddle plate being separably movable and respectively engaging the medial condyle and the lateral condyle of the femur, and the at least one lower paddle plate engaging the tibia. In one example, a first lower paddle plate of the first body and a second lower paddle plate of the second body jointly engage the tibia. The tensioner may include a drive assembly including a first electric motor and a first displacement mechanism coupled between the first electric motor and the medial upper paddle plate. The tensioner may include a second electric motor and a second displacement mechanism coupled between the second electric motor and the lateral upper paddle plate. The tensioner may include a first sensor for sensing the force applied to the medial upper paddle plate.The tensioner may include a second sensor for sensing the force applied to the lateral upper paddle. The control system can control the tensioner in the force control mode by commanding the medial upper paddle and the lateral upper paddle to apply forces to the medial and lateral condyles of the femur, respectively, until a predetermined force is reached against one or both of the medial and lateral upper paddles. The control system can further capture the plurality of force-displacement data pairs based on measurements from the first and second sensors and the displacements of the medial and lateral upper paddles. The control system can control the tensioner in the displacement control mode to perform the extension test by progressively decreasing the displacements of the medial upper paddle and the lateral upper paddle according to the displacements from the plurality of force-displacement data pairs.

[0033] The sensor may include one or more of the following: a load cell, a strain gauge, a pressure sensor, a displacement sensor, a Hall effect sensor, an encoder, etc. The sensor can move in response to the movement of the displacement mechanism. The displacement mechanism may include a ball screw connected to and rotatable by the electric motor. The displacement mechanism may include a ball screw nut engaging the ball screw. The ball screw nut can linearly shift along the ball screw in response to the rotation of the ball screw by the electric motor. The displacement mechanism may include a ball spline shaft fixed to the ball screw nut and to the upper paddle. The ball spline shaft can linearly shift in response to the movement of the ball screw nut. The ball spline shaft may include a threaded interface for receiving fasteners. Various upper paddles of different sizes may be attached to the tensioner, such as by fastening the ball spline shaft. The tensioner may receive multiple lower paddles of different sizes. The sensor may be located between the ball screw nut and the ball spline shaft, or between any other component of the displacement mechanism (such as any component located within the load path of the force applied to the upper paddle). The displacement mechanism may include a connector disposed between the ball screw nut and the ball spline shaft. The connector may be threaded to the ball screw nut. The connector may be fixed to the ball spline shaft. The sensor may be located between the connector and the ball screw nut. The sensor may be annular or disc-shaped. The sensor may be disposed around the ball screw. The body of the tensioner may be hermetically sealed. The body may be a first body, and the tensioner may include a second body that may be coupled relative to the first body. The upper paddle may be movable relative to the second body and may engage the first bone of the anatomical joint. The lower paddle may be coupled to the second body and may engage the second bone of the anatomical joint. The drive assembly may be disposed within the second body and may include an electric motor and a displacement mechanism coupled between the electric motor and the upper paddle, wherein the electric motor causes the displacement mechanism to move so that the upper paddle is linearly displaced relative to the lower paddle. A sensor is capable of sensing the force applied to the upper paddle, wherein the sensor is located within the displacement mechanism of the second body. The first body may be hermetically sealed. The second body may be hermetically sealed independently of the first body. The first body and the second body may be completely separable from each other.

[0034] A retainer can engage the first body and the second body relative to each other. The retainer can release the first body and the second body from the retainer, allowing them to separate from each other. The retainer may define a first sleeve for receiving the first body. The retainer may define a second sleeve for receiving the second body. The first sleeve and the second sleeve may each have a cylindrical configuration to hold a cylindrical portion of the first body and a cylindrical portion of the second body, respectively. The sleeve may have any other shape (such as ellipse, rectangle, triangle, polygon, etc.) conforming to the correspondingly shaped outer surfaces of the first body and the second body. Each of the first body and the second body may have circumferential, annular, or peripheral features that can engage the first sleeve and the second sleeve, respectively, to axially lock the first body and the second body relative to the retainer. The locking mechanism may include a first locking mechanism coupled to the first sleeve and actuated to rotatably lock the first body to the first sleeve. The locking mechanism may include a second locking mechanism coupled to the second sleeve and actuated to rotatably lock the second body to the second sleeve. Each of the first and second sleeves may include an adjustable size, opening, width, length, or diameter. The locking mechanism may be actuated to simultaneously reduce the size, opening, width, length, or diameter of the first sleeve to rotatably lock the first and second bodies relative to the retainer. The retainer may be split into a first portion and a second portion. Each of the first and second portions may partially define the first and second sleeves. The locking mechanism may be actuated to bring the first and second portions of the retainer closer together to simultaneously and rotatably lock the first and second bodies relative to the retainer. Each of the first and second portions may define internal teeth. Each of the first and second bodies may define external teeth. The locking mechanism may be actuated to bring the first and second portions closer together such that the internal teeth engage with the external teeth to simultaneously and rotatably lock the first and second bodies relative to the retainer. The retainer may include a first sleeve and a second sleeve spaced apart from each other, and a connecting portion connecting the first sleeve and the second sleeve. The connecting portion may be rigidly fixed between the first sleeve and the second sleeve. The first sleeve and the second sleeve may be fixed relative to each other. The connecting portion may be adjustable.The connecting portion may include a rotary joint capable of enabling rotational movement between the first sleeve and the second sleeve, and / or a prismatic joint capable of enabling translational movement between the first sleeve and the second sleeve. The locking mechanism or a separate locking mechanism may be actuated to lock the connecting portion. The locking mechanism or a separate locking mechanism may be coupled to the one or more joints. When the connecting portion includes one or more rotary joints, the rotary joints enable rotational adjustment of the first body and the second body to enable rotational adjustment of the first set of paddles and the second set of paddles, and the locking mechanism may be actuated to lock the one or more rotary joints to lock the first body and the second body rotationally relative to each other. When the connecting portion includes one or more translational joints, the translational joints enable translational adjustment of the first body and the second body to enable translational adjustment of the first set of paddles and the second set of paddles, and the locking mechanism may be actuated to lock the one or more translational joints to lock the first body and the second body translationally relative to each other. The one or more joints may be ball joints or universal joints. The locking mechanism may be at least one knob disposed outside the retainer and rotatable in a first direction to rotatably lock the first body and the second body relative to the retainer, and rotateable in a second direction to rotatably unlock one or both of the first body and the second body relative to the retainer. The locking mechanism may be at least one lever disposed outside the retainer and movable in a first direction to rotatably lock one or both of the first body and the second body relative to the retainer, and movable in a second direction to rotatably unlock one or both of the first body and the second body relative to the retainer. The locking mechanism may be at least one button disposed outside the retainer and actuated to rotatably lock one or both of the first body and the second body relative to the retainer, and / or actuated to rotatably unlock one or both of the first body and the second body relative to the retainer. The first electric motor can move the first displacement mechanism to linearly displace the first upper paddle relative to the first lower paddle along a first axis, and the first body can rotate within the retainer about the first axis. The second electric motor can move the second displacement mechanism to linearly shift the second upper blade relative to the second lower blade along the second axis, and the second body can rotate about the second axis within the retainer.

[0035] The orthopedic tensioner may include an auxiliary paddleboard as part of a kit or assembly. The orthopedic tensioner may command the upper paddleboard and / or the lower paddleboard to move relative to each other to capture the auxiliary paddleboard between the upper and lower paddleboards. The auxiliary paddleboard may be secured to the orthopedic tensioner solely by being captured between the upper and lower paddleboards. The orthopedic tensioner may operate in a force control mode to capture the auxiliary paddleboard. The orthopedic tensioner may include a force sensor to sense the force applied to the upper paddleboard. In the force control mode, the orthopedic tensioner may command the upper paddleboard to move toward the lower paddleboard until the force sensor detects a predetermined force. The predetermined force may indicate that the auxiliary paddleboard is properly captured between the upper and lower paddleboards. In response to the distal portion contacting the first and second bones, the auxiliary paddleboard may apply a force to the upper paddleboard. The force sensor may sense the force applied by the auxiliary paddleboard to the upper paddleboard. The orthopedic tensioner can operate in a displacement control mode to capture the auxiliary paddleboard. The orthopedic tensioner may include a displacement sensor to sense displacement between the upper and lower paddleboards. In the displacement control mode, the orthopedic tensioner can command the upper paddleboard to move toward the lower paddleboard until the displacement sensor detects a predetermined displacement between the upper and lower paddleboards. The predetermined displacement indicates that the auxiliary paddleboard is properly captured between the upper and lower paddleboards. In response to the distal portion contacting the first and second bones, the auxiliary paddleboard can apply a force to the upper paddleboard, and the displacement sensor can measure the displacement between the upper and lower paddleboards resulting from the force applied by the auxiliary paddleboard to the upper paddleboard. The auxiliary paddleboard can pivot in response to the distal portion contacting the first and second bones to apply a force to the upper paddleboard. The auxiliary paddleboard may include a rocker surface. The rocker surface may be profiled or curved and may engage the lower paddle. The rocker surface allows the auxiliary paddle to pivot in response to contact of the distal portion with the first and second bones. The auxiliary paddle may include a top surface opposite to the rocker surface. The top surface may be planar and configured to engage the upper paddle. The distal portion of the auxiliary paddle, the rocker surface, and the top surface may be a single, integral, or monolithic part of a body. The distal portion of the auxiliary paddle may include an auxiliary distal upper paddle configured to contact the upper paddle and the first bone, and the distal portion of the auxiliary paddle may include an auxiliary distal lower paddle configured to contact the lower paddle and the second bone.The auxiliary distal upper paddleboard is capable of pivoting relative to the auxiliary distal lower paddleboard in response to contact of the distal portion with the first and second bones to apply force to the upper paddleboard. The upper paddleboard of the tensioner is designed to contact the first bone, and the lower paddleboard of the tensioner is designed to contact the second bone. When the auxiliary paddleboard is engaged, the distal portion of the auxiliary paddleboard provides an alternative for contacting the first and second bones by the upper and lower paddleboards. The first and second bones of the anatomical joint may be unresected bones, and the lower paddleboard is designed to engage the resected surface of the second bone. The auxiliary paddleboard provides an alternative for the unresected surface of the lower paddleboard engaging the second bone. The upper paddleboard of the tensioner has a bottom surface configured to engage the auxiliary paddleboard. The lower paddleboard has a top surface configured to engage the auxiliary paddleboard. The bottom surface of the upper paddleboard and the top surface of the lower paddleboard cooperate to engage the auxiliary paddleboard. The upper and lower paddles of the tensioner each have a length defined between a proximal end and a distal end. An auxiliary paddle has a length defined between its proximal end and the distal end of the distal portion, wherein the length of the auxiliary paddle may be greater than the length of the upper paddle and greater than the length of the lower paddle. The auxiliary paddle may include a body portion that rests on the lower paddle. The body portion may have a shape substantially conforming to the shape of the lower paddle. The tensioner body may be used in an inverted or upside-down orientation. The tensioner body may have an inverted or upside-down configuration, wherein the upper paddle pulls upward rather than pushes upward on the femur. A spacer may be selectively coupled to any paddle in any tensioner configuration.

[0036] The inventors have envisioned that any of the above implementations can be combined, in whole or in part, with any aspect described herein. Attached Figure Description

[0037] The advantages of this disclosure will become readily apparent as they are considered with reference to the following detailed description and in conjunction with the accompanying drawings.

[0038] Figure 1 It is a perspective view of a surgical system including an orthopedic tensioner according to one implementation method.

[0039] Figure 2 This is a block diagram of an example control system used to control a surgical system.

[0040] Figure 3 This is a perspective view of a tensioner based on one implementation method.

[0041] Figure 4 This is a perspective view of a tensioner inserted into the knee joint according to one implementation method.

[0042] Figure 5 It is a partial cross-sectional side view of a body of a tensioner in one implementation, wherein the paddle is positioned in a closed position.

[0043] Figure 6 It is a partial cross-sectional side view of a body of a tensioner with the paddleboard positioned in the open position according to one implementation.

[0044] Figure 7 This is a block diagram of an example control system for controlling a tensioner, based on one implementation method.

[0045] Figure 8 This is an assembled perspective view of two bodies of a tensioner according to one implementation method, the two bodies being inserted into a retainer.

[0046] Figure 9 It is a perspective view of two bodies of a tensioner according to one implementation, the two bodies being inserted into a retainer and configured to rotate within the retainer.

[0047] Figure 10 It is a top view of a tensioner body according to one implementation, the tensioner body being disposed within a retainer, wherein the body and its corresponding paddle are rotated into a first configuration.

[0048] Figure 11 It is a top view of a tensioner body according to one implementation, wherein the tensioner body is disposed within a retainer, and the body and its corresponding paddle are rotated into a second configuration.

[0049] Figure 12 It is a top view of a tensioner body and its corresponding paddles according to one implementation, the tensioner body and its corresponding paddles being disposed on the resected tibia of the right knee and rotated into a first configuration such that a set of paddles can bypass the patellar tendon.

[0050] Figure 13 It is a top view of a tensioner body and its corresponding paddles according to one implementation, the tensioner body and its corresponding paddles being disposed on the resected tibia of the left knee and rotated into a second configuration so that the two sets of paddles can bypass the patellar tendon.

[0051] Figure 14 This is a perspective view of one configuration of a retainer for a tensioner body. According to one implementation, the retainer includes a locking mechanism and a separable retainer portion, the locking mechanism including a knob.

[0052] Figure 15 It is based on one implementation method. Figure 14The diagram shows a top view of the retainer, which illustrates the retainer portions being separated into an open state, and illustrates the actuation of the locking mechanism to bring the retainer portions closer together.

[0053] Figure 16 It is based on one implementation method. Figure 14 A top-view diagram of the retainer, showing the retainer portion positioned in a closed state via a locking mechanism.

[0054] Figure 17 This is a perspective view of another configuration of the retainer for the tensioner body. According to one implementation, the retainer includes a locking mechanism and a separable retainer portion, the locking mechanism including a lever.

[0055] Figure 18 It is based on one implementation method. Figure 17 The diagram shows a retainer portion separated into an open state, and illustrates a locking mechanism actuated to bring the retainer portions closer together.

[0056] Figure 19 It is based on one implementation method. Figure 17 A top-view diagram of the retainer, showing the retainer portion positioned in a closed state via a locking mechanism.

[0057] Figure 20 It is a top-view illustration of a retainer configuration disposed around a tensioner body according to one implementation, wherein the retainer portion is separated into an open state, and the retainer portion and the tensioner body include corresponding teeth for engaging with each other.

[0058] Figure 21 It is based on one implementation method. Figure 20 A top-view illustration of the configuration shows the retainer portion positioned in a closed state by a locking mechanism, with corresponding teeth engaging to rotatably lock the tensioner body to the retainer.

[0059] Figure 22 This is a top-view illustration of a retainer configuration according to one implementation, the retainer comprising separately and independently movable sleeves, each sleeve including a dedicated locking mechanism.

[0060] Figure 23 This is a top-view illustration of a configuration of a holding device for holding a tensioner body according to one implementation. The holding device includes an adjustable connection portion having a translational joint connected between sleeves, and wherein the holding device holds the sleeves in a laterally spaced configuration.

[0061] Figure 24It is based on one implementation method. Figure 23 A top-view illustration of the configuration shows the retaining mechanism in a laterally closed state and the locking mechanism for locking the translation joint of the connecting portion.

[0062] Figure 25 This is a top-view illustration showing a configuration of a holding device for holding a tensioner body according to one implementation. The holding device includes an adjustable connection portion having a rotary joint connected between sleeves, and wherein the holding device holds the sleeves in a rotationally neutral state.

[0063] Figure 26 It is based on one implementation method. Figure 25 The diagram shows a top view of the configuration, which illustrates the retaining mechanism in a lateral adjustment state and the locking mechanism of the rotary joint for locking the connecting part.

[0064] Figure 27 It is a perspective view of an auxiliary paddleboard configured for use with a tensioner according to one implementation method.

[0065] Figure 28 yes Figure 27 Side view of the auxiliary paddleboard (partially in dashed lines).

[0066] Figure 29 It is a perspective view of an assembly including an auxiliary paddleboard according to one implementation, wherein the auxiliary paddleboard is inserted between an upper paddleboard and a lower paddleboard of a tensioner body.

[0067] Figure 30 It is based on one implementation method. Figure 29 A perspective view of the components, showing an auxiliary paddleboard trapped between the paddleboards of the tensioner body, and the distal portion of the auxiliary paddleboard for manipulating the femur and tibia of the knee joint.

[0068] Figure 31 It is a perspective view of an assembly including an auxiliary paddleboard according to one implementation, the auxiliary paddleboard being inserted between an upper paddleboard and a lower paddleboard of a tensioner body, wherein the paddleboard of the tensioner body is in an open state and the hinged auxiliary distal paddleboard included in the auxiliary paddleboard is in a closed state.

[0069] Figure 32 It is based on one implementation method. Figure 32 A perspective view of the components, in which the paddle of the tensioner body is in the closed state and the hinged auxiliary distal paddle is in the open state.

[0070] Figure 33 This is a flowchart of a method for controlling a tensioner according to one implementation.

[0071] Figure 34 This is the first part of a flowchart illustrating another method for evaluating anatomical joints using a tensioner, based on one implementation approach.

[0072] Figure 35 This is the second part of a flowchart illustrating a method for evaluating anatomical joints using a tensioner, based on one implementation approach.

[0073] Figure 36 This is the third part of a flowchart illustrating a method for evaluating anatomical joints using a tensioner, based on one implementation approach.

[0074] Figure 37 This is a flowchart of another method for evaluating anatomical joints using a tensioner, based on one implementation approach.

[0075] Figure 38 A first example of a graphical user interface provided on a display device according to one implementation is shown, the display device being used in conjunction with a tensioner and its usage method.

[0076] Figure 39 A second example of a graphical user interface provided on a display device according to one implementation is shown, which can be used together with a tensioner and its usage method.

[0077] Figure 40 A third example of a graphical user interface provided on a display device according to one implementation is illustrated, the display device being used together with the tensioner and its usage method.

[0078] Figure 41 A fourth example of a graphical user interface provided on a display device according to one implementation is shown, the display device being used together with the tensioner and its usage method.

[0079] Figure 42A This is a side view of the paddle plate of a tensioner, which is an example of a load element for measuring forces on a paddle plate according to one implementation method, wherein the paddle plate is shown as stationary and deflected under load.

[0080] Figure 42B This is a side view of the paddle of a tensioner, which is another example of a load element used to measure the force on the paddle according to another implementation, where the paddle is shown as stationary and deflected under load.

[0081] Figure 43 This is a side view of a tensioner according to one implementation, in which spacers are configured to be attached to the paddles to increase the spread distance range.

[0082] Figure 44 It is based on one implementation method. Figure 9A perspective view of a tensioner used in an inverted or upside-down orientation, wherein the upper paddle plate engages the tibia and the lower paddle plate engages the femur.

[0083] Figure 45 It is a perspective view of a tensioner body according to one implementation, the tensioner body including an inverted or upside-down configuration, wherein the paddle is located near the bottom of the tensioner body, rather than near the top of the tensioner body. Detailed Implementation

[0084] I. Example System Overview

[0085] refer to Figure 1 An example of a surgical system 10 is shown. System 10 can be used to treat or assess a surgical site or anatomical volume (A) of a patient 12, such as treating bone or soft tissue. Figure 1 In the middle, patient 12 is undergoing surgical procedures. Figure 1 The anatomical structures included are the femoral F and tibial TIB of patient 12. Surgical procedures may involve tissue removal or other forms of treatment. Treatment may include cutting, coagulation, damaging tissue, other in situ tissue treatments, etc. In some examples, surgical procedures involve partial or total knee or hip replacement surgery, shoulder replacement surgery, spinal surgery, or ankle surgery. In some examples, system 10 is designed to remove material to be replaced by a surgical implant, such as hip and knee implants, including single-compartment knee implants, double-compartment knee implants, multi-compartment knee implants, or total knee implants. Some of these types of implants are illustrated in U.S. Patent Application Publication 2012 / 0330429 entitled “Prosthetic Implant and Method of Implantation,” the disclosure of which is hereby incorporated by reference. The system 10 and techniques disclosed herein can be used to perform other surgical or non-surgical procedures, or for industrial or other applications utilizing robotic systems.

[0086] System 10 includes a manipulator 14. The manipulator 14 has a base 16 and a plurality of links 18. A manipulator trolley 17 supports the manipulator 14, such that the manipulator 14 is fixed to the manipulator trolley 17. The links 18 together form one or more arms of the manipulator 14. The manipulator 14 may have a tandem arm configuration (e.g., Figure 1 (as shown), parallel arm configuration, or any other suitable manipulator configuration. In other examples, more than one manipulator 14 may be used in a multi-arm configuration.

[0087] exist Figure 1In the example shown, the manipulator 14 includes multiple joints J and multiple joint encoders 19 located at the joints J for determining the position data of the joints J. For simplicity, in Figure 1 Only one joint encoder 19 is illustrated, although other joint encoders 19 may be illustrated similarly. According to one example, the manipulator 14 has six joints J1 to J6, which implement at least six degrees of freedom (DOF) of the manipulator 14. However, the manipulator 14 may have any number of degrees of freedom and may have any suitable number of joints J and may have redundant joints.

[0088] Manipulator 14 does not necessarily require joint encoder 19, but may instead utilize motor encoders present on the motors at each joint J. Furthermore, manipulator 14 does not necessarily require rotary joints, but may instead utilize one or more movable joints. Any suitable combination of joint types is contemplated.

[0089] The base 16 of the manipulator 14 is part of a fixed reference coordinate system that provides a reference coordinate system for the manipulator 14 or, in general, other components of the system 10. The origin of the manipulator coordinate system MNPL is defined at the fixed reference point of the base 16. The base 16 may be defined relative to any suitable part of the manipulator 14, such as one or more of the links 18. Alternatively or additionally, the base 16 may be defined relative to the manipulator trolley 17, such as at the location where the manipulator 14 is physically attached to the manipulator trolley 17. In one example, the base 16 is defined at the intersection of the axes of joints J1 and J2. Thus, although joints J1 and J2 are moving parts in reality, the intersection of the axes of joints J1 and J2 remains a virtual fixed reference pose that provides both fixed position and orientation references and does not move relative to the manipulator 14 and / or the manipulator trolley 17. In other examples, the manipulator 14 may be a handheld manipulator, wherein the base 16 is the base portion of the tool (e.g., the portion held by the user's hand) and the tool tip is movable relative to the base portion. The base portion has a tracked reference coordinate system, and the tool tip has a tool tip coordinate system calculated relative to the reference coordinate system (e.g., calculated via motor and / or joint encoders and forward kinematics). The movement of the tool tip can be controlled to follow a path because its pose relative to the path can be determined.

[0090] Manipulator 14 and / or manipulator cart 17 house manipulator controller 26 or other types of control units. Manipulator controller 26 may include one or more computers, or any other suitable form of controller that directs the movement of manipulator 14. Manipulator controller 26 may have a central processing unit (CPU) and / or other processors, memory (not shown), and storage devices (not shown). Manipulator controller 26 is loaded with software as described below. The processor may include one or more processors for controlling the operation of manipulator 14. The processor may be any type of microprocessor, multiprocessor, and / or multicore processing system. Manipulator controller 26 may additionally or alternatively include: one or more microcontrollers, field-programmable gate arrays, systems-on-a-chip, discrete circuitry, and / or other suitable hardware, software, or firmware capable of implementing the functions described herein. The term processor is not intended to limit any implementation to a single processor. Manipulator 14 may also include a user interface UI having one or more displays and / or input devices (e.g., push buttons, keyboards, mice, microphones (voice-activated), gesture controls, touchscreens, etc.).

[0091] Tool 20 is coupled to manipulator 14 and is movable relative to base 16 to interact with anatomical structures in certain modes. Tool 20 is a physical and surgical tool and, in some implementations, is or forms part of an end effector 22 supported by manipulator 14. Tool 20 can be gripped by a user. One possible arrangement of manipulator 14 and tool 20 is described in U.S. Patent No. 9,119,655, entitled “Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes,” the disclosure of which is incorporated herein by reference. Manipulator 14 and tool 20 may be arranged in alternative configurations. Tool 20 may be similar to the tool shown in U.S. Patent Application Publication 2014 / 0276949, entitled “End Effector of a Surgical Robotic Manipulator,” filed March 15, 2014, which is incorporated herein by reference.

[0092] Tool 20 may include an energy applicator 24 designed to contact, assess, or remove tissue from patient 12 at a surgical site. In one example, energy applicator 24 is a drill 25. Drill 25 may be substantially spherical and include a spherical center, radius (r), and diameter. Alternatively, energy applicator 24 may be a drill bit, saw blade, ultrasonic vibrating tip, etc. In other examples, tool 20 does not include an energy applicator 24. For example, tool 20 may be a grooving guide for sawing, a guide tube for receiving another tool, etc.

