TW202322771A - 人工椎間盤 - Google Patents

人工椎間盤 Download PDF

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Publication number
TW202322771A
TW202322771A TW110145176A TW110145176A TW202322771A TW 202322771 A TW202322771 A TW 202322771A TW 110145176 A TW110145176 A TW 110145176A TW 110145176 A TW110145176 A TW 110145176A TW 202322771 A TW202322771 A TW 202322771A
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Taiwan
Prior art keywords
intervertebral disc
artificial intervertebral
joint block
block
concave
Prior art date
Application number
TW110145176A
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English (en)
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TWI789143B (zh
Inventor
張方杰
蔡佩宜
林詩萍
李明駿
黃志傑
沈欣欣
吳孟晃
Original Assignee
財團法人工業技術研究院
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Application filed by 財團法人工業技術研究院 filed Critical 財團法人工業技術研究院
Priority to TW110145176A priority Critical patent/TWI789143B/zh
Priority to US17/550,889 priority patent/US11801146B2/en
Priority to CN202111549171.6A priority patent/CN116211552A/zh
Application granted granted Critical
Publication of TWI789143B publication Critical patent/TWI789143B/zh
Publication of TW202322771A publication Critical patent/TW202322771A/zh

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    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
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Abstract

一種人工椎間盤用以結合於一人體椎間。人工椎間盤包含一第一組接塊、一關節塊及一第二組接塊。關節塊具有一滑動凸面及一背面。關節塊之背面疊設於第一組接塊。第二組接塊可滑動地疊設於關節塊之滑動凸面,以令第二組接塊相對第一組接塊彎曲。其中,滑動凸面為圓弧面並呈偏軸配置。

Description

人工椎間盤
本發明係關於一種人工椎間盤,特別是一種具偏軸設計的人工椎間盤。
