TW201924611A - External fixation device of knee joint which is suitable for high tibial osteotomy or knee cartilage tissue repair surgery - Google Patents

External fixation device of knee joint which is suitable for high tibial osteotomy or knee cartilage tissue repair surgery Download PDF

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TW201924611A
TW201924611A TW106140427A TW106140427A TW201924611A TW 201924611 A TW201924611 A TW 201924611A TW 106140427 A TW106140427 A TW 106140427A TW 106140427 A TW106140427 A TW 106140427A TW 201924611 A TW201924611 A TW 201924611A
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fixing
tibia
knee joint
rod
fixation
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TW106140427A
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TWI658810B (en
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葉中權
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寶楠生技股份有限公司
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Abstract

An external fixation device of knee joint includes: a tibia upper fixation member, a tibia lower fixation member and a femur fixation member, wherein a universal connection or support formed by at least one main supporting shaft and at least one sub-supporting shaft is arranged between the tibia upper fixation member and the tibia lower fixation member, so as to respond to the high tibial osteotomy for expanding the inner side of the tibia to have various angles according to different patient's requirements. There is a joint member arranged between the tibia fixation member and the tibia upper fixation member for counteracting the pressure of femur applied to the inner side of the tibial plateau. The joint member includes a protrusion capable of relatively rolling and sliding on a receiving base of the joint member so as to respond to the rolling or traverse shifting movement of the femur on the tibial plateau when the knee joint moves. Therefore, the present invention provides an external fixation device mounted outside the patient's leg, which is suitable for high tibial osteotomy or knee cartilage tissue repair surgery.

Description

膝關節之外固定裝置 Knee joint fixation device

本發明係涉及一種膝關節之外固定裝置。 The present invention relates to a knee joint fixation device.

目前對於膝關節病變,除了更換人工膝關節外,病患也可選擇「高位脛骨截骨手術(HTO,High Tibial Osteotomy)」或者膝關節軟骨組織修復手術,以消除病灶。 At present, in addition to the replacement of the artificial knee joint, the patient may also choose "Hy High Tibial Osteotomy" or knee cartilage tissue repair surgery to eliminate the lesion.

「高位脛骨截骨手術(HTO,High Tibial Osteotomy)」,是將脛骨接近上平台處斜切一道切縫並撐開,以形成楔形角度,通過改變膝關節力軸線,以改善膝關節功能,達到解除病患膝關節疼痛的病灶。在進行「高位脛骨截骨手術」後,被截骨後的脛骨通常有兩種固定方式,一種是內固定式的固定裝置,通常是以一體成型的金屬板體鎖接在被截脛骨的兩端,並被縫合、包覆在皮膚裡面,此一方式,用以固定的金屬板體因為是植入於人體組織內部,患者除了易有排斥等不良副作用外,當復原過程中出現任何不適或者在完全康復後,患者必須再接受一次進行拆卸該金屬板體的手術,而顯現出內固定式的固定裝置在「高位脛骨截骨手術」的缺點。 "High Tibial Osteotomy" (HTO) is to cut the tibia close to the upper platform and open it to form a wedge angle. By changing the axis of the knee joint to improve knee function , Remove the lesion of the patient's knee pain. After the "high tibial osteotomy", the osteotomy of the osteotomy is usually fixed in two ways. One is an internal fixation device, usually an integral metal plate is locked to the two of the truncated bone. The end is stitched and covered in the skin. In this way, the metal plate body to be fixed is implanted in the human body tissue, and the patient has any discomfort during the recovery process, in addition to the adverse side effects such as repulsion. After complete recovery, the patient must undergo another operation to disassemble the metal plate, which shows the shortcomings of the internal fixation device in the "high tibial osteotomy".

除了上述內固定式的固定裝置外,目前「高位脛骨截骨手術」也可藉由一種外固定式的固定裝置,予以固定,如中國發明專利案第CN 106420020 A,是有關於一種「脛骨截骨術後的針外固定裝置」,係包括滑動定位桿(1)、固定螺釘(4)、蝶形螺栓(2)和滑套(3);其中該滑動定位桿(1)的 上、下兩端分別滑合一滑套(3),並分別以蝶形螺栓(2)固定鎖於被截切脛骨兩端的固定螺釘(4),並將該滑套(3)緊固在該滑動定位桿(1)上,以界定被截骨後脛骨張開的楔形角度(如圖15所示A或A’)。由於在手術時,依不同病患脛骨平台翻轉的狀況,醫生會藉由張開被截脛骨處的角度大小,矯正膝關節軸線,如圖15示,當脛骨切割處撐開的楔形角度(A,A’)不同時,垂直於該固定螺釘(4)的垂線[即該滑動定位桿(1)的安裝位置]也會隨之改變,即會改變上、下兩滑套(3)對正的角度,由於該滑動定位桿(1)是一剛性的金屬桿,並無法任意彎曲,因而無法因應這樣的角度變化,造成無法安裝,使此一結構無法因應不同的病患的需求。 In addition to the above-mentioned internal fixation type fixation device, the current "high-level tibia osteotomy" can also be fixed by an external fixation type fixing device, such as the Chinese invention patent case CN 106420020 A, which is related to a "sacral sacral section". The external fixation device for postoperative bone surgery includes a sliding positioning rod (1), a fixing screw (4), a butterfly bolt (2) and a sliding sleeve (3); wherein the sliding positioning rod (1) The upper and lower ends respectively slide a sliding sleeve (3), and respectively fix the locking screws (4) at both ends of the cut tibia with butterfly bolts (2), and fasten the sliding sleeve (3) The sliding positioning rod (1) is defined to define a wedge angle of the posterior tibial opening (such as A or A' shown in FIG. 15). Because during the operation, depending on the condition of the patient's tibial plateau, the doctor will correct the axis of the knee by opening the angle of the paraplegic bone. As shown in Fig. 15, when the tibial cut is opened, the wedge angle (A) , A') At the same time, the perpendicular to the fixing screw (4) [that is, the mounting position of the sliding positioning rod (1)] will also change, that is, the upper and lower sliding sleeves (3) will be aligned. Since the sliding positioning rod (1) is a rigid metal rod and cannot be bent arbitrarily, it cannot be changed according to such an angle, and the installation cannot be performed, so that the structure cannot meet the needs of different patients.

緣此,近來已有揭示一種應用於「高位脛骨截骨手術」的外固定裝置,如圖16所示,是含有一上固定件(U)及一下固定件(D),該上、下固定件(U、D)分別以一球部(U1、D1)耦合一中間件(M),藉由該球部(U1、U2)以因應該上、下固定件(U、D)與該中間件(M)的角度對應關係,以改進上述CN 106420020 A案的缺點,惟仍有以下的缺點: Accordingly, an external fixation device for "high-level tibia osteotomy" has recently been disclosed, as shown in FIG. 16, which includes an upper fixing member (U) and a lower fixing member (D), which are fixed up and down. The pieces (U, D) are respectively coupled with a middle piece (M) by a ball portion (U1, D1), by means of the ball portions (U1, U2) for the upper and lower fixing members (U, D) and the middle The angle correspondence of the piece (M) to improve the above disadvantages of the CN 106420020 A case, but still has the following disadvantages:

1.該上固定件(U)、中間件(M)與該下固定件(D),是略呈一直線,脛骨上平台(T1)所承受的合力(F)完全沿一直線向下傳遞,即該中間件(M)僅以單一支點(即該球部(U1)處)支撐該上固定件(U),然而病患在手術完成復健的期間,被截骨的脛骨組織尚未穩定,被截切、撐開的缺口尚未癒合,病患在運動時,重量(w)並不會平均施加於脛骨上平台(T1)的各處,緣此,不平均的受力,僅由單一支點(即球部(U1)支撐,便容易造成脛骨上平台(T1)產生或位移翻轉,改變原已矯正的膝關節軸線,不利患者復原,甚至導致手術失敗。 1. The upper fixing member (U), the intermediate member (M) and the lower fixing member (D) are slightly in line, and the resultant force (F) of the upper tibia (T1) is transmitted completely downward along the straight line, that is, The middle piece (M) supports the upper fixing member (U) only at a single point (ie, at the ball portion (U1)), but the patient's tibial tissue has not been stabilized during the period of completion of the surgery. The cut and spread gap has not yet healed. When the patient is exercising, the weight (w) is not applied to the entire platform of the humerus (T1). Therefore, the uneven force is only caused by a single point ( That is to say, the support of the ball (U1) is easy to cause the plateau (T1) on the humerus to be generated or displaced, which changes the axis of the knee that has been corrected, which is unfavorable for the patient to recover and even causes the operation to fail.

