Method for correcting the position of an osteotomy guide and orthopedic surgery system

By tracking and feedbacking the position and posture of the osteotomy guide in real time and controlling its movement with the robot arm, the problem of insufficient positioning accuracy of the osteotomy guide is solved, achieving higher positioning accuracy and surgical safety.

JP7657207B2Active Publication Date: 2025-04-04SUZHOU MICROPORT ORTHOBOT CO LTD
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Patent Information

Application Number
JP2022519982
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2019-09-30
Filing Date
2020-06-09
Publication Date
2025-04-04
Estimated Expiration
2040-06-09

AI Technical Summary

Technical Problem

In the prior art, when performing orthopedic surgery, the positioning accuracy of the osteotomy guide is insufficient, which affects the accuracy and safety of the operation.

Method used

By tracking and feedbacking the position and posture of the osteotomy guide in real time, and controlling its movement with the robot arm, ensuring that the guide reference marker reaches the desired position, thereby improving the positioning accuracy of the osteotomy guide.

Benefits of technology

It improves the positioning accuracy of the osteotomy guide, reduces errors during surgery, and enhances the accuracy and safety of the surgery.

✦ Generated by Eureka AI based on patent content.

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Patent Text Reader

Abstract

A method for correcting the position of an osteotomy guide and an orthopedic surgery system are provided. A guide reference marker (3) attached to an osteotomy guide (4) or a robotic arm (2) tracks the position of the osteotomy guide (4) and generates position information for the guide reference marker (3). The robotic arm (2) is controlled to move based on the current and desired positions of the guide reference marker (3), moving the guide reference marker (3) to the desired position and achieving positioning of the osteotomy guide (4). This method eliminates the need to consider the absolute position accuracy of the robotic arm (2) or rely on the surgeon's experience, allowing for more accurate placement of the osteotomy guide (4), resulting in improved positioning accuracy for the osteotomy guide (4). The osteotomy guide (4) has multiple guide features and can provide multiple osteotomy guide modes. Therefore, a single osteotomy guide (4) can be used for various osteotomy guidance and drilling tasks, eliminating the need to frequently switch from one osteotomy guide (4) to another during surgery. This significantly reduces surgical time and improves surgical efficiency.
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Description

[Technical field]

[0001] The present invention relates to the technical field of a robot-assisted surgery system and method, and in particular to a method for correcting the position of osteotomy guides, a computer-readable recording medium, an orthopedic surgery system, and an osteotomy guide. [Background technology]

[0002] In total knee arthroplasty, in order to ensure the accuracy of osteotomy, it is necessary to perform osteotomy using various locators and guides before the arrival of the artificial joint. Currently, many methods have been proposed to help surgeons position the osteotomy guide in total knee arthroplasty (TKR).

[0003] However, existing devices / methods for positioning the osteotomy guide during surgery have problems such as insufficient positioning accuracy, etc. Therefore, it is necessary to develop a method and a surgical system that can improve the positioning accuracy of the osteotomy guide. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention has been made in consideration of the above-mentioned conventional technology, and aims to provide a method for correcting the position of a bone cutting guide, a computer-readable recording medium, an orthopedic surgery system, and a bone cutting guide that can realize positioning of the bone cutting guide and improve the positioning accuracy of the bone cutting guide by tracking and feeding back the position and posture of the bone cutting guide in real time and controlling the movement of the bone cutting guide by a robot arm. [Means for solving the problem]

[0005] A method for correcting a position of a bone resection guide according to a first aspect of the present invention includes the steps of: A control step of driving the osteotomy guide and the guide reference marker to move so that the guide reference marker reaches the desired position by controlling the movement of the robot arm based on the current position and the desired position of the osteotomy guide or the guide reference marker attached to the robot arm; The position of the guide fiducial marker characterizes the position of the osteotomy guide.

[0006] Furthermore, the method further includes a verification step of verifying whether the osteotomy guide and / or the guide reference marker are deformed before the control step of controlling the movement of the robot arm, the verification step including: a determination step of determining whether or not the initial position information of the verification fiducial marker matches the current position information of the verification fiducial marker attached to the bone resection guide based on initial position information of the verification fiducial marker with respect to the guide fiducial marker before delivery from a factory and current position information of the guide fiducial marker with respect to the guide fiducial marker at the time of use; if so, determining that the osteotomy guide and / or the guide fiducial marker are not deformed and controlling the robot arm to move based on the current and desired positions of the osteotomy guide or the guide fiducial marker attached to the robot arm; If they do not match, it is determined that the bone cutting guide and / or the guide reference marker have been deformed, and the relative positions of the guide reference marker and the bone cutting guide are corrected, and then the robot arm is controlled to move based on the current position and desired position of the bone cutting guide or the guide reference marker attached to the robot arm.

[0007] Furthermore, the amendment is acquiring position information of at least two correction fiducial markers attached to the osteotomy guide relative to the guide fiducial markers; acquiring information about a current position of the bone resection guide relative to the guide reference marker based on position information of the at least two correction reference markers relative to the guide reference marker, and updating a position of the bone resection guide relative to the guide reference marker using the acquired information about the current position; Includes.

[0008] Furthermore, the position information of the two correction reference markers relative to the guide reference marker is represented as T1 and T2, respectively, where T1 represents the position of one of the two correction reference markers in the coordinate system of the guide reference marker, and T2 represents the position of the other of the two correction reference markers in the coordinate system of the guide reference marker; Obtaining information regarding a current position of the osteotomy guide relative to the guide fiducial marker comprises: Acquiring a position T0 of the center point of the bone resection guide block in the coordinate system of the guide reference marker and a position T3 of the surface of the bone resection guide block in the coordinate system of the guide reference marker based on the position information of T1 and T2 in the coordinate system of the at least two correction reference markers; Acquiring a position and a posture of the bone resection guide relative to the guide reference marker based on a position T0 of a center point of the bone resection guide block in the coordinate system of the guide reference marker and a position T3 of a surface of the bone resection guide block in the coordinate system of the guide reference marker; Includes.

[0009] Furthermore, prior to the control step, determining a desired path of movement of the guide reference marker from the current position and the desired position of the guide reference marker; In the control step, the robot arm is controlled based on a current position of the guide reference marker so that the guide reference marker moves to a desired position along a desired movement path; Includes.

[0010] Further, a desired position of the guide fiducial marker is obtained based on both the position and orientation correlation between the guide fiducial marker and the bone resection guide and a target position of the bone resection guide.

[0011] Further, the position and orientation correlation between the guide fiducial marker and the osteotomy guide includes position and orientation correlation between a plurality of guide features on the osteotomy guide and the guide fiducial marker.

[0012] Further, obtaining a position and orientation correlation between each of the guide features and the guide fiducial markers includes: determining a relative positional relationship between fiducial marker balls on the guide fiducial marker and establishing a coordinate system for the guide fiducial marker based on the relative positional relationship; determining position information of a center point of the osteotomy guide block in a coordinate system of the guide fiducial marker; determining a position and orientation of the guide fiducial in a coordinate system based on both position information of the guide feature relative to a center point of the osteotomy guide block and position information of the center point of the osteotomy guide block in a coordinate system of the guide fiducial; Includes.

[0013] According to a second aspect of the present invention, there is provided a computer readable storage medium storing instructions which, when executed by a processor, perform a method for correcting the position of a bone cutting guide according to any one of claims 1 to 8.

[0014] According to a third aspect of the present invention, there is provided an orthopaedic surgical system comprising a control device, a navigation device, a robotic arm, and a bone cutting guide, the bone cutting guide being attached to one end of the robotic arm, the robotic arm being configured to adjust a position and an orientation of the bone cutting guide; a navigation device including a tracker and a guide fiducial marker, the guide fiducial marker being attached to the osteotomy guide or the robotic arm, the tracker being configured to track a current position of the guide fiducial marker and generate information regarding the current position, the position of the guide fiducial marker being configured to characterize a position of the osteotomy guide; The control device is configured to control movement of the robot arm based on both information regarding the current position of the guide reference marker fed back from the tracker and information regarding the desired position of the guide reference marker, thereby moving the osteotomy guide and the guide reference marker so that the guide reference marker reaches the desired position.

[0015] and a verification device configured to verify whether the osteotomy guide and / or the guide fiducial marker have been deformed. the osteotomy guide includes an osteotomy guide block having a plurality of guide features thereon to provide an osteotomy guide, and the verification device includes at least one verification fiducial marker configured to be removably attached to the osteotomy guide block; The tracker is configured to record initial position information of the verification fiducial marker relative to the guide fiducial marker before shipment from a factory, and to record current position information of the verification fiducial marker relative to the guide fiducial marker each time the tracker is used in surgery; The control device is configured to determine whether the initial position information of the verification reference marker and the current position information of the verification reference marker match, and if they match, determine that the bone resection guide and / or the guide reference marker are not deformed, and if they do not match, determine that the bone resection guide and / or the guide reference marker are deformed.

