Knee joint force line measuring system

Abstract

The embodiment of the invention provides a knee joint force line measuring system, which comprises a thighbone positioning and adjusting device, a force line measuring device and a force line measuring device, the tibia positioning and adjusting device is arranged at the tibia during the operation; the navigator comprises a standard device and a measurer, is arranged on the thighbone positioning and adjusting device or the tibia positioning and adjusting device, and is used for cooperatively navigating the movement of the thighbone positioning and adjusting device so as to calculate and determine a thighbone force line according to navigation data, and cooperatively navigating the movement of the tibia positioning and adjusting device so as to calculate and determine a tibia force line according to navigation data; calculating and determining a tibia force line according to the navigation data; the data processing device is connected with the navigator and used for obtaining the thighbone force line and the tibia force line and determining a knee joint force line at least based on the thighbone force line and the tibia force line. According to the measuring system, the measuring precision and efficiency of the knee joint force line can be improved.

Description

Technical Field

[0001] The embodiments of the present invention relate to the technical field of orthopedic medical devices, and in particular to a knee joint force line measurement system. Background Art

[0002] In knee replacement surgery, restoring the normal force line of the knee joint is crucial to ensure the success of the operation. The force line of the knee joint usually refers to a straight line from the center of the hip joint to the center of the ankle joint, which should pass through the center of the knee joint. If the force line deviates from the normal position, it may cause excessive wear of the joint, uneven load distribution during knee joint movement, knee pain, joint dysfunction, and thus lead to surgical failure.

[0003] Traditional knee replacement surgery usually relies on the surgeon's vision and experience to determine the osteotomy position and prosthesis placement, so the overall error is large. Due to individual anatomical differences and potential errors during surgery, it is difficult for the surgeon to accurately restore the normal force line of the knee joint every time. This uncertainty will greatly lead to unsatisfactory alignment of the femur and tibia, or prosthesis, in the knee joint after surgery, which will affect the surgical results in the long term. Summary of the invention

[0004] An embodiment of the present invention provides a knee joint force line measurement system, comprising: The femoral positioning and adjustment device is installed on the femur during surgery; The tibia positioning and adjustment device is installed on the tibia during surgery; A navigator, including a reference device and a measuring device, is installed on the femoral positioning and adjustment device or the tibial positioning and adjustment device, and is used to cooperate with navigation of the movement of the femoral positioning and adjustment device to calculate and determine the femoral force line according to the navigation data, and cooperate with navigation of the movement of the tibial positioning and adjustment device to calculate and determine the tibial force line according to the navigation data; A data processing device is connected to the navigator and is used to obtain the femoral force line and the tibial force line, and determine the knee joint force line at least based on the femoral force line and the tibial force line.

[0005] In one embodiment, the femoral positioning and adjustment device comprises: A tray module, comprising two tray assemblies, for mounting a reference device and a measuring device respectively; A fixed module is detachably connected to a tray assembly; The adjusting module is installed on the fixed module and connected to another tray assembly of the tray module, and is used to adjust the horizontal position and vertical position of the tray assembly relative to the fixed module so that the reference device and the measuring device can cooperate to determine the femoral force line.

[0006] In one embodiment, the fixing module comprises a bracket, and the bracket has a first part and a second part in the length direction of the femur; The first part of the support is a plate body, which can be connected to the femur. A beam is vertically provided on the first part. A connecting component is provided at one end of the beam. The tray component is detachably connected to the connecting component. The beam is perpendicular to the tray component, and the other end of the beam is used to point to the center of the knee joint. The cross-section of the second part of the bracket is concave-shaped, and has a bottom plate and two ear plates. The bottom plate is provided with an adjustment window. The adjustment module includes a positioning rod and an adjustment component. The adjustment component is arranged between the two ear plates and can move relative to the two ear plates. The positioning rod is passed through the adjustment window and the adjustment component, and one end is detachably connected to the other tray component.

[0007] In one embodiment, the positioning rod is L-shaped, including a horizontal rod body and a vertical rod body, the horizontal rod body passes through the adjustment window and the adjustment assembly, the vertical rod body is detachably connected to another tray assembly, and a positioning seat for connecting the osteotomy guide plate is also provided on the horizontal rod body; The adjustment assembly includes a rotating fixed column, a rotating column sleeved on the rotating fixed column, the rotating column is provided with a through hole for the horizontal rod body to pass through, the horizontal rod body is provided with a positioning column, the rotating column is provided with a positioning through hole, the positioning column is correspondingly connected with the positioning through hole, so that the rotating column and the positioning rod are correspondingly connected and can rotate relatively; The rotating column is also threaded with a first adjusting knob, which is perpendicular to the positioning rod and can abut against each other to lock the positioning rod and fix the relative position between the positioning rod and the rotating column; A second adjusting knob is screwed on the ear plate, and the second adjusting knob passes through the ear plate to lock and fix the rotating column, prohibiting the rotating column and the positioning plate from rotating around the rotating and fixing column together, or moving away from the rotating column so that the rotating column and the positioning plate can rotate around the rotating and fixing column together.

[0008] In one embodiment, the tibial positioning and adjustment device comprises: A joint rod assembly comprises a plurality of different joint rods, wherein the reference device and the measuring device are detachably mounted on different joint rods in the joint rod assembly; A measuring module, mounted at both ends of the joint rod assembly, for assisting in measuring the tibial force line; Among them, multiple different joint rods are controlled by different rotating switches respectively, so as to realize the rotation of the navigator and the measurement module in different dimensions alone or together with multiple joint rods to complete the measurement of the tibial force line.

