WO2022040952A1 - Motion axis positioner for artificial knee replacement - Google Patents

Motion axis positioner for artificial knee replacement Download PDF

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Publication number
WO2022040952A1
WO2022040952A1 PCT/CN2020/111205 CN2020111205W WO2022040952A1 WO 2022040952 A1 WO2022040952 A1 WO 2022040952A1 CN 2020111205 W CN2020111205 W CN 2020111205W WO 2022040952 A1 WO2022040952 A1 WO 2022040952A1
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WIPO (PCT)
Prior art keywords
connecting body
spoon
arms
axis
artificial knee
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PCT/CN2020/111205
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French (fr)
Chinese (zh)
Inventor
王志坚
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王志坚
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Priority to PCT/CN2020/111205 priority Critical patent/WO2022040952A1/en
Publication of WO2022040952A1 publication Critical patent/WO2022040952A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/14Surgical saws ; Accessories therefor
    • A61B17/15Guides therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor

Definitions

  • the present invention relates to an apparatus for artificial knee joint replacement, in particular to a motion axis locator for artificial knee joint replacement.
  • a current total knee arthroplasty (Total Knee Arthroplasty, TKA)
  • TKA Total Knee Arthroplasty
  • the surgical procedure is to firstly replace the proximal tibia (Proximal Tibial) and the distal femur (Distal Femur) for trimming, followed by re-implantation of the artificial joint and cushion.
  • the proximal tibia and distal femur cannot be recovered after surgical trimming and resection.
  • the artificial joint cannot cooperate with the patient's native skeleton after surgery and has good adaptability. Therefore, how to correct the proximal tibia and distal femur in a correct way?
  • the repair of the femur is one of the important topics in knee replacement surgery.
  • an existing method is the so-called Mechanical Alignment (MA).
  • MA Mechanical Alignment
  • the line is used as a reference axis, which can generally be obtained through X-ray fluoroscopy.
  • the proximal tibia and distal femur can be cut through the mechanical axis to cut out the vertical joint surface, and then implant the artificial joint and the pad to complete the artificial joint replacement.
  • the articular surfaces of the patient's original proximal tibia and distal femur are no longer perpendicular to the mechanical axis.
  • the articular surfaces that are perpendicular to the mechanical axis are obtained surgically through the aforementioned mechanical axis calibration for artificial joint replacement.
  • the articular surfaces can be restored after surgery It is perpendicular to the mechanical axis, but the collateral ligament on the narrow side before correction must be pulled apart during the operation so that the so-called "knee varus" or "knee valgus" deformity can be corrected. It causes relaxation, which leads to the instability of the knee joint and the sequelae of walking weakness and pain.
  • KA Kinematic Alignment
  • condyle femur is the reference axis that rolls relative to the Tibial Plateau as the lower extremity flexes.
  • the difference from the aforementioned mechanical axis-aligned knee replacement surgery is that if the knee replacement surgery is performed according to the motion axis alignment, the articular surfaces of the proximal tibia and distal femur after correction will almost overlap with the articular surfaces before the correction, that is, The original angle of the tibia and femur is still maintained after the operation, and the collateral ligaments on both sides of the knee do not need to be pulled apart during the operation. Therefore, compared with the knee replacement surgery with mechanical axis alignment, the collateral ligaments will not be loosened. Sequelae of knee joint weakness and pain.
  • the "movement axis" is a virtual imaginary axis rather than measurable with the naked eye.
  • One of the existing ways to find the motion axis is to measure the upper and lower positions of the patient's femur and tibia through images, and to use the dynamic motion of the lower limb to swing. The process is calculated and modeled, and a humanized surgical tool (Personal Specific Instrument, PSI), and finally apply this personalized surgical tool for knee replacement surgery with motion axis alignment.
  • PSI Personal Specific Instrument
  • the current practice is to perform image measurement and computational modeling, and then send the modeling-related data to Singapore for certification. It is produced by a mold factory in Belgium. This certification and production process takes two weeks to a month to complete, and the production cost is expensive, resulting in a time-consuming, labor-intensive and costly knee replacement surgery using motion axis alignment. high.
  • the present invention provides a motion axis locator for artificial knee joint replacement, which can assist the surgeon in positioning the motion axis before the articular surfaces of the proximal tibia and the distal femur are trimmed.
  • An embodiment of the present invention provides a motion axis locator for artificial knee joint replacement, which includes two spoon arms and a connecting body.
  • the two spoon arms of the guiding cutting member are symmetrically arranged on the connecting body of the guiding cutting member
  • the two spoon arms of the guiding cutting member are arc-shaped respectively to correspond to the curvature of the medial and lateral femoral condyles of the human body on the sagittal plane, the two spoon arms of the guiding cutting member can be placed along the sagittal axis into the proximal tibia and the proximal tibia.
  • the medial and lateral condyles are respectively clamped against the two spoon arms of the guiding cutting member on the tibial plateau with corresponding curvatures, and the guiding and cutting members are connected
  • the body naturally locates a reference axis according to the position where the two spoon arms of the guiding cutting member are clamped, and the reference axis of the guiding cutting member is parallel to the movement axis of the relative pivoting of the medial condyle and the lateral condyle on the tibial platform,
  • the articular surface between the proximal tibia and the distal femur is trimmed according to the reference axis of the guide cutter.
  • the connecting body is elongated and extends along a straight line
  • the two spoon arms include a fixed spoon arm and a movable spoon arm
  • the fixed spoon arm is integrally formed at one end of the connecting body;
  • the connecting body slides in the longitudinal direction, and is fixed to the connecting body after adjusting the distance between the movable arm and the fixed arm.
  • the movable spoon arm has one end, and the end has a chute, the inner contour of the chute corresponds to the cross-sectional contour of the connecting body, and the end is slidable along the length direction by the connecting body being sleeved on the chute.
  • the connecting body has a guide groove on the side away from the two spoon arms, the guide groove is opened along the length direction of the connecting body, and the end part has a convex part corresponding to the guide groove in the chute, and the end part is parallel to the guide groove.
  • a pressing piece is arranged on the side away from the convex portion.
  • the pressing member is a bolt
  • the end corresponding to the pressing member is provided with a screw hole
  • the pressing member is screwed in the screw hole, and can be screwed to abut against the connecting body and clamp the end portion of the convex portion in the connection. body.
  • the connecting body has a handle portion, the handle portion is extended and the extension direction is perpendicular to the linear extending direction of the connecting body, and the handle portion is opposite to the direction in which the two spoon arms extend from the connecting body, and the handle portion is located at the two ends.
  • the curvature radius of each spoon body is 17mm to 29mm.
  • the guide cutting member has a sleeve opening and a fixing portion, the sleeve opening is located above the fixing portion, and the guiding cutting member has a sleeve between the sleeve opening and the fixing portion.
  • Long slit when the connecting body is naturally positioned to the reference axis as described above, the handle is sleeved on the sleeve with a corresponding thickness, and is fixed to the proximal tibia at the location by the fixing part, and the length direction of the long slit is parallel to the reference axis , for the cutting tool to extend into the long slit and trim the tibial plateau along the reference axis.
  • the guiding cutting member has an installation groove between the sleeve opening and the fixing portion, and the side edge of the installation groove close to the guiding cutting member is open, the guiding cutting member has a piece, and the block has a long slit. and the open side of the block body is assembled in the installation groove and positioned in the installation groove.
  • the width direction of the long slit on the block is inclined from high to low from the side of the connecting body with the handle to the side of the two spoon arms.
  • the fixing part has a plurality of perforations, and a bone screw for surgery can be pierced through one of the perforations, and the fixing part is locked at an appropriate position of the proximal tibia.
  • the motion axis locator for artificial knee arthroplasty of the present invention is a simple-structured and easy-to-operate surgical aid.
  • the reference axis is compared, and then the articular surface modification of the proximal tibia and the distal femur can be carried out, and it has been clinically proven to be as accurate as the articular surface modification of the proximal tibia and the distal femur using a personalized surgical tool, and the operation is easy.
  • Simple and easy to implement to achieve the effect of saving time and money for computational model verification and mold opening.