[0093] Tool 20 may include a tool controller to control the operation of tool 20, such as controlling the power supplied to the tool (e.g., power supplied to a rotary motor of tool 20), controlling the movement of tool 20, controlling flushing / suction and / or similar operations of tool 20. The tool controller may communicate with manipulator controller 26 or other components. Tool 20 may also include a user interface (UI) with one or more displays and / or input devices (e.g., push buttons, keyboards, mice, microphones (voice-activated), gesture controls, touchscreens, etc.). For example, one of the user input devices on the user interface UI of tool 20 may be a tool input device (e.g., a switch or other form of user input device) having a first input state and a second input state (see...). Figure 1 ).

[0094] System 10 also includes a navigation system 32. An example of the navigation system 32 is described in U.S. Patent No. 9,008,757, filed September 24, 2013, entitled “Navigation System Including Optical and Non-Optical Sensors,” which is incorporated herein by reference. The navigation system 32 tracks the movement of various objects. Such objects include, for example, manipulators 14, tools 20, and anatomical structures (e.g., the femur F and tibia TIB). The navigation system 32 tracks these objects to acquire state information for each object relative to the (navigation) locator coordinate system LCLZ. Transformations can be used to transform the coordinates in the locator coordinate system LCLZ to the manipulator coordinate system MNPL and / or vice versa.

[0095] The navigation system 32 may include a trolley assembly 34 that houses a trolley assembly of a navigation controller 36 and / or other types of control units. A navigation user interface (UI) operatively communicates with the navigation controller 36. The navigation user interface includes one or more displays 38. The navigation system 32 is capable of displaying a graphical representation of the relative state of a tracked object to a user using one or more displays 38. The navigation user interface (UI) also includes one or more input devices to input information into the navigation controller 36 or otherwise select / control certain aspects of the navigation controller 36. Such input devices include interactive touchscreen displays. However, input devices may include any one or more of push buttons, keyboards, mice, microphones (voice-activated), gesture controls, etc. In some cases, the display 38 may be a head-mounted device, which includes a display located in front of the user's eyes. The head-mounted device may be configured to present mixed reality or augmented reality computer images over real images of objects or surgical sites. The head-mounted device may display any of the media described herein and may be similar to the device described in U.S. Patent No. 10,499,997 entitled “Systems and Methods for Surgical Navigation,” the entire contents of which are hereby incorporated by reference.

[0096] The navigation system 32 also includes a navigation locator 44 coupled to the navigation controller 36. In one example, the locator 44 is an optical locator and includes a camera unit 46. The camera unit 46 has an external housing 48 that houses one or more optical sensors 50. The locator 44 may include its own locator controller 49 and may also include a camera VC.

[0097] Navigation system 32 may include one or more trackers. In one example, the trackers include a pointer tracker PT, one or more manipulator trackers 52A, 52B, 52C, a first patient tracker 54, and a second patient tracker 56. Figure 1In the illustrated example, the manipulator tracker is coupled to tool 20 (i.e., tracker 52A), the first patient tracker 54 is securely attached to the femur F of patient 12, and the second patient tracker 56 is securely attached to the tibia TIB of patient 12. In this example, patient trackers 54 and 56 are securely attached to segments of the bone. A pointer tracker PT is securely attached to a pointer P, which is used to align anatomical structures to the locator coordinate system LCLZ. Manipulator trackers 52A, 52B, and 52C may be attached to any suitable component of manipulator 14 other than tool 20, such as base 16 (i.e., tracker 52B), or any one or more links 18 of manipulator 14 (i.e., tracker 52C). Trackers 52, 54, 56, and PT may be secured to their respective components in any suitable manner. For example, the tracker can be rigidly fixed, flexibly connected (fiber optic), or not physically connected at all (ultrasound), as long as there is a suitable (supplementary) way to determine the relationship (measurement result) between the respective tracker and the object associated with it.

[0098] Any one or more of the trackers may include an active marker 58. The active marker 58 may include a light-emitting diode (LED). Alternatively, trackers 52, 54, 56, and PT may have passive markers, such as reflectors that reflect light emitted from camera unit 46. Other suitable markers not specifically described herein may be used.

[0099] Positioner 44 tracks trackers 52, 54, 56, and PT to determine the state of each of the trackers, each state corresponding to the state of the object to which it is attached. Positioner 44 can perform known triangulation techniques to determine the state of trackers 52, 54, 56, PT, and the associated object. Positioner 44 provides the states of trackers 52, 54, 56, and PT to navigation controller 36. In one example, navigation controller 36 determines the states of trackers 52, 54, 56, and PT and transmits the states to manipulator controller 26. As used herein, the state of an object includes, but is not limited to, data defining the position and / or orientation of the tracked object, or equivalents / derivatives of position and / or orientation. For example, the state can be the pose of the object and may include linear velocity data and / or angular velocity data, etc.

[0100] The navigation controller 36 may include one or more computers, or any other suitable form of controller. The navigation controller 36 has a central processing unit (CPU) and / or other processor, non-transitory memory (not shown), and storage devices (not shown). The processor may be any type of processor, microprocessor, or multiprocessor system. The navigation controller 36 is loaded with software. For example, the software converts signals received from the locator 44 into data representing the position and orientation of the object being tracked. The navigation controller 36 may additionally or alternatively include one or more microcontrollers, field-programmable gate arrays, systems-on-a-chip, discrete circuitry, and / or other suitable hardware, software, or firmware capable of implementing the functions described herein. The term processor is not intended to limit any implementation to a single processor.

[0101] Although one example of the navigation system 32 is shown as employing triangulation techniques to determine the state of an object, the navigation system 32 may have any other suitable configuration for tracking the manipulator 14, the tool 20, and / or the patient 12.

[0102] In another example, navigation system 32 and / or locator 44 are ultrasound-based. For example, navigation system 32 may include an ultrasound imaging device coupled to navigation controller 36. The ultrasound imaging device images any of the aforementioned objects (e.g., manipulator 14, tool 20, and / or patient 12) and generates status signals to navigation controller 36 based on the ultrasound images. The ultrasound images may be 2D, 3D, or a combination of both. Navigation controller 36 can process the images in near real-time to determine the state of the object. The ultrasound imaging device may have any suitable configuration and may differ from, for example, […]. Figure 1 The camera unit 46 shown.

[0103] In another example, navigation system 32 and / or locator 44 are radio frequency (RF) based. For example, navigation system 32 may include an RF transceiver coupled to navigation controller 36. Manipulator 14, tool 20, and / or patient 12 may include an RF transmitter or transponder attached thereto. The RF transmitter or transponder may be passive or actively powered. The RF transceiver transmits RF tracking signals based on RF signals received from the RF transmitter and generates status signals to navigation controller 36. Navigation controller 36 may analyze the received RF signals to correlate with relevant statuses. The RF signals may have any suitable frequency. The RF transceiver may be positioned at any suitable location to effectively track objects using the RF signals. Furthermore, the RF transmitter or transponder may have any suitable structural configuration, which may be largely consistent with... Figure 1 The trackers shown are 52, 54, 56, and PT.

[0104] In yet another example, the navigation system 32 and / or locator 44 are electromagnetic. For example, the navigation system 32 may include an EM transceiver coupled to the navigation controller 36. The manipulator 14, tool 20, and / or patient 12 may include EM components attached thereto, such as any suitable magnetic tracker, electromagnetic tracker, inductive tracker, etc. The tracker may be passive or actively powered. The EM transceiver generates an EM field and generates a status signal to the navigation controller 36 based on the EM signals received from the tracker. The navigation controller 36 may analyze the received EM signals to correlate with the relevant status. Similarly, such an example of a navigation system 32 may have... Figure 1 The navigation system 32 shown has different structural configurations.

[0105] In yet another example, navigation system 32 and / or locator 44 utilize a machine vision system including a camera coupled to navigation computer 36. The camera is configured to locate physical objects in a target space. The physical objects have geometry represented by virtual object data stored by navigation computer 36. The detected objects can be tools, obstacles, anatomical features, trackers, etc. The camera and navigation computer 36 are configured to detect the physical objects using image processing techniques such as pattern, color, or shape recognition, edge detection, pixel analysis, neural network or deep learning processing, optical character recognition, barcode detection, etc. Navigation computer 36 can compare the captured images with virtual object data to identify and track the objects. Trackers may or may not be coupled to the physical objects. If trackers are used, the machine vision system may also include an infrared detector for tracking the trackers and comparing the tracking data with machine vision data. Similarly, such examples of navigation system 32 may have structural configurations different from those shown throughout the figures. Examples of machine vision tracking systems may be similar to those described in U.S. Patent No. 9,603,665 entitled “Systems and Methods for Establishing Virtual Constraint Boundaries”, and / or similar to those described in U.S. Patent No. 11,291,507 entitled “Systems and Methods for Image Based Registration and Calibration”, the entire contents of which are incorporated herein by reference.

[0106] Navigation system 32 may have any other suitable components or structures not specifically listed herein. Furthermore, any of the techniques, methods, and / or components described above with respect to the illustrated navigation system 32 may be implemented or provided for any of the other examples of navigation system 32 described herein. For example, navigation system 32 may utilize only inertial tracking or any combination of tracking techniques, and may additionally or alternatively include fiber-optic tracking, machine vision tracking, etc.

[0107] refer to Figure 2 System 10 may include a control system 60, which, among other components, includes a manipulator controller 26, a navigation controller 36, and a tool controller 21. The control system 60 also includes... Figure 3 One or more software programs and software modules are shown. A software module may be part of one or more programs that operate on the manipulator controller 26, navigation controller 36, tool controller 21, or any combination thereof to process data to assist in the control of system 10. The software program and / or module includes computer-readable instructions stored in non-transitory memory 64 on the manipulator controller 26, navigation controller 36, tool controller 21, or any combination thereof, executable by one or more processors 70 of controllers 21, 26, 36. Memory 64 may be any suitable memory configuration, such as RAM, non-volatile memory, etc., and may be implemented locally or from a remote database. Additionally, software modules for prompting and / or communicating with the user may form part of one or more programs and may include instructions stored in memory 64 on the manipulator controller 26, navigation controller 36, tool controller 21, or any combination thereof. The user may interact with any of the input devices of the navigation user interface UI or other user interface UIs to communicate with the software modules. The user interface software may run on a device separate from the manipulator controller 26, navigation controller 36, and / or tool controller 21.

[0108] The control system 60 may include any suitable configuration of input devices, output devices, and processing devices appropriate for implementing the functions and methods described herein. The control system 60 may include a manipulator controller 26, a navigation controller 36, or a tool controller 21, or any combination thereof, or may include only one of these controllers. These controllers may be accessible via, for example... Figure 2 The wired bus or communication network shown communicates wirelessly or otherwise. Control system 60 may also be referred to as a controller. Control system 60 may include one or more microcontrollers, field-programmable gate arrays, systems-on-a-chip, discrete circuitry, sensors, displays, user interfaces, indicators, and / or other suitable hardware, software, or firmware capable of implementing the functions described herein.

[0109] A clinical application CA can be provided to manage user interactions. The clinical application CA manages many aspects of user interactions and coordinates surgical workflows, including preoperative planning, joint assessment, implant placement, registration, bone preparation visualization, and postoperative assessment of implant fit. The clinical application CA is configured to output to any of the displays in display 38.

[0110] II. Orthopedic tensioners and methods

[0111] This section describes the configuration and use of an orthopedic tensioner T (hereinafter referred to as "tensioner") for evaluating anatomical joints (AJ). The anatomical joint AJ primarily described here is the knee joint, including the femoral F and tibial TIB. However, the anatomical joint AJ can be any other joint, such as the hip, shoulder, elbow, ankle, etc. The tensioner T is inserted into the anatomical joint AJ to evaluate its soft tissues and ligaments. The tensioner T can be used to assess the laxity, stiffness, ligament balance, kinematic properties, flexion, extension, and / or range of motion of the anatomical joint AJ. The configuration and uses of the orthopedic tensioner T are described in detail below. The tensioner T can be used in total knee arthroplasty procedures, partial knee arthroplasty procedures, anatomical shoulder arthroplasty procedures, reverse shoulder arthroplasty procedures, or any other surgical procedures requiring evaluation of adjacent bones. The tensioner T can be used to evaluate bones before, during, or after resection, or including one or more bones to which prosthetic implants are attached.

[0112] In most cases, the tensioner T is intended to be held and supported by the user's hand. However, in some examples, the tensioner T may be a tool 20 attached to the manipulator 14. The tensioner T may be attached to the manipulator 14 actively or passively. When passively attached, the tensioner T may be held in certain positions by the manipulator 14 to facilitate any of the methods described herein for evaluating anatomical joints AJ, and the user controls the tensioner T independently of the robot control. When actively attached, the control system of the manipulator 14 may be coupled to the control system of the tensioner T to coordinate the two systems. The tensioner T may be selectively attached to or removed from the manipulator 14 as needed by the user. The tensioner T may be used with or without the system 10 described above, and may be used with any type of surgical system other than the system 10 specifically shown.

[0113] A. Tensioner Configuration

[0114] refer to Figure 3An example of a tensioner T is illustrated below. The tensioner T includes a first body TB1 and a second body TB2. The first body TB1 and the second body TB2 are configured to be separate from each other and can operate independently. In the example shown, the first body TB1 and the second body TB2 are temporarily joined together and used synergistically to evaluate the knee joint (AJ). The bodies TB1 and TB2 are configured to be grasped by the surgeon's hand (either as a joined unit or separately). The outer surface of each body TB1 and TB2 can be profiled to optimize ergonomics and user comfort during grasping. Each body TB1 and TB2 is hermetically sealed independently of the other body TB1 and TB2, ensuring that the internal components of each body TB1 and TB2 are not exposed to a sterile environment. As will be understood below, the separate bodies TB1 and TB2 offer numerous advantages, such as optimized adjustability of the tensioner T, increased contact with the bones B1 and B2, extended lifespan of the tensioner T, and improved cleanability of the tensioner T.

[0115] The first body TB1 and the second body TB2 each include an upper paddle plate UP and a lower paddle plate LP. To separate the skeletons B1 and B2, the upper paddle plate UP of each body TB1 and TB2 is configured to move relative to the lower paddle plate LP of each body TB1 and TB2. Each lower paddle plate LP is fixed relative to the corresponding body TB1 and TB2. In other configurations, both the upper paddle plate UP and the lower paddle plate LP may be movable, or the lower paddle plate LP may be movable relative to the fixed upper paddle plate UP. In some configurations, the first body TB1 and the second body TB2 may share a common lower paddle plate LP.

[0116] The upper paddle plate UP of each body TB1, TB2 is configured to engage the first bone B1 of the anatomical joint AJ, and the lower paddle plate LP of each body TB1, TB2 is configured to engage the second bone B2 of the anatomical joint AJ. Figure 4 In the diagram, anatomical joint AJ is the knee joint, where the first bone B1 is the distal femur (F), and the second bone B2 is the tibia (TIB). Figure 4 In this configuration, tensioner T is inserted into the knee joint AJ, such that the upper paddle plate UP of each body TB1, TB2 engages the femur F, and the lower paddle plate of each body TB1, TB2 engages the tibia TIB. Figure 4 In this configuration, one upper paddle plate (UP) engages the medial compartment or condyle of the femur (F), and the other upper paddle plate (UP) engages the lateral compartment or condyle of the femur (F). Figure 4In this procedure, the tibial TIB is removed as part of a mid-tissue resection workflow. The lower paddle plate LP of each body TB1, TB2 rests flat on the removed tibia with sufficient contact coverage and depth to avoid the need for invasively fastening each lower paddle plate LP to the plane of the removed tibia. However, it is conceivable that the lower paddle plate LP may optionally be fastened to the plane of the removed tibia. In a non-resection workflow, the tibial surface can be the native, unresected surface. The lower paddle plate LP is also configured to engage the native, unresected tibial surface. Furthermore, the tensioner T can be used to evaluate the knee joint AJ after the implant has been placed in one or both of the femoral F or tibial TIB. For example, the upper paddle plate UP can engage a femoral implant with artificial medial and lateral condyles. The lower paddle plate LP can engage a tibial implant. Therefore, the tensioner T can be adapted to a variety of surgical workflows without disassembly or reconfiguration.

[0117] 1. Tensioner drive assembly

[0118] refer to Figure 5 and Figure 6 This document describes the various internal components of the tensioner T. For simplicity, the illustrated components are shown with respect to the first body TB1 of the tensioner T. It should be understood that the second body TB2 may include a similar or identical configuration. Any references in this document to the contents that the first body TB1 may include apply fully to the contents that the second body TB1 may include, and will not be repeated for simplicity.

[0119] The first body TB1 includes a drive assembly DA, which is coupled to or disposed within the body TB1. The drive assembly DA includes an electric motor M, such as a brushless DC motor. The motor M is in a fixed position relative to the body TB1. A displacement mechanism DM is coupled between the electric motor M and an upper paddle plate UP. The electric motor M is configured to move the displacement mechanism DM to linearly displace the upper paddle plate UP relative to the lower paddle plate LP. Figure 5 Examples are shown of paddles UP and LP in the closed position, while Figure 6 The example shows propellers UP and LP in the open, spaced-out position. Alternatively, the displacement mechanism DM can linearly displace the upper propeller UP and the lower propeller LP relative to each other.

[0120] In one implementation, the displacement mechanism DM may include a ball screw BS, which is coupled to and rotatable by an electric motor M. A ball screw nut BN engages the ball screw BS. The ball screw nut BN can move linearly up and down along the ball screw BS in the direction of rotation of the ball screw BS by the electric motor M. The displacement mechanism DM may include a ball spline shaft BSS, which is fixed to the ball screw nut BN and to an upper paddle. The ball spline shaft BSS and the ball screw nut BN may be a single unit or separately connected components. The ball spline shaft BSS can be linearly displaced according to the movement of the ball screw nut BN. The upper paddle UP will move correspondingly to the ball spline shaft BSS. The ball spline shaft BSS may include an inner bore for receiving the ball screw BS and providing clearance for the ball spline shaft during axial movement of the ball spline shaft BSS. A ball spline nut BSN can be fixed relative to the body TB1 and can surround the ball spline shaft BSS. The ball spline nut BSN provides internal guide channels and linear bearing surfaces to facilitate movement of the ball spline shaft BSS. The tight fit of the ball spline nut BSN also maintains the seal of the internal components of the body TB1 and eliminates the need for a bellows seal between the body TB1 and the upper paddle UP. The displacement mechanism DM may also include a lock nut JN disposed between the ball screw nut BN and the ball spline shaft BSS. The lock nut JN moves with the ball screw nut BN and can be provided to stop upward movement of the ball screw nut BN by abutting against an internal flange within the body TB1. The ball spline shaft BSS may include a threaded interface that receives a fastener FN. Various sizes of upper paddle UP can be attached to the body TB1, such as by attaching the upper paddle UP to the ball spline shaft BSS using the fastener FN. The upper propeller UP can be removed from the body TB1 by removing the fastener FN. The lower propeller LP is secured to the body TB1. However, in other configurations, when removing the upper propeller UP, the lower propeller LP can be installed onto the body TB1 by sliding any of the various types of lower propeller LP onto the ball spline shaft BSS and securing the lower propeller LP to the body TB1.

[0121] A hard stop HS can be positioned above the motor M to stop the downward movement of the ball screw nut BN. The hard stops HS can be specifically spaced such that once the ball screw nut BN reaches the hard stop HS, the upper propeller UP will be in a closed position relative to the lower propeller LP, i.e., in contact with the lower propeller LP, without over-driving the upper propeller UP. The hard stop HS also protects the motor M from contact by the ball screw nut BN.

[0122] A printed circuit board (PCB) is located axially below the motor M. The PCB supports the operation of the motor and a tensioner encoder EN for sensing the rotational position of the motor M. The encoder EN may include a magneto-based sensor, such as a Hall effect sensor. The encoder EN can also act as a displacement sensor for sensing the displacement of the upper paddle UP relative to the lower paddle LP.

[0123] Cable C can be connected to tensioner T. Cable C can be connected to the power supply and / or control system TCS of tensioner T. Cable C can be led out through a cable seal to body TB1. Control signals for tensioner T can be provided via cable C. Power to components of tensioner T (such as motor M, PCB, and sensor S) can also be provided via cable C. Alternatively, body TB1 can be battery powered (self-powered). Replaceable or rechargeable battery cells can be coupled to body TB1, such as by attaching to the lower end of body TB1, for example, below motor M and PCB. Body TB1 may include battery terminals that mat with corresponding terminals of the battery cells. Battery cells and / or body TB1 may be provided with seals to prevent liquid from reaching the battery terminals. Body TB1 may also include one or more user input devices TID for providing control signals to tensioner T. User input devices TID can be coupled to the PCB and can take any form, such as buttons, sliders, knobs, switches, triggers, all accessible from the outer surface of the body and actuated by the user.

[0124] The main body TB1 can be disassembled. For example, see [link to relevant documentation]. Figure 5 and Figure 6 The main body TB1 may include a lower body portion LBP threadedly connected to the upper body portion UBP. When disconnected, the lower body portion LBP accommodates the motor M, PCB, ball screw BS, ball screw nut BN, and ball spline shaft BSS. The upper body portion UBP accommodates the lower propeller LP and ball spline nut BSN. Before disconnecting the main body portions UBP and LBP, it may be necessary to loosen the upper propeller UP from the ball spline shaft BSS.

[0125] The configuration of the drive assembly DA and the displacement mechanism DM is not limited to the configuration shown and described above. For example, instead of a ball screw system, the displacement mechanism DM may include a lead screw with a carriage, a planetary roller actuator system, a worm gear system, etc. Any of the features described above or their equivalents may be used with the second body TB2 of the tensioner T.

[0126] 2. Improved sensor configuration

[0127] 2a. Sensors attached to the displacement mechanism

[0128] Continue to refer to Figure 5 and Figure 6The tensioner T's body TB1 includes a sensor S configured to sense the force applied to the upper paddle plate UP. The force can be applied to the upper paddle plate UP via the femur F, in this case, by applying a force to the top surface of the femur F that contacts the upper paddle plate UP. Alternatively or additionally, a force can be applied to the bottom surface UBS of the upper paddle plate UP. For example, by inserting an auxiliary paddle plate AP between the upper paddle plate UP and the lower paddle plate LP, as will be described in detail below. The sensor S can sense any of these forces in any axial direction. Figure 5 and Figure 6 In the example shown, the sensor is a load cell. However, the sensor S may include one or more of a load cell, strain gauge, pressure sensor, etc. The sensor S can sense forces of 400 Newtons or more.

[0129] In the example shown, sensor S is located in displacement mechanism DM and / or configured to move in response to movement of displacement mechanism DM. In one implementation, sensor S may be located between ball screw nut BN and ball spline shaft BSS. Displacement mechanism DM may include sensor adapter SA disposed between ball screw nut BN and ball spline shaft BSS. Sensor adapter SA may be secured to ball spline shaft BSS and threadedly engaged to ball screw nut BN. Sensor S may be located between sensor adapter SA and ball screw nut BN. Sensor S may be directly attached to sensor adapter SA or simply captured between components. Sensor S will move correspondingly to ball screw nut BN. Alternatively, sensor S may be located between any other components of displacement mechanism DM, such as any component in the load path of the force applied to the upper paddle UP.

[0130] The sensor S can be annular or disc-shaped, allowing it to be positioned around the ball screw BS. This annular configuration of the sensor S provides reliable and accurate load measurement for any directional force applied to the upper paddle UP. The sensor S can be arranged along the inner surface of the body TB1 to bypass the path of the ball screw nut BN and avoid cable clamping. The sensor S can be connected to the PCB. Similarly, any references to the contents that may be included in the first body TB1 throughout the text fully apply to the contents that may be included in the second body TB1, and will not be repeated for simplicity.

[0131] By positioning the sensor S within or moving with the displacement mechanism DM, the tensioner T offers several improvements. Because the sensor S is positioned closer to the applied force, the load path between the upper propeller and the sensor S is minimized in length, thus improving measurement accuracy. The motor M can remain in an axially fixed position without experiencing load from the upper propeller. In other words, because the sensor S is above the motor M, the motor M does not need axial movement to allow the sensor S to sense the force. Positioning the sensor S below the motor M would require the motor M to experience some axial force and would necessitate additional flexible components to move the motor M. By positioning the sensor S within the displacement mechanism, the tensioner T eliminates the need for compliant flexible components and improves the robustness of the drive component DA by maintaining the axial position of the motor M.

[0132] 2b. Sensors attached to the paddleboard

[0133] In addition to or replacing the location of sensor S in the displacement mechanism, sensor S can be directly attached to the paddle plate, such as... Figure 42A and Figure 42B As shown. In Figure 42A and Figure 42B In the example, the upper paddleboard UP is illustrated for illustrative purposes. However, the described sensor S configuration can be applied to the upper paddleboard UP, the lower paddleboard LP, or both. In this example, the sensor S is disposed on, disposed within, or combined with or integrated with the paddleboards UP and LP.

