TWI236368B - Bone implantate, particularly intervertebral implantate - Google Patents

Bone implantate, particularly intervertebral implantate Download PDF

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Publication number
TWI236368B
TWI236368B TW090131611A TW90131611A TWI236368B TW I236368 B TWI236368 B TW I236368B TW 090131611 A TW090131611 A TW 090131611A TW 90131611 A TW90131611 A TW 90131611A TW I236368 B TWI236368 B TW I236368B
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TW
Taiwan
Prior art keywords
item
patent application
bone implant
bone
hollow body
Prior art date
Application number
TW090131611A
Other languages
English (en)
Inventor
Robert Mathys Jr
Beat Lechmann
Beat Gasser
Original Assignee
Synthes Ag
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Publication date
Application filed by Synthes Ag filed Critical Synthes Ag
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Publication of TWI236368B publication Critical patent/TWI236368B/zh

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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
    • A61F2/44—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
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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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
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    • 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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    • 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
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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
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    • A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Description

A7 1236368 五、發明說明（/ ) [發明的詳細說明] 本發明關於一種如申請專利範圍第1項的引文的一種 骨植入物，特別是椎間植入物，以及如申請專利範圍第16 項的引文的一種製造這種骨植入物的方法。 在法國專利案FR-A-2 703 580 ROBERT發表了一種此 類的骨植入物。這種習知的椎間植入物的缺點在於： A) 該植入物的蓋面與底面（它們設有粗糙的肋條）的光 滑表面（該表面與相鄰的脊椎體的端板接觸）不能造成骨組 織最適當的生長， B) 當在該植入物的空腔中使用塡充材料時，由於該內 壁光滑，塡充材料容易掉出來。 以上背景技術的討論只用於說明本發明的背景，但不 表示所引述的背景技術在目前對本發明或其優先權案而言 也是實際上公開或公知者。 對此，本發明乃提出策。本發明的目的在於提供一種 骨植入物，特別是一種椎間植入物，該椎間植入物的表面 椎間植入物造最適合骨組織生長。 本發明利用一種骨植入物達成此目的，該骨植入物具 有申請專利範圍第16項的特點。 依本發明，表面粗糙度至少2//m，可使新生長的骨在 植入物上錨合作用較佳，亦即骨整合較佳。 一種較佳的進一步的發展的特點在於:該空心體被至少 二個中間壁劃分，其中，該中間壁宜利用一橫樑互相桁接 。這些中間壁提高了倚靠在脊椎體的相鄰端板上的倚靠面 ------------------ (請先閱讀背面之注意事項再填寫本頁) 訂--- 線Φ 3 A7 1236368 __B7___ 五、發明說明（之） 積，並因此減少單位面積的壓力，並防止植入物陷入相鄰 的脊椎體中。此外，在其間空腔可使更骨質化的構造完全 生長穿過該植入物。 另一種較佳的進一步的發展的特點在於:該表面粗糙度 小於10// m。表面粗糙度太大會使留下的突起尖端部 (Spitze)變弱，這種變弱又會導致溶骨（骨質溶解 )(Osteolyse)因而使關節固定(融合)部(Arthrodese)損害。 