2.由於上、下固定件(U、D)及中間件(M)呈直線排列,因此侷限用以固定脛骨的針也會呈一直線鎖在脛骨上,無法呈多角度鎖入脛骨,因此使整組外固定裝置較不穩固。 2. Since the upper and lower fixing members (U, D) and the middle piece (M) are arranged in a straight line, the needle for limiting the fixation of the tibia is also locked in the tibia in a straight line, and cannot be locked into the tibia at multiple angles, thus The entire set of external fixtures is less stable.

當病患選擇施以「膝關節軟骨組織修復手術」後,如圖17所示,通常會以一股骨固定件(7)固定於股骨(F)端,以一脛骨固定件(8)固定於脛骨(T)端,並以一樞軸(P)連接該股骨固定件(7)及該脛骨固定件(8),雖然樞軸(P)可以提供股骨(F)與脛骨(T)相對以樞軸(P)為中心進行擺動,但是依人體結構,當在曲膝、蹲下時,股骨的下端不但相對於脛骨有滾動運動,也有微量的向前滑移的運動,如圖17虛線所示,由於樞軸(P)的位置固定,且只能提供單純的旋轉運動,並無法容許股骨(F)與脛骨(T)間進行滑移運動,因此,患者安裝外固定裝置後,並無法正常的進行大角度曲膝或蹲下動作,造成病患術後生活上極大的不便,而顯有改進的必要。 When the patient chooses to apply "Knee articular cartilage tissue repair surgery", as shown in Figure 17, it is usually fixed to the femur (F) end with a bone fixation (7), and fixed with a patella fixation member (8). The tibia (T) end is connected to the femoral fixation member (7) and the patella fixation member (8) with a pivot (P), although the pivot (P) can provide the femur (F) opposite the tibia (T) The pivot (P) oscillates at the center, but according to the human body structure, when knees and underarms are bent, the lower end of the femur not only has a rolling motion with respect to the tibia, but also has a slight amount of forward sliding movement, as shown by the dotted line in Fig. 17. It is shown that since the position of the pivot (P) is fixed and only a simple rotational motion can be provided, and the slip motion between the femur (F) and the tibia (T) cannot be allowed, the patient cannot install the external fixation device. Normal high-angle knee or underarm movements cause great inconvenience in patients' postoperative life, and there is a need for improvement.

本案發明人有鑑於此,乃加予研究創新,揭示出本發明所示可適用於「高位脛骨截骨手術」、「膝關節軟骨組織修復手術」的膝關節外固定裝置。 In view of this, the inventors of the present invention have added research and innovation, and have revealed that the present invention can be applied to a knee joint external fixation device which can be applied to "high-level tibia osteotomy" and "knee articular cartilage tissue repair surgery".

本發明旨在提供一種膝關節之外固定裝置,可包括:一脛骨上固定構件、一脛骨下固定構件以及一股骨固定構件,其中在該脛骨上、下固定構件間,至少由一主支撐桿及一次支撐桿連接或支撐,使本發明可以因應不同高位脛骨截骨手術撐開脛骨內側的各種角度;而在股骨固定構件與該脛骨上固定構件間,設有一關節構件,以抵消股骨施加於脛骨平台內側的壓力,該關節構件含有一突部可於該關節構件的一承接座上相對地 滾動、滑移,以因應膝關節在運動時,股骨在脛骨平台上所進行的滾動、滑移運動,使本發明可以適用於「高位脛骨截骨手術」或「膝關節軟骨組織修復手術」於患者腿部外側所裝置的外固定裝置。 The present invention is directed to a knee joint fixation device, which may include: an patella fixation member, a humeral fixation member, and a femur fixation member, wherein at least one main support rod is disposed between the upper and lower fixation members of the tibia And a support rod connection or support, so that the present invention can accommodate various angles of the medial aspect of the humerus in response to different high tibial osteotomy operations; and between the femoral fixation member and the supracondylar fixation member, a joint member is provided to offset the application of the femur to the femur The pressure on the inside of the tibial plateau, the joint member having a protrusion on the socket of the joint member Rolling and sliding, in order to cope with the rolling and sliding movement of the femur on the tibial plateau during the movement of the knee joint, so that the present invention can be applied to "high tibial osteotomy" or "knee cartilage tissue repair surgery" An external fixation device mounted on the outside of the patient's leg.

本發明所揭示膝關節之外固定裝置,可包括:一脛骨上固定構件,穿設有多數固定孔,分別用以固定於鎖在脛骨截切處上方近脛骨上平台端並裸露在人體腿部外的針(Pin)上,該脛骨上固定構件設有第一連接部及位於該第一連接部一側的第二連接部;一脛骨下固定構件,穿設有多數固定孔,分別用以固定於鎖在脛骨截切處下方脛骨骨幹並裸露在人體腿部外的針(Pin)上,該脛骨下固定構件的頂端,設有一第三連接部及位於該第三連接部一側的第四連接部;一主支撐桿,緊固於該脛骨上固定構件之第一連接部與脛骨下固定構件的第三連接部間;以及一次支撐桿,連接在該第二、四連接部。 The knee joint external fixation device disclosed in the present invention may include: a humeral upper fixation member, which is provided with a plurality of fixing holes, respectively for being fixed to the upper humerus upper end of the humerus at the upper end of the humerus and exposed to the human leg. In the outer pin (Pin), the supra-condylar fixation member is provided with a first connecting portion and a second connecting portion on one side of the first connecting portion; a lower tibial fixing member is provided with a plurality of fixing holes for respectively The needle is fixed on a pin (Pin) which is locked under the tibia and is exposed outside the leg of the human body. The top end of the lower tibial fixing member is provided with a third connecting portion and a first side of the third connecting portion. a fourth connecting portion; a main support rod fastened between the first connecting portion of the supra-physeal upper fixing member and the third connecting portion of the lower tibial fixing member; and a primary support rod connected to the second and fourth connecting portions.

上述令該主支撐桿在該第一、三連接部處可以萬向調整角度後為該第一連接部、第三連接部分別緊緊地固定;以及該次支撐桿,其上、下兩端分別形成一球面或尖部,對應地頂撐於該脛骨上固定構件的第二連接部及該脛骨下固定構件的第四連接部,可於所對應的上、第四連接部中萬向調整其角度。 The first support portion and the third connecting portion are respectively tightly fixed after the main support rod can be universally adjusted at the first and third connecting portions; and the secondary support rod has upper and lower ends Forming a spherical surface or a tip portion respectively, correspondingly supporting the second connecting portion of the upper tibial upper fixing member and the fourth connecting portion of the lower tibial fixing member, and being universally adjustable in the corresponding upper and fourth connecting portions Its angle.

本發明所揭示膝關節之外固定裝置,其中該脛骨上固定構件的第一連接部,含有一設於該脛骨上固定構件的基座及一固定座,令該固定座鎖接於該脛骨上固定構件上,並與該基座構成一上球穴;該主支撐桿的近上端穿套一上球面襯套,該上球面襯套設有一軸孔及一開口縫,令該上球面襯套在未將固定座鎖緊在該脛骨上固定構件時,可在該基座與該固 定座所構成的上球穴中自由旋轉,且該主支撐桿可於該上球面襯套的軸孔中自由地軸向位移,令該固定座鎖緊在該脛骨上固定構件時,該基座與該固定座是緊緊地固定該上球面襯套及該主支撐桿。 The knee joint external fixation device disclosed in the present invention, wherein the first connecting portion of the supra-physical fixation member comprises a base disposed on the fixation member of the tibia and a fixing seat, and the fixing seat is locked on the tibia Fixing member and forming an upper ball hole with the base; the upper end of the main support rod is sleeved with an upper spherical bushing, the upper spherical bushing is provided with a shaft hole and an opening slit, and the upper spherical bushing is provided When the fixing seat is not locked to the fixation member of the tibia, the base and the solid can be The upper ball formed by the seat is freely rotatable, and the main support rod is freely axially displaceable in the shaft hole of the upper spherical bushing, and the base is locked to the fixation member of the tibia. The seat and the fixing seat are tightly fixed to the upper spherical bushing and the main support bar.

