TWI615136B - Intervertebral implant and preparation method thereof - Google Patents
Intervertebral implant and preparation method thereof Download PDFInfo
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Abstract
一種椎間植入物，特別係指一種利用多孔氫氧基磷灰石為支架模型填入金屬粉體後經燒結成形，組成局部可降解之氫氧基磷灰石/金屬塊材之椎間植入物，隨植入人體時間氫氧基磷灰石結構逐步進行降解，並引導骨組織攀附於多孔金屬內部，形成穩固上部與下部骨頭融合效果。 An intervertebral implant, in particular, a porous interstitial apatite as a scaffold model filled with metal powder and sintered to form a partially degradable interstitial intervertebral hydroxide / metal block The implant gradually degrades the hydroxyapatite structure as it is implanted into the body, and guides the bone tissue to cling to the inside of the porous metal, forming a stable fusion effect of the upper and lower bones.
Description
本發明係關於一種醫療植入體之技術領域，具體而言係指一種局部可降解且呈多孔型態之椎間植入物，藉以組成局部可降解之氫氧基磷灰石及金屬混合塊材，從而引導骨再生且形成穩固上、下部骨頭融合之效果。 The present invention relates to the technical field of a medical implant, specifically refers to a partially degradable and porous intervertebral implant, thereby forming a locally degradable mixed block of hydroxide apatite and metal Materials to guide bone regeneration and form a solid fusion of upper and lower bones.
按，腰椎椎間融合術，意指從兩節脊椎中取出椎間盤，然後把二者融合起來。這個步驟又名為「脊柱融合術」。通常用於治療由脊椎退化、椎間盤突出等脊柱病而引致的持續背痛、坐骨神經痛或雙腿酸軟無力等病患。脊柱融合也是矯正脊柱畸形(如脊柱側彎、脊椎滑脫或脊柱創傷等)手術的其中重要環節。 Pressing, lumbar interbody fusion, means removing the disc from two vertebrae and then fusing the two together. This step is also called "spine fusion". It is commonly used to treat patients with persistent back pain, sciatica, or sore legs caused by spinal diseases such as spinal degeneration and disc herniation. Spinal fusion is also an important part of surgery to correct spinal deformities (such as scoliosis, spondylolisthesis, or spinal trauma).
如果修復骨組織的種植體(或用以修復骨組織之植入物)在提供支撐功能的同時是生物可吸收的，在實際應用上會有極大的好處。現有的脊柱融合裝置是由一個金屬骨架和置於其內的生物可吸收材料組成的，例如美國專利號5,645,598所示的裝置。惟，該些用以修復骨組織之種植體係置於兩節脊椎骨之間，卻礙於該種植體本身硬度不足及相對體積小於該脊椎骨，致使該種植體產生下沉現象，反而相互磨損甚至破壞了脊椎骨與脊 椎骨之間的骨組織，特別是對脊椎骨的末端平面更是帶來嚴重傷害。 If an implant that repairs bone tissue (or an implant used to repair bone tissue) is bioabsorbable while providing support, it will have great benefits in practical applications. The existing spinal fusion device is composed of a metal skeleton and a bioabsorbable material placed therein, such as the device shown in US Patent No. 5,645,598. However, these implant systems for repairing bone tissue are placed between the two vertebrae, but the implant itself is insufficient in hardness and the relative volume is smaller than the vertebrae, causing the implant to sink, and instead wear and even damage each other. Vertebrae and spine The bone tissue between the vertebrae, especially the end plane of the vertebrae, causes serious damage.
