TWI682791B

TWI682791B - Cartilage implant

Info

Publication number: TWI682791B
Application number: TW107141997A
Authority: TW
Inventors: 黃建元; 王禎麒; 黃世樺
Original assignee: 財團法人金屬工業研究發展中心
Priority date: 2018-11-26
Filing date: 2018-11-26
Publication date: 2020-01-21
Also published as: TW202019497A

Abstract

A Cartilage Implant adapted to be implanted to an opening on a bone structure. The bone structure includes a bone layer and a cartilage layer. The cartilage implant concluding a bracket adapted to be installed into the opening and link up with the bone layer, a combine layer mounted on the bracket, and a surface layer formed on the combine layer. The combine layer includes a bottom part connected to the bracket, and a plurality of extension parts extending from the bottom part to define multiple accommodating areas. The surface layer is composed of multiple micro bubbles. And the surface-layer includes a plurality of filling parts which fills the micro bubbles, and a tissue part connecting with the filling parts and adapted to link up with the cartilage layer.

Description

軟骨植體Cartilage implant

本發明是有關於一種用於骨骼的植入物，特別是指一種軟骨植體。The invention relates to an implant for bones, in particular to a cartilage implant.

軟骨組織為脊椎動物特有的骨骼種類，藉由其略帶彈性以及堅韌的物理性質，能在關節活動時產生潤滑甚至緩衝效果，確保關節活動時的順暢度，也對硬骨產生支撐及保護的作用。軟骨組織的主要成分為膠原蛋白以及纖維質，當軟骨組織在長期磨耗下受損時，傳統會配合受損處的形狀，如圖1所示地直接以一對應形狀的膠原蛋白薄膜11來填補破損處，藉此達成修補軟骨組織的目的。然而，直接在表面修補的手法，並未與硬骨組織有完整連結，造成填入的膠原蛋白薄膜11固定性不佳，不但容易再次剝離、脫落，也難以與生物體形成較佳的融合性。Cartilage tissue is a type of bone unique to vertebrates. With its slightly elastic and tough physical properties, it can produce lubrication and even cushioning effects when joints are in motion, ensuring smoothness during joint movements and also supporting and protecting hard bones. . The main components of cartilage tissue are collagen and fibrous. When cartilage tissue is damaged under long-term wear, the traditional shape will match the shape of the damaged area. As shown in FIG. 1, it is directly filled with a corresponding shape of collagen film 11 The damaged part, so as to achieve the purpose of repairing cartilage tissue. However, the method of repairing directly on the surface is not completely connected to the hard bone tissue, resulting in poor fixation of the filled collagen film 11, which is not only easy to peel off and fall off again, but also difficult to form a better fusion with the organism.

參閱圖2，為一現有的軟骨植入物12，適用於植入一產生一破損處200的骨骼2，該骨骼2包含一硬骨21，及一包覆於該硬骨21的軟骨層22。該軟骨植入物12除了直接填補於該破損處200而達成修補該軟骨層22的效果以外，還穿設固定於該骨骼2的硬骨21，藉此強化固定的強度。然而，該軟骨植入物12僅有修補的功能，在長期使用下仍會產生磨耗，甚至在未與生物體細胞相容而無法提供軟骨再生功能的情況下，還會與周遭的該軟骨層22產生摩擦，使得該軟骨層22產生纖維化，造成潤滑度的下降。Referring to FIG. 2, it is a conventional cartilage implant 12 suitable for implanting a bone 2 that produces a break 200. The bone 2 includes a hard bone 21 and a cartilage layer 22 covering the hard bone 21. The cartilage implant 12 not only directly fills the damaged portion 200 to achieve the effect of repairing the cartilage layer 22, but also penetrates the hard bone 21 fixed to the bone 2, thereby strengthening the strength of the fixation. However, the cartilage implant 12 has only the function of repairing, and it will still cause wear under long-term use, even if it is not compatible with biological cells and cannot provide cartilage regeneration function, it will also interact with the surrounding cartilage layer. 22 generates friction, causing fibrosis of the cartilage layer 22, resulting in a decrease in lubricity.