  • FIG. 1 is a three-dimensional combined view of a motion axis positioner according to an embodiment of the present invention
  • FIG. 2 is an exploded configuration diagram of a motion axis positioner according to an embodiment of the present invention
  • Fig. 3 is the side sectional view of Fig. 1 as seen on the 3-3 section line;
  • FIG. 4 is a schematic side view of the motion axis locator according to the embodiment of the present invention with two spoon arms inserted into the knee joint along the sagittal axis;
  • FIG. 5 is a schematic front view of the motion axis locator according to the embodiment of the present invention, and two spoon arms are inserted into the knee joint along the sagittal axis;
  • FIG. 6 is a schematic front view of FIG. 5 after the guide cutting member is installed on the handle;
  • FIG. 7 is a schematic view of the guide cutting member of FIG. 6 being fixed to the proximal tibia with bone screws;
  • Figure 8 is a schematic view of the proximal tibia corrected to remove the tibial plateau.
  • Bone screw K motion axis
  • T proximal tibia
  • X reference axis
  • Y sagittal axis
  • the motion shaft positioner 100 mainly includes two spoon arms 10, 20 and a connecting body 30, and in a preferred embodiment, also includes a guiding cutting member 40, wherein:
  • the two spoon arms 10 and 20 are symmetrical in shape and are respectively curved and similar to the spoon shape.
  • the curved shapes of the two spoon arms 10 and 20 correspond to the curvature of the human femoral medial and lateral condyles on the sagittal plane.
  • each of the spoon arms 10 and 20 is flat and has a smooth surface, and each of the spoon arms 10 and 20 respectively has side walls 11 and 21 on both sides of the middle part, and the two side walls 11 of the spoon arm 10 are symmetrical.
  • the side walls 21 of the spoon arm 20 are also symmetrically arranged, and the top edges of the side walls 11 and 21 are flat.
  • the connecting body 30 is provided with two spoon arms 10 and 20 on the same side.
  • the connecting body 30 is elongated and extends along a straight line, and is a long rectangular block. The sides are respectively planar along the extending direction of the straight line.
  • the spoon arm 10 is a fixed spoon arm in this embodiment, and the other spoon arm 20 is a movable spoon arm in this embodiment.
  • the spoon arm 10 is integrally formed at one end of the connecting body 30;
  • the connecting body 30 can slide along the length direction of the connecting body 30 to adjust the distance between the spoon arm 20 and the spoon arm 10 , and then the spoon arm 20 can be fixed on the connecting body 30 .
  • the spoon arm 20 has one end 22 , and the end 22 has a chute 23 , the inner contour of the chute 23 corresponds to the cross-sectional profile of the connecting body 30 , and the end 22 of the spoon arm 20 is set through the chute 23 .
  • the connecting body 30 is provided so that the spoon arm 20 can slide along the length direction of the connecting body 30 .
  • the curved curvature radius R of the spoon arm 20 is 17mm to 29mm, so as to adapt to the different curvatures of the medial and lateral femoral condyles on the sagittal plane, and when the knee joint performs the straightening-bending movement, it naturally reflects the different curvatures.
  • the motion axis when the medial and lateral femoral condyles rotate like a sphere, and the radius of curvature R of the two spoon arms 20 in this embodiment is both 25mm.
  • the two spoon arms 20 of the present embodiment correspond to the positions of the curvature of the medial and lateral femoral condyles on the sagittal plane, and the thickness t thereof is both 1 mm.
  • the connecting body 30 of this embodiment has a guide groove 31 on the side away from the two spoon arms 10 and 20.
  • the guide groove 31 is also opened along the length direction of the connecting body 30, that is, the guide groove 31 penetrates the connecting body
  • the end 22 of the spoon arm 20 has a convex portion 24 in the chute 23, and the convex portion 24 is provided corresponding to the guide groove 31;
  • the end portion 22 has a protruding portion 24 to fit with the guide groove 31 of the connecting body 30 , which is only an implementation state of the present invention.
  • the guide grooves 31 can be arranged on the end portion 22 , and can also achieve a restricting effect when the end portion 22 slides on the connecting body 30 .
  • the pressing member 25 is a bolt in this embodiment
  • the end 22 is provided with a screw hole 221 corresponding to the pressing member 25, and the pressing member 25 is screwed into the screw hole 221 and can be screwed to the connecting body 30.
  • the pressing member 25 is linked with the convex portion 24 to clamp the end portion 22 to the connecting body 30 , so that the fixed spoon arm 20 is fixed on the connecting body 30 . fixed on.
  • the connecting body 30 has a handle portion 32, and the extension direction of the handle portion 32 is perpendicular to the linear extending direction of the connecting body 30 (that is, the handle portion 32 and the connecting body 30 are connected in a T shape), and the handle portion 32 Contrary to the direction in which the two spoon arms 10 and 20 extend from the connecting body 30 , the handle 32 in this embodiment extends from the side of the connecting body 30 with the guide groove 31 , and the handle 32 is located on the two spoon arms 10 and 20 . In between, the handle 32 can be held by the operator.
  • the motion axis locator 100 of the above-mentioned embodiment taking the left foot as an example, when the patient cuts the skin and flesh tissue at the knee joint, and the joint parts of the proximal tibia T and the distal femur F are visible, the two are moved together.
  • the spoon arms 10 and 20 are placed between the proximal tibia T and the distal femur F along the sagittal axis Y (as shown in FIG. 4 ).
  • the collateral ligament and cruciate ligament are restrained, the proximal tibia T and the distal femur F will maintain an opposite tensile force, and the two spoon arms 10, 20 can be maintained between the tibial plateau P and the medial condyle IC and lateral condyle OC of the femur contact, and make the medial condyle IC and lateral condyle OC clamp the two spoon arms 10, 20 against the tibial plateau P (as shown in FIG. 5) with corresponding curvatures, and as the two spoon arms 10, 20 are The horizontal direction is parallel or there is a difference in height.
  • the connecting body 30 will naturally locate a reference axis X according to the position where the two spoon arms 10 and 20 are clamped.
  • This reference axis X is related to the inner condyle IC and the outer condyle OC.
  • the relative pivoting motion axis K (see FIG. 8 ) of the tibial plateau P is nearly parallel, and the articular surface between the proximal tibia T and the distal femur F can be trimmed according to the reference axis X at this time.
  • the present invention further includes a guiding cutting member 40 to assist the tibia Trim of Platform P.
  • the guiding cutting member 40 has a sleeve opening 41 and a fixing portion 42 , the sleeve opening 41 is opposite to the position of the guiding cutting member 40 , and the fixing portion 42 is located at the position of the guiding cutting member 40 .
  • the guiding cutting member 40 has a long slit 43 between the sleeve opening 41 and the fixing portion 42 .
  • the guiding cutting member 40 has an installation groove 44 between the sleeve opening 41 and the fixing portion 42 , and one side of the installation groove 44 close to the guiding cutting member 40 is open.
  • the block 45 is provided with a long slit 43 .
  • the block 45 is assembled in the mounting groove 44 from the open side of the mounting groove 44 , so that the block 45 is positioned in the mounting groove 44 .
  • the fixing portion 42 has a plurality of through holes 421 , and each through hole 421 can be passed through by the bone screw 50 for surgery, so as to lock the fixing portion 42 in the proper position of the proximal tibia T.
  • the long slit 43 is provided on the block 45, which is inclined from high to low from the side with the handle 32 of the connecting body 30 to the side with the two spoon arms 10 and 20 (as shown in FIG. 3 ).
  • the blocks 45 can be separated and reassembled on the guide cutting member 40, the long slits 43 of the blocks 45 can be designed with different inclinations, and the blocks with different inclinations of the long slits 43 can be selected according to the actual situation. 45 is assembled on the guiding cutting member 40, which is beneficial to the smooth progress of artificial joint replacement.
  • the handle 32 corresponds to the position of the connecting body 30 .
  • the handle 32 can be sleeved in the sleeve 41 of the guide cutting member 40 with a corresponding thickness (as shown in FIG. 6 ), and the guide cutting member 40 can be inserted along the handle 32 And approach the proximal tibia T, and then use the bone screw 50 to select a suitable through hole 421 to pass through and lock it on the proximal tibia T (as shown in FIG.