[0016] Further, the verification device further includes a correction device that corrects a position of the bone resection guide relative to the guide reference marker when the verification device determines that the bone resection guide and / or the guide reference marker has been deformed, and the correction device includes at least two correction reference markers configured to be detachably attached to the bone resection guide block, the tracker is configured to record position information of the at least two correction fiducial markers relative to the guide fiducial marker; The control device is configured to obtain information regarding a current position of the bone resection guide relative to the guide reference marker based on position information of the at least two correction reference markers relative to the guide reference marker, and to update the position of the bone resection guide relative to the guide reference marker using the obtained information regarding the current position.

[0017] Furthermore, the position information of the two correction reference markers relative to the guide reference marker is represented as T1 and T2, respectively, where T1 represents the position of one of the two correction reference markers in the coordinate system of the guide reference marker, and T2 represents the position of the other of the two correction reference markers in the coordinate system of the guide reference marker; the control device is configured to acquire a position T0 of the center point of the bone resection guide block in the coordinate system of the guide reference marker and a position T3 of the surface of the bone resection guide block in the coordinate system of the guide reference marker based on the position information of T1 and T2 in the coordinate system of the at least two correction reference markers, and acquire a position and an attitude of the bone resection guide relative to the guide reference marker based on the position T0 of the center point of the bone resection guide block in the coordinate system of the guide reference marker and the position T3 of the surface of the bone resection guide block in the coordinate system of the guide reference marker; Includes.

[0018] Additionally, the navigation device further comprises a base reference marker that is maintained stationary, the position of the guide reference marker being relative to the position of the base reference marker.

[0019] The controller is further configured to provide a desired path of travel defined by a plurality of positioning points and to control the robot arm such that the guide reference marker reaches the desired position along the desired path of travel.

[0020] The apparatus further includes a storage device for storing position and orientation correlation between the guide fiducial marker and the osteotomy guide.

[0021] Further, the osteotomy guide includes an osteotomy guide block having a plurality of guide features thereon for providing a plurality of osteotomy guidance modes, and a position and orientation correlation between the guide reference marker and the osteotomy guide includes a position and orientation correlation between the guide features and the guide reference marker.

[0022] Further, obtaining position and orientation correlation between each of the guide features and the guide fiducial markers includes: determining a relative positional relationship between fiducial marker balls on the guide fiducial marker and establishing a coordinate system for the guide fiducial marker based on the relative positional relationship; determining position information of a center point of the osteotomy guide block in a coordinate system of the guide fiducial marker; determining a position and orientation of the guide feature in the coordinate system of the guide reference marker based on both position information of the guide feature relative to the center point of the osteotomy guide block and position information of the center point of the osteotomy guide block in the coordinate system of the guide reference marker; Includes.

[0023] Additionally, the osteotomy guide block includes at least one verification hole therein in which a respective verification fiducial marker is mounted, each verification fiducial marker having a stepped surface parallel to a surface of the osteotomy guide block.

[0024] Furthermore, the osteotomy guide block has a top surface on which the guide feature is provided, the verification hole is provided perpendicular to the top surface, and the step surface is coincident with the top surface.

[0025] Furthermore, the axis of the verification hole is located within the symmetry plane of the bone cutting guide block, and the end face of the verification hole, the upper surface of the bone cutting guide block, and the step surface are on the same plane.

[0026] Furthermore, the position information of the verification fiducial marker relative to the guide fiducial marker comprises the position and orientation of the front end point of the verification fiducial marker in the coordinate system of the guide fiducial marker.

[0027] Furthermore, the position of each of the correction reference markers in the coordinate system of the guide reference marker is The position and orientation of the front end point of the correction reference marker in the coordinate system of the guide reference marker; and a position and orientation of the step surface of the correction reference marker in the coordinate system of the guide reference marker. The step surface is a step of the correction reference marker and is parallel to the surface of the bone cutting guide block.

[0028] Furthermore, a correction hole is provided in the bone cutting guide block, and two correction reference markers are fixed to the correction holes, respectively, or two correction reference markers are fixed to one verification hole and the correction hole, respectively.

[0029] Additionally, each correction hole has an end surface that is coplanar with both the surface of the osteotomy guide block and the step surface of each correction fiducial marker.

[0030] Further, the osteotomy guide comprises an osteotomy guide block and a mounting interface, the mounting interface is coupled to the osteotomy guide block by a connecting shaft, the osteotomy guide block comprises a plurality of guide features thereon for providing an osteotomy guide, and the mounting interface is removably attached to an end of the robotic arm.

[0031] Further, the connecting shaft is an eccentric crank that is connected to both the osteotomy guide block and the mounting interface such that the axis of rotation of the osteotomy guide block is offset from the axis of rotation of the osteotomy guide block.

[0032] Furthermore, the osteotomy guide further comprises a holder, the osteotomy guide block, the eccentric crank, the holder and the mounting interface are sequentially coupled in this order, and the holder has a fiducial marker mounting hole therein.

[0033] Furthermore, the bone cutting guide block is detachably attached to the eccentric crank.

[0034] Additionally, the guide features may include multiple guide grooves disposed on a single surface of the osteotomy guide block or on different surfaces about an axis of the osteotomy guide block.

[0035] Further, the guide groove is a 0° guide groove or a 45° guide groove.

[0036] Further, the osteotomy guide comprises two osteotomy guide blocks arranged in mirror image to one another, each having an attachment interface thereon configured to releasably connect with the eccentric crank.

[0037] Further, the osteotomy guide comprises an osteotomy guide block having two mounting interfaces disposed thereon and opposite to each other, and the eccentric crank is selectively detachably connected to one of the mounting interfaces.

[0038] The present invention further includes a sterile bag disposed at an end of the robot arm and covering a connection port of the robot arm, the connection port being detachably connected to the osteotomy guide.

[0039] Furthermore, the sterile bag has a through hole at one end thereof.

[0040] According to a further aspect of the present invention there is provided an osteotomy guide for use in an orthopaedic surgical system as defined above, comprising: The osteotomy guide comprises an osteotomy guide block, a connecting shaft and a mounting interface, the osteotomy guide block has a plurality of guide features thereon for providing a plurality of osteotomy guidance modes, both ends of the connecting shaft are connected to both the osteotomy guide block and the mounting interface, and the mounting interface is configured to be removably coupled to one end of a robotic arm.

[0041] Additionally, the guide features include guide grooves and guide holes.

[0042] Furthermore, the connecting shaft is an eccentric crank.

[0043] The osteotomy guide block, the eccentric crank, the holder and the mounting interface are coupled together in this order, and the holder further comprises a holder having a fiducial marker mounting hole therein.

[0044] Furthermore, the bone cutting guide block is detachably attached to the eccentric crank.

[0045] Additionally, each guide channel has an end opening that extends through a surface of the osteotomy guide block.

[0046] Furthermore, each guide groove has a flared shape.

[0047] Furthermore, a plurality of guide grooves are arranged on different surfaces of the bone cutting guide block centered on the axis line of the bone cutting guide block. Each guide groove is a 0° guide groove or a 45° guide groove.

[0048] Further, the guide groove includes at least one of a 0° guide groove, a 45° guide groove, and a trochlear cutting guide groove, and the guide hole includes at least one of a guide hole for attaching an artificial femur, a guide hole for positioning a left tibia tool, a guide hole for positioning a right tibia tool, and a fixation hole for a bone cutting guide.

[0049] Furthermore, the guide grooves include two 0° guide grooves, two 45° guide grooves and two pulley cutting guide grooves.

[0050] Furthermore, the bone resection guide block has an axisymmetric structure.

[0051] Furthermore, the osteotomy guide block includes two mounting interfaces thereon disposed opposite one another, and the eccentric crank is selectively detachably coupled to one of the mounting interfaces.

[0052] Additionally, the bone cutting guide block has a verification hole defined therein.

[0053] Additionally, the osteotomy guide block further includes an offset hole therein.

[0054] In the above method, the position and orientation of the osteotomy guide are tracked in real time and fed back as the basis for control to move the robot arm. In this way, the osteotomy guide can be placed and positioned more accurately without considering the absolute positional accuracy of the robot arm or relying on the doctor's experience. Furthermore, in the above orthopedic surgery system, the osteotomy guide is hung on the robot arm rather than fixed to the patient's body, so secondary damage to it can be avoided.

[0055] Furthermore, in the above method, the verification fiducial markers can be used to timely determine whether the osteotomy guide and / or the guide fiducial marker are deformed, which can facilitate replacement or correction of the deformed osteotomy guide and / or the guide fiducial marker, thereby reducing the risk of surgery and improving the accuracy of surgery. For example, in the above method, at least two correction fiducial markers can be further used to correct and update the position of the osteotomy guide relative to the guide fiducial markers, and such correction can be achieved in a simple and convenient manner.

[0056] The osteotomy guide block in the osteotomy guide may be provided with multiple guide features, which may be any of various combinations of guide holes and guide grooves. These guide features can provide various osteotomy guidance modes, allowing a single osteotomy guide to be applied to different bone cutting and drilling operations, thus eliminating the need to frequently switch from one osteotomy guide to another. This can greatly shorten the operation time and improve the operation efficiency.

