Joint distraction device and system

Abstract

The present invention relates to a joint distraction device and system. The joint distraction device comprises a swivel assembly, an upper arm, a lower arm, and a one-way locking mechanism. The upper arm and the lower arm are rotatably connected at the swivel assembly and are capable of performing a distraction rotation and a closure rotation about the swivel assembly. The distraction rotation causes an upper front end of the upper arm and a lower front end of the lower arm to move away from each other, and the closure rotation causes the upper front end and the lower front end to move closer to each other. The one-way locking mechanism has a one-way locking state and a free state. When in the one-way locking state, the one-way locking mechanism allows the upper arm and the lower arm to perform the distraction rotation and prevents the upper arm and the lower arm from performing the closure rotation. When in the free state, the one-way locking mechanism allows the upper arm and the lower arm to perform the distraction rotation and the closure rotation. By utilizing the one-way locking mechanism, the present invention can maintain the joint distraction device in a distraction state, which can improve the consistency and accuracy of the acquired force data, and thus can more accurately evaluate the relationship between the knee joint space and the soft tissue tension.

Description

[0001] This application is a divisional application of the invention patent application filed on January 22, 2025, with application number 202510096681.4, entitled "Joint Spreading Device and System". Technical Field

[0002] This invention relates to the field of medical devices, and more particularly to an osteotomy assist system for use in knee replacement surgery. Background Technology

[0003] Total knee arthroplasty (TKA) is the most effective treatment for end-stage knee osteoarthritis. Considering the surgical difficulty, risks, costs, and long-term efficacy of TKA, the benefit-risk ratio of this treatment is very high. However, overall patient satisfaction with the surgery remains only about 80%, and only about 60% of patients feel their knee joint is normal. The incidence of residual symptoms and functional impairment is approximately 33-54%, leading to a high TKA revision rate. Patient dissatisfaction mainly focuses on postoperative pain, joint instability, and limited joint movement, all of which are related to imbalances in the soft tissues surrounding the knee joint.

[0004] A normal knee joint is surrounded by the posterolateral complex, consisting of the tibial collateral ligament, fibular collateral ligament, and anterior cruciate ligament, as well as the posteromedial angle, consisting of the posteromedial joint capsule, posterior oblique ligament, and popliteal oblique ligament. These soft tissues of the knee joint work together to limit varus / valgus and rotation, providing stability. However, in total knee arthroplasty (TKA), it is necessary to remove the soft tissues around the knee joint to accommodate the prosthesis. For example, the anterior cruciate ligament needs to be removed for CR-type knee prostheses, and both the anterior and posterior cruciate ligaments need to be removed for PS-type knee prostheses. Therefore, after TKA, such as in a knee with a CR-type prosthesis, the knee joint can only limit varus / valgus by providing coronal stability through the tibial and fibular collateral ligaments, and limit anterior tibial movement by providing sagittal stability through the posteromedial angle, posterolateral complex, and posterior cruciate ligament. After implantation of artificial joint prostheses, overstretched knee soft tissues can lead to joint pain, stiffness, and reduced range of motion, while overly loose knee soft tissues can cause joint instability, increased impingement between prosthesis components, and thus increased revision risk. Although there is a wealth of research and techniques on soft tissue tension balancing, current methods are not yet universally accepted in the industry due to several factors: firstly, the quantitative value of soft tissue tension is difficult to obtain accurately, relying more on the surgeon's sensory experience; and secondly, there are many individual differences among patients.

[0005] The methods currently available on the market for obtaining soft tissue tension values ​​include the following categories.

[0006] 1. Method of adjusting knee joint space with pads. The specific operation of this method is as follows: the user changes the joint space by adding or removing pads, and then assesses whether the patient's soft tissue is balanced by touching the tension of the patient's soft tissue and ligaments. However, this method has the following disadvantages: (1) it requires multiple removals and placements to select the appropriate space assessment block for measurement, which is cumbersome; (2) the combined space assessment block will have a large overall thickness error after combination due to the processing error of each individual, which will result in a large error in the space measurement and may easily lead to an unsuitable thickness of the selected knee joint prosthesis; (3) there is no quantitative data, it relies entirely on experience, it is difficult to improve the accuracy, and it often relies on soft tissue release to balance the knee joint soft tissue tension, which increases the possibility of permanent soft tissue damage.

[0007] 2. The method of measuring pressure changes in the medial and lateral compartments of the knee joint using pressure sensors is based on the use of a smart pad equipped with pressure sensors and with the same thickness and size as a standard test pad implant. This smart pad can detect and record the pressure in the medial and lateral compartments of the knee joint during the trial molding and after the final implant placement. The surgeon compares these quantified values ​​with standard values ​​for balancing the knee joint to determine whether additional treatment (such as re-osteotomy, soft tissue release, etc.) is needed to achieve soft tissue tension balance. However, this method also has many disadvantages, such as: (1) due to individual differences, there is a possibility that the pressure sensor may not be able to make consistent and continuous contact with a specific joint surface, and studies have found that when the pressure occurs outside the sensor's sensing area, the measurement error of the pressure sensor will increase, resulting in inaccurate measurement of tibiofemoral contact force and contact position; (2) Tibial resection must be completed before the trial molding measurement can be performed using this method.

[0008] In conclusion, existing methods for assessing soft tissue tension need to be improved to increase patient satisfaction with TKA surgery. Summary of the Invention

[0009] The technical solution proposed in this invention aims to solve the problem caused by postoperative soft tissue imbalance around the knee joint in the prior art.

[0010] In one aspect of the invention, a joint opening device is provided, the joint opening device comprising: a pivot assembly; an upper arm and a lower arm rotatably connected to the pivot assembly and capable of opening and closing rotations about the pivot assembly, the opening rotation causing the upper front end of the upper arm and the lower front end of the lower arm to move away from each other, and the closing rotation causing the upper front end of the upper arm and the lower front end of the lower arm to move closer to each other; and a one-way locking mechanism having a one-way locked state and a free state, wherein, when in the one-way locked state, the one-way locking mechanism allows the upper arm and lower arm to open and prevents the upper arm and lower arm from closing; and when in the free state, the one-way locking mechanism allows the upper arm and lower arm to open and close.

[0011] In at least one embodiment of one aspect of the invention, the joint opening device further includes one or more force sensors, each of the one or more force sensors being located on the upper arm or the lower arm for measuring the force acting on the upper arm or the lower arm.

[0012] In at least one embodiment of one aspect of the invention, the upper arm has an upper front portion and an upper rear portion separated by the pivot assembly, the lower arm has a lower front portion and a lower rear portion separated by the pivot assembly, the upper front portion of the upper arm has the upper front end portion, the lower front portion of the lower arm has the lower front end portion, the upper front end portion and the lower front end portion are configured to be inserted into a patient joint, the upper rear portion of the upper arm and the lower rear portion of the lower arm each have an upper operating portion and a lower operating portion for applying a force thereon to cause the upper arm and the lower arm to perform a spreading rotation, and each of the one or more force sensors is located in the upper rear portion of the upper arm or the lower rear portion of the lower arm.

[0013] In at least one embodiment of one aspect of the invention, the upper rear portion of the upper arm has a cantilever beam configured to have a force-sensitive region, at least one of the one or more force sensors being located within the force-sensitive region of the cantilever beam of the upper arm.

[0014] In at least one embodiment of one aspect of the invention, the upper arm has a housing that includes a first housing portion that is flexible and bendable and completely surrounds the force-sensitive region for positioning at least one force sensor.

[0015] In at least one embodiment of one aspect of the invention, the upper arm has a reinforcing metal member for mounting within the housing.