參閱圖3，為另一種軟骨植入物13，包含一適用於設置在該硬骨21表面並與該軟骨層22接合的支架131，及一搭載於該支架131上的細胞層132。透過該細胞層132，能提升軟骨修復效率以及成功率。然而，雖然該軟骨植入物13能產生軟骨修復的效果，但因該支架131並未完整嵌入該硬骨21，而只是與周遭的該軟骨層22接合，不但結合強度仍有所疑慮，在軟骨組織成長時，也只能沿該軟骨層22的表層延伸方向形成二維生長，進而發展為潤滑性較差的纖維軟骨，而非預期之潤滑性較佳的透明軟骨。Referring to FIG. 3, another cartilage implant 13 includes a scaffold 131 adapted to be disposed on the surface of the hard bone 21 and joined to the cartilage layer 22, and a cell layer 132 mounted on the scaffold 131. Through the cell layer 132, the cartilage repair efficiency and success rate can be improved. However, although the cartilage implant 13 can produce the effect of cartilage repair, the scaffold 131 is not completely embedded in the hard bone 21, but is only engaged with the surrounding cartilage layer 22. Not only is the bonding strength still doubtful, but also in the cartilage When the tissue grows, it can only form a two-dimensional growth along the extension direction of the surface layer of the cartilage layer 22, and then develop into a fibrous cartilage with poor lubricity, rather than a transparent lubricating cartilage with better lubricity.

因此，本發明之目的，即在提供一種結合穩定性高，並有利於再生為透明軟骨的軟骨植體。Therefore, the object of the present invention is to provide a cartilage implant with high binding stability and beneficial for regeneration into hyaline cartilage.

於是，本發明軟骨植體，適用於植入一形成有一預鑽孔的骨骼，該骨骼包含一硬骨層，及一貼附於該硬骨層表面的軟骨層。本發明軟骨植體包含一適用於設置於該預鑽孔中而與該硬骨層相互銜接的支架、一設置於該支架相對外側的結合層，及一形成於該結合層上的表面層。Therefore, the cartilage implant of the present invention is suitable for implanting a bone formed with a pre-drilled hole. The bone includes a hard bone layer and a cartilage layer attached to the surface of the hard bone layer. The cartilage implant of the present invention includes a bracket suitable for being disposed in the pre-drilled hole to connect with the hard bone layer, a bonding layer disposed on the opposite outer side of the bracket, and a surface layer formed on the bonding layer.

該結合層包括一個一體結合於該支架的底部，及多個自該底部以遠離該支架之方向延伸，且彼此相互間隔界定出多個容置區的延伸部。The bonding layer includes a bottom integrated with the bracket, and a plurality of extensions extending from the bottom in a direction away from the bracket and spaced apart from each other to define a plurality of receiving areas.

該表面層是以多個微球堆疊所構成，並包括多個填充於該等容置區的填充部，及一個一體連接於該等填充部，且適用於銜接該軟骨層而共同形成一軟骨結構面的組織部。The surface layer is formed by stacking a plurality of microspheres, and includes a plurality of filling parts filled in the accommodating regions, and an integrally connected to the filling parts, and suitable for connecting the cartilage layer to form a cartilage together The structural department of the structural plane.

本發明之功效在於：藉由植入該骨骼之預鑽孔的該支架與該硬骨層相互銜接，能有效提高結合的穩定性，且該表面層銜接於該軟骨層後，該軟骨層正常生長的細胞得以透過該等微球，形成三維結構的生長組織，有利於重新成長為結構較為緊實的透明軟骨，確實能修補軟骨破損，並與該軟骨層一同維持該軟骨層的既有功能。The effect of the present invention is that the pre-drilled scaffold implanted into the bone is connected to the hard bone layer to effectively improve the stability of the bond, and after the surface layer is connected to the cartilage layer, the cartilage layer grows normally The cells can penetrate these microspheres to form a three-dimensional structure of growth tissue, which is conducive to re-grow into a more compact hyaline cartilage, can indeed repair cartilage damage, and maintain the existing function of the cartilage layer together with the cartilage layer.