另，目前用於組織工程學技術的支架(大部分由可生物降解的聚合物製成)具有多孔的結構可以允許細胞培養過程中活體細胞(通常取自治療中的患者)滲入結構內。經過一段時間的細胞培養，此種有細胞的支架被植入去除免疫系統的動物(例如大鼠)或患者本人體內(為便於後續操作通常是在皮下)。在此期間(數周到數月)細胞吸收動物或患者體內提供的營養成分而迅速繁殖，同時支架本身逐漸溶解吸收。之後，就從動物或患者的皮下取出種植體(一個真正的骨組織)，重新植入需要治療的(受傷或患病)部位。例如US6,139,578；US6,200,606；US5,306,303和US6,132,463等案所描述者。 In addition, the scaffolds currently used for tissue engineering techniques (mostly made of biodegradable polymers) have a porous structure that allows living cells (usually taken from patients under treatment) to penetrate into the structure during cell culture. After a period of cell culture, such a scaffold with cells is implanted in an animal (such as a rat) or the patient who has the immune system removed (usually under the skin to facilitate subsequent operations). During this period (weeks to months), the cells absorb nutrients provided by the animal or patient and rapidly multiply, while the scaffold itself gradually dissolves and absorbs. After that, the implant (a real bone tissue) is removed from the animal or patient's skin and re-implanted into the area that needs treatment (injury or disease). For example, those described in US 6,139,578; US 6,200,606; US 5,306,303 and US 6,132,463.
但，如果用於組織工程技術的支架可被生物吸收、有充足的孔隙同時又可以提供支援，那麼這樣的材料就有很大的優越性。其中如中國專利CN 119346A：一種含有成孔劑的多孔磷酸鈣骨水泥，其特徵在於是由常規的磷酸鈣骨水泥和成孔劑所組成，所說的成孔劑為微溶性鹽、酸式鹽和鹼式鹽或表面活性劑中的一種或一種以上。但其為無固定型態骨水泥，其機械強度差，無法單獨使用作為骨融合物。 However, if the scaffold used in tissue engineering technology is bioabsorbable, has sufficient porosity and can provide support, then such a material has great advantages. Among them, such as Chinese Patent CN 119346A: a porous calcium phosphate bone cement containing a pore-forming agent, characterized by being composed of a conventional calcium phosphate bone cement and a pore-forming agent, the pore-forming agent is a slightly soluble salt, acid One or more of salts and basic salts or surfactants. However, it is an unfixed bone cement, which has poor mechanical strength and cannot be used alone as a bone fusion.
又如中國專利CN 101099873A：一種多孔鎂/羥基磷灰石的生產工藝方法，其特徵是將羥基磷灰石粉和鎂粉按比例混合，冷壓成型，然後進行燒結，鎂在高溫下發生汽化、被蒸發，使羥基磷灰石形成多孔狀。惟鎂高溫移除後，僅剩多孔氫氧基磷灰石本體，一樣存在有機械強度差的問題。 Another example is the Chinese patent CN 101099873A: A production method of porous magnesium / hydroxyapatite, which is characterized in that hydroxyapatite powder and magnesium powder are mixed in proportion, cold-pressed and then sintered, and magnesium is vaporized at high temperature It is evaporated to make hydroxyapatite porous. However, after the magnesium is removed at high temperature, only the porous hydroxyapatite body remains, which also has the problem of poor mechanical strength.
另如中國專利CN 101797400A：一種含有HA奈米粉多孔可降解鎂合金骨支架材料，其特徵在於，所述的多孔可降解鎂合金骨支架材料由加入微量細化Zn晶粒的鎂粉、HA奈米粉，以及造孔劑組成，期中，鎂鋅合金粉微50~80%，HA奈米粉為10~20%，造孔劑組成，其中，鎂鋅合金粉微50~80%，HA奈米粉為10~20%，造孔劑為10~30%。惟鎂高溫移除後，僅剩多孔氫氧基磷灰石本體，一樣存在有機械強度差的問題。 Another example is the Chinese patent CN 101797400A: a porous degradable magnesium alloy bone scaffold material containing HA nano-powder, characterized in that the porous degradable magnesium alloy bone scaffold material is composed of magnesium powder and HA nanoparticles added with a small amount of refined Zn grains The composition of rice flour and pore-forming agent. In the interim, magnesium-zinc alloy powder is 50 ~ 80%, HA nano-powder is 10-20%. The pore-forming agent is composed of magnesium-zinc alloy powder 50-80%, HA nano-powder 10 ~ 20%, the pore-forming agent is 10 ~ 30%. However, after the magnesium is removed at high temperature, only the porous hydroxyapatite body remains, which also has the problem of poor mechanical strength.