[0016] In at least one embodiment of one aspect of the present invention, the one-way locking mechanism includes a locking member and a locking engagement member. When the one-way locking mechanism is in the one-way locked state, the locking member and the locking engagement member are in a first predetermined position relative to each other; and when the one-way locking mechanism is in the free state, the locking member and the locking engagement member are in a second predetermined position relative to each other.

[0017] In at least one embodiment of one aspect of the invention, the locking member has a first toothed surface, the locking engagement member has a second toothed surface, the first predetermined position includes engagement of the first toothed surface and the second toothed surface, the second predetermined position includes separation of the first toothed surface and the second toothed surface, and the first toothed surface and the second toothed surface are configured such that when the first toothed surface engages with the second toothed surface, the locking member and the locking engagement member can only move in a single direction, thereby causing the upper arm and the lower arm to only be able to rotate relative to each other.

[0018] In at least one embodiment of one aspect of the invention, the lower arm has an opening at its lower rear portion, a first toothed surface of the locking member is disposed within the opening, one end of the locking engagement member is connected to the upper arm, and the other end is used to pass through the opening of the lower arm. The one-way locking mechanism further includes: an elastic member located at the connection between the locking engagement member and the upper arm, for pushing a second toothed surface of the locking engagement member toward the first toothed surface of the locking member; and a switch located on the lower arm for being operated to push the second toothed surface of the locking engagement member away from the first toothed surface of the locking member.

[0019] In at least one embodiment of one aspect of the invention, the pivot assembly includes: a pivot connected to the upper arm and having a variable diameter region; and a bushing connected to the lower arm and for fitting the pivot, the locking engagement including the variable diameter region of the pivot, the locking member including a pressing member disposed in a cavity of the lower arm for abutting the variable diameter region of the pivot, a first predetermined position including the pressing member abutting the variable diameter region of the pivot, and a second predetermined position including the pressing member being separated from the variable diameter region of the pivot.

[0020] In at least one embodiment of one aspect of the invention, the one-way locking mechanism further includes: a push rod disposed within the cavity of the lower arm; and a button, a portion of which is disposed within the cavity of the lower arm, the button being operable to push the push rod toward the extruder, thereby causing the extruder to abut against the variable diameter region of the rotating shaft.

[0021] In at least one embodiment of one aspect of the invention, the lower arm has an opening at its lower rear portion, the locking engagement includes a threaded rod, a first end of which is connected to the upper arm, and a second end which is for passing through the opening in the lower arm. The threaded rod includes a locking section and a non-locking section, the outer surface of which is threaded. The locking section of the threaded rod is closer to the first end than the non-locking section. The locking member includes a nut for engaging the threaded rod from the second end of the threaded rod. A first predetermined position includes the nut being threadedly connected to the threaded rod within the locking section of the threaded rod, and a second predetermined position includes the nut being located within the non-locking section of the threaded rod or the nut being separated from the threaded rod.

[0022] In at least one embodiment of one aspect of the invention, the joint spreading device further includes a position sensor configured to measure position data for determining the spreading distance of the joint spreading device.

[0023] In at least one embodiment of one aspect of the invention, the position sensor includes an angle encoder located at the shaft assembly and configured to measure rotation angles.

[0024] In another aspect of the invention, a joint spreading system is provided, the joint spreading system comprising: a joint spreading device as described in the preceding paragraphs; a processing module, the processing module being communicatively coupled to the joint spreading device and configured to: receive one or more force data from a force sensor and one or more position data from a position sensor from the joint spreading device; determine one or more spreading pressures based on the one or more force data; and determine one or more spreading distances based on the one or more position data; and a display module, the display module being communicatively coupled to the processing module and configured to display the determined one or more spreading pressures and one or more spreading distances.

[0025] In at least one embodiment of another aspect of the invention, the display module is further configured to display each of the one or more expansion distances in association with a corresponding expansion pressure among the one or more expansion pressures.

[0026] In at least one embodiment of another aspect of the invention, for each of the one or more measurement locations, the one or more location data are acquired, and for each of the one or more measurement locations, the one or more force data are acquired.

[0027] In at least one embodiment of another aspect of the invention, the processing module is further configured to: perform osteotomy analysis based on the spreading pressure and the corresponding spreading distance determined for each of one or more measurement locations to determine the osteotomy amount, and the display module is configured to display the determined osteotomy amount.

[0028] In at least one embodiment of another aspect of the present invention, the osteotomy amount analysis includes: determining a plurality of expansion pressures and their corresponding expansion distances within a predetermined expansion pressure range based on the expansion pressure and its corresponding expansion distance obtained for each measurement location; plotting a curve of the expansion pressure versus expansion distance based on the plurality of expansion pressures and their corresponding expansion distances within the predetermined expansion pressure range; determining a target expansion distance based on the slope of the plotted curve, wherein the target expansion distance is the expansion distance corresponding to a feature point in the curve; and determining the osteotomy amount based on the target expansion distance.

[0029] The technical solution proposed in this invention may have at least one of the following advantages:

[0030] (1) By dynamically assessing the relationship between the knee joint space and soft tissue tension before osteotomy, it can help improve the precision and accuracy of knee replacement surgery and promote the standardization process of research on knee joint soft tissue tension balance, providing new ideas and methods for the treatment of knee joint diseases.

[0031] (2) In the process of using the joint opening device to open the joint gap to obtain force data related to soft tissue tension, the one-way locking mechanism can keep the joint opening device in the open state, which can improve the consistency and accuracy of the obtained force data, thereby enabling a more accurate assessment of the relationship between the knee joint gap and soft tissue tension. Attached Figure Description

[0032] To further illustrate the above and other advantages and features of the various embodiments of the present invention, a more specific description of the various embodiments of the present invention will be presented with reference to the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the present invention and are therefore not intended to limit the scope of protection claimed by the present invention.

[0033] Figure 1 A schematic diagram of a joint spreading system according to an embodiment of the present invention is shown.

[0034] Figure 2 A schematic diagram of a joint-opening device according to some embodiments of the present invention is shown, installed in the lateral space of the left knee joint.

[0035] Figure 3A schematic diagram of a joint-opening device installed in the lateral space of the left knee joint according to some embodiments of the present invention is shown in the open state.

[0036] Figure 4 A schematic diagram of a joint opening device in a closed state, according to some embodiments of the present invention, is shown from one perspective.

[0037] Figure 5 A schematic diagram of a joint opening device in a closed state, according to some embodiments of the present invention, is shown from another perspective.

[0038] Figure 6 A schematic diagram of a joint opening device in an open state, according to some embodiments of the present invention, is shown from one perspective.

[0039] Figure 7 A schematic diagram of a joint opening device in an open state, according to some embodiments of the present invention, is shown from another perspective.

[0040] Figure 8 A schematic diagram of the one-way locking mechanism of the joint opening device according to another embodiment of the present invention in a one-way locked state is shown.

[0041] Figure 9 A partially enlarged schematic diagram of the one-way locking mechanism of the joint opening device according to another embodiment of the present invention in a one-way locked state is shown.

[0042] Figure 10 A schematic diagram of the one-way locking mechanism of the joint opening device according to another embodiment of the present invention in a free state is shown.

[0043] Figure 11 A schematic diagram of the one-way locking mechanism of the joint opening device according to another embodiment of the present invention in a free state is shown.

[0044] Figure 12 A partial exploded view of the upper arm with a joint opening the pivot axis according to an embodiment of the present invention is shown.

[0045] Figure 13 A method for performing osteotomy analysis according to an embodiment of the present invention is shown.