在本發明被詳細描述之前，應當注意在以下的說明內容中，類似的元件是以相同的編號來表示。Before the present invention is described in detail, it should be noted that in the following description, similar elements are denoted by the same numbers.

參閱圖4，本發明軟骨植體之一第一實施例，適用於植入一形成有一預鑽孔900的骨骼9，該骨骼9包含一硬骨層91，及一貼附於該硬骨層91表面的軟骨層92，且該預鑽孔900至少深及該硬骨層91的一部分。本第一實施例包含一適用於設置於該預鑽孔900中而與該硬骨層91相互銜接的支架3、一設置於該支架3相對外側的結合層4，及一形成於該結合層4上的表面層5。Referring to FIG. 4, a first embodiment of a cartilage implant according to the present invention is suitable for implanting a bone 9 formed with a pre-drilled hole 900. The bone 9 includes a hard bone layer 91 and a surface attached to the hard bone layer 91 The cartilage layer 92, and the pre-drilled hole 900 is at least deep and a part of the hard bone layer 91. The first embodiment includes a bracket 3 suitable for being disposed in the pre-drilled hole 900 and connected with the hard bone layer 91, a bonding layer 4 disposed on the opposite outer side of the bracket 3, and a bonding layer 4 formed on the bonding layer 4上的层层5。 5. The surface layer 5.

該支架3是以多孔性的生醫材質所製成，且為可生物降解及可吸收的材質。其中，該支架3的孔隙率為40~70%，且較佳為50%，在與該硬骨層91相互結合時，能因生物體細胞成長而形成連結效果，優化該支架3與該硬骨層91的結合穩定性，也藉由孔隙率來調整適當的材質密度，使得所採用之生醫材質較容易降解而為生物體所吸收，提高與生物體的相容性。例如，生醫材質可為人工合成陶瓷、高分子複合材料，或是動物/人體骨組織等。The bracket 3 is made of porous biomedical material, and is a biodegradable and absorbable material. Among them, the porosity of the scaffold 3 is 40 to 70%, and preferably 50%, when combined with the hard bone layer 91, the connection effect can be formed due to the growth of biological cells, and the scaffold 3 and the hard bone layer are optimized The binding stability of 91 also adjusts the appropriate material density through the porosity, so that the biomedical material used is more easily degraded and absorbed by the organism, improving the compatibility with the organism. For example, the biomedical material can be synthetic ceramics, polymer composites, or animal/human bone tissue.

同時參閱圖4與圖5，該結合層4包括一個一體結合於該支架3的底部41，及多個自該底部41以遠離該支架3之方向延伸，且彼此相互間隔界定出多個容置區400的延伸部42。其中，該結合層4是採用與該支架3相同的生醫材質所製成，結合層4的孔隙率為60%~70%，特別較佳為70%。結合層4具有較大的孔隙率是為了使表面層5能順利進入結合層4並與之結合。而每一延伸部42具有一連接於該底部41的直桿段421，及一個一體銜接於該直桿段421遠離該底部41之一端的倒鉤段422。4 and FIG. 5 at the same time, the bonding layer 4 includes a bottom 41 integrally integrated with the bracket 3, and a plurality of extending from the bottom 41 away from the bracket 3 in a direction away from each other defines a plurality of accommodating spaces区400的伸部42。 The extension 42 of the area 400. Wherein, the bonding layer 4 is made of the same biomedical material as the stent 3, and the porosity of the bonding layer 4 is 60% to 70%, particularly preferably 70%. The bonding layer 4 has a relatively large porosity so that the surface layer 5 can smoothly enter and bond with the bonding layer 4. Each extension 42 has a straight rod section 421 connected to the bottom 41, and a barb section 422 integrally connected to one end of the straight rod section 421 away from the bottom 41.