臨床上常以植入人工椎間盤來治療椎間盤退化性疾病(Degenerative Disc Disease)。現今市售的人工椎間盤多為三件式設計,包含上、下金屬板及一襯墊,其活動方式為上金屬板於一襯墊上作固定半徑的圓周滑移,然而此一活動方式難以重建原天然椎間盤的活動自由度,長期下來可能造成人工椎間盤過度磨耗的問題。此外,進行局部椎間盤植入手術,除了有可能要犧牲原來的椎間活動性之外,植入後的僵直不適感也常影響患者生活質量。
本發明在於提供一種人工椎間盤,藉以重建原天然椎間盤的活動自由度,以及減少人工椎間盤過度磨耗的問題。
本發明之一實施例所揭露之人工椎間盤用以結合於一人體椎間。人工椎間盤包含一第一組接塊、一關節塊及一第二組接塊。關節塊具有一滑動凸面及一背面。關節塊之背面疊設於第一組接塊。第二組接塊可滑動地疊設於關節塊之滑動凸面,以令第二組接塊相對第一組接塊彎曲。其中,滑動凸面為圓弧面並呈偏軸配置。
根據上述實施例之人工椎間盤,透過滑動凸面呈偏軸配置,可讓人工椎間盤提供使用者最佳之活動角度及應力分散,減少磨耗造成之材料破壞。
以上關於本發明內容的說明及以下實施方式的說明係用以示範與解釋本發明的原理,並且提供本發明的專利申請範圍更進一步的解釋。
請參閱圖1至圖5。圖1為根據本發明第一實施例所述之人工椎間盤10的立體示意圖。圖2為圖1的分解示意圖。圖3為圖2之另一視角的分解示意圖。圖4為圖1的剖面示意圖。圖5為圖1之另一視角的剖面示意圖。
本實施例之人工椎間盤10用以結合於人體椎間(未繪示)。人工椎間盤10包含一第一組接塊100、一關節塊200及一第二組接塊300。
第一組接塊100組接於脊椎骨,且第一組接塊100的材質例如但不限於為鈦合金、鈷鉻鉬合金或不鏽鋼,以提升第一組接塊100的耐用性與結構強度。第一組接塊100包含一第一本體部110及二第一凹凸結構120。第一本體部110具有相對的一第一外表面111及一第一內表面112。關節塊200疊設於第一組接塊100之第一本體部110的第一內表面112。二第一凹凸結構120凸出於第一本體部110的第一外表面111,並對稱地位於第一外表面111的相對兩側。
在本實施例中,第一凹凸結構120類似於錐形倒勾的設計,以利於讓第一組接塊100嵌入椎間,並防止第一組接塊100前後左右滑脫。
在本實施例中,二第一凹凸結構120呈對稱分佈,但並不以此為限。在其他實施例中,二第一凹凸結構也可以呈非對稱分佈。此外,在本實施例中,第一凹凸結構120的數量為二個,但並不以此為限。在其他實施例中,第一凹凸結構的數量也可以改為單個。
在本實施例中,第一本體部110還可以具有多個第一孔狀結構130。第一孔狀結構130例如為孔洞型、格子型、海綿型、波浪型,且這些第一孔狀結構130位於第一本體部110之第一外表面111,以增加第一本體部110與脊椎骨的整合能力並減少第一組接塊100滑脫的併發症。本實施例之第一孔狀結構130在第一外表面111的分佈比例例如介於20%~80%,且第一孔狀結構130的分佈疏密度可平均、漸密或漸疏。此外,每一第一孔狀結構130的直徑例如介於0.3毫米~0.6毫米。
此外,具有第一孔狀結構130的第一外表面111與平滑的第一內表面112的距離例如佔第一組接塊100厚度的40%~60%。
關節塊200的材質例如但不限於為超高分子量聚乙烯(UHMWPE)、聚醚醚酮(PEEK)或聚亞苯基碸樹脂(PPSU),且關節塊200具有一滑動凸面S1及一背面S2。詳細來說,關節塊200包含一基部210及一凸出部220。凸出部220凸出於基部210。背面S2位於基部210遠離凸出部220之一側,且關節塊200之背面S2疊設於第一組接塊100。滑動凸面S1位於凸出部220遠離基部210之一側。在本實施例中,關節塊200還可以具有一連接面S3。滑動凸面S1之一側S11連接於基部210,且滑動凸面S1之相對一側S12透過連接面S3連接基部210,使得滑動凸面S1之相對兩側至基部210的距離相異。以本實施例來說,滑動凸面S1之一側S11至基部210的距離為零,滑動凸面S1之另一側S12至基部210的距離D大於零,但並不以此為限。在其他實施例中,亦可改為滑動凸面之一側至基部的距離與滑動凸面之另一側至基部的距離皆大於零,且滑動凸面之一側至基部的距離大於滑動凸面之另一側至基部的距離。