[0046] Figure 14 A graph showing the variation of the spreading pressure relative to the spreading distance according to some embodiments of the present disclosure is shown. Detailed Implementation

[0047] The present invention will be further described below with reference to specific embodiments and accompanying drawings. More details are set forth in the following description in order to provide a full understanding of the present invention. However, the present invention can obviously be implemented in many other ways different from those described herein. Those skilled in the art can make similar extensions and derivations based on actual application situations without departing from the spirit of the present invention. Therefore, the scope of protection of the present invention should not be limited by the content of this specific embodiment.

[0048] This application uses specific terms to describe embodiments of the application. Terms such as "one embodiment," "other embodiments," and / or "some embodiments" refer to a particular feature, structure, or characteristic associated with at least one embodiment of the application. Therefore, it should be emphasized and noted that "one embodiment," "other embodiments," or "some embodiments" mentioned twice or more in different locations in this specification do not necessarily refer to the same embodiment. Furthermore, certain features, structures, or characteristics in one or more embodiments of the application can be appropriately combined.

[0049] It should be noted that, in order to simplify the description of the present application and thus aid in the understanding of one or more embodiments, the description of the embodiments of the present application may sometimes combine multiple features into a single embodiment, drawing, or description thereof. However, this disclosure method does not imply that the subject matter of the application requires more features than those mentioned in the claims.

[0050] In the description of this disclosure, it should be noted that the terms "clockwise," "counterclockwise," "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this disclosure and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this disclosure. In this disclosure, the end closer to the operator (e.g., a doctor) is defined as the rear end or rear part, and the end closer to the surgical patient is defined as the front end or front part.

[0051] Reference Figure 1 , Figure 1 A schematic diagram of a joint spreading system 100 according to an embodiment of the present invention is shown.

[0052] like Figure 1As shown, the joint dislocation system 100 (hereinafter referred to as system 100) may include a joint dislocation device 10, a processing module 20, and a display module 30. The joint dislocation device 10 can dislocate a patient's joint, such as the knee joint. The joint dislocation device 10 may include one or more force sensors 101. During the dislocation of a patient's joint using the joint dislocation device 10, the force sensors 101 on the joint dislocation device 10 can measure force data, which can reflect the tension of the soft tissues surrounding the patient's joint. In some embodiments, the force sensors 101 may include resistance strain gauges. The joint dislocation device 10 may also include one or more position sensors 103. During the dislocation of a patient's joint using the joint dislocation device 10, the position sensors 103 on the joint dislocation device 10 can measure position data, which can be used to determine the dislocation distance of the joint dislocation device 10 (i.e., the distance the joint is dislocated). In some embodiments, the position sensor 103 may include an angle encoder, which may be located on the shaft assembly 130 of the joint dislocation device 10. Figure 1 Not shown in the image, see [link / reference]. Figure 4 The position sensor 103 is configured to measure a rotation angle, which can be used to determine the opening distance of the joint spreading device 10 (i.e., the distance the joint is spread apart). In other embodiments, the position sensor 103 may include a Hall sensor, which can be used to determine the opening distance of the joint spreading device 10 (i.e., the distance the joint is spread apart) by utilizing data measured by the Hall sensor.

[0053] See Figure 1 The processing module 20 can be communicatively coupled to the joint spreading device 10. The processing module 20 can be configured to receive force data and position data from the joint spreading device 10. The display module 30 can be communicatively coupled to the processing module 20 and / or the joint spreading device 10 and can be configured to receive information from the processing module 20 and / or the joint spreading device 10 and display the received information.

[0054] During operation, the joint spreading device 10 can be installed on the patient's joint (e.g., the knee joint). Figure 2 A schematic diagram is shown of a joint spreading device 10 installed in the lateral space of the left knee joint 40 according to some embodiments of the present invention. Figure 2As shown, the joint spreading device 10 may have an upper arm 110 and a lower arm 120. The upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are in a closed state and are inserted into the lateral space of the patient's left knee joint 40. When the joint spreading device 10 is inserted into the lateral space of the patient's left knee joint 40, the upper front end 111 of the upper arm 110 may contact the femoral condyle (not shown in the figure), and the lower front end 121 of the lower arm 120 may contact the tibial plateau of the knee joint 40 (not shown in the figure). The upper arm 110 and the lower arm 120 may be spread apart and rotated relative to each other under the action of an external force, so that the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are moved away from each other. Figure 3 A schematic diagram of a joint spreading device 10, installed in the lateral space of the left knee joint 40 according to some embodiments of the present invention, is shown in its spread state. Figure 3As shown, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint spreading device 10 are in a spread state. In this spread state, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are separated by a certain distance. At this time, the tibial plateau and femoral condyle of the knee joint 40 are also spread apart by a certain distance by the upper arm 110 and the lower arm 120 of the joint spreading device 10. Under the tension of the surrounding soft tissues (not shown in the figure), the tibial plateau and femoral condyle will exert a compressive force on the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint spreading device 10. The force sensor 101 located on the upper arm 110 or the lower arm 120 can measure the force on the upper arm 110 or the lower arm 120. When the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are at different spreading distances (i.e., the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 are separated by different distances), the distance that the knee joint 40 is spread apart by the upper arm 110 and the lower arm 120 of the joint spreading device 10 will be different. This results in different compressive forces exerted by the tibial plateau and femoral condyle of the knee joint 40 on the upper arm 110 and the lower arm 120 under the tension of the surrounding soft tissues. Generally, the compressive force increases with the increase of the spreading distance. By using the position data measured by the position sensor 103 to determine the height of the spreading of the tibial plateau and femoral condyle of the knee joint 40, and using the force data measured by the force sensor 101 to determine the soft tissue tension, the soft tissue tension at different spreading distances can be obtained, thereby allowing the assessment of the relationship between the joint space and the soft tissue tension. This can help surgeons determine the appropriate amount of bone to be removed during knee replacement surgery, avoiding reliance on soft tissue release to balance knee joint soft tissue tension, reducing the likelihood of permanent postoperative soft tissue damage around the knee joint, thereby improving patient comfort and satisfaction. Furthermore, those skilled in the art can use the joint dispersing system 100 of this disclosure to dynamically assess the relationship between the knee joint space and soft tissue tension, which can promote the standardization of research on knee joint soft tissue tension balance and provide new ideas and methods for the treatment of knee joint diseases.

[0055] The following will combine Figures 4-7 The structure of the joint spreading device 10 is described in detail. Figure 4 A schematic diagram of the joint opening device 10 in a closed state according to some embodiments of the present invention is shown from one perspective. Figure 5 A schematic diagram of the joint opening device 10 in a closed state according to some embodiments of the present invention is shown from another perspective. Figure 6 A schematic diagram of the joint opening device 10 in an open state according to some embodiments of the present invention is shown from one perspective. Figure 7 A schematic diagram of the joint opening device 10 in an open state according to some embodiments of the present invention is shown from another perspective.

[0056] See Figure 4-7 The joint spreading device 10 may include an upper arm 110, a lower arm 120, and a pivot assembly 130. The upper arm 110 and the lower arm 120 are rotatably connected to the pivot assembly 130. With the pivot assembly 130 as the boundary, the upper arm 110 may be divided into an upper front portion 112 and an upper rear portion 114, and the lower arm 120 may be divided into a lower front portion 122 and a lower rear portion 124. The upper front portion 112 of the upper arm 110 may have an upper front end 111, and the lower front portion 122 of the lower arm 120 may have a lower front end 121. The upper arm 110 and the lower arm 120 can perform spreading rotation and closing rotation around the pivot assembly 130. During spreading rotation, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 may move away from each other. During closing rotation, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 may move closer to each other. When the joint spreading device 10 is in the closed state, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 can approach each other. In some embodiments, such as Figure 4 and Figure 5 As shown, when the joint spreading device 10 is in the closed state, the upper front end 111 and the lower front end 121 can contact each other, that is, the distance between the upper front end 111 and the lower front end 121 is zero. In other embodiments, when the joint spreading device 10 is in the closed state, the upper front end 111 and the lower front end 121 can be slightly spaced apart, that is, separated by a non-zero distance. When the joint spreading device 10 is in the extended state, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 can be spaced apart from each other and separated by a greater distance than in the closed state, such as... Figure 6 and Figure 7 As shown.