該表面層5是以多個相互堆疊的微球所構成，材料則是選自高分子材料、明膠、膠原蛋白，或其任意組合，而該表面層5包括多個填充於該等容置區400的填充部51，及一個一體連接於該等填充部51，且適用於銜接該軟骨層92而共同形成一軟骨結構面的組織部52。其中，所述微球的大小可限制在80~500微米。The surface layer 5 is composed of a plurality of microspheres stacked on top of each other, and the material is selected from polymer materials, gelatin, collagen, or any combination thereof, and the surface layer 5 includes a plurality of filling areas The filling portion 51 of 400, and a tissue portion 52 integrally connected to the filling portions 51 and adapted to connect the cartilage layer 92 to form a cartilage structure plane. Wherein, the size of the microsphere can be limited to 80-500 microns.

在本實施例中，該表面層5是以多個分別圍繞界定出一內腔500的微泡50（即一空心微球）所構成，製作該表面層5時，是先在調配材料後，逐一使所調配的材料形成微泡50，接著再使多個微泡50逐漸填補該等延伸部42所形成的容置區400，此時該等延伸部42的倒鉤段422即可利用其結構的特性，達成定位該等填充部51的效果。直到該等微泡50滿溢出該等容置區400，將逐漸相互堆疊為層狀的該組織部52，即可形成該表面層5的結構。最後，透過抽真空的方式，可讓該等微泡50相鄰接觸的位置破裂而連通，該等微泡50所界定的該等內腔500即能如圖6所示地相互連通，使得該等內腔500能共同形成一個與外界連通之三維網狀結構。In this embodiment, the surface layer 5 is composed of a plurality of microbubbles 50 (ie, a hollow microsphere) that respectively define an inner cavity 500. When the surface layer 5 is fabricated, the materials are prepared first. The prepared materials are formed into microbubbles 50 one by one, and then a plurality of microbubbles 50 are gradually filled into the accommodating area 400 formed by the extensions 42. At this time, the barb segments 422 of the extensions 42 can use the The characteristics of the structure achieve the effect of locating the filling portions 51. Until the microbubbles 50 overflow the accommodating regions 400, the tissue portion 52 will gradually be stacked on top of each other to form the structure of the surface layer 5. Finally, by evacuating, the adjacent positions of the microbubbles 50 can be broken and connected, and the inner cavities 500 defined by the microbubbles 50 can communicate with each other as shown in FIG. The inner cavity 500 can form a three-dimensional network structure communicating with the outside world.

要特別說明的是，在本第一實施例中，每一延伸部42是藉由個別的倒鉤段422來達成定位效果，但實際實施時，也能利用其他型態的結構達成定位該等微泡50，也就是該表面層5之該等填充部51的效果，並不以此為限。It should be particularly noted that, in the first embodiment, each extending portion 42 is achieved by a separate barb segment 422, but in actual implementation, other types of structures can also be used to achieve positioning. The effect of the microbubbles 50, that is, the filled portions 51 of the surface layer 5, is not limited to this.