  • the fixed portion 42 of the guiding cutting member 40 can be positioned at the location. It is fixed on the proximal tibia T, and the long slit 43 on the block 45 is parallel to the reference axis X in the length direction, and the cutting tool (not shown in the figure) can extend into the long slit 43 and along the reference axis X
  • the tibial plateau P is removed to complete the articular surface modification between the proximal tibia T and the distal femur F.
  • the proximal tibia T is corrected and the tibial plateau is removed, it can be obtained parallel to the motion axis K (ie the reference axis X). slice.
  • the motion axis locator 100 for artificial knee replacement of the present invention is only composed of two spoon arms 10, 20 and a connecting body 30, which is a simple and convenient structure. It is a simple and easy-to-operate surgical aid, and before the articular surface of the proximal tibia and the distal femur is trimmed, the two spoon arms 10 and 20 can be clamped against the tibial plateau P with the corresponding curvature through the medial condyle IC and the lateral condyle OC respectively.
  • a reference axis X which is compared with the motion axis, can be located, and the articular surface modification of the proximal tibia T and the distal femur F can be successively performed.
  • the result is as accurate as the articular surface trimming of the distal femur, and there is no problem of having to repeat the correction during the resection process to achieve balance. Even if the surgeon is not an experienced surgeon, it can be easily positioned by the motion axis locator 100 of the present invention.
  • the reference axis X of the motion axis is compared, thereby achieving the effect of saving time and money for computational model verification and mold opening.

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Abstract

A motion axis positioner (10) for an artificial knee replacement, comprising two spoon arms (10, 20) and a connecting body (30); the two spoon arms (10, 20) can be placed between the proximal tibia (T) and the distal femur (F); in addition, the proximal tibia (T) and the distal femur (F) are restrained by a ligament (L), so that the inner condyle (IC) and the outer condyle (OC) of the femur clamp against the two spoon arms (10, 20) on the tibial plateau (P) at corresponding curvatures; the connecting body (30) naturally positions a reference axis (X) according to the positions of the two spoon arms (10, 20) when clamped, the reference axis (X) is approximately parallel to a motion axis (K) about which the inner condyle (IC) and the outer condyle (OC) pivot relative to one another on the tibial plateau (P), and articular surface trimming is carried out between the proximal tibia (T) and the distal femur (F) according to the reference axis (X).

Description

人工膝关节置换术的运动轴定位器Motion axis locator for artificial knee arthroplasty 技术领域technical field
本发明关于一种人工膝关节置换术的器械,尤指一种人工膝关节置换术的运动轴定位器。The present invention relates to an apparatus for artificial knee joint replacement, in particular to a motion axis locator for artificial knee joint replacement.
背景技术Background technique
人体骨胳中的众多关节,处于下肢的膝关节所承受的重量重且频繁磨擦,所以膝关节在经年累月的使用下必然造成磨损,此时疼痛随之而来,且当磨损严重时,则会导致行动不便而有着生活上的困扰,此时就必须通过手术置换人工关节来加以改善。There are many joints in the human skeleton, and the knee joint in the lower limb bears heavy weight and frequent friction, so the knee joint will inevitably cause wear and tear after years of use, and pain will follow at this time, and when the wear and tear is serious, it will be It leads to inconvenience of movement and has troubles in life. At this time, it must be improved by surgical replacement of artificial joints.
目前现行的一种全膝关节置换手术(Total Knee Arthroplasty , TKA) ,其手术过程是先对近端胫骨(Proximal Tibial)与远端股骨(Distal Femur)进行修整,接着再植入人工关节以及垫体。其中,近端胫骨与远端股骨经手术修整而切除后就无法复原,人工关节在手术后不能配合患者原生骨胳而具有良好的适应性,因此如何以正确的方式对近端胫骨与远端股骨进行修整,即为膝关节置换手术重要课题之一。A current total knee arthroplasty (Total Knee Arthroplasty, TKA), the surgical procedure is to firstly replace the proximal tibia (Proximal Tibial) and the distal femur (Distal Femur) for trimming, followed by re-implantation of the artificial joint and cushion. Among them, the proximal tibia and distal femur cannot be recovered after surgical trimming and resection. The artificial joint cannot cooperate with the patient's native skeleton after surgery and has good adaptability. Therefore, how to correct the proximal tibia and distal femur in a correct way? The repair of the femur is one of the important topics in knee replacement surgery.
技术问题technical problem
关于进行近端胫骨与远端股骨的修整,一种现有方式即所谓机械轴校准(Mechanical Alignment,MA),所称机械轴以股骨头旋转中心通过近端胫骨中心至内外踝中点的连线作为参考轴,一般可通过X光透视而获得,近端胫骨与远端股骨可分别通过所述机械轴而切出垂直的关节面,接着植入人工关节以及垫体,以完成人工关节置换。然而在临床上发现,对比人口普查占比,符合机械轴设定的下肢者不到2%,许多患者常见有所谓不同程度的“膝内翻”或“膝外翻”的畸形现象,此时患者的原近端胫骨与远端股骨的关节面与所述机械轴已非垂直,经前述机械轴校准而手术获得垂直机械轴的关节面以进行人工关节置换,虽手术后的关节面可回复与机械轴垂直,但矫正前位于窄侧的副韧带在手术过程中必须拉开,才能使所谓“膝内翻”或“膝外翻”的畸形现象获得矫正,但副韧带因被拉开而造成松弛,而导致膝关节不稳而产生走路无力与疼痛的后遗症。Regarding the trimming of the proximal tibia and the distal femur, an existing method is the so-called Mechanical Alignment (MA). The line is used as a reference axis, which can generally be obtained through X-ray fluoroscopy. The proximal tibia and distal femur can be cut through the mechanical axis to cut out the vertical joint surface, and then implant the artificial joint and the pad to complete the artificial joint replacement. . However, it is clinically found that, compared with the proportion of the census, less than 2% of the lower limbs conform to the mechanical axis setting. Many patients often have the so-called "knee varus" or "knee valgus" deformity of different degrees. At this time The articular surfaces of the patient's original proximal tibia and distal femur are no longer perpendicular to the mechanical axis. The articular surfaces that are perpendicular to the mechanical axis are obtained surgically through the aforementioned mechanical axis calibration for artificial joint replacement. Although the articular surfaces can be restored after surgery It is perpendicular to the mechanical axis, but the collateral ligament on the narrow side before correction must be pulled apart during the operation so that the so-called "knee varus" or "knee valgus" deformity can be corrected. It causes relaxation, which leads to the instability of the knee joint and the sequelae of walking weakness and pain.
另一种现有修整近端胫骨与远端股骨的方式,即所谓运动轴对准(Kinematic Alignment,KA),所谓运动轴是股骨内/外髁(Medial/ Lateral condyle femur)随下肢弯曲时相对于胫骨平台(Tibial Plateau)翻转的参考轴。与前述机械轴校准的膝关节置换手术的不同在于,若依运动轴校准进行膝关节置换手术,经修正后近端胫骨与远端股骨的关节面将与修整前的关节面几近重叠,即手术后仍维持胫骨与股骨原本的角度,膝关节两侧的副韧带在手术过程中不需要被拉开,故相对于机械轴校准的膝关节置换手术而言,不会造成副韧带松弛而导致膝关节走路无力与疼痛的后遗症。Another existing way of trimming the proximal tibia and the distal femur is the so-called Kinematic Alignment (KA). condyle femur) is the reference axis that rolls relative to the Tibial Plateau as the lower extremity flexes. The difference from the aforementioned mechanical axis-aligned knee replacement surgery is that if the knee replacement surgery is performed according to the motion axis alignment, the articular surfaces of the proximal tibia and distal femur after correction will almost overlap with the articular surfaces before the correction, that is, The original angle of the tibia and femur is still maintained after the operation, and the collateral ligaments on both sides of the knee do not need to be pulled apart during the operation. Therefore, compared with the knee replacement surgery with mechanical axis alignment, the collateral ligaments will not be loosened. Sequelae of knee joint weakness and pain.