[0057] In some embodiments, the upper front end 111 and the lower front end 121 may be configured as a toothed structure, such as Figure 7 As shown. In other embodiments, the upper front end 111 and / or the lower front end 121 may be configured in other structures, such as a double-pointed structure, a single-pointed structure, etc. The upper front end 111 may be configured to be integral with other parts of the upper arm 110 or detachable from other parts of the upper arm 110. Similarly, the lower front end 121 may be configured to be integral with other parts of the lower arm 120 or detachable from other parts of the lower arm 120. Detachable upper front end 111 and / or lower front end 121 can allow for personalized customization of the upper front end 111 and / or lower front end 121 to suit the patient. Furthermore, detachable upper front end 111 and / or lower front end 121 can also allow the joint dispersing device 10 to be reused for different patients, requiring only the upper front end 111 and / or lower front end 121 to be replaced. This not only improves the safety of the surgery but also reduces the cost of the surgery.

[0058] See Figures 4-7 The upper rear portion 114 of the upper arm 110 may have an upper operating portion 113, and the lower rear portion 124 of the lower arm 120 may have a lower operating portion 123. The upper operating portion 113 and the lower operating portion 123 can be used by an operator (e.g., a doctor) to apply force to cause the upper arm 110 and the lower arm 120 to spread and rotate about the pivot assembly 130, thereby increasing the spreading distance between the upper front end 111 and the lower front end 121.

[0059] In some embodiments, the force sensor 101 may be positioned on the upper rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120. When the force sensor 101 is positioned on the upper rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120, if the point of force application by the operator on the upper arm 110 or lower arm 120 changes, the force data measured by the force sensor 101 will change even if the force applied by the operator to the upper arm 110 or lower arm 120 is the same. To solve this problem, the present invention proposes to provide a one-way locking mechanism 140 (or one-way locking mechanism 150 or 160) in the joint spreading device 10 (or joint spreading device 50 or 60). The one-way locking mechanism 140 (or one-way locking mechanism 150 or 160) will be described in detail below.

[0060] In other embodiments, the force sensor 101 may be located on the upper front portion 112 of the upper arm 110 or the lower front portion 122 of the forearm. For example, the force sensor 101 may be located outside the upper front end 111 of the upper front portion 112 of the upper arm 110, or the force sensor 101 may be located outside the lower front end 121 of the lower front portion 122 of the forearm 110. The force data measured by the force sensor 101 located on the upper front portion 112 or the lower front portion 122 will not be affected by the operator's point of force application.

[0061] See Figures 4-7 The joint spreading device 10 may also include a one-way locking mechanism 140. The one-way locking mechanism 140 can be used to prevent the upper arm 110 and the lower arm 120 from closing rotation about the pivot assembly 130, thereby maintaining the joint spreading device 10 in the spread state. By using the one-way locking mechanism 140 to maintain the joint spreading device 10 in the spread state, rather than by the operator applying force, the influence of changes in the operator's point of force application on the consistency of the force data measured by the force sensor 101 (e.g., the force sensor 101 located at the lower rear portion 114 of the upper arm 110 or the lower rear portion 124 of the lower arm 120) can be eliminated.

[0062] The one-way locking mechanism 140 can have a one-way locked state and a free state. In the one-way locked state, the one-way locking mechanism 140 can only allow the upper arm 110 and the lower arm 120 to rotate open about the pivot assembly 130 and prevent the upper arm 110 and the lower arm 120 from rotating closed about the pivot assembly 130. In the free state, the one-way locking mechanism 140 can allow the upper arm 110 and the lower arm 120 to rotate open and close about the pivot assembly 130.

[0063] See Figures 4-7 The one-way locking mechanism 140 may include a locking member 141 and a locking engagement member 143. When the one-way locking mechanism 140 is in a one-way locked state, the locking member 141 and the locking engagement member 143 may be in a first predetermined position relative to each other, for example, the locking member 141 and the locking engagement member 143 are engaged. When the one-way locking mechanism 140 is in a free state, the locking member 141 and the locking engagement member 143 may be in a second predetermined position relative to each other, for example, the locking member 141 and the locking engagement member 143 are separated. Figure 5 In the illustrated embodiment, the locking member 141 may have a first toothed surface 1411, which may be located within the opening 125 of the lower rear portion 124 of the lower arm 120. The locking engagement member 143 may have a second toothed surface 1431, with one end of the locking engagement member 143 connected to the upper rear portion 114 of the upper arm 110 and the other end passing through the opening 125 of the lower rear portion 124 of the lower arm 120.

[0064] See Figure 5 The one-way locking mechanism 140 may further include an elastic element 145, such as a torsion spring. The elastic element 145 may be located at the connection between the locking engagement member 143 and the upper arm 110, and is used to push the second toothed surface 1431 of the locking engagement member 143 against the first toothed surface 1411 of the locking member 141, so as to force the first toothed surface 1411 to engage with the second toothed surface 1431. When the first toothed surface 1411 engages with the second toothed surface 1431, the locking member 141 can only move relative to the locking engagement member 143 in the first direction L1, and the locking engagement member 143 can only move relative to the locking member 141 in the second direction L2. At this time, the upper arm 110 and the lower arm 120 can only be spread and rotated around the pivot assembly 130. That is, when the first toothed surface 1411 engages with the second toothed surface 1431, the one-way locking mechanism 140 is in a one-way locked state.

[0065] See Figure 5 The one-way locking mechanism 140 may further include a switch 147. The switch 147 may be located near an opening 125 in the lower rear portion 124 of the lower arm 120. The opening 147 can be operated to push the second toothed surface 1431 of the locking engagement 143 away from the first toothed surface 1411 of the locking member 141. For example, the switch 147 can be toggled to position it as follows: Figure 5The first state is shown. In this first state, one end 1471 of the switch 147 abuts against the locking engagement member 143 to push the second tooth surface 1431 of the locking engagement member 143 away from the first tooth surface 1411 of the locking member 141, thereby releasing the engagement between the first tooth surface 1411 and the second tooth surface 1431. When the engagement between the first tooth surface 1411 and the second tooth surface 1431 is released, the one-way locking mechanism 140 can be in a free state. The switch 147 can also be placed as follows: Figure 6 The second state is shown. In this second state, one end 1471 of the switch 147 no longer abuts against the locking engagement member 143. At this time, the second tooth surface 1431 of the locking engagement member 143 can contact and engage the first tooth surface 1411 of the locking member 141 under the action of the elastic member 145, so that the one-way locking mechanism 140 is in a one-way locking state.

[0066] In addition to the above references Figures 4-7 In addition to the described joint spreading device 10, the joint spreading system 100 may also include other joint spreading devices, such as... Figures 8-10 The joint spreading device 50 shown Figure 11 The joint opening device 60 is shown. Most of the components of the joint opening devices 10, 50 and 60 (e.g., upper arm 110, lower arm 120, pivot assembly 130) can be constructed to be substantially the same, and their differences may lie in the different one-way locking mechanisms.

[0067] Figure 8 A schematic diagram of the joint opening device 50 according to another embodiment of the present invention in a one-way locking state is shown. Figure 9 A partially enlarged structural schematic diagram of the one-way locking mechanism 150 of the joint opening device 50 according to another embodiment of the present invention in a one-way locked state is shown. Figure 10 A schematic diagram of the one-way locking mechanism 150 of the joint opening device 50 according to another embodiment of the present invention in a free state is shown.