參閱圖7與圖8，將該第一實施例植入該骨骼9的該預鑽孔900時，該支架3是與該硬骨層91相結合，並利用該硬骨層91之細胞的自然生長，滲入該支架3的孔隙中，確保該第一實施例得以穩定地固定於該預鑽孔900中。而該軟骨層92為了修復而生長的軟骨細胞，將進入該等微泡50與外界連通的該等內腔500，當所述的軟骨細胞逐漸生長而填補該等內腔500所形成的三維網狀結構，較佳地，配合以含有膠原蛋白成分之該組織部52(繪示於圖4)，即有利於因三維生長而形成養分交換的優異條件，優化細胞訊息交流而保持活性，降低生長之軟骨組織纖維化的機率，因而較能生長而替補原先破損的軟骨。7 and 8, when the first embodiment is implanted into the pre-drilled hole 900 of the bone 9, the scaffold 3 is combined with the hard bone layer 91 and utilizes the natural growth of the cells of the hard bone layer 91, Infiltration into the pores of the bracket 3 ensures that the first embodiment is stably fixed in the pre-drilled hole 900. The chondrocytes grown by the cartilage layer 92 for repair will enter the inner cavities 500 where the microbubbles 50 communicate with the outside world. When the chondrocytes gradually grow to fill the three-dimensional network formed by the inner cavities 500 The shape-like structure, preferably combined with the tissue part 52 (shown in FIG. 4) containing collagen components, is conducive to the excellent conditions for the formation of nutrient exchange due to three-dimensional growth, optimizing the communication of cellular information while maintaining activity and reducing growth The probability of fibrosis of cartilage tissue, so it can grow and replace the original damaged cartilage.

在其他應用上，該表面層5亦可由多個實心微球所構成，而該軟骨層92為了修復而生長的軟骨細胞，將進入該多個實心微球間的孔隙，當軟骨細胞逐漸生長而填補該等孔隙所形成的三維網狀結構，亦能替補原先破損的軟骨。In other applications, the surface layer 5 may also be composed of a plurality of solid microspheres, and the chondrocytes grown by the cartilage layer 92 for repair will enter the pores between the plurality of solid microspheres, when the chondrocytes gradually grow and The three-dimensional network structure formed by filling these pores can also replace the originally damaged cartilage.

參閱圖9，為本發明軟骨植體的一第二實施例，該第二實施例與該第一實施例的差別在於：該第二實施例還包含一設置於該支架3與該結合層4之間，且用以形成該支架3與該表面層5之隔離效果的隔離層6。其中，該隔離層6的孔隙率小於該支架3及該結合層4的孔隙率，該隔離層的孔隙率為5%~15%，且較佳為10%。9 is a second embodiment of the cartilage implant of the present invention. The difference between the second embodiment and the first embodiment is that the second embodiment further includes a bracket 3 and the bonding layer 4 And used to form the isolation layer 6 between the bracket 3 and the surface layer 5. Wherein, the porosity of the isolation layer 6 is less than the porosity of the bracket 3 and the bonding layer 4, and the porosity of the isolation layer is 5% to 15%, and preferably 10%.

該隔離層6的目的，在於利用孔隙率較低而難以滲透的性質，隔離當該支架3生物降解後可能滲入該表面層5的組織液，確保該表面層5能發揮利於細胞發展為軟骨的效果。也就是說，該第二實施例除了得以達成與該第一實施例相同的效果之外，更可透過該隔離層6進一步防止組織液造成的不良影響。The purpose of the isolation layer 6 is to use the property of low porosity and difficult penetration, to isolate the tissue fluid that may infiltrate the surface layer 5 after the scaffold 3 is biodegraded, to ensure that the surface layer 5 can play an effect that facilitates the development of cells into cartilage . That is to say, in addition to achieving the same effect as the first embodiment, the second embodiment can further prevent the adverse effects caused by the tissue fluid through the isolation layer 6.

綜上所述，本發明軟骨植體，能透過該支架3提高結合的穩定性，並利用該表面層5的該等微球，構成使該軟骨層92重新發展出軟骨的生長條件，藉此達成優異的修復效果，故確實能達成本發明之目的。In summary, the cartilage implant of the present invention can improve the stability of bonding through the scaffold 3, and use the microspheres of the surface layer 5 to form a growth condition for the cartilage layer 92 to redevelop cartilage, thereby Achieve excellent repair effect, so it can really achieve the purpose of cost invention.

惟以上所述者，僅為本發明之實施例而已，當不能以此限定本發明實施之範圍，凡是依本發明申請專利範圍及專利說明書內容所作之簡單的等效變化與修飾，皆仍屬本發明專利涵蓋之範圍內。However, the above are only examples of the present invention, and should not be used to limit the scope of the present invention. Any simple equivalent changes and modifications made according to the scope of the patent application of the present invention and the content of the patent specification are still classified as This invention covers the patent.