所述“运动轴”,其为一虚拟的假想轴线而非肉眼可测,现有的一种寻找运动轴的方式,为通过影像量测患者股骨与胫骨的上下位置,并通过下肢摆动的动态过程进行计算后建模,再建立一个人化手术工具(Personal Specific Instrument,PSI),最后套用该个人化手术工具进行运动轴对准的膝关节置换手术。然而,若要取得所述个人化手术工具进行膝关节置换手术,目前作法是经影像量测并计算建模后,再将建模的相关数据送至新加坡进行认证,而在认证后再由位于比利时的模具工厂开模制作而得,此认证及制作过程需要耗费两个星期至一个月才能完成,且制作成本要价不菲,导致应用运动轴对准的膝关节置换手术耗时费工且成本高。The "movement axis" is a virtual imaginary axis rather than measurable with the naked eye. One of the existing ways to find the motion axis is to measure the upper and lower positions of the patient's femur and tibia through images, and to use the dynamic motion of the lower limb to swing. The process is calculated and modeled, and a humanized surgical tool (Personal Specific Instrument, PSI), and finally apply this personalized surgical tool for knee replacement surgery with motion axis alignment. However, in order to obtain the personalized surgical tool for knee replacement surgery, the current practice is to perform image measurement and computational modeling, and then send the modeling-related data to Singapore for certification. It is produced by a mold factory in Belgium. This certification and production process takes two weeks to a month to complete, and the production cost is expensive, resulting in a time-consuming, labor-intensive and costly knee replacement surgery using motion axis alignment. high.
又如美国公告第US08900242B2发明专利案,提出了一种针笔组件(Stylus Assembly),主要在于利用一端部抵靠未磨损的股骨后髁而提供定位的参考表面,再依据所述参考表面进行近端胫骨的切除,该发明专利的针笔组件仍是以机械轴对准为原则的工具设计。该案利用多个针笔组件,且各针笔组件的端部具有不同厚度(如1~3mm)的设计,以对应不同关节面磨损后因内侧副韧带变松,而用以撑开膝关节的髁骨而恢复内侧副韧带至正常的紧度,实务上并非用来定位运动轴;且在临床上操作发现,如前述端部所抵靠的若是未磨损侧的股骨外髁,且通过其提供定位的参考表面进行近端胫骨的切除,容易导致对已磨损的胫骨内髁切除不足;反之,前述端部所抵靠的若是已磨损侧的股骨内髁,则容易导致对未磨损的胫骨外髁切除太多,因此必须在切除过程反复修正才能达到平衡,故而造成在膝关节面修整上的不便与困扰。Another example is the US Bulletin No. US08900242B2 Invention Patent, which proposes a stylus pen assembly (Stylus Assembly), mainly using one end against the unworn posterior condyle of the femur to provide a reference surface for positioning, and then resection of the proximal tibia is performed according to the reference surface. The needle and pen assembly of the invention patent is still aligned with the mechanical axis Designed for principled tools. In this case, multiple needle-pen assemblies are used, and the ends of the needle-pen assemblies are designed with different thicknesses (such as 1-3mm), so that the medial collateral ligament becomes loose after different articular surfaces are worn and used to stretch the knee joint. It is not used to locate the motion axis in practice, and it is found in clinical operations that, as the aforementioned end abuts on the lateral femoral condyle on the unworn side, and through its Provide a reference surface for positioning for proximal tibia resection, which may easily lead to insufficient resection of the worn tibial medial condyle; on the contrary, if the aforesaid end abuts against the worn side femoral medial condyle, it will easily lead to insufficient resection of the unworn tibial condyle. There are too many lateral condyle resections, so it is necessary to repeat the resection process to achieve a balance, which causes inconvenience and trouble in the repair of the knee joint surface.
技术解决方案technical solutions
为解决上述课题,本发明提供一种人工膝关节置换术的运动轴定位器,以在近端胫骨与远端股骨的关节面修整前,辅助手术医师进行运动轴定位。In order to solve the above problem, the present invention provides a motion axis locator for artificial knee joint replacement, which can assist the surgeon in positioning the motion axis before the articular surfaces of the proximal tibia and the distal femur are trimmed.
本发明的一项实施例提供一种人工膝关节置换术的运动轴定位器,其包括两个勺臂及一连结体,导引切割件两个勺臂对称设在导引切割件连结体的同一侧,且导引切割件两个勺臂分别呈弯弧状以对应人体股骨内髁和外髁在矢球面的曲率,导引切割件两个勺臂可沿矢状轴置入近端胫骨与远端股骨之间,且近端胫骨与远端股骨受韧带牵制,使所述内髁和外髁分别以对应曲率夹抵导引切割件两个勺臂于胫骨平台上,导引切割件连结体依导引切割件两个勺臂受夹抵时的所在位置自然定位一参考轴,导引切割件参考轴与所述内髁和外髁在所述胫骨平台相对枢转的运动轴平行,依导引切割件参考轴进行近端胫骨与远端股骨间的关节面修整。An embodiment of the present invention provides a motion axis locator for artificial knee joint replacement, which includes two spoon arms and a connecting body. The two spoon arms of the guiding cutting member are symmetrically arranged on the connecting body of the guiding cutting member On the same side, and the two spoon arms of the guiding cutting member are arc-shaped respectively to correspond to the curvature of the medial and lateral femoral condyles of the human body on the sagittal plane, the two spoon arms of the guiding cutting member can be placed along the sagittal axis into the proximal tibia and the proximal tibia. Between the distal femurs, and the proximal tibia and distal femur are restrained by ligaments, the medial and lateral condyles are respectively clamped against the two spoon arms of the guiding cutting member on the tibial plateau with corresponding curvatures, and the guiding and cutting members are connected The body naturally locates a reference axis according to the position where the two spoon arms of the guiding cutting member are clamped, and the reference axis of the guiding cutting member is parallel to the movement axis of the relative pivoting of the medial condyle and the lateral condyle on the tibial platform, The articular surface between the proximal tibia and the distal femur is trimmed according to the reference axis of the guide cutter.
较佳地,连结体呈长形且沿直线延伸,两个勺臂包括一固定勺臂及一活动勺臂,固定勺臂一体成型于连结体的一端;活动勺臂设于连结体而可沿连结体的长度方向滑动,在调整活动勺臂与固定勺臂的间距后固定于连结体。Preferably, the connecting body is elongated and extends along a straight line, the two spoon arms include a fixed spoon arm and a movable spoon arm, the fixed spoon arm is integrally formed at one end of the connecting body; The connecting body slides in the longitudinal direction, and is fixed to the connecting body after adjusting the distance between the movable arm and the fixed arm.
较佳地,活动勺臂具有一端部,端部具有一滑槽,滑槽的内轮廓对应连结体的断面轮廓,端部通过滑槽套设连结体而可沿所述长度方向滑动。Preferably, the movable spoon arm has one end, and the end has a chute, the inner contour of the chute corresponds to the cross-sectional contour of the connecting body, and the end is slidable along the length direction by the connecting body being sleeved on the chute.
较佳地,连结体在远离两个勺臂的一侧具有一导沟,导沟沿连结体的长度方向开设,端部在滑槽中具有一对应导沟而设的凸部,端部并在远离所述凸部的一侧设有一迫紧件,端部通过滑槽套设在连结体且凸部位于导沟内时,锁紧迫紧件与凸部夹掣连结体而定位。Preferably, the connecting body has a guide groove on the side away from the two spoon arms, the guide groove is opened along the length direction of the connecting body, and the end part has a convex part corresponding to the guide groove in the chute, and the end part is parallel to the guide groove. A pressing piece is arranged on the side away from the convex portion. When the end is sleeved on the connecting body through the chute and the convex portion is located in the guide groove, the pressing piece and the convex portion are clamped and positioned by locking the connecting body.
较佳地,迫紧件为一螺栓,端部对应迫紧件设有一螺孔,迫紧件旋设于螺孔中,且可旋至与连结体相抵而与凸部夹掣端部于连结体。Preferably, the pressing member is a bolt, the end corresponding to the pressing member is provided with a screw hole, the pressing member is screwed in the screw hole, and can be screwed to abut against the connecting body and clamp the end portion of the convex portion in the connection. body.