[0009] In one embodiment, the joint rod assembly includes a first joint rod and a second joint rod, the first ends of the first joint rod and the second joint rod in the same direction are flush and rotatably connected, the first joint rod is provided with a strip slot along its length direction, the strip slot radially penetrates the first joint rod, a connecting hook is provided between the first joint rod and the second joint rod, the connecting hook is L-shaped, including a long rod and a short rod, the long rod extends into the first joint rod and corresponds to the position of the strip slot, and can move along the length direction of the first joint rod, the short rod is located outside the first joint rod, extends into the second joint rod, and is connected to the second joint rod; The tibial positioning and adjustment device includes a first rotating switch, one end of which is rotatably connected to a fixed rod, the fixed rod is vertically penetrated in the strip slot and the long rod, and can move relative to them, and a locking piece is also penetrated on the fixed rod. When the first rotating switch is rotated, the locking piece can be pushed to move along the fixed rod, and when the locking piece moves to abut against the long rod, the long rod is locked. When the locking piece moves away from the long rod, the first combined rod and the second combined rod can rotate relative to each other and drive the fixed rod and the long rod to move along the strip slot.

[0010] In one embodiment, the first joint rod is longer than the second joint rod, and an extension rod is disposed on the outer cover of a portion of the first joint rod that is longer than the second joint rod, and the extension rod is movably connected to the first joint rod to extend the first joint rod; The joint rod assembly further includes a third joint rod, wherein the first joint rod and the third joint rod are respectively located on both sides of the second joint rod, the first joint rod, the second joint rod and the third joint rod are close to each other and parallel to each other, and the third joint rod is rotatably connected to the second joint rod so as to be able to swing relative to the second joint rod; The third joint rod is symmetrically provided with two tray assemblies for mounting a measuring device, and the first joint rod is provided with a tray assembly for mounting a reference device; The measuring module includes a first measuring module and a second measuring module. The first measuring module is arranged at one end of the first and third joint rods away from the second measuring module, and the second measuring module is arranged at one end of the extension rod away from the second joint rod.

[0011] In one embodiment, the second joint rod is provided with a limiting groove, and the third joint rod is provided with an arc-shaped guide member at a position corresponding to the limiting groove, the arc-shaped guide member is located in the limiting groove, and the limiting groove can move along the arc-shaped guide member as the second joint rod swings; The tibial positioning and adjustment device also includes a second rotating switch, one end of which extends into the second combining rod and is rotatably connected to the second combining rod, and one end of the second rotating switch located in the second combining rod is connected to an elastic locking piece, which can extend into the limiting groove and resist the arc-shaped guide piece, thereby locking the third combining rod.

[0012] In one embodiment, the reference device and the measuring device both include an inertial measurement module for outputting posture data, and a Bluetooth module for assisting in calculating the femoral force line and the tibial force line according to the posture data; When the navigator determines the femoral force line, the Bluetooth module of the reference device determines the spatial position of the reference device based on the data collected by the inertial measurement module, and determines the distance between the two position points based on the center position of the femoral head to be measured, and uses the Taylor series expansion algorithm and the Kalman filter algorithm to calculate the formula of the distance to obtain the coordinates of the center position of the femoral head in the coordinate system of the reference device; When the femoral positioning and adjustment system rotates with the coordinates of the center position of the femoral head as the center point, the measuring device collects corresponding posture data based on the inertial measurement module, and calculates the collected posture data and the coordinates of the center position of the femoral head based on its own Bluetooth module, thereby determining the femoral force line; The spatial position of the reference device matches the spatial position of the intercondylar fossa of the femur, and the distance is different for different patients.

[0013] In one embodiment, when determining the tibial force line, the navigator installs the reference device in a tray assembly on the first joint rod in the tibial positioning and adjustment device, and installs the measuring device in a tray assembly on the third joint rod in the tibial positioning and adjustment device according to whether the affected limb is the left leg or the right leg. When the tibial positioning and adjustment device is fixed on the tibia, the probe of the first measuring module in the tibial positioning and adjustment device is driven to point to the center of the knee joint, and the length of the first joint rod is adjusted at the same time, and the first joint rod and the second joint rod are driven to move in different dimensions to adjust the relative position between the reference device and the measuring device. The reference device obtains the posture data about the tibia collected by it and the measuring device during the movement of the joint rod, and calculates the tibial force line based on the posture data and the position coordinates of the center of the knee joint.

[0014] Based on the disclosure of the above embodiments, it can be known that the beneficial effects of the embodiments of the present invention include that the designed knee joint force line measurement system can assist medical personnel in real time during surgery to accurately measure the patient's knee joint force line, process the collected data in real time, and promptly feedback the force line measurement results to medical personnel during surgery, thereby ensuring the precise alignment of the femur and tibia during surgery, reducing human errors, improving surgical efficiency and success rate, ensuring the functional recovery of the patient's knee joint and the correctness of the force line after surgery, and reducing postoperative complications.

[0015] Other features and advantages of the present application will be described in the following description, and partly become apparent from the description, or be understood by practicing the present application. The purpose and other advantages of the present application can be realized and obtained by the structures specifically pointed out in the written description, claims, and drawings.

[0016] The technical solution of the present application is further described in detail below through the accompanying drawings and embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0018] Figure 1 Schematic diagram of the structure of the knee joint force line measurement system in an embodiment of the present invention.

[0019] Figure 2 Schematic diagram of the structure of the femoral positioning and adjustment device in an embodiment of the present invention.

[0020] Figure 3 It is a partial structural schematic diagram of the femoral positioning and adjustment device in an embodiment of the present invention.

[0021] Figure 4 Schematic diagram of the femur cross section determined by the reference device and the measuring device in the embodiment of the present invention.