在本實施例中,滑動凸面S1例如為圓弧面並呈偏軸配置。藉此,可讓人工椎間盤10提供使用者最佳之活動角度及應力分散,減少磨耗造成之材料破壞。所謂之偏軸配置例如係指滑動凸面S1之中心軸線C與背面S2的法線N的夾角θ1大於0度,且連接面S3與背面S2的法線N的夾角θ2大於0度。在本實施例中,連接面S3與背面S2的法線N的夾角θ2等於滑動凸面S1之中心軸線C與背面S2的法線N的夾角θ1,但並不以此為限。在其他實施例中,連接面與背面的法線的夾角亦可改為不等於滑動凸面之中心軸線與背面的法線的夾角。此外,滑動凸面的半徑例如介於6至10毫米。藉此,可提高疲勞破壞前可承受之使用次數。
此外,所謂之偏軸配置又例如係指滑動凸面S1的頂點T至背面S2的距離D1異於中心軸線C與滑動凸面S1交會點X至背面S2的距離D2。
此外,由於關節塊200之位置與人體脊椎的天然位置一致時,人工椎間盤10具有最佳活動角度,所以關節塊200之滑動凸面S1的偏軸角度例如可係依據人體脊椎的天然位置客製而定。實際上,在客製人工椎間盤10時,可先取得患者的人體脊椎的天然位置,再依據患者的人體脊椎的天然位置取得理想偏軸角度值,如2、5或8度。如此一來,經過客製的人工椎間盤10能夠獲得較廣的彎曲範圍,如在偏軸屈曲方向(如方向B)上以及在偏軸伸展方向(如方向A)上,第二組接塊300能夠相對第二組接塊300轉彎的角度例如約30度。當本實施例之人工椎間盤10沿偏軸伸展方向(如方向A)前彎時,本實施例之人工椎間盤10所承受之平均應力皆小於以往人工椎間盤10(無偏軸設計)所承受的平均應力。當本實施例之人工椎間盤10沿偏軸屈曲方向(如方向B)後仰時,雖然在關節塊200之部分基部210處所承受的平均應力會大於以往人工椎間盤10(無偏軸設計)所承受的平均應力,但關節塊200之凸出部220處所承受的平均應力會小於以往人工椎間盤10(無偏軸設計)所承受的平均應力。由於關節塊200的主要磨耗多發生於凸出部220,故本實施例之關節塊200之凸出部220承受較小的平均應力將有助於提升本實施例之人工椎間盤10的使用壽命。
在本實施例中,關節塊200之基部210具有二凹槽211,二凹槽211位於基部210之背面S2。第一組接塊100更包含二限位柱140,二限位柱140凸出於第一本體部110之第一內表面112,且二限位柱140之至少部分分別位於二凹槽211。此外,限位柱140例如為圓柱,且限位柱140於抵靠於關節塊200之一側具一圓角結構141。限位柱140之設計係用來防止人工椎間盤10過度位移,同時兼顧椎間盤環狀邊界完整。此外,在本實施例中,限位柱140的直徑例如介於2至6毫米(mm)。
在本實施例中,關節塊200的邊界具有仿生纖維環設計,其環狀結構完整,無缺損處,如真實纖維環之完整包覆。所謂之邊界完整的設計係指關節塊200的周緣無缺口。此外,關節塊200的平滑結構設計能夠增加關節塊200的耐磨性。
第二組接塊300可滑動地疊設於關節塊200之滑動凸面S1,以令第二組接塊300相對第一組接塊100彎曲,即第二組接塊300可相對第一組接塊100前彎或後仰。詳細來說,第二組接塊300組接於脊椎骨,且第二組接塊300的材質例如但不限於為鈦合金、鈷鉻鉬合金或不鏽鋼,以提升第二組接塊300的耐用性與結構強度。第二組接塊300包含一第二本體部310及二第二凹凸結構320,第二本體部310具有相對的一第二外表面311及一第二內表面312。第二外表面311具有一平面區3111及一凸起區3112,且平面區3111將凸起區3112環繞於內。第二內表面312具有一平面區3121及一凹陷區3122,且平面區3121將凹陷區3122環繞於內。
第二組接塊300之第二本體部310的第二內表面312疊設於關節塊200,使得關節塊200的滑動凸面S1抵靠於第二內表面312之凹陷區3122。二第二凹凸結構320凸出於第二本體部310的第二外表面311之平面區3111,並對稱地位於第二外表面311的相對兩側。此外,第二凹凸結構320的高度H與第二組接塊300的厚度T的高度厚度比值例如為50%。