[0057] Preferably, the osteotomy guide is implemented as an axisymmetric structure, so that the osteotomy guide can support osteotomy for any leg, thereby reducing costs, improving the ease of osteotomy, and further improving surgical efficiency.

[0058] In the osteotomy guide, each guide groove may be, for example, a 45° guide groove or a 0° guide groove, and both ends extend through the surface of the osteotomy guide block, thus having end openings, so that the osteotomy guide can be applied to osteotomy guidance of various types of artificial joints.

[0059] In the above-mentioned osteotomy guide, each guide groove may be, for example, a 45° guide groove or a 0° guide groove, and its shape may be a flare shape, so that this osteotomy guide can also be applied to osteotomy guidance of various types of artificial joints.

[0060] In the above bone cutting guide, the guide grooves (e.g., 0° or 45°) are preferably provided on different faces around the axis of the bone cutting guide block, so that the bone cutting guide has a shorter moving distance to switch to another bone surface to be cut, and thus avoids positioning and orientation determination errors and failures caused by large rotation strokes of the fiducial markers and large rotation errors of the robot arm caused by excessive positioning and orientation changes, thereby further improving the positioning accuracy.

[0061] The rotation axis of the bone resection guide is offset from the rotation axis of the tip of the robot arm. In this way, the angle of the bone resection guide can be adjusted by simply rotating the robot arm after translating it a small distance. This reduces the rotation error of the robot arm and improves the positioning accuracy. [Brief description of the drawings]

[0062] The features, properties and advantages of the embodiments of the present invention and related implementations will be described with reference to the drawings. [Figure 1] FIG. 1 is a diagram for explaining how to perform total knee replacement surgery using an orthopaedic surgical system according to one embodiment of the present invention. [Diagram 2] 1A to 1C are diagrams showing the structure of a bone cutting guide according to one embodiment of the present invention. [Diagram 3]FIG. 2 is a diagram for explaining that bone resection guidance can be achieved in a plurality of positions and directions by translating a bone resection guide according to one embodiment of the present invention. [Figure 4] FIG. 13 is a diagram illustrating how the osteotomy guide rotates to transition from the bone surface to be cut to another bone surface by rotating the osteotomy guide according to one embodiment of the present invention. [Diagram 5] FIG. 3 is a cross-sectional view of the osteotomy guide of FIG. 2 taken along line AA showing that the 0° guide groove is flared. [Figure 6] 13A and 13B are diagrams illustrating a method in which a verification reference marker verifies whether or not a bone resection guide and / or a guide reference marker has been deformed during use in accordance with an embodiment of the present invention. [Figure 7] FIG. 2 is a schematic structural diagram of a bone cutting guide according to an embodiment of the present invention, showing a correction hole provided therein. [Figure 8] 11A to 11C are diagrams for explaining how a bone resection guide is corrected using a correction reference marker according to an embodiment of the present invention. [Figure 9] 1A-1C show guide reference markers attached alternately to the contours of end joints of a robotic arm according to an embodiment of the present invention. [Figure 10] FIG. 13 shows the structure of two bone cutting guides arranged as mirror images of each other according to another embodiment of the present invention. [Figure 11] FIG. 13 shows another osteotomy guide block with two quick-change interfaces, capable of guiding an osteotomy in either the left or right leg, according to another embodiment of the present invention. [Figure 12] 5A and 5B are diagrams illustrating a movement path of a guide reference marker according to an embodiment of the present invention. [Figure 13] 1A and 1B are diagrams illustrating guidance for tibial plateau preparation according to an embodiment of the present invention. [Figure 14] 11A and 11B are diagrams for explaining guidance for cutting the anterior femur according to an embodiment of the present invention. [Figure 15]FIG. 13 shows the structure of a first embodiment of a bone resection guide including only one 0° guide groove. [Figure 16] 13A and 13B show the structure of a second embodiment of a bone resection guide including two 0° guide grooves. [Figure 17] FIG. 13 shows the structure of a third embodiment of the bone cutting guide, which includes two trochlear cutting grooves and two 0° guide grooves. [Figure 18] FIG. 13 shows the structure of a fourth embodiment of the osteotomy guide, which includes one 0° guide groove and two guide holes. [Figure 19] FIG. 13 shows the structure of a fifth embodiment of the osteotomy guide, which includes two 0° guide grooves and two guide holes. [Figure 20] FIG. 13 shows the structure of a sixth embodiment of the bone cutting guide, which includes two 0° guide grooves, two trochlear cut grooves and two guide holes. [Figure 21] FIG. 13 shows the structure of a seventh embodiment of the bone cutting guide, which includes two fixing holes and multiple guide grooves. [Figure 22] FIG. 13 shows the structure of an eighth embodiment of the bone cutting guide, which includes a rectangular trochlear cutting groove, an elongated guide groove and two guide holes. [Figure 23] FIG. 13 is a diagram showing the structure of a ninth embodiment of the bone cutting guide, which includes a guide groove having an opening at one end. [Figure 24] 13A to 13C are diagrams showing the structure of a tenth embodiment of a bone cutting guide, which is a tibial tool guide. [Diagram 25] 13A and 13B are diagrams showing the structure of an eleventh embodiment of a bone cutting guide, which is a trochlear cutting guide. [Figure 26a] FIG. 1 illustrates a configuration of a sterile bag placed on an end joint of a robotic arm according to an embodiment of the present invention. [Figure 26b] 1 is a partially enlarged view of a sterile bag having a passage hole at one end according to an embodiment of the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0063] Hereinafter, the technical means according to the embodiments of the present invention will be described clearly and completely with reference to the drawings. Of course, the embodiments described below are only some of the embodiments of the present invention, and are not all of the embodiments. Based on the embodiments of the present invention, all other embodiments that can be easily conceived by those skilled in the art without any creative ingenuity are included in the protection scope of the present invention.

[0064] In the description of this specification, the singular terms "a", "one" and "the" include the plural, unless expressly indicated otherwise. In the description of this specification, the term "or" includes the meaning of "and / or" unless expressly indicated otherwise. In the description of this specification, the term "plurality" is used to mean "at least one" unless expressly indicated otherwise. In the description of this specification, the expression "at least two" is usually used to mean "two or more" unless expressly indicated otherwise. In the description of this specification, the terms "first", "second" and "third" are intended for easy understanding and should not be construed as indicating or suggesting relative importance or as implicitly indicating the quantity of the technical features described. Thus, the term "first", "second" or "third" technical feature is to explicitly or implicitly indicate the presence of one or at least two of the technical features.

[0065] In the method for correcting the position of the bone cutting guide according to the present invention, the technical idea of ​​the position correction is as follows. By tracking the position of the bone cutting guide using the guide reference marker attached to the bone cutting guide or the robot arm and acquiring the position information of the guide reference marker, the movement of the robot arm can be controlled based on the position information of the guide reference marker (including the current position and the desired position). Therefore, the bone cutting guide and the guide reference marker attached to one end of the robot arm can be driven by the robot arm to move the guide reference marker to the desired position. Since the position of the guide reference marker and the position of the bone cutting guide are associated with each other, the position and the posture of the guide reference marker are adjusted to adjust the position and posture of the bone cutting guide. That is, the position of the bone cutting guide is characterized by the position of the guide reference marker. In this way, it is not necessary to consider the absolute position accuracy of the robot arm or to rely on the experience of the doctor, and the bone cutting guide can be positioned more accurately, the positioning accuracy of the bone cutting guide is improved, and the accuracy of the surgery is improved.

[0066] The orthopedic surgery system according to the present invention for achieving accurate positioning of the osteotomy guide includes a control device, a navigation device, a robot arm, and an osteotomy guide (also referred to as "osteotomy guide"). The osteotomy guide or osteotomy guide is attached to the end of the robot arm, which adjusts the position and posture of the osteotomy guide. The navigation device includes a tracker and a guide reference marker. The guide reference marker is attached to the osteotomy guide or the robot arm, and the tracker tracks the current position of the guide reference marker and generates information related to the current position. In actual use, based on the information of the current position and the desired position of the guide reference marker fed back from the tracker, the control device controls the movement of the robot arm to drive the osteotomy guide and the guide reference marker by the robot arm so that the guide reference marker reaches the desired position. In addition to the above effects, the orthopedic surgery system according to the present invention can further suspend the osteotomy guide by the robot arm, and there is no need to fix the osteotomy guide to the patient's body, thereby avoiding secondary damage to the patient's body.

[0067] However, the orthopedic surgical system according to the present invention is not limited to a specific application in which it can be used. For example, the orthopedic surgical system can be used for other orthopedic surgical procedures besides total knee replacement. In the following, the orthopedic surgical system will be described as being used for knee replacement as an example, but this should not be construed as limiting the scope of protection of the present invention in any way.