[0022] Figure 5 Schematic diagram of the structure of the tibia positioning and adjusting device in an embodiment of the present invention.

[0023] Figure 6 It is a partial structural schematic diagram of the tibia positioning and adjusting device in an embodiment of the present invention.

[0024] Figure 7 Schematic diagram of the structure of the osteotomy guide plate in an embodiment of the present invention.

[0025] Figure 8 Schematic diagram of a navigator housing in an embodiment of the present invention.

[0026] Reference numerals: 1-tray assembly; 2-bracket; 3-first part; 4-second part; 5-beam; 6-connecting assembly; 7-adjusting window; 8-positioning rod; 9-rotating fixed column; 10-rotating column; 11-positioning column; 12-first adjusting knob; 13-second adjusting knob; 14-positioning seat; 15-first joint rod; 16-second joint rod; 17-connecting hook; 18-strip slot; 19-first rotating switch; 20-fixing rod; 21-locking piece; 22-first measuring module; 23-third joint rod; 24-second measuring module; 25-limiting groove; 26-arc-shaped guide; 27-second rotating switch; 28-elastic locking piece; 29-extension rod; 30-osteotomy guide; 31-probe; 32-probe rod; 33-probe hammer. DETAILED DESCRIPTION

[0027] The specific embodiments of the present invention are described in detail below with reference to the accompanying drawings, but are not intended to limit the present invention.

[0028] It should be understood that various modifications may be made to the embodiments disclosed herein. Therefore, the following description should not be considered as limiting, but merely as an example of an embodiment. Other modifications within the scope and spirit of the present disclosure will occur to those skilled in the art.

[0029] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the present disclosure and, together with the general description of the present disclosure given above and the detailed description of the embodiments given below, serve to explain the principles of the present disclosure.

[0030] These and other characteristics of the invention will become apparent from the following description of a preferred form of embodiment given as a non-limiting example, with reference to the accompanying drawings.

[0031] It should also be understood that, although the invention has been described with reference to some specific examples, those skilled in the art will be able to realize many other equivalent forms of the invention that have the characteristics recited in the claims and are therefore within the scope of protection defined thereby.

[0032] The above and other aspects, features and advantages of the present disclosure will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

[0033] Specific embodiments of the present disclosure are described hereinafter with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be implemented in a variety of ways. Well-known and / or repeated functions and structures are not described in detail to avoid obscuring the present disclosure with unnecessary or redundant details. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely serve as a basis and representative basis for the claims to teach those skilled in the art to use the present disclosure in a variety of ways with substantially any suitable detailed structure.

[0034] This specification may use the phrases "in one embodiment," "in another embodiment," "in a further embodiment," or "in other embodiments," all of which may refer to one or more of the same or different embodiments according to the present disclosure.

[0035] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0036] like Figure 1 As shown, an embodiment of the present invention provides a knee joint force line measurement system, comprising: A femoral positioning and adjusting device is installed on the femur during surgery and can move relative to the femur; A tibia positioning and adjusting device is installed on the tibia during surgery and can move relative to the tibia; A navigator, including a reference device and a measuring device, is installed on the femoral positioning and adjustment device or the tibial positioning and adjustment device, and is used to cooperate with navigation of the movement of the femoral positioning and adjustment device to calculate and determine the femoral force line according to the navigation data, and cooperate with navigation of the movement of the tibial positioning and adjustment device to calculate and determine the tibial force line according to the navigation data; A data processing device is connected to the navigator and is used to obtain the femoral force line and the tibial force line, and determine the knee joint force line at least based on the femoral force line and the tibial force line.

[0037] The data processing device in this embodiment can be, but is not limited to, a computer. After the navigator obtains the femoral posture data and the tibial posture data based on the auxiliary collection of the femoral positioning and adjustment device and the tibial positioning and adjustment device, it calculates the femoral force line and the tibial force line respectively, and uploads them to the data processing device, which calculates and determines the knee joint force line based on the femoral force line and the tibial force line, and can further calculate the valgus angle and the anteroposterior tilt angle of the femur and tibia based on the knee joint force line and the posture data collected by the navigator in combination with the angulation algorithm, and calculate and determine the osteotomy angle, osteotomy amount and other parameters accordingly. After obtaining the parameters, medical personnel can perform osteotomy surgery based on the parameters.

[0038] Based on the above content, it can be seen that the knee joint force line measurement system designed in this embodiment can assist medical personnel in real time during surgery to accurately measure the patient's knee joint force line, process the collected data in real time, and promptly feedback the force line measurement results to medical personnel during surgery, thereby ensuring the precise alignment of the femur and tibia during surgery, reducing human errors, and improving the efficiency and accuracy of determining osteotomy parameters, thereby improving surgical efficiency and success rate, effectively ensuring the functional recovery of the patient's knee joint and the correctness of the force line after surgery, and reducing postoperative complications.

[0039] like Figure 2 , Figure 3 As shown, the femoral positioning and adjusting device in this embodiment includes: The tray module comprises two tray assemblies 1, which are used to install a reference device and a measuring device respectively; A fixed module, detachably connected to a tray assembly 1; The adjustment module is installed on the fixed module and connected to another tray component 1 of the tray module, and is used to adjust the horizontal position and vertical position of the tray component 1 relative to the fixed module so that the reference device and the measuring device can cooperate to determine the femoral force line.