[0134] The paddles UP and LP may be configured with one or more openings or slots SL formed in the body of the paddles UP and LP. The slots SL may have any suitable shape, such as circular, elliptical, pill-shaped, non-rectangular, oblong, stadium-shaped, rectangular, or any other complex shape. For example, as... Figure 42A As shown, the groove SL (when stationary) is formed by two spaced-apart, vertical pill-shaped structures connected by a rectangular shape. The pill-shaped structures can extend along the main body axis BA, or along the axis along which the paddle can move up and down. In another example, as... Figure 42BAs shown, the groove SL (at rest) can be a single pill shape, which is horizontally oriented, i.e., parallel to or coincident with an axis defined along the length of the paddles UP and LP. One or more grooves SL can be formed to extend completely through the body of the respective paddles UP and LP. Alternatively, one or more grooves SL can be formed to extend partially into the body of the respective paddles UP and LP. In another example, the groove SL can be formed directly into the force-experiencing surface of the respective paddles UP and LP, such as the upper surface of the upper paddle UP that contacts the femur, or the lower surface of the lower paddle LP that contacts the tibia. Other configurations of the groove SL are contemplated in addition to those specifically shown and described.

[0135] One or more slots SL are configured to deform in response to a load or force (shown as F) applied to the respective propeller plates UP, LP. One or more slots SL are configured to provide a pivot point for the respective propeller plates UP, LP in response to the force applied to them. By deforming and providing a pivot point, one or more slots SL enable the respective propeller plates UP, LP to undergo displacement (D) relative to their rest position. For example, in response to a load applied to the propeller plates UP, LP, one or more slots SL may form a four-bar linkage to achieve the displacement D of the propeller plates. The buckling of the propeller plates UP, LP and the corresponding displacement D depend on the magnitude of the applied force and the location and orientation of the force relative to the length of the propeller plates. The respective propeller plates UP, LP may be formed from any suitable material that enables them to deform, including but not limited to stainless steel, such as 17-4, 440C, or 900 grade stainless steel.

[0136] The deformation of one or more slots SL is proportional to or related to the applied force. Therefore, the deformation of one or more slots SL can be measured to derive the corresponding force F applied to the paddle plate. The sensor S can be implemented by placing one or more strain gauges SG on the paddle plate. The strain gauges have resistive wires (not shown) attached to a surface adjacent to the slot SL. The length of the surface of the slot SL expands or contracts in response to a load. The strain gauge is a passive device that changes in response to a change in strain on the surface adjacent to the slot SL. That is, the length of the wire changes in response to a change in the length of the surface. The resistance of the wire changes in response to a change in the length of the wire. When the surface is stretched, the resistance in the strain gauge increases, and when the surface is compressed, the resistance in the strain gauge decreases. The strain is proportional to the change in the resistance of the strain gauge. The change in resistance is derived by measuring the voltage across the strain gauge. Any suitable means of resistance measurement can measure the change in resistance. One or more strain gauges can be positioned relative to one or more slots SL. In these configurations, the sensor S can be implemented as a load cell using one or more slots SL and strain gauges SG.

[0137] exist Figure 42BIn the example, two strain gauges SG1 and SG2 are positioned on a paddle plate above a pill-shaped groove SL, for example, above the groove SL and along the flat side of the pill shape. The two strain gauges can form a half-bridge configuration. Here, the strain gauges are arranged in a series circuit configuration such that if the resistance of one strain gauge increases, the resistance of the other strain gauge decreases. Figure 42A In the example, two strain gauges SG1 and SG2 are positioned above the slot SL on the paddle plate, and two other strain gauges SG3 and SG4 are positioned below the slot SL on the paddle plate. For example, each corresponding strain gauge SG may be positioned above or below the pill-shaped end. The four strain gauges can form a full-bridge configuration, which includes two half-bridge configurations arranged in a parallel circuit configuration. The full-bridge configuration is more sensitive to measuring small voltage changes. The number and positioning of the strain gauges SG can vary depending on whether the paddle plate is an upper or lower paddle plate, or the shape of the corresponding paddle plate and / or slot SL. In addition to the configurations specifically shown and described, other configurations of the strain gauges are contemplated.

[0138] The strain gauge SG can be coupled to any of the described controllers, such as a motor controller MC and a behavior controller BC, which may be located within the tensioner body TB. In one example, this coupling is made via electrical wires. To allow the wires to adapt to the movement of the corresponding paddles UP, LP, the tensioner body TB may include channels for the wires, and the wires may include service loops to provide slack. Alternatively, the strain gauge SG can transmit signals wirelessly (e.g., radio frequency or other means). For example, a compact wireless communication device may be embedded within the paddle.

[0139] The described configuration provides a more compact sensor design by directly incorporating the groove SL and strain gauge SG (e.g., load cell) onto / inside the body of the paddle plate. Furthermore, by positioning the load cell directly on the paddle plate near the force source (e.g., compared to a force source further away), more accurate force measurements are provided.

[0140] 3. Paddleboard Configuration

[0141] Such as at least Figure 3 and Figures 10 to 13 As shown, the tensioner T is configured to use a variety of different paddles. For example... Figure 3 As shown, for example, the upper paddleboard UP and the lower paddleboard LP can each have corresponding peripheral profiles. Alternatively, the peripheral profiles of the paddleboards can be different from each other, such as... Figure 12 As shown. For example, the lower paddleboard LP can be similar in shape to the upper paddleboard UP, but slightly wider. (See diagram) Figure 3 As shown, the upper propeller UP and the lower propeller LP can contact each other with parallel, flush surfaces. Alternatively, as Figure 12As shown, the lower propeller LP can define a recessed surface with sidewalls, which is used to capture the upper propeller UP when the upper propeller UP is lowered to contact the lower propeller LP.

[0142] like Figure 4 As shown, the upper paddle plate (UP) and the lower paddle plate (LP) may each have a narrow proximal portion (PPP) and a distal portion (PDP) with a surface area larger than the proximal portion (PPP). The distal portion (PDP) of the upper paddle plate (UP) is configured to contact the femur (F), while the distal portion (PDP) of the lower paddle plate (LP) is configured to contact the tibia (TIB). The distal portion (PDP) of each paddle plate may have a textured or corrugated surface to prevent slippage between the distal portion (PDP) and the bone surface. For example, the contact surface of each paddle plate may have one or more ridges or channels extending along the axis of the respective paddle plate. To facilitate rapid engagement with the left or right knee without removing the paddle plate and to avoid impact with the patellar tendon (PAT), each paddle plate may have a recessed or indented profile in the region of the proximal portion (PPP). The indented profile may exhibit a smooth curve. The indented surface may be formed on one edge of each paddle plate or on the opposite edge of each paddle plate. For example, as... Figure 10 As shown, the upper propeller UP and lower propeller LP of the first body TB1 are recessed on the left outer edge of each propeller, and the upper propeller UP and lower propeller LP of the second body TB1 are recessed on the right outer edge of each propeller. On the other hand, in Figure 12 In the middle, the upper propeller UP and lower propeller LP of each main body TB1 and TB2 are symmetrically recessed on both the inner and outer edges of each propeller.

[0143] Additionally, by including a separate set of upper paddles UP and lower paddles LP in each body TB1, TB2, the paddle footprint can be reduced in size. For example, by including two smaller lower paddles LP, the design eliminates the need for a single lower paddle with a larger profile and unusable surface area. The small footprint of the paddles UP, LP facilitates easy insertion of the tensioner T into the knee joint AJ.

[0144] Advantages, such as Figure 4As shown, the lower paddle plate LP can make full contact with the resected tibial surface without requiring invasive fastening of the lower paddle plate LP to the resected tibial plane. The lower paddle plate LP does not require a keel opening for receiving the keel punch, which is inserted into the tibial TIB to secure the lower paddle plate to the tibial TIB. The lower paddle plate LP maintains sufficient length and contact surface area to contact the tibial plane without slippage. Therefore, the configuration of the lower paddle plate LP enables rapid assessment of the joint AJ by eliminating the additional surgical steps required by the keel punch and eliminating unnecessary trauma to the bone caused by the keel punch. Eliminating the keel opening also reduces the possibility of surgical fragments being trapped within the keel opening, thereby reducing interference with measurements.

[0145] 4. Tensioner control system

[0146] refer to Figure 2 A tensioner control system (TCS) is provided to support the operation of the tensioner T. The TCS can be coupled to any one or more components of the control system 60 described above, including but not limited to the navigation controller 36. The TCS may include any number of controllers or processors to implement any of the functions described herein. The TCS can be implemented remotely from the tensioner T. This remote configuration can be achieved via wireless or wired communication. For example, the TCS may be implemented in a tensioner console (TCC) that is brought into the operating room, such as... Figure 1 As shown. The tensioner control console TCC provides wireless or wired communication with the tensioner T. When wired, the cable C of the main body TB1 can be attached to the control console TCC. Alternatively, the tensioner control system TCS can be implemented within the navigation trolley or the operator trolley by attaching the cable C to the navigation trolley 24 or the operator trolley 17, respectively. The tensioner control system TCS can be controlled via the clinical application CA and / or via the user input device TID on the tensioner T itself. The tensioner control system TCS can be implemented by a software control module located within or remotely from the tensioner T.

[0147] Tensioner T may utilize or use with locator information 44, which is derived from the tracked pose of the anatomical joint AJ (such as the pose of the femur and tibia). Optionally, tensioner T may be tracked by navigation system 32. A tracker may be selectively attached to tensioner T, or any movable or stationary component of tensioner T, such as a paddle. In other cases, tracking of tensioner T is not required.

[0148] Figure 7An example of a tensioner control system TCS is illustrated in more detail. The tensioner control system TCS is operatively coupled to the drive assembly DA of the first body TB1 and the second body TB2. Any references in this document to the contents that may be included in the first body TB1 are entirely applicable to the contents that may be included in the second body TB1, and will not be repeated for simplicity. As described above, the drive assembly DA includes a displacement mechanism DM, a motor M, a sensor S, and a PCB and an encoder EN. The tensioner control system TCS controls the motor M to move the displacement mechanism DM and obtains readings from the sensor S and the encoder EN. The tensioner control system TCS may include a non-transitory computer-readable medium for storing information related to the tensioner T, such as sensor measurements, default settings, calibration settings, tensioner operation, tensioner performance, error signals, etc.

[0149] The tensioner control system TCS includes one or more motor controllers MC, which are coupled to drive components DA to execute commanded actions (position or force) on drive components DA and ultimately on the upper paddle plate UP. The motor controllers MC can control the power to drive components DA and their corresponding components. For example, the motor controllers MC can supply three-phase motor power to motor M. The motor controllers MC can be implemented on the PCB of each body TB1, TB2, or remotely to each body TB1, TB2. When implemented in the tensioner T, each body TB1, TB2 may include its own dedicated motor controller MC. When implemented remotely to the tensioner T, one motor controller MC can be used to control two drive components DA. The motor controllers MC can receive feedback from drive components DA, including feedback from encoder EN, sensor S, or motor M. The motor controllers MC can control motor M based on the feedback signals. The feedback signals may relate to the position, velocity, acceleration, force, commutation, gain, or any other parameter experienced or exhibited by any component of drive components DA. In one version, the motor controller MC regulates the motor M and continuously adjusts the torque output of the motor M to ensure, as closely as possible, that the motor M drives the displacement mechanism DM to achieve the commanded position or force. In some examples, the motor controller MC is a proportional-integral-derivative (PID) controller. Other types of controllers are conceivable.

[0150] The tensioner control system (TCS) includes one or more behavior controllers (BCs). The behavior controllers (BCs) are coupled to the motor controller (MC) and provide commands to the MC. For example, the behavior controller (BC) can command the motor controller (MC) to move the upper paddle plate (UP) to a commanded position or until a force is applied to the upper paddle plate (UP). When commanding the motor controller (MC), the behavior controllers (BCs) can utilize the output from the sensor (S) or the encoder (EN). For example, as... Figure 7As shown, an analog-to-digital converter A2D connected between the drive component DA and the behavior controller BC can be used to convert the analog voltage signal from the sensor S into a digital signal. The behavior controller BC can be connected to the A2D using any type of communication technology, such as via USB. The behavior controller BC can be implemented on the PCB of each body TB1, TB2, or remotely. When implemented in the tensioner T, each body TB1, TB2 may include its own dedicated behavior controller BC. When implemented remotely to the tensioner T, a behavior controller BC can be shared between bodies TB1, TB2. The behavior controller BC can receive control input from the clinical application CA and / or via the user input TID device on the tensioner T itself. In one example, the behavior controller BC is a hard real-time operating system (RTOS) microkernel. The behavior controller BC can be connected to the motor controller MC using any type of communication technology, such as via Ethernet or EtherCat. Other types of controllers are conceivable.

[0151] 4A. Force Control Mode

[0152] like Figure 7As shown, the tensioner control system TCS is configured, via the behavior controller BC and the motor controller MC, to control the tensioner T in force control mode (FCM). In force control mode (FCM), the drive assembly DA is commanded to move the displacement mechanism DM (and therefore the upper paddle plate UP) until a certain force is reached. Force can be sensed in many ways. In one example, the force is sensed by a sensor S. Additionally or alternatively, electric motor current, strain gauges, load cells, etc., can be used to measure the force. The sensed force can be applied to the upper paddle plate UP. For example, the drive assembly DA can be commanded to move the displacement mechanism DM axially upwards to move the upper paddle plate UP upwards until the sensor S detects a force of X Newtons (applied to the upper paddle plate UP). The force can be any value, such as up to 400 N or greater. Force control mode (FCM) can be the primary mode for stretching the anatomical joint AJ. Once a force is detected, the drive assembly DA can be commanded to stop the movement of the upper paddle plate UP or retract it. Force control mode (FCM) can be understood as a closed-loop or open-loop control scheme that uses feedback from sensor S to achieve or maintain a desired setpoint for tensioner T. The force can be a positive force applied downwards to the upper paddle plate UP, or a negative force applied upwards to the upper paddle plate UP. The force can be discrete or a range of forces. The force can be sensed continuously or intermittently. The force to be detected can be a predetermined force and can be stored in memory. For example, the force can be a predetermined joint balance force, a force based on surgeon preferences, a force obtained from statistical data, or a force previously recorded from the movement of tensioner T. Force control mode (FCM) can be triggered or configured via a clinical application (CA) and / or via a user input device (TID) on tensioner T itself. For example, the user can input a preferred threshold force for force control mode (FCM). Each body TB1, TB2 of tensioner T can operate selectively and independently under force control mode (FCM). Further uses of force control mode (FCM) will be described below. For any aspect of force control mode, it is conceivable that the tensioner control system (TCS) can monitor the displacement of tensioner T. For example, a tensioner control system (TCS) can monitor the displacement of the tensioner T as the force increases, or monitor the displacement of the tensioner once the desired force is reached.

[0153] 4B. Displacement Control Method

[0154] like Figure 7As shown, the tensioner control system TCS is further configured, via the behavior controller BC and the motor controller MC, to control the tensioner T in displacement control mode DCM. In displacement control mode DCM, the command drive component DA causes the displacement mechanism DM (and therefore the upper paddle UP) to move until a certain position / displacement is reached on the upper paddle UP. Displacement control mode DCM can be understood as the tensioner T acting as a spacer or tibial mannequin. In this control mode, position and displacement can be interchangeable or equivalent. In other words, this mode can alternatively be called position control mode. Position / displacement can be measured using any suitable method, such as using encoder EN feedback or other parameters of the motor M. Measurements from a navigation system can also be used to measure position / displacement. For example, a tracking marker can be attached to the tensioner T or the paddle, and a positioner can detect the pose of the tracking marker to determine the position / displacement of the tensioner T. The position of the paddle UP is the location of the paddle UP at a given time. The position can be a discrete position or a range of positions. The displacement of the upper paddle plate UP can be understood as a change in position of the upper paddle plate UP relative to a reference point (such as relative to the lower paddle plate LP). The displacement can be a discrete displacement or a range of displacements. The zero displacement baseline condition can be set when the tensioner T is in the closed position, with the upper paddle plate UP in contact with the lower paddle plate LP. In one example, the drive assembly DA can be commanded to move the displacement mechanism DM axially upwards, causing the upper paddle plate UP to move upwards until the upper paddle plate UP has shifted X mm relative to the lower paddle plate LP. The displacement can be any range, for example, between 0-30 mm or 6-24 mm. Once the commanded position or displacement is obtained, the drive assembly DA can be commanded to stop the movement of the upper paddle plate UP or retract the upper paddle plate. The displacement control mode DCM can be understood as an open-loop or closed-loop control scheme in which the output position / displacement of the paddle plate UP depends on the input commanded position / displacement, but not vice versa. The position / displacement can be a positive position / displacement causing the upper paddle plate UP to move axially upwards, or a negative position / displacement causing the upper paddle plate UP to move axially downwards. Position / displacement can be predetermined and stored in memory. For example, position / displacement can be a predetermined joint balance position / displacement, a position / displacement based on surgeon preferences, a position / displacement obtained from statistical data, or a position / displacement previously recorded from the tensioner T's movements. The displacement control mode (DCM) can be triggered or configured via the clinical application (CA) and / or via the user input (TID) device on the tensioner T itself. For example, the user can input a preferred threshold position / displacement for the displacement control mode (DCM). Each body TB1, TB2 of the tensioner T can selectively and independently operate under the displacement control mode (DCM). Additionally, the tensioner control system (TCS) can independently control each body TB1, TB2 to switch between force control mode (FCM) and displacement control mode (DCM), or vice versa.For any aspect of the displacement control mode, it is conceivable that the tensioner control system (TCS) can monitor the force on the tensioner T; for example, the TCS can monitor the force applied to the tensioner until the commanded displacement is reached, or it can monitor the force applied to the tensioner when the commanded displacement is reached. Further uses of the displacement control mode (DCM) will be described below.

[0155] 4C. Force-Displacement Control Mode

[0156] It is conceivable that aspects of Force Control Mode (FCM) and Displacement Control Mode (DCM) can be implemented simultaneously or combined in a single mode (i.e., Force-Displacement Control Mode). In one implementation, in Force-Displacement Control Mode, the command drive component DA moves the upper propeller UP according to a predetermined position / displacement until a predetermined force is reached by the sensor S. In another implementation, in Force / Displacement Control Mode, the command drive component DA moves the upper propeller UP to apply a predetermined force until a predetermined position / displacement is reached. Therefore, in Force-Displacement Control Mode, force and displacement can be commanded until one or both of the commanded force or displacement are achieved. Any of the above aspects and implementations of Force Control Mode (FCM) and Displacement Control Mode (DCM) can also be applied to Force-Displacement Control Mode.

[0157] 5. Adjustability of the tensioner body

[0158] Tensioner T may include one of many configurations that promote the unique adjustability of the first body TB1 and the second body TB2. As will be understood from the description below, the adjustability of tensioner T allows it to adapt to various bone sizes in any knee joint. The first body TB1 and the second body TB2 can be uniquely adjusted to enable rapid assessment of either the left or right knee without requiring paddle replacement or reconfiguration. The adjustability of bodies TB1 and TB2 further reduces the likelihood of tensioner T slipping from the joint AJ and reduces the likelihood of collision with the patellar tendon PAT.

[0159] 5A. Tensioner body retainer

[0160] refer to Figures 3 to 6 and Figures 8 to 22 The tensioner T includes a retainer R configured to hold or connect a first body TB1 and a second body TB2 relative to each other. The retainer R is a component detachable from the first body TB1 and the second body TB2. Figure 8 As shown, the first body TB1 and the second body TB2 are inserted into the retainer R. The retainer R captures bodies TB1 and TB2. Figure 9As shown, after insertion, the first body TB1 is configured to rotate within the retainer R to achieve rotational adjustment of a set of propellers UP, LP of the first body TB1. Similarly, the second body TB2 is configured to rotate within the retainer R to achieve rotational adjustment of a set of propellers UP, LP of the second body TB2. A locking mechanism LM is coupled to the retainer R and configured to be actuated to rotatably lock one or both of the first body TB1 and the second body TB2 relative to the retainer R. In other words, once the locking mechanism LM is actuated, the first body TB1 and / or the second body TB2 are prevented from rotating about their respective body axes BA1, BA2 (i.e., axes longitudinally defined along the direction of movement of the displacement mechanism DM or the upper propeller UP). When not rotatably locked by the locking mechanism LM, the bodies TB1 and TB2 can rotate freely 360 degrees within the retainer R. Using the retainer R, the propellers of the first body TB1 and the second body TB2 can be advantageously positioned in numerous configurations. This allows for fine-tuning of the paddles UP and LP, tailored to the patient's specific anatomy. Once the desired orientation of the bodies TB1 and TB2 is confirmed, the user can actuate the locking mechanism LM to fix the desired orientation.

[0161] The retainer R facilitates the rapid release of bodies TB1 and TB2, allowing them to be removed from the retainer R and separated from each other. This is achieved by releasing the locking mechanism LM from a locked state to a released state. Advantageously, removing bodies TB1 and TB2 from the retainer R facilitates easy cleaning or disinfection of bodies TB1 and TB2 and the retainer R.

[0162] As if penetrating Figures 8 to 22 As shown, the retainer R defines a first sleeve SL1 configured to receive a first body TB1 of a tensioner T, and a second sleeve SL2 configured to receive a second body TB2 of the tensioner T. The retainer R allows the first body TB1 to rotate within the first sleeve SL1 to achieve rotational adjustment of the paddle of the first body TB1, and allows the second body TB2 to rotate within the second sleeve SL2 to achieve rotational adjustment of the paddle of the second body TB2. Each of the first sleeve SL1 and the second sleeve SL2 may include adjustable dimensions, openings, widths, lengths, or diameters. A locking mechanism LM can be actuated to simultaneously reduce the dimensions, openings, widths, lengths, or diameters of the first sleeve SL1 and the second sleeve SL2 to rotatably lock the first body TB1 and the second body TB2 relative to the retainer R.

[0163] like Figure 8As shown, the first sleeve SL1 and the second sleeve SL2 may each have an opening configuration to secure correspondingly shaped retainer body portions RBP formed on the outer surfaces of the first body TB1 and the second body TB2, respectively. The sleeves SL1 and SL2 may have any opening shape (such as circular, elliptical, rectangular, polygonal, etc.) conforming to the correspondingly shaped retainer body portions RBP of the first body TB1 and the second body TB2. The retainer body portions RBP of the first body TB1 and the second body TB2 may each have circumferential, annular, or peripheral features that can respectively engage the first sleeve SL1 and the second sleeve SL2 to constrain the first body TB1 and the second body TB2 axially relative to the retainer R. For example, as... Figure 8 and Figure 9 As shown, the retainer body portion RBP of the first body TB1 and the second body TB2 includes a peripheral flange FL, which is wider than the opening of each corresponding sleeve SL1, SL2. The flange FL acts as a hard stop to prevent each sleeve SL1, SL2 from slipping beyond the flange FL. The flange FL constrains the corresponding sleeve SL in one direction relative to the body axis BA. Alternatively, each retainer body portion RBP may include an upper flange and a lower flange, wherein the distance between the upper flange and the lower flange is sized to fit the sleeve SL. The upper flange and the lower flange may constrain the corresponding sleeve SL in two directions relative to the body axis BA. Alternatively or additionally, each retainer body portion RBP may define a recessed surface around the periphery of the corresponding body TB1, TB2 to capture the corresponding sleeve SL. In this way, once the corresponding sleeve SL is captured around the corresponding body TB1, TB2, the sleeve SL can be flush with the remaining surfaces of the body TB1, TB2.

[0164] To facilitate ergonomic rotation within the retainer R, each body TB1, TB2 may have a gripping feature G located on the surface of the body. For example, as Figure 8 As shown, the gripping feature can be a ridge or channel formed around the corresponding body TB1, TB2. The user can grip the corresponding body TB1, TB2 in the area including the gripping feature G to facilitate rotation of the corresponding body TB1, TB2.

[0165] Figure 10 and Figure 11 This illustrates how the retainer R can be used to rotate the bodies TB1 and TB2. Here, the retainer R holds the bodies TB1 and TB2 in a fixed lateral direction, such that the distance between the body axes BA1 and BA2 is fixed. Figure 10In this configuration, the first body TB1 rotates clockwise around the body axis BA, and the second body TB1 rotates counterclockwise around the body axis BA. The distal portions PDP of the paddles UP and LP move very close to each other and can contact one another. This adjustment allows the tensioner paddles to be inserted into and adapted to smaller knee joints. Figure 11 In this configuration, the first body TB1 rotates counterclockwise around the body axis BA1, and the second body TB1 rotates clockwise around the body axis BA2. This causes the distal portions PDP of the paddles UP and LP to move further away from each other. This adjustment allows the tensioner paddles to be inserted into and adapted to larger knee joints.

[0166] Figure 12 and Figure 13 This illustrates a practical implementation of the adjustability of the tensioner T using a retainer R. Figure 12 In this procedure, tensioner T is inserted into the right knee, and both bodies TB1 and TB2 are rotated clockwise within retainer R, such that the paddles UP and LP of the second body TB2 bypass the patellar tendon PAT. The lower paddle LP of each corresponding body TB1, TB2 is in full contact with the plane of the resected tibia (for the pre-resection workflow). Advantageously, bodies TB1, TB2 can be rotated even when inserted into the knee joint. Once the surgeon has rotated bodies TB1, TB2 into the desired orientation, the surgeon can actuate locking mechanism LM to fix the desired orientation of the paddles. Of course, bodies TB1, TB2 can be rotated before the tensioner T is inserted into the knee joint, if desired. Figure 13 During the assessment process (for the same patient), the locking mechanism LM is released to allow rotation of the bodies TB1 and TB2, and the tensioner T is inserted into the left knee. Both bodies TB1 and TB2 rotate counterclockwise within the retainer R, causing the paddles UP and LP of the first body TB1 to bypass the patellar tendon PAT. Figure 12 and Figure 13 The beneficial ability of the tensioner T to be used with both the right and left knees without requiring the replacement of any parts or the time-consuming reconfiguration of the tensioner T is further illustrated.