本發明所揭示膝關節之外固定裝置,其中該脛骨下固定構件的第三連接部,含有一設於該脛骨下固定構件的基座部及一固定座部,令該固定座部鎖接於該脛骨下固定構件上,並與該基座部構成一下球穴;該主支撐桿的近下端穿套一下球面襯套,該下球面襯套設有一軸孔及一開口縫,令該下球面襯套在未將固定座鎖緊在該脛骨下固定構件時,可在該基座部與該固定座部所構成的下球穴中自由旋轉,且該主支撐桿可於該下球面襯套的軸孔中自由地軸向位移,令該固定座鎖緊在該脛骨下固定構件時,該基座部與該固定座是緊緊地固定該下球面襯套與該主支撐桿。 The knee joint external fixation device disclosed in the present invention, wherein the third connecting portion of the lower tibial fixing member comprises a base portion disposed on the lower tibial fixing member and a fixing seat portion, and the fixing seat portion is locked The lower tibia fixing member forms a lower hole with the base portion; the lower end of the main support rod is sleeved with a spherical bushing, and the lower spherical bushing is provided with a shaft hole and an opening slit to make the lower spherical surface The bushing is freely rotatable in the lower pocket formed by the base portion and the fixing seat portion when the fixing seat is not locked to the lower tibial fixing member, and the main supporting rod is available on the lower spherical bushing The shaft hole is freely axially displaced, and when the fixing seat is locked to the lower tibial fixing member, the base portion and the fixing seat tightly fix the lower spherical bushing and the main supporting rod.

本發明所揭示膝關節之外固定裝置,其中該上、下球面襯套的軸孔壁設有突齒或者形成粗糙面。 The knee joint external fixation device disclosed in the present invention, wherein the shaft hole wall of the upper and lower spherical bushings is provided with a protruding tooth or a rough surface.

本發明所揭示膝關節之外固定裝置,其中該脛骨上固定構件的各該固定孔之軸心線是呈相互平行或至少兩固定孔的軸心線呈一夾角。該脛骨下固定構件的各該固定孔之軸心線是呈相互平行或至少兩固定孔的軸心線呈一夾角。 The knee joint external fixation device disclosed in the present invention, wherein the axis of each of the fixing holes of the supracondylar fixation member is at an angle of an axis line parallel to each other or at least two fixing holes. The axis line of each of the fixing holes of the lower tibial fixing member is at an angle of an axis line parallel to each other or at least two fixing holes.

本發明所揭示膝關節之外固定裝置,其中該脛骨上固定構件的一側進一步設有一切刀工具固定孔。 The knee joint external fixation device disclosed in the present invention, wherein one side of the supracondylar fixation member is further provided with all knife tool fixing holes.

本發明所揭示膝關節之外固定裝置,其中該主支撐桿可以是一實心桿體或者是中空桿體;或者令該主支撐桿是由第一桿體及第二桿體相互組成,使該第一、二桿體可以沿軸向伸縮,並由至少一固定螺絲徑向 地迫緊固定該第一、二桿體;上述該第一桿體外緣形成有外螺紋並螺合一迫緊螺母,以迫緊固定該第二桿體,以阻擋該第一、二桿體沿軸向縮退。 The knee joint external fixation device disclosed in the present invention, wherein the main support rod may be a solid rod body or a hollow rod body; or the main support rod is composed of a first rod body and a second rod body, so that The first and second rods can be extended and contracted in the axial direction and are radially oriented by at least one fixing screw Firmly fixing the first and second rod bodies; the outer edge of the first rod is externally threaded and screwed with a pressing nut to firmly fix the second rod body to block the first and second rod bodies Axial retraction.

本發明所揭示膝關節之外固定裝置,其中該上、下脛骨固定構件之各該固定孔之孔壁上設有突齒或形成粗糙面,令一迫緊螺絲徑向地鎖入該上、脛骨下固定構件該固定孔後,可迫使該針緊抵於該突齒或粗糙面上。 The knee joint external fixation device disclosed in the present invention, wherein the hole wall of each of the fixing holes of the upper and lower tibia fixing members is provided with a protruding tooth or a rough surface, so that a pressing screw radially locks the upper part and the tibia After the fixing member of the lower fixing member, the needle can be forced to abut against the protruding tooth or the rough surface.

本發明所揭示膝關節之外固定裝置,其中該次支撐桿由第一桿體及第二桿體相互螺接組成,使該第一、二桿體可以沿軸向伸縮,其中該第一桿體上徑向地螺合有一迫緊螺母,以迫緊固定該第一、二桿體,以擋阻該第一、二桿體沿軸向縮退。 The knee joint external fixation device disclosed in the present invention, wherein the secondary support rod is composed of a first rod body and a second rod body being screwed together, so that the first and second rod bodies can be extended and contracted in the axial direction, wherein the first rod A tightening nut is screwed radially to the body to firmly fix the first and second rods to block the first and second rods from retracting in the axial direction.

本發明所揭示膝關節之外固定裝置,其中該股骨固定構件是穿設有多數固定孔,用以固定於釘入股骨並裸露在人體腿部外的針(Pin)上,以隨股骨運動;在該股骨固定構件與該脛骨上固定構件間所設的關節構件,其中該突部的第一端是連接於該股骨固定構件[或者連接在該脛骨上固定構件],而其第二端是形成一弧面或球面的接觸面,而該承接座的第一端是連接於該脛骨上固定構件[或者連接在該股骨固定構件],而其第二端係界定形成一承接面,以供該突部的第二端抵靠在該承接面,其中令該承接面之面積足以容許該突部的第二端滾動及滑移;上述該承接面,是可成一平面、弧面或球面,本發明並不予自限。 The knee joint external fixation device disclosed in the present invention, wherein the femoral fixation member is provided with a plurality of fixing holes for fixing on a pin which is nailed into the femur and exposed outside the human leg to move with the femur; a joint member disposed between the femoral fixation member and the supracondylar fixation member, wherein the first end of the protrusion is connected to the femoral fixation member [or attached to the supracondylar fixation member], and the second end thereof is Forming a curved or spherical contact surface, and the first end of the receiving seat is connected to the tibia upper fixing member [or connected to the femoral fixing member], and the second end thereof defines a receiving surface for The second end of the protrusion abuts against the receiving surface, wherein the receiving surface has an area sufficient to allow the second end of the protrusion to roll and slide; the receiving surface may be a flat surface, a curved surface or a spherical surface. The invention is not intended to be self limiting.

本發明所揭示膝關節之外固定裝置,其中該關節構件的突部或承接座是可分別一體成形連接於該股骨固定構件或脛骨上固定構件上;或以螺絲、螺栓鎖接在該股骨固定構件或脛骨上固定構件上。 The knee joint external fixation device disclosed in the present invention, wherein the protrusion or the socket of the joint member can be integrally formed and connected to the femoral fixation member or the tibia upper fixation member respectively; or the screw and the bolt are locked to the femur for fixation. The member or the tibia is attached to the member.

本發明所揭示之可取實體,可由以下的說明及所附各圖式,而得以明晰。 The desirable entities disclosed in the present invention can be clarified by the following description and the accompanying drawings.