再者，常規高溫(通常>1000℃)燒結的孔狀羥基磷灰石(HA)材料不具備足夠的微米/納米級的孔隙並且難以被生物體吸收。另一方面，常規用於骨架的可生物降解聚合物又有強度相對較低和溶解速率太高的缺點。換言之在考量輕量化、增加生物性結合的前題下，有必要發展能促進骨引導之連通多孔金屬醫材。 Furthermore, conventional high-temperature (usually> 1000 ° C) sintered porous hydroxyapatite (HA) materials do not have sufficient micro / nano-scale pores and are difficult to be absorbed by organisms. On the other hand, the biodegradable polymers conventionally used for backbones have the disadvantages of relatively low strength and too high dissolution rate. In other words, under the prerequisite of considering light weight and increasing biological integration, it is necessary to develop connected porous metal medical materials that can promote bone guidance.
本案發明人鑑於上述習用促進骨引導之連通多孔金屬醫材所衍生的各項缺點，乃亟思加以改良創新，終於成功研發完成本件一種椎間植入物。 In view of the above-mentioned shortcomings derived from the conventional porous metal medical materials that promote bone guidance, the inventor of the present case is eager to improve and innovate, and finally successfully developed this intervertebral implant.
本發明之目的即在於提供一種椎間植入物，藉以能組成局部可降解之氫氧基磷灰石/金屬塊材之椎間植入物，隨植入人體時間氫氧基磷灰石結構逐步進行降解，並引導骨組織攀附於多孔金屬內部，形成穩固上部與下部骨頭融合效果。 The purpose of the present invention is to provide an intervertebral implant, whereby an intervertebral implant that can form a partially degradable hydroxyapatite / metal block material, and the hydroxyapatite structure is implanted with the human body time Gradually degrade and guide bone tissue to attach to the porous metal, forming a stable fusion effect of the upper and lower bones.
本發明之次一目的係在於提供一種椎間植入 物，為使用陶瓷材料或金屬材料的可降解高分子材料或複合物，按照仿生原理設計製造具有優異性能和結構的材料，並具有調節材料的降解速率。 The second object of the present invention is to provide an intervertebral implant It is a degradable polymer material or composite that uses ceramic materials or metal materials. It is designed and manufactured according to the principle of bionics to have materials with excellent performance and structure, and has the ability to adjust the degradation rate of the material.
本發明之另一目的係在於提供一種具備細胞的生物學行為和培養效率的支架材料，當椎間植入物移植後能與人體腔洞具有很好的適應、結合和修復的椎間植入物。 Another object of the present invention is to provide a scaffold material with biological behavior and culture efficiency of cells, which can be well adapted, combined and repaired with the cavity of the human body after the intervertebral implant is transplanted Thing.
本發明之又一目的係在於提供一種具有良好的生物相容性的椎間植入物，該椎間植入物在體外培養時具備無細胞毒性，植入人體內時不會引起人體骨的排斥反應的優點。 Another object of the present invention is to provide an intervertebral implant with good biocompatibility. The intervertebral implant is non-cytotoxic when cultured in vitro and does not cause human bones when implanted in the human body. The advantages of rejection.
本發明之再一目的係在於提供一種椎間植入物，該椎間植入物具有三維立體結構，且具有高度多孔狀結構，該椎間植入物具有很大的內表面積，以有利於細胞的植入、粘附，又有利於細胞營養成份的滲入和代謝產物的排出。 Another object of the present invention is to provide an intervertebral implant having a three-dimensional structure and a highly porous structure. The intervertebral implant has a large internal surface area to facilitate The implantation and adhesion of cells are also conducive to the penetration of cell nutrients and the discharge of metabolites.