[0068] See Figure 8 The joint opening device 50 may include a pivot assembly 130. In some embodiments, the above is combined with Figures 4-7 The described joint spreading device 10 includes the pivot assembly 130 and / or the following combinations: Figure 11 The pivot assembly 130 of the described joint spreading device 60 can be substantially similar to the following combination. Figure 8 The described joint spreading device 50 includes a pivot assembly 130. (As follows) Figure 8As shown, the pivot assembly 130 may include a pivot 131 and a bushing 133. The pivot 131 may be connected to the upper arm 110, and the bushing 133 may be connected to the lower arm 120, with the bushing 133 fitting over the pivot 131. When the upper arm 110 and lower arm 120 rotate in a closed position around the pivot assembly 130, the pivot 131 may rotate counterclockwise within the bushing 133. When the upper arm 110 and lower arm 120 rotate in an open position around the pivot assembly 130, the pivot 131 may rotate clockwise within the bushing 133.

[0069] See Figure 8 The joint spreading device 50 may further include an upper arm 110 and a lower arm 120. The upper arm 110 and lower arm 120 of the joint spreading pivot 50 may be substantially similar to the above-described combination. Figures 4-7 The described joint spreading device 50 includes the upper arm 110 and the lower arm 120.

[0070] See Figures 8-10 The joint spreading device 50 may also include a one-way locking mechanism 150. For example... Figure 9 As shown, the one-way locking mechanism 150 may include a locking member 151 and a locking mating member 153. When the one-way locking mechanism 150 is in a one-way locked state, the locking member 151 and the locking mating member 153 may be in a first predetermined position relative to each other; for example, the locking member 151 may abut against the locking mating member 153. Figure 9 In the illustrated embodiment, the locking member 151 may include a pressing member 152, which may be disposed within a cavity of the lower arm 120. This cavity may communicate with the bushing 133. The locking engagement member 153 may include a diameter-changing region 1311 of the shaft 131. The shaft 131 may have the following diameter characteristics in the diameter-changing region 1311: the diameter of the shaft 131 in the diameter-changing region 1311 is smaller than the diameter of other portions of the shaft 131, and the diameter of the shaft 131 in the diameter-changing region 1311 gradually increases in a clockwise direction. When a portion of the extruder 152 extends into the bushing 133 and abuts against the variable diameter region 1311 of the shaft 131, due to the aforementioned diameter characteristics of the shaft 131 in the variable diameter region 1311 (i.e., the diameter of the shaft 131 in the variable diameter region 1311 is smaller than the diameter of the other parts of the shaft 131 and gradually increases in the clockwise direction), the shaft 131 may be unable to rotate counterclockwise within the bushing 133, but can only rotate clockwise within the bushing 133. This can result in the upper arm 110 and the lower arm 120 only being able to rotate outward around the shaft assembly 130, but not being able to rotate in a closed manner around the shaft assembly 130.

[0071] See also Figure 9The one-way locking mechanism 150 may further include a push rod 155 and a button 157. The engagement of the pressing member 152 with the variable diameter region 1311 of the rotating shaft 131 is accomplished through the cooperation of the pressing member 152, the push rod 155, and the button 157. In some embodiments, the button 157 can be pressed by an operator to push the push rod 155 toward the pressing member 152, thereby causing the pressing member 152 to abut against the variable diameter region 1311 of the rotating shaft 131. When the operator releases the pressure on the button 157, the push rod 155 moves away from the pressing member 152, thereby causing the pressing member 152 to separate from the variable diameter region 1311 of the rotating shaft 131.

[0072] like Figure 9 As shown, the extruder 152 may have an extrusion head 1521, an extrusion positioning portion 1522, and an extrusion tail portion 1523. The extrusion positioning portion 1522 may be rotatably fixed to the inner wall of the cavity of the lower arm 120. The extrusion head 1521 and the extrusion tail portion 1523 may be connected to the extrusion positioning portion 1522. A push rod 155 may be disposed in the cavity of the lower arm 120. The push rod 155 may have a first push rod portion 1551, a push rod recess 1553, and a second push rod portion 1555 along its extension direction. The end of the first push rod portion 1551 near the push rod recess 1553 may have a push rod inclined surface 1552, and the other end of the first push rod portion 1551 away from the push rod recess 1553 may be connected to a first spring 158. A portion of the button 157 may be disposed in the cavity of the lower arm 120. The button 157 may have a first button portion 1571, a button recess 1573, and a second button portion 1575 along its extending direction. The end of the first button portion 1571 away from the button recess 1573 may be connected to a second spring 159. The end of the second button portion 1575 near the button recess 1573 may have a button bevel 1572, and the other end of the second button portion 1575 away from the button recess 1573 may have a button operation portion 1574.

[0073] See Figure 9 When the one-way locking mechanism 150 is in the one-way locking state, the pressing head 1521 can abut against the diameter change area 1311 of the rotating shaft 131, and the pressing tail 1523 can be clamped between the second push rod part 1555 and the inner wall of the cavity of the lower arm 120. The first push rod part 1551 can be at least partially located in the button recess 1573.

[0074] When the operator presses the button operation part 1574 upward, the button inclined surface 1572 and the push rod inclined surface 1552 can slide relative to each other, thereby causing the push rod 155 as a whole to move away from the extruder 152 (in Figure 9(In the middle, in the right direction) moves. At this time, the extrusion tail 1523 can fall back under the action of gravity, thereby driving the extrusion positioning part 1522 to rotate clockwise. The clockwise rotating extrusion positioning part 1522 can further drive the extrusion head 1521 to move away from the diameter change area 1311 of the rotating shaft 131. When the extrusion head 1521 separates from the diameter change area 1311 of the rotating shaft 131, the one-way locking mechanism 150 can be in a free state, such as Figure 10 shown.

[0075] When the one-way locking mechanism 150 is in the free state, the pressing head 1521 is separated from the diameter-changing region 1311 of the rotating shaft 131, the pressing tail 1523 is located between the second push rod portion 1555 and the inner wall of the lower arm 120, and the pressing tail 1523 contacts the second push rod portion 1555 but does not contact the inner wall of the lower arm 120. The second button portion 1575 may be at least partially located within the push rod recess 1553. In some embodiments, compared to the one-way locking state, the first spring 158 and the second spring 159 of the one-way locking mechanism 150 in the free state are further compressed. This allows the compressed second spring 159 to move the button 157 downwards through its restoring force when the operator releases the pressing force applied at the button operation portion 1574, and the compressed first spring 158 to move the push rod 155 towards the direction closer to the pressing member 152 (in Figure 10 The mechanism moves (in the left direction) to restore the one-way locking mechanism 150 to the one-way locking state. In this way, the initial state of the one-way locking mechanism 150 can be set to the one-way locking state.

[0076] Figure 11 A schematic diagram of the one-way locking mechanism 160 of the joint opening device 60 according to another embodiment of the present invention in a free state is shown.

[0077] See Figure 11 The joint spreading device 60 may include an upper arm 110 and a lower arm 120. The upper arm 110 and lower arm 120 of the joint spreading pivot 60 may be substantially similar to the above-described combination. Figures 4-7 The described joint spreading device 50 includes an upper arm 110 and a lower arm 120. The joint spreading device 60 may also include a pivot assembly 130. The pivot assembly 130 of the joint spreading device 60 may be generally similar to the combination described above. Figure 8 The described joint spreading device 50 has a pivot assembly 130.