(10)‧‧‧脛骨上固定構件 (10) ‧‧‧Sacral fixation components

(11)‧‧‧固定孔 (11) ‧‧‧Fixed holes

(110)‧‧‧軸心線 (110)‧‧‧Axis line

(111)‧‧‧突齒或粗糙面 (111)‧‧‧ teeth or rough surfaces

(12)‧‧‧第一連接部 (12) ‧‧‧First Connection

(120)‧‧‧上球穴 (120)‧‧‧上球

(121)‧‧‧基座 (121)‧‧‧Base

(122)‧‧‧固定座 (122)‧‧‧ Fixed seat

(13)‧‧‧第二連接部 (13) ‧‧‧Second connection

(14)‧‧‧切刀工具固定孔 (14)‧‧‧Cutter tool fixing hole

(15)‧‧‧迫緊螺絲 (15) ‧ ‧ tighten the screws

(20)‧‧‧脛骨下固定構件 (20) ‧‧‧Underlying humeral fixation members

(21)‧‧‧固定孔 (21)‧‧‧Fixed holes

(210)‧‧‧軸心線 (210)‧‧‧Axis line

(211)‧‧‧突齒或粗糙面 (211)‧‧‧ teeth or rough surfaces

(22)‧‧‧第三連接部 (22) ‧ ‧ third connection

(220)‧‧‧下球穴 (220) ‧‧‧ Under the ball

(221)‧‧‧基座部 (221) ‧ ‧ pedestal

(222)‧‧‧固定座部 (222)‧‧‧ Fixed seat

(23)‧‧‧第四連接部 (23) ‧ ‧ fourth connection

(25)‧‧‧迫緊螺絲 (25) ‧ ‧ tighten the screws

(30)(30’)‧‧‧主支撐桿 (30) (30’) ‧ ‧ main support rod

(30a)(30a’)‧‧‧第一桿體 (30a) (30a’) ‧ ‧ first body

(30b)(30b’)‧‧‧第二桿體 (30b) (30b’) ‧‧‧Second body

(31)‧‧‧上球面襯套 (31)‧‧‧Upper spherical bushing

(311)‧‧‧軸孔 (311)‧‧‧Axis hole

(311a)‧‧‧突齒或粗糙面 (311a)‧‧‧Tooth or rough surface

(312)‧‧‧開口縫 (312)‧‧‧Open seam

(32)‧‧‧下球面襯套 (32)‧‧‧Spherical bushings

(321)‧‧‧軸孔 (321)‧‧‧Axis hole

(321a)‧‧‧突齒或粗糙面 (321a) ‧‧‧ teeth or rough surfaces

(322)‧‧‧開口縫 (322)‧‧‧Open seam

(33)‧‧‧固定螺絲 (33)‧‧‧ fixing screws

(34)‧‧‧迫緊螺母 (34) ‧‧‧Forcing nuts

(35)‧‧‧彈性物 (35)‧‧‧ Elastomers

(40)‧‧‧次支撐桿 (40) ‧ ‧ support rods

(40a)‧‧‧上端 (40a) ‧ ‧ upper end

(40b)‧‧‧下端 (40b) ‧‧‧Bottom

(41)‧‧‧第一桿體 (41)‧‧‧First body

(42)‧‧‧第二桿體 (42)‧‧‧Second body

(43)‧‧‧迫緊螺母 (43)‧‧‧Forced nuts

(50)‧‧‧股骨固定構件 (50) ‧‧‧ femoral fixation members

(51)‧‧‧固定孔 (51) ‧‧‧Fixed holes

(60)‧‧‧關節構件 (60) ‧‧‧ joint components

(61)‧‧‧突部 (61) ‧‧‧

(611)‧‧‧第一端 (611) ‧ ‧ first end

(612)‧‧‧第二端 (612) ‧‧‧ second end

(62)‧‧‧承接座 (62) ‧‧‧ socket

(621)‧‧‧第一端 (621)‧‧‧ first end

(622)‧‧‧第二端 (622)‧‧‧ second end

(A1、A2、A3)‧‧‧夾角 (A1, A2, A3) ‧ ‧ angle

(F)‧‧‧股骨 (F) ‧ ‧ femur

(S1、S2、S3)‧‧‧針 (S1, S2, S3) ‧ ‧ needle

(T)‧‧‧脛骨 (T)‧‧‧胫骨骨

(T1)‧‧‧脛骨上平台端 (T1) ‧ ‧ 胫 上 上

(T2)‧‧‧骨幹 (T2) ‧ ‧ backbone

圖1:為本發明第一實施例的立體分解圖。 Figure 1 is an exploded perspective view of a first embodiment of the present invention.

圖2:為本發明主支撐桿的立體分解圖。 Figure 2 is an exploded perspective view of the main support rod of the present invention.

圖3:為圖1於組合後的平面結構示意圖。 Figure 3 is a schematic view of the planar structure of Figure 1 after combination.

圖4:為圖1所示實施例安裝在患者上的應用狀態立體圖。 Figure 4 is a perspective view of an application state mounted on a patient for the embodiment of Figure 1.

圖5:為圖4的平面結構示意圖。 Figure 5 is a schematic view of the planar structure of Figure 4.

圖6:為圖5的6-6方向的剖面結構示意圖。 Fig. 6 is a schematic cross-sectional view showing the direction of 6-6 of Fig. 5.

圖7:為本發明所示脛骨上固定構件之俯視結構示意圖。 Fig. 7 is a top plan view showing the tibia upper fixing member of the present invention.

圖8:為本發明所示脛骨下固定構件之俯視結構示意圖。 Fig. 8 is a top plan view showing the lower tibial fixation member of the present invention.

圖9:為本發明所示脛骨上固定構件的固定孔結構示意圖。 Fig. 9 is a schematic view showing the structure of a fixing hole of the tibia upper fixing member shown in the present invention.

圖10:為本發明所示脛骨下固定構件的固定孔結構示意圖。 Fig. 10 is a schematic view showing the structure of a fixing hole of the lower tibial fixing member of the present invention.

圖11:為本發明應用於高位脛骨截骨手術及膝關節軟骨組織修復手術之第二實施例結構示意圖。 Figure 11 is a schematic view showing the structure of a second embodiment of the present invention applied to a high tibial osteotomy and a knee cartilage tissue repair operation.

圖12:為自圖11進行曲膝運動之示意圖。 Figure 12 is a schematic illustration of the knee movement from Figure 11.

圖13:為本發明僅應用於膝關節軟骨組織修復手術之第三實施例結構示意圖。 Figure 13 is a schematic view showing the structure of a third embodiment of the knee cartilage tissue repairing operation of the present invention.

圖14:為本發明第四實施例結構示意圖。 Figure 14 is a schematic view showing the structure of a fourth embodiment of the present invention.

圖15:為第一種習知高位脛骨截骨手術的外固定裝置示意圖。 Figure 15 is a schematic illustration of the external fixation device of the first conventional high tibial osteotomy.

圖16:為第二種習知高位脛骨截骨手術的外固定裝置示意圖。 Figure 16: Schematic diagram of an external fixation device for the second conventional high tibial osteotomy.

圖17:為習知應用於膝關節軟骨組織修復手術之結構示意圖。 Figure 17 is a schematic view showing the structure of a knee cartilage tissue repair operation.

如圖1~13所示,本發明係有關於一種膝關節之外固定裝置,用以裸露地裝置在人體腿部外,可以包括:一脛骨上固定構件(10)、一脛骨下固定構件(20),其中在該脛骨上、下固定構件(10、20)間,至少由一主支撐桿(30)及一次支撐桿(40)連接或支撐,使本發明可以因應高位脛骨截骨術(HTO,High Tibial Osteotomy)依不同病患撐開脛骨內側的各種角度;而本發明進一步可以包括一股骨固定構件(50),在股骨固定構件(50)與該脛骨上固定構件(10)間,連接有一關節構件(60),以界定該股骨(F)與徑骨(T)間的間距,以抵消股骨(F)施加於脛骨(T)平台內側的壓力,該關節構件(60)含有一突部(61)及一承接座(62),該突部(61)可於該承接座(62)上相對地滾動、滑移,以因應人體膝關節在運動時,股骨在脛骨平台上所進行的滾動及橫移的運動,使本發明可以適用於高位脛骨截骨手術或膝關節軟骨組織修復手術後,安裝於患者腿部外。 As shown in FIGS. 1-13, the present invention relates to a knee joint fixation device for barely mounting outside a human leg, and may include: a supracondylar fixation member (10) and a subtibial fixation member ( 20), wherein at least a main support rod (30) and a primary support rod (40) are connected or supported between the upper and lower fixation members (10, 20), so that the present invention can cope with high tibial osteotomy ( HTO, High Tibial Osteotomy) depending on the patient's various angles of the medial aspect of the tibia; and the present invention may further include a femoral fixation member (50) between the femoral fixation member (50) and the supracondylar fixation member (10), A joint member (60) is coupled to define a spacing between the femur (F) and the radial bone (T) to counteract the pressure exerted by the femur (F) on the inside of the tibia (T) platform, the joint member (60) containing a a protrusion (61) and a receiving seat (62), the protrusion (61) can relatively roll and slide on the receiving seat (62), so as to cope with the femur on the tibial plateau when the human knee joint is in motion The rolling and traversing movements made the invention applicable to high tibial osteotomy or knee cartilage After the tissue repair surgery, it is installed outside the patient's leg.

如圖1~7所示,該膝關節之外固定裝置,係包括:一脛骨上固定構件(10),穿設有多數固定孔(11),分別用以固定於鎖在脛骨截切處上方近脛骨上平台端(T1)並裸露在人體腿部外的針(S1)上,該脛骨上固定構件(10)設有第一連接部(12)及位於該第一連接部(12)一側的第二連接部(13);一脛骨下固定構件(20),穿設有多數固定孔(21),分別用以固定於鎖在脛骨截切處下方脛骨之骨幹(T2)並裸露在人體腿部外的針(S2)上,該脛骨下固定構件(20)設有一第三連接部(22)及位於該第三連接部(22)一側的第四連接部(23);一主支撐桿(30),連接於該脛骨上固定構件(10)的第一連接部(12)與脛骨下固定構 件(20)的第三連接部(22)間;以及一次支撐桿(40),位於該脛骨上固定構件(10)的第二連接部(13)及該脛骨下固定構件(20)的第四連接部(23)間。 As shown in FIG. 1 to 7, the external fixation device for the knee joint includes: a humeral upper fixation member (10), and a plurality of fixing holes (11) are provided for fixing to the lock above the tibia The proximal humerus platform end (T1) is exposed on a needle (S1) outside the human leg, and the patella upper fixing member (10) is provided with a first connecting portion (12) and a first connecting portion (12) a second connecting portion (13) on the side; a lower tibial fixing member (20) is provided with a plurality of fixing holes (21) for fixing to the backbone (T2) of the tibia below the tibia cutting and being exposed The lower tibial fixation member (20) is provided with a third connecting portion (22) and a fourth connecting portion (23) on a side of the third connecting portion (22); a main support rod (30) connected to the first connecting portion (12) of the supra-physeal upper fixing member (10) and the lower tibial fixation structure Between the third connecting portion (22) of the member (20); and a primary support rod (40) located at the second connecting portion (13) of the fixation member (10) of the tibia and the second fixation member (20) Between the four connections (23).

