CN109771104A - 一种mts内侧胫骨平台补片、组配式mts内侧胫骨平台补片及其微创置换方法 - Google Patents

一种mts内侧胫骨平台补片、组配式mts内侧胫骨平台补片及其微创置换方法 Download PDF

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Publication number
CN109771104A
CN109771104A CN201910180639.5A CN201910180639A CN109771104A CN 109771104 A CN109771104 A CN 109771104A CN 201910180639 A CN201910180639 A CN 201910180639A CN 109771104 A CN109771104 A CN 109771104A
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CN
China
Prior art keywords
mts
tibial plateau
sticking patch
medial tibial
assembly type
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201910180639.5A
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English (en)
Inventor
王岩
柴伟
徐宁
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chai Wei
Wang Yan
Original Assignee
Beijing Lidakang Technology Co Ltd
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Filing date
Publication date
Application filed by Beijing Lidakang Technology Co Ltd filed Critical Beijing Lidakang Technology Co Ltd
Priority to CN201910180639.5A priority Critical patent/CN109771104A/zh
Priority to KR1020217022241A priority patent/KR102649339B1/ko
Priority to JP2021505992A priority patent/JP2022522557A/ja
Priority to US17/427,113 priority patent/US20220096242A1/en
Priority to PCT/CN2019/082730 priority patent/WO2020181608A1/zh
Publication of CN109771104A publication Critical patent/CN109771104A/zh
Pending legal-status Critical Current

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Abstract

本发明公开了一种MTS内侧胫骨平台补片、组配式MTS内侧胫骨平台补片及其微创置换方法，MTS内侧胫骨平台补片包括关节面和底面，的关节面上设有弧形凹陷区域，与股骨髁形成良好匹配和滑动配合，且不增加关节内撞击，底面上设有3个呈三角分布的立柱或者呈非平行分布的两条纵行龙骨或者呈三角状的两条龙骨翼，保证假体的稳定性，实现微创的手术理念，减少对正常组织的破坏。组配式MTS内侧胫骨平台补片包括骨小梁金属的胫骨托和VE高交联聚乙烯的衬垫。本发明的补片和组配式补片结构简单，形似度好，符合国人解剖特点。其微创置换方法截骨量小，纠正冠状面及矢状面畸形，恢复关节韧带原有张力及关节力线，缓解疼痛。

Description

一种MTS内侧胫骨平台补片、组配式MTS内侧胫骨平台补片及 其微创置换方法
技术领域