[0068] FIG. 1 is a diagram showing an orthopaedic surgical system used for knee replacement according to one embodiment of the present invention. As shown in FIG. 1, the orthopaedic surgical system includes a control device, a navigation device, a robot arm 2, and an osteotomy guide 4. The control device may be a computer, which includes a controller, a master monitor 8, and a keyboard 10, and more preferably further includes a slave monitor 7. In this embodiment, the slave monitor 7 and the master monitor 8 display the same content, for example, an image of the area where the osteotomy is being performed. The navigation device may be an electromagnetic or optical positioning navigator / sensor. In some embodiments, the navigation device may be based on optical positioning, which can provide higher measurement accuracy and improve the positioning accuracy of the osteotomy guide compared to other navigation techniques.

[0069] In the following, the navigation device will be described as an optical positioning navigator, but is not limited thereto.

[0070] In a specific embodiment, the navigation device includes a navigation marker and tracker 6. The navigation markers include a base fiducial marker 15 and a guide fiducial marker 3. The base fiducial marker 15 is fixed, for example, to a surgical cart 1 to provide a base coordinate system (or a base fiducial marker coordinate system), and the guide fiducial marker 3 is attached to the osteotomy guide 4 so that the position of the osteotomy guide 4 can be tracked. The osteotomy guide 4 is attached to and supported at the end of a robot arm 2, and the spatial position and attitude (direction) of the osteotomy guide 4 are adjusted by the robot arm 2.

[0071] In practice, the tracker 6 captures a signal (preferably an optical signal) reflected from the guide fiducial marker 3 and records the position of the guide fiducial marker 3 (i.e., its position and orientation in the base coordinate system). The controller then controls the movement (motion) of the robot arm 2 based on the instructions stored in the storage device and the current and desired positions of the guide fiducial marker, thereby driving the osteotomy guide 4 and the guide fiducial marker 3 to move the guide fiducial marker 3 to the desired position. The desired position of the guide fiducial marker corresponds to the desired position of the osteotomy guide 4.

[0072] In this way, in the application of the orthopedic surgery system, the bone cutting guide 4 can be automatically positioned. Also, during surgery, the guide reference marker 3 tracks and feeds back the position and posture of the bone cutting guide 4 in real time, and based on that, the robot arm is controlled and moved, and as a result, the position and posture of the bone cutting guide can be adjusted. In this way, in addition to being able to obtain high positional accuracy of the bone cutting guide, the bone cutting guide 4 can be supported by the robot arm 2 rather than fixed to the patient's body, and therefore secondary damage to the patient's body can be avoided.

[0073] In general, the orthopedic surgery system further includes a surgical cart 1 and a navigation cart 9. A control device and a part of the navigation device are mounted on the navigation cart 9. For example, the control device may be mounted inside the navigation cart 9, and the keyboard 10 may be disposed outside the navigation cart 9 to facilitate operation. Furthermore, the master monitor 8, the slave monitor 7, and the tracker 6 may all be fixed to a support frame mounted vertically on the surface of the navigation cart 9, and the robot arm 2 may be mounted on the surgical cart 1. By using the surgical cart 1 and the navigation cart 9, surgical operations can be easily performed.

[0074] When the orthopaedic surgical system according to this embodiment is used for knee replacement surgery, the following operations are typically performed.

[0075] First, both the surgical cart 1 and the navigation cart 9 are moved to the appropriate locations next to the patient's bed.

[0076] Subsequently, the navigation markers (which may further include femoral fiducial marker 11 and tibial fiducial marker 13), osteotomy guide 4 and other necessary components (eg, a sterile bag) are operably attached.

[0077] Subsequently, the doctor 18 performs preoperative planning based on the CT / MR scan model of the bone region of the patient 17 requiring osteotomy treatment, which is captured in the computer, and formulates an osteotomy plan including, for example, information such as the coordinates of the bone surface to be cut, the model of the artificial joint, the target position and direction, etc. Specifically, image data of the patient's knee joint is obtained from the CT / MR scan, and a three-dimensional (3D) digital knee joint model is created for formulating an osteotomy plan that serves as a basis for the doctor to perform preoperative evaluation. More specifically, the osteotomy plan may be created based on the 3D digital knee joint model, as well as the dimensions of the artificial joint, the target position of the osteotomy plate, etc., and is finally output in the form of a surgical report. The surgical report may record a series of reference data including the coordinates of the bone surface to be cut, the amount of bone to be cut, the osteotomy angle, the size of the artificial joint, the target position (position to be attached) of the artificial joint, auxiliary surgical instruments, etc. In particular, it may include a series of sentences explaining, for example, the reason for the osteotomy angle, etc., for the surgeon's reference. The 3D digital knee joint model may be displayed on the master monitor 8. Furthermore, during pre-operative planning, the surgeon can input surgical parameters via keyboard 10 .

[0078] After pre-operative evaluation, the doctor 18 registers the features of the patient's femur and tibia (including multiple anatomical features of the patient's femur and multiple anatomical features of the patient's tibia) with a pointer or a pod with tracking capabilities and uses a navigation device to record the positions of all the feature points of the patient's tibia 14 and femur 12 relative to a base fiducial marker 15 taken as a reference. Information regarding the positions of all the feature points is then sent to the controller, which uses a feature matching algorithm to determine the actual position and pose (orientation) of the femur 12 and tibia 14 and correlates them to their respective graphical representations in the CT / MR images.

[0079] The navigation device then relates the actual position and orientation of the femur and tibia, respectively, to the fiducial markers fixed to the femur and tibia, allowing the femoral fiducial marker 11 and the tibial fiducial marker 13 to track the current position of the bones in real time, and as long as the fiducial markers maintain a fixed position relative to their respective bones during surgery, any movement of the bones will not adversely affect the surgical outcome.

[0080] The navigation device then transmits the coordinates of the bone surface to be cut, determined during preoperative planning, to the robot arm 2, which identifies the position of the bone surface to be cut based on the guide reference markers 3 and moves to the appropriate position. After the robot arm 2 is stationary (i.e., motionless), the surgeon uses a surgical instrument 5, such as a hanging cross saw or an electric drill, to perform the osteotomy guidance and / or hole drilling operation with the aid of the osteotomy guide 4. After completing the osteotomy guidance and / or hole drilling operation, the doctor can set the artificial joint in position and perform other necessary operations.

[0081] In this embodiment, the navigation markers further include a femoral fiducial marker 11 and a tibial fiducial marker 13. The femoral fiducial marker 11 is used to identify / track the spatial position and orientation of the femur 12, and the tibial fiducial marker 13 is used to identify / track the spatial position and orientation of the tibia 14. Note that, although the guide fiducial marker 3 is attached to the osteotomy guide 4 in the above, in other embodiments, the guide fiducial marker 3 may be attached to the end of the robot arm 2.

[0082] FIG. 2 is a diagram showing the structure of an osteotomy guide according to one embodiment of the present invention. As shown in FIG. 2, the osteotomy guide 4 according to this embodiment is used in knee joint replacement surgery and includes an osteotomy guide block 40 provided with guide features, which may include guide grooves, guide holes, or both. That is, the guide features of the osteotomy guide block 40 may be either guide grooves or guide holes, or a combination thereof. Thus, it can support the guidance of one or more osteotomies that may be involved in knee joint replacement. Specific examples of such osteotomies include distal femoral cutting, anterior femoral cutting, posterior femoral cutting, anterior femoral oblique cutting, posterior femoral oblique cutting, trochlear cutting, drilling holes for femoral prosthesis fixation studs, tibial plateau preparation, and drilling positioning holes for tibial keel preparation tools. In this way, a single osteotomy guide can be used to perform various osteotomy guidance and hole drilling operations, eliminating the need to switch to another osteotomy guide during surgery, significantly shortening the surgery time and improving the surgery efficiency.

[0083] As described above, the position of the osteotomy guide is characterized by the position of the guide reference marker. For this reason, it is necessary to calibrate the position-direction correspondence (correlation) between the guide reference marker 3 and the osteotomy guide 4 in advance. In this embodiment, the position-direction correspondence between the guide reference marker 3 and the osteotomy guide 4 includes the position-direction correspondence between all the guide features and the guide reference marker 3. For example, when the guide features include both the guide groove and the guide hole, the position-direction correlation between the guide reference marker 3 and the osteotomy guide 4 includes the position information of each guide groove of the osteotomy guide 4 in the guide reference marker coordinate system and the position information of each guide hole of the osteotomy guide 4 in the guide reference marker coordinate system.

[0084] In this embodiment, the position-orientation correlation between each guide feature (eg, guide groove or guide hole) and the guide reference marker 3 is obtained by the following steps.

[0085] (Step 1) The relative positional relationship between the reference marker balls (usually four) in the guide reference marker 3 is acquired, and a guide reference marker coordinate system is constructed based on the relative positional relationship.

[0086] (Step 2) The coordinates (i.e., position information) of the center point (geometric center or center of gravity) of the osteotomy guide block 40 in the guide reference marker coordinate system are acquired.

[0087] (Step 3) Based on both the position information of the guide feature relative to the center point of the bone cutting guide block 40 and the coordinate (or position information) of the center point of the bone cutting guide block 40 in the guide reference marker coordinate system, position information (including both position and orientation) of the guide feature in the guide reference marker coordinate system is obtained. The position information of the guide feature in the guide reference marker coordinate system is the position-direction correlation of the guide feature relative to the guide reference marker 3.