本發明之他一目的係在於提供一種椎間植入物，該椎間植入物具有良好的表面活性，能促進細胞的粘附並為細胞在其表面的增殖提供良好的微環境。 Another object of the present invention is to provide an intervertebral implant with good surface activity, which can promote cell adhesion and provide a good microenvironment for cell proliferation on its surface.
可達成上述發明目的之一種椎間植入物，為利用多孔氫氧基磷灰石為支架模型填入金屬粉體後經燒結成形，組成局部可降解之氫氧基磷灰石/金屬塊材之椎間植入物，其製備方法，其包括有：步驟a、混合：將可於人體內產生降解作用之可降 解生物材與膠黏劑液體進行攪拌，而形成一種微黏稠液體；步驟b、沾覆：以多孔性之高分子支架沾覆上述微黏稠液體，使得該高分子支架表面及/或其腔洞狀之空間內披覆有該微黏稠液體；步驟c、烘乾定型：且在完成沾覆後進行烘乾，使微黏稠液體緊密的披覆於高分子支架與腔洞狀空間上，並依高分子支架與腔洞狀空間原始多孔排列不同，緊密披覆於表層而呈現相同之多孔排列；步驟d、燒結移除：以大氣爐體進行高溫燒結，而將高分子支架與膠黏劑移除，以獲得多孔排列的一可降解生物材支架；以及步驟e、填充繞結：利用該可降解生物材支架為支架模型填入金屬粉體，並進行真空高溫燒結，以獲得由可降解生物材與金屬粉體相互嵌合的一椎間植入物。 An intervertebral implant that can achieve the above-mentioned object of the invention is to use porous hydroxyapatite as a scaffold model filled with metal powder and then sintered to form a locally degradable hydroxyapatite / metal block Intervertebral implant, and its preparation method, including: step a, mixing: can reduce the degradation effect in the human body The biodegradable material and the adhesive liquid are stirred to form a micro-viscous liquid; Step b, dipping: the micro-viscous liquid is covered with a porous polymer scaffold to make the surface of the polymer scaffold and / or its cavity The micro-viscous liquid is covered in the shape-like space; Step c, drying and setting: and drying after the completion of the coating, so that the micro-viscous liquid is closely coated on the polymer support and the cavity-shaped space, and The original porous arrangement of the polymer scaffold and the cavity-shaped space is different, and it closely covers the surface layer to show the same porous arrangement; Step d. Sintering removal: high-temperature sintering with an atmospheric furnace body, and the polymer scaffold and the adhesive are moved In addition, a porous biodegradable biomaterial scaffold is obtained; and step e, filling and winding: using the biodegradable biomaterial scaffold as a scaffold model to fill in metal powder, and performing vacuum high temperature sintering to obtain biodegradable biomaterial An intervertebral implant fitted with metal powder and metal powder.
藉此，透過上述技術手段的具體實現，使得本發明可透過氫氧基磷灰石生物材料具有良好生物相容性、骨傳導性和生物降解性，氫氧基磷灰石/金屬塊材之椎間植入物內後可逐漸發生溶解和生物降解，一定時間後非生命的氫氧基磷灰石椎間植入物逐漸溶解消失，被有生命的新生骨組織所取代，亦使用氫氧基磷灰石/金屬塊材之椎間植入物植入人體腔洞，在氫氧基磷灰石/金屬塊材之椎間植入物植入人體腔洞內後逐漸引導骨組織長入腔洞狀空間，同時阻止軟組織的長入，從而實現氫氧基磷灰石/金屬塊材之椎間植入物在人體骨內牢固的機械結合，且能有效 增加產品的附加價值，並提升其經濟效益。 In this way, through the specific implementation of the above technical means, the permeable hydroxyapatite biomaterial of the present invention has good biocompatibility, bone conductivity and biodegradability. The intervertebral implant can gradually dissolve and biodegrade. After a certain period of time, the non-living hydroxyapatite intervertebral implant gradually dissolves and disappears, and is replaced by living new bone tissue. Hydrogen and oxygen are also used. The intervertebral implant based on apatite / metal block is implanted into the cavity of the human body, and the intervertebral implant based on the apatite / metal block is implanted into the cavity of the human body to gradually guide the bone tissue to grow into Cavity-like space, while preventing the growth of soft tissue, so as to achieve a strong mechanical combination of the hydroxyapatite / metal block intervertebral implant in the human bone, and can be effective Increase the added value of products and enhance their economic benefits.