本发明涉及人工膝关节假体置换领域，特别是指一种应用于胫骨关节面明显磨损，软骨缺失或胫骨畸形的患者进行微创手术置换用的MTS内侧胫骨平台补片、组配式MTS内侧胫骨平台补片及其微创置换方法。
背景技术
随着中国老龄化社会的到来和医疗卫生事业的迅猛发展，人均寿命逐渐延长，关节炎作为一种退行性变，已经成为当今社会困扰中老年人的重大医疗问题。膝关节作为主要的负重关节，关节炎的发生率尤其高。另外，日益严重的肥胖问题和各种原因的运动伤，也在膝关节骨关节炎发生发展中起到了推波助澜的作用。患病的膝关节面和软骨受到破坏，表面明显磨损和缺失造成膝关节活动范围受限、疼痛，严重影响患者的日常生活和工作。
目前国内外采用的手术方案有：全膝关节置换(TKA)、单髁关节置换(UKA) 和胫骨高位截骨(HTO)。
现有的手术方案的缺点如下：1、全膝关节表面置换，手术将内外侧间室或(和)髌股间室及交叉韧带全部或部分切除，手术创伤大，对于只有单间室关节炎的患者来说，全膝关节置换无疑是削足适履，牺牲了正常的关节面和韧带，本体感觉不佳，全膝关节置换术后不满意率达20％。一旦手术发生感染、松动、磨损、脱位等并发症，翻修手术为破坏性手术、难度大且需要特殊的假体，花费非常高。2、单髁关节置换，该手术仅切除胫骨股骨的单侧间室关节面，植入胫骨、股骨、衬垫假体，本体感觉较好；但是，该手术使用年限有限，胫骨平台松动、衬垫脱位发生率较高，截骨过多，翻修为全膝手术时难度较大，需要垫块等额外辅助固定，限制了其推广。3、胫骨高位截骨仅对胫骨畸形的膝关节炎患者有效，且需要额外钢板固定，花费较高，手术后需要限制活动，不符合骨科患者快速康复的理念和需求。研究表明截骨术后的患者行关节置换时解剖位置改变，功能效果不如初次关节置换的患者。
发明内容
本发明的目的在于提供一种MTS内侧胫骨平台补片、组配式MTS内侧胫骨平台补片及其微创置换方法，用于解决现有技术中手术创伤大、难度大、使用年限少、胫骨平台松动、衬垫脱位发生率较高和截骨过多等问题。
为实现上述目的，本发明提供以下技术方案：
一种MTS内侧胫骨平台补片，包括关节面和底面，所述关节面上设有弧形凹陷区域，所述底面上设置3个呈三角形分布的立柱或2个呈非平行分布的纵行龙骨或者2个呈三角形的龙骨翼。
其中，所述立柱与所述底面之间的夹角呈20°-40°。
其中，所述立柱上设有均匀分布的3-4个弧形凹槽。
其中，所述纵行龙骨带有3°-7°的锥度。
其中，所述纵行龙骨上设有3-5条均匀分布的凸脊。
其中，所述的三角形龙骨翼有2-4条防旋圆弧槽。其中，所述底面形态为带网格状凹形骨水泥槽、多条纵向分布的燕尾型骨水泥槽或无槽的抛光面的其中一种。
其中，所述MTS内侧胫骨平台补片的横截面呈D字型，按照国人膝关节胫骨平台的解剖形态进行仿生设计，假体分为1-6型不同大小的尺寸。
其中，还包括数个不同厚度规格的胫骨平台补片，其厚度为3-14mm。
其中，所述关节面前后厚度相等。
其中，所述MTS内侧胫骨平台补片的材料为VE高交联聚乙烯。
一种组配式MTS内侧胫骨平台补片，包括胫骨托和衬垫，所述胫骨托包括上表面和底面，所述上表面设置有锥形突出部，所述底面上设置有3-4个呈三角形分布的立柱或2-3个呈非平行分布的纵行龙骨；所述衬垫包括关节面和下表面，所述的关节面上设有弧形凹陷区域，所述下表面设置有锥形凹陷部；
所述胫骨托与所述衬垫之间通过所述胫骨托的锥形突出部与所述衬垫的锥形凹陷部锁紧。
其中，所述胫骨托的底面设有骨小梁多孔结构层，厚度为1-5mm。
其中，所述胫骨托的材料为医用钛合金或钴铬钼合金或聚醚醚酮(PEEK)
或其衍生物，所述衬垫的材料为VE高交联聚乙烯。
一种用于置换所述的MTS内侧胫骨平台补片或组配式MTS内侧胫骨平台补片的微创置换方法，采用髌旁入路小切口的微创手术方法暴露患者的患肢胫骨内侧或外侧平台，按照术前计划的冠状位内外翻角度及矢状位后倾角度切除病变胫骨的骨组织，将MTS内侧胫骨平台补片植入被切除的胫骨上，所述一体式的MTS内侧胫骨平台补片与所述被切除的胫骨采用水泥固定，所述组配式MTS内侧胫骨平台补片与所述被切除的胫骨采用生物固定。
本发明的上述技术方案的有益效果如下：