3‧‧‧支架 4‧‧‧結合層 400‧‧‧容置區 41‧‧‧底部 42‧‧‧延伸部 421‧‧‧直桿段 422‧‧‧倒鉤段 5‧‧‧表面層 50‧‧‧微泡 500‧‧‧內腔 51‧‧‧填充部 52‧‧‧組織部 6‧‧‧隔離層 9‧‧‧骨骼 900‧‧‧預鑽孔 91‧‧‧硬骨層 92‧‧‧軟骨層3‧‧‧Bracket 4‧‧‧Combination layer 400‧‧‧accommodation area 41‧‧‧Bottom 42‧‧‧Extension 421‧‧‧Straight rod section 422‧‧‧Barb section 5‧‧‧Surface layer 50‧‧‧Microbubble 500‧‧‧Inner cavity 51‧‧‧Filling Department 52‧‧‧Organization Department 6‧‧‧Isolation layer 9‧‧‧Bone 900‧‧‧Pre-drilled 91‧‧‧ Hard bone layer 92‧‧‧ Cartilage layer

本發明之其他的特徵及功效，將於參照圖式的實施方式中清楚地呈現，其中：圖1是一示意圖，說明傳統採用一膠原蛋白薄膜修補軟骨破損處的技術；圖2是一剖視示意圖，說明一種現有的軟骨植入物；圖3是一剖視示意圖，說明另一種現有的軟骨植入物；圖4是一示意圖，說明本發明軟骨植體的一第一實施例；圖5是一局部剖視圖，說明該第一實施例的一結合層；圖6是一示意圖，說明該第一實施例的一表面層；圖7是一立體分解圖，說明使用該第一實施例植入一骨骼之一預鑽孔的情況；圖8是一示意圖，說明本第一實施例的功效；及圖9是一類似圖4的示意圖，說明本發明軟骨植體的一第二實施例。Other features and functions of the present invention will be clearly presented in the embodiment with reference to the drawings, in which: FIG. 1 is a schematic diagram illustrating a traditional technique for repairing damaged cartilage with a collagen film; FIG. 2 is a cross-sectional view Schematic diagram illustrating an existing cartilage implant; Figure 3 is a schematic sectional view illustrating another existing cartilage implant; Figure 4 is a schematic diagram illustrating a first embodiment of the cartilage implant of the present invention; Figure 5 Is a partial cross-sectional view illustrating a bonding layer of the first embodiment; FIG. 6 is a schematic diagram illustrating a surface layer of the first embodiment; FIG. 7 is a perspective exploded view illustrating implantation using the first embodiment FIG. 8 is a schematic diagram illustrating the efficacy of the first embodiment; and FIG. 9 is a schematic diagram similar to FIG. 4 illustrating a second embodiment of the cartilage implant of the present invention.