[0040] Specifically, the fixing module includes a bracket 2, and the bracket 2 has a first part 3 and a second part 4 in the length direction of the femur. The first part 3 of the bracket 2 is a plate body, which can be connected to the femur. A beam 5 is vertically penetrated through the first part 3, and a connecting component 6 is provided at one end of the beam 5. The tray component 1 is detachably connected to the connecting component 6. The specific connection method is not fixed, for example, it can be connected by a connecting nail, or it can be connected by a snap-on method, which is not unique. The beam 5 is perpendicular to the tray component 1 to which it is connected, and the other end of the beam 5 has a tip, such as a nail connected, which is used to point to the center position of the knee joint.

[0041] The second part 4 of the bracket 2 is located above the first part 3, and its cross section is concave, with a bottom plate and two ear plates, and the bottom plate is provided with an adjustment window 7. The adjustment module includes a positioning rod 7 and an adjustment component, and the adjustment component is arranged between the two ear plates and can move relative to the two ear plates, that is, the adjustment component is movably connected with the two ear plates. The positioning rod 7 is inserted into the adjustment window 7 and the adjustment component, and one end is detachably connected to the other tray component 1.

[0042] Furthermore, the positioning rod 7 is L-shaped, including a horizontal rod body and a vertical rod body, the horizontal rod body passes through the adjustment window 7 and the adjustment assembly, the vertical rod body is detachably connected to another tray assembly 1, and the horizontal rod body is also provided with a positioning seat 14 for connecting the osteotomy guide plate 30; The adjustment assembly includes a rotating fixed column 9 and a rotating column 10 sleeved on the rotating fixed column 9. The rotating column 10 is provided with a through hole for the horizontal rod body to pass through. The horizontal rod body is provided with a positioning column 11. The rotating column 10 is provided with a positioning through hole. The positioning column 11 is correspondingly connected to the positioning through hole so that the rotating column 10 is correspondingly connected to the positioning rod 7 and can rotate relatively, that is, the positioning rod 7 rotates around the positioning column 11 in the through hole of the adjustment window 7 and the rotating column 10, thereby adjusting the angle of the connected tray assembly 1, that is, adjusting the angle of the connected reference device or measuring device.

[0043] The rotating column 10 is also screwed with a first adjusting knob 12, which is perpendicular to the positioning rod 7, and one end of the first adjusting knob 12 can approach the positioning rod 7 as it rotates, until it abuts against the positioning rod 7 to lock the positioning rod 7 and fix the relative position between the positioning rod 7 and the rotating column 10, that is, the positioning rod 7 cannot rotate horizontally at this time. Only by loosening the first adjusting knob 12 and releasing the lock on the positioning rod 7 can the positioning rod 7 be driven to rotate horizontally.

[0044] The ear plate is screwed with a second adjustment knob 13, one end of which passes through the ear plate and approaches the rotating column 10 as it rotates, until it abuts against the rotating column 10 or extends into a part of the column body, so as to lock and fix the rotating column 10 and prohibit the rotating column 10 and the positioning plate from rotating around the rotating fixed column 9. Only when the second adjustment knob 13 is loosened and one end of the second adjustment knob is away from the rotating column 10, can the rotating column 10 and the positioning plate be driven to rotate around the rotating fixed column 9 together to adjust the pitch angle of the connected tray assembly 1.

[0045] For the human femur, when the human thigh rotates around the center point of the femoral head, a geometric positioning model can be established according to the relevant algorithm of spatial geometry rotating around a fixed point, and then a joint center navigation positioning algorithm scheme can be constructed to achieve hip joint center navigation positioning. For example, when the femoral posture data is measured using a femoral positioning and adjustment device, the reference device and the measuring device can be respectively installed on two tray assemblies 1, where the left and right legs are not distinguished. In this embodiment, the reference device is arranged on the tray assembly 1 corresponding to the first part 3 of the bracket 2, and the measuring device is arranged on the tray assembly 1 corresponding to the second part 4 of the bracket 2. The other end of the beam 5, that is, its tip, is pointed to the femoral medullary point, that is, to the center point of the knee joint, and the first part 3 of the bracket 2 fits the distal end surface of the femur. After that, the driving device as a whole rotates around the center point of the femoral head, so that the reference device collects the motion process data and sends it to the measuring device, and the measuring device calculates the current femoral force line angle, that is, determines the femoral force line, and at this time, the measuring device is fixed so that its position cannot be adjusted.

[0046] like Figure 4As shown, the reference device in this embodiment is used to determine plane A in the figure, that is, the extension of the distal condylar surface of the femur on the z-axis; similarly, the measuring device is used to determine plane B in the figure, that is, the osteotomy surface B. After the femoral force line is determined, the medical staff can turn on the first rotating switch 19 and the second rotating switch 27 to adjust the angle of the reference device relative to the measuring device, including the valgus and valgus angle, the anteroposterior tilt angle, and then adjust the angle between the measuring device and the reference device, that is, adjust the osteotomy angle. The measured angle values ​​and femoral force lines are uploaded to the data processing device, which calculates and determines the osteotomy angle and osteotomy amount (osteotomy thickness, etc.). After the osteotomy angle is determined, the position of the positioning seat 14 can be fixed on the femur, and then the osteotomy guide plate 30 (such as Figure 7 As shown in the figure, the osteotomy guide plate 30 is mounted on the positioning seat 14 to restore the osteotomy angle, and the osteotomy thickness is determined by the osteotomy thickness scale on the osteotomy guide plate 30, after which the osteotomy operation can be performed.

[0047] like Figure 5 , Figure 6 As shown, the tibial positioning and adjusting device comprises: A joint rod assembly comprises a plurality of different joint rods, wherein the reference device and the measuring device are detachably mounted on different joint rods in the joint rod assembly; A measuring module, mounted at both ends of the joint rod assembly, for assisting in measuring the tibial force line; Among them, multiple different joint rods are controlled by different rotating switches respectively, so as to realize the rotation of the navigator and the measurement module in different dimensions alone or together with multiple joint rods to complete the measurement of the tibial force line.