较佳地,连结体具有一柄部,柄部延伸设置且延伸方向与连结体的直线延伸方向垂直,且柄部与两个勺臂从连结体伸设的方向相反,柄部并位于两个勺臂之间;各勺体呈弯弧状的曲率半径为17mm至29mm。Preferably, the connecting body has a handle portion, the handle portion is extended and the extension direction is perpendicular to the linear extending direction of the connecting body, and the handle portion is opposite to the direction in which the two spoon arms extend from the connecting body, and the handle portion is located at the two ends. Between the spoon arms; the curvature radius of each spoon body is 17mm to 29mm.
较佳地,还包括一导引切割件,导引切割件具有一套口以及一固定部,该套口位于该固定部的上方,且导引切割件在套口和固定部之间具有一长狭缝,连结体如前述自然定位出参考轴时,柄部以对应的厚度套接于套口,且通过固定部固定于所在位置的近端胫骨,长狭缝的长度方向与参考轴平行,供切割刀具伸入长狭缝且沿参考轴而修整所述胫骨平台。Preferably, it also includes a guide cutting member, the guide cutting member has a sleeve opening and a fixing portion, the sleeve opening is located above the fixing portion, and the guiding cutting member has a sleeve between the sleeve opening and the fixing portion. Long slit, when the connecting body is naturally positioned to the reference axis as described above, the handle is sleeved on the sleeve with a corresponding thickness, and is fixed to the proximal tibia at the location by the fixing part, and the length direction of the long slit is parallel to the reference axis , for the cutting tool to extend into the long slit and trim the tibial plateau along the reference axis.
较佳地,导引切割件在套口和固定部之间具有一安装槽,安装槽靠近导引切割件的一侧边呈开放状,导引切割件具有一块体,块体具有长狭缝,块体自安装槽呈开放状的侧边组设于安装槽内且定位。Preferably, the guiding cutting member has an installation groove between the sleeve opening and the fixing portion, and the side edge of the installation groove close to the guiding cutting member is open, the guiding cutting member has a piece, and the block has a long slit. and the open side of the block body is assembled in the installation groove and positioned in the installation groove.
较佳地,长狭缝在块体上的宽度方向,从连结体有柄部的一侧往有两个勺臂的一侧由高至低而倾斜。Preferably, the width direction of the long slit on the block is inclined from high to low from the side of the connecting body with the handle to the side of the two spoon arms.
较佳地,固定部具有多个穿孔,供手术用的骨螺钉可择一所述穿孔穿设,并将该固定部在所述近端胫骨的适当位置锁紧。Preferably, the fixing part has a plurality of perforations, and a bone screw for surgery can be pierced through one of the perforations, and the fixing part is locked at an appropriate position of the proximal tibia.
借此,本发明的人工膝关节置换术的运动轴定位器为一结构简单及操作简易的手术辅助器具,在近端胫骨与远端股骨的关节面修整前,可通过其定位与运动轴的参考轴比较,之后即可进行近端胫骨与远端股骨的关节面修整,且经临床实验证实与使用个人化手术工具进行近端胫骨与远端股骨的关节面修整结果同样精确,且操作上简单易行,以达到节省运算模型验证及开模所耗费的时间和金钱的功效。Thereby, the motion axis locator for artificial knee arthroplasty of the present invention is a simple-structured and easy-to-operate surgical aid. The reference axis is compared, and then the articular surface modification of the proximal tibia and the distal femur can be carried out, and it has been clinically proven to be as accurate as the articular surface modification of the proximal tibia and the distal femur using a personalized surgical tool, and the operation is easy. Simple and easy to implement, to achieve the effect of saving time and money for computational model verification and mold opening.
附图说明Description of drawings
下面结合附图和具体实施方式对本发明作进一步详细的说明;The present invention will be described in further detail below in conjunction with the accompanying drawings and specific embodiments;
图1为本发明实施例的运动轴定位器立体组合图;1 is a three-dimensional combined view of a motion axis positioner according to an embodiment of the present invention;
图2为本发明实施例的运动轴定位器分解配置图;2 is an exploded configuration diagram of a motion axis positioner according to an embodiment of the present invention;
图3为图1在3-3剖线所见的侧面剖视图;Fig. 3 is the side sectional view of Fig. 1 as seen on the 3-3 section line;
图4为本发明实施例的运动轴定位器以两个勺臂沿矢状轴置入膝关节的侧视示意图;4 is a schematic side view of the motion axis locator according to the embodiment of the present invention with two spoon arms inserted into the knee joint along the sagittal axis;
图5为本发明实施例的运动轴定位器以两个勺臂沿矢状轴置入膝关节的前视示意图;5 is a schematic front view of the motion axis locator according to the embodiment of the present invention, and two spoon arms are inserted into the knee joint along the sagittal axis;
图6为图5在柄部装设导引切割件后的前视示意图;FIG. 6 is a schematic front view of FIG. 5 after the guide cutting member is installed on the handle;
图7为图6的导引切割件以骨螺钉固定于近端胫骨的示意图;7 is a schematic view of the guide cutting member of FIG. 6 being fixed to the proximal tibia with bone screws;
图8为近端胫骨经修正切除胫骨平台的示意图。Figure 8 is a schematic view of the proximal tibia corrected to remove the tibial plateau.
附图标记说明Description of reference numerals
100:运动轴定位器     10:勺臂100: Motion axis locator 10: Spoon arm
11:侧墙              20:勺臂11: side wall 20: Spoon Arm
21:侧墙              22:端部21: Side Wall 22: End
221:螺孔             23:滑槽221: screw hole 23: Chute
24:凸部              25:迫紧件24: convex part 25: Pressing parts
30:连结体             31:导沟30:Connector 31: Guide ditch
32:柄部              40:导引切割件32: Handle 40: Guide cutting pieces
41:套口              42:固定部41: mouthpiece 42: Fixed part
421:穿孔             43:长狭缝421: Piercing 43: Long slit
44:安装槽            45:块体44: Installation slot 45: Block
50:骨螺钉           K:运动轴50: Bone screw K: motion axis
F:远端股骨           IC:内髁F: Distal femur IC: medial condyle
L:韧带               OC:外髁L: ligament OC: Lateral Condyle
P:胫骨平台           T:近端胫骨P: tibial plateau T: proximal tibia
X:参考轴            Y:矢状轴X: reference axis Y: sagittal axis
R:曲率半径            t:厚度。R: radius of curvature t: thickness.
本发明的最佳实施方式BEST MODE FOR CARRYING OUT THE INVENTION
为便于说明本发明在上述发明内容一栏中所表示的中心思想,现以具体实施例表达。实施例中各种不同物件按适于说明的比例、尺寸、变形量或位移量而描绘,而非按实际元件的比例予以绘制。In order to facilitate the description of the central idea of the present invention expressed in the column of the above-mentioned summary of the invention, it is now expressed with specific embodiments. The various objects in the embodiments are drawn in proportions, dimensions, deformations or displacements suitable for illustration, rather than to the scale of the actual elements.
请参阅图1至图8所示,本发明提供一种人工膝关节置换术的运动轴定位器100,用于人工膝关节置换术时定位运动轴,此运动轴的定义已于先前技术清楚描述,于此不再另行赘述。所述运动轴定位器100,主要包括两个勺臂10、20及一连结体30,且在一较佳实施例中还包括一导引切割件40,其中:Please refer to FIGS. 1 to 8 , the present invention provides a motion axis locator 100 for artificial knee joint replacement, which is used for positioning the motion axis during artificial knee replacement. The definition of the motion axis has been clearly described in the prior art , and will not be repeated here. The motion shaft positioner 100 mainly includes two spoon arms 10, 20 and a connecting body 30, and in a preferred embodiment, also includes a guiding cutting member 40, wherein:
所述两个勺臂10、20,形状对称而分别呈弯弧状,与勺形状相似,两个勺臂10、20所述的弯弧状对应人体股骨内髁和外髁在矢球面的曲率。在本实施例中,各勺臂10、20呈扁平状且表面光滑,且各勺臂10、20在中间部位的两侧分别具一侧墙11、21,勺臂10的两侧墙11对称而设,勺臂20的两侧墙21也对称而设,且各侧墙11、21顶缘呈平整状。所述连结体30,在同一侧设两个勺臂10、20,此连结体30于本实施例中呈长形且沿直线延伸,而呈一长矩形块,连结体30于宽度方向的两侧分别沿所述直线延伸方向而呈平面状。The two spoon arms 10 and 20 are symmetrical in shape and are respectively curved and similar to the spoon shape. The curved shapes of the two spoon arms 10 and 20 correspond to the curvature of the human femoral medial and lateral condyles on the sagittal plane. In this embodiment, each of the spoon arms 10 and 20 is flat and has a smooth surface, and each of the spoon arms 10 and 20 respectively has side walls 11 and 21 on both sides of the middle part, and the two side walls 11 of the spoon arm 10 are symmetrical. In addition, the side walls 21 of the spoon arm 20 are also symmetrically arranged, and the top edges of the side walls 11 and 21 are flat. The connecting body 30 is provided with two spoon arms 10 and 20 on the same side. In this embodiment, the connecting body 30 is elongated and extends along a straight line, and is a long rectangular block. The sides are respectively planar along the extending direction of the straight line.