圖1為本發明一種椎間植入物的簡要流程示意圖；圖2為該一種椎間植入物之步驟製成示意圖；附件1~附件4為細胞平攤於多孔金屬結構表面顯示皆為正常狀態細胞行為之作用圖。 Fig. 1 is a schematic flow diagram of an intervertebral implant of the present invention; Fig. 2 is a schematic diagram of the steps of manufacturing the intervertebral implant; Annexes 1 to 4 are cells spread on the surface of a porous metal structure, showing normal Diagram of the role of state cell behavior.
請參閱圖1，本發明所提供之一種椎間植入物，其係由金屬粉體與可降解生物材共同構成；其中，該可降解生物材係經燒結而具有複數連通孔，該金屬粉體則係填充於該複數連通孔內，並經燒結而與該可降解生物材相互嵌合。藉此，該椎間植入物所含有之可降解生物材遂可通過體液溶解和細胞介導的生物降解，一部分參與骨組織植入局部或遠端的骨組織重建，另一部分逐漸被代謝系統排出體外，最終使缺損部位完全被新生的骨組織替代，而該金屬支架同時起到永久支架作用，即骨組織工程支架材料。基於此，該可降解生物材亦可選擇由可吸收生物材所取代，以據相同原則達成如前所述之功效。 Please refer to FIG. 1, an intervertebral implant provided by the present invention is composed of a metal powder and a biodegradable biomaterial; wherein the biodegradable biomaterial is sintered to have a plurality of connecting holes, the metal powder The body is filled in the plurality of communication holes, and is sintered to fit with the degradable biological material. In this way, the biodegradable biomaterial contained in the intervertebral implant can be dissolved by body fluids and cell-mediated biodegradation, part of which is involved in the reconstruction of bone tissue implanted locally or distally, and the other part is gradually metabolized by the metabolic system After being excreted from the body, the defect is completely replaced by the new bone tissue, and the metal scaffold also serves as a permanent scaffold, that is, bone tissue engineering scaffold material. Based on this, the degradable bio-materials can also be replaced by absorbable bio-materials to achieve the aforementioned effects according to the same principles.