在本實施例中,第一凹凸結構120類似於錐形倒勾的設計,以利於讓第一組接塊100嵌入椎間,並防止第一組接塊100前後左右滑脫。
在本實施例中,二第二凹凸結構320呈對稱分佈,但並不以此為限。在其他實施例中,二第二凹凸結構也可以呈非對稱分佈。此外,在本實施例中,第一凹凸結構120的數量為二個,但並不以此為限。在其他實施例中,第一凹凸結構的數量也可以改為單個。
在本實施例中,第二本體部310還可以具有多個第二孔狀結構330。第二孔狀結構330例如為孔洞型、格子型、海綿型、波浪型,且這些第二孔狀結構330位於第二本體部310之第二外表面311的平面區3111與凸起區3112,以增加第二本體部310與脊椎骨的整合能力並減少第二組接塊300滑脫的併發症。本實施例之第二孔狀結構330在第二外表面311的分佈比例例如介於20%~80%,且第二孔狀結構330的分佈疏密度可平均、漸密或漸疏。此外,每一第二孔狀結構330的直徑例如介於0.3毫米~0.6毫米。
請參閱圖6至圖7。圖6為圖1之第一組接塊100的平面示意圖。圖7為圖1之第二組接塊300的平面示意圖。
在本實施例中,第一凹凸結構120之這些第一勾部121的寬度W1~W4依序遞增且第一凹凸結構120之錐形角度θ3例如介於2~8度,且第一凹凸結構120之這些第二勾部321的寬度W1~W4依序遞增且第二凹凸結構320之錐形角度θ4例如介於2~8度。
請參閱圖8與圖9。圖8為圖1之第一組接塊100的側視示意圖。圖9為圖1之第二組接塊300的側視示意圖。在本實施例中,每一第一凹凸結構120包含多個第一勾部121,且每一第一勾部121具有一第一斜面1211。每一第二凹凸結構320包含多個第二勾部321,且每一第二勾部321具有一第二斜面3211。這些第一勾部121與第二勾部321的高度H1~H4依序遞增,並例如介於1~3毫米(mm),使得這些第一勾部121以及第二勾部321的傾斜角度θ5、θ6為1~5度,以透過高度漸增的勾部讓第一組接塊100與第二組接塊300更容易地安裝於椎間。
上述限位柱的數量為二個,但並不以此為限。請參閱圖10至圖12。圖10為根據本發明第二實施例所述之第一組接塊100A與關節塊200A的分解示意圖。圖11為根據本發明第三實施例所述之第一組接塊100B與關節塊200B的分解示意圖。圖12為根據本發明第四實施例所述之第一組接塊100C與關節塊200C的分解示意圖。
如圖10所示,本實施例之第一組接塊100A包含一第一本體部110A、一第一凹凸結構120A及一限位柱140A。第一本體部110A具有一第一外表面111A及一第一內表面112A。第一凹凸結構120A凸出於第一外表面111A。限位柱140A凸出於第一內表面112A。關節塊200A包含一基部210A及一凸出部220A。凸出部220A凸出於基部210A之一側,且凸出部220A遠離基部210A之一側具有一滑動凸面S1,以及基部210A遠離凸出部220A之一側具有一背面S2。凸出部220A之基部210A具有一凹槽211A,凹槽211A用以讓限位柱140A設置,以用來防止人工椎間盤過度位移。
如圖11所示,本實施例之第一組接塊100B包含一第一本體部110B、一第一凹凸結構120B及三限位柱140B。第一本體部110B具有一第一外表面111B及一第一內表面112B。第一凹凸結構120B凸出於第一外表面111B。限位柱140B凸出於第一內表面112B。關節塊200B包含一基部210B及一凸出部220B。凸出部220B凸出於基部210B之一側,且凸出部220B遠離基部210B之一側具有一滑動凸面S1,以及基部210B遠離凸出部220B之一側具有一背面S2。凸出部220B之基部210B具有一凹槽211B,凹槽211B用以讓限位柱140B設置,以用來防止人工椎間盤過度位移。