[0048] Further, the joint rod assembly includes a first joint rod 15 and a second joint rod 16. The first ends of the first joint rod 15 and the second joint rod 16 in the same direction are flush and rotatably connected. The first joint rod 15 is provided with a strip slot 18 along its length direction. The strip slot 18 radially penetrates the first joint rod 15. A connecting hook 17 is provided between the first joint rod 15 and the second joint rod 16. The connecting hook 17 is L-shaped and includes a long rod and a short rod. The long rod extends into the first joint rod 15 and corresponds to the position of the strip slot 18, and can move along the length direction of the first joint rod 15. The short rod is located outside the first joint rod 15, extends into the second joint rod 16, and is connected to the second joint rod 16.

[0049] The tibial positioning and adjustment device comprises a first rotating switch 19, one end of which is rotatably connected to a fixed rod 20, and the fixed rod 20 is vertically inserted into the strip slot 18 and the long rod, and can move relative thereto. The fixed rod 20 is also penetrated with a locking member 21, which is plate-shaped, and has a convex portion extending into the strip slot 18 in the middle area. When the first rotating switch 19 is rotated, the locking member 21 can be pushed to move along the fixed rod 20. When the locking member 21 moves to the point where its convex portion abuts against the long rod, the long rod is locked, and at this time, the first joint rod 15 and the second joint rod 16 cannot be rotated to adjust the pitch angle. When the locking member 21 moves away from the long rod, the first joint rod 15 and the second joint rod 16 can rotate relative to each other, and drive the fixed rod 20 and the long rod to move along the strip slot 18. That is, the strip-shaped slots 18 , the long rods and the fixing rods 20 are arranged to enable the first connecting rod 15 and the second connecting rod 16 to rotate relative to each other.

[0050] In this embodiment, the first joint rod 15 is longer than the second joint rod 16, but in order to make the length of the first joint rod 15 match the tibia length of different patients, an extension rod 29 is provided on the outer sleeve of the portion of the first joint rod 15 that is longer than the second joint rod 16, and the extension rod 29 is movably connected to the first joint rod 15 to extend the first joint rod 15. The extension rod 29 and the first joint rod 15 can be locked or unlocked by turning a switch, or can be movably connected by cooperating with other concave-convex structures, and the specific method is not unique.

[0051] The joint rod assembly also includes a third joint rod 23. The first joint rod 15 and the third joint rod 23 are respectively located on both sides of the second joint rod 16. The first joint rod 15, the second joint rod 16 and the third joint rod 23 are close to each other and parallel to each other. The third joint rod 23 is rotatably connected with the second joint rod 16 so as to be able to swing relative to the second joint rod 16. Two tray assemblies 1 are symmetrically arranged on the first joint rod 15 for installing a measuring device. For example, when the affected limb is the left leg or the right leg, the tray assemblies 1 installed on the measuring device are different. The third joint rod 23 is provided with a tray assembly 1 for installing a reference device. The measuring module includes a first measuring module 22 and a second measuring module 24. The second measuring module 24 is connected to the end of the extension rod 29 away from the second joint rod 16. The first measuring module 22 is arranged on the end of the first joint rod 15 and the third joint rod 23 away from the second measuring module 24. In this embodiment, the second measurement module 24 includes a sliding seat connected to the extension rod 29, a probe rod 32 that is inserted into the sliding seat and can slide relative to the sliding seat, and a hammer 33 provided at one end of the probe rod 32. When measuring the force line, the hammer 33 is used to abut against the ankle bone. The probe rod 32 is provided with a scale. The first measurement module 22 includes a probe 31 that is provided with a scale and corresponds to the scale of the probe rod 32. The probe 31 is detachably connected to the third joint rod 23 through a column. Of course, the first measurement module 22 can also include other structural parts, which are not unique.

[0052] In order to control the swing of the third joint rod 23, the second joint rod 16 is provided with a limit groove 25, and the third joint rod 23 is provided with an arc guide 26 corresponding to the limit groove 25, and the arc guide 26 is located in the limit groove 25, and the limit groove 25 can move along the arc guide 26 as the second joint rod 16 swings. The tibial positioning and adjustment device also includes a second rotation switch 27, and the second rotation switch 27 is used to lock or release the second joint rod 16 and the third joint rod 23 to allow or prohibit their swing. Specifically, one end of the second rotation switch 27 extends into the second joint rod 16 and is rotatably connected to the second joint rod 16, that is, the second rotation switch 27 can rotate relative to the second joint rod 16, and one end of the second rotation switch 27 located in the second joint rod 16 is connected to an elastic lock 28, and the elastic lock 28 can be formed by connecting a spring with a clamp, for example, and of course the specific method is not limited to this, and can be flexibly set. The elastic lock 28 is located below the limit slot 25, and can be pushed into the limit slot 25 when the second rotary switch 27 is rotated, so as to abut against the arc guide 26, thereby limiting the movement of the arc guide 26 relative to the limit slot 25, thereby locking the second joint rod 16 and the third joint rod 23 and prohibiting the two from swinging relative to each other. When the second rotary switch 27 is rotated to drive the elastic lock 28 to move away from the limit slot 25, the elastic lock 28 is separated from the arc guide 26, and the second joint rod 16 and the third joint rod 23 are in an unlocked state and can swing relative to each other. That is, the second joint rod 16 and the third joint rod 23 can swing relative to each other.