續參圖1及2，該椎間植入物係以下列步驟製成，包含：步驟a、混合：將可於人體內產生降解作用之可降解生物材與膠黏劑液體進行攪拌，其攪拌溫度1100~1300℃，攪拌混合 時間為10~60min，而形成一種微黏稠液體；其中，該可降解生物材可以選擇為氫氧基磷灰石，且該膠黏劑則可以選擇為聚乙酸乙烯酯(也稱作聚醋酸乙烯酯，簡稱PVA、PVAc)，其屬於一種有彈性的合成聚合物，較佳者，本實施例係由氫氧基磷灰石混和聚乙酸乙烯酯，以形成如圖2所示之氫氧基磷灰石/PVA漿料；步驟b、沾覆：以多孔性之高分子支架(high-molecular support)與上述微黏稠液體進行沾覆作業而於高分子支架表面及/或腔洞狀之空間內披覆有該微黏稠液體；其中該高分子支架為陶瓷材料或金屬材料所製成，其皆如圖2所示之高分子支架具有複數腔洞狀空間；步驟c、烘乾定型：且在完成沾覆後於烘箱進行烘乾，烘乾溫度50~100℃，烘乾定型時間為8~24hr，使微黏稠液體緊密的披覆於高分子支架表面及/或腔洞狀空間上，並依高分子支架及/或腔洞狀空間原始多孔排列不同，緊密披覆於表層而呈現相同多孔排列；較佳者，本實施例以該高分子支架沾附氫氧基磷灰石/PVA漿料後，係使得該高分子支架表面及其腔洞狀空間內均披覆有前述之漿料，且呈多孔型態排列；步驟d、燒結移除：以大氣爐體進行高溫燒結，高溫燒結溫度1100~1300℃，而將高分子支架與膠黏劑移除，進而獲得多孔排列的可降解生物材支架，詳參圖2；以及步驟e、填充繞結：利用多孔可降解生物材支架為支架模型(support mounting model)填入金屬粉體，其中該可降解生物材支架的支架模型可呈連通孔立體結構，且該可降解生物材支架的支架模型的線徑結構寬度為10μm~200μm，而金屬粉體 可選自能以燒結成形方式製備之鈦、鈦合金、鋯、鋯合金、鉭、鉭合金之其一或其一以上混合，且金屬粉體燒結後其呈現均一金屬球體結構大小，並等同於未燒結前金屬粉體粒徑，又金屬粉體粒徑介於10μm~100μm之間；待金屬粉體填入該高分子支架後，隨之進行真空高溫燒結，真空高溫燒結溫度較家係控制於1100~1300℃，烘乾定型時間為1~3hr，以獲得該可降解生物材與金屬粉體相互嵌合的該椎間植入物；較佳者，本實施例係獲得可如圖2之氫氧基磷灰石與金屬共同燒結而成的塊材結構(即圖面之一種局部可降解引導股再生之多孔金屬結構)，該塊材即為本發明之呈多孔型態的椎間植入物。 Continuing with reference to Figures 1 and 2, the intervertebral implant is made in the following steps, including: Step a, mixing: the biodegradable biological material that can produce degradation in the human body and the adhesive liquid are stirred, and the stirring Temperature 1100 ~ 1300 ℃, stirring and mixing The time is 10 ~ 60min, and a slightly viscous liquid is formed; wherein, the degradable biomaterial can be selected as hydroxide apatite, and the adhesive can be selected as polyvinyl acetate (also known as polyvinyl acetate) Ester, abbreviated as PVA, PVAc), which is a kind of elastic synthetic polymer. Preferably, this embodiment is composed of hydroxyl apatite mixed with polyvinyl acetate to form the hydroxyl group shown in FIG. 2 Apatite / PVA slurry; Step b, coating: the porous polymer scaffold (high-molecular support) and the above-mentioned slightly viscous liquid are used for the coating operation on the surface of the polymer scaffold and / or the cavity-like space The micro-viscous liquid is coated inside; wherein the polymer scaffold is made of ceramic material or metal material, and the polymer scaffold as shown in FIG. 2 has a plurality of cavity-shaped spaces; step c, drying and shaping: and After the coating is completed, it is dried in an oven. The drying temperature is 50 ~ 100 ℃, and the drying and setting time is 8 ~ 24hr, so that the micro-viscous liquid is closely coated on the surface of the polymer support and / or the cavity-like space. According to the original porous arrangement of the polymer scaffold and / or cavity-like space Differently, it closely covers the surface layer and exhibits the same porous arrangement; preferably, in this embodiment, the polymer scaffold is impregnated with hydroxyl apatite / PVA slurry to make the surface of the polymer scaffold and its cavity The space is covered with the aforementioned slurry and arranged in a porous pattern; Step d, sintering removal: high-temperature sintering with an atmospheric furnace body, high-temperature sintering temperature 1100 ~ 1300 ℃, and the polymer scaffold and adhesive The agent is removed to obtain a porous array of biodegradable biomaterial scaffolds, see Figure 2 for details; and step e, filling and winding: using a porous biodegradable biomaterial scaffold to fill the support model with metal powder, in which The support model of the biodegradable biomaterial support may have a three-dimensional