上述,令該主支撐桿(30)的上、下兩端可在該第一、三連接部(12、22)處萬向調整角度後為該第一、三連接部(12、22)分別緊緊地固定;令該次支撐桿(40),其上、下兩端(40a、40b)分別可於所對應的第二、四連接部(13、23)上呈萬向調整其角度。 In the above, the upper and lower ends of the main support bar (30) can be universally adjusted at the first and third connecting portions (12, 22) for the first and third connecting portions (12, 22) respectively. Tightly fixed; the upper and lower ends (40a, 40b) of the support rod (40) can be adjusted in a gimbal direction on the corresponding second and fourth connecting portions (13, 23), respectively.

上述該次支撐桿(40),其上、下兩端(40a、40b)分別形成一球面或尖部,以對應地頂撐於該脛骨上固定構件(10)的第二連接部(13)及該脛骨下固定構件(20)的第四連接部(23)上呈萬向調整其角度。 The upper and lower ends (40a, 40b) of the support rod (40) respectively form a spherical surface or a tip portion for correspondingly supporting the second connecting portion (13) of the upper fixation member (10) of the tibia And the fourth connecting portion (23) of the lower tibial fixing member (20) is gimbalized to adjust its angle.

如圖1、2、5或6所示,其中該脛骨上固定構件(10)的第一連接部(12)含有一設於該脛骨上固定構件(10)的基座(121)及一獨立的固定座(122),令該固定座(122)鎖接於該脛骨上固定構件(10)上,並與該基座(121)構成一上球穴(120);該主支撐桿(30)的近上端穿套一上球面襯套(31),該上球面襯套(31)設有一軸孔(311)及一開口縫(312),令該上球面襯套(31)在未將固定座(122)鎖緊在該脛骨上固定構件(10)時,可在該基座(121)與該固定座(122)所構成的上球穴(120)中自由旋轉,且該主支撐桿(30)可於該上球面襯套(31)的軸孔(311)中自由地軸向位移,令該固定座(122)鎖緊在該脛骨上固定構件(10)時,該基座(121)與該固定座(122)是緊緊地固定該上球面襯套(31)與該主支撐桿(30)。 As shown in FIG. 1, 2, 5 or 6, wherein the first connecting portion (12) of the supra-condylar fixing member (10) comprises a base (121) and an independent unit disposed on the tibia upper fixing member (10). The fixing seat (122) is configured to lock the fixing seat (122) to the sacral upper fixing member (10), and form an upper ball (120) with the base (121); the main supporting rod (30) The upper end is provided with an upper spherical bushing (31), the upper spherical bushing (31) is provided with a shaft hole (311) and an opening slit (312), so that the upper spherical bushing (31) is not When the fixing seat (122) is locked to the fixation member (10) of the tibia, the upper seat (120) formed by the base (121) and the fixed seat (122) can be freely rotated, and the main support The rod (30) is freely axially displaceable in the shaft hole (311) of the upper spherical bushing (31) to lock the fixing seat (122) to the tibia upper fixing member (10) (121) The upper spherical bushing (31) and the main support rod (30) are tightly fixed to the fixing base (122).

如圖1、2、5或6所示,其中該脛骨下固定構件(20)的第三連接部(22)含有一設於該脛骨下固定構件(20)的基座部(221)及一獨立的固定座部(222),令該固定座部(222)鎖接於該脛骨下固定構件(20)上,並與該基座部 (221)構成一下球穴(220);該主支撐桿(30)的近下端穿套一下球面襯套(32),該下球面襯套(32)設有一軸孔(321)及一開口縫(322),令該下球面襯套(32)在未將固定座部(222)鎖緊在該脛骨下固定構件(20)時,可在該基座部(221)與該固定座部(222)所構成的下球穴(220)中自由旋轉,且該主支撐桿(30)可於該下球面襯套(32)的軸孔(321)中自由地軸向位移,令該固定座部(222)鎖緊在該脛骨下固定構件(20)時,該基座部(221)與該固定座部(222)是緊緊地固定該下球面襯套(32)與該主支撐桿(30)。 As shown in FIG. 1, 2, 5 or 6, the third connecting portion (22) of the lower tibial fixing member (20) includes a base portion (221) and a base provided on the lower tibial fixing member (20). a separate fixing seat (222), the fixing seat (222) is locked to the lower tibial fixing member (20), and the base portion (221) forming a ball hole (220); the lower end of the main support bar (30) is sleeved with a spherical bushing (32), the lower spherical bushing (32) is provided with a shaft hole (321) and an opening slit (322), the lower spherical bushing (32) is detachable from the base portion (221) and the fixed seat portion when the fixing seat portion (222) is not locked to the lower tibial fixing member (20) 222) the lower ball (220) formed is freely rotatable, and the main support rod (30) is freely axially displaceable in the shaft hole (321) of the lower spherical bushing (32), so that the fixing seat When the portion (222) is locked to the lower tibial fixation member (20), the base portion (221) and the fixing portion (222) tightly fix the lower spherical bushing (32) and the main support rod (30).

如圖2所示,其中該上、下球面襯套(31、32)的軸孔(311、321)孔壁是設有突齒或者形成粗糙面(311a、321a),以嚙合或緊抵於該主支撐桿(30)上,避免該主支撐桿(30)沿該上、下球面襯套(31、32)的軸孔(311、321)產生軸向位移。 As shown in FIG. 2, the hole holes (311, 321) of the upper and lower spherical bushings (31, 32) are provided with protruding teeth or rough surfaces (311a, 321a) to engage or abut against The main support rod (30) prevents axial displacement of the main support rod (30) along the axial holes (311, 321) of the upper and lower spherical bushings (31, 32).

如圖7所示,其中該脛骨上固定構件(10)的各該固定孔(11)之軸心線(110)是呈相互平行或令至少兩固定孔(11)的軸心線(110)呈一夾角(A1)。該夾角(A1)是小於140度,例如可介於15~35度,最佳為26度。 As shown in FIG. 7, the axis line (110) of each of the fixing holes (11) of the supra-condylar fixing member (10) is an axis line (110) which is parallel to each other or at least two fixing holes (11). At an angle (A1). The included angle (A1) is less than 140 degrees, for example, may be between 15 and 35 degrees, and most preferably 26 degrees.

如圖8所示,其中該脛骨下固定構件(20)的各該固定孔(21)之軸心線(210)是呈相互平行或令至少兩固定孔(21)的軸心線(210)呈一夾角(A2)。該夾角(A2)是小於140度,例如可介於15~35度,最佳為22度。 As shown in FIG. 8, the axis line (210) of each of the fixing holes (21) of the lower tibial fixing member (20) is an axis line (210) which is parallel to each other or at least two fixing holes (21). At an angle (A2). The angle (A2) is less than 140 degrees, for example between 15 and 35 degrees, and most preferably 22 degrees.

如圖1所示,其中該脛骨上固定構件(10)的一側,進一步設有一切刀工具固定孔(14),用以固定一用以截切脛骨之刀架(圖未示出),而不需額外架設截骨刀具的輔具,以降低手術成本。 As shown in FIG. 1 , one side of the humeral upper fixing member (10) is further provided with a knife tool fixing hole (14) for fixing a knife holder (not shown) for cutting the tibia. It does not require additional erecting tools for the osteotomy tool to reduce the cost of surgery.