[0053] In the tibial positioning and adjustment device in this embodiment, the reference device is arranged on the first joint rod 15, and two symmetrically arranged on the third joint rod 23, respectively corresponding to the tray assemblies 1 of the left and right legs for installing the measuring device, and the position of the reference device is located on the center line between the two tray assemblies 1 for installing the measuring device. In this embodiment, the reference device is fixed to the tibial tubercle, and the measuring device is always fixed to the main body of the tibial navigation instrument. One end of the probe 31 in the second measurement module 24 points to the ACL point of the tibial plateau, that is, the center point of the knee joint, the hinge of the first joint rod 15 and the second joint rod 16 is fixed at the tibial tubercle, the pad in the first measurement module 22 fits the front side of the tibia, and the hammer 33 is attached to the front side of the ankle joint. At this time, the scale corresponding to the indication point of the probe 31 is consistent with the scale of the position of the sliding seat on the probe rod 32 in the first measurement module 22, that is, the distance between the two ends of the tibial positioning and adjustment device relative to the tibia matches. At this time, the tibia positioning and adjusting device is fixed on the tibia, such as the upper end of the device is fixed to the tibia by a steel needle, and the lower end is fixed by a bandage legging connected to a pad. Then, turn on the second rotating switch 27, control the second joint rod 16 to drive the first joint rod 15, that is, drive the hammer 33 to swing on the xz plane, so that the inner and outer ends of the hammer 33 touch the inner and outer malleolus of the tibia in turn to collect corresponding data, and turn on the first rotating switch 19 at the same time, control the first joint rod 15 to rotate on the zy plane, and collect data, and then calculate the tibia force line and osteotomy parameters based on the collected data. In the above process, the position of the measuring device is fixed, and only the reference device moves, and the relative position relationship between it and the measuring device is adjusted to determine the tibia force line and osteotomy angle.

[0054] Specifically, the reference device and the measuring device described in this embodiment both include an inertial measurement module for outputting posture data, and a Bluetooth module for assisting in calculating the femoral force line and the tibial force line based on the posture data. For example, the reference device and the measuring device are mainly composed of an IMU sensor and a Bluetooth module. The IMU sensor includes a gyroscope, an accelerometer, a magnetometer, etc., which are responsible for data measurement and processing, including being able to output stable posture data after Kalman filtering and integral filtering, and then collecting, calculating and integrating the position according to a certain period, and finally obtaining the coordinates of the center of the femoral head; the Bluetooth module has an MCU, so it not only has Bluetooth transmission capabilities, but also has data processing capabilities. For example, the MCU receives the posture data and the coordinates of the center of the femoral head and calculates the femoral force line. Similarly, the navigator can also calculate the tibial force line. When preparing the navigator, such as Figure 8 As shown, the navigator housing 31 can be but is not limited to being made of medical nylon (or other plastic materials) by injection molding / 3D printing, and a coordinate system is provided on its surface to indicate the installation direction. There are chip card slots, fixed circuit boards, etc. inside, and the external shells can be sealed and connected by processes such as ultrasonic welding.

[0055] When the navigator determines the femoral force line, the Bluetooth module of the reference device determines the spatial position of the reference device based on the data collected by the inertial measurement module, and determines the distance between the two position points based on the center position of the femoral head to be measured, and uses the Taylor series expansion algorithm and the Kalman filter algorithm to calculate the formula of the distance to obtain the coordinates of the center position of the femoral head in the coordinate system of the reference device; when the femoral positioning and adjustment system rotates with the coordinates of the center position of the femoral head as the center point, the measuring device collects corresponding posture data based on the inertial measurement module, and calculates the collected posture data and the coordinates of the center position of the femoral head based on its own Bluetooth module, and then determines the femoral force line; wherein the spatial position of the reference device matches the spatial position of the intercondylar fossa of the femur, and the distance is different for different patients.

[0056] For example, medical personnel can operate the femoral positioning and adjustment device to rotate the reference device around the center of the femoral head and collect corresponding data. According to the algorithm flow, data iteration is performed. After the filtered data converges to the preset accuracy, the coordinates of the center of the femoral head are obtained, and the femoral force line vector can be determined based on this. The specific algorithm is briefly described as follows: Assume that the coordinates of the center of the femoral head in the reference coordinate system (the coordinate system where the reference device is located) are , the current position coordinates of the reference device calculated by MEMS inertial navigation are , then the distance between the two points is calculated as:

[0057] in, Number the sampling points of the reference device; It is the distance from the intercondylar fossa (equivalent placement point of the reference device) to the center point of the knee joint. When the reference device is fixed to the human body, the distance should be a fixed value. The distance is usually different for different human bodies.

[0058] When solving the above nonlinear equation, Taylor series expansion is performed on the above equation, and after ignoring the high-order terms, we have:

[0059] Since the femoral head center coordinates is the quantity to be estimated and is a fixed value, so the state model of the Kalman filter is selected as follows:

[0060] in, is the state vector, For the The state transfer matrix in the discretized form of the step.

[0061] Based on the above state model, the Kalman filter observation model can be calculated as follows:

[0062] in, For the The observation vector of the step, For the The observation matrix of the step, is the estimated value of the femoral head center position in the previous step.

[0063] According to the established Kalman filter state model and observation model, the center coordinates of the femoral head can be obtained by filtering and calculating using the Kalman filter algorithm, namely: .

[0064] After obtaining the coordinates of the center of the femoral head, the femoral force line vector can be determined accordingly. The force line vector measured by the reference device is transferred to the measuring device for osteotomy angle calculation. After receiving the vector, the measuring device calculates its angle relative to the force line vector based on the data collected by itself and the physical size data involved in the device. The projection angle of this angle relative to the xz plane and the yz plane is the medical valgus angle and anteroposterior tilt angle. After knowing the angle, the data processing device can further calculate the osteotomy parameters.