[0088] The position and orientation data of all the guide features of the osteotomy guide block in the guide fiducial marker coordinate system are pre-calibrated and recorded, and then the controller reads these data for position transformation calculation. Preferably, the step of obtaining the position and orientation correlation of each guide feature with respect to the guide fiducial marker is performed by the controller.

[0089] 2, the osteotomy guide 4 further includes an attachment interface 401, which is connected to the osteotomy guide block 40 by a connecting shaft and detachably connected to one end of the robot arm 2, thereby realizing the connection between the osteotomy guide 4 and the robot arm. It should be noted that the attachment interface 401 may be a flange disk, which is fixed to a flange provided at the end of the robot arm by a fastener such as a screw, a positioning pin, etc. In another embodiment, the attachment interface 401 may be a quick-change interface that can establish a quick-disconnect connection with the end of the robot arm 2 to enable quick attachment and detachment.

[0090] The osteotomy guide 4 further includes a connecting shaft, each of both ends of which is connected to the osteotomy guide block 40 and the mounting interface 401. As shown in FIG. 2, the connecting shaft is preferably an eccentric crank 403 that offsets the rotation axis of the mounting interface 401 (i.e., the spin rotation axis of the end joint of the robot arm) from the rotation axis of the osteotomy guide block 40. When the angle of the osteotomy guide 4 needs to be changed to allow cutting of other bone surfaces, it can be easily achieved by translating and rotating the robot arm 2 a small distance. Thus, it is possible to avoid the position and orientation identification error or failure that may be caused by the large rotation stroke of the guide reference marker 3, and the large rotation error of the robot arm that may be caused by excessive position and orientation changes, and the positioning accuracy of the osteotomy guide can be further improved. More preferably, the eccentric crank 403 is detachably connected to the osteotomy guide block 40. This allows different osteotomy guides to be guided by only replacing the osteotomy guide block instead of replacing the entire guide, which can reduce costs. Furthermore, the eccentric crank 403 may be coupled to the osteotomy guide block 40 by a quick-change interface. The present invention does not impose any limitations on the structure of the quick-change interface.

[0091] 2, in one embodiment, the osteotomy guide 4 further includes a holder 402 for mounting the guide reference marker 3, and the osteotomy guide block 40, the eccentric crank 403, the holder 402 and the mounting interface 401 are sequentially coupled in this order. In this embodiment, the holder 402 is provided with a reference marker mounting hole 4021, and the guide reference marker 3 is mounted in the reference marker mounting hole 4021. The number of the reference marker mounting holes 4021 may be two, but is not limited thereto.

[0092] As shown in Fig. 9, in another embodiment, the holder 402 can be omitted, and the bone cutting guide block 40, the eccentric crank 403 and the mounting interface 401 are sequentially connected in this order, and the guide reference marker 3 is directly attached to the outer shell of the terminal joint of the robot arm. This not only simplifies the structure of the bone cutting guide 4, but also allows the guide reference marker 3 to be separated from the surgical site, thereby preventing the reference marker from being accidentally touched during surgery and adversely affecting positioning performance. For example, the outer shell of the tip of the robot arm 2 is provided with a reference marker mounting hole 4021 for mounting the guide reference marker 3.

[0093] As shown in FIG. 2, to enable the osteotomy guide 4 to guide a variety of osteotomies, in accordance with a preferred embodiment of the present invention, the osteotomy guide block 40 includes the following guide features:

[0094] The guide features include a guide hole 404 for attachment of a femoral prosthesis, a osteotomy guide groove 405 for the right trochlear groove, a guide hole 406 for positioning of a tool for use with the left tibia, a first 0° guide groove 407, a first 45° guide groove 408, a second 45° guide groove 410, a second 0° guide groove 411, a osteotomy guide groove 412 for the left trochlear groove and a guide hole 413 for positioning of a tool for use with the right tibia.

[0095] In practical use, by simply adjusting the position and attitude of the osteotomy guide 4 via the robot arm 2, one osteotomy guide can support the osteotomy guidance and drilling operations such as distal femoral cutting, anterior femoral cutting, posterior femoral cutting, anterior femoral oblique cutting, posterior femoral oblique cutting, trochlear cutting, drilling holes for femoral artificial joint fixation studs, tibial plateau preparation and drilling positioning holes for tibial keel preparation tools. Therefore, osteotomy in total knee arthroplasty can be performed simply and conveniently, greatly shortening the operation time and improving the operation efficiency.

[0096] Furthermore, when using the bone cutting guide 4 according to this embodiment, as shown in Fig. 3, by simply translating the bone cutting guide 4 (moving it in the direction indicated by the arrow in Fig. 3) using the 0° guide grooves (407, 411) and 45° guide grooves (408, 410) provided in the bone cutting guide block 40, it is possible to realize operations for guiding bone cutting including anterior femur cutting, posterior femur cutting, anterior femur oblique cutting, and posterior femur oblique cutting. Therefore, since excessive changes in position and orientation of the guide reference marker 3 can be avoided, it is possible to reduce rotation errors of the robot arm 2 and position tracking errors of the reference markers, thereby improving positional accuracy.

[0097] Furthermore, in the bone cutting guide 4 according to the present embodiment, as shown in FIG. 4, an eccentric crank 403 is provided, so that there is an offset between the rotation center of the bone cutting guide block 40 and the rotation center of the mounting interface 401, and the rotation center of the bone cutting guide 40 is relatively close to the rotation center of the terminal joint of the robot arm (i.e., the offset is small), so that when the angle of the bone cutting guide 4 needs to be changed to enable cutting of other bone surfaces, it can be easily realized by translating and rotating the robot arm 2 by a small distance. More specifically, when the bone cutting guide 4 is located at the position indicated by L1, a distal cut (distal femoral cut) of the femur 12 can be realized using a surgical instrument (e.g., a hanging cross saw). Also, after the bone cutting guide 4 is rotated to the position indicated by L2, a front cut (anterior femoral cut) and a rear cut (posterior femoral cut) of the femur 12 as well as an anterior femoral oblique cut and a posterior femoral oblique cut can be realized using a surgical instrument. The amount of offset is determined according to factors such as the type of artificial joint used and the range of movement of the bone resection guide, and so the present invention does not place any restrictions on the amount of offset.

[0098] In order to further expand the range of artificial joints to which the osteotomy guide of the present invention can be applied, it is preferable that the 0° guide groove, the 45° guide groove, or both of them have a flared shape, as shown in Figure 5. With such a shape, a surgical instrument such as a hanging cross saw can be swung with a larger amplitude in the guide groove, and the guide can be adapted to a wider range of osteotomies required by different types of artificial joints.

[0099] Preferably, the orthopaedic surgery system further includes a verification device for identifying and confirming the degree of deformation of either or both of the osteotomy guide 4 and the guide fiducial marker 3. If significant deformation is confirmed, the osteotomy guide 4 and / or the guide fiducial marker 3 may be replaced with new ones, or the relative position between the osteotomy guide 4 and the guide fiducial marker 3 may be corrected. In the latter case, the original position and orientation of the osteotomy guide are updated with the corrected information, and the movement of the robot arm is controlled by the corrected position and orientation of the osteotomy guide.

[0100] As shown in FIG. 6 , the verification device includes at least one verification fiducial marker 16, which is detachably attached to the osteotomy guide block 40. For example, the osteotomy guide block 40 may be provided with at least one verification hole 409, and the verification fiducial marker 16 may be attached to each of the verification holes 409. The verification fiducial marker 16 may have a stepped surface extending parallel to the surface of the osteotomy guide block 40. In this embodiment, the stepped surface extends parallel to (including the fitting of) the upper surface of the osteotomy guide block 40, and each verification hole 409 is a through hole, preferably a through hole provided perpendicular to the upper surface of the osteotomy guide block 40.

[0101] To facilitate calculations, most or all of the guide features (e.g., guide grooves and guide holes) may be provided on the top surface of the osteotomy guide block 40. Furthermore, the axis of the verification holes 409 may be located in the symmetrical plane of the osteotomy guide block 40, and the end surface of each verification hole 409, the top surface of the osteotomy guide block, and the step surface may be coplanar, which may further facilitate calculations.

[0102] In a specific embodiment, the verification step first involves recording initial position information of the verification fiducial marker 16 (attached to the osteotomy guide block) relative to the guide fiducial marker 3 by the tracker 6 before delivery from the factory. Then, before each surgery, the tracker 6 records current position information of the verification fiducial marker 16 relative to the guide fiducial marker 3, and the controller compares the received current position information with the initial position information to determine whether or not they match. If they match, the controller determines that no deformation has occurred in either the osteotomy guide 4 or the guide fiducial marker 3, and if they do not match, the controller determines that deformation has occurred in either or both of the osteotomy guide 4 and the guide fiducial marker 3.