3‧‧‧支架 3‧‧‧Bracket

4‧‧‧結合層 4‧‧‧Combination layer

41‧‧‧底部 41‧‧‧Bottom

42‧‧‧延伸部 42‧‧‧Extension

5‧‧‧表面層 5‧‧‧Surface layer

50‧‧‧微泡 50‧‧‧Microbubble

51‧‧‧填充部 51‧‧‧Filling Department

52‧‧‧組織部 52‧‧‧Organization Department

9‧‧‧骨骼 9‧‧‧Bone

900‧‧‧預鑽孔 900‧‧‧Pre-drilled

91‧‧‧硬骨層 91‧‧‧ Hard bone layer

92‧‧‧軟骨層 92‧‧‧ Cartilage layer

Claims

一種軟骨植體，適用於植入一形成有一預鑽孔的骨骼，該骨骼包含一硬骨層，及一貼附於該硬骨層表面的軟骨層，該軟骨植體包含：一支架，適用於設置於該預鑽孔中而與該硬骨層相互銜接；一結合層，設置於該支架相對外側，並包括一個一體結合於該支架的底部，及多個自該底部以遠離該支架之方向延伸，且彼此相互間隔界定出多個容置區的延伸部；及一表面層，形成於該結合層上，是以多個微球堆疊所構成，該表面層包括多個填充於該等容置區的填充部，及一個一體連接於該等填充部，且適用於銜接該軟骨層而共同形成一軟骨結構面的組織部。A cartilage implant is suitable for implanting a bone formed with a pre-drilled hole, the bone includes a hard bone layer, and a cartilage layer attached to the surface of the hard bone layer, the cartilage implant includes: a bracket, suitable for setting In the pre-drilled hole to connect with the hard bone layer; a bonding layer is provided on the opposite outer side of the bracket, and includes a bottom integrally integrated with the bracket, and a plurality of directions extending from the bottom away from the bracket, And an extension portion defining a plurality of accommodating regions at intervals from each other; and a surface layer formed on the bonding layer, which is formed by stacking a plurality of microspheres, the surface layer includes a plurality of filling the accommodating regions And a tissue part integrally connected to the filler parts and suitable for connecting the cartilage layer to form a cartilage structure plane.

如請求項1所述的軟骨植體，其中，該多個微球為多個實心微球。The cartilage implant according to claim 1, wherein the plurality of microspheres are solid microspheres.

如請求項1所述的軟骨植體，其中該多個微球是以多個分別圍繞界定出一內腔的微泡所構成，該等微泡所界定的該等內腔相互連通。The cartilage implant as claimed in claim 1, wherein the plurality of microspheres are composed of a plurality of microbubbles that respectively define an inner cavity, and the inner cavities defined by the microbubbles communicate with each other.

如請求項1至3之任一項所述的軟骨植體，還包含一設置於該支架與該結合層之間，且用以形成該支架與該表面層之隔離效果的隔離層。The cartilage implant according to any one of claims 1 to 3, further comprising an isolation layer disposed between the scaffold and the bonding layer and used to form an isolation effect between the scaffold and the surface layer.

如請求項4所述的軟骨植體，其中，該隔離層的孔隙率小於該支架及該結合層的孔隙率。The cartilage implant of claim 4, wherein the porosity of the isolation layer is smaller than the porosity of the scaffold and the bonding layer.

如請求項5所述的軟骨植體，其中，該隔離層的孔隙率為5%~15%，該支架的孔隙率為40%~70%，而該結合層的孔隙率為60%~70%。The cartilage implant according to claim 5, wherein the porosity of the isolation layer is 5% to 15%, the porosity of the scaffold is 40% to 70%, and the porosity of the bonding layer is 60% to 70 %.

如請求項4所述的軟骨植體，其中，該隔離層是以多孔性之可生物降解及可吸收的生醫材質所製成。The cartilage implant of claim 4, wherein the isolation layer is made of porous biodegradable and absorbable biomedical material.

如請求項1至3之任一項所述的軟骨植體，其中，該支架及該結合層是以多孔性之可生物降解及可吸收的生醫材質所製成。The cartilage implant according to any one of claims 1 to 3, wherein the scaffold and the bonding layer are made of porous biodegradable and absorbable biomedical materials.

如請求項1至3之任一項所述的軟骨植體，其中，該結合層的每一延伸部具有一連接於該底部的直桿段，及一個一體銜接於該直桿段遠離該底部之一端的倒鉤段。The cartilage implant according to any one of claims 1 to 3, wherein each extension of the bonding layer has a straight rod segment connected to the bottom, and an integrally connected to the straight rod segment away from the bottom Barb segment at one end.

如請求項1至3之任一項所述的軟骨植體，其中，該表面層的材料是選自高分子材料、明膠、膠原蛋白，或其任意組合。The cartilage implant according to any one of claims 1 to 3, wherein the material of the surface layer is selected from a polymer material, gelatin, collagen, or any combination thereof.