[0078] See Figure 11The joint opening device 60 may further include a one-way locking mechanism 160. The one-way locking mechanism 160 may include a nut 161 and a threaded rod 163. A first end 162 of the threaded rod 163 may be connected to the upper rear portion 114 of the upper arm 110, and a second end 164 may pass through an opening 125 in the lower rear portion 124 of the lower arm 120. The outer dimensions of the nut 161 may be larger than the size of the opening 125 of the lower arm 120, thereby preventing the nut 161 from passing through the opening 125. In use, the nut 161 may be fitted onto the threaded rod 163 from the second end 164.

[0079] See Figure 11 The threaded rod 163 may have a locking section 1631 and a non-locking section 1633. The outer surface of the locking section 1631 is threaded to facilitate threaded connection with the nut 161. The outer surface of the non-locking section 1633 may also have threads (e.g., Figure 11 (As shown) or without threads (not shown in the figure). Figure 11 As shown, the locking section 1631 is closer to the first end 162 of the threaded rod 163 than the unlocked section 1633. In other words, the unlocked section 1633 is closer to the second end 164 of the threaded rod 163 than the locking section 1631.

[0080] During the operation of the one-way locking mechanism 160, by tightening the nut 161, the nut 161 is threadedly connected to the threaded rod 163 within the locking section 1631 and pressed against the lower arm 120. This prevents the upper arm 110 and the lower arm 120 from rotating in a closed manner around the rotating shaft assembly 130, while allowing the upper arm 110 and the lower arm 120 to rotate outward around the rotating shaft assembly 130. At this time, the one-way locking mechanism 160 is in a one-way locked state.

[0081] When the nut 161 is placed within the non-locking section 1633 of the threaded rod 163 (e.g., as... Figure 11 As shown, when the nut 161 is threadedly connected to the threaded rod 163 within the non-locking section 1633, the joint opening device 60 can be placed in a closed state. Since the final result of the closed rotation is that the joint opening device 60 is in a closed state, it can be considered that when the nut 161 is placed within the non-locking section 1633 of the threaded rod 163, the one-way locking mechanism 160 is in a free state, that is, the upper arm 110 and the lower arm 120 can perform closed rotation and open rotation around the pivot assembly 130. Furthermore, the one-way locking mechanism 160 can also be placed in a free state by separating the nut 161 from the threaded rod 163.

[0082] See Figure 12 , Figure 12 A partially exploded view of the upper arm 110 with joint-opening pivots 10, 50, or 60 according to an embodiment of the present invention is shown. Figure 12As shown, the upper rear portion 114 of the upper arm 110 may have a housing 115 and a cantilever beam 116. The cantilever beam 116 may be located within the housing 115. The cantilever beam 116 may be configured to have a force-sensitive region for at least one force sensor 101 to be fixed thereto (e.g., by adhesive bonding). The force-sensitive region may be configured to include holes, grooves, notches, rounded corners, or other irregular shapes in the design of the sensitive beam. By providing a force-sensitive region on the cantilever beam 116, the force experienced by the upper arm 110 can be concentrated in the force-sensitive region, thereby improving the accuracy of the force measured by the force sensor 101 located within the force-sensitive region.

[0083] See Figure 12 The housing 115 may have a first housing portion 1151, which may be flexible and bendable and completely surround the force-sensitive region of the cantilever beam 116. In some embodiments, the first housing portion 1151 may be made of a flexible and bendable material (such as soft rubber), or the first housing portion 1151 may be configured to have a flexible and bendable structure. When the upper arm 110 is subjected to force, the flexible and bendable first housing portion 1151 can sufficiently release the external force, concentrating the stress of the upper arm 110 in the force-sensitive region of the cantilever beam 116, thereby improving the accuracy of the force measured by the force sensor 101 in the force-sensitive region.

[0084] See Figure 12 The upper rear portion 114 of the upper arm 110 may also have a reinforcing metal member 117. The reinforcing metal member 117 may be mounted within the housing 115 and may be connected (e.g., by screws, etc.) to the housing 115. The reinforcing metal member 117 may include one or more polygonal metal rings 1171 (in... Figure 12 The diagram shows two polygonal metal rings 1171. The inner wall of the housing 115 may have one or more mounting portions, each for mounting a corresponding polygonal metal ring 1171. In some embodiments, the housing 115 may include one or more reinforcing metal members 17 as described above. By providing reinforcing metal members 117 within the housing 115, the likelihood of deformation of the housing 115 when the upper arm 110 is under stress can be reduced, thereby reducing the force loss due to deformation of the housing 115 and improving the accuracy of the force measured by the force sensor 101 on the upper arm 110. Furthermore, the design of the polygonal metal rings 1171 can improve the positioning stability of the reinforcing metal members 117 within the housing 115. When the upper arm 110 is under stress, the polygonal metal rings 1171 can prevent the reinforcing metal members 117 from sliding relative to the housing 115, thereby further reducing the likelihood of deformation of the housing 115.

[0085] Based on the above references Figure 12In the described embodiment, the housing 115, cantilever beam 116, and reinforcing metal member 117 are disposed on the upper rear portion 114 of the upper arm 110. In other embodiments, the housing 115, cantilever beam 116, and reinforcing metal member 117 may also be disposed on the lower rear portion 124 of the lower arm 120.

[0086] Figure 13 A method 1300 for performing osteotomy analysis according to an embodiment of the present invention is shown. In some embodiments, the method 1300 may be performed using the joint dispersing system 100 described above.

[0087] At step 1301, a joint dispersing device is installed at a measurement location. In some embodiments, the processing module 20 and display module 30 of the joint dispersing system 100 may be located in an external device (e.g., a host computer), and one or more joint dispersing devices (e.g., joint dispersing devices 10, 50, or 60) may be paired with the external device. In this case, before installing the joint dispersing device at the measurement location, the operator (e.g., a doctor) can first pair the joint dispersing device to be used with the external device, and then the operator can input patient information and calibrate the joint dispersing device. In other embodiments, the processing module 20 and display module 30 may be integrated into the joint dispersing device. In this case, the operator can skip the pairing process described above, directly input patient information, and calibrate the joint dispersing device. Next, the operator can select a measurement location to install the joint dispersing device as needed. In some embodiments, the measurement location can be defined by different joint sites (e.g., medial left knee, lateral left knee, medial right knee, lateral right knee, etc.) and different joint flexion angles (e.g., approximately 0°, 30°, 60°, 90°, 120°, etc.). That is, the measurement location may include the medial left knee flexed at approximately 0°, the lateral left knee flexed at 30°, the medial right knee flexed at 60°, the lateral right knee flexed at 90°, etc. Taking the measurement location of "medial left knee flexed at approximately 0°" as an example, the operator can fix the patient's left knee joint to approximately 0° flexion at step 1301. Then, the operator can install a joint spreading device (e.g., joint spreading device 10, 50, or 60) at this measurement location. During the installation of the joint spreading device 10, 50, or 60, the joint spreading device 10, 50, or 60 can be placed in a closed state. Once installed, the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 of the joint spreading device 10, 50 or 60 can be inserted into the gap of the corresponding joint site of the patient (e.g., the medial side of the left knee joint).

[0088] Next, method 1300 can proceed to step 1303.

[0089] At step 1303, force and position data are acquired. In some embodiments, after the joint spreader 10, 50, or 60 is installed at the measurement location (e.g., the medial side of the left knee joint with flexion at approximately 0°), the operator can apply force to the upper arm 110 and lower arm 120 of the joint spreader 10, 50, or 60, causing the upper arm 110 and lower arm 120 to spread relative to each other about the pivot assembly 130, thereby causing the upper front end 111 of the upper arm 110 and the lower front end 121 of the lower arm 120 to move away from each other and thus spread the tibial plateau and femoral condyle of the patient's knee joint. Under the tension of the surrounding soft tissues, the tibial plateau and femoral condyle of the knee joint will exert compressive force on the upper arm 110 and lower arm 120 of the joint spreader 10, 50, or 60. The force sensor 101 located on the joint spreader 10, 50, or 60 can measure the force acting on the upper arm 110 or lower arm 120. Simultaneously, a position sensor 103 located on the joint spreading device 10, 50, or 60 can measure position data to determine the distance the tibial plateau and femoral condyles of the knee joint are spread apart. During the spreading of the tibial plateau and femoral condyles of the knee joint, a force sensor 101 can perform real-time measurements to acquire one or more force data points varying over time. Similarly, during the spreading of the tibial plateau and femoral condyles of the knee joint, the position sensor 103 can also perform real-time measurements to acquire one or more position data points varying over time. Each of the acquired position data points can correspond (e.g., temporally) to a corresponding force data point in one or more force data points.