[0167] refer to Figures 14 to 26 The following will describe an additional configuration of the retainer R and the locking mechanism LM. For simplicity, the bodies TB1 and TB2 of the tensioner T are not illustrated in these figures. For any configuration shown and described, it should be understood that the bodies TB1 and TB2 are designed to be inserted into the retainer R and rotatably locked by the locking mechanism LM.

[0168] refer to Figures 14 to 16An example is illustrated where a retainer R includes two sleeves SL1 and SL2. The retainer R is divisible into a first portion RP1 and a second portion RP2. Each of the first portion RP1 and the second portion RP2 partially defines the first sleeve SL1 and the second sleeve SL2. For example, when the sleeves have a circular or cylindrical shape, the first portion RP1 and the second portion RP2 may partially define a semi-circular or semi-cylindrical portion of the first sleeve SL1 and the second sleeve SL2. The portions of sleeves SL1 and SL2 are laterally secured relative to each other by a rigid connecting portion LKP connected between the sleeve portions. A locking mechanism LM is operatively connected to the first portion RP1 and the second portion RP2. Figure 15 As shown, the locking mechanism LM can be actuated to simultaneously bring the first portion RP1 and the second portion RP2 of the retainer R closer together. Although not shown for simplicity, the bodies TB1 and TB2 can be inserted into the retainer R before this step of bringing the first portion RP1 and the second portion RP2 together. Figure 16 As shown, the locking mechanism LM can continue to be actuated until the first part RP1 and the second part RP2 of the retainer R apply sufficient restraining force to the retainer body part RBP of the bodies TB1 and TB2 to rotatably lock the bodies TB1 and TB2 relative to the retainer R. The restraining force can be radial (towards the body axis BA) and / or transverse to the body axis BA. When the locking mechanism LM can no longer be easily actuated, the user knows that the bodies TB1 and TB2 are held. When rotatably locked, the first part RP1 and the second part RP2 can remain slightly spaced apart from each other (e.g., ...). Figure 16 (As shown), or the first part RP1 and the second part RP2 can be in contact with each other. To release the bodies TB1 and TB2, rotate the locking mechanism LM in opposite directions to reopen the first part RP1 and the second part RP2 (as shown). Figure 15 (As shown). The spacing between the first part RP1 and the second part RP2 will provide sufficient clearance to remove the main bodies TB1 and TB2 from the retainer R.

[0169] exist Figures 14 to 16In the example, the locking mechanism LM includes at least one knob K, which is accessible to a user from the outer surface of the retainer R. Knob K is coupled to a bolt BT, which extends through the retainer R and more specifically through an opening formed in a first portion RP1. The bolt BT is secured to a second portion RP2 at its distal end. Knob K includes a threaded opening inside for threaded engagement of the proximal end of the bolt BT. When knob K is rotated in a first direction, knob K moves along the bolt BT toward the second portion RP2. The end of knob K presses against the surface of the first portion RP1, causing the first portion RP1 to gradually slide along the bolt B. This moves the first portion RP1 toward the second portion RP2. When knob K is rotated in a second (opposite) direction, knob K moves along the bolt BT in a direction away from the second portion RP2. Knob K creates clearance for the first portion RP1 to slide away from the second portion RP2 along the bolt BT to rotationally release the bodies TB1, TB2. When the retainer R is closed, the knob K and bolt BT do not interfere with the sleeve opening or the rotation of the bodies TB1 and TB2 with the sleeve SL. One configuration of the knob K and bolt B is shown. However, other configurations are also possible.

[0170] exist Figures 17 to 19 The example illustrates another instance, which includes a retainer R divided into a first part RP1 and a second part RP2. Here, the locking mechanism LM includes at least one lever LR, which is accessible to a user from the outer surface of the retainer R. Figure 18 and Figure 19 The retainer R and locking mechanism LM are illustrated in the side view. A lever LR is coupled to an arm AR that extends through the retainer R and, more specifically, through an opening formed in the first portion RP1. The arm AR is coupled at its distal end to a second portion RP2, for example, using a fastener. A biasing mechanism BM is coupled to the second portion RP and mats with the distal end of the arm AR. The biasing mechanism BM can be, for example, a coil spring or a disc spring. The lever LR can rotate eccentrically about a hinge. Figure 18 As shown, when lever LR is rotated (e.g., pulled downwards) in the first direction, lever LR pulls arm AR in the first lateral direction, thereby moving the second part RP2 toward the first part RP1. Figure 19 In the middle, lever LR is in the fully closed position, and the second part RP2 moves to close retainer R and capture bodies TB1 and TB2 (when inserted). When bodies TB1 and TB2 are inserted into retainer R and lever LR is in the fully closed position ( Figure 19When the first part RP1 is engaged, the biasing mechanism BM extends to move the second part RP2 slightly away from the first part RP1. The biasing mechanism BM extends due to the reaction force of the bodies TB1 and TB2 acting on the second part RP2. In turn, the biasing mechanism BM regulates the force acting on the bodies TB1 and TB2 to ensure that the bodies TB1 and TB2 are adequately captured by the retainer R, while preventing damage to the bodies TB1 and TB2 or the retainer R. The biasing mechanism BM also acts as a preload to ensure that the lever LR applies appropriate tension to restrain the bodies TB1 and TB2 within the retainer R. To release the bodies TB1 and TB2, the lever LR can be rotated (e.g., pulled upward) in the second direction. Thus, the lever LR pushes the arm AR in the second (opposite) lateral direction, thereby pushing the second part RP2 away from the first part RP1 to open the retainer R.

[0171] Figure 20 and Figure 21 Another example of a retainer R and a locking mechanism LM is illustrated. In this example, the retainer R is again divided into a first part RP1 and a second part RP2. The first part RP1 and the second part RP2 each define an internal tooth IT defined in a corresponding sleeve portion. A first body TB1 and a second body TB2 are shown located within the retainer R and are modified to include external teeth OT formed on the outer surface of each body TB1, TB2. The internal teeth IT and the external teeth are formed to have complementary shapes and dimensions, allowing the teeth IT, OT to easily mesh with each other. Any number of teeth IT, OT other than the number shown can be provided. Increasing the number of teeth IT, OT will increase the number of discrete rotational positions in which the bodies TB1, TB2 can be locked. In this example, the locking mechanism LM includes an arm AR connected between the first part RP1 and the second part RP2. A first biasing mechanism BM1 is located on the first part RP1, and a second biasing mechanism BM2 is located on the second part RP2. The arm AR is connected between the biasing mechanisms BM1 and BM2. The locking mechanism LM may include any example user interface (such as a knob K, lever L, push button, etc.) for locking and unlocking the actuating parts RP1 and RP2. Figure 20 In the middle, parts of RP1 and RP2 are in the open state, and the main bodies TB1 and TB2 can rotate freely within the retainer R because the teeth IT and OT are not yet engaged. Figure 20In this example, the locking mechanism LM is actuated, causing one or both of portions RP1 and RP2 to move closer together to enter a closed state, where teeth IT and OT are fully engaged to rotatably and simultaneously lock TB1 and TB2 relative to the retainer R. In this example, lever LR may be placed on one or both portions of RP1 and RP2. The biasing mechanisms BM1 and BM2 perform the same beneficial functions as described in the previous examples. In this example, it is envisioned that only one biasing mechanism BM is used, instead of two biasing mechanisms BM1 and BM2.

[0172] In another example, the locking mechanism LM may include a button, which can be coupled to a mechanical or electromechanical system to facilitate locking of the retainer R. For example, the retainer R may include a motor coupled to a lead screw connected between portions RP1 and RP2 (similar to...). Figure 15 and Figure 16 (See the lead screw shown). The button sends a signal to the motor controller to drive the lead screw in a first direction, thereby moving portions RP1 and RP2 closer together to close the retainer R. The same button (or another button) can send another signal to the motor controller to drive the lead screw in the opposite direction, thereby moving portions RP1 and RP2 away from each other to open the retainer R.

[0173] It is envisioned that the sleeves SL2 of the retainer R can be actuated individually and / or detachably. Figure 22 An example of this configuration is shown. Figure 22 Examples are similar to Figure 15The example illustrates the use of locking mechanisms LM1 and LM2 for each sleeve SL1 and SL2. The first locking mechanism LM1 is coupled to the first sleeve SL1 and can be actuated to rotatably lock the first body TB1 to the first sleeve SL1. The second locking mechanism LM2 is coupled to the second sleeve SL2 and can be actuated to rotatably lock the second body TB2 to the second sleeve SL2. Each sleeve SL1 and SL2 is separately divided into sleeve portions SL1A, SL1B and SL2A, SL2B, respectively. Each locking mechanism LM1 and LM2 includes knobs K1 and K2 coupled to bolts BT1 and BT2, which extend through a shared connecting portion LKP of the retainer R. Each bolt BT1 and BT2 is secured to the second sleeve portion SL2A and SL2B at its distal end. Each knob K1 and K2 can be detachably rotated to open and close the corresponding sleeve SL1 and SL2. This example illustrates the use of locking mechanisms LM1 and LM2 with knobs and bolts. However, this configuration is possible for any of the examples described (e.g., levers, teeth, push buttons, etc.). By including separate locking mechanisms LM1, LM2, the retainer R is able to hold one of the bodies TB1, TB2 in place while allowing the other body of TB1, TB2 to be rotatably adjusted or removed. This configuration is advantageous when only one body TB1, TB2 needs adjustment or removal. The tensioner T can be retained inserted into the knee joint when one body TB1, TB2 is rotatably locked in place, while the other body TB1, TB2 can be rotatably adjusted or removed (separated from the locked body). One body can be locked in a preferred position that the surgeon wants to maintain without affecting the preferred position due to adjustment of the other body. Removal of one body can be for purposes such as adjusting, replacing or altering the paddle, or temporarily cleaning said body.

[0174] 5B. Adjustable connection section

[0175] The several retainer R configurations described above include a connecting portion LKP that is rigidly connected between sleeves SL1, SL2 to secure the lateral position of sleeves SL1, SL2, or sleeve portions relative to each other. In this section, and with reference to... Figures 23 to 26 Several examples of adjustable connecting parts ALKP with one or more connecting parts LPJ are described. The adjustable connecting parts ALKP advantageously allow for adjustment of sleeves SL1, SL2 relative to each other, providing additional degrees of freedom for the tensioner T. Figures 23 to 26 The examples shown include sleeves SL2, SL2 (as shown) that are individually and / or detachably actuated by the retainer R. Figure 22(As described in the example). In this way, the bodies TB1 and TB2 can be rotatably adjusted and locked within each corresponding sleeve SL1 and SL2. Using the adjustable connecting part ALKP and the rotatable bodies TB1 and TB2, the tensioner T can provide two or more degrees of freedom for each body TB1 and TB2.

[0176] In these examples, it is conceivable that the adjustable connecting portion ALKP serves as a supplement to the retainer R or is utilized in the absence of the retainer R. For example, sleeves SL1 and SL2 may be non-adjustable, allowing them to be permanently or semi-permanently connected to each corresponding body TB1 and TB2. Therefore, a locking mechanism LM may or may not be used for each sleeve SL1 and SL2. Alternatively, the adjustable connecting portion ALKP may be directly connected to each corresponding tensioner body TB1 and TB2, eliminating the need for sleeves. The degrees of freedom provided by the adjustable connecting portion ALKP are sufficient to allow for rotational adjustment of each body TB1 and TB2.

[0177] exist Figure 23 and Figure 24 In the example, the adjustable connecting part ALKP separates the sleeves SL1 and SL2, and the connecting part joint LPJ is a translational joint. The translational direction will be perpendicular to the axes BA1 and B2 of the bodies TB1 and TB2. The translational connecting part joint LPJ allows for translational adjustment of one degree of freedom of the sleeves SL1 and SL2 (e.g., along the X direction) to increase or decrease the lateral distance between the bodies TB1 and TB2. By doing so, the adjustable connecting part ALKP achieves translational adjustment of the paddles UP and LP of each body TB1 and TB2. Figure 23 In this configuration, the adjustable connecting portion ALKP is positioned in a laterally extended position to maximize the gap between sleeves SL1 and SL2. Figure 24 In this configuration, the adjustable connecting portion ALKP is positioned in a laterally retracted position to minimize the gap between sleeves SL1 and SL2. This design allows the tensioner T to be further adjusted for different sizes of knee joints or bones. The translational connecting portion joint LPJ can be a telescopic rod, a prism joint, a sliding link, etc. Additionally, the adjustable connecting portion ALKP may include more than one translational connecting portion joint LPJ. For example, it can be perpendicular to... Figure 23 and Figure 24 The illustrated translational connector LPJ is equipped with a second translational connector LPJ. The second translational connector LPJ allows for independent adjustment of the second degree of freedom (e.g., along the Y direction) of the sleeves SL1 and SL2. A third translational connector LPJ, perpendicular to the first and second translational connectors LPJ, is envisioned to allow for independent adjustment of the third degree of freedom (e.g., along the Z direction) of the sleeves SL1 and SL2.

[0178] Optionally, the connecting part locking mechanism LPLM can be operatively coupled to the connecting part connector LPJ to facilitate locking and unlocking of the connecting part connector LPJ. Conversely, the connecting part locking mechanism LPLM can translate relative to each other to lock / unlock sleeves SL1, SL2 and bodies TB1, TB2. For any example described herein, the connecting part locking mechanism LPLM may include similar... Figures 14 to 22 The example describes the configuration or user interface of the locking mechanism LM (e.g., knob, lever, tooth, push button, etc.).

[0179] exist Figure 25 and Figure 26 In the example, the adjustable connection ALKP includes a connecting part joint LPJ that is a rotary joint. The direction of rotation can be parallel to the axes BA1, B2 of the bodies TB1, TB2. In one example, the rotary connecting part joint LPJ allows for rotational adjustment of one degree of freedom (e.g., about the Z direction) of the sleeves SL1, SL2 to increase or decrease the angle or arc length between the bodies TB1, TB2. By doing so, the adjustable connection ALKP allows for adjustment of the angle or arc length of the paddles UP, LP of each body TB1, TB2. Figure 23 In this configuration, the adjustable connecting portion ALKP is positioned in a rotational neutral position to maintain the alignment (e.g., 0 degrees) between sleeves SL1 and SL2. Figure 24 In this configuration, the adjustable ALKP joint can be rotated (e.g., rotated to approximately 40 / 140 degrees) to rotatably adjust the angle or arc length between sleeves SL1 and SL2. The rotating LPJ joint is adjustable up to 360 degrees. This design allows for further adjustments of the tensioner T to different knee joint or bone sizes, or provides fine-tuning of the paddleboard's pose to provide additional contact coverage or bypass the patellar tendon PAT. The rotating LPJ joint can be a ball joint, universal joint, swivel joint, rotary joint, helical joint, omnidirectional joint, elbow joint, etc.

[0180] Additionally, the adjustable connection portion ALKP may include more than one rotary connection portion joint LPJ, or a rotary connection portion joint LPJ providing more than one rotational degree of freedom. For example, it may be perpendicular to... Figure 25 and Figure 26The illustrated rotary joint LPJ includes a second rotary joint LPJ. This second rotary joint LPJ allows for independent adjustment of the second degree of freedom (e.g., rotational adjustment about the Y direction) of the sleeves SL1 and SL2. A third rotary joint LPJ, perpendicular to the first and second rotary joints LPJs, is envisioned to allow for independent adjustment of the third degree of freedom (e.g., rotational adjustment about the Z direction) of the sleeves SL1 and SL2. Instead of multiple rotary joints, a single ball joint, universal joint, swivel joint, or omnidirectional joint can provide these three degrees of rotational freedom.

[0181] The LPLM (Limited Part Locking Mechanism) is operably coupled to the LPJ (Limited Part Connector) to facilitate locking and unlocking of the LPJ. Conversely, the LPLM can lock / unlock the sleeves SL1, SL2 and the bodies TB1, TB2 relative to each other by rotation. For example, a knob can be used to lock / unlock the universal joint.

[0182] Additionally, the adjustable connecting portion ALKP can combine the above implementations in any way to include one or more connecting portion joints LPJ, thereby providing translational and rotational degrees of freedom (up to six degrees of freedom).

[0183] 6. Auxiliary paddleboard components and their usage

[0184] This article references Figures 27 to 32The configuration and use of an auxiliary paddle plate AP that expands the functionality of the tensioner T are described. The tensioner T described in the examples above (in some configurations) includes a lower paddle plate LP designed with a flat bottom surface LBS suitable for interaction with the resected tibial surface, for example, in a mid-tibial resection workflow. However, the flat lower paddle plate LP may not be optimally suited for interaction with the unresected tibia, native tibia, or tibial implant joint surface. The auxiliary paddle plate AP provides a workaround for enabling the tensioner T to interact with the unresected tibia, native tibia, or tibial implant joint surface. The auxiliary paddle plate AP advantageously expands the functionality of the tensioner T without requiring the removal or replacement of any paddle plates UP, LP attached to the respective bodies TB1, TB2. This functionality is beneficial because surgeons may expect to first perform a pre-resection assessment of the knee joint (where the native tibial surface is intact) followed by a mid-tibial resection assessment (where the tibia has already been removed). The auxiliary paddle plate (AP) can be easily inserted into the tensioner T to enable the tensioner T to perform pre-resection assessment. Subsequently, the auxiliary paddle plate (AP) can be easily removed from the tensioner T to allow the tensioner T to perform intermediate resection assessment, for example, using the upper paddle plate (UP) and the lower paddle plate (LP). Other uses of the auxiliary paddle plate (AP) besides pre-resection assessment are also possible. For example, the auxiliary paddle plate (AP) can be used for post-implantation assessment of the knee joint, where a femoral prosthesis is implanted in the femur and a tibial prosthesis is implanted in the tibia. Therefore, the auxiliary paddle plate (AP) can interact with any native (unresected) articular bone surface or any artificial articular bone surface.

[0185] The auxiliary propeller AP is configured to be inserted between and captured by the upper propeller UP and lower propeller LP of a main body TB1. More specifically, the auxiliary propeller AP is configured to be captured between the bottom surface UBS of the upper propeller UP and the top surface LTS of the lower propeller LP (as in...). Figure 29 and Figure 30 (As seen in the accompanying drawings). For simplicity, the corresponding figures illustrate a single auxiliary paddle plate AP used in conjunction with a first body TB1. An auxiliary paddle plate AP may be used with each body TB1, TB2 (one at a time), or the tensioner T may be used simultaneously with two separate auxiliary paddle plate APs (one auxiliary paddle plate per body TB1, TB2). In some cases, the tensioner T may include a common lower paddle plate LP shared between bodies TB1, TB2. In this case, the single auxiliary paddle plate AP may be configured to be used concurrently with both bodies TB1, TB2. The orthopedic tensioner T may include one or more auxiliary paddle plate APs as part of a kit or assembly.

[0186] 6A. Auxiliary Paddleboard Design

[0187] The configuration and implementation of the auxiliary paddleboard (AP) will now be described. Refer to an example, such as... Figures 27 to 29 As shown, the auxiliary paddleboard (AP) includes a main body (APB), which comprises a proximal portion (APP) and a distal portion (ADP). In one example, the proximal portion (APP) is configured to be captured between the upper paddleboard (UP) and the lower paddleboard (LP). Figure 29 As shown, the proximal portion of the APP can rest on the top surface LTS of the lower propeller LP before being captured. The main body APB of the auxiliary propeller AP or the proximal portion of the APP can have a shape substantially conforming to the shape of the lower propeller LP (e.g., Figure 29 (As shown).

[0188] The distal portion of the ADP extends from the proximal portion of the APP. The distal portion of the ADP is the part of the auxiliary paddle plate AP configured to directly contact the first bone B1 and the second bone B2 of the anatomical joint AJ. Once the auxiliary paddle plate AP is inserted into the tensioner T, the distal portion of the ADP will extend beyond the distal end PDE of each paddle plate UP, LP. As will be described below, there are cases where portions of the distal portion of the ADP can be captured between the upper paddle plate UP and the lower paddle plate LP.

[0189] like Figure 29 As shown, the upper paddleboard UP and the lower paddleboard LP each include a length PL defined between the proximal end PPE and the distal end PDE of each paddleboard. The paddleboard lengths PL may be the same or slightly different between the upper paddleboard UP and the lower paddleboard LP. The auxiliary paddleboard AP has a length APL defined between the proximal end APE of the auxiliary paddleboard AP and the distal end ADE of the distal portion ADP of the auxiliary paddleboard AP. The length APL of the auxiliary paddleboard AP may be greater than the length PL of each of the upper paddleboard UP and the lower paddleboard LP.

[0190] The auxiliary paddleboard AP includes a pivot APVT, which is disposed on the main body APB of the auxiliary paddleboard AP and / or connected to the distal portion ADP of the auxiliary paddleboard AP. The pivot APVT is designed such that the auxiliary paddleboard AP can apply a force to the upper paddleboard UP in response to the distal portion ADP contacting the first bone B1 and / or the second bone B2 of the anatomical joint AJ. The force applied by the bones to the distal portion ADP causes the auxiliary paddleboard AP to apply a load to the upper paddleboard UP. The auxiliary paddleboard AP is utilized in conjunction with existing paddleboard UP, LP, and tensioner control system TCS. When the auxiliary paddleboard AP is engaged, the distal portion ADP of the auxiliary paddleboard AP can be understood as a substitute for the contacting bones of the upper paddleboard UP and the lower paddleboard LP.

[0191] exist Figures 27 to 30In the example shown, the pivot APVT is disposed or formed on the body APB of the auxiliary paddle plate AP. Here, the auxiliary paddle plate AP includes a rocker surface RS. The rocker surface RS can engage the top surface LTS of the lower paddle plate LP. In the example shown, the rocker surface RS may include a convex, profiled, or curved portion of the bottom surface of the body ABP and / or a protrusion extending from the bottom surface of the body ABP. The rocker surface RS enables the auxiliary paddle plate AP to pivot or provide a fulcrum so that the auxiliary paddle plate AP can act as a lever in response to contact of the distal portion ADP with the skeleton. The auxiliary paddle plate AP may include a top surface ATS opposite to the rocker surface RS. The top surface ATS may be planar and configured to engage the bottom surface UBS of the upper paddle plate UP to securely capture the auxiliary paddle plate AP and improve measurement accuracy. Within the top surface ATS, a channel AC may be formed so that the auxiliary paddle plate AP can engage with a correspondingly formed protrusion UPP formed or disposed on the bottom surface UBS of the upper paddle plate UP. Once the auxiliary propeller AP is captured, the protrusion UPP enters the channel AC. The engagement between the protrusion UPP and the channel AC helps ensure that the auxiliary propeller AP is firmly attached to the body TB once captured, without the possibility of slipping out.

[0192] like Figures 27 to 29 As shown in the example, the distal portion of the ADP has a tongue-like configuration with opposing top and bottom surfaces, the top and bottom surfaces being designed to contact the first bone B1 and the second bone B2, respectively (e.g., Figure 30 (As shown). The distal portion of the ADP may include curvature. Curvature can be provided to enhance the mechanical advantage of forcing the bones apart. The curved distal portion of the ADP may extend above the plane of the top surface ATS. Alternatively, the curved distal portion of the ADP may be flat or curved downwards, for example, downwards to below the plane of the top surface ATS. To facilitate smooth lever action of the auxiliary paddle AP, the curvature of the distal portion of the ADP may be the same radius or arc along the rocker surface RS. In the example shown, the distal portion of the ADP shares a common surface with the rocker surface RS and transitions seamlessly to the rocker surface. The distal portion of the ADP may include configurations other than those specifically shown. For example, the distal portion of the ADP may include a wider tongue, or two surfaces that are open to each other (e.g., horizontally or vertically).

[0193] In some cases, auxiliary paddleboards (APs) (such as...) Figures 27 to 30The same configuration shown can be utilized in a flipped manner. When flipped, the top surface ATS of the auxiliary paddle plate AP engages the top surface LTS of the lower paddle plate LP, and the rocking surface RS of the auxiliary paddle plate AP engages the bottom surface UBS of the upper paddle plate UP. Alternatively, the auxiliary paddle plate AP may include a design opposite to that shown, wherein instead of being on the bottom surface of the auxiliary paddle plate AP, the rocking surface RS is located on the top surface ATS.

[0194] The main body (APB) of the auxiliary paddle plate (AP), including the distal portion (ADP), the rocker surface (RS), and the top surface (ATS), can be a single, integral, or monolithic part of a main body, or integrally formed from a common material. The common material can be a metal, a metal alloy, PTFE, etc. Alternatively, any feature of the main body (APB) can be a separate component assembled to the main body. For example, the rocker surface (RS) may include a separate component formed from a material different from the main body (APB).