structure of connecting holes, and the wire diameter structure width of the support model of the degradable biomaterial support is 10 μm to 200 μm, and the metal powder It can be selected from one or more of titanium, titanium alloy, zirconium, zirconium alloy, tantalum, and tantalum alloy that can be prepared by sintering. After the metal powder is sintered, it exhibits a uniform metal sphere structure size, which is equivalent to The particle size of the metal powder before unsintering, and the particle size of the metal powder is between 10μm ~ 100μm; after the metal powder is filled into the polymer scaffold, vacuum high temperature sintering is carried out, and the vacuum high temperature sintering temperature is controlled by the family At 1100 ~ 1300 ℃, the drying and setting time is 1 ~ 3hr to obtain the intervertebral implant in which the biodegradable biomaterial and the metal powder are fitted with each other; preferably, this embodiment can be obtained as shown in FIG. 2 The block structure of hydroxyapatite and metal co-sintered (that is, a porous metal structure in the figure that can be locally degraded to guide the regeneration of the strand), the block is the porous intervertebral body of the present invention Implants.
藉此，透過上述的製備方法可獲得氫氧基磷灰石/金屬塊材之椎間植入物植入人體腔洞來保證椎間植入物植入後骨組織能逐漸長入腔洞狀空間，其中氫氧基磷灰石植入於人體中為可降解之材質，氫氧基磷灰石材料中的物質結構是決定其生物降解性的關鍵因素，氫氧基磷灰石的鈣磷比率(Ca/P)為1.65~1.75，燒結後仍保持磷灰石(apatite)物質結構，在新骨形成過程中產生骨引導作用，藉由植入時間之增加而緩慢進行降解，其慢速降解過程中，能利用氫氧基磷灰石優秀的骨引導功效，引導新骨組織從宿主骨沿氫氧基磷灰石/金屬塊材之椎間植入物進入氫氧基磷灰石/金屬塊材之椎間植入物內部，達到上部與下部骨組織穩固癒合與實現牢固的機械固定之功效。 In this way, the intervertebral implant of hydroxyapatite / metal block can be implanted into the human cavity through the above preparation method to ensure that the bone tissue can gradually grow into the cavity after the intervertebral implant is implanted Space, in which the hydroxyl apatite is implanted in the human body as a degradable material, the material structure of the hydroxyl apatite material is a key factor determining its biodegradability, the calcium phosphorus of the hydroxyl apatite The ratio (Ca / P) is 1.65 ~ 1.75, and the apatite structure is maintained after sintering. It produces bone guidance during the formation of new bone. It slowly degrades with the increase of implantation time. Its slow speed During the degradation process, the excellent bone guiding effect of hydroxyapatite can be utilized to guide new bone tissue from the host bone along the hydroxyapatite / metal block intervertebral implant into the hydroxyapatite / The internal of the intervertebral implant of the metal block material achieves the effects of the solid healing of the upper and lower bone tissues and the realization of a firm mechanical fixation.
綜上所述，透過前述的結構設計，本發明能製備出一種多孔金屬結構，藉以能組成局部可降解之氫氧基磷灰石/金屬塊材之椎間植入物，隨其植入人體的時間，使其中氫氧基磷灰 石結構逐步進行降解，並在降解過程中，引導骨組織攀附於多孔金屬結構內部，使植入部形成穩固的上部與下部之骨頭融合效果，令其進一步具有輕易化及增加生物性結合的功效。 In summary, through the aforementioned structural design, the present invention can prepare a porous metal structure by which an intervertebral implant that can form a partially degradable hydroxyl apatite / metal block can be implanted with the human body Time to make hydroxyapatite The stone structure is gradually degraded, and during the degradation process, the bone tissue is guided to climb inside the porous metal structure, so that the implanted part forms a solid fusion effect of the upper and lower bones, making it easier to further increase the biological bonding effect .