[0103] In this embodiment, the position information of the verification fiducial marker 16 relative to the guide fiducial marker 3 includes the position and orientation of the front end point of the verification fiducial marker in the guide fiducial marker coordinate system. As shown in FIG. 6, the front end point of the verification fiducial marker 16 may be the tip S of the verification fiducial marker 16. During use, if the controller determines that the current position information of the front end point of the verification fiducial marker does not match the initial information recorded before delivery from the factory, it determines that deformation has occurred in either one or both of the bone resection guide 4 and the guide fiducial marker 3. This is because if either the guide fiducial marker or the bone resection guide 4 is deformed, it will ultimately affect the verification hole 409, and the deformation of the verification hole 409 can be identified and confirmed by the verification fiducial marker.

[0104] Preferably, the orthopedic surgery system further includes a correction device. When the verification device identifies the deformation of at least one of the osteotomy guide 4 and the guide reference marker 3, the correction device corrects the relative position of the guide reference marker 3 and the osteotomy guide 4, and then, based on the corrected information, the controller updates the position and posture correlation between the osteotomy guide 4 and the guide reference marker 3. As shown in FIG. 7 and FIG. 8, the correction device includes at least two correction reference markers detachably attached to the osteotomy guide block 40. Furthermore, one or more of the correction reference markers may be selected as the verification reference marker 16. In this embodiment, two correction reference markers 161, 162 are provided to correct the position of the osteotomy guide 4 relative to the guide reference marker 3.

[0105] More specifically, in the correction process, first, the tracker 6 records position information of the two correction reference markers 161, 162 relative to the guide reference marker 3. Next, the controller calculates current position information of the bone resection guide 4 relative to the guide reference marker 3 based on the position information of the two correction reference markers 161, 162 relative to the guide reference marker 3, and updates the position-posture correspondence (correlation) between the bone resection guide 4 and the guide reference marker 3 based on the calculated information.

[0106] Position information of the correction reference marker 161 relative to the guide reference marker 3 can be represented by T1, and position information of the correction reference marker 162 relative to the guide reference marker 3 can be represented by T2. Here, T1 is the position of the correction reference marker 161 in the guide reference marker coordinate system, and T2 is the position of the correction reference marker 162 in the guide reference marker coordinate system.

[0107] In the present embodiment, in the correction step, the position information of the bone resection guide 4 with respect to the guide reference marker 3 is acquired by the following process.

[0108] First, based on the positions T1 and T1 of the two correction reference markers 161, 162 in the guide reference marker coordinate system, the controller calculates the position T0 of the center point of the bone cutting guide block 40 in the guide reference marker coordinate system and the position T3 of the surface of the bone cutting guide block 40 (the surface that coincides with the above-mentioned step surface, for example the upper surface) in the guide reference marker coordinate system.

[0109] Next, the controller determines the position and orientation of the bone resection guide 4 relative to the guide reference marker 3 based on the position T0 of the center point of the bone resection guide in the guide reference marker coordinate system and the position T3 of the surface of the bone resection guide in the guide reference marker coordinate system.

[0110] Subsequently, the initial position information recorded before delivery from the factory is updated with the corrected position and orientation of the bone cutting guide 4 relative to the guide reference marker 3, and during surgery, the position of the bone cutting guide is tracked and the motion of the robot arm is controlled using the corrected position information. In this way, accurate positioning of the bone cutting guide can be achieved. Preferably, the control device further includes a storage device for storing the position and orientation correlation between the bone cutting guide 4 and the guide reference marker 3. Furthermore, the navigation device may be integrated with the control device to form a navigation system.

[0111] As shown in FIG. 7, the bone cutting guide block 40 is provided with at least two correction holes. In another embodiment, the verification hole 409 may be one correction hole. In this embodiment, in addition to the verification hole 409, two correction holes, a first correction hole 414a and a second correction hole 414b, are provided. In the present invention, the positions of the correction holes are not particularly limited, and they may be provided on the same surface or different surfaces. Furthermore, two verification reference markers 16 (i.e., two correction reference markers) are provided in any two of the first correction hole 414a, the second correction hole 414b, and the verification hole 409, and the step surfaces of the two verification reference markers 16 are matched with the upper surface of the bone cutting guide, whereby the positions and orientations of the holes in which the two verification reference markers are located can be obtained, that is, the positions and orientations of the guide grooves and guide holes relative to the guide reference markers can be further calculated, whereby the relative positions of the guide reference markers and the guide are corrected. In another embodiment, the end surface of each correction hole, the upper surface of the bone cutting guide block and the step surface of the correction fiducial marker are provided on a common plane, which makes the calculation easier and improves the correction efficiency.

[0112] In this embodiment, the position of each correction reference marker in the guide reference marker coordinate system includes the position and orientation of the front end point of the correction reference marker in the guide reference marker coordinate system, and the position and orientation of the step surface of the correction reference marker in the guide reference marker coordinate system.

[0113] Furthermore, the bone cutting guide block 40 may be axially symmetrical to allow bone cutting of the left and right legs. In another embodiment, as shown in FIG. 10, two bone cutting guide blocks 41 and 42 may be provided, which are arranged as mirror images of each other. In this case, the bone cutting guide block 41 realizes bone cutting guidance for the left leg, and the bone cutting guide block 42 realizes bone cutting guidance for the right leg. To facilitate attachment and detachment, each bone cutting guide block may be connected to the eccentric crank 403 by a quick change interface. In this embodiment, the bone cutting guide block 41 is connected to the eccentric crank 403 by a quick change interface 415, and the bone cutting guide block 42 is connected to the eccentric crank 403 by a quick change interface 421. Note that the two quick change interfaces 415 and 421 may be arranged to correspond to each other in position, rather than being arranged as mirror images of each other.

[0114] As shown in FIG. 11, in another embodiment, only one osteotomy guide block 43 is provided, and the osteotomy guide block 43 is provided with two quick-change interfaces 431, 432 arranged on opposite sides. The eccentric crank 403 is selectively detachably connected to one of the quick-change interfaces 431, 432. By selectively connecting the eccentric crank 403 to each of the quick-change interfaces of the osteotomy guide block, osteotomy can be performed on any knee joint of the left or right leg. However, the present invention is not limited to the relative positions of the two quick-change interfaces 431, 432, and they may be arranged on opposite surfaces so that their axes are collinear. As yet another method, the osteotomy guide block 43 is provided with only one quick-change interface, and the osteotomy guide block 43 may be connected to the eccentric crank 403 by rotating it 180 degrees, and the osteotomy guide block 43 can be used for osteotomy of the left or right leg in the same manner. As described above, the osteotomy of the left and right legs can be realized by one osteotomy guide block or two osteotomy guide blocks, and the present invention is not limited thereto. Naturally, it is preferable to perform the osteotomy of the left and right legs by one osteotomy guide block. Taking the osteotomy of the left leg as an example, the osteotomy guide 4 of the present invention can provide guidance for the osteotomy of the tibial plateau as shown in FIG. 13, and can also provide guidance for the femoral cutting as shown in FIG. 14, so that there is no need to switch to another osteotomy guide during the operation, which improves the convenience and efficiency of the operation.

[0115] In this embodiment, the controller can provide a desired movement path defined by multiple position points, and by controlling the movement of the robot arm 2, drives the osteotomy guide 4 and the guide reference marker 3 to move so that the guide reference marker 3 reaches a desired position according to the desired movement path. This further improves the positioning accuracy. Furthermore, the controller obtains a desired movement path of the guide reference marker based on the current position and the desired position of the guide reference marker 3. The controller determines the desired position of the guide reference marker based on both the position and posture correlation between the guide reference marker and the osteotomy guide and the target position of the osteotomy guide.

[0116] More specifically, as shown in FIG. 12, before osteotomy is performed, the controller first obtains the current position A of the guide fiducial marker 3 based on the registration information of the robot arm 2 (including the position and posture correlation between the guide fiducial marker and the osteotomy guide), and then obtains the desired position B of the guide fiducial marker 3 based on the registration information of the patient's bone (for example, information obtained from a 3D digital knee joint model or a CT / MR scan image) and information on a suitable artificial joint. Then, by utilizing inverse kinematics, the controller plans the desired movement path of the guide fiducial marker 3 and controls the movement of the guide fiducial marker 3 by sending movement commands to different joints (sessions) of the robot arm to drive the joints to move. During the movement, the tracker 6 tracks the position (for example, A' and A'') of the guide fiducial marker 3 in real time and feeds it back to the controller. The controller calculates the deviation between the real-time position and the desired position, and based on that, updates the movement path of the guide fiducial marker 3, and finally controls the guide fiducial marker 3 to reach the desired position B, thereby realizing accurate positioning of the osteotomy guide 4.

[0117] Hereinafter, the guide features on the osteotomy guide block will be described in detail with specific examples.

[0118] As shown in FIG. 15, in the first embodiment, an osteotomy guide is provided that includes an osteotomy guide block 20 and is used for guiding distal femoral cutting and tibial plateau preparation. More specifically, the osteotomy guide block 20 has only one guide feature, a 0° guide groove 201, provided on the upper surface of the osteotomy guide block 20. The osteotomy guide can be rotated to switch between a distal femoral cutting mode and a tibial plateau preparation mode. In this specification, a "0° guide groove" refers to a groove that runs parallel to the side surface of the osteotomy guide block, i.e., at an angle of 0° to the side surface of the osteotomy guide block, for example, from the upper surface to the lower surface of the osteotomy guide block. Similarly, a "45° guide groove" refers to a groove that runs at an angle of 45° to the side surface of the osteotomy guide block, for example, from the upper surface to the lower surface of the osteotomy guide block.