上述方案中，本发明的MTS内侧胫骨平台补片和组配式MTS内侧胫骨平台补片结构简单，形似度好、符合国人解剖特点；MTS内侧胫骨平台补片和组配式MTS内侧胫骨平台补片植入方便、器械简单、手术微创、不触及重要软组织，患者术后恢复快预期可进行门诊手术治疗，当天出院；MTS内侧胫骨平台补片固定牢靠、耐磨性强、生物相容度高；MTS内侧胫骨平台补片或组配式MTS内侧胫骨平台补片的微创置换方法截骨量小，翻修手术简单，不增加全膝关节置换手术难度；MTS内侧胫骨平台补片可以减少金属离子毒性及过敏反应，不影响核磁共振成像。
附图说明
图1为本发明的MTS内侧胫骨平台补片的立体结构图一；
图2为本发明的MTS内侧胫骨平台补片的立体结构图二；
图3为本发明的MTS内侧胫骨平台补片结构图一的矢状面视图；
图4为本发明的MTS内侧胫骨平台补片的立体结构图三；
图5为本发明的MTS内侧胫骨平台补片的结构图三的矢状面视图；
图6为本发明的MTS内侧胫骨平台补片的立体结构图四；
图7为本发明的MTS内侧胫骨平台补片的结构图四的矢状面视图；
图8为本发明的组配式MTS内侧胫骨平台补片的立体结构图；
图9为本发明的组配式MTS内侧胫骨平台补片的立体分解图；
图10为本发明的组配式MTS内侧胫骨平台补片的矢状面剖视图；
图11为本发明的置换MTS内侧胫骨平台补片前的效果图；
图12为本发明的置换MTS内侧胫骨平台补片后的效果图。
附图标记：
1、底面；2、凹状骨水泥槽；3、立柱；4、纵行龙骨；5、衬垫；6、突出部；7、凹陷部；8、胫骨托；9、三角形龙骨翼；10、燕尾型骨水泥槽；11、圆柱形龙骨翼。
具体实施方式
为使本发明要解决的技术问题、技术方案和优点更加清楚，下面将结合附图及具体实施例进行详细描述。
本发明针对现有的手术创伤大、难度大、使用年限少、胫骨平台松动、衬垫脱位发生率较高和截骨过多的问题，提供一种MTS内侧胫骨平台补片、组配式MTS内侧胫骨平台补片及其微创置换方法。
如图1所示的，本发明实施例提供了一种MTS内侧胫骨平台补片的第一个实施例，一种MTS内侧胫骨平台补片，包括关节面和底面1，所述关节面上设有弧形凹陷区域，所述弧形凹陷区域与股骨髁形成良好匹配和滑动配合，且不增加关节内撞击，所述底面1上设置有3-4个呈三角形分布的立柱3，优选3个立柱3。
如图2所示的，本发明实施例提供了一种MTS内侧胫骨平台补片的第二个实施例，一种MTS内侧胫骨平台补片，包括关节面和底面1，所述关节面上设有弧形凹陷区域，所述弧形凹陷区域与股骨髁形成良好匹配和滑动配合，且不增加关节内撞击，所述底面1上设置有2-3个呈非平行分布的纵行龙骨4，优选2个纵行龙骨4。
如图4所示的，本发明实施例提供了一种MTS内侧胫骨平台补片的第三个实施例，一种MTS内侧胫骨平台补片，包括关节面和底面1，所述关节面上设有弧形凹陷区域，所述弧形凹陷区域与股骨髁形成良好匹配和滑动配合，且不增加关节内撞击，所述底面1上设置有2-3个呈纵向分布的三角形龙骨翼 9，三角形龙骨翼上设有2-4个防旋圆弧槽，本实施例优选2个三角形龙骨翼9。
如图6所示的，本发明实施例提供了一种MTS内侧胫骨平台补片的第四个实施例，一种MTS内侧胫骨平台补片，包括关节面和底面1，所述关节面上设有弧形凹陷区域，所述弧形凹陷区域与股骨髁形成良好匹配和滑动配合，且不增加关节内撞击，所述底面1上设置有2-3个呈纵向分布的截面呈圆柱状的龙骨翼11，圆柱状的龙骨翼11上设有2-4个防旋圆弧槽，本实施例优选2 个圆柱状的龙骨翼11。
其中，所述底面形态为带网格状凹形骨水泥槽、多条纵向分布的燕尾型骨水泥槽或无槽的抛光面的其中一种。
本发明的所述MTS内侧胫骨平台补片的厚度均为3-14mm。可以纠正0-15°以内的冠状面力线畸形并恢复关节韧带原有张力及关节力线，缓解疼痛。所述 MTS内侧胫骨平台补片的材料为VE高交联聚乙烯，减少金属离子毒性及过敏反应。不影响核磁共振成像。所述VE高交联聚乙烯的耐磨度极高，VE高交联聚乙烯与现有的常用的超高分子量聚乙烯材料相比较，所述VE高交联聚乙烯的耐磨性好、抗屈强度高和抗疲劳强度高，所述VE高交联聚乙烯的弹性模量更接近人体关节面软骨的弹性模量，使得所述MTS内侧胫骨平台补片与之形成关节面更好配合。本发明的MTS内侧胫骨平台补片采用水泥固定，植入后能与自由基结合，减低材料的氧化率。
其中，所述胫骨托的材料为医用钛合金或钴铬钼合金或聚醚醚酮(PEEK) 或其衍生物，所述衬垫的材料为VE高交联聚乙烯。
本发明的MTS内侧胫骨平台补片可以根据人体的骨骼形状设置成不同厚度和不同大小规格的MTS内侧胫骨平台补片，本发明的MTS内侧胫骨平台补片的型号分为1-6型，前后径与左右径均有较好匹配，用以纠正患者不同程度的力线畸形，患者在使用本发明的MTS内侧胫骨平台补片时的运动力学特征更接近自然关节。