本發明所提供之一種椎間植入物，與前述引證案及其他習用技術相互比較時，更具有下列之優點：該氫氧基磷灰石/金屬塊材之椎間植入物具有生物可降解性，椎間植入物在骨組織形成過程中應逐漸被降解，並且不影響新生成骨組織的結構和功能。 The intervertebral implant provided by the present invention has the following advantages when compared with the aforementioned cited cases and other conventional technologies: the intervertebral implant of the hydroxyapatite / metal block is bioavailable Degradability, intervertebral implants should be gradually degraded during the formation of bone tissue, and does not affect the structure and function of newly generated bone tissue.
該氫氧基磷灰石/金屬塊材之椎間植入物具有可塑性，可被加工成所需要的形狀並具有一定的機械強度，在椎間植入物內後的一定時間內仍可保持其形狀，並使新形成的組織具有符合設計的外形。 The hydroxyapatite / metal block intervertebral implant has plasticity, can be processed into a desired shape and has a certain mechanical strength, and can be maintained within a certain time after the intervertebral implant Its shape, and make the newly formed tissue have a shape that meets the design.
上列詳細說明係針對本發明之一可行實施例之具體說明，惟該實施例並非用以限制本發明之專利範圍，凡未脫離本發明技藝精神所為之等效實施或變更，均應包含於本案之專利範圍中。 The above detailed description is a specific description of a feasible embodiment of the present invention, but the embodiment is not intended to limit the patent scope of the present invention, and any equivalent implementation or change without departing from the technical spirit of the present invention should be included in The patent scope of this case.
綜上所述，本案不但在空間型態上確屬創新，並能較習用物品增進上述多項功效，應已充分符合新穎性及進步性之法定發明專利要件，爰依法提出申請，懇請 貴局核准本件發明專利申請案，以勵發明，至感德便。 In summary, this case is not only innovative in terms of space type, but also can improve the above-mentioned multiple functions compared with conventional items. It should have fully met the requirements of novelty and progressive legal invention patents. This invention patent application is to inspire invention and feel good.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001036013A1 (en) * | 1999-11-15 | 2001-05-25 | Phillips-Origen Ceramic Technology, Llc. | Process for producing rigid reticulated articles |
| US20080249638A1 (en) * | 2007-04-05 | 2008-10-09 | Cinvention Ag | Biodegradable therapeutic implant for bone or cartilage repair |
| US20090148592A1 (en) * | 2000-03-24 | 2009-06-11 | Lyles Mark B | Methods of Making Ceramic and Metal Compositions |
| CN102014798A (en) * | 2008-03-18 | 2011-04-13 | 友和安股份公司 | Composite implant having porous structure filled with biodegradable alloy and method of magnesium-based manufacturing the same |
| CN102089238A (en) * | 2008-07-08 | 2011-06-08 | 海斯特赛尔有限公司 | Three-dimensional matrices of structured porous monetite for tissue engineering and osseous regeneration, and method for the preparation thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001036013A1 (en) * | 1999-11-15 | 2001-05-25 | Phillips-Origen Ceramic Technology, Llc. | Process for producing rigid reticulated articles |
| US20090148592A1 (en) * | 2000-03-24 | 2009-06-11 | Lyles Mark B | Methods of Making Ceramic and Metal Compositions |
| US20080249638A1 (en) * | 2007-04-05 | 2008-10-09 | Cinvention Ag | Biodegradable therapeutic implant for bone or cartilage repair |
| CN102014798A (en) * | 2008-03-18 | 2011-04-13 | 友和安股份公司 | Composite implant having porous structure filled with biodegradable alloy and method of magnesium-based manufacturing the same |
| CN102089238A (en) * | 2008-07-08 | 2011-06-08 | 海斯特赛尔有限公司 | Three-dimensional matrices of structured porous monetite for tissue engineering and osseous regeneration, and method for the preparation thereof |
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