[0195] exist Figure 31 and Figure 32 In another example shown, the pivot APVT of the auxiliary paddleboard AP is implemented using a hinged component. The distal portion ADP of the auxiliary paddleboard AP includes an auxiliary upper paddleboard AUP, which is configured to contact the upper paddleboard UP and a first skeleton B1. The distal portion ADP also includes an auxiliary lower paddleboard ALP, which is configured to contact the lower paddleboard LP and a second skeleton B2. The auxiliary upper paddleboard AUP can pivot relative to the auxiliary lower paddleboard ALP in response to the distal portion ADP contacting the first skeleton B1 and the second skeleton B2 to apply a force to the upper paddleboard UP. The pivot APVT is a hinge connecting the auxiliary upper paddleboard AUP and the auxiliary lower paddleboard ALP. The body APB of the auxiliary paddleboard AP can rest on the lower paddleboard LP. The auxiliary lower paddleboard ALP can be fixed relative to the body APB, and the auxiliary upper paddleboard AUP can be pivoted relative to the body APB. When the auxiliary paddle plate AP is inserted into the tensioner T, the pivot APVT can be located between the upper paddle plate UP and the lower paddle plate LP. The auxiliary upper paddle plate AUP includes a lever AUP-L that extends rearward toward the pivot APVT and is designed to engage the bottom surface UBS of the upper paddle plate UP.

[0196] like Figure 31As shown, the body TB1 of the tensioner T has blades UP and LP spaced apart, with the upper blade UP touching the auxiliary upper blade AUP but not yet pressed down on it. In this configuration, the auxiliary upper blade AUP and the auxiliary lower blade ALP can be in a closed state, with the distal blades AUP and ALP touching each other. Blades UP and LP can be positioned to hold the auxiliary blade AP in a closed state. The auxiliary lower blade ALP can define a gap configured to receive the auxiliary upper blade AUP and surround the periphery of the auxiliary upper blade in the closed state. The auxiliary blade AP can be in a closed state (similar to...) Figure 31 It is inserted into the anatomical joint JP. In the closed state, the distal paddle plates AUP and ALP can interact with the first bone B1 and the second bone B2, respectively. The distal paddle plates AUP and ALP can have corresponding curvatures to enhance the mechanical advantage of forcing the bones apart.

[0197] Figure 32 The diagram illustrates the open state of the auxiliary paddleboard AP. The upper paddleboard UP can be commanded to move downward toward the lower paddleboard LP. The upper paddleboard UP presses down on the lever AUP-L, causing the auxiliary upper paddleboard AUP to rotate about the pivot APVT. Thus, the auxiliary upper paddleboard AUP becomes spaced apart from the lower paddleboard AUP (e.g., in the open state). The auxiliary paddleboard AP can be inserted between the bones in the closed state and then changed to the open state. This process can separate or spread the bones so that the tensioner control system TCS can obtain readings related to the joint AJ. Movement of the upper paddleboard UP can cause the distal paddleboards AUP and ALP to move from the closed state to the open state, from the open state to the closed state, or to any position in between.

[0198] Imagine the Figure 31 and Figure 32 Modifications to the configuration of the auxiliary paddles AP. For example, the auxiliary lower paddle ALP may alternatively or additionally move in response to a corresponding movement of the upper paddle UP. The pivot APVT may be any type of hinge or swivel joint other than the hinge or swivel joint shown. The pivot APVT may be positioned at a location other than the position shown. The distal paddles AUP and ALP may be planar or flat. A lever AUP-L may be additionally or alternatively provided for the auxiliary lower paddle ALP.

[0199] 6B. Tensioner control scheme for use with auxiliary paddles

[0200] Here, the operation of the tensioner control system (TCS) will be described in conjunction with the use of the auxiliary paddle plate (AP). The TCS can be used to facilitate the capture of the auxiliary paddle plate (AP) and to facilitate the sensing of displacement or force caused by the interaction between the auxiliary paddle plate (AP) and the skeleton.

[0201] First, insert the auxiliary paddle plate AP into the tensioner T or the main body TB1, for example, between paddle plates UP and LP (e.g., as shown in the image). Figure 29 (As shown). At this stage, the auxiliary blade AP may be passively rested on the top surface LTS of the lower blade LP. The tensioner control system TCS controls the drive assembly DA to move the upper blade UP relative to the lower blade LP (e.g., downward). Due to the movement of the upper blade UP, the auxiliary blade AP becomes trapped between blades UP and LP. Alternatively or additionally, the auxiliary blade AP may be trapped by the movement of the lower blade LP relative to the upper blade UP, or by the movement of both blades UP and LP. The auxiliary blade AP may be secured to the tensioner T simply by being trapped between blades UP and LP (e.g., by opposing forces provided by blades UP and LP on the auxiliary blade AP). In some cases, the auxiliary blade AP and / or the lower blade LP may include holding features for temporarily holding the auxiliary blade AP to the lower blade LP before trapping. For example, the lower paddleboard LP may include sidewalls designed or configured to temporarily hold the auxiliary paddleboard AP and prevent it from slipping off the lower paddleboard LP before being captured. When the auxiliary paddleboard AP is captured, the distal portion ADP of the auxiliary paddleboard AP will extend beyond the distal end PDE of each paddleboard in the paddleboards UP and LP. The distal portion ADP is then used to contact the bones of the anatomical joints (e.g., as shown in the image). Figure 30 (As shown).

[0202] As described in the preceding sections, the tensioner T can operate in displacement control mode (DCM), force control mode (FCM), or force-displacement control mode. Any of these modes can be used to capture the auxiliary paddle plate (AP) and obtain measurements resulting from the AP's contact with the bone. The tensioner control system (TCS) can be controlled via the clinical application (CA) and / or via the user input device (TID) on the tensioner T itself to trigger the capture of the auxiliary paddle plate AP.

[0203] To capture the auxiliary paddle plate AP in Displacement Control Mode (DCM), the tensioner control system (TCS) commands the upper paddle plate UP to displace towards the lower paddle plate LP. This process can be manually guided or automatically implemented. In one example, the TCS can automatically lower the upper paddle plate UP until a predetermined capture displacement between the upper paddle plate UP and the lower paddle plate LP is detected or reached. The predetermined capture displacement can be used to prevent the upper paddle plate UP from being overdriven onto the auxiliary paddle plate AP and potentially damaging system components. The predetermined capture displacement can be detected by a displacement or position sensor (such as a motor encoder M) or any other sensing system described herein. The predetermined capture displacement indicates that the auxiliary paddle plate AP is properly or adequately captured between the paddle plates UP and LP. For example, the TCS can include predetermined data related to the geometry of the auxiliary paddle plate AP and derive the predetermined capture displacement from such data. In one example, the predetermined capture displacement can be defined by the difference between the current spacing between the paddle plates UP and LP and the thickness of the auxiliary paddle plate AP. In another example, the paddles UP and LP can be automatically positioned at their maximum open position, and then the upper paddle UP can be automatically lowered by a predetermined capture displacement. The maximum open position provides a consistent reference displacement to avoid additional calculations related to various possible paddle spacings. In another example, the user can lower the upper paddle UP in displacement control mode DCM using the clinical application CA and / or the user input device TID on the tensioner T itself. The user-implemented lowering of the upper paddle UP can be adjusted by the tensioner control system TCS to ensure that it does not exceed the predetermined capture displacement. In other words, the user can control the tensioner T to lower the upper paddle UP until the tensioner control system TCS determines that the auxiliary paddle is adequately captured. Thereafter, the tensioner control system TCS can prohibit further movement of the upper paddle UP and / or provide the user with visual confirmation on a display that the auxiliary paddle AP has been captured and is ready for use. This visual guidance can be presented on any display described herein, including head-mounted displays.

[0204] To obtain joint measurements in Displacement Control Mode (DCM) using the auxiliary paddle plate (AP), the distal portion (ADP) of the AP contacts the bone, and in response, the AP applies a force to the upper paddle plate (UP). A displacement or position sensor measures the displacement between paddle plates UP and LP resulting from the force applied by the AP to the upper paddle plate UP. Alternatively or additionally, a force sensor (S) can be used to measure the force applied by the AP to the upper paddle plate UP. The tensioner control system (TCS) can use the measured displacement and / or force to obtain readings about the joint AJ, such as relaxation, stiffness, ligament balance, kinematic characteristics, flexion, extension, and / or range of motion. In Displacement Control Mode (DCM), the tensioner control system (TCS) can also be configured to ( Figures 31 to 32 The auxiliary paddle plate AP is positioned in an open or closed state to control the paddle plates UP and LP. For example, the tensioner control system TCS may include predetermined data related to the geometry of the auxiliary paddle plate AP, and use the predetermined data to move the upper paddle plate UP in the manner required to open or close the distal paddle plates AUP and ALP.

[0205] To capture the auxiliary blade AP in Force Control Mode (FCM), the tensioner control system (TCS) commands the upper blade UP to move toward the lower blade LP. This process can be manually guided or automatically implemented. In one example, the TCM can automatically lower the upper blade UP until a predetermined capture force applied by the auxiliary blade AP to the upper blade UP is detected or reached. The predetermined capture force can be used to prevent the upper blade UP from being overdriven onto the auxiliary blade AP and potentially damaging system components. The predetermined capture force can be detected by a force sensor S. The predetermined capture force indicates that the auxiliary blade AP is properly or adequately captured between blades UP and LP. For example, the TCS can include predetermined data related to the geometry of the auxiliary blade AP and derive the predetermined capture force from such data. Alternatively or additionally, the predetermined capture force can be derived from factory measurements based on tests involving capturing the auxiliary blade AP. The predetermined capture force can also be the maximum permissible force of the tensioner T or any force less than the maximum permissible force. In another example, the paddles UP and LP can be automatically positioned at their maximum open position, and then the upper paddle UP can be automatically lowered until a predetermined capture force is achieved. In yet another example, the user can lower the upper paddle UP in force control mode (FCM) using the clinical application CA and / or the user input device TID on the tensioner T itself. The user-implemented lowering of the upper paddle UP can be adjusted by the tensioner control system TCS to ensure that the predetermined capture force is not exceeded. In other words, the user can control the tensioner T to lower the upper paddle UP until the tensioner control system TCS determines that the predetermined capture force has been achieved and the auxiliary paddle is adequately captured. Thereafter, the tensioner control system TCS can prevent further movement of the upper paddle UP and / or provide the user with visual confirmation on a display that the auxiliary paddle AP has been captured and is ready for use. This visual guidance can be presented on any display described herein, including head-mounted displays.

[0206] To obtain joint measurements in force-controlled mode FCM using the auxiliary paddleboard (AP), the distal portion (ADP) of the AP contacts the bone, and in response, the AP applies a force to the upper paddleboard (UP). A force sensor (S) measures the force generated by the auxiliary paddleboard (AP) applied to the upper paddleboard (UP). The tensioner control system (TCS) uses the measured force to obtain readings about the joint (AJ), such as relaxation, stiffness, ligament balance, kinematic characteristics, flexion, extension, and / or range of motion. In force-controlled mode FCM, the tensioner control system (TCS) can also be configured to ( Figures 31 to 32 The auxiliary paddles AP are positioned in an open or closed state to control the paddles UP and LP. For example, the tensioner control system TCS may include a predetermined force indicating the open and closed states, and move the upper paddle UP in a manner required to open or close the distal paddles AUP and ALP.

[0207] The tensioner control system (TCS) can combine the functions or features described above for displacement and / or force to capture the auxiliary paddle plate (AP) and utilize the AP to obtain joint measurement results in force-displacement control mode.

[0208] The tensioner control system TCS can capture the auxiliary paddle plate AP in any of the described modes and utilize the auxiliary paddle plate AP to obtain joint measurement results in any other mode of the described modes. The two purposes do not need to employ the same mode. Additionally, the tensioner control system TCS can utilize any two modes to capture the auxiliary paddle plate AP or switch between any two modes to capture the auxiliary paddle plate. Furthermore, the tensioner control system TCS can utilize any two modes to obtain joint measurement results using the auxiliary paddle plate AP or switch between any two modes to obtain joint measurement results using the auxiliary paddle plate. In another implementation, the user can manually press down on the upper paddle plate UP to capture the auxiliary paddle plate AP (regardless of any control mode). Then, once the user confirms that the auxiliary paddle plate AP has been captured, the tensioner control system TCS can lock the position of the upper paddle plate UP. In yet another implementation, the tensioner control system TCS can simply space the paddle plates UP and LP apart just enough space to accommodate the auxiliary paddle plate AP. The user can then insert the auxiliary paddle plate AP while the paddle plates UP and LP remain in this spaced-out position.

[0209] 7. Reinforcing elements / spacers for paddle plates

[0210] refer to Figure 43It is envisioned that reinforcements or spacers (SPs) be incorporated into any one or more paddles UP, LP, or tensioners T. The spacer (SP) can increase the height of any of the paddles in one or more UP, LP, allowing the paddles to exhibit a greater spread. By providing a greater spread, such spacers (SPs) enable the tensioner T to be more versatile and usable in a wider range of applications. For example, the greater spread provided by the spacer (SP) is advantageous for TKA repair procedures and / or for initial surgeries where the tibia is removed first or the patient has a large joint space.

[0211] The spacer SP is configured to be removably attached to any paddle plate UP, LP. For example, as... Figure 43 As shown, two spacers SP1 and SP2 are connected to the skeletal contact surface of the upper paddleboard UP, and one spacer SP3 is connected to the skeletal contact surface of the lower paddleboard LP. The spacers SP can be applied only to the upper paddleboard UP, only to the lower paddleboard LP, or simultaneously or at different times to both paddleboards. The connection between the spacers SP and the corresponding paddleboards UP and LP can be achieved in various ways. The spacers SP can be connected to the corresponding paddleboards UP and LP using magnetic connections, mechanical connections, or temporary adhesive connections. For example, as... Figure 43 As shown, the spacer SP or corresponding paddle plate may have one or more protrusions (e.g., posts or bosses), and the other may have one or more corresponding holes configured to receive the protrusions for securing the components together. The protrusion / hole technique can be used in conjunction with magnetic coupling to ensure that the lower paddle plate spacers (SP) remain connected. To increase the spacer height, spacers SP can be stacked together by incorporating similar coupling techniques (e.g., as shown in SP1, SP2, and UP).

[0212] The spacers SP can have any suitable thickness (e.g., height) and size. For example, the tensioner T is equipped with a set of spacers SP with incremental thicknesses (e.g., 2 mm, 5 mm, ..., 20 mm, etc.) and incremental sizes (sizes 1, 2, 3, ..., 10, etc.). SPs of different thicknesses and / or sizes can be applied to different paddles, depending, for example, on the desired range of expansion. For example, in the case where the tensioner T has separate inner and outer upper paddles, the size and / or thickness of the spacers SP on the inner upper paddle can differ from that on the outer upper paddle. Additionally, for TKA repair procedures, the spacers SP can be conveniently designed to increase the thickness increment to match the preparation of the reinforcing bone (e.g., removal of bone to make room for the reinforcing implant).

[0213] The spacer SP can have any suitable shape. For example, the spacer SP can be disc-shaped or conform to the shape of a corresponding paddle. The spacer SP can have substantially flat upper and lower surfaces. In another example, the bone contact surface of the spacer SP can be curved or profiled to provide an articular surface that allows the contacting bone to rotate on the spacer SP during joint assessment. The curvature or profile setting can be generic or patient-specific and can be additively manufactured.

[0214] Spacer SPs can be used during any type of procedure and at any stage of the procedure. For example, in a primary case, spacer SPs can be used to access the native bone surface (before bone preparation), the bone surface after preparation, or the implant surface (after implant placement). Spacer SPs can be used once both the femoral and tibial surfaces have been removed / prepared, or once one of the femoral and tibial surfaces has been removed / prepared. In a restorative procedure, spacer SPs can be used to access any of the described surfaces and the primary implant (from the previous procedure). In another example, for either a primary or restorative procedure, spacer SPs can be used to simulate the geometry of a test implant. In yet another example, instead of attaching to a corresponding paddle, spacer SPs can be attached to the (primary or restorative) implant itself.

[0215] 8. Tensioner Method and Workflow

[0216] refer to Figures 33 to 41 The following sections describe several examples of how tensioner T can be used to evaluate anatomical joints AJ using any of the configurations described above. As described above, tensioner T can be used to evaluate multiple parameters of the joint, such as laxity, stiffness, ligament balance, kinematic properties, flexion, extension, and / or range of motion. In these examples, tensioner T leverages the advantages of computer-aided methods, such as surgical navigation systems 32 and / or clinical applications CA. Therefore, surgeons do not need to rely on their subjective knowledge and skills to predict the state of the joint. In turn, the methods and workflows described herein can be used to optimize joint assessment and surgical outcomes.

[0217] In the description of the following method, it should be understood that the method can be used with one tensioner body or with two tensioner bodies TB1, TB2. Depending on the configuration of the tensioner T, certain steps can be performed once on the knee joint, i.e., using one tensioner body TB or simultaneously using two tensioner bodies TB1, TB2, or can be performed twice, i.e., once for each tensioner body TB1, TB2. Therefore, although some steps of the method are described in a single manner for the sake of simplicity, it is conceivable that these steps can be performed multiple times, simultaneously, sequentially, or in parallel.

[0218] 8A. Knee extension test

[0219] A particularly challenging part of the knee assessment process involves determining the optimal degree of relaxation required for the knee to achieve full extension (e.g., approximately 0 degrees of knee flexion). Opening the knee to 0 degrees (full extension) with any tensioner is likely to produce inaccurate measurements due to posterior capsule tension. To assess knee extension at full extension, this paper describes enhanced workflows and methods for using a tensioner T. These workflows and methods provide surgeons with a seamless and optional automated or semi-automated process for assessing knee extension, while avoiding the need for trial-and-error or educated guesswork in adjusting the tensioner T or assessing the knee. The techniques described herein reduce assessment time, produce accurate results, and offer greater convenience to surgeons.

[0220] Figure 33 An example method 200 for performing an "extension test" using a tensioner T is described. The term "extension test" is used herein to describe the process of assessing whether the knee joint AJ can achieve acceptable full extension using a tensioner T. An acceptable full extension posture can be full extension (e.g., approximately 0 degrees of knee flexion). Alternatively, an acceptable full extension posture may not be full extension, depending on the patient's soft tissue and skeletal anatomy, as well as surgeon preferences and surgical planning. For example, an acceptable full extension posture can be any value within the range of -1 to 5 degrees of full extension. An acceptable full extension posture can be a single value or a range of values. The acceptability of full extension can be determined by the surgeon, surgical planning, implant parameters, or can be based on automated planning predictions made by System 10.

[0221] Method 200 includes a first step 202: controlling the tensioner T in force control mode FCM via the tensioner control system TCS to apply force to the knee joint AJ until a predetermined force is reached. In some cases, it is conceivable that force control mode FCM can be initiated once the paddleboard contacts the bone and a certain initial force or resistance is measured. For example, the tensioner T can be used in displacement control mode, or the paddleboard can move at a constant speed until a certain force or resistance is measured. Thereafter, the tensioner T can be operated in force control mode FCM to apply force to the knee joint AJ until a predetermined force is reached.

[0222] Then, at step 204, the tensioner control system TCS captures multiple force-displacement data pairs from the tensioner T, generated by the force applied by the tensioner T in force control mode FCM. At step 206, the tensioner T is operated in displacement control mode DCM by progressively reducing the displacement of the tensioner T based on the displacement from the multiple force-displacement data pairs. The reduction in displacement can occur until the knee joint AJ reaches an acceptable full extension posture. The knee joint may reach an acceptable full extension posture during the extension test or after the extension test is completed. Specific aspects, implementations, and variations of this method 200 will be described below.

[0223] refer to Figures 34 to 36 This paper illustrates a method 300 for assessing the anatomical joint AJ (e.g., by performing an extension test) using a tensioner T. The steps of method 300 do not need to be performed in the order shown. Furthermore, the invention is not limited to requiring each step illustrated. The tensioner T has a variety of possible uses, which can utilize the selected steps in various orders and for different purposes other than assessing knee extension. For example, the tensioner T can be used with certain steps of the described method 300 to assess whether the knee joint can reach other positions, such as a moderately flexed position or a flexed position (e.g., about 90 degrees).

[0224] At step 302, navigation system 32 uses locator 44 to track the femoral F and tibial TIB of the knee joint AJ. This can be achieved using various aspects of the tracking system described above (e.g., using anatomical trackers 54, 56, or any other tracking modality). This step 302 is optional but can provide useful information to help surgeons understand the parameters of the knee joint AJ.

[0225] At 302a, the pose of the knee joint AJ can be dynamically tracked using information from the locator 44. The femoral F and tibial TIB can be registered to the navigation system 32. By understanding the corresponding poses of the femoral F and tibial TIB, the navigation controller 36 can calculate the relationship between the corresponding long axes of the bones. Figures 38 to 41 An example of a graphical user interface (GUI) for a clinical application CA is illustrated, which can display the output of tracking the femur (F) and tibia (TIB) on a display device 38. The GUI can display a virtual representation of the femur (F') and a virtual representation of the tibia (T'), and can dynamically adjust the pose of the virtual bones according to the pose of the bones tracked by the locator 44. The relationship between the bones can be a flexion / extension angle or a varus / valgus angle. For example, in Figure 38In this configuration, the knee joint is in a 15-degree flexion position, and the virtual representations F' and TIB' are correspondingly shown as being in a 15-degree flexion position. Furthermore, the knee joint posture exhibits a 2-degree varus alignment. The navigation system 34 can record the posture over time, including changes in posture, and output the posture data for display on a graphical user interface (GUI). Alternatively or additionally, such information can be presented on any display described herein, including head-mounted displays.

[0226] At 302b, information from locator 44 can be used to dynamically track the gap of the knee joint AJ. The gap is the distance or gap between the surfaces of the femur (F) and tibia (TIB). When measuring the gap, any bone surface may be resected, unresected, or partially resected. Any resected surface may be smooth (e.g., tibiactomy) or irregular (e.g., for repair procedures). Furthermore, the surface can be the articular surface of bone or an existing implant in the bone. The articular surface can be a native articular surface (e.g., the native condyle of the femur) or an artificial articular surface (e.g., the surface of an artificial condyle component of a femoral implant or a test implant). The gap between the surfaces can be calculated based on the most distal point of each surface, or based on an average value taken from some distal points. Navigation system 34 can record the gap over time, including changes in the gap, and output the gap data for display to a graphical user interface (GUI). In other cases, the gap can be measured based on virtual surfaces of the bone rather than actual surfaces. For example, a 3D virtual model of the bone can be compared to determine the joint gap, e.g., in discrete poses or within a range of motion. The implant can be virtually planned relative to a 3D virtual bone model, and gaps can be compared relative to the surface of the virtual implant. Movement of the bone tracked by locator 44 can cause corresponding movement of the virtual bone model and / or the virtual implant to evaluate the gap. Any gap in the described examples for calculating the gap can be used alone or in combination.

[0227] At step 304, the knee joint AJ is positioned in a first acceptable flexion position. An acceptable flexion position is a knee position between full extension and full flexion, such as moderate flexion or partial flexion. In one example, the first acceptable flexion position could be a value between 2 and 15 degrees of knee flexion, such as 10 degrees (e.g., ...). Figure 34(As illustrated). The first acceptable flexion pose can be a single value or a range of values. The acceptability of the first acceptable flexion pose can be defined by the surgeon, surgical planning, implant parameters, or can be based on automated planning predictions made by System 10. The term "first" is not intended to limit the first acceptable flexion pose to the initial pose of the knee joint, but is used as a modifier to distinguish this knee joint pose from the other poses described herein. In other examples, as will be described below, the knee joint AJ may initially be positioned in a moderately flexed or semi-flexed pose (e.g., approximately 90 degrees).

[0228] The process of positioning the knee joint AJ into any of the positions described herein (including the first acceptable flexion position) can be manual, automated, or semi-automated. When performed manually, the surgeon or technician physically moves the knee joint AJ into the first acceptable flexion position. At 304b, for example, the navigation system 34 may use a graphical user interface (GUI) to provide visual guidance to assist the surgeon or technician in positioning the knee joint AJ into the first acceptable flexion position. For example, as Figure 38 As shown, the GUI illustrates the angle of the knee joint's current pose, in this case, 15 degrees of flexion. The GUI can further represent the current pose of the knee joint AJ using a movement indicator MI. In this example, the movement indicator MI is a shape object (e.g., a circle) that moves along a bar based on the knee joint's flexion. The bar indicates the total range of flexion of the joint. A static indicator SI (e.g., an elliptical shape) is located on the bar in an area indicating the range of the first acceptable flexion pose. When the movement indicator MI is within or within the range of the static indicator SI, the GUI can confirm to the user that the knee joint is in the first acceptable flexion pose. Confirmation can be achieved by changing the color of the indicators MI and SI, for example, by changing the color to green. Additionally or alternatively, the GUI can provide text or graphical indicators to convey that the knee joint is in the first acceptable flexion pose. The indicator shown is one of many possible examples of techniques for conveying the above information. The inventors have considered other graphical techniques, such as showing a side view comparison between a representation of the knee joint's current pose and the first acceptable flexion pose.