如圖2、6所示,其中該主支撐桿(30)是由第一桿體(30a)及第二桿體(30b)相互組成,並由至少一固定螺絲(33)徑向地迫緊固定該第一、二桿 體(30a、30b)。上述之第一桿體(30a)可令具有一外螺紋段,吻合地螺合於該第二桿體(30b)之一螺孔中,以旋轉地調整該第一、二桿體(30a、30b)的長度,惟本發明並不自限該第一、二桿體(30a、30b)的組合方式。 As shown in Figures 2 and 6, wherein the main support rod (30) is composed of a first rod body (30a) and a second rod body (30b), and is radially pressed by at least one fixing screw (33). Fix the first and second poles Body (30a, 30b). The first rod body (30a) is configured to have an externally threaded portion that is screwed into one of the screw holes of the second rod body (30b) to rotationally adjust the first and second rod bodies (30a, The length of 30b), but the invention does not limit the combination of the first and second rods (30a, 30b).

如圖1、2、6所示,本發明所揭示膝關節之外固定裝置,其中於該主支撐桿(30)的第一桿體(30a)外緣形成有外螺紋並螺合一迫緊螺母(34),以迫緊固定該第二桿體(30b),用以阻擋該第一、二桿體(30a、30b)沿軸向縮退。 As shown in FIG. 1 and 2, the knee joint external fixation device disclosed in the present invention, wherein an outer thread is formed on an outer edge of the first rod body (30a) of the main support rod (30) and a pressing nut is screwed. (34), the second rod body (30b) is tightly fixed to block the first and second rod bodies (30a, 30b) from retracting in the axial direction.

如圖9、10所示,其中該上、下脛骨固定構件(10、20)之各該固定孔(11、21)之孔壁上設有突齒或形成粗糙面(111、211),令一迫緊螺絲(15、25)徑向地鎖入該上、下脛骨固定構件(10、20)並抵壓位於固定孔(11、21)中的針(S1、S2)後,便會迫使該針(S1、S2)緊抵於該突齒或粗糙面(111、211)上。上述之固定孔(11、21)是沿所對應的迫緊螺絲(15或25)鎖入方向形成一長孔,使該針(S1、S2)穿入所對應的固定孔(11、21),並為迫緊螺絲(15或25)迫緊時,針(S1、S2)的局部外緣可以相對地嚙合該突齒中或緊抵在該粗糙面(111或211),使該上、下脛骨固定構件(10、20)可以緊緊固定在各該針(S1、S2)上。 As shown in FIGS. 9 and 10, wherein the fixing holes (11, 21) of the upper and lower tibia fixing members (10, 20) are provided with protruding teeth or rough surfaces (111, 211), When a tightening screw (15, 25) radially locks the upper and lower tibia fixing members (10, 20) and presses the needles (S1, S2) located in the fixing holes (11, 21), the force is forced The needles (S1, S2) abut against the teeth or rough surfaces (111, 211). The fixing holes (11, 21) are formed with a long hole in the locking direction of the corresponding pressing screw (15 or 25), so that the needle (S1, S2) penetrates into the corresponding fixing hole (11, 21). And when the tightening screw (15 or 25) is pressed, the partial outer edge of the needle (S1, S2) can relatively engage the tooth or abut against the rough surface (111 or 211), so that the upper and lower sides The tibial fixation members (10, 20) can be tightly attached to each of the needles (S1, S2).

如圖1、3、5所示,其中該次支撐桿(40)由第一桿體(41)及第二桿體(42)相互螺接組成,以藉由相對旋轉軸向地調整該次支撐桿(40)的軸向長度;其中該第一桿體(41)上可進一步徑向地螺合有一迫緊螺母(43),以迫緊固定該第一、二桿體(41、42),以擋阻該第一、二桿體(41、42)沿軸向縮退。 As shown in FIGS. 1, 3 and 5, wherein the support rod (40) is composed of a first rod body (41) and a second rod body (42), which are axially connected to each other to adjust the axial direction by relative rotation. The axial length of the support rod (40); wherein the first rod body (41) is further radially screwed with a pressing nut (43) to firmly fix the first and second rod bodies (41, 42) ) to prevent the first and second rods (41, 42) from retracting in the axial direction.

本發明所揭示膝關節之外固定裝置,其中該主支撐桿(30)是可 呈一中空桿體、實心或如圖14所示,該主支撐桿(30’)是呈一彈性桿,含有第一、二桿體(30a’、30b’),令該第一、二桿體(30a’、30b’)相互軸向套接,並於該第一、二桿體(30a’、30b’)間置有一彈性墊片、彈性塊或彈簧等彈性物(35),使該第一、二體桿(30a’、30b’)固定在脛骨上、下固定構件(10、20)時,可藉由該彈性物(35)提供該脛骨上、下固定構件(10、20)微量的彈性震動,用以刺激骨組織生長,以增進被截切脛骨的復原速度。 The knee joint external fixation device disclosed by the present invention, wherein the main support rod (30) is In a hollow rod body, solid or as shown in FIG. 14, the main support rod (30') is an elastic rod containing first and second rod bodies (30a', 30b'), so that the first and second rods are The bodies (30a', 30b') are axially sleeved with each other, and an elastic spacer (35) such as an elastic spacer, an elastic block or a spring is disposed between the first and second rod bodies (30a', 30b'). When the first and second body rods (30a', 30b') are fixed to the upper and lower fixation members (10, 20), the upper and lower fixation members (10, 20) of the tibia can be provided by the elastic body (35). A small amount of elastic vibration is used to stimulate the growth of bone tissue to improve the recovery rate of the cut tibia.

如圖11、12所示,本發明所揭示膝關節之外固定裝置,其中該股骨固定構件(50),穿設有多數固定孔(51),用以固定於釘入股骨(F)並裸露於腿部外的針(S3)上,以隨股骨(F)運動,在該股骨固定構件(50)與該脛骨上固定構件(10)間所設的關節構件(60),其中該突部(61)的第一端(611)是連接於該股骨固定構件(50)[或者連接在該脛骨上固定構件(圖未示出)],而其第二端(612)是可形成一弧面或球面的接觸面,而該承接座(62)的第一端(621)是連接於該脛骨上固定構件(10)[或者連接在該股骨固定構件(圖未示出)],而其第二端(622)是界定地形成一承接面,以供該突部(61)的第二端(612)抵靠在該承接座(62)第二端(622)上,其中令該承接座(62)之第二端(622)之面積足以容許該突部(61)的第二端(612)滾動及滑移,(在人體曲膝、蹲下的動作中,該股骨除轉動外猶向前滑移,如圖12所示虛線所示);上述該承接座(62)之第二端(622),是可成一平面、弧面或球面,本發明並不予自限其形狀。 As shown in FIGS. 11 and 12, the knee joint external fixation device disclosed in the present invention, wherein the femoral fixation member (50) is provided with a plurality of fixing holes (51) for fixing to the femur (F) and being exposed. a joint member (60) disposed between the femoral fixation member (50) and the supracondylar fixation member (10) on the needle (S3) outside the leg to move with the femur (F), wherein the protrusion The first end (611) of (61) is connected to the femoral fixation member (50) [or attached to the tibia upper fixation member (not shown)], and the second end (612) is formed to form an arc a contact surface of the face or the spherical surface, and the first end (621) of the receiving seat (62) is coupled to the fixation member (10) of the tibia [or attached to the femoral fixation member (not shown)] The second end (622) defines a receiving surface for the second end (612) of the protrusion (61) to abut against the second end (622) of the receiving seat (62), wherein the receiving end The second end (622) of the seat (62) has an area sufficient to allow the second end (612) of the protrusion (61) to roll and slip. (In the action of the human knee and the underarm, the femur is rotated. Still sliding forward, as shown by the dotted line in Figure 12; The second end (622) of the receiving seat (62) is formed into a flat surface, a curved surface or a spherical surface, and the present invention does not limit its shape.

本發明所揭示膝關節之外固定裝置,其中該關節構件(60)之突部(61)與承接座(62),是可分別一體成形連接於該股骨固定構件(50)或脛骨上固定構件(10)上,或以螺絲或螺栓鎖接在該股骨固定構件(50)或脛骨上固定構件(10)上,本發明並不予自限。 The knee joint external fixation device disclosed in the present invention, wherein the protrusion (61) and the socket (62) of the joint member (60) are integrally and integrally connected to the femoral fixation member (50) or the tibia upper fixation member. (10) Upper, or screwed or bolted to the femoral fixation member (50) or the tibia upper fixation member (10), the invention is not limited.