[0090] Next, method 1300 can proceed to step 1305.

[0091] At step 1305, the spreading pressure and the corresponding spreading distance are determined. In some embodiments, the joint spreading device 10, 50, or 60 may be communicatively coupled to the processing module 20 and may transmit one or more acquired force data and one or more position data to the processing module 20. The processing module 20 may determine one or more spreading pressures based on the received one or more force data and determine one or more spreading distances based on the received one or more position data. Each of the determined one or more spreading pressures may correspond to (e.g., in time) a corresponding spreading distance among the one or more spreading distances.

[0092] In some embodiments, when an operator applies force to the joint spreading device 10, 50, or 60 to spread the joint, the operator can gradually spread the joint to a target spreading distance or target spreading pressure in a "force application-force withdrawal-further force application-force withdrawal..." manner. During this process, due to the presence of the one-way locking mechanism 140, 150, or 160 of the joint spreading device 10, 50, or 60, the joint spreading device 10, 50, or 60 can be maintained in the spread state even if the operator withdraws the force. Furthermore, the force data acquired by the force sensor 101 at this time can more accurately reflect the tension of the soft tissue surrounding the spread joint. The processing module 20 can be configured to determine one or more spreading pressures by selecting force data acquired when the operator withdraws the force from one or more force data sets. Compared to the force data acquired when the operator applies the force, the force data acquired when the operator withdraws the force may exhibit less change or even no change over time.

[0093] In some embodiments, the position sensor 103 may include an angle encoder, which may be located at the pivot assembly 130 and configured to measure the rotation angle α of the upper arm 110 relative to the lower arm 120. The processing module 20 may determine the distance the joint is spread apart (i.e., the spreading distance H) based on the rotation angle α. For example, the spreading distance H may be determined by the following formula: H = 2 × L × sin(α / 2), where α is the rotation angle of the upper arm 110 of the joint spreading device 10 relative to the lower arm 120, and L is the distance from the lowest point of the upper arm 110 or the lower arm 120 to the center of the pivot of the pivot assembly 120.

[0094] Next, method 1300 can proceed to step 1307.

[0095] At step 1307, the dislocation pressure and the corresponding dislocation distance are displayed. In some embodiments, the processing module 20 may be communicatively coupled to the display module 30 and transmit the determined one or more dislocation pressures and one or more dislocation distances to the display module 30. The display module 30 may display one or more dislocation pressures and one or more dislocation distances. In some embodiments, the display module 30 may display each of the one or more dislocation pressures in association with a corresponding dislocation distance. For example, the display module 30 may display a scatter plot, bar chart, or line graph with the dislocation distance as the horizontal axis and the dislocation pressure as the vertical axis. Alternatively, the display module 30 may display a table where the first column may include time, the second column may include the dislocation distance at each time point, and the third column may include the dislocation pressure at each time point. The table may also include one or more additional columns, such as columns displaying left and right leg information, columns displaying information on the inner and outer sides of the joint, columns displaying different joint flexion angles, etc. In some embodiments, the joint dislocation device 10, 50, or 60 may transmit the acquired force and position data to the processing module 20 in real time. The processing module 20 determines the dislocation pressure and dislocation distance based on the received force and position data, and transmits the determined dislocation pressure and dislocation distance to the display module 30 in real time. The display module 30 can display the received dislocation pressure and dislocation distance in real time. In this way, the operator can view the dislocation pressure and dislocation distance in real time while operating the joint dislocation device 10, 50, or 60 to dislocate the patient's joint. This allows the operator to flexibly adjust the force applied to the joint dislocation device 10, 50, or 60 during the dislocation process, so as to determine the dislocation pressure at the desired dislocation distance or the dislocation distance at the desired dislocation pressure.

[0096] Next, method 1300 can proceed to step 1309.

[0097] At step 1309, it is determined whether there are other measurement locations to be measured. In some embodiments, after performing steps 1301-1307 at a measurement location (e.g., the medial side of the left knee joint with approximately 0° flexion), the operator may determine, as needed, whether steps 1301-1307 need to be performed at other measurement locations to obtain one or more dislocation pressures and one or more dislocation distances at those other measurement locations. If it is determined that there are other measurement locations to be measured, method 1300 may return to step 1301. At step 1301, a joint dislocation device may be installed at the other measurement location, depending on the specific circumstances. In some embodiments, the other measurement location may be the lateral side of the left knee joint with 30° flexion, where the operator may fix the patient's corresponding joint (e.g., the left knee joint) at the corresponding flexion angle (e.g., approximately 30° flexion). The operator may then install a joint dislocation device 10, 50, or 60 at the other measurement location. If it is determined that there are no other measurement locations to be measured, method 1300 may proceed to step 1311.

[0098] At step 1311, osteotomy analysis is performed. In some embodiments, after obtaining the dislocation pressure and its corresponding dislocation distance for each of one or more measurement locations, the processor 20 may perform osteotomy analysis to determine the osteotomy amount (e.g., osteotomy amount of the tibia and / or femur). This osteotomy analysis may include: determining a predetermined dislocation pressure range [F1, F2] based on the dislocation pressure and its corresponding dislocation distance obtained for each measurement location. N Multiple expansion pressures and their corresponding expansion distances within a given range, where N is greater than 2. The predetermined expansion pressure range is [F1, F...]. N F1 and F in ] N It can be determined based on clinical experience. For example, F1 and F... N This can be set by a clinician. In some embodiments, F1 can be 10N, 20N, 30N, or other expansion pressure values. N It can be 120N, 130N, 140N, or other expansion pressure values. The determined corresponding expansion distances can be located within the expansion distance range [H1, H...]. N Within [H1, H] . In some embodiments, the spanning distance range is [H1, H] N The step size l of the adjacent expansion distance in [] can be 0.1, 0.2, 0.3, 0.5 mm or other step sizes. The osteotomy analysis performed by the processor 20 may also include: based on a predetermined expansion pressure range [F1, F] NThe system calculates multiple dislocation pressures and their corresponding dislocation distances within a given area, and plots a curve showing the change in dislocation pressure relative to the dislocation distance. Based on the slope of the plotted curve, it determines the target dislocation distance and, based on the target dislocation distance, determines the osteotomy amount. In some embodiments, the target dislocation distance may be the dislocation distance corresponding to a feature point in the plotted curve (e.g., the point with the steepest slope, the point with the gentlest slope, the point with the fastest change in slope, etc.). Figure 14 A graph showing the variation of the spreading pressure relative to the spreading distance according to some embodiments of the present disclosure is shown. Figure 14 As shown, the horizontal axis of the graph describes the opening height (i.e., the opening distance), and the vertical axis describes the opening force (i.e., the opening pressure). The target opening distance can be determined as the opening distance corresponding to the point with the steepest slope in the graph, which is 8.00 mm. Next, method 1300 can proceed to step 1313.

[0099] At step 1313, the analysis results are displayed. In some embodiments, the display module 30 may display the determined osteotomy amount as an analysis result for clinicians to refer to in determining the final osteotomy amount. Next, method 1300 may proceed to step 1315.

