TW201519851A - 椎間植入物 - Google Patents
椎間植入物 Download PDFInfo
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- TW201519851A TW201519851A TW102143685A TW102143685A TW201519851A TW 201519851 A TW201519851 A TW 201519851A TW 102143685 A TW102143685 A TW 102143685A TW 102143685 A TW102143685 A TW 102143685A TW 201519851 A TW201519851 A TW 201519851A
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/02—Inorganic materials
- A61L27/04—Metals or alloys
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- A—HUMAN NECESSITIES
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/10—Sintering only
- B22F3/11—Making porous workpieces or articles
- B22F3/1103—Making porous workpieces or articles with particular physical characteristics
- B22F3/1109—Inhomogenous pore distribution
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/10—Sintering only
- B22F3/11—Making porous workpieces or articles
- B22F3/1121—Making porous workpieces or articles by using decomposable, meltable or sublimatable fillers
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- B22F7/00—Manufacture of composite layers, workpieces, or articles, comprising metallic powder, by sintering the powder, with or without compacting wherein at least one part is obtained by sintering or compression
- B22F7/06—Manufacture of composite layers, workpieces, or articles, comprising metallic powder, by sintering the powder, with or without compacting wherein at least one part is obtained by sintering or compression of composite workpieces or articles from parts, e.g. to form tipped tools
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- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C1/00—Making non-ferrous alloys
- C22C1/04—Making non-ferrous alloys by powder metallurgy
- C22C1/045—Alloys based on refractory metals
- C22C1/0458—Alloys based on titanium, zirconium or hafnium