所述勺臂10于本实施例中为一固定勺臂,而另一勺臂20于本实施例中为一活动勺臂,勺臂10一体成型于连结体30的一端;勺臂20设于连结体30而可沿连结体30的长度方向滑动,以调整勺臂20与勺臂10的间距后,勺臂20可固定于连结体30。较佳地,勺臂20具有一端部22,此端部22中具有一滑槽23,滑槽23的内轮廓与连结体30的断面轮廓对应,勺臂20的端部22通过滑槽23套设连结体30,使勺臂20可沿连结体30的长度方向滑动。所述勺臂20呈弯弧状的曲率半径R为17mm至29mm,以适用所述股骨内髁和外髁在矢球面的不同曲率,而在膝关节执行伸直-弯曲运动时,自然反映出不同股骨内髁和外髁如球体般转动时的运动轴,而本实施例中的两个勺臂20的曲率半径R皆为25mm。此外,本实施例的两个勺臂20对应所述股骨内髁和外髁在矢球面的曲率的部位,其厚度t皆为1mm。The spoon arm 10 is a fixed spoon arm in this embodiment, and the other spoon arm 20 is a movable spoon arm in this embodiment. The spoon arm 10 is integrally formed at one end of the connecting body 30; The connecting body 30 can slide along the length direction of the connecting body 30 to adjust the distance between the spoon arm 20 and the spoon arm 10 , and then the spoon arm 20 can be fixed on the connecting body 30 . Preferably, the spoon arm 20 has one end 22 , and the end 22 has a chute 23 , the inner contour of the chute 23 corresponds to the cross-sectional profile of the connecting body 30 , and the end 22 of the spoon arm 20 is set through the chute 23 . The connecting body 30 is provided so that the spoon arm 20 can slide along the length direction of the connecting body 30 . The curved curvature radius R of the spoon arm 20 is 17mm to 29mm, so as to adapt to the different curvatures of the medial and lateral femoral condyles on the sagittal plane, and when the knee joint performs the straightening-bending movement, it naturally reflects the different curvatures. The motion axis when the medial and lateral femoral condyles rotate like a sphere, and the radius of curvature R of the two spoon arms 20 in this embodiment is both 25mm. In addition, the two spoon arms 20 of the present embodiment correspond to the positions of the curvature of the medial and lateral femoral condyles on the sagittal plane, and the thickness t thereof is both 1 mm.
承上,本实施例的连结体30在远离两个勺臂10、20的一侧具有一导沟31,此导沟31也是沿着连结体30的长度方向开设,即导沟31贯穿连结体30的两端,勺臂20的端部22在滑槽23中具有一凸部24,此凸部24是对应导沟31而设;端部22在远离凸部24的一侧设有一迫紧件25,端部22通过滑槽23套设在连结体30且凸部24位在导沟31内时,操作者可通过迫紧件25的锁紧,而以迫紧件25与导沟31内的凸部24夹掣于连结体30而定位。所述端部22具有凸部24而与连结体30的导沟31配合,仅为本发明的一种实施状态,在不同实施例中,所述凸部24亦可设在连结体30,而导沟31则可设在端部22,亦可达到端部22于连结体30上滑动时的限制作用。On the other hand, the connecting body 30 of this embodiment has a guide groove 31 on the side away from the two spoon arms 10 and 20. The guide groove 31 is also opened along the length direction of the connecting body 30, that is, the guide groove 31 penetrates the connecting body At both ends of 30, the end 22 of the spoon arm 20 has a convex portion 24 in the chute 23, and the convex portion 24 is provided corresponding to the guide groove 31; When the end part 22 is sleeved on the connecting body 30 through the sliding groove 23 and the convex part 24 is located in the guide groove 31, the operator can lock the pressing part 25 to connect the pressing part 25 with the guide groove 31. The inner convex portion 24 is clamped and positioned by the connecting body 30 . The end portion 22 has a protruding portion 24 to fit with the guide groove 31 of the connecting body 30 , which is only an implementation state of the present invention. The guide grooves 31 can be arranged on the end portion 22 , and can also achieve a restricting effect when the end portion 22 slides on the connecting body 30 .
较佳地,迫紧件25于本实施例中为一螺栓,端部22对应迫紧件25设有一螺孔221,迫紧件25旋设于螺孔221中而可旋至与连结体30相抵,而当迫紧件25于螺孔221中旋至一定深度时,将迫紧件25连动凸部24而使端部22夹掣于连结体30,使固定勺臂20在连结体30上固定。此外,本实施例中连结体30具有一柄部32,此柄部32的延伸方向与连结体30的直线延伸方向垂直(即柄部32和连结体30呈T形相连),且柄部32与两个勺臂10、20从连结体30伸设的方向相反,本实施例的柄部32从连结体30有导沟31的一侧伸设,柄部32位于两个勺臂10、20之间,此柄部32可供操作者握持。Preferably, the pressing member 25 is a bolt in this embodiment, the end 22 is provided with a screw hole 221 corresponding to the pressing member 25, and the pressing member 25 is screwed into the screw hole 221 and can be screwed to the connecting body 30. When the pressing member 25 is screwed to a certain depth in the screw hole 221 , the pressing member 25 is linked with the convex portion 24 to clamp the end portion 22 to the connecting body 30 , so that the fixed spoon arm 20 is fixed on the connecting body 30 . fixed on. In addition, in this embodiment, the connecting body 30 has a handle portion 32, and the extension direction of the handle portion 32 is perpendicular to the linear extending direction of the connecting body 30 (that is, the handle portion 32 and the connecting body 30 are connected in a T shape), and the handle portion 32 Contrary to the direction in which the two spoon arms 10 and 20 extend from the connecting body 30 , the handle 32 in this embodiment extends from the side of the connecting body 30 with the guide groove 31 , and the handle 32 is located on the two spoon arms 10 and 20 . In between, the handle 32 can be held by the operator.
上述实施例的运动轴定位器100于实际操作时,以左脚为例,是在患者切开膝关节处的皮肉组织,而可见近端胫骨T与远端股骨F的关节部位时,将两个勺臂10、20沿矢状轴Y置入近端胫骨T与远端股骨F之间(如图4所示),此时由于近端胫骨T与远端股骨F受韧带L(包括外侧副韧带以及十字韧带)牵制,近端胫骨T与远端股骨F会维持一相向的拉力,两个勺臂10、20即可在胫骨平台P与股骨的内髁IC和外髁OC之间保持接触,且使所述内髁IC和外髁OC分别以对应曲率将两个勺臂10、20夹抵于胫骨平台P(如图5所示),而随着两个勺臂10、20在水平方向呈平行或有高低差,此时连结体30会依着两个勺臂10、20受夹抵时的所在位置自然定位一参考轴X,此参考轴X与内髁IC和外髁OC于胫骨平台P相对枢转的运动轴K(请参阅图8)接近平行,此时便可依参考轴X进行近端胫骨T与远端股骨F间的关节面修整。In the actual operation of the motion axis locator 100 of the above-mentioned embodiment, taking the left foot as an example, when the patient cuts the skin and flesh tissue at the knee joint, and the joint parts of the proximal tibia T and the distal femur F are visible, the two are moved together. The spoon arms 10 and 20 are placed between the proximal tibia T and the distal femur F along the sagittal axis Y (as shown in FIG. 4 ). The collateral ligament and cruciate ligament) are restrained, the proximal tibia T and the distal femur F will maintain an opposite tensile force, and the two spoon arms 10, 20 can be maintained between the tibial plateau P and the medial condyle IC and lateral condyle OC of the femur contact, and make the medial condyle IC and lateral condyle OC clamp the two spoon arms 10, 20 against the tibial plateau P (as shown in FIG. 5) with corresponding curvatures, and as the two spoon arms 10, 20 are The horizontal direction is parallel or there is a difference in height. At this time, the connecting body 30 will naturally locate a reference axis X according to the position where the two spoon arms 10 and 20 are clamped. This reference axis X is related to the inner condyle IC and the outer condyle OC. The relative pivoting motion axis K (see FIG. 8 ) of the tibial plateau P is nearly parallel, and the articular surface between the proximal tibia T and the distal femur F can be trimmed according to the reference axis X at this time.