[0229] Alternatively, the knee joint AJ can be positioned automatically or semi-automatically in any of the poses described herein (such as a first acceptable flexion pose). Automated or semi-automated movement can be predefined or set by the surgeon or staff. Parameters of automated movement can be discrete positions, continuous movements, prescribed manner, target pose, target range, etc. Anatomical manipulators (such as robotically controlled limb supports) can be attached to the knee joint AJ to provide automated movement in or between different poses. Automated manipulators can reposition and / or reorient the knee joint AJ in any suitable manner. Anatomical manipulators may include mechanisms for extending or flexing the knee joint AJ. For example, an anatomical manipulator may be supported by a skid that moves along a support rod. Automated movement may involve moving the skid along the support rod to achieve the desired movement of the knee joint AJ. Anatomical manipulators can also rotate or tilt the knee joint AJ medially or laterally (towards or away from the patient's centerline). Fixation mechanisms can be used to fix other parts of the leg or knee to the support. Anatomical manipulators can be locked in any of the given poses described herein. Of course, the anatomical manipulator can have various other configurations and can be manipulated in various other ways. In another implementation, the manipulator 14 itself is used as the anatomical manipulator. For example, a limb support end effector can be attached to the manipulator 14 to achieve movement of the knee joint AJ. The limb fixator end effector can then be exchanged for end effector 22 to manipulate tissue during the procedure. In this example, one or more controllers 60, 36, 26 can control the manipulator 14 to move the limb support end effector in any suitable automated manner as described. In some cases, a force / torque sensor S can detect forces / torques indicating a target pose or target range of the knee joint AJ. One or more controllers 60, 36, 26 can detect these forces / torques to identify that the knee joint AJ has moved. In other implementations, one or more controllers 60, 36, 26 can capture and analyze joint encoder data and / or joint motor torque to determine that the knee joint AJ has moved.Anatomical manipulators may be similar to those described in the following: U.S. Patent Application Publication No. 20190262203 entitled “Motorized JointPositioner”, U.S. Patent No. 10390737 entitled “System and Method of Controlling a Robotic System for Manipulating Anatomy of a Patient During a Surgical Procedure”, and / or U.S. Patent Application No. 18 / 135,280 entitled “Systems and Methods for Guided Placement of a Robotic Manipulator”, the entire contents of each of which are incorporated herein by reference.

[0230] At step 306, the knee joint AJ has been positioned in a first acceptable flexion position, and the tensioner control system TCS controls the tensioner T in force control mode FCM to apply force to the knee joint AJ until a predetermined force is reached. For this step, the tensioner control system TCS may automatically trigger force control mode FCM in response to detecting that the knee joint AJ has been positioned in the first acceptable flexion position. Alternatively, the user may selectively activate force control mode FCM using the clinical application CA or the tensioner input device TID. The process of applying force to the knee joint AJ may involve the two tensioner bodies TB1, TB2 of the tensioner T. The upper paddle UP of the first tensioner body TB1 engages one condyle (medial / lateral) of the femur F, and the upper paddle UP of the second tensioner body TB2 engages the other condyle (medial / lateral) of the femur F. The lower paddle LP of the first tensioner body TB1 and the lower paddle LP of the second tensioner body TB2 jointly engage the tibia. In one example, the tibial TIB is removed during a mid-tissue resection workflow. In force-controlled mode (FCM), each corresponding upper paddle is commanded to move until a predetermined force is reached. The predetermined force can be detected by a sensor S within each tensioner body TB1, TB2 and recorded by the tension control system TCS. The applied force is gradually increased until the predetermined force is reached. For tensioner bodies TB1, TB2, the commanded movements can be simultaneous or separate. In one example, the predetermined force is a value in the range of 50 N to 150 N, such as 100 N. Other values ​​and ranges of predetermined forces are envisioned. For both tensioner bodies TB1, TB2, the predetermined force can be the same or can differ depending on various factors (such as predetermined information regarding the relaxation of the medial / lateral components). For the medial and lateral compartments of the knee joint AJ, the predetermined force can be reached at the same time or at different times.

[0231] At step 308, based on the force applied at step 306, the tensioner control system TCS (optionally combined with navigation system 34) can capture multiple force-displacement data pairs. The process of obtaining these force-displacement data pairs advantageously provides a test or sampling of the relaxation of the knee joint in a partially extended rather than fully extended posture, a posture that presents a challenge for evaluating the knee joint. As described below, one of the force-displacement data pairs can present an optimal dataset for enabling the knee joint to achieve full extension. Each force-displacement data pair includes a force measurement and a displacement measurement. For the multiple discrete forces applied in step 306, corresponding displacements of the knee joint AJ are captured. In one example, each corresponding displacement value is the displacement between the upper paddle UP and the lower paddle LP of each corresponding tensioner body TB. The displacement can be measured using the tensioner encoder EN described above. In another example, each corresponding displacement value is the knee joint clearance as measured by positioner 44. Force-displacement data pairs can be captured for both inner and outer compartments, for example, using tensioner bodies TB1 and TB2. In one example, at 308b, the tensioner control system TCS and / or navigation system 34 can generate a lookup table (LUT) based on multiple force-displacement data pairs. Figure 34 (As illustrated). The lookup table (LUT) can be visualized to the user using a graphical user interface (GUI), or it can be hidden from the user but stored for backend use. In the example shown, the lookup table LUT exemplifies seven discrete forces applied at step 306, ranging from 70 N to 130 N. For each discrete force, corresponding inner and outer displacements are provided. Data from the lookup table LUT can be used to generate relaxation curves for the inner and outer components, which can also be visualized using a GUI.

[0232] At 308b, the tensioner control system TCS and / or navigation system 34 can capture the target displacement of the tensioner T when a predetermined force is reached. The target displacement can indicate the target clearance of the knee joint. The target clearance can be the optimal clearance or preferred clearance of the knee joint. As described, the navigation system 34 can utilize a locator to measure the clearance of the knee joint. The target clearance can be utilized in a subsequent step (312) during which an extension test is performed.

[0233] Figure 38The following illustrations illustrate what the GUI may display during the processes of steps 306 and 308. The knee joint is virtually represented in a first acceptable flexion position (e.g., 15 degrees). Numerical buttons are provided on the GUI for selecting an operating mode. The GUI indicates the selected operating mode of the tensioner T, i.e., the force control mode. A predetermined force (e.g., 110 N) can be selected and set on the GUI for the medial and lateral compartments. The GUI may include a "Send Command" button for triggering the tensioner T to apply the predetermined force. Real-time force-displacement data (e.g., force X N, position X mm) can be displayed for the medial and lateral compartments. Real-time relaxation values ​​(e.g., X mm) can be displayed for the medial and lateral compartments. Relaxation can be represented using a bar graph, which can show directionality in a positive (upward) or negative (downward) direction based on the relaxation value. This GUI, or any aspect thereof, can be presented on any display described herein, including head-mounted displays.

[0234] exist Figure 35 In the middle, method 300 from Figure 34 Step 308 continues to step 310. At step 310, the tensioner control system TCS switches the tensioner T from force control mode (FCM) to displacement control mode (DCM). For this step 310, the mode switch can be automatically triggered by the tensioner control system TCS in response to the capture of force-displacement data pairs. Alternatively, the user can selectively activate displacement control mode (DCM) using the clinical application CA or the tensioner input device TID. This step can be performed while the knee joint is held in a first acceptable flexion position. Furthermore, this step can be performed (after step 308) while the medial and lateral compartments are still under tension due to the force applied by the tensioner T. For example, the position of the tensioner T can be locked after a predetermined force is reached, and the tensioner T can be switched to displacement control mode (DCM) while maintaining this locked position. Alternatively, in response to switching to displacement control mode (DCM), the tensioner T can adopt a nominal or default position, such as a closed paddle position.

[0235] At step 312, with the tensioner T in displacement control mode (DCM), the extension test can begin. The tensioner control system (TCS) can control the tensioner T in displacement control mode (DCM) to perform the extension test by commanding or changing the displacement of the tensioner T based on displacements from multiple force-displacement data pairs (captured in step 308). In one example, the tensioner T progressively reduces the displacement of the upper blade UP (relative to the lower blade LP) based on displacements from multiple force-displacement data pairs (e.g., lowering or reducing the upper blade). When using two tensioner bodies TB1 and TB2, the tensioner T progressively reduces the displacements of the inner upper blade UP of one body TB and the outer upper blade UP of the other body TB based on corresponding inner and outer displacements from multiple force-displacement data pairs.

[0236] The gradual reduction of the upper paddle plate UP can be performed using various methods. In one example, at 312a, the tensioner T can lower the upper paddle plate UP according to specific displacement values ​​stored in a lookup table LUT. For example, the tensioner control system TCS first lowers the upper paddle plate UP to the maximum displacement value from the table LUT, then lowers the upper paddle plate UP to the second largest displacement value from the table LUT, and so on. The process can continue in descending order for each displacement value as needed to complete the extension test. For example, the process can continue until a displacement value is identified that allows the knee joint to reach an acceptable fully extended posture (as described below at 316). Alternatively, the process can continue in descending order for each displacement value until the last (or smallest) displacement value from the LUT is reached. When transitioning from one displacement value to the next, the tensioner control system TCS can transition continuously or smoothly between displacement values, or it can wait for a predetermined amount of time (e.g., 1 second) between transitions. Advantageously, as will be described below, by lowering the upper paddleboard UP based on the specific displacement values ​​stored in the table LUT, the tensioner control system TCS can be correlated with the forces in the table LUT to determine parameters related to the knee joint.

[0237] Additionally or alternatively, at 312b, a progressive reduction in the displacement of the upper paddle plate UP can be performed with reference to a target displacement. As described at 308b, the target displacement of the tensioner T can be captured at the time when a predetermined force is reached. The target displacement can indicate a target clearance of the knee joint. Before performing an extension test, the tensioner control system TCS can control the tensioner T in displacement control mode DCM by progressively reducing the displacement of the tensioner T from the target displacement to position the tensioner T at the target displacement and / or perform the extension test. Here, the degree of reduction of the upper paddle plate UP can be progressively reduced as needed (starting from the target displacement) to complete the extension test. For example, the paddle plate UP can be reduced based on the displacement value from the data pair, or the paddle plate can be reduced until the paddle plate reaches a predetermined state, such as a fully closed state.

[0238] In one implementation, at 312c, the tensioner control system TCS can perform an extension test by automatically reducing the displacement of the tensioner T. In other words, once the command to perform an extension test is given, the tensioner T automatically lowers the upper paddleboard UP based on the displacement from the data pair (and without further user intervention). The automatic extension test can be triggered via the clinical application CA and / or via the user input TID device on the tensioner T itself.

[0239] In another implementation, at 312d, the tensioner control system TCS can perform a stretching test by decreasing the displacement of the tensioner T based on user input. The user can provide input to the tensioner control system TCS using the clinical application CA and / or the user input TID device on the tensioner T itself to lower the upper paddle plate UP to a first displacement from the data pair. Once the first displacement is reached, the user provides subsequent input to the tensioner control system TCS to lower the upper paddle plate UP to the next displacement from the data pair. This process can be repeated as needed to complete the stretching test.

[0240] The process of performing an extension test on the knee joint (AJ) may involve two tensioner bodies TB1 and TB2 of the tensioner T. The upper paddle UP of the first tensioner body TB1 engages one condyle of the femur F (medial / lateral), and the upper paddle UP of the second tensioner body TB2 engages the other condyle of the femur F (medial / lateral). The lower paddle LP of the first tensioner body TB1 and the lower paddle LP of the second tensioner body TB2 jointly engage the tibia. In one example, the tibia TIB is removed in a mid-trimester resection workflow. In displacement control mode (DCM), each corresponding upper paddle is commanded to move according to displacement values ​​specifically captured for the corresponding tensioner body and the medial and lateral compartments. The commanded displacement can be detected by the encoder EN within each tensioner body TB1, TB2 and recorded by the tensioner control system TCS. The commanded displacement of the upper paddle UP can be simultaneous or separate. For the two tensioner bodies TB1 and TB2, the commanded displacements can be the same or different depending on various factors (such as predetermined information about the slack of the medial / lateral components). For the medial and lateral compartments of the knee joint AJ, an acceptable full extension position can be achieved at the same time or at different times.

[0241] Based on any variation or combination of the techniques described at step 312 above, the tensioner T displacement is progressively reduced to attempt to assess whether the knee joint AJ has achieved an acceptable full extension posture. Therefore, method 300 includes step 314: assessing whether the knee joint AJ can achieve an acceptable full extension posture according to an extension test. As described above, an acceptable full extension posture can be full extension (e.g., approximately 0 degrees of knee flexion). Alternatively, an acceptable full extension posture may not be full extension, depending on the patient's soft tissue and skeletal anatomy, as well as surgeon preferences and surgical planning. For example, acceptable full extension can be any value ranging from -1 degree to 5 degrees of full extension.

[0242] The knee joint AJ may not be able to achieve an acceptable full extension position according to the extension test. For example, the ligaments of the knee joint AJ may exhibit flexion contracture or hyperextension, thereby hindering full extension. If the knee joint AJ cannot achieve an acceptable full extension position, method 300 may return to any of the previous steps 306, 308, 310, and 312 to re-perform aspects of the method.

[0243] For example, if overextension is present at step 314, step 306 can be repeated, where, in the first acceptable flexion pose, the tensioner can be controlled in force control mode to apply force to the knee joint until an incrementally larger predetermined force (compared to the predetermined force utilized in the first iteration) is reached. For example, the larger predetermined force can be selected as incrementally higher than the highest force value of the previous lookup table LUT. Based on the larger predetermined force, the captured force-displacement pair will change, and the lookup table LUT will be refilled (at step 308). Steps 310 and 312 can then be repeated to determine whether the knee joint has reached an acceptable full extension pose.

[0244] If flexion contracture is present at step 314, the input parameters for the stretch test can be modified. For example, the stretch test can be performed using alternative displacement values ​​from (e.g., from step 308) data pairs. Alternative displacement values ​​can be displacement values ​​from a table LUT that were not used in the first iteration of the stretch test. These displacement values ​​can be, for example, displacement values ​​smaller than the smallest displacement value used in the first iteration of the stretch test. For example, the first iteration may have already used displacement values ​​of 13 mm, 12.5 mm, 12 mm, 11.5 mm, 10 mm, and 9 mm from the table LUT. In the second iteration, the parameters for the stretch test can be modified to reduce the range of displacement values ​​to: 12.5 mm, 12 mm, 11.5 mm, 10 mm, 9 mm, and 8 mm. Alternative displacement values ​​can be from a table LUT, or interpolation or prediction based on previously used displacement values ​​can be performed using any statistical or mathematical method (such as linear regression, standard deviation, etc.). A second iteration can then be performed using any variation or combination of the techniques described in steps 306, 308, 310, and 312 to determine if a fully extended pose can be achieved. If an acceptable fully extended pose cannot be achieved, the surgeon may need to remove more material from one or both bones before repeating any of steps 306 through 312.

[0245] If the knee joint AJ cannot achieve an acceptable full extension posture, it is also conceivable that method 300 could return to step 306 to re-execute the process of applying force to the knee joint until a predetermined force is reached. Here, the predetermined force can be adjusted. For example, the predetermined force can be increased or decreased, thereby changing the force-displacement data pair values ​​that will subsequently be captured. The predetermined force can also be calculated or predicted based on the force values ​​from the table LUT. For example, the predetermined force can be increased by a default value of 10%. In another example, the predetermined force can be calculated or predicted based on the minimum displacement value utilized in the first iteration of the extension test.

[0246] Ideally, because the method described herein assumes that the knee joint AJ should be able to achieve an acceptable full extension posture based on performing only one extension test. If so, method 300 proceeds to step 316. At 316, during or after the extension test, the tensioner control system TCS identifies a first force-displacement data pair that enables the knee joint AJ to achieve an acceptable full extension posture. In other words, when the knee joint AJ achieves an acceptable full extension posture, it will be based on a commanded displacement performed by the tensioner T, where the commanded displacement includes a stress value. The first force-displacement data pair includes the value of the displacement that enables the knee joint to achieve an acceptable full extension posture, and the force value corresponding to the displacement value. Regarding the first force-displacement data pair, the term "first" is used only to distinguish this data pair from the other data pairs described below. The term "first" is not limited to meaning that the data pair is the initial data pair or the first data pair in the list of data pairs.

[0247] Figure 39 The diagram illustrates what the GUI can display after a successful extension test. The knee joint is actually positioned in an acceptable fully extended posture (e.g., 0 degrees of flexion). The GUI illustrates the current angle of the knee joint posture, in this case, 0 degrees of flexion. By illustrating the movement indicator MI within or within the range of the static indicator SI for an acceptable fully extended posture, and optionally changing either indicator MI or SI, the GUI can provide confirmation that the knee joint has reached an acceptable fully extended posture. Additionally or alternatively, the GUI can provide text or graphical indicators to convey that the knee joint has reached an acceptable fully extended posture. The GUI also indicates the selected operating mode of the tensioner T, i.e., the displacement control mode. The GUI may include a "Send Command" button to trigger the tensioner T to perform the extension test. The first force-displacement data pair (e.g., force XN, position Xmm) identified in step 316 can be displayed for the medial and lateral compartments, respectively. Real-time relaxation values ​​(e.g., X mm) can be displayed for the medial and lateral compartments.

[0248] exist Figure 36 In the middle, method 300 from Figure 35 Step 316 continues to step 318. In step 318, the knee joint AJ is positioned in a second acceptable flexion position. The second acceptable flexion position can be a moderate or semi-flexion position of the knee joint. In one example, the second acceptable flexion position can be a knee flexion value from 80 degrees to 105 degrees, such as 90 degrees (e.g., ...). Figure 36(As illustrated). The second acceptable flexion position can be a single value or a range of values. The acceptability of the second acceptable flexion position can be defined by the surgeon, surgical planning, implant parameters, or can be based on automated planning predictions made by System 10. As described, the process of positioning the knee AJ in any of the positions described herein (including the second acceptable flexion position) can be a manual, automated, or semi-automated process. When performed manually, the surgeon or technician physically moves the knee AJ to the second acceptable flexion position.

[0249] At 318a, for example, navigation system 34 may use a graphical user interface (GUI) to provide visual guidance to assist surgeons or technicians in positioning the knee joint AJ in a second acceptable flexion position. For example, as Figure 40 As shown, the GUI illustrates the angle of the knee joint's current pose, in this case, 90 degrees of flexion. The GUI can further represent the knee joint AJ's current pose with a movement indicator MI relative to a static indicator SI representing a second acceptable flexion pose. When the movement indicator MI is within or within the range of the static indicator SI, the GUI can confirm to the user that the knee joint is in the second acceptable flexion pose. Confirmation can be achieved by changing the color of the indicators MI and SI, for example, by changing the color to green. Additionally or alternatively, the GUI can provide text or graphical indicators to convey that the knee joint is in the second acceptable flexion pose. In another example, the GUI can provide a side-view comparison between a representation of the knee joint's current pose and the second acceptable flexion pose. Furthermore, the anatomical manipulator described above (and not repeated for simplicity) can be used to automatically or semi-automatically position the knee joint AJ in any pose described herein (such as the second acceptable flexion pose).

[0250] At step 320, when the knee joint AJ is in an acceptable fully extended position, the tensioner control system TCS switches the control of the tensioner T from force control mode FCM to displacement control mode DCM. Here, the tensioner control system TCS controls the tensioner T in force control mode FCM to apply a second predetermined force to the knee joint when the knee joint is in a second acceptable flexion position. Regarding the second predetermined force, the term "second" is used only to distinguish it from the predetermined force applied in step 306. The term "second" actually means "another" force, and is not limited to specifically meaning the second force in a series of forces.

[0251] For step 320, the tensioner control system TCS can automatically trigger the force control mode FCM in response to detecting that the knee joint AJ is positioned in a second acceptable flexion posture. Alternatively, the user can selectively activate the force control mode FCM using the clinical application CA or the tensioner input device TID. The process of applying a second predetermined force to the knee joint AJ may involve the two tensioner bodies TB1, TB2 of the tensioner T. The upper paddle UP of the first tensioner body TB1 engages one condyle (medial / lateral) of the femur F, and the upper paddle UP of the second tensioner body TB2 engages the other condyle (medial / lateral) of the femur F. The lower paddle LP of the first tensioner body TB1 and the lower paddle LP of the second tensioner body TB2 jointly engage the tibia. In one example, the tibial TIB is removed in a mid-tissue resection workflow. Under the force control mode FCM, each corresponding upper paddle is commanded to move until the second predetermined force is reached. The second predetermined force can be detected by sensor S within each tensioner body TB1, TB2 and recorded by the tension control system TCS. The applied force will gradually increase until the second predetermined force is reached. For tensioner bodies TB1, TB2, the commanded movements can be simultaneous or separate. For both tensioner bodies TB1, TB2, the second predetermined force can be the same or can vary depending on various factors (such as predetermined information regarding the slack of the medial / lateral components). For the medial and lateral compartments of the knee joint AJ, the second predetermined force can be reached at the same time or at different times.

[0252] The second predetermined force applied at step 320 can be derived or obtained from various sources. At 320a, the tensioner control system TCS can obtain the second predetermined force from the force value of the first force-displacement data pair (at step 316) that enables the knee joint to reach an acceptable full extension posture. Advantageously, by using the force from the first force-displacement data pair, the knee joint can be stretched into a second acceptable flexion posture using the force value captured (but not applied) when the knee joint is in an acceptable full extension posture. The process of extracting this force value from the corresponding displacement value of this force value avoids the need to forcibly open the knee joint into a full extension posture with the tensioner T. In turn, the force value is an accurate measurement unaffected by inaccuracies caused by posterior capsule tension in the full extension posture. Alternatively or additionally, at 320a, the tensioner control system TCS can obtain the second predetermined force from: a predetermined joint balance force, a force based on surgeon preference, a force obtained from statistical data, or any force from any force-displacement data pair in the force-displacement data pair.

[0253] At step 322, based on the second predetermined force applied at step 320, the tensioner control system TCS (optionally combined with navigation system 34) can capture or identify a second force-displacement data pair. The process of obtaining the second force-displacement data pair advantageously provides a test or sampling of the relaxation of the knee joint in a second acceptable flexion posture. Regarding the second force-displacement data pair, the term "second" is used only to distinguish it from the first force-displacement data pair identified in step 316. Here, the term "second" actually means "another" force-displacement data pair, and is not limited to specifically referring to a second data pair in a data pair sequence or data pair table. The second force-displacement data pair includes a force measurement result and a displacement measurement result. The second force-displacement data pair may include a force component, which is the second predetermined force applied at step 320. Alternatively, the second force-displacement data pair may include a force component that is different from or less than the second predetermined force applied at step 320. The displacement component of the second force-displacement data pair may be the displacement achieved by the knee joint AJ based on the second predetermined force applied at step 320. Displacement can be derived from the displacement of the upper paddle plate UP and / or from the knee joint gap measured, for example, by tracking the bone via locator 44. At step 322, it is conceivable that the tensioner control system TCS and / or navigation system 34 can generate another lookup table LUT (similar to...). Figure 34 (As illustrated in the lookup table), the other lookup table includes another set of force-displacement data pairs. A second force-displacement data pair can be selected from the lookup table LUT. Two separate second force-displacement data pairs can be captured for the corresponding inner and outer compartments, for example, using tensioner bodies TB1, TB2. In this case, the second force-displacement data pairs may have the same or different force and / or displacement values.

[0254] At step 324, the tensioner control system TCS (and optionally in conjunction with navigation system 34) determines parameters of the knee joint AJ based on (1) a first force-displacement data pair that enables the knee joint to reach an acceptable full extension position (from step 316) and based on (2) a second force-displacement data pair determined when the knee joint is in a second acceptable flexion position (from step 322). These parameters may be the laxity, stiffness, ligament balance, kinematic characteristics, flexion, extension, and / or range of motion of the anatomical joint AJ. These parameters may be the laxity of the medial and lateral compartments of the knee joint. For example, two force-displacement data pairs may provide four laxity data points (two forces and two displacements) defined within the range of full extension to full or near-full flexion (90 degrees to 120 degrees). Figure 41An example of knee joint parameters provided by a GUI is illustrated for the application of method 300 described above. The GUI can display force-displacement curves for the medial and lateral components of the knee joint AJ. These force-displacement curves are derived from data captured during the execution of steps of method 300 described above (such as any one or more steps 306, 308, 312, 316, 320, 322, and 324). The GUI can plot several data points derived from the extension test along the force-displacement curve. In this example, the extension test begins with 14 degrees of flexion (within a first acceptable flexion position) and ends with 2 degrees of knee flexion (within an acceptable full extension position). The flexion angles (14 degrees and 2 degrees) for each position are shown on the plot. Furthermore, the force (e.g., 2 N) applied by one or both of the medial and lateral compartments at the completion of the extension test can be plotted. Discrete force-displacement data pairs captured at step 308 can also be plotted along the curve. Surgeons can use the curves to assess the mechanical properties of the soft tissues of the knee joint (AJ). Based on the curves and patient-specific parameters (age, BMI, sex, etc.), surgeons can assess optimal knee extension for a particular patient. Other curves, plots, or graphs can be created using the techniques described herein. For example, other types of data that can be visualized include, but are not limited to: displacement versus time, force versus time, displacement versus flexion, force versus flexion, gap versus flexion, relaxation versus flexion, displacement versus flexion, force versus flexion, and / or any of the foregoing used in combination with varus / valgus alignment.