如圖13所示,當病患只進行膝關節軟骨組織修復手術時,本發明所應用的膝關節之外固定裝置,是包括:一脛骨上固定構件(10),穿設有多數固定孔(11),分別用以固定於鎖在脛骨(T)並裸露在人體腿部外的針(S1)上;一股骨固定構件(50),穿設有多數固定孔(51),用以固定於釘入股骨(F)並裸露在人體腿部外的針(S3)上,以隨股骨(F)運動;以及在該股骨固定構件(50)與該脛骨上固定構件(10)間所設的關節構件(60),該關節構件(60)含有一突部(61)及一承接座(62),該突部(61)可於該承接座(62)上相對地滾動、滑移;其中該突部(61)的第一端(611)是連接於該股骨固定構件(50)[或者連接在該脛骨上固定構件(圖未示出)],而其第二端(612)是可形成一弧面或球面的接觸面,而該承接座(62)的第一端(621)是連接於該脛骨上固定構件(10)[或者連接在該股骨固定構件(圖未示出)],而其第二端(622)是界定地形成一承接面,以供該突部(61)的第二端(612)抵靠在該承接座(62)的第二端(622)上,其中令該承接座(62)第第二端(622)面積足以容許該突部(61)的第二端(612)滾動及滑移。 As shown in FIG. 13, when the patient performs only knee articular cartilage tissue repair surgery, the knee joint external fixation device to which the present invention is applied includes: a humeral upper fixation member (10), which is provided with a plurality of fixation holes ( 11), respectively, for fixing to a needle (S1) locked on the tibia (T) and exposed outside the human leg; a bone fixing member (50), wearing a plurality of fixing holes (51) for fixing to Nailed into the femur (F) and exposed on the needle (S3) outside the human leg to move with the femur (F); and between the femoral fixation member (50) and the metatarsal fixation member (10) a joint member (60), the joint member (60) includes a protrusion (61) and a socket (62), the protrusion (61) can relatively roll and slide on the socket (62); The first end (611) of the protrusion (61) is connected to the femoral fixation member (50) [or attached to the fixation member (not shown)], and the second end (612) is Forming a curved or spherical contact surface, and the first end (621) of the receiving seat (62) is coupled to the tibia upper fixation member (10) [or connected to the femoral fixation member (not shown)] And its second end (62 2) defining a receiving surface for the second end (612) of the protrusion (61) to abut against the second end (622) of the receiving seat (62), wherein the receiving seat (62) The second end (622) is of sufficient area to allow the second end (612) of the projection (61) to roll and slip.

本發明所揭示膝關節之外固定裝置,乃具有以下特徵及優點; The knee joint external fixation device disclosed in the present invention has the following features and advantages;

1.以主支撐桿(30)及次支撐桿(40)兩個支點支撐該脛骨上固定構件(10),即以多支點支撐患者脛骨上平台(T1)的受力,避免手術後脛骨上平台(T1)產生翻轉或位移,增進「高位脛骨截骨手術」成功率。 1. Supporting the humeral upper fixation member (10) with two support points of the main support rod (30) and the secondary support rod (40), that is, supporting the force on the upper tibia (T1) of the patient with multiple points, and avoiding the humerus after the operation The platform (T1) produces a flip or displacement that increases the success rate of the "high tibial osteotomy".

2.於安裝時,該主支撐桿(30)及次支撐桿(40),可於該上、下脛骨固定構件(10、20)間可呈萬向調整其角度,且可沿軸向伸縮調整,以因應不同患者在該脛骨截切處因撐開不同角度(A,如圖4所示),所需固定的角度關係。 2. During installation, the main support rod (30) and the secondary support rod (40) can be adjusted in a gimbal direction between the upper and lower tibia fixing members (10, 20), and can be extended and contracted in the axial direction. Adjustment, in order to accommodate different angles (A, as shown in Figure 4) at different points in the fracture of the tibia.

3.上、下脛骨固定構件(10、20)上的固定孔(11、21),分佈對應於該脛骨的周緣,不在同一直線上,使針(S1或S2)以不同角度鎖固在截骨後的脛骨上,使本發明所揭示的外固定裝置可更為穩固地定位患者截骨後脛骨所撐開的角度及位置。 3. The fixing holes (11, 21) on the upper and lower tibia fixation members (10, 20) are distributed corresponding to the circumference of the tibia, not on the same line, so that the needle (S1 or S2) is locked at different angles. The posterior tibia of the bone enables the external fixation device disclosed by the present invention to more stably locate the angle and position of the tibia of the patient after the osteotomy.

4.該主支撐桿(30)可以採用中空桿體,大大降低整個外固定裝置的重量,以減輕患者荷重,降低患者不適感。 4. The main support rod (30) can adopt a hollow rod body, which greatly reduces the weight of the entire external fixing device, thereby reducing the patient's load and reducing the patient's discomfort.

5.當病患同時進行高位脛骨截骨手術與膝關節軟骨組織修復手術時,可進一步藉由股骨固定構件(50)與脛骨上固定構件(10)間的關節構件(60),穩定撐開該股骨(F)與脛骨(T)上端平台間的間距,且該關節構件(60)也可以適應股骨(F)與脛骨(T)在運動中所產生的滾動與滑移運動路徑,使病患可以正常的進行蹲、站的動作。 5. When the patient underwent high tibial osteotomy and knee cartilage repair, the joint member (60) between the femoral fixation member (50) and the supracondylar fixation member (10) can be further stably opened. The distance between the femur (F) and the upper end of the tibia (T), and the joint member (60) can also adapt to the rolling and slipping motion paths generated by the femur (F) and the tibia (T) during exercise, so that the disease Suffering from normal squatting and standing movements.

6.當病患脛骨復原後,可單獨卸除下脛骨固定構件(20)、主支撐桿(30)及次支撐桿(40),待膝關節軟骨組織再生復原後,再卸除股骨固定構件(50)與脛骨上固定構件(10),使本發明可以因應不同患者在治療膝關節病症時所選擇的手術治療方法及復原狀態。 6. When the patient's humerus is restored, the mandibular fixation member (20), the main support rod (30) and the secondary support rod (40) can be separately removed. After the knee joint cartilage tissue is regenerated and restored, the femoral fixation member is removed. (50) and the supracondylar fixation member (10), the present invention can be adapted to the surgical treatment method and recovery state selected by different patients in the treatment of knee joint disorders.

本發明所揭示之結構或形狀,可於不違本發明之精神或範疇下予以修飾應用,本發明並不自限於上述實施方式 The structure or shape disclosed in the present invention can be modified and applied without departing from the spirit or scope of the present invention, and the present invention is not limited to the above embodiment.

Claims (16)