本发明中的MTS内侧胫骨平台补片的关节面前后厚度相等，根据关节原有后倾决定截骨角度，实现关节在屈伸活动中的正常后滚，恢复关节原有偏心距。
如图3所示的，本发明的关节面是根据仿人体膝关节半月板形状和尺寸而设定，其中，所述MTS内侧胫骨平台补片的横截面呈D字型，所述MTS内侧胫骨平台补片的横截面呈D字型，按照国人膝关节胫骨平台的解剖形态进行仿生设计，假体分为1-6型不同大小的尺寸。所述MTS内侧胫骨平台补片的矢状面上带有弧形凹陷，所述弧形凹陷的弧度小而平。
其中，还包括数个不同厚度规格的胫骨平台补片，其厚度为3-14mm。
其中，所述关节面前后厚度相等。
如图8-9所示的，本发明实施例提供了一种组配式MTS内侧胫骨平台补片，包括胫骨托8和衬垫5，所述胫骨托8包括上表面和底面，所述上表面设置有锥形突出部6，所述底面1上设置有3-4个呈三角形分布的立柱或2-3个呈非平行分布的纵行龙骨；所述衬垫包括关节面和下表面，所述的关节面上设有弧形凹陷区域，所述下表面设置有锥形凹陷部7。如图10所示的，所述胫骨托8与所述衬垫5之间通过所述胫骨托8的锥形突出部6与所述衬垫5的锥形凹陷部7锁紧，有效防止组配式胫补片的松脱，保证两者结合的牢靠性。衬垫5的下表面与所述胫骨托8平台的上表面相匹配。
其中，所述胫骨托8的底面设有骨小梁多孔结构层，厚度为2-3mm。衬垫 5厚度为4-12mm，可纠正0-15°以内的冠状面畸形。
本实施例中，由目前骨长入性能最好的骨小梁金属胫骨托8联合VE高交联聚乙烯衬垫5组成，其弹性模量及孔隙率接近正常骨骼组织，固定方式为生物固定，衬垫5的材料采用耐磨度极高的VE高交联聚乙烯制成，此材料的假体植入后能与自由基结合，减低材料的氧化率，并且具有吸收震荡和缓冲的作用，避免了传统手术术后应力遮挡问题。
如图1和图3所示的，本发明的立柱3是根据受力情况进行优化设计，有利于分解应力，达到极佳的定位固定效果。所述立柱3与所述底面1之间的夹角呈28°-31°，优选夹角为30°。所述立柱3上设有均匀分布的3个弧形凹槽，所述弧形凹槽可以加强所述MTS内侧胫骨平台补片的稳定性，同时方便所述 MTS内侧胫骨平台补片安装，减少对正常组织的破坏，实现了微创手术的理念。
如图2所示的，本发明的纵行龙骨4是根据受力情况进行优化设计，有利于分解应力，达到极佳的定位固定效果。所述纵行龙骨4带有3°-4°的锥度。所述纵行龙骨4上设有3-5条均匀分布的凸脊，优选3条。所述纵行龙骨4可以加强所述MTS内侧胫骨平台补片的稳定性，同时方便所述MTS内侧胫骨平台补片安装，减少对正常组织的破坏，实现了微创手术的理念。
如图1和图2所示的，本发明的所述底面1上还设有网格状凸起2。便于MTS内侧胫骨平台补片的固定，防止MTS内侧胫骨平台补片松动或脱落。
如图4-7所示的，本发明的所述底面1上设有多条纵向分布的燕尾型骨水泥槽10，便于MTS内侧胫骨平台补片的固定，防止MTS内侧胫骨平台补片松动或脱落或前移。
本发明实施例提供了一种用于置换所述的MTS内侧胫骨平台补片或组配式MTS内侧胫骨平台补片的微创置换方法，采用髌旁入路小切口的微创手术方法暴露患者的患肢胫骨内侧或外侧平台，按照术前计划的冠状位内外翻角度及矢状位后倾角度切除病变胫骨的骨组织，将MTS内侧胫骨平台补片或者组配式MTS内侧胫骨平台补片植入被切除的胫骨上，所述MTS内侧胫骨平台补片与所述被切除的胫骨采用水泥固定，所述组配式MTS内侧胫骨平台补片与所述被切除的胫骨采用生物固定。
如图11-12所示的，图11为置换前的胫骨效果图，图12为置换后的效果图，对比置换前的效果图和置换后的效果图，采用本发明的微创置换方法将本发明的MTS内侧胫骨平台补片或组配式MTS内侧胫骨平台补片植入到胫骨上，可以纠正0-15°以内的冠状面畸形，效果显著。
上述方案中，本发明的所述的MTS内侧胫骨平台补片和组配式MTS内侧胫骨平台补片结构简单，植入方便、固定牢靠、翻修频率低，手术微创，切口小、能最大限度的保留骨量及软组织，患者术后恢复快，能解决目前棘手的临床难题、更好的服务于患者，其市场前景广阔。
本说明书中的各个实施例均采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似的部分互相参见即可。