[0255] refer to Figures 34 to 36 The described method 300 includes: positioning the knee joint in a first acceptable flexion position (e.g., about 10 degrees) such that the knee joint can reach an acceptable full extension position (e.g., 0 degrees), and positioning the knee joint in a second acceptable flexion position (e.g., about 90 degrees). Evaluation of the knee joint in positions other than those described above is also envisioned.

[0256] 8B. Knee Extension Test—Alternative Workflow

[0257] Additionally, and refer to Figure 37An alternative workflow for evaluating the knee joint AJ is envisioned, involving a rearrangement of the steps of method 300. The alternative workflow is described with reference to method 400. Alternative method 400 includes: first positioning the knee joint in a second acceptable flexion position (e.g., approximately 90 degrees), then positioning the knee joint in a first acceptable flexion position (e.g., 10 degrees), and then allowing the knee joint to reach an acceptable full extension position (e.g., 0 degrees). This method 400 offers unique advantages, such as convenience for the surgeon and reduced duration of the surgical workflow. For intermediate resection workflows, the tibial TIB is typically removed while the knee joint AJ is in a flexed position (approximately 90 degrees). Method 400 advantageously begins with the knee joint in a second acceptable flexion position (e.g., approximately 90 degrees). Therefore, method 400 can be initiated without reconfiguring the knee joint AJ. The knee joint AJ will remain in substantially the same position it was in after the tibial TIB resection. The steps of method 400 may, where applicable, incorporate any and all implementations, functions, options, and features of the corresponding steps of method 300. Therefore, for the sake of simplicity, certain aspects of method 400 will not be repeated.

[0258] At step 400, the knee joint AJ is positioned in a second acceptable flexion position (e.g., approximately 90 degrees), and the tensioner control system TCS controls the tensioner T in force control mode FCM to apply a predetermined force to the knee joint AJ. At step 404, the tensioner control system TCS (and optionally in conjunction with the navigation system 34) captures a first set of force-displacement data pairs resulting from the force applied at step 402. These data pairs are stored for later use in method 400. For example, as described above, the first set of force-displacement data pairs may be stored in a lookup table LUT. At step 406, the knee joint AJ is positioned in a first acceptable flexion position (e.g., 10 degrees), and the tensioner control system TCS controls the tensioner T in force control mode FCM to apply a force to the knee joint AJ until a predetermined force is reached. This predetermined force may be the same as or different from the predetermined force applied at step 402. Any of these predetermined forces can be obtained from: predetermined joint balance forces, forces based on surgeon preferences, forces obtained from statistical data, or any force from any force-displacement data pair. At step 408, the tensioner control system TCS (optionally combined with navigation system 34) captures a second set of force-displacement data pairs resulting from the forces applied at step 406. The values ​​in the second set of force-displacement data pairs may or may not correspond to values ​​from the first set of force-displacement data pairs. At step 410, while the knee joint AJ is held in a first acceptable flexion position (e.g., 10 degrees), the tensioner control system TCS can switch the operation of the tensioner T to displacement control mode DCM to perform an extension test. Here, the displacement of the tensioner T is progressively reduced based on the displacement values ​​from the second set of force-displacement data pairs. Similar to step 314 described above, an assessment can be made regarding whether the knee joint can achieve an acceptable full extension position. Assuming the knee joint reaches an acceptable full extension position, at step 412, the tensioner control system TCS (optionally combined with navigation system 34) identifies force-displacement data pairs from the second group that enable the knee joint to reach an acceptable full extension position. At step 414, the tensioner control system TCS (optionally combined with navigation system 34) uses the force-displacement data pairs from the second group to identify force-displacement data pairs from the first group (at 404). For example, force and / or displacement values ​​from the first group can be correlated, compared, or otherwise evaluated with respect to force and / or displacement values ​​from the force-displacement data pairs from the second group. This process can be performed by comparing rows or columns of a table LUT to identify the same or substantially similar force or displacement values. In fact, as with method 300 described above, method 400 can utilize two force-displacement data pairs to obtain four relaxation data points (two forces and two displacements) defined within the range of full extension to moderate flexion or full flexion.Method 400 can also be used to determine any other described parameters of the knee joint AJ.

[0259] 8C. Paddleboard Deflection Compensation Technology

[0260] This document describes a technique for compensating for mechanical deflection of any paddles in a tensioner T due to applied load. For example, during any of the described workflows, one or more upper paddles UP in contact with the femoral condyle may deflect mechanically. The paddle deflection is linear and measurable. Because the load experienced by the actuator of the tensioner T is known, the measured displacement or force of the tensioner T, as observed by sensors in the tensioner T, can be compensated for by predicting the corresponding paddle deflection. For example, when capturing an extension pose, the tensioner T may operate in a position control mode. A lookup table recording a force-position mapping can be used to determine the force recorded for the extension pose. The lookup table can be configured to provide a predicted paddle deflection. The lookup table can be paddle-specific and correlates the force on the paddle with the paddle deflection. For example, for every N Newtons of force applied to the paddle, the paddle will deflect D mm from rest. Again, this mapping is based on a linear relationship between force and deflection. In other configurations, the lookup table can be configured to provide a table of predicted spread / force of the tensioner T, based on predicted paddle deflection. The lookup table can be stored in any suitable non-transitory memory, such as memory located in the tensioner T or tensioner body TB, or memory located away from the tensioner location.

[0261] During the surgical workflow, the commanded / measured force and / or spread of the tensioner T is captured. Assume a commanded spread of 9.5 mm at a force of 95 N. Using the value of the commanded / measured force and / or spread, a lookup table can be consulted to obtain the predicted deflection or predicted spread / force value of the paddleboard. Assume a paddleboard deflection value of 1.5 for a force of 95 N. Based on this, the controller can adjust the commanded / measured spread by referencing the deflection (e.g., 9.5 mm minus 1.5 mm) to produce a compensated final spread value (or predicted spread) of 8 mm, which compensates for the paddleboard deflection caused by the force. From this, the predicted force value corresponding to the predicted deflection value can be obtained. For example, instead of an actual recorded force of 95 N based on a spread of 9.5 mm, the predicted force can be adjusted to 85 N based on a predicted spread of 8.0 mm.

[0262] This paddle deflection compensation technology can be applied to force or displacement measurements, and can be applied to force control mode, displacement control mode, and / or force-displacement control mode. Furthermore, paddle deflection compensation can be applied in any one or more steps of the described workflow 300, 400, or at the end of any step in the described workflow (e.g., after recording all necessary measurement results). The predicted values ​​(e.g., as visual indicators (or new table columns) on the software application can be used to display the predicted values). Figure 34 The new column shown in the lookup table (LUT) informs the surgeon, or can remain hidden from the user (by automatically adjusting the actual force / displacement values ​​via software). By compensating for paddleboard deflection in this way, the technology can provide a more accurate representation of force and displacement for any stage of the surgical workflow.

[0263] 9. Configuration and Use of Inverted Tensioner

[0264] In some of the examples above, the tensioner T has been described using a configuration in which the upper paddle UP engages the femur and the lower paddle LP engages the tibia. In these examples, the lower paddle LP typically remains stationary, and the upper paddle UP moves relative to the lower paddle LP. It is conceivable that this tensioner T could be used in alternative ways. For example, see reference... Figure 44 The tensioner T may have the same configuration as described above, but it may be inverted (flipped upside down). In this example, the lower paddle plate LP remains stationary, and the upper paddle plate UP moves relative to the lower paddle plate LP. However, the upper paddle plate UP engages the tibia instead of the femur, and the lower paddle plate engages the femur instead of the tibia. During operation of the tensioner T, the upper paddle plate UP pushes the tibia downward (instead of pushing the femur upward), and the lower paddle plate remains stationary in contact with the femur. This configuration may be achieved using a paddle plate surface (e.g., a flat surface) that is not specific to the type of bone being engaged. An inverted tensioner T may be useful for a variety of reasons, including, but not limited to, surgeon ergonomics or comfort, avoiding contact between the tensioner and surgical objects (e.g., bone pins, anatomical trackers, retractors, incision openings, or tensioner cables), or adapting to a specific knee position. Advantageously, depending on the situation and for a given procedure, the same tensioner T may be used in either an upright or inverted orientation. In this inverted usage, the terms "upper" and "lower" propellers are used to maintain consistency in the above tensioner description, but are not intended to limit the relative pose of the respective propellers. In other words, in this configuration, it is entirely conceivable that the upper propeller becomes the lower propeller, and vice versa.

[0265] In another example, such as Figure 45 As shown, the tensioner T has an inverted configuration compared to the tensioner T described and shown throughout the accompanying drawings. Figure 45In this configuration, the tensioner body TB extends upward from the lower paddle plate LP. In other words, the lower paddle plate LP is located at the bottom (not near the top) of the tensioner body TB. The upper paddle plate UP remains above the lower paddle plate LP. The lower paddle plate LP remains stationary, and the upper paddle plate UP moves relative to the lower paddle plate LP. The described components within the tensioner body TB (such as the displacement mechanism DM) are inverted. Therefore, instead of the upper paddle plate UP pushing the femur upward, it pulls the femur upward. This inverted tensioner configuration can be beneficial for the surgeon's ergonomics or comfort, to avoid contact between the tensioner and surgical objects (e.g., bone pins, anatomical trackers, retractors, incision openings, or tensioner cables), or to adapt to specific knee positions. The inverted tensioner body TB can be coupled to a retainer R and can be used with any configuration of the retainer R described. Thus, the retainer R provides the surgeon with the ability to selectively exchange the upright and inverted tensioner body TB during the procedure.

[0266] In another example, the tensioner T can be configured such that a portion of the tensioner body TB (e.g., a handle or gripping feature G) is configured to rotate or pivot relative to the paddle plate or relative to a portion of the tensioner body TB including a displacement mechanism DM for the paddle plate. The pivoting or rotation of the movable portion of the tensioner body TB allows the tensioner body TB to have an inverted configuration, such as... Figure 45 As described. The pivot or swivel can be lockable to set the orientation of a movable portion of the tensioner body TB. Using this technique, it is also conceivable to orient a portion of the tensioner body TB in other ways, such as at an angle (e.g., 45 degrees) relative to other portions of the tensioner body TB or the paddle, so that the tensioner body TB can avoid obstacles.

[0267] Any feature or configuration of the tensioner T described in the previous sections can be fully realized for the inverted use or inverted configuration of the tensioner T described herein. For example, it is conceivable that the two paddles UP, LP can move in the inverted use or inverted configuration of the tensioner T, and so on.

[0268] Several embodiments have been described in the foregoing description. However, the embodiments discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be descriptive rather than restrictive in nature. In view of the foregoing teachings, many modifications and variations are possible, and the invention may be practiced in ways other than those specifically described.

[0269] Referring to the disclosure provided above, for convenience and clarity only, directional terms such as top, bottom, above, upper part, lower part, near side, far side, vertical, horizontal, etc., are used relative to the context of the accompanying drawings, and those skilled in the art will understand these terms in relation to such context. Such directional terms used in conjunction with the following description of the drawings should not be construed as limiting the scope of the invention in any way not explicitly stated. Additionally, as used in this specification, the term "a" means "at least one". The term includes the words specifically mentioned above, their derivatives, and words with similar meanings.

Claims

1. A surgical system configured to assess a knee joint, the surgical system comprising: a tensioner that is electrically powered and configured to operate in a force control mode and a displacement control mode; and a control system coupled to the tensioner and configured to: control the tensioner in the force control mode to apply a force to the knee joint until a predetermined force is reached; capture, from the tensioner, a plurality of force-displacement data pairs resulting from the force applied by the tensioner in the force control mode; and control the tensioner to switch from the force control mode to the displacement control mode and control the tensioner in the displacement control mode to perform a stretch test in which a displacement of the tensioner is progressively reduced according to a displacement from the plurality of force-displacement data pairs until the knee joint is able to reach an acceptable full extension pose during or after completion of the stretch test.

2. The surgical system of claim 1, wherein the control system is configured to control the tensioner in the force control mode to apply a force to the knee joint until the predetermined force is reached when a current pose of the knee joint is at a first acceptable flexion pose.

3. The surgical system of claim 2, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a localizer and a display device, and wherein the control system is configured to: track, by the localizer, a pose of the femur and a pose of the tibia; control the display device to provide visual guidance to assist in placing the current pose of the knee joint to be at the first acceptable flexion pose; capture, by the localizer, the current pose of the knee joint relative to the first acceptable flexion pose; and control the display device to provide a visual confirmation in response to the current pose of the knee joint being at the first acceptable flexion pose.

4. The surgical system of claim 2, wherein the first acceptable flexion pose is a value between 2 degrees to 15 degrees of knee flexion.

5. The surgical system of claim 1, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a localizer and a display device, and wherein the control system is configured to: track, by the localizer, a pose of the femur and a pose of the tibia; and control the display device to provide a visual representation of a current pose of the knee joint based on the pose of the femur and the pose of the tibia tracked by the localizer.

6. The surgical system of claim 5, wherein the control system is configured to measure a gap of the knee joint based on the pose of the femur and the pose of the tibia tracked by the localizer.

7. The surgical system of claim 5, wherein the control system is configured to: capture, by the localizer, the current pose of the knee joint relative to the acceptable full extension pose; and control the display device to provide a visual representation of a current pose of the knee joint based on the pose of the femur and the pose of the tibia tracked by the localizer. control the display device to provide a visual confirmation in response to the current pose of the knee joint being in the acceptable full extension pose.

8. The surgical system of claim 1, wherein the acceptable full extension pose is a value from 0 degrees to 2 degrees of knee flexion.

9. The surgical system of claim 1, wherein the control system is configured to: generate a lookup table based on the plurality of force-displacement data pairs captured from the tensioner; and perform the extension test according to a displacement from the lookup table.

10. The surgical system of claim 1, wherein the control system is configured to: capture a target displacement of the tensioner at a time when the predetermined force is reached, the target displacement indicating a target gap of the knee joint; and control the tensioner in the displacement control mode to place the tensioner at the target displacement prior to performing the extension test; and perform the extension test by progressively decreasing the displacement of the tensioner from the target displacement.

11. The surgical system of claim 1, wherein the control system performs the extension test by being configured to automatically and progressively decrease the displacement of the tensioner according to a displacement from the plurality of force-displacement data pairs.

12. The surgical system of claim 1, wherein the tensioner includes a user control input, and wherein the control system performs the extension test by being configured to progressively decrease the displacement of the tensioner according to a displacement from the plurality of force-displacement data pairs in response to the user control input.

13. The surgical system of claim 1, wherein, during the extension test or after the extension test is completed, the control system is configured to identify a first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose.

14. The surgical system of claim 13, wherein, after the extension test is completed, the control system is configured to: control the tensioner to switch from the displacement control mode to the force control mode and control the tensioner in the force control mode to apply a second predetermined force to the knee joint while the knee joint is in a second acceptable flexion pose.

15. The surgical system of claim 13, wherein, prior to the control system controlling the tensioner in the force control mode to apply a force to the knee joint until the predetermined force is reached, the control system is configured to: control the tensioner in the force control mode for applying a second predetermined force to the knee joint while the knee joint is in a second acceptable flexion pose.

16. The surgical system of claim 14, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a positioner and a display device, and wherein the control system is configured to: track a pose of the femur and a pose of the tibia by the positioner; and control the display device to provide a visual confirmation in response to the current pose of the knee joint being in the acceptable full extension pose. controlling the display device to provide visual guidance to assist in placing the current pose of the knee joint in the second acceptable flexion pose; capturing the current pose of the knee joint relative to the second acceptable flexion pose; and controlling the display device to provide a visual confirmation in response to the current pose of the knee joint being in the second acceptable flexion pose.

17. The surgical system of claim 14, wherein the second acceptable flexion pose is a value from 80 degrees to 105 degrees of knee flexion.

18. The surgical system of claim 14, wherein the control system is configured to obtain the second predetermined force from a force of the first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose.

19. The surgical system of claim 14, wherein the control system is configured to obtain the second predetermined force from one of: a predetermined joint balancing force, a force based on surgeon preference, a force obtained from statistical data, or a force from any of the force-displacement data pairs.

20. The surgical system of claim 14, wherein, while the knee joint is in the second acceptable flexion pose and during or after applying the second predetermined force to the knee joint, the control system is configured to: capture a second force-displacement data pair from the tensioner.

21. The surgical system of claim 20, wherein the control system is configured to: determine a parameter of the knee joint based on the first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose and based on the second force-displacement data pair identified while the knee joint is in the second acceptable flexion pose.

22. The surgical system of claim 1, wherein the knee joint further comprises a femur having a medial condyle and a lateral condyle and a tibia, and wherein the tensioner further comprises: a medial upper paddle and a lateral upper paddle each detachably movable and configured to engage the medial condyle and the lateral condyle of the femur, respectively, and at least one lower paddle configured to engage the tibia; a drive assembly including a first electric motor and a first displacement mechanism coupled between the first electric motor and the medial upper paddle, and a second electric motor and a second displacement mechanism coupled between the second electric motor and the lateral upper paddle; a first sensor configured to sense a force applied to the medial upper paddle; and a second sensor configured to sense a force applied to the lateral upper paddle, and wherein the control system is configured to: control the tensioner in the force control mode by being configured to command the medial upper paddle and the lateral upper paddle to apply a force to the medial condyle and the lateral condyle of the femur, respectively, until the predetermined force is reached for one or both of the medial upper paddle and the lateral upper paddle; further based on measurements from the first sensor and the second sensor and displacements of the medial upper paddle and the lateral upper paddle to capture the plurality of force-displacement data pairs; and controlling the tensioner in the displacement control mode to perform the extension test by being configured to progressively reduce the displacements of the medial upper paddle and the lateral upper paddle as a function of displacements from the plurality of force-displacement data pairs.

23. A method of evaluating a knee joint with a surgical system that includes a tensioner and a control system, the tensioner being motorized and configured to operate in a force control mode and a displacement control mode, the control system being configured to control the tensioner, the method comprising: controlling the tensioner in the force control mode by the control system for applying a force to the knee joint until a predetermined force is reached; capturing, by the control system from the tensioner, a plurality of force-displacement data pairs resulting from the tensioner applying the force in the force control mode; and controlling the tensioner by the control system for switching from the force control mode to the displacement control mode and controlling the tensioner in the displacement control mode by progressively reducing displacements of the tensioner as a function of displacements from the plurality of force-displacement data pairs until the knee joint is able to reach an acceptable full extension pose during or after completion of the extension test.

24. The method of claim 23, wherein the step of controlling the tensioner in the force control mode for applying a force to the knee joint until the predetermined force is reached occurs when a current pose of the knee joint is at a first acceptable flexion pose.

25. The method of claim 24, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a localizer and a display device, the method comprising: tracking, by the localizer, a pose of the femur and a pose of the tibia; controlling, by the control system, the display device for providing visual guidance to assist in placing the current pose of the knee joint to be at the first acceptable flexion pose; capturing, by the localizer, the current pose of the knee joint relative to the first acceptable flexion pose; and controlling, by the control system, the display device for providing a visual confirmation in response to determining that the current pose of the knee joint is at the first acceptable flexion pose.

26. The method of claim 24, wherein the first acceptable flexion pose is a value between 2 degrees to 15 degrees of knee flexion.

27. The method of claim 23, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a localizer and a display device, the method comprising: tracking, by the localizer, a pose of the femur and a pose of the tibia; and controlling, by the control system, the display device for providing a visual representation of a current pose of the knee joint based on tracking, by the localizers, the pose of the femur and the pose of the tibia.

28. The method of claim 27, further comprising: measuring, by the control system, a gap of the knee joint based on tracking, by the localizers, the pose of the femur and the pose of the tibia.

29. The method of claim 27, comprising: capturing, by the localizers, the current pose of the knee joint relative to the acceptable full extension pose; and controlling, by the control system, the display device for providing a visual confirmation in response to determining that the current pose of the knee joint is at the acceptable full extension pose.

30. The method of claim 23, wherein the acceptable full extension pose is a value from 0 degrees to 2 degrees of knee flexion.

31. The method of claim 23, further comprising: generating, by the control system, a lookup table based on the plurality of force-displacement data pairs captured from the tensioner; and performing the extension test according to a displacement from the lookup table.

32. The method of claim 23, further comprising: capturing, by the control system, a target displacement of the tensioner at a time when the predetermined force is reached, the target displacement indicating a target gap of the knee joint; and controlling the tensioner in the displacement control mode to place the tensioner at the target displacement prior to performing the extension test; and performing the extension test by progressively reducing the displacement of the tensioner from the target displacement.

33. The method of claim 23, wherein performing the extension test further occurs by the control system automatically and progressively reducing the displacement of the tensioner according to a displacement from the plurality of force-displacement data pairs.

34. The method of claim 23, wherein the tensioner comprises a user control input, and wherein performing the extension test further occurs by the control system progressively reducing the displacement of the tensioner according to a displacement from the plurality of force-displacement data pairs in response to the user control input.

35. The method of claim 23, wherein during the extension test or after the extension test is complete, the method further comprises: identifying, by the control system, a first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose.

36. The method of claim 35, further comprising: after the extension test is complete, moving a current pose of the knee joint to a second acceptable flexion pose; and controlling, by the control system, the tensioner for switching from the displacement control mode to the force control mode and controlling the tensioner in the force control mode for applying a second predetermined force to the knee joint at the second acceptable flexion pose.

37. The method of claim 35, further comprising: moving a current pose of the knee joint to a second acceptable flexion pose prior to controlling the tensioner by the control system in the force control mode for applying a force to the knee joint until the predetermined force is reached; and controlling the tensioner by the control system in the force control mode for applying a second predetermined force to the knee joint in the second acceptable flexion pose.

38. The method of claim 36, wherein the knee joint includes a femur and a tibia, and the surgical system further includes a localizer and a display device, the method comprising: tracking a pose of the femur and a pose of the tibia by the localizer; and controlling the display device by the control system for providing visual guidance to assist in placing a current pose of the knee joint in the second acceptable flexion pose; capturing the current pose of the knee joint relative to the second acceptable flexion pose by the localizer; and controlling the display device by the control system for providing a visual confirmation in response to determining that the current pose of the knee joint is in the second acceptable flexion pose.

39. The method of claim 36, wherein the second acceptable flexion pose is a value from 80 degrees to 105 degrees of knee flexion.

40. The method of claim 36, comprising: the control system obtains the second predetermined force from a force of the first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose.

41. The method of claim 36, comprising: the control system obtains the second predetermined force from one of: a predetermined joint balancing force, a force based on surgeon preference, a force obtained from statistical data, or a force from any of the force-displacement data pairs.

42. The method of claim 36, wherein while the knee joint is in the second acceptable flexion pose and during or after applying the second predetermined force to the knee joint, the method further comprises: capturing a second force-displacement data pair by the control system from the tensioner.

43. The method of claim 42, further comprising: determining, by the control system, a parameter of the knee joint based on the first force-displacement data pair that enables the knee joint to reach the acceptable full extension pose and based on the second force-displacement data pair identified while the knee joint is in the second acceptable flexion pose.

44. The method of claim 23, wherein the knee joint further comprises a femur having a medial condyle and a lateral condyle and a tibia, and wherein the tensioner further comprises: a medial upper paddle and a lateral upper paddle each detachably movable and configured to respectively engage the medial condyle and the lateral condyle of the femur, and at least one lower paddle configured to engage the tibia; a drive assembly including a first electric motor and a first displacement mechanism coupled between the first electric motor and the medial upper paddle, and a second electric motor and a second displacement mechanism coupled between the second electric motor and the lateral upper paddle; a first sensor configured to sense a force applied to the medial upper paddle; a second sensor configured to sense a force applied to the lateral upper paddle; and a second sensor configured to sense a force applied to the lateral upper paddle, and wherein: controlling, by the control system, the tensioner in the force control mode further comprises commanding the medial and lateral upper paddles for applying forces to the medial and lateral condyles of the femur, respectively, until the predetermined force is reached for one or both of the medial and lateral upper paddles; capturing, by the control system, the plurality of force-displacement data pairs further based on measurements from the first and second sensors and displacements of the medial and lateral upper paddles; and controlling the tensioner in the displacement control mode for performing the extension test is further defined by progressively reducing the displacements of the medial and lateral upper paddles according to displacements from the plurality of force-displacement data pairs.

45. A surgical system configured to evaluate an anatomical joint, the surgical system comprising: a tensioner that is motorized and configured to operate in a force control mode and a displacement control mode; and a control system configured to control the tensioner and configured to: control the tensioner in the force control mode to apply a force to the anatomical joint until a predetermined force is reached; capture, from the tensioner, a plurality of force-displacement data pairs resulting from the force applied by the tensioner in the force control mode; and control the tensioner in the displacement control mode, wherein displacements of the tensioner are progressively reduced according to displacements from the plurality of force-displacement data pairs.