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30957—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using a positive or a negative model, e.g. moulds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2002/30968—Sintering
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/38—Materials or treatment for tissue regeneration for reconstruction of the spine, vertebrae or intervertebral discs
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/10—Sintering only
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Abstract
一種椎間植入物,其係由複數金屬球體所組成的一多孔結構,且椎間植入物包括骨支撐區及骨成長區;其中,骨支撐區及骨成長區各具有複數個連通孔,且骨支撐區的孔隙率係小於骨成長區的孔隙率。
Description
本發明係關於一種椎間植入物,特別是一種由複
數個均一粒徑的金屬球體所組成的椎間植入物,且椎間植入物具有多個區域,其中各區依金屬球體所組成的數量不同,分別形成相異的孔隙率及孔隙大小,使椎間植入物為具有多重剛性的復合孔隙結構。
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。
現存椎間融合植體於植入骨後有融合效果不佳並且造成滑脫的問題,因此臨床常利用人工骨、生長因子與藥物等輔助治療方法,促進脊椎骨質與植體的融合度,但是利用額外添加方式其釋放期程短且具有局部區域濃度不均勻等問題,因此在植體上設置多孔結構,用以使骨生長於孔隙中提高植體於骨的融合度。
習知技術中,如中國專利號202086620所揭示的
一種具有生物活性多孔鈦合金人頸椎間融合器。該生物活性多孔鈦合金人頸椎間融合器的外周部具有規則孔隙,平均孔徑300至400μm,孔隙率40%至50%;但中央部具有骨小梁樣不規則孔隙,平均孔徑400至1000μm,孔隙率60%至80%,且在外周部及中央部的孔隙中附著有rhBMP-2或明膠微球,多孔結構及其內部生物活性因數緩釋系統能誘導新生骨組織長入,解決了骨與材料介面結合問題,具有比緻密材料更好的力學相容性與骨整合能力,但中央部具有骨小梁樣不規則孔隙,此結構成形難,目前金屬粉體雷射燒結成形設備仍無法達成內部不規則與外部規則接合,且孔隙大小不平均,其結構容易產生不同應力。
習知技藝中,如中國專利號CN101279106所揭示
的一種多孔鈦鈷合金醫用植入物的凝膠注模製備方法。屬於醫用材料製備技術領域。將單體丙烯醯胺、交聯劑亞甲基雙丙烯醯胺與去離子水配製成一定濃度的預混液,加入分散劑油酸使鈦鈷粉末懸浮於預混液中製成漿體,調節pH值至9.0~10.0,然後加入適量催化劑N-四甲基乙二胺和引發劑過硫酸銨攪拌均勻,經排氣後注入模具中,模內的單體發生聚合反應形成網狀結構將鈦鈷粉體包裹,成為由大分子網路定型的坯體。坯體經乾燥、排膠、燒結得到產品,此外還可以通過調節固含量來改變多孔鈦鈷合金的孔隙率和力學性能。
習知技藝中,如美國專利號US8361150
Composite implant所揭示一種可用於椎間融合治療之綜合結構的腰椎植入物。包含上下層多孔狀金屬結構,中間夾合一層高分子結構。其中上下兩層多孔結構物讓骨細胞攀附後往內孔生長,中間層高分子結構物具備黏合上下兩層多孔結構功能與支撐整體植入物功能。整體綜合結構植入物具備使上下兩節椎體融合之功能,此技術價格較高昂,因上下層為單一孔細隙率多孔結構,穩定度較低。
本發明目的係以提供一種椎間植入物,其由複數個均一粒徑的金屬球體所組成,且具有多個區域,各區依金屬球體所組成的數量不同,具有相異的孔隙率及孔隙大小,藉此提供具有多重剛性復合孔隙結構的椎間植入物,且各區孔隙分佈平均,其所產生應力也平均,使椎間植入物可承受的應力效果更佳。
本發明利用造孔劑混合複數個均一粒徑的金屬粉粒,接著經由燒結得到的椎間植入物,因此可直接透過調整造孔劑混合於金屬粉粒的重量百分比,控制椎間植入物的孔隙率及孔隙大小,達成所需的力學性能。進一步地,本發明利用具有骨支撐形成區及骨成長形成區的製具,分別填充具有相異重量百分比之造孔劑混合於金屬粉粒的混料,藉此形成具有骨支撐區及骨成長區的椎間植入物,且骨支撐區及骨成長區具有相異孔隙率及孔隙大小,使椎間植入物不需要