[0119] As shown in FIG. 16, in the second embodiment, an osteotomy guide is provided which is used for guiding the distal femoral cut and tibial plateau preparation and includes an osteotomy guide block 21. The osteotomy guide block 21 has two guide features with 0° guide grooves 211 provided on different surfaces of the osteotomy guide block 21. For example, one may be provided on the upper surface and the other on a side surface adjacent to the upper surface. Since the two 0° guide grooves 211 are arranged around the rotation axis of the osteotomy guide block 21, the surgical instrument 5 can switch from the bone surface to be cut to the other bone surface by rotating at a small angle. Therefore, it is possible to avoid large identification errors that may occur when the movement stroke of the fiducial marker is large and large rotation errors that may occur due to excessive changes in the position and attitude of the robot arm.

[0120] 17, in the third embodiment, an osteotomy guide is provided which is used for guiding distal femoral resection, tibial plateau preparation, and trochlear groove cutting and includes an osteotomy guide block 22. Specifically, two trochlear cutting grooves 221 are added to the osteotomy guide block 21 of the second embodiment for trochlear groove cutting of the left and right legs, respectively.

[0121] 18, in the fourth embodiment, an osteotomy guide is provided which is used for guidance for distal femoral resection and tibial plateau preparation and includes an osteotomy guide block 23. Based on the osteotomy guide block 20 of the first embodiment, a number of guide holes 231 (e.g., two) are added which can be used for guidance for drilling mounting holes for the femoral prosthesis and tibial tool.

[0122] 19, in a fifth embodiment, an osteotomy guide is provided that includes an osteotomy guide block 24 that can be used to guide the distal femoral cut and tibial plateau preparation. In addition to the two guide grooves of the second embodiment, there are also guide holes 241 (e.g., two) that can be used to guide the drilling of mounting holes for the femoral prosthesis and tibial tool.

[0123] 20, in the sixth embodiment, in addition to the guide features of the third embodiment, an osteotomy guide is provided that further includes an osteotomy guide block 25 having a plurality of (e.g., two) guide holes 251. The osteotomy guide block 25 can be used for distal femoral resection, tibial plateau preparation, and trochlear resection, as well as for guidance in drilling mounting holes for femoral prostheses and tibial tools.

[0124] As shown in FIG. 21, in the seventh embodiment, an osteotomy guide is provided that includes an osteotomy guide block 26 further having a locating hole 261 in addition to other necessary guide features. Once the osteotomy guide is placed in position by the robot arm 2, a locating pin passes through the locating hole 261 in the osteotomy guide block 26 to secure the osteotomy guide to the bone. Thus, anterior femoral cut, anterior femoral oblique cut, posterior femoral cut, posterior femoral oblique cut and trochlear cut can be completed in one procedure. This can avoid the movement of the osteotomy guide during surgery due to lack of rigidity of the robot arm, thereby reducing guiding errors.

[0125] As shown in Fig. 22, the eighth embodiment provides an osteotomy guide including an osteotomy guide block 27 which is a variation of the fifth embodiment having two guide grooves and two guide holes. Specifically, the osteotomy guide block 27 includes a rectangular groove 272 used for guidance for cutting the trochlea, an elongated guide groove 273 used for guidance for cutting the other femoral and tibial surfaces, and a guide hole 271 used for guidance for drilling mounting holes for the femoral prosthesis and tibial tool.

[0126] As shown in FIG. 23, in a ninth embodiment, an osteotomy guide is provided, which includes an osteotomy guide block 28 having a guide groove with an opening 281 at one or both ends. The guide groove can be either a 0° or a 45° guide groove. The end opening 281 allows a surgical instrument 5, such as a hanging cross saw, to move within a larger range and shorten the length of the guide block, thereby lowering the requirement for application of the lesion and reducing damage to the patient's tissue. Here, the opening at the end refers to the guide groove penetrating from one or both ends to each side of the osteotomy guide block and having one or more open ends.

[0127] As shown in Fig. 24, the tenth embodiment provides a bone cutting guide including a bone cutting guide block 29, which is a tibial tool guide capable of automatically positioning a tibial tool, different from those in the above embodiments. As shown in Fig. 25, the eleventh embodiment provides a bone cutting guide including a bone cutting guide block 30, and differs from the above embodiments in that a trochlear cutting guide is used as the bone cutting guide block 30, realizing automatic positioning of the trochlear cutting guide.

[0128] Therefore, in various embodiments of the present invention, the osteotomy guide block may have different combinations of guide features as required by practical applications. In some embodiments, both guide grooves and holes may be provided on the osteotomy guide block, but the present invention does not limit the number or location of guide grooves on the osteotomy guide block. Similarly, the present invention does not limit the number or location of guide holes on the osteotomy guide block. The osteotomy guide block may also include a 0° guide groove, a 45° guide groove, and a trochlear cutting groove, or any combination thereof. Furthermore, the osteotomy guide block may include a femur prosthesis positioning guide hole, a left tibial tool positioning guide hole, a right tibial tool positioning guide hole, and an osteotomy guide fixation hole, or any combination thereof.

[0129] FIG. 26a shows a sterile bag 31 for use with a robotic arm. For clarity, only a portion of the sterile bag 31 is shown. The sterile bag 31 may be placed on the end of the robotic arm such that one end covers a connection port (e.g., a flange) of the robotic arm. The connection port may be removably connected to the osteotomy guide. In this way, the surgical site can be isolated to ensure a sterile surgical environment. Preferably, the end of the sterile bag 31 that is connected to the flange of the robotic arm is made of a material having a predetermined hardness, such as medical PEEK resin, and may be provided with through holes 311 through which respective fasteners 312 for locking the osteotomy guide, such as screws or positioning pins, can pass. The sterile bag 31 supports the attachment of surgical instruments and minimizes their exposure to non-sterile parts of the robotic arm.

[0130] According to an embodiment of the present invention, there is also provided a computer-readable storage medium having stored thereon instructions which, when executed by a processor, cause the controller to perform the steps of the processing method described above.

[0131] Although the preferred embodiment of the present invention has been described above, the scope of protection of the present invention is by no means limited to the above embodiment. For example, the present invention does not limit the number or type of guide features on the osteotomy guide block. When the orthopedic surgery system is used for other types of orthopedic surgery, other guides and holes may be included. Furthermore, the present invention does not limit the location of the verification hole, nor does it limit the location of the correction hole. Furthermore, in order to ensure accurate guidance and allow the thickness of the osteotomy guide block to be thin, the guide holes are preferably provided on the same surface of the osteotomy guide block. Furthermore, the fiducial marker is preferably an optical fiducial marker that can emit an optical signal.

[0132] The above description merely illustrates preferred embodiments of the present invention, and is not intended to limit the scope of the present invention in any way. All modifications and improvements made by those skilled in the art based on the above content are included within the scope of protection of the claims. [Explanation of symbols]

[0133] 1 surgical cart, 2 robotic arms, 3 Guide fiducial markers, 4 Osteotomy guide, 5 surgical instruments, 6 trackers, 7 Slave Monitor, 8 Master Monitor, 9 Navigation cart, 10 keyboards, 11 Femoral fiducial marker, 12 femur, 13 Tibial fiducial marker, 14 Tibia, 15 base fiducial markers, 16 Verification fiducial markers, 17 patients, 18 Doctor, 40, 41, 42, 43, 20, 21, 22, 23, 24 Osteotomy guide block, 401 mounting interface, 402 Holder, 4021 Reference marker mounting hole, 403 Eccentric crank, 404 Guide hole for mounting a femoral prosthesis; 405 Osteotomy guide groove for the trochlear groove of the right leg, 406 Guide hole for positioning the tool used on the left tibia, 407 First 0° guide groove, 408 First 45° guide groove, 409 Verification hole, 410 Second 45° guide groove, 411 Second 0° guide groove, 412 Osteotomy guide groove for the trochlear groove of the left leg, 413 Guide hole for positioning the tool used on the right leg tibia, 414a First correction hole, 414b Second correction hole, 415, 421, 431, 432 Quick Change Interface, 201, 211 0° guide groove, 221 Pulley cutting groove, 231, 241, 251, 271 Guide Hall, 261 Positioning hole, 272 rectangular groove, 273 Long and narrow guide groove, 281 End openings, 31 sterile bags, 311 Passing hole, 312 Fasteners.