为配合上述实施例的运动轴定位器100实施人工膝关节置换术,在上述连结体30定位出参考轴X后,本发明在一较佳实施例中进一步包括导引切割件40,以辅助胫骨平台P的修整。所述导引切割件40,其具有一套口41以及一固定部42,所述套口41于导引切割件40的位置相对在上,而固定部42于导引切割件40的位置则相对在下,且导引切割件40在套口41和固定部42之间具有一长狭缝43。In order to cooperate with the motion axis locator 100 of the above embodiment to perform artificial knee joint replacement, after the above-mentioned connecting body 30 locates the reference axis X, in a preferred embodiment of the present invention, the present invention further includes a guiding cutting member 40 to assist the tibia Trim of Platform P. The guiding cutting member 40 has a sleeve opening 41 and a fixing portion 42 , the sleeve opening 41 is opposite to the position of the guiding cutting member 40 , and the fixing portion 42 is located at the position of the guiding cutting member 40 . Opposite to the bottom, the guiding cutting member 40 has a long slit 43 between the sleeve opening 41 and the fixing portion 42 .
较佳地,导引切割件40在套口41和固定部42之间具有一安装槽44,此安装槽44靠近导引切割件40的一侧边呈开放状,导引切割件40设置有一块体45,块体45上设置有长狭缝43,块体45从安装槽44呈开放状的侧边组设于安装槽44内,使块体45在安装槽44定位。Preferably, the guiding cutting member 40 has an installation groove 44 between the sleeve opening 41 and the fixing portion 42 , and one side of the installation groove 44 close to the guiding cutting member 40 is open. The block 45 is provided with a long slit 43 . The block 45 is assembled in the mounting groove 44 from the open side of the mounting groove 44 , so that the block 45 is positioned in the mounting groove 44 .
承上,所述固定部42具有多个穿孔421,各穿孔421皆可供手术用的骨螺钉50穿设,从而将固定部42锁固在所述近端胫骨T的适当位置。并且,长狭缝43设置在块体45上,从连结体30有柄部32的一侧向有两个勺臂10、20的一侧由高至低而倾斜(如图3所示),且因块体45可在导引切割件40上分离再组装,因此块体45的长狭缝43可设计不同的倾斜度,而可依实际情况选择不同倾斜度的长狭缝43的块体45组装在导引切割件40,有利于人工关节置换术顺利进行。On top of that, the fixing portion 42 has a plurality of through holes 421 , and each through hole 421 can be passed through by the bone screw 50 for surgery, so as to lock the fixing portion 42 in the proper position of the proximal tibia T. In addition, the long slit 43 is provided on the block 45, which is inclined from high to low from the side with the handle 32 of the connecting body 30 to the side with the two spoon arms 10 and 20 (as shown in FIG. 3 ). And because the blocks 45 can be separated and reassembled on the guide cutting member 40, the long slits 43 of the blocks 45 can be designed with different inclinations, and the blocks with different inclinations of the long slits 43 can be selected according to the actual situation. 45 is assembled on the guiding cutting member 40, which is beneficial to the smooth progress of artificial joint replacement.
接续前述运动轴定位器100的实际操作,在于连结体30依着两个勺臂10、20受夹抵时的所在位置自然定位出参考轴X时,柄部32对应连结体30的所在位置而伸出于外,此时即可将柄部32以对应的厚度套接在导引切割件40的套口41 内(如图6所示),并且将导引切割件40沿着柄部32而靠向近端胫骨T,再以骨螺钉50选择适合的穿孔421穿设并锁于近端胫骨T(如图7所示),即可将导引切割件40的固定部42在所在位置固定于近端胫骨T上,而在块体45上的长狭缝43在长度方向上平行于参考轴X,切割刀具(图中未示)可伸入长狭缝43,且沿参考轴X而切除胫骨平台P,便可完成近端胫骨T与远端股骨F间的关节面修整,此时近端胫骨T经修正切除胫骨平台后,可获得与运动轴K(即参考轴X)平行的切面。Continuing the actual operation of the aforementioned motion axis positioner 100 , when the connecting body 30 naturally locates the reference axis X according to the position where the two spoon arms 10 and 20 are clamped, the handle 32 corresponds to the position of the connecting body 30 . At this time, the handle 32 can be sleeved in the sleeve 41 of the guide cutting member 40 with a corresponding thickness (as shown in FIG. 6 ), and the guide cutting member 40 can be inserted along the handle 32 And approach the proximal tibia T, and then use the bone screw 50 to select a suitable through hole 421 to pass through and lock it on the proximal tibia T (as shown in FIG. 7 ), so that the fixed portion 42 of the guiding cutting member 40 can be positioned at the location. It is fixed on the proximal tibia T, and the long slit 43 on the block 45 is parallel to the reference axis X in the length direction, and the cutting tool (not shown in the figure) can extend into the long slit 43 and along the reference axis X The tibial plateau P is removed to complete the articular surface modification between the proximal tibia T and the distal femur F. At this time, after the proximal tibia T is corrected and the tibial plateau is removed, it can be obtained parallel to the motion axis K (ie the reference axis X). slice.
由上述的说明不难发现本发明的特点在于,本发明的人工膝关节置换术的运动轴定位器100仅由两个勺臂10、20以及连结体30即可构成,实为一结构简单及操作简易的手术辅助器具,而在近端胫骨与远端股骨的关节面修整前,可通过内髁IC和外髁OC分别以对应曲率将两个勺臂10、20夹抵于胫骨平台P,即可定位出一比照运动轴的参考轴X,便可接续进行近端胫骨T与远端股骨F的关节面修整,且经临床实验证实,与先前技术中使用个人化手术工具进行近端胫骨与远端股骨的关节面修整结果同样精确,而且不会有必须在切除过程反复修正才能达到平衡的问题,即使不是经验丰富的外科医生,也可通过本发明的运动轴定位器100简单定位出比照运动轴的参考轴X,借此达到节省运算模型验证及开模所耗费的时间和金钱的功效。From the above description, it is not difficult to find that the present invention is characterized in that the motion axis locator 100 for artificial knee replacement of the present invention is only composed of two spoon arms 10, 20 and a connecting body 30, which is a simple and convenient structure. It is a simple and easy-to-operate surgical aid, and before the articular surface of the proximal tibia and the distal femur is trimmed, the two spoon arms 10 and 20 can be clamped against the tibial plateau P with the corresponding curvature through the medial condyle IC and the lateral condyle OC respectively. A reference axis X, which is compared with the motion axis, can be located, and the articular surface modification of the proximal tibia T and the distal femur F can be successively performed. The result is as accurate as the articular surface trimming of the distal femur, and there is no problem of having to repeat the correction during the resection process to achieve balance. Even if the surgeon is not an experienced surgeon, it can be easily positioned by the motion axis locator 100 of the present invention. The reference axis X of the motion axis is compared, thereby achieving the effect of saving time and money for computational model verification and mold opening.
以上所举实施例仅用来说明本发明而已,非用来限制本发明的范围。凡不违本发明精神所从事的种种修改或变化,均属于本发明保护的范畴。The above-mentioned embodiments are only used to illustrate the present invention, but not to limit the scope of the present invention. All modifications or changes that do not violate the spirit of the present invention belong to the protection scope of the present invention.