高分子材料也可以達到多重剛性功能。
本發明椎間植入物,其係由複數金屬球體所組成的多孔結構,且椎間植入物包括骨支撐區及骨成長區;其中,骨支撐區及骨成長區各具有複數個連通孔,且骨支撐區的孔隙率係小於骨成長區的孔隙率。
如上述,在一實施例中,多孔結構係由複數個金屬粉粒混合一造孔劑,以真空燒結成複數個金屬球體所組成。
如上述,在一實施例中,骨支撐區及骨生長區所含複數金屬球體各具有均一粒徑。
如上述,在一實施例中,其中當複數個金屬粉粒混合造孔劑時,造孔劑的重量百分比介於1wt%至70wt%之間。
如上述,在一實施例中,複數個金屬球體的粒徑介於10um至100um之間。
如上述,在一實施例中,其中複數個連通孔的孔徑大小各介於50um至500um之間。
如上述,在一實施例中,其中骨支撐區及骨生長區的孔隙率各介於10%至90%之間。
如上述,在一實施例中,其中骨支撐區及骨成長區的彈性膜數介於0.17GPa至30GPa之間。
如上述,在一實施例中,多孔結構的孔洞分別均勻分布。
為了達到上述目的,本發明提供一種椎間植入物
的製造方法,包括:提供一製具,製具區分有骨支撐形成區及骨成長形成區;接著以金屬粉粒混合造孔劑,形成第一混料及第二混料,其中第一混料之造孔劑含量小於第二混料之造孔劑含量;接著填充第一混料於骨支撐區,且填充第二混料於骨生長區,最後以真空燒結,形成具有骨支撐區及骨成長區的椎間植入物,且骨支撐區的孔隙率係小於骨成長區的孔隙率。
本發明椎間植入物係由複數個均一粒徑的金屬
球體所組成,且具有多個區域,各區因分別填充具有相異重量百分比之造孔劑混合於金屬粉粒的混料,經真空燒結後,使各區所含的金屬球體數量不同,而形成為具有相異孔隙率及孔隙大小的多孔結構,多孔結構使骨生長於孔隙中,提高植體於骨的融合度,且各區的孔洞分別均勻分佈且孔隙尺寸平均,因此所產生的應力也平均,則具有較佳的力學相容性。
本發明椎間植入物因各層體分別具有相異的孔
隙率及孔隙大小,其不需要高分子材料也可以達到多重剛性功能,也因此當椎間植入物植入腰椎椎間時,可承受由腰椎活動時所產生的各種應力,可承受的應力範圍廣,穩定度高。
本發明利用造孔劑混合複數個金屬粉粒,經由燒
結得到的椎間植入物,因此可透過調整造孔劑混合於金屬粉粒的重量百分比,來控制椎間植入物的孔隙率及孔隙大小,達到所需的剛性表現。
本發明椎間植入物更接近人體椎間骨格力學性
能之仿生異相多孔鈦合金醫材,使人體活動時,椎間可承受的應力效果更佳。
1‧‧‧製具
10‧‧‧骨支撐形成區
20‧‧‧骨成長形成區
30‧‧‧第一混料
35‧‧‧第二混料
40‧‧‧金屬粉粒
50‧‧‧造孔劑
60‧‧‧第二金屬胚
70‧‧‧椎間植入物
71‧‧‧骨支撐區
72‧‧‧骨成長區
73‧‧‧金屬球體
74‧‧‧連通孔
90‧‧‧中心塊
91‧‧‧上蓋
95‧‧‧弧面
96‧‧‧器械挾持部
步驟S1~步驟S3‧‧‧椎間植入物的製造方法
圖1係根據本發明之一種椎間植入物的製造方法流程圖。
圖2係根據本發明之一種椎間植入物的製造方法之製具分解示意圖。
圖3A係根據本發明之一種椎間植入物的製造方法之第一混料示意圖。
圖3B係根據本發明之一種椎間植入物的製造方法的第二混料示意圖。
圖4A至圖4C係根據本發明之一種椎間植入物的製造方法的第一混料及第二混料填滿於製具示意圖。
圖5係根據本發明之一種椎間植入物的製造方法之金屬胚示意圖。
圖6係根據本發明之一種椎間植入物的立體圖。
為使對本發明之目的、構造特徵及其功能有進一步之了解,茲配合相關實施例及圖示詳細說明如下:請參閱圖1及圖2,圖1係根據本發明之一種椎間植入物的製造方法流程圖,圖2係根據本發明之一種椎間植入
物的製造方法之製具分解示意圖。
本發明一種椎間植入物,其製造方法包括下列步驟:首先,步驟S1,提供製具1,製具1區分有骨支撐形成區10、骨成長形成區20、中心塊90及上蓋91。
製具1是經由電腦模擬與繪圖,依所需的剛性表現,設計出椎間植入物的模具。
製具1的骨成長形成區20為可自由取出的中心塊90。
使用鹼性液體對製具1進行表面清潔,鹼性液體的PH值為9以上。
接著請參閱圖3A及圖3B,圖3A係根據本發明之一種椎間植入物的製造方法之第一混料示意圖,圖3B係根據本發明之一種椎間植入物的製造方法的第二混料示意圖,步驟S2,以金屬粉粒40混合造孔劑50,形成第一混料30及第二混料35,第一混料30之造孔劑50含量小於該第二混料35之造孔劑50含量,也就是說,第一混料30之造孔劑50的重量百分比小於第二混料35之造孔劑50的重量百分比。