Claims

1. 1. An orthopaedic surgical system comprising: a control device; a navigation device; a robotic arm; and an osteotomy guide, the osteotomy guide being attached to one end of the robotic arm, the robotic arm being configured to adjust a position and an orientation of the osteotomy guide, a navigation device including a tracker and a guide fiducial marker, the guide fiducial marker being attached to the osteotomy guide or the robotic arm, the tracker being configured to track a current position of the guide fiducial marker and generate information regarding the current position, the position of the guide fiducial marker being configured to characterize a position of the osteotomy guide; the control device is configured to control the movement of the robot arm based on both information regarding the current position of the guide reference marker fed back from the tracker and information regarding a desired position of the guide reference marker, thereby moving the osteotomy guide and the guide reference marker such that the guide reference marker reaches the desired position; a verification device configured to verify whether the osteotomy guide and / or the guide fiducial marker have been deformed; the osteotomy guide includes an osteotomy guide block having a plurality of guide features thereon to provide an osteotomy guide, and the verification device includes at least one verification fiducial marker configured to be removably attached to the osteotomy guide block; The tracker is configured to record initial position information of the verification fiducial marker relative to the guide fiducial marker before shipment from a factory, and to record current position information of the verification fiducial marker relative to the guide fiducial marker each time the tracker is used in surgery; The control device is configured to determine whether or not the initial position information of the verification fiducial marker and the current position information of the verification fiducial marker match, and if they match, determine that the bone resection guide and / or the guide fiducial marker are not deformed, and if they do not match, determine that the bone resection guide and / or the guide fiducial marker are deformed. Orthopedic surgery system.

2. The verification device further includes a correction device that corrects a position of the bone resection guide relative to the guide reference marker when the verification device determines that the bone resection guide and / or the guide reference marker has been deformed, and the correction device includes at least two correction reference markers configured to be detachably attached to the bone resection guide block, the tracker is configured to record position information of the at least two correction fiducial markers relative to the guide fiducial marker; The control device is configured to obtain information regarding a current position of the bone resection guide relative to the guide reference marker based on position information of the at least two correction reference markers relative to the guide reference marker, and to update a position of the bone resection guide relative to the guide reference marker using the obtained information regarding the current position. The orthopaedic surgical system of claim 1 .

3. The position information of the two correction reference markers relative to the guide reference marker is T 1 and T 2 and T 1 represents the position of one of the two correction fiducial markers in the coordinate system of the guide fiducial marker, and T 2 represents the position of the other of the two correction fiducial markers in the coordinate system of the guide fiducial marker, The control device calculates the position T of the center point of the bone resection guide block in the coordinate system of the guide reference marker. 0 and the position T of the surface of the osteotomy guide block in the coordinate system of the guide reference marker. 3 , the T in the coordinate system of the at least two correction reference markers. 1 and T 2 The position T of the center point of the bone resection guide block in the coordinate system of the guide reference marker is acquired based on the position information of 0 and the position T of the surface of the osteotomy guide block in the coordinate system of the guide reference marker. 3 and acquiring a position and orientation of the osteotomy guide relative to the guide reference marker based on the and / or and / or The position of each of the correction reference markers in the coordinate system of the guide reference marker is The position and orientation of the front end point of the correction reference marker in the coordinate system of the guide reference marker; and a position and orientation of the step surface of the correction reference marker in the coordinate system of the guide reference marker. The step surface is a step of the correction reference marker and is parallel to a surface of the bone resection guide block. The orthopaedic surgical system of claim 2 .

4. the navigation device further comprises a base reference marker that is maintained stationary, the position of the guide reference marker being relative to the position of the base reference marker; and / or the control device is configured to provide a desired path of travel defined by a plurality of positioning points and to control the robot arm such that the guide reference marker reaches the desired position along the desired path of travel. The orthopaedic surgical system of claim 1 .

5. The orthopaedic surgical system of claim 1 , further comprising a memory device for storing position and orientation correlation between the guide fiducial marker and the osteotomy guide.

6. 6. The orthopaedic surgical system of claim 5, wherein the osteotomy guide comprises an osteotomy guide block having a plurality of guide features thereon for providing a plurality of osteotomy guidance modes, and the position and orientation correlation between the guide reference marker and the osteotomy guide comprises a position and orientation correlation between the guide features and the guide reference marker.

7. Obtaining position and orientation correlations between each of the guide features and the guide fiducial markers includes: determining a relative positional relationship between fiducial marker balls on the guide fiducial marker and establishing a coordinate system for the guide fiducial marker based on the relative positional relationship; determining position information of a center point of the osteotomy guide block in a coordinate system of the guide fiducial marker; determining a position and orientation of the guide feature in the coordinate system of the guide reference marker based on both position information of the guide feature relative to the center point of the osteotomy guide block and position information of the center point of the osteotomy guide block in the coordinate system of the guide reference marker; The orthopaedic surgical system of claim 6, further comprising:

8. 2. The orthopaedic surgical system of claim 1, wherein the osteotomy guide block includes at least one verification hole therein into which a respective verification fiducial marker is attached, and each verification fiducial marker has a stepped surface parallel to a surface of the osteotomy guide block.

9. the osteotomy guide block has a top surface on which the guide features are provided, the verification hole is provided perpendicular to the top surface, and the step surface is coincident with the top surface; and / or The bone cutting guide block is provided with a correction hole, and two correction reference markers are fixed to the correction holes, respectively, or two correction reference markers are fixed to one verification hole and the correction hole, respectively. The orthopaedic surgical system of claim 8 .

10. The orthopaedic surgical system of claim 9, wherein an axis of the verification hole is located within a symmetry plane of the osteotomy guide block, and an end face of the verification hole, an upper surface of the osteotomy guide block, and the step surface are on the same plane.

11. The bone cutting guide block is provided with a correction hole, and two correction reference markers are fixed to the correction hole, respectively, or two correction reference markers are fixed to one verification hole and the correction hole, respectively; The orthopaedic surgical system of claim 8 , wherein each correction hole has an end surface that is coplanar with both a surface of the osteotomy guide block and a step surface of each correction fiducial marker.

12. 2. The orthopaedic surgical system of claim 1, wherein the osteotomy guide comprises an osteotomy guide block and a mounting interface, the mounting interface coupled to the osteotomy guide block by a connecting shaft, the osteotomy guide block comprising a plurality of guide features thereon for providing the osteotomy guide, and the mounting interface removably attached to an end of the robotic arm.

13. 13. The orthopaedic surgical system of claim 12, wherein the connecting shaft is an eccentric crank that is connected to both the osteotomy guide block and the mounting interface such that an axis of rotation of the osteotomy guide block is offset from an axis of rotation of the osteotomy guide block.

14. The osteotomy guide further comprises a holder, and the osteotomy guide block, the eccentric crank, the holder and the mounting interface are sequentially coupled in this order, and the holder comprises a fiducial marker mounting hole therein; and / or The bone cutting guide block is detachably attached to the eccentric crank. The orthopaedic surgical system of claim 13 .

15. The orthopaedic surgical system of claim 12, wherein the guide features include a plurality of guide grooves disposed on a single surface of the osteotomy guide block or on different surfaces about an axis of the osteotomy guide block.

16. The osteotomy guide comprises two osteotomy guide blocks arranged in a mirror image of one another, each having an attachment interface thereon configured to releasably connect with the eccentric crank; or The osteotomy guide comprises an osteotomy guide block having two mounting interfaces disposed opposite each other on the osteotomy guide block, and the eccentric crank is selectively detachably connected to one of the mounting interfaces. The orthopaedic surgical system of claim 13 .

17. 2. The orthopaedic surgical system of claim 1, further comprising a sterile bag disposed at an end of the robotic arm and covering a connection port of the robotic arm, the connection port being detachably connected to the osteotomy guide.

18. The orthopaedic surgical system of claim 17 , wherein the sterile bag is perforated at one end thereof.

19. 10. An osteotomy guide for use in an orthopaedic surgical system according to claim 1, comprising: The osteotomy guide comprises an osteotomy guide block, a connecting shaft and a mounting interface, the osteotomy guide block comprises a plurality of guide features thereon for providing a plurality of osteotomy guidance modes, both ends of the connecting shaft are connected to both the osteotomy guide block and the mounting interface, and the mounting interface is configured to be removably coupled to one end of a robotic arm; The bone cutting guide is characterized by the above.

20. The guide features include guide grooves and guide holes; and / or The connecting shaft is an eccentric crank.

20. The osteotomy guide according to claim 19.

21. Each guide channel has an end opening that extends through a surface of the osteotomy guide block; and / or each guide groove is flared; and / or A plurality of guide grooves are arranged on different surfaces around the axis of the bone cutting guide block. The osteotomy guide according to claim 20 .

22. The guide groove includes at least one of a 0° guide groove, a 45° guide groove, and a trochlear cutting guide groove, and the guide hole includes at least one of a guide hole for attaching a femur prosthesis, a guide hole for positioning a left tibia tool, a guide hole for positioning a right tibia tool, and a fixing hole for a bone cutting guide; or The guide grooves include two 0° guide grooves, two 45° guide grooves and two pulley cutting guide grooves; The osteotomy guide according to claim 20 .

23. The osteotomy guide block has an axisymmetric structure, and / or The osteotomy guide block has a verification hole and / or a correction hole therein.

20. The osteotomy guide according to claim 19.

Citation Information

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