[0065] When determining the tibial force line, the navigator installs the reference device in a tray assembly 1 on the third joint rod 23 in the tibial positioning and adjustment device, and installs the measuring device in a tray assembly 1 on the first joint rod 15 in the tibial positioning and adjustment device according to whether the affected limb is the left leg or the right leg. When the tibial positioning and adjustment device is fixed on the tibia, the probe 31 of the first measuring module 22 in the tibial positioning and adjustment device is driven to point to the center of the knee joint, and at the same time, the length of the first joint rod 15 is adjusted, and the first joint rod 15 and the second joint rod 16 are driven to move in different dimensions (the two joint rods are connected to each other and thus move synchronously) to adjust the relative position between the reference device and the measuring device. The reference device obtains the posture data about the tibia collected by it and the measuring device during the movement of the joint rod, and calculates the tibial force line based on the posture data and the position coordinates of the center of the knee joint.

[0066] For example, the position of the center point of the knee joint is first determined based on the probe 31 in the tibial positioning and adjustment device, and then the position of the hammer 33 is adjusted to measure the left and right ankle positions of the tibia, the position of the hammer 33, and the position of the reference device, and then the tibial force line vector can be obtained by combining the following algorithm: The reference module measures and normalizes the left and right ankles to obtain the unit vector and Since the two vectors are in the reference module coordinate system, they need to be transposed to the ACL point coordinate system. The ACL point coordinate system is determined by the measurement module. Let the conversion matrix between the reference module coordinate system and the ACL point coordinate system be , then the transformed vector is:

[0067] Then the angular bisector of the two vectors is the force line vector .

[0068]

[0069] Line of force vector Then converted to the reference module coordinate system:

[0070] At this time, the left and right and up and down swing angles of the reference device are adjusted by driving the first joint rod 15, so that and , that is, the correction of the force line is completed, and the plane perpendicular to the longitudinal axis of the measuring module at this time is the surgical cutting plane.

[0071] When measuring, the length of the first joint rod 15 needs to match the tibia, and the scale indicated on the probe 31 is as consistent as possible with the scale indicated on the probe rod 32, so that the probe 31, the probe rod 32, the first joint rod 15, and the tibia / force line are approximately enclosed in a rectangle, and the corresponding sides are as parallel as possible, which can effectively reduce the measurement error. And it can be concluded that if the measurement accuracy is to be improved, the length of the first joint rod 15 should be as long as possible when designing the required instrument.

[0072] The above embodiments are only exemplary embodiments of the present invention and are not intended to limit the present invention. The protection scope of the present invention is defined by the claims. Those skilled in the art may make various modifications or equivalent substitutions to the present invention within the essence and protection scope of the present invention, and such modifications or equivalent substitutions shall also be deemed to fall within the protection scope of the present invention.

Claims

1. A knee joint force line measurement system, characterized in that: include: The femoral positioning and adjustment device is installed on the femur during surgery; The tibia positioning and adjustment device is installed on the tibia during surgery; A navigator, including a reference device and a measuring device, is installed on the femoral positioning and adjustment device or the tibial positioning and adjustment device, and is used to cooperate with navigation of the movement of the femoral positioning and adjustment device to calculate and determine the femoral force line according to the navigation data, and cooperate with navigation of the movement of the tibial positioning and adjustment device to calculate and determine the tibial force line according to the navigation data; A data processing device is connected to the navigator and is used to obtain the femoral force line and the tibial force line, and determine the knee joint force line at least based on the femoral force line and the tibial force line.

2. The knee joint force line measurement system according to claim 1, characterized in that: The femoral positioning and adjusting device comprises: A tray module, comprising two tray assemblies, for mounting a reference device and a measuring device respectively; A fixed module is detachably connected to a tray assembly; The adjusting module is installed on the fixed module and connected to another tray assembly of the tray module, and is used to adjust the horizontal position and vertical position of the tray assembly relative to the fixed module so that the reference device and the measuring device can cooperate to determine the femoral force line.

3. The knee joint force line measurement system according to claim 2, characterized in that: The fixing module comprises a bracket, and the bracket has a first part and a second part in the length direction of the femur; The first part of the support is a plate body, which can be connected to the femur. A beam is vertically provided on the first part. A connecting component is provided at one end of the beam. The tray component is detachably connected to the connecting component. The beam is perpendicular to the tray component, and the other end of the beam is used to point to the center of the knee joint. The cross-section of the second part of the bracket is concave-shaped, and has a bottom plate and two ear plates. The bottom plate is provided with an adjustment window. The adjustment module includes a positioning rod and an adjustment component. The adjustment component is arranged between the two ear plates and can move relative to the two ear plates. The positioning rod is passed through the adjustment window and the adjustment component, and one end is detachably connected to the other tray component.

4. The knee joint force line measurement system according to claim 3, characterized in that: The positioning rod is L-shaped and includes a horizontal rod body and a vertical rod body. The horizontal rod body passes through the adjustment window and the adjustment assembly. The vertical rod body is detachably connected to another tray assembly. A positioning seat for connecting the osteotomy guide plate is also provided on the horizontal rod body. The adjustment assembly includes a rotating fixed column, a rotating column sleeved on the rotating fixed column, the rotating column is provided with a through hole for the horizontal rod body to pass through, the horizontal rod body is provided with a positioning column, the rotating column is provided with a positioning through hole, the positioning column is correspondingly connected with the positioning through hole, so that the rotating column and the positioning rod are correspondingly connected and can rotate relatively; The rotating column is also threaded with a first adjusting knob, which is perpendicular to the positioning rod and can abut against each other to lock the positioning rod and fix the relative position between the positioning rod and the rotating column; A second adjusting knob is screwed on the ear plate, and the second adjusting knob passes through the ear plate to lock and fix the rotating column, prohibiting the rotating column and the positioning plate from rotating around the rotating and fixing column together, or moving away from the rotating column so that the rotating column and the positioning plate can rotate around the rotating and fixing column together.