在本发明的描述中，需要理解的是，术语“上”、“一端”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
在本发明的描述中，需要说明的是，除非另有明确的规定和限定，术语“设有”、“连接”应做广义理解。例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连。固定连接可以为焊接、螺纹连接和加紧等常见技术方案。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
以上所述是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明所述原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (15)

1.一种MTS内侧胫骨平台补片，其特征在于，包括关节面和底面，所述关节面上设有弧形凹陷区域，所述底面上设置有3个呈三角形分布的立柱或2个呈非平行分布的纵行龙骨或者2个呈三角形的龙骨翼。
2.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述立柱与所述底面之间的夹角呈20°-40°。
3.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述立柱上设有均匀分布的3-4个弧形凹槽。
4.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述纵行龙骨带有3°-7°的锥度。
5.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述纵行龙骨上设有3-5条均匀分布的凸脊。
6.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述三角形的龙骨翼上设有2-4条防旋圆弧槽。
7.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述底面形态为带网格状凹形骨水泥槽、多条纵向分布的燕尾型骨水泥槽或无槽的抛光面的其中一种。
8.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述MTS内侧胫骨平台补片的横截面呈D字型，按照国人膝关节胫骨平台的解剖形态进行仿生设计，假体分为1-6型不同大小的尺寸。
9.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，包括数个不同厚度规格的胫骨平台补片，其厚度为3-14mm。
10.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，其关节面前后厚度相等。
11.如权利要求1所述的MTS内侧胫骨平台补片，其特征在于，所述MTS内侧胫骨平台补片的材料为VE高交联聚乙烯。
12.一种组配式MTS内侧胫骨平台补片，包括胫骨托和衬垫，其特征在于，所述胫骨托包括上表面和底面，所述上表面设置有锥形突出部，所述底面上设置有3-4个呈三角形分布的立柱或2-3个呈非平行分布的纵行龙骨；所述衬垫包括关节面和下表面，所述的关节面上设有弧形凹陷区域，所述下表面设置有锥形凹陷部；所述胫骨托与所述衬垫之间通过所述胫骨托的锥形突出部与所述衬垫的锥形凹陷部锁紧。
13.如权利要求11所述组配式MTS内侧胫骨平台补片，其特征在于，所述胫骨托的底面设有骨小梁多孔结构层，厚度为1-5mm。
14.如权利要求11所述组配式MTS内侧胫骨平台补片，其特征在于，所述胫骨托的材料为医用钛合金或钴铬钼合金或聚醚醚酮(PEEK)或其衍生物，所述衬垫的材料为VE高交联聚乙烯。
15.一种用于置换所述的MTS内侧胫骨平台补片或组配式MTS内侧胫骨平台补片的微创置换方法，其特征在于，采用髌旁入路小切口的微创手术方法暴露患者的患肢胫骨内侧或外侧平台，按照术前计划的冠状位内外翻角度及矢状位后倾角度切除病变胫骨的骨组织，将MTS内侧胫骨平台补片植入被切除的胫骨上，所述一体式的MTS内侧胫骨平台补片与所述被切除的胫骨采用水泥固定，所述组配式MTS内侧胫骨平台补片与所述被切除的胫骨采用生物固定。
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