如圖12所示,本實施例之第一組接塊100C包含一第一本體部110C、一第一凹凸結構120C及四限位柱140C。第一本體部110C具有一第一外表面111C及一第一內表面112C。第一凹凸結構120C凸出於第一外表面111C。限位柱140C凸出於第一內表面112C。關節塊200C包含一基部210C及一凸出部220C。凸出部220C凸出於基部210C之一側,且凸出部220C遠離基部210C之一側具有一滑動凸面S1,以及基部210C遠離凸出部220C之一側具有一背面S2。凸出部220C之基部210C具有一凹槽211C,凹槽211C用以讓限位柱140C設置,以用來防止人工椎間盤過度位移。
根據上述實施例之人工椎間盤,透過滑動凸面呈偏軸配置,可讓人工椎間盤提供使用者最佳之活動角度及應力分散,減少磨耗造成之材料破壞。
此外,組接塊的凹凸結構類似於錐形倒勾的設計,以利於讓組接塊嵌入椎間,並防止組接塊前後左右滑脫。
此外,透過組接塊的孔狀結構設計能夠增加組接塊與脊椎骨的整合能力並減少組接塊滑脫的併發症。
此外,透過限位柱之設計,可用來防止人工椎間盤過度位移,同時兼顧椎間盤環狀邊界完整。
此外,關節塊的平滑結構設計能夠增加關節塊的耐磨性。
雖然本發明以前述之諸項實施例揭露如上,然其並非用以限定本發明,任何熟習相像技藝者,在不脫離本發明之精神和範圍內,當可作些許之更動與潤飾,因此本發明之專利保護範圍須視本說明書所附之申請專利範圍所界定者為準。
10:人工椎間盤 100、100A、100B、100C:第一組接塊 110、110A、110B、110C:第一本體部 111、111A、111B、111C:第一外表面 112、112A、112B、112C:第一內表面 120、120A、120B、120C:第一凹凸結構 121:第一勾部 1211:第一斜面 130:第一孔狀結構 140:限位柱 141:圓角結構 200、200A、200B、200C:關節塊 210、210A、210B、210C:基部 211、211A、211B、211C:凹槽 220、220A、220B、220C:凸出部 300:第二組接塊 310:第二本體部 311:第二外表面 3111:平面區 3112:凸起區 312:第二內表面 3121:平面區 3122:凹陷區 320:第二凹凸結構 321:第二勾部 3211:第二斜面 330:第二孔狀結構 A、B:方向 S1:滑動凸面 S11、S12:側 S2:背面 S3:連接面 C:中心軸線 N:法線 θ1、θ2:夾角 θ3、θ4:錐形角度 θ5、θ6:傾斜角度 H1~H4:高度 W1~W4:寬度 D、D1、D2:距離 T:頂點 X:交點
圖1為根據本發明第一實施例所述之人工椎間盤的立體示意圖。 圖2為圖1的分解示意圖。 圖3為圖2之另一視角的分解示意圖。 圖4為圖1的剖面示意圖。 圖5為圖1之另一視角的剖面示意圖。 圖6為圖1之第一組接塊的平面示意圖。 圖7為圖1之第二組接塊的平面示意圖。 圖8為圖1之第一組接塊的側視示意圖。 圖9為圖1之第二組接塊的側視示意圖。 圖10為根據本發明第二實施例所述之第一組接塊與關節塊的分解示意圖。 圖11為根據本發明第三實施例所述之第一組接塊與關節塊的分解示意圖。 圖12為根據本發明第四實施例所述之第一組接塊與關節塊的分解示意圖。
100:第一組接塊
111:第一外表面
112:第一內表面
120:第一凹凸結構
121:第一勾部
1211:第一斜面
130:第一孔狀結構
140:限位柱
200:關節塊
210:基部
211:凹槽
220:凸出部
300:第二組接塊
310:第二本體部
311:第二外表面
312:第二內表面
A、B:方向
S1:滑動凸面
S11、S12:側
S2:背面
S3:連接面
C:中心軸線
N:法線
θ1、θ2:夾角
D、D1、D2:距離
T:頂點
X:交點

Claims (19)