5. The knee joint force line measurement system according to claim 1, characterized in that: The tibia positioning and adjusting device comprises: A joint rod assembly comprises a plurality of different joint rods, wherein the reference device and the measuring device are detachably mounted on different joint rods in the joint rod assembly; A measuring module, mounted at both ends of the joint rod assembly, for assisting in measuring the tibial force line; Among them, multiple different joint rods are controlled by different rotating switches respectively, so as to realize the rotation of the navigator and the measurement module in different dimensions alone or together with multiple joint rods to complete the measurement of the tibial force line.

6. The knee joint force line measurement system according to claim 5, characterized in that: The joint rod assembly comprises a first joint rod and a second joint rod, wherein the first ends of the first joint rod and the second joint rod in the same direction are flush and rotatably connected, a strip slot is provided on the first joint rod along its length direction, and the strip slot radially penetrates the first joint rod, and a connecting hook is provided between the first joint rod and the second joint rod, and the connecting hook is L-shaped, comprising a long rod and a short rod, the long rod extends into the first joint rod and corresponds to the position of the strip slot, and can move along the length direction of the first joint rod, and the short rod is located outside the first joint rod, extends into the second joint rod, and is connected to the second joint rod; The tibial positioning and adjustment device includes a first rotating switch, one end of which is rotatably connected to a fixed rod, the fixed rod is vertically penetrated in the strip slot and the long rod, and can move relative to them, and a locking piece is also penetrated on the fixed rod. When the first rotating switch is rotated, the locking piece can be pushed to move along the fixed rod, and when the locking piece moves to abut against the long rod, the long rod is locked. When the locking piece moves away from the long rod, the first combined rod and the second combined rod can rotate relative to each other and drive the fixed rod and the long rod to move along the strip slot.

7. The knee joint force line measurement system according to claim 6, characterized in that: The first joint rod is longer than the second joint rod, and an extension rod is provided on the outer sleeve of a portion of the first joint rod that is longer than the second joint rod. The extension rod is movably connected to the first joint rod to extend the first joint rod; The joint rod assembly further includes a third joint rod, wherein the first joint rod and the third joint rod are respectively located on both sides of the second joint rod, the first joint rod, the second joint rod and the third joint rod are close to each other and parallel to each other, and the third joint rod is rotatably connected to the second joint rod so as to be able to swing relative to the second joint rod; The third joint rod is symmetrically provided with two tray assemblies for mounting a measuring device, and the first joint rod is provided with a tray assembly for mounting a reference device; The measuring module comprises a first measuring module and a second measuring module. The first measuring module is connected to one end of the first joint rod and the third joint rod away from the second measuring module. The second measuring module is arranged at one end of the extension rod away from the second joint rod.

8. The knee joint force line measurement system according to claim 7, characterized in that: The second joint rod is provided with a limiting groove, and the third joint rod is provided with an arc-shaped guide piece at a position corresponding to the limiting groove, the arc-shaped guide piece is located in the limiting groove, and the limiting groove can move along the arc-shaped guide piece as the second joint rod swings; The tibial positioning and adjustment device also includes a second rotating switch, one end of which extends into the second combining rod and is rotatably connected to the second combining rod, and one end of the second rotating switch located in the second combining rod is connected to an elastic locking piece, which can extend into the limiting groove and resist the arc-shaped guide piece, thereby locking the third combining rod.

9. The knee joint force line measurement system according to claim 1, characterized in that: The reference device and the measuring device both include an inertial measurement module for outputting posture data, and a Bluetooth module for assisting in calculating the femoral force line and the tibial force line according to the posture data; When the navigator determines the femoral force line, the Bluetooth module of the reference device determines the spatial position of the reference device based on the data collected by the inertial measurement module, and determines the distance between the two position points based on the center position of the femoral head to be measured, and uses the Taylor series expansion algorithm and the Kalman filter algorithm to calculate the formula of the distance to obtain the coordinates of the center position of the femoral head in the coordinate system of the reference device; When the femoral positioning and adjustment system rotates with the coordinates of the center position of the femoral head as the center point, the measuring device collects corresponding posture data based on the inertial measurement module, and calculates the collected posture data and the coordinates of the center position of the femoral head based on its own Bluetooth module, thereby determining the femoral force line; The spatial position of the reference device matches the spatial position of the intercondylar fossa of the femur, and the distance is different for different patients.

10. The knee joint force line measurement system according to claim 9, characterized in that: When determining the tibial force line, the navigator installs the reference device in a tray assembly on the first joint rod in the tibial positioning and adjustment device, and installs the measuring device in a tray assembly on the third joint rod in the tibial positioning and adjustment device according to whether the affected limb is the left leg or the right leg. When the tibial positioning and adjustment device is fixed on the tibia, the probe of the first measuring module in the tibial positioning and adjustment device is driven to point to the center of the knee joint, and the length of the first joint rod is adjusted at the same time, and the first joint rod and the second joint rod are driven to move in different dimensions to adjust the relative position between the reference device and the measuring device. The reference device obtains the posture data about the tibia collected by it and the measuring device during the movement of the joint rod, and calculates the tibial force line based on the posture data and the position coordinates of the center of the knee joint.

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