[0100] At step 1315, method 1300 for performing osteotomy analysis ends.

[0101] In some embodiments, after the osteotomy of the tibia and / or femur is completed based on, for example, the osteotomy amount determined by method 1300 described above, a knee prosthesis can be implanted at the patient's knee joint. Subsequently, method 1300 can be performed again on the patient with the implanted knee prosthesis to obtain the dislocation pressure and its corresponding dislocation distance, and osteotomy amount analysis can be performed again based on the obtained dislocation pressure and its corresponding dislocation distance to determine whether the osteotomy amount needs to be corrected (e.g., increased). Determining the osteotomy amount by considering the relationship between joint space and soft tissue tension can improve the precision and accuracy of knee replacement surgery, reduce the possibility of permanent soft tissue damage, and reduce reliance on physician experience. Furthermore, a database can be established using the determined dislocation pressure and its corresponding dislocation distance. Using this database and based on real-time data, surgical models can be built preoperatively or intraoperatively to provide physicians with relevant surgical references, thereby improving the success rate of the surgery.

[0102] The above steps are exemplary and not intended to be limiting. Those skilled in the art may add one or more steps, delete one or more of the above steps, combine or replace one or more of the above steps, or adjust the order of one or more of the above steps as needed.

[0103] One or more modules in the various embodiments of this disclosure can be implemented in hardware. For example, they can be implemented using at least one of application-specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field-programmable gate arrays (FPGAs), processors, controllers, micro-controllers, micro-processors, and electrical units for performing other functions.

[0104] Certain portions of the embodiments of this disclosure can be provided as a computer program product, which may include a computer-readable medium having computer program instructions stored thereon, the computer program instructions being used to program a computer (or other electronic device) to be executed by one or more processors to perform processes according to certain embodiments. The computer-readable medium may include, but is not limited to, a magnetic disk, an optical disk, a read-only memory (ROM), a random access memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic card or optical card, flash memory, or other types of computer-readable media suitable for storing electronic instructions. Furthermore, the embodiments can also be downloaded as a computer program product, wherein the program can be transferred from a remote computer to a requesting computer. In some embodiments, a non-transient computer-readable storage medium has data stored thereon representing a sequence of instructions that, when executed by a processor, cause the processor to perform certain operations, for example, in combination with the above. Figure 13 One or more steps in the described method 1300.

[0105] Although the invention has been described with reference to preferred embodiments of this disclosure, it is not intended to be limited thereto, but rather to be limited only by the scope set forth in the appended claims. Those skilled in the art will understand that various modifications and changes may be made to the embodiments described herein without departing from the broader spirit and scope of the invention as set forth in the appended claims.

Claims

1. A joint spreading device, characterized in that, The joint opening device includes: Spindle assembly; An upper arm and a lower arm, rotatably connected to the pivot assembly and capable of opening and closing rotations about the pivot assembly, wherein the opening rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move away from each other, and the closing rotation causes the upper front end of the upper arm and the lower front end of the lower arm to move closer to each other; and A one-way locking mechanism, which has a one-way locked state and a free state. The one-way locking mechanism includes: A locking member having a first toothed surface disposed within an opening at the lower rear portion of the lower arm; and A locking element, one end of which is connected to the upper arm and the other end of which passes through the opening in the lower arm, is provided. The locking element has a second toothed surface. The first and second toothed surfaces are configured such that when the first and second toothed surfaces engage, the locking element and the locking element can only move in a single direction, thereby allowing the upper arm and the lower arm to rotate relative to each other only. When the first tooth surface engages with the second tooth surface, the one-way locking mechanism is in the one-way locking state, allowing the upper arm and lower arm to rotate outwards while preventing them from rotating inwards. When the first tooth surface separates from the second tooth surface, the one-way locking mechanism is in the free state, allowing the upper arm and lower arm to perform opening and closing rotations.

2. The joint spreading device as described in claim 1, characterized in that, The joint opening device further includes one or more force sensors, each of which is located on the upper arm or the lower arm, for measuring the force acting on the upper arm or the lower arm.

3. The joint spreading device as described in claim 2, characterized in that, The upper arm has an upper front portion and an upper rear portion, divided by the pivot assembly, and the lower arm has a lower front portion and a lower rear portion, divided by the pivot assembly. The upper anterior portion of the upper arm has the upper front end, and the lower anterior portion of the forearm has the lower front end, the upper and lower front ends being configured to be inserted into a patient's joint. The upper rear portion of the upper arm and the lower rear portion of the lower arm each have an upper operating portion and a lower operating portion, respectively, for applying a force thereon to cause the upper arm and the lower arm to rotate and spread apart. Each of the one or more force sensors is located at the upper rear part of the upper arm or the lower rear part of the lower arm.

4. The joint spreading device as described in claim 3, characterized in that, The upper rear portion of the upper arm has a cantilever beam, which is configured to have a force-sensitive region. At least one of the one or more force sensors is located within the force-sensitive area of ​​the cantilever beam of the upper arm.

5. The joint spreading device as described in claim 4, characterized in that, The upper arm has a housing that includes a first housing portion that is flexible and bendable and completely surrounds the force-sensitive area for positioning at least one force sensor.

6. The joint spreading device as described in claim 5, characterized in that, The upper arm has a reinforcing metal component for mounting within the housing.

7. The joint spreading device as described in claim 2, characterized in that, The one-way locking mechanism further includes: An elastic element, located at the connection between the locking engagement member and the upper arm, is used to push the second toothed surface of the locking engagement member against the first toothed surface of the locking member; and A switch, located on the lower arm, is operated to push the second toothed surface of the locking engagement away from the first toothed surface of the locking member.

8. The joint spreading device as described in any one of claims 2-7, characterized in that, The joint spreading device further includes a position sensor configured to measure position data used to determine the spreading distance of the joint spreading device.

9. The joint spreading device as described in claim 8, characterized in that, The position sensor includes an angle encoder located at the shaft assembly and configured to measure rotation angles.

10. A joint spreading system, characterized in that, The joint opening system includes: The joint opening device as described in claim 8 or 9; A processing module, which is communicatively coupled to the joint spreading device and configured to: Receive one or more force data from a force sensor and one or more position data from a position sensor from the joint opening device; Based on the one or more force data, determine one or more spreading pressures; and Based on the one or more location data, determine one or more expansion distances; and a display module, which is communicatively coupled to the processing module and configured to display the determined one or more expansion pressures and one or more expansion distances.

11. The joint spreading system as described in claim 10, characterized in that, The display module is further configured to display each of the one or more expansion distances in association with a corresponding expansion pressure among the one or more expansion pressures.

12. The joint spreading system as described in claim 11, characterized in that, For each of one or more measurement locations, acquire the one or more location data, and For each of the one or more measurement locations, acquire the one or more force data.

13. The joint spreading system as described in claim 12, characterized in that, The processing module is further configured to: perform osteotomy analysis based on the spreading pressure and corresponding spreading distance determined for each of one or more measurement locations, to determine the amount of osteotomy. The display module is configured to display the determined osteotomy amount.

14. The joint spreading system as described in claim 13, characterized in that, The osteotomy volume analysis includes: Based on the spreading pressure and its corresponding spreading distance obtained for each measurement position, multiple spreading pressures and their corresponding spreading distances within a predetermined spreading pressure range are determined. Based on multiple expansion pressures and their corresponding expansion distances within a predetermined expansion pressure range, plot a curve showing the change of expansion pressure relative to expansion distance. Based on the slope of the plotted curve, the target spreading distance is determined, whereby the target spreading distance is the spreading distance corresponding to the feature point in the curve; and The amount of bone to be removed is determined based on the target span.

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