Claims (10)

  1. 一种人工膝关节置换术的运动轴定位器,其特征在于,其包括两个勺臂及一连结体,该两个勺臂设在该连结体的同一侧,且该两个勺臂形状对称而分别呈弯弧状以对应人体股骨内髁和外髁在矢球面的曲率,该两个勺臂沿矢状轴置入近端胫骨与远端股骨之间,且近端胫骨与远端股骨受韧带牵制,使所述内髁和外髁分别以对应曲率夹抵该两个勺臂于胫骨平台,该连结体依该两个勺臂受夹抵时的所在位置定位一参考轴,该参考轴与所述内髁和外髁在胫骨平台相对枢转的运动轴平行,依该参考轴进行近端胫骨与远端股骨间的关节面修整。A motion axis locator for artificial knee arthroplasty, characterized in that it comprises two spoon arms and a connecting body, the two spoon arms are arranged on the same side of the connecting body, and the two spoon arms are symmetrical in shape The two spoon arms are respectively curved to correspond to the curvature of the human femoral medial and lateral condyles on the sagittal plane. The two spoon arms are placed between the proximal tibia and the distal femur along the sagittal axis, and the proximal tibia and the distal femur are affected by The ligament is restrained, so that the medial condyle and the lateral condyle are respectively clamped against the two spoon arms on the tibial plateau with corresponding curvature, and the connecting body is positioned according to the position of the two spoon arms when they are clamped. A reference axis, the reference axis Parallel to the movement axis of the relative pivoting of the medial and lateral condyles on the tibial plateau, the articular surface between the proximal tibia and the distal femur is trimmed according to the reference axis.
  2. 如权利要求1所述的人工膝关节置换术的运动轴定位器,其特征在于,该连结体呈长形且沿直线延伸,该两个勺臂包括一固定勺臂及一活动勺臂,该固定勺臂一体成型于该连结体的一端;该活动勺臂设于该连结体而沿该连结体的长度方向滑动,在调整该活动勺臂与该固定勺臂的间距后固定于该连结体。The motion axis locator for artificial knee arthroplasty as claimed in claim 1, wherein the connecting body is elongated and extends along a straight line, the two spoon arms comprise a fixed spoon arm and a movable spoon arm, the The fixed scoop arm is integrally formed at one end of the connecting body; the movable scoop arm is arranged on the connecting body and slides along the length direction of the connecting body, and is fixed to the connecting body after adjusting the distance between the movable scoop arm and the fixed scoop arm .
  3. 如权利要求2所述的人工膝关节置换术的运动轴定位器,其特征在于,该活动勺臂具有一端部,该端部具有一滑槽,该滑槽的内轮廓对应该连结体的断面轮廓,该端部通过该滑槽套设该连结体而沿所述长度方向滑动。The motion shaft positioner for artificial knee arthroplasty as claimed in claim 2, wherein the movable spoon arm has one end, the end has a chute, and the inner contour of the chute corresponds to the cross section of the connecting body The end portion slides along the length direction through the sliding groove sleeved on the connecting body.
  4. 如权利要求3所述的人工膝关节置换术的运动轴定位器,其特征在于,该连结体在远离该两个勺臂的一侧具有一导沟,该导沟沿该连结体的长度方向开设,该端部在该滑槽中具有一对应该导沟而设的凸部,该端部并在远离所述凸部的一侧设有一迫紧件,该端部通过该滑槽套设在该连结体且该凸部位于该导沟内时,锁紧该迫紧件与该凸部夹掣该连结体而定位。3. The motion axis positioner for artificial knee arthroplasty as claimed in claim 3, wherein the connecting body has a guide groove on a side away from the two spoon arms, and the guide groove is opened along the length direction of the connecting body , the end part has a pair of convex parts in the chute, which are provided with the guide groove, the end part is provided with a pressing piece on the side away from the convex part, and the end part is sleeved on the chute through the chute. When the connecting body and the protruding portion are located in the guide groove, the pressing member and the protruding portion are locked to clamp the connecting body to be positioned.
  5. 如权利要求4所述的人工膝关节置换术的运动轴定位器,其特征在于,该迫紧件为一螺栓,该端部对应该迫紧件设有一螺孔,该迫紧件旋设于该螺孔中,且可旋至与该连结体相抵而与该凸部夹掣该端部于该连结体。The motion shaft positioner for artificial knee arthroplasty as claimed in claim 4, wherein the pressing member is a bolt, the end portion is provided with a screw hole corresponding to the pressing member, and the pressing member is screwed on the in the screw hole, and can be screwed to abut against the connecting body to clamp the end portion to the connecting body with the protruding part.
  6. 如权利要求3所述的人工膝关节置换术的运动轴定位器,其特征在于,该连结体具有一柄部,该柄部延伸设置且延伸方向与该连结体的直线延伸方向垂直,且该柄部与该两个勺臂从该连结体伸设的方向相反,该柄部并位于该两个勺臂之间;各勺体呈弯弧状的曲率半径为17mm至29mm。The motion axis positioner for artificial knee arthroplasty as claimed in claim 3, wherein the connecting body has a handle portion, the handle portion is extended and the extending direction is perpendicular to the linear extending direction of the connecting body, and the connecting body has a handle portion. The handle portion is opposite to the direction in which the two spoon arms extend from the connecting body, and the handle portion is located between the two spoon arms; the curvature radius of each spoon body is 17mm to 29mm.
  7. 如权利要求6所述的人工膝关节置换术的运动轴定位器,其特征在于,还包括一导引切割件,该导引切割件具有一套口以及一固定部,该套口位于该固定部的上方,且该导引切割件在该套口和该固定部之间具有一长狭缝,该连结体定位出该参考轴时,该柄部以对应的厚度套接于该套口,且通过该固定部固定在所在位置的近端胫骨,该长狭缝的长度方向与该参考轴平行,切割刀具伸入该长狭缝且沿该参考轴修整所述胫骨平台。The motion axis locator for artificial knee arthroplasty as claimed in claim 6, further comprising a guide cutting member, the guide cutting member has a socket and a fixing portion, the socket is located at the fixing portion The guide cutting element has a long slit between the sleeve opening and the fixing part, and when the connecting body locates the reference axis, the handle part is sleeved on the sleeve opening with a corresponding thickness, And the proximal tibia at the position is fixed by the fixing part, the length direction of the long slit is parallel to the reference axis, and the cutting tool extends into the long slit and trims the tibial plateau along the reference axis.
  8. 如权利要求7所述的人工膝关节置换术的运动轴定位器,其特征在于,该导引切割件在该套口和该固定部之间具有一安装槽,该安装槽靠近该导引切割件的一侧边呈开放状,该导引切割件具有一块体,该块体具有该长狭缝,该块体自该安装槽呈开放状的侧边组设于该安装槽内且定位。The motion shaft locator of claim 7, wherein the guide cutting member has an installation groove between the sleeve and the fixing portion, and the installation groove is close to the guide cutting One side of the piece is open, the guiding and cutting piece has a block, the block has the long slit, and the block is assembled and positioned in the mounting groove from the open side of the mounting groove.
  9. 如权利要求8所述的人工膝关节置换术的运动轴定位器,其特征在于,该长狭缝在该块体的宽度方向,从该连结体有该柄部的一侧往有该两个勺臂的一侧由高至低而倾斜。The motion axis locator for artificial knee arthroplasty as claimed in claim 8, wherein the long slit is in the width direction of the block, from the side of the connecting body with the handle to the two One side of the spoon arm slopes from high to low.
  10. 如权利要求7所述的人工膝关节置换术的运动轴定位器,其特征在于,该固定部具有多个穿孔,供手术用的骨螺钉择一所述穿孔穿设,并将该固定部在所述近端胫骨的适当位置锁紧。The motion axis locator for artificial knee arthroplasty as claimed in claim 7, wherein the fixing part has a plurality of perforations, and one of the perforations is selected for the bone screw used for surgery to pass through, and the fixing part is inserted into the fixed part. The proximal tibia is locked in place.
PCT/CN2020/111205 2020-08-26 2020-08-26 Motion axis positioner for artificial knee replacement WO2022040952A1 (en)

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