一種膝關節之外固定裝置,係包括:一脛骨上固定構件,穿設有多數固定孔,分別用以固定於鎖在脛骨截切處上方近脛骨上平台端並裸露在人體腿部外的針上,該脛骨上固定構件設有第一連接部及位於該第一連接部一側的第二連接部;一脛骨下固定構件,穿設有多數固定孔,分別用以固定於鎖在脛骨截切處下方脛骨骨幹並裸露在人體腿部外的針上,該脛骨下固定構件設有一第三連接部及位於該第三連接部一側的第四連接部;一主支撐桿,連接於該脛骨上固定構件之第一連接部與脛骨下固定構件的第三連接部間;以及一次支撐桿,位於該脛骨上固定構件的第二連接部及該脛骨下固定構件的第四連接部間。 The utility model relates to a knee joint external fixation device, which comprises: a humeral upper fixation member, which is provided with a plurality of fixing holes, respectively for fixing to a needle locked on the upper humerus platform end and exposed outside the human leg at the upper part of the tibia cut. The upper humeral fixation member is provided with a first connecting portion and a second connecting portion on a side of the first connecting portion; a lower tibia fixing member is provided with a plurality of fixing holes for respectively being fixed to the humerus Cutting the lower tibia backbone and exposing the needle outside the leg of the human body, the lower tibial fixation member is provided with a third connecting portion and a fourth connecting portion on a side of the third connecting portion; a main supporting rod connected to the a first connecting portion of the supracondylar fixation member and a third connecting portion of the lower tibial fixing member; and a primary support rod located between the second connecting portion of the supracondylar upper fixing member and the fourth connecting portion of the lower tibial fixing member. 如請求項1所述膝關節之外固定裝置,其中令該主支撐桿的上、下兩端可以在該第一、三連接部處萬向調整角度後為該第一、三連接部分別緊緊地固定。 The fixing device of the knee joint according to claim 1, wherein the upper and lower ends of the main support bar are respectively tightened at the first and third connecting portions, and the first and third connecting portions are respectively tight. Tightly fixed. 如請求項1所述膝關節之外固定裝置,其中令該次支撐桿,其上、下兩端分別可於所對應的第二、四連接部上呈萬向調整其角度。 The fixing device for the knee joint according to claim 1, wherein the upper and lower ends of the supporting rod are respectively adjustable in the universal direction on the corresponding second and fourth connecting portions. 如請求項1所述膝關節之外固定裝置,其中該脛骨上固定構件的第一連接部含有一設於該脛骨上固定構件的基座及一獨立的固定座,令該固定座鎖接於該脛骨上固定構件上,並與該基座構成一上球穴;該主支撐桿的近上端穿套一上球面襯套,該上球面襯套設有一軸孔及一開口縫,令該上球面襯套在未將固定座鎖緊在該脛骨上固定構件時,可在該基座與 該固定座所構成的上球穴中自由旋轉,且該主支撐桿可於該上球面襯套的軸孔中自由地軸向位移,令該固定座鎖緊在該脛骨上固定構件時,該基座與該固定座是緊緊地固定該上球面襯套與該主支撐桿。 The knee joint external fixation device according to claim 1, wherein the first connecting portion of the supra-condylar fixing member comprises a base provided on the tibia upper fixing member and a separate fixing seat, so that the fixing seat is locked The upper sacral upper fixing member forms an upper ball hole with the base; the upper end of the main support rod is sleeved with an upper spherical bushing, and the upper spherical bushing is provided with a shaft hole and an opening slit, so that the upper ball bushing The spherical bushing can be on the base when the fixing seat is not locked to the fixation member of the tibia The upper ball formed by the fixing seat is freely rotatable, and the main supporting rod is freely axially displaceable in the shaft hole of the upper spherical bushing, so that when the fixing seat is locked on the tibia upper fixing member, The base and the fixing seat tightly fix the upper spherical bushing and the main support bar. 如請求項1所述膝關節之外固定裝置,其中該脛骨下固定構件的第三連接部含有一設於該脛骨下固定構件的基座部及一獨立的固定座部,令該固定座部鎖接於該脛骨下固定構件上,並與該基座部構成一下球穴,該下球面襯套設有一軸孔及一開口縫,令該下球面襯套在未將固定座部鎖緊在該脛骨下固定構件時,可在該基座部與該固定座部所構成的下球穴中自由旋轉,且該主支撐桿可於該下球面襯套的軸孔中自由地軸向位移,令該固定座部鎖緊在該脛骨下固定構件時,該基座部與該固定座部是緊緊地固定該下球面襯套與該主支撐桿。 The knee joint external fixation device according to claim 1, wherein the third connecting portion of the lower tibial fixing member comprises a base portion provided on the lower tibial fixing member and a separate fixing portion, and the fixing portion is Locking on the lower tibial fixing member, and forming a lower ball hole with the base portion, the lower spherical bushing is provided with a shaft hole and an opening slit, so that the lower spherical bushing does not lock the fixing seat portion The lower tibial fixation member is freely rotatable in the lower pocket formed by the base portion and the fixing seat portion, and the main support rod is freely axially displaceable in the shaft hole of the lower spherical bushing. When the fixing seat is locked to the lower tibial fixing member, the base portion and the fixing seat portion tightly fix the lower spherical bushing and the main supporting rod. 如請求項4或5所述之膝關節之外固定裝置,其中該上、下球面襯套的軸孔壁設有突齒或者形成粗糙面。 The knee joint fixing device according to claim 4 or 5, wherein the shaft hole wall of the upper and lower spherical bushings is provided with a protruding tooth or a rough surface. 如請求項1所述膝關節之外固定裝置,其中該脛骨上固定構件的各該固定孔之軸心線是呈相互平行或令至少兩固定孔的軸心線呈一夾角;其中該脛骨下固定構件的各該固定孔之軸心線是呈相互平行或令至少兩固定孔的軸心線呈一夾角。 The fixation device of the knee joint according to claim 1, wherein the axis of the fixing hole of the fixation member of the tibia is parallel to each other or at least at an angle of the axis of the at least two fixing holes; wherein the humerus is under the humerus The axis lines of the fixing holes of the fixing member are parallel to each other or at an angle to the axis of at least two fixing holes. 如請求項1所述膝關節之外固定裝置,其中該主支撐桿是由第一桿體及第二桿體相互組成,並由至少一固定螺絲徑向地迫緊固定該第一、二桿體。 The knee joint external fixation device according to claim 1, wherein the main support rod is composed of a first rod body and a second rod body, and the first and second rods are radially fixed by at least one fixing screw. body. 如請求項8所述膝關節之外固定裝置,其中該第一桿體外緣形成有外螺紋並螺合一迫緊螺母,用以迫緊固定該第二桿體。 The knee joint external fixation device according to claim 8, wherein the outer edge of the first rod is formed with an external thread and a nut is screwed to firmly fix the second rod. 如請求項1所述膝關節之外固定裝置,其中該上、下脛骨固定構件之各該固定孔之孔壁上設有突齒或形成粗糙面。 The knee joint external fixation device according to claim 1, wherein the wall of each of the fixing holes of the upper and lower tibia fixing members is provided with a protruding tooth or a rough surface. 如請求項1所述膝關節之外固定裝置,其中該次支撐桿由第一桿體及第二桿體相互螺接組成,其中該第一桿體上徑向地螺合有一迫緊螺母,以迫緊固定該第一、二桿體,擋阻該第一、二桿體沿軸向縮退。 The fixation device of the knee joint according to claim 1, wherein the secondary support rod is composed of a first rod body and a second rod body, wherein the first rod body is screwed with a compression nut radially. The first and second rod bodies are tightly fixed to block the first and second rod bodies from retracting in the axial direction. 如請求項1所述膝關節之外固定裝置,進一步包含一股骨固定構件,該股骨固定構件,穿設有多數固定孔,用以固定於釘入股骨並裸露在人體腿部外的針上;以及一設於該股骨固定構件與該脛骨上固定構件間的關節構件,該關節構件含有一突部及一承接座,該突部可於該承接座上相對地滾動或滑移。 The fixation device for knee joint according to claim 1, further comprising a femoral fixing member, the femoral fixing member is provided with a plurality of fixing holes for fixing to a needle which is nailed into the femur and exposed outside the leg of the human body; And a joint member disposed between the femoral fixation member and the supracondylar fixation member, the joint member includes a protrusion and a socket, and the protrusion can relatively roll or slide on the socket. 一種膝關節之外固定裝置,係包括:一脛骨上固定構件,穿設有多數固定孔,分別用以固定於鎖在脛骨並裸露在人體腿部外的針上;一股骨固定構件,穿設有多數固定孔,用以固定於釘入股骨並裸露在人體腿部外的針上;以及位於該股骨固定構件與該脛骨上固定構件間所設的關節構件,該關節構件含有一突部及一承接座,該突部可於該承接座上相對地滾動或滑移。 The utility model relates to a knee joint external fixation device, which comprises: a humeral upper fixation member, which is provided with a plurality of fixing holes for respectively fixing on a needle locked on the tibia and exposed outside the human leg; a femur fixing member is worn a plurality of fixing holes for fixing to a needle which is nailed into the femur and exposed outside the leg of the human body; and a joint member disposed between the femoral fixing member and the upper fixation member of the tibia, the joint member having a protrusion and A socket that can be relatively rolled or slipped on the socket. 如請求項12或13所述膝關節之外固定裝置,其中該突部的第一端是連接於該股骨固定構件或者連接在該脛骨上固定構件,而其第二端是可形成一弧面或球面的接觸面,而該承接座的第一端是連接於該脛骨上固定構件或者連接在該股骨固定構件,而其第二端是界定地形成一承接面,以供該突部的第二端抵靠在該承接座之第二端上,其中令該承接座第二 端的面積足以容許該突部的第二端滾動及滑移。 The knee joint fixation device according to claim 12 or 13, wherein the first end of the protrusion is connected to the femoral fixation member or connected to the fixation member on the tibia, and the second end thereof is formed into a curved surface. Or a spherical contact surface, and the first end of the socket is connected to the fixation member of the tibia or connected to the femoral fixation member, and the second end of the socket is defined to form a receiving surface for the protrusion The two ends abut against the second end of the socket, wherein the socket is second The area of the end is sufficient to allow the second end of the projection to roll and slip. 如請求項1所述膝關節之外固定裝置,其中該主支撐桿為一彈性桿或中空桿。 The knee joint fixing device according to claim 1, wherein the main support rod is an elastic rod or a hollow rod. 如請求項15所述膝關節之外固定裝置,其中該主支撐桿,含有第一、二桿體,令該第一、二桿體相互軸向套接,並於該第一、二桿體間置有一彈性墊片、彈性塊或彈簧等彈性物。 The knee joint external fixation device according to claim 15, wherein the main support rod includes first and second rod bodies, and the first and second rod bodies are axially sleeved with each other, and the first and second rod bodies are respectively An elastic material such as an elastic spacer, an elastic block or a spring is interposed.
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