  1. 一種人工椎間盤,用以結合於一人體椎間,該人工椎間盤包含: 一第一組接塊;一關節塊,具有一滑動凸面及一背面,該關節塊之該背面疊設於該第一組接塊;以及一第二組接塊,可滑動地疊設於該關節塊之該滑動凸面,以令該第二組接塊相對該第一組接塊彎曲;其中,該滑動凸面為圓弧面並呈偏軸配置。
  2. 如請求項1所述之人工椎間盤,其中該滑動凸面之中心軸線與該背面之法線的夾角大於0度。
  3. 如請求項2所述之人工椎間盤,其中該滑動凸面的半徑介於6至10毫米。
  4. 如請求項2所述之人工椎間盤,其中該滑動凸面頂點與該中心軸線與該滑動凸面交會點分別至該背面的距離相異。
  5. 如請求項1所述之人工椎間盤,其中該關節塊包含一基部及一凸出部,該凸出部凸出於該基部,該背面位於該基部遠離該凸出部之一側,該滑動凸面位於該凸出部遠離該基部之一側,該滑動凸面之相對兩側至該基部的距離相異。
  6. 如請求項5所述之人工椎間盤,其中該關節塊更具有一連接面,該滑動凸面之一側連接於該基部,該滑動凸面之相對一側透過該連接面連接該基部。
  7. 如請求項6所述之人工椎間盤,其中該連接面與該背面的法線的夾角大於0度。
  8. 如請求項6所述之人工椎間盤,其中該連接面與該背面的法線的夾角等於該滑動凸面之中心軸線與該背面的法線的夾角。
  9. 如請求項5所述之人工椎間盤,其中該第一組接塊包含一第一本體部及至少一第一凹凸結構,該第一本體部具有相對的一第一外表面及一第一內表面,該關節塊疊設於該第一組接塊之該第一本體部的該第一內表面,該至少一第一凹凸結構凸出於該第一本體部的該第一外表面,該第二組接塊包含一第二本體部及至少一第二凹凸結構,該第二本體部具有相對的一第二外表面及一第二內表面,該第二組接塊之該第二本體部的該第二內表面疊設於該關節塊,該至少一第二凹凸結構凸出於該第二本體部的該第二外表面。
  10. 如請求項9所述之人工椎間盤,其中該至少一第一凹凸結構包含多個第一勾部,該些第一勾部的高度依序遞增,該至少一第二凹凸結構包含多個第二勾部,該些第二勾部的高度依序遞增。
  11. 如請求項9所述之人工椎間盤,其中該至少一第一凹凸結構包含多個第一勾部,該些第一勾部的寬度依序遞增,該至少一第二凹凸結構包含多個第二勾部,該些第二勾部的寬度依序遞增。
  12. 如請求項9所述之人工椎間盤,其中該第二內表面具有一平面區及一凹陷區,該平面區將該凹陷區環繞於內,該滑動凸面抵靠於該第二內表面之該凹陷區。
  13. 如請求項9所述之人工椎間盤,其中該關節塊之該基部具有至少一凹槽,該至少一凹槽位於該基部之該背面,該第一組接塊更包含至少一限位柱,該至少一限位柱凸出於該第一本體部之該第一內表面,且該至少一限位柱之至少部分位於該至少一凹槽。
  14. 如請求項13所述之人工椎間盤,其中該至少一限位柱為圓柱,且該至少一限位柱於抵靠於該關節塊之一側具一圓角結構。
  15. 如請求項9所述之人工椎間盤,其中該第二外表面具有一平面區及一凸起區,該平面區將該凸起區環繞於內,該第一本體部具有多個第一孔狀結構,該些第一孔狀結構位於該第一本體部之該第一外表面,該第二本體部具有多個第二孔狀結構,該些第二孔狀結構位於該第二本體部之該第二外表面的該平面區與該凸起區,該至少一第二凹凸結構凸出於該第二外表面之該平面區。
  16. 如請求項15所述之人工椎間盤,其中該第一孔狀結構在該第一外表面的分佈比例介於20%~80%,該第二孔狀結構在該第二外表面的分佈比例介於20%~80%。
  17. 如請求項15所述之人工椎間盤,其中每一該第一孔狀結構與該第二孔狀結構的直徑介於0.3毫米~0.6毫米。
  18. 如請求項9所述之人工椎間盤,其中該第一外表面與該第一內表面的距離佔該第一組接塊厚度的40%~60%。
  19. 如請求項1所述之人工椎間盤,其中該第一組接塊與該第二組接塊的材質為鈦合金、鈷鉻鉬合金或不鏽鋼,該關節塊的材質為超高分子量聚乙烯(UHMWPE)、聚醚醚酮(PEEK)或聚亞苯基碸樹脂(PPSU)。
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