46. A method of evaluating an anatomical joint with a surgical system, the surgical system comprising a tensioner that is motorized and configured to operate in a force control mode and a displacement control mode, and a control system configured to control the tensioner, the method comprising: controlling, by the control system, the tensioner in the force control mode for applying a force to the anatomical joint until a predetermined force is reached; capturing, by the control system, from the tensioner, a plurality of force-displacement data pairs resulting from the tensioner applying a force in the force control mode; and controlling, by the control system, the tensioner in the displacement control mode by progressively reducing displacements of the tensioner according to displacements from the plurality of force-displacement data pairs.

47. An orthopedic tensioner comprising: a body; an upper paddle movable relative to the body and configured to engage a first bone of an anatomical joint; a lower paddle coupled to the body and configured to engage a second bone of the anatomical joint; a drive assembly disposed within the body and including an electric motor and a displacement mechanism coupled between the electric motor and the upper paddle, and wherein the electric motor is configured to move the displacement mechanism to linearly displace the upper paddle relative to the lower paddle; and a sensor configured to sense a force applied to the upper paddle, wherein the sensor is located in the displacement mechanism.

48. The orthopedic tensioner of claim 47, wherein the sensor is configured to move in accordance with movement of the displacement mechanism.

49. The orthopedic tensioner of claim 47, wherein the displacement mechanism further includes a ball screw coupled to the electric motor and configured to be rotated by the electric motor.

50. The orthopedic tensioner of claim 49, wherein the displacement mechanism further includes a ball screw nut configured to engage the ball screw and move along the ball screw in accordance with rotation of the ball screw by the electric motor.

51. The orthopedic tensioner of claim 50, wherein the displacement mechanism further includes a ball spline fixed to the ball screw nut and to the upper paddle, and wherein the ball spline is configured to linearly displace in accordance with movement of the ball screw nut.

52. The orthopedic tensioner of claim 51, wherein the ball spline includes a threaded interface configured to receive a fastener, and wherein each of a plurality of different sized upper paddles is configured to be attached to the ball spline by the fastener.

53. The orthopedic tensioner of claim 51, wherein the sensor is located between the ball screw nut and the ball spline.

54. The orthopedic tensioner of claim 51, wherein the displacement mechanism further includes an adapter disposed between the ball screw nut and the ball spline.

55. The orthopedic tensioner of claim 54, wherein the adapter is threadably connected to the ball screw nut and fixed to the ball spline.

56. The orthopedic tensioner of claim 54, wherein the sensor is located between the adapter and the ball screw nut.

57. The orthopedic tensioner of claim 56, wherein the sensor is annular and configured to be disposed around the ball screw.

58. The orthopedic tensioner of claim 47, wherein the body is hermetically sealed.

59. The orthopedic tensioner of claim 47, wherein the sensor is a load cell.

60. The orthopedic tensioner of claim 47, wherein the body is a first body, and the orthopedic tensioner further includes: a second body configured to be coupled relative to the first body; an upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint; a lower paddle coupled to the second body and configured to engage the second bone of the anatomical joint; a drive assembly disposed within the second body and including an electric motor and a displacement mechanism coupled between the electric motor and the upper paddle, and wherein the electric motor is configured to move the displacement mechanism to linearly displace the upper paddle relative to the lower paddle; and a sensor configured to sense a force applied to the upper paddle, wherein the sensor is located in the displacement mechanism of the second body.

61. The orthopedic tensioner of claim 60, wherein the anatomical joint is a knee joint, wherein the first bone is a femur having a medial condyle and a lateral condyle, and the second bone is a tibia, and wherein: the upper paddle of the first body is a medial upper paddle configured to engage the medial condyle of the knee joint; the upper paddle of the second body is a lateral upper paddle configured to engage the lateral condyle of the knee joint; and the lower paddle of each of the first body and the second body is configured to engage the tibia.

62. The orthopedic tensioner of claim 60, wherein: the first body is hermetically sealed; the second body is hermetically sealed independently of the first body; and a retainer is configured to couple the first body and the second body relative to one another; and the retainer is configured to release the first body and the second body from the retainer such that the first body and the second body can be separated from one another.

63. An orthopedic tensioner, comprising: a body; an upper paddle movable relative to the body and configured to engage a first bone of an anatomical joint; a lower paddle coupled to the body and configured to engage a second bone of the anatomical joint; a drive assembly coupled to the body and including an electric motor and a displacement mechanism coupled between the electric motor and one or both of the upper paddle and the lower paddle, and wherein the electric motor is configured to move the displacement mechanism to displace the upper paddle and / or the lower paddle relative to one another; and a sensor configured to sense a force applied to one or both of the upper paddle and the lower paddle, wherein the sensor is configured to move in accordance with movement of the displacement mechanism.

64. An orthopedic tensioner, comprising: a first body; a first set of paddles coupled to the first body, the first set of paddles including a first upper paddle movable relative to the first body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second body separate from the first body; a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a drive assembly coupled to the first body and the second body and including an electric motor and a displacement mechanism coupled between the electric motor and one or both of the first upper paddle and the second upper paddle, and wherein the electric motor is configured to move the displacement mechanism to displace the first upper paddle and / or the second upper paddle relative to one another. a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a holder configured to hold the first body and the second body relative to one another, wherein the first body is configured to rotate within the holder to effect rotational adjustment of the first set of paddles, and wherein the second body is configured to rotate within the holder to effect rotational adjustment of the second set of paddles; and wherein a locking mechanism is coupled to the holder and configured to be actuated to rotationally lock one or both of the first body and the second body relative to the holder.

65. The orthopedic tensioner of claim 64, wherein the holder defines a first sleeve configured to receive the first body, and a second sleeve configured to receive the second body.

66. The orthopedic tensioner of claim 65, wherein: the first sleeve has a cylindrical configuration and is configured to hold a cylindrical portion of the first body; and the second sleeve has a cylindrical configuration and is configured to hold a cylindrical portion of the second body.

67. The orthopedic tensioner of claim 65, wherein: the first body has a circumferential feature configured to engage the first sleeve to axially lock the first body relative to the holder; and the second body has a circumferential feature configured to engage the second sleeve to axially lock the second body relative to the holder.

68. The orthopedic tensioner of claim 65, wherein the locking mechanism comprises: a first locking mechanism coupled to the first sleeve and configured to be actuated to rotationally lock the first body to the first sleeve; and a second locking mechanism coupled to the second sleeve and configured to be actuated to rotationally lock the second body to the second sleeve.

69. The orthopedic tensioner of claim 65, wherein each of the first sleeve and the second sleeve includes an adjustable diameter, and wherein the locking mechanism is configured to be actuated to simultaneously reduce the diameter of each of the first sleeve and the second sleeve to rotationally lock the first body and the second body relative to the holder.

70. The orthopedic tensioner of claim 65, wherein the holder is split into a first portion and a second portion, wherein each of the first portion and the second portion partially defines the first sleeve and the second sleeve. ​ 71. The orthopedic tensioner of claim 70, wherein the locking mechanism is configured to be actuated to bring the first portion and the second portion of the retainer closer together to simultaneously and rotationally lock the first body and the second body relative to the retainer.

72. The orthopedic tensioner of claim 71, wherein: each of the first portion and the second portion defines internal teeth; each of the first body and the second body defines external teeth; and the locking mechanism is configured to be actuated to bring the first portion and the second portion closer together such that the internal teeth collectively mesh with the external teeth to simultaneously and rotationally lock the first body and the second body relative to the retainer.

73. The orthopedic tensioner of claim 65, wherein the retainer comprises the first sleeve and the second sleeve spaced apart from one another, and a linking portion connected between the first sleeve and the second sleeve.

74. The orthopedic tensioner of claim 73, wherein the linking portion is rigidly fixed between the first sleeve and the second sleeve such that the first sleeve and the second sleeve are fixed relative to one another.

75. The orthopedic tensioner of claim 73, wherein the linking portion is adjustable and comprises: a rotational joint configured to enable rotational movement between the first sleeve and the second sleeve; and / or a prismatic joint configured to enable translational movement between the first sleeve and the second sleeve.

76. The orthopedic tensioner of claim 75, wherein the locking mechanism is configured to be actuated to further lock the linking portion.

77. The orthopedic tensioner of claim 64, wherein the locking mechanism comprises at least one knob disposed external to the retainer and configured to: rotate in a first direction to rotationally lock one or both of the first body and the second body relative to the retainer; and rotate in a second direction to rotationally unlock one or both of the first body and the second body relative to the retainer.

78. The orthopedic tensioner of claim 64, wherein the locking mechanism comprises at least one lever disposed external to the retainer and configured to: move in a first direction to rotationally lock one or both of the first body and the second body relative to the retainer; and move in a second direction to rotationally unlock one or both of the first body and the second body relative to the retainer.

79. The orthopedic tensioner of claim 64, wherein the locking mechanism comprises at least one button disposed external to the retainer and configured to: be pushed to rotationally lock one or both of the first body and the second body relative to the retainer; and / or be pushed to rotationally unlock one or both of the first body and the second body relative to the retainer.

80. The orthopedic tensioner of claim 64, further comprising: a first drive assembly disposed within the first body and including a first electric motor and a first displacement mechanism coupled between the first electric motor and the first upper paddle, and wherein the first electric motor is configured to move the first displacement mechanism to displace the first upper paddle relative to the first lower paddle along a first axis, wherein the first body is configured to rotate within the holder about the first axis; and a second drive assembly including a second electric motor and a second displacement mechanism coupled between the second electric motor and the second upper paddle, and wherein the second electric motor is configured to move the second displacement mechanism to displace the second upper paddle relative to the second lower paddle along a second axis, wherein the second body is configured to rotate within the holder about the second axis.

81. The orthopedic tensioner of claim 64, wherein each of the first body and the second body are separate from one another and individually hermetically sealed.

82. The orthopedic tensioner of claim 64, wherein each of the first body and the second body are configured to enable installation of a plurality of different sizes of upper paddles and a plurality of different sizes of lower paddles.

83. The orthopedic tensioner of claim 64, wherein the anatomical joint is a knee joint, wherein the first bone is a femur having a medial condyle and a lateral condyle, and the second bone is a tibia, and wherein: the upper paddle is a medial upper paddle configured to engage the medial condyle of the knee joint; the second upper paddle of the second body is a lateral upper paddle configured to engage the lateral condyle of the knee joint; and the first lower paddle of the first body and the second lower paddle of the second body are collectively configured to engage the tibia.

84. An orthopedic tensioner, comprising: a first body; a first set of paddles coupled to the first body, the first set of paddles including a first upper paddle movable relative to the first body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second body separate from the first body; a second set of paddles coupled to the second body, the second set of paddles including a second upper paddle movable relative to the second body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a linking portion coupled between the first body and the second body, the linking portion including one or more joints configured to enable adjustment of the first body and the second body so as to enable adjustment of the first set of paddles and the second set of paddles. wherein a locking mechanism is coupled to the link portion and configured to be actuated to lock the one or more joints so as to lock the first body and the second body relative to each other.

85. The orthopedic tensioner of claim 84, wherein the locking mechanism comprises a knob or lever coupled to the one or more joints.

86. The orthopedic tensioner of claim 84, wherein the one or more joints comprise one or more rotary joints configured to enable rotational adjustment of the first body and the second body so as to enable rotational adjustment of the first set of paddles and the second set of paddles, wherein the locking mechanism is configured to be actuated to lock the one or more rotary joints so as to rotationally lock the first body and the second body relative to each other.

87. The orthopedic tensioner of claim 84, wherein the one or more joints comprise one or more translational joints configured to enable translational adjustment of the first body and the second body so as to enable translational adjustment of the first set of paddles and the second set of paddles, wherein the locking mechanism is configured to be actuated to lock the one or more translational joints so as to translationally lock the first body and the second body relative to each other.

88. An assembly for evaluating an anatomical joint comprising a first bone and a second bone, the assembly comprising: an orthopedic tensioner comprising a lower paddle and an upper paddle and a drive assembly configured to move the upper paddle relative to the lower paddle; and an auxiliary paddle configured to be inserted between the upper paddle and the lower paddle and captured by the upper paddle and the lower paddle, wherein the auxiliary paddle comprises a distal portion that extends beyond a distal end of each of the upper paddle and the lower paddle after the auxiliary paddle is captured, wherein the distal portion is configured to contact the first bone and the second bone of the anatomical joint.

89. The assembly of claim 88, wherein the orthopedic tensioner is configured to command movement of the upper paddle toward the lower paddle to capture the auxiliary paddle between the upper paddle and the lower paddle.

90. The assembly of claim 89, wherein the auxiliary paddle is configured to be secured to the orthopedic tensioner only by being captured between the upper paddle and the lower paddle.

91. The assembly of claim 89, wherein: the orthopedic tensioner is configured to operate in a force control mode to capture the auxiliary paddle; the orthopedic tensioner comprises a force sensor configured to sense a force applied to the upper paddle; and and In the force control mode, the orthopedic tensioner is configured to command movement of the upper paddle toward the lower paddle until the force sensor detects a predetermined force, the predetermined force indicating that the secondary paddle is properly captured between the upper paddle and the lower paddle.

92. The assembly of claim 91, wherein: in response to the distal portion contacting the first bone and the second bone, the secondary paddle is configured to apply a force to the upper paddle; and the force sensor is configured to sense the force applied to the upper paddle by the secondary paddle.

93. The assembly of claim 89, wherein: the orthopedic tensioner is configured to operate in a displacement control mode to capture the secondary paddle; the orthopedic tensioner includes a displacement sensor configured to sense a displacement between the upper paddle and the lower paddle; and in the displacement control mode, the orthopedic tensioner is configured to command movement of the upper paddle toward the lower paddle until the displacement sensor detects a predetermined displacement between the upper paddle and the lower paddle, the predetermined displacement indicating that the secondary paddle is properly captured between the upper paddle and the lower paddle.

94. The assembly of claim 93, wherein: in response to the distal portion contacting the first bone and the second bone, the secondary paddle is configured to apply a force to the upper paddle; and the displacement sensor is configured to measure the displacement between the upper paddle and the lower paddle that results in response to the force applied to the upper paddle by the secondary paddle.

95. The assembly of claim 88, wherein the secondary paddle is configured to pivot in response to the distal portion contacting the first bone and the second bone to apply a force to the upper paddle.

96. The assembly of claim 95, wherein the secondary paddle includes a rocker surface that is contoured and configured to engage the lower paddle, and wherein the rocker surface enables the secondary paddle to pivot in response to the distal portion contacting the first bone and the second bone.

97. The assembly of claim 96, wherein the secondary paddle includes a top surface opposite the rocker surface, and wherein the top surface is planar and configured to engage the upper paddle.

98. The assembly of claim 97, wherein the distal portion, the rocker surface, and the top surface of the secondary paddle are portions of a single monolithic body.

99. The assembly of claim 95, wherein the distal portion of the secondary paddle includes: a secondary upper paddle configured to contact the upper paddle and to contact the first bone; a secondary lower paddle configured to contact the lower paddle and to contact the second bone; and the secondary upper paddle is pivotable relative to the secondary lower paddle in response to the distal portion contacting the first bone and the second bone to apply a force to the upper paddle.

100. The assembly of claim 88, wherein: the upper paddle is designed to contact the first bone; the lower paddle is designed to contact the second bone; and the distal portion is configured to provide a substitute for the upper paddle and the lower paddle for contacting the first bone and the second bone when the supplemental paddle is captured.

101. The assembly of claim 88, wherein the first bone and the second bone of the anatomical joint are un-resected bones, and wherein: the lower paddle is designed to engage a resected surface of the second bone; and the supplemental paddle is configured to provide a substitute for the lower paddle to engage an un-resected surface of the second bone.

102. The assembly of claim 88, wherein: the upper paddle has a bottom surface configured to engage the supplemental paddle; the lower paddle has a top surface configured to engage the supplemental paddle; and the bottom surface of the upper paddle and the top surface of the lower paddle cooperate to capture the supplemental paddle.

103. The assembly of claim 88, wherein: the upper paddle has a length defined between a proximal end and a distal end; the lower paddle has a length defined between a proximal end and a distal end; and the supplemental paddle has a length defined between a proximal end and a distal end of the distal portion, wherein the length of the supplemental paddle is greater than the length of the upper paddle and greater than the length of the lower paddle.

104. The assembly of claim 88, wherein the supplemental paddle comprises a body portion configured to rest on the lower paddle, and wherein the body portion has a shape that substantially conforms to a shape of the lower paddle.

105. A method of utilizing an assembly for assessing an anatomical joint comprising a first bone and a second bone, the assembly comprising: an orthopedic tensioner comprising a lower paddle and an upper paddle and a drive assembly to move the upper paddle relative to the lower paddle; and a supplemental paddle comprising a distal portion, the method comprising: inserting the supplemental paddle between the upper paddle and the lower paddle; with the supplemental paddle inserted between the upper paddle and the lower paddle, controlling the orthopedic tensioner to move the upper paddle toward the lower paddle; and capturing the supplemental paddle between the upper paddle and the lower paddle such that the distal portion of the supplemental paddle extends beyond a distal end of each of the upper paddle and the lower paddle; and contacting the first bone and the second bone of the anatomical joint with the distal portion of the supplemental paddle.

106. The method of claim 105, comprising: operating the orthopedic tensioner in a force control mode for capturing the supplemental paddle by commanding movement of the upper paddle toward the lower paddle until a force sensor detects a predetermined force, the predetermined force indicating that the supplemental paddle is properly captured between the upper paddle and the lower paddle.

107. The method of claim 106, comprising: the supplemental paddle applying a force to the upper paddle in response to the distal portion contacting the first bone and the second bone; and sensing, by the force sensor, the force applied by the supplemental paddle to the upper paddle.

108. The method of claim 105, comprising: operating the orthopedic tensioner in a displacement control mode for capturing the supplemental paddle by commanding movement of the upper paddle toward the lower paddle until a displacement sensor detects a predetermined displacement between the upper paddle and the lower paddle, the predetermined displacement indicating that the supplemental paddle is properly captured between the upper paddle and the lower paddle.

109. The method of claim 108, comprising: the supplemental paddle applying a force to the upper paddle in response to the distal portion contacting the first bone and the second bone; and sensing, by the displacement sensor, a displacement between the upper paddle and the lower paddle resulting in response to the supplemental paddle applying a force to the upper paddle.

110. A supplemental paddle configured to be used with an orthopedic tensioner to evaluate an anatomical joint comprising a first bone and a second bone, the orthopedic tensioner comprising a lower paddle and an upper paddle and a drive assembly to move the upper paddle relative to the lower paddle, wherein the supplemental paddle comprises: a body configured to be inserted between the upper paddle and the lower paddle of the orthopedic tensioner and captured by the upper paddle and the lower paddle; and a distal portion coupled to the body and configured to extend beyond a distal end of each of the upper paddle and the lower paddle, wherein the distal portion is configured to contact the first bone and the second bone of the anatomical joint.

111. The supplemental paddle of claim 110, wherein the supplemental paddle is configured to pivot to apply a force to the upper paddle in response to the distal portion contacting the first bone and the second bone.

112. The supplemental paddle of claim 111, wherein the supplemental paddle comprises a rocker surface profiled and configured to engage the lower paddle, and wherein the rocker surface enables the supplemental paddle to pivot in response to the distal portion contacting the first bone and the second bone.

113. The supplemental paddle of claim 112, wherein the supplemental paddle comprises a top surface opposite the rocker surface, and wherein the top surface is planar and configured to engage the upper paddle.

114. The supplemental paddle of claim 113, wherein the distal portion, the rocker surface, and the top surface of the supplemental paddle are portions of a single monolithic body.

115. The supplemental paddle of claim 110, wherein the distal portion of the supplemental paddle comprises: an auxiliary upper paddle configured to contact the upper paddle and to contact the first bone; an auxiliary lower paddle configured to contact the lower paddle and to contact the second bone; and the auxiliary upper paddle is pivotable relative to the auxiliary lower paddle in response to the distal portion contacting the first bone and the second bone to apply a force to the upper paddle.

116. The auxiliary paddle of claim 110, wherein the distal portion is configured to provide a substitute for the upper paddle and the lower paddle to contact the first bone and the second bone.

117. The auxiliary paddle of claim 110, wherein the distal portion is configured to provide a substitute for the lower paddle to engage an un-resected surface of the second bone.

118. The auxiliary paddle of claim 110, wherein a length of the auxiliary paddle is greater than a length of the upper paddle and greater than a length of the lower paddle.

119. The auxiliary paddle of claim 110, wherein the body includes a body portion configured to rest on the lower paddle, and wherein the body portion has a shape that substantially conforms to a shape of the lower paddle.

120. An auxiliary paddle configured for use with an orthopedic tensioner, wherein the auxiliary paddle comprises: a body; a distal portion coupled to the body and configured to contact un-resected surfaces of a first bone and a second bone of an anatomical joint; and a pivot disposed on the body and / or coupled to the distal portion.

121. An orthopedic tensioner comprising: a body; an upper paddle coupled to the body and configured to engage a first bone of an anatomical joint; a lower paddle coupled to the body and configured to engage a second bone of the anatomical joint; and a load cell configured to sense a force applied to one of the upper paddle or the lower paddle, wherein the load cell is incorporated into the one of the upper paddle or the lower paddle.

122. The orthopedic tensioner of claim 121, wherein the load cell includes one or more slots and one or more strain gauges disposed adjacent to the one or more slots.

123. The orthopedic tensioner of claim 122, wherein the one or more slots are formed to extend completely through the one of the upper paddle or the lower paddle.

124. The orthopedic tensioner of claim 122, wherein the one or more slots at least partially include a pill shape.

125. The orthopedic tensioner of claim 124, wherein: the load cell is incorporated into the upper paddle; the one or more slots include a single pill-shaped slot; and the one or more strain gauges include two strain gauges disposed over the single pill-shaped slot.

126. The orthopedic tensioner of claim 124, wherein: the load cell is incorporated into the upper paddle; the one or more slots include a pill-shaped slot; and the one or more strain gauges include two strain gauges disposed over the pill-shaped slot. The one or more slots include two pill-shaped slots that are spaced apart and connected by a rectangular slot to form an H-shaped slot; and The one or more strain gauges include two strain gauges disposed above the H-shaped slot and another two strain gauges disposed below the H-shaped slot.

127. The orthopedic tensioner of claim 121, comprising: a first load cell incorporated into the upper paddle and a second load cell incorporated into the lower paddle.

128. The orthopedic tensioner of claim 121, wherein: the upper paddle is movable relative to the main body by a motor; and the lower paddle is fixed relative to the main body.

129. A paddle for an orthopedic tensioner, the paddle comprising: a paddle base configured to be removably attached to the orthopedic tensioner; a paddle surface extending from the paddle base and configured to engage a bone of an anatomical joint; and a load cell configured to sense a force applied to the paddle, wherein the load cell is incorporated into the paddle base or the paddle surface.

130. An orthopedic tensioner assembly comprising: a first main body; a first set of paddles coupled to the first main body, the first set of paddles including a first upper paddle movable relative to the first main body and configured to engage a first bone of an anatomical joint, and a first lower paddle configured to engage a second bone of the anatomical joint; a second main body coupled to the first main body; a second set of paddles coupled to the second main body, the second set of paddles including a second upper paddle movable relative to the second main body and configured to engage the first bone of the anatomical joint, and a second lower paddle configured to engage the second bone of the anatomical joint; and a spacer configured to be coupled to a paddle of the first set of paddles or the second set of paddles.

131. The orthopedic tensioner assembly of claim 130, wherein the spacer is configured to be coupled to the paddle by magnetic coupling.

132. The orthopedic tensioner assembly of claim 130, wherein the spacer is configured to be coupled to the paddle by: configuring one of the spacer or the paddle to have a protrusion; and configuring the other of the spacer or the paddle to have a hole configured to receive the protrusion.

133. The orthopedic tensioner assembly of claim 130, comprising: a kit, the kit including a plurality of spacers having incremental thicknesses.

134. The orthopedic tensioner assembly of claim 132, wherein at least one of the spacers is configured to be stacked on another spacer.

135. The orthopedic tensioner assembly of claim 130, wherein the spacer includes a joint surface configured to slidably contact the bone or an implant coupled to the bone.

136. The orthopedic tensioner assembly of claim 135, wherein the joint surface is patient-specific and customized to the bone of the anatomical joint.

137. The orthopedic tensioner assembly of claim 130, wherein the spacer is configured to mimic a geometry of a trial implant.

138. A surgical system configured to assess a knee joint, the surgical system comprising: a tensioner comprising a body supporting: a first paddle and a second paddle configured to interact with the knee joint; and a sensing system configured to sense: a force applied to at least one of the first paddle and the second paddle, and / or a displacement between the first paddle and the second paddle; and a control system coupled to the tensioner, the control system configured to: obtain, from the sensing system, sensed values of the force and / or the displacement; utilize the sensed values to predict a deflection of one or both of the first paddle and the second paddle; and update the sensed values based on the predicted deflection.

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