使第一混料30及第二混料35中的金屬粉粒40於造孔劑50中為均勻分布。
如上述,在一實施例中,第一混料30及第二混料35中的金屬粉粒40為均一粒徑,但本發明不限於此,依所需剛性進行設計,第一混料30及第二混料35中的金屬粉粒40為
相異粒徑。
如上述,在一實施例中,金屬粉粒為鈦或鈦合金,且粒徑介於10um至100um。
如上述,在一實施例中,造孔劑50為粉狀、濃稠度高的漿狀或具可塑性的固狀,可使第一混料30及第二混料35經壓實後定型。
接著,請參閱圖4A至圖4C及圖5,圖4A至圖4C係根據本發明之一種椎間植入物的製造方法的第一混料及第二混料填滿於製具示意圖,圖5係根據本發明之一種椎間植入物的製造方法之金屬胚示意圖。步驟S3,填充第一混料30於骨支撐形成區10,藉由上蓋91及中心塊90壓實後,形成具有與骨支撐形成區10相對應形狀的第一金屬胚,如圖4A所示。
接著打開上蓋91,取出中心塊90,此時骨生長形成區20為一腔室,且腔室為對應中心塊90的形狀,如圖4B所示。
接著填充第二混料35於骨生長形成區20,如圖4C所示,再藉由上蓋91壓實後形成第二金屬胚60,如圖5所示。
請參閱圖6,圖6係根據本發明之一種椎間植入物的立體圖,為了使圖示能清晰表現,以實線代表椎間植入物外觀形狀,以虛線代表骨生長區72形狀。
接著對第二金屬胚60進行真空燒結,經真空燒結後,形成具有骨支撐區71及該骨成長區72的一椎間植入物
70,且該骨支撐區71的孔隙率係小於該骨成長區72的孔隙率。
本發明藉由上述製造方法形成一種椎間植入物
70,其係由複數金屬球體73所組成的一多孔結構,且該椎間植入物70包括骨支撐區71及骨成長區72;其中,骨支撐區71及骨成長區72各具有複數個連通孔74,且如上述步驟S2所述,因第一混料30之造孔劑50含量小於第二混料35之造孔劑50含量,所以當第二金屬胚60燒結後,骨支撐區71的孔隙率係小於骨成長區72的孔隙率。
如上述,在一實施例中,多孔結構係由複數個金
屬粉粒40混合一造孔劑50,以真空燒結成該複數個金屬球體73所組成,所以金屬球體73與金屬粉粒40的粒徑大抵相同,且金屬球體73的粒徑介於10um至100um之間。
如上述步驟S2所述,因第一混料30及第二混料35
中的金屬粉粒40為均一粒徑,所以該骨支撐區71及該骨生長區72所含複數金屬球體各具有均一粒徑。
如上述步驟S2中,當複數個金屬粉粒40混合造孔
劑50時,造孔劑50的重量百分比介於1wt%至70wt%之間,且造孔劑50主要為碳酸氫胺或聚甲基丙烯酸甲酯(PMMA),但本發明不限於此,造孔劑50進一步為高分子材料。
如上述,在一實施例中,其中複數個連通孔74
的孔徑大小各介於50um至500um之間,骨支撐區71及骨生長區72的孔隙率各介於10%至90%之間,骨支撐區71及骨成長區
72的彈性膜數介於0.17GPa至30GPa之間。
如上述步驟S2中所述,因第一混料30及第二混料
35中的金屬粉粒40於造孔劑50中為均勻分布,所以經燒結後所形成於椎間植入物70的多孔結構的孔洞分別均勻分布。
本發明椎間植入物70進一步包括一弧面95的設
計,使在手術時易於植入椎間,另外,椎間植入物70進一步包括器械挾持部96,方便夾具挾持,使手術作業效率提升。
如上述,椎間植入物70包括骨支撐區71及骨生長
區72的結構,分別具有相異的孔隙率及孔隙大小,但本發明不限於此,椎間植入物可經由製具設計為一多個區域結構,再調配出含有不同重量百分比之造孔劑的混料,由最內層填滿含有重量百分比最高之造孔劑的混料依序逐層向外填滿含有重量百分比較低之造孔劑的混料,接著經真空燒結後形成具有多個區域的椎間植入物,使椎間植入物具備多重剛性。
本發明椎間植入物是由複數個均一粒徑的金屬
球體所組成,且具有多個區域,各區分別因添加造孔劑於金屬粉粒的重量百分比不同,形成具有相異數量的複數個均一金屬球體,使各區具有相異的孔隙率及孔隙大小,使椎間植入物為具有多重剛性的復合孔隙結構。因椎間植入物具有多重剛性,所以植入腰椎椎間時,可承受由腰椎活動時所產生的各種應力。且椎間植入物的各層孔隙均勻分布,使骨生長時與腰椎椎間植體融合的效率提升。
本發明具有複合孔隙結構的椎間植入物更接近人體椎間骨格力學性能之仿生異相多孔金屬植體醫材,當腰椎椎間植體植入人體椎間,使人體活動時,椎間可承受的應力效果更佳。
綜上所述,乃僅記載本創作為呈現解決問題所採用的技術手段之實施方式或實施例而已,並非用來限定本創作專利實施之範圍。即凡與本創作專利申請範圍文義相符,或依本創作專利範圍所做的均等變化與修飾,皆為本創作專利範圍所涵蓋。
70‧‧‧椎間植入物
71‧‧‧骨支撐區
72‧‧‧骨生長區
73‧‧‧金屬球體
74‧‧‧連通孔
95‧‧‧弧面
96‧‧‧器械挾持部
Claims (10)
- 一種椎間植入物,其係由複數金屬球體所組成的一多孔結構,且該椎間植入物包括一骨支撐區及一骨成長區;其中,該骨支撐區及該骨成長區各具有複數個連通孔,且該骨支撐區的孔隙率係小於該骨成長區的孔隙率。
- 如申請專利範圍第1項之椎間植入物,其中該多孔結構係由複數個金屬粉粒混合一造孔劑,以真空燒結成該複數個金屬球體所組成。
- 如申請專利範圍第1項之椎間植入物,其中該骨支撐區及該骨生長區所含複數金屬球體各具有均一粒徑。
- 如申請專利範圍第2項之椎間植入物,其中當該複數個金屬粉粒混合該造孔劑時,該造孔劑的重量百分比介於1wt%至70wt%之間。
- 如申請專利範圍第1項之椎間植入物,其中該複數個金屬球體的粒徑介於10um至100um之間。
- 如申請專利範圍第1項之椎間植入物,其中該複數個連通孔的孔徑大小各介於50um至500um之間。
- 如申請專利範圍第1項之椎間植入物,其中該骨支撐區及該骨生長區的孔隙率各介於10%至90%之間。
- 如申請專利範圍第1項之椎間植入物,其中該骨支撐區及該骨成長區的彈性膜數介於0.17GPa至30GPa之間。
- 如申請專利範圍第1項之椎間植入物,其中該多孔結構的孔洞分別均勻分布。
- 一種椎間植入物的製造方法,包括:提供一製具,該製具區分有一骨支撐形成區及一骨成長形成區;以金屬粉粒混合造孔劑,形成一第一混料及一第二混料,該第一混料之造孔劑含量小於該第二混料之造孔劑含量;填充該第一混料於該骨支撐形成區,且填充該第二混料於該骨生長形成區,經真空燒結後,形成具有該骨支撐區及該骨成長區的一椎間植入物,且該骨支撐區的孔隙率係小於該骨成長區的孔隙率。
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US9757247B2 (en) * | 2012-10-01 | 2017-09-12 | DePuy Synthes Products, Inc. | Interbody fusion implant |
US9295565B2 (en) * | 2013-10-18 | 2016-03-29 | Spine Wave, Inc. | Method of expanding an intradiscal space and providing an osteoconductive path during expansion |
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2013
- 2013-11-29 TW TW102143685A patent/TWI607736B/zh active
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2014
- 2014-07-18 US US14/335,251 patent/US9610174B2/en active Active
- 2014-10-09 CN CN201410527785.8A patent/CN104667342B/zh active Active
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107837133A (zh) * | 2017-12-14 | 2018-03-27 | 中奥汇成科技股份有限公司 | 一种新型仿生钛人工关节假体 |
Also Published As
Publication number | Publication date |
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CN104667342A (zh) | 2015-06-03 |
US9610174B2 (en) | 2017-04-04 |
US20150150689A1 (en) | 2015-06-04 |
CN104667342B (zh) | 2017-03-01 |
TWI607736B (zh) | 2017-12-11 |
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