又一種較佳的進一步的發展的特點在於:該中間壁設有 穿孔，該穿孔的最小面積爲3.5mm2。側壁的穿孔用於將新 生長骨構造作空間錨合作用，也可使在有必要時初次放入 的塡充劑作空間錨合作用。 再一種較佳的進一步的發展的特點在於:該空心體函殼 的側部段具有穿孔，該穿孔最小面積宜爲3.5mm2。函殻 的側部段的穿孔用於將新生長的骨構造作空間的錨合，且 主要也用於在該植入物放入時，將植入物保持住。 另一種較佳的進一步的發展的特點在於:該可透過輻射 線的材料由以下的組類選出:聚芳基醚酮(PAEK)、聚醚亞醯 胺(PEI)、聚氧基甲撐(P0M)、液晶聚合物(LCP)、聚甲基戊 烯(PMP)、聚嗍硼(PSU)、聚***嗍硼(PESU或PES)、聚 .乙撐對苯二酸酯（PETP)、聚甲基甲基丙烯酸酯（PMMA)、 與超高分子的聚乙烯(UHMW-PE)。 所有這些較佳材料爲彈性者，但有各種不同的機械性 質，如彈性（韌性）及剛性。它們與其他材料相較，部分具 有很有利的性質，或吸水性低。因此可各依應應用的需求 4 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ----------------- (請先閱讀背面之注意事項再填寫本頁) 訂----- 線％ A7 1236368 五、發明說明（）） 而定，作最佳選擇。 另一種較佳的進一步的發展的特點在於:該可透過輻射 線的材料用纖維補強，且宜用碳纖維或用PEEK纖維補強 。將這：種可透過輻射線的材料用纖維補強，可全面性地或 依標的地，加強機械性質。 又一種較佳的進一步的發展的特點在於:該骨植入物的 總體積V與該空心體的體積v之間的比例V : v在1.9〜 2.3之間的範圍中。事實顯示，這種比例可兼具植入物的 機械性質穩定的優點及新生長骨質構造有最大體積的優點 〇 再一種較佳的進一步的發展的特點在於:該植入物的表 面至少一部分設有一種可透過X-射線的覆層，或一個不會 影響X-射線穿透性的薄覆層。這種對X-射線透明的覆層 的優點可確保在關節固定部上生長上來時可以用照X光觀 察。雖然純PEEK己以出色的生物相容性見長，但由適當 材料構成的附加的覆層可再提高機械性質及新生長的骨與 植入物之間的界面性質。適用的施覆材料宜爲金屬，其厚 度極薄，不會明顯影響X-射線穿透性。特別適合者爲鈦、 金、或鉑、或其他適合的植入物金屬。 > 另一種較佳的進一步的發展的特點在於:該覆層由一種 陶瓷材料構成，且宜由羥基磷酸鈣或二磷酸三鈣構成。這 二種適合作施覆的陶瓷一羥基磷酸鹽或磷酸鹽一的特色爲 一種優點，即:它們完全整合到骨中或甚至完全被天然骨組 織所取代。 5 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ---------------------訂·— (請先閱讀背面之注意事項再填寫本頁) A7 1236368 ___B7 五、發明說明（^ ) 又一種較佳的進一步的發展的特點在於:該空心體至少 部分地用一種塡充劑塡充，該塡充劑由磷酸鈣構成，且宜 爲羥基磷灰石、或二磷酸三鈣構成。因此可達成對關節固 定部的較佳的無礙的控制。該空心體也可用硫酸鈣、除礦 物化的骨、自體(autolog)的骨、或珊瑚物質構成的一種塡 充劑充塡。 再一種較佳的進一步的發展的特點在於:該空心體（1) 至少部分地用一種對X-射線不透明的材料充塡，該材料由 一種可吸收(resorbieren )的且宜多孔隙的聚合物構成。爲 了使該塡充劑對X-射線不透明，故將對比劑加到該聚合物 。在PLA的場合，舉例而言，可將一種標示劑(Marker)， 例如二氧化锆加入，在PEEK的場合可將硫酸鋇混入。 另一種較佳的進一步的發展的特點在於:在植入物中可 能存在的穿孔至少部分地用該對X-射線不透明塡充劑塡充 。如此可防止該塡充劑掉出來。 用於製造本發明的骨植入物的方法特點在於:該管形的 空心體利用射出成形-、熱成形-、或熱壓技術製造。利用 熱變形可將該聚合物壓縮成所有模製元件，這點的特色爲 耐疲勞性較佳。 、 本發明與本發明的進一步的發展特點在以下利用一實 施例部分示意圖式更詳細說明。圖式中： [圖式的簡單說明] 第1圖係一個本發明的椎間植入物的立體圖， 第2圖係第1圖的植入物的上視圖， 6 本紙張尺度適用中國國家標準（CNS)A4規格（210 X 297公釐） ------------------- ---訂_| (請先閱讀背面之注意事項再填寫本頁) 線%· A7 1236368 五、發明說明（’） 第3圖係第1圖的植入物的前視圖， 第4圖係第1圖的植入物的側視圖。 [圖號說明] (1) 環形空心體 (2) 骨植入物的表面 (3) 中間壁 (4) 橫樑 (5) 穿孔 (6) 函殼 (7) 圓筒軸 (8) 穿孔 (9) 函殻的前部段 (10) 函殻的後部段 (11) 函殻的側部段 [實施例的說明] 在第1〜第4圖中所示的椎間植入物由一種可透過輻 射線的材料(PEEK，它可選擇性地用碳纖維或玻璃纖維補 強）構成，該材料用射出成形方法設計成環形空心體（1)形 式。它包含一個空心圓筒部段形的函殻(6)，該函殼有一個 .前部段(9)、一個後部段（1〇)、及二個側部段（11)，且定義 出一條圓筒軸(7)。 空心體（1)利用二個中間壁（3)分隔成室，該中間壁（3) 大致平行於該圓筒軸(7)延伸並把函殼的前部段(9)與後部段 (10)連接。該二個中間壁(3)利用一橫樑(4)互相桁接。中間 7 本紙張尺度適用中國國家標準（CNS)A4規格（21〇 x 297公釐) 一 —訂--------- 線％ (請先閱讀背面之注意事項再填寫本頁) 1236368 A7 _ __B7___ 一 五、發明說明（6 ) 壁設有穿孔(5)，這些穿孔的面積約l〇mm2。函殻(6)的側部 段（11)也有穿孔(8)，這些穿孔的面積約10mm2。 該骨植入物的表面(2)的表面粗糙度爲6//m，且設有 一個由金構成的薄鍍覆層，可透過X射線。 該骨植入物的總體積V與該空心體（1)的體積v之間的 比例V : v約爲2 : 1 。 空心體（1)可利用一種由羥基磷灰石構成的，對X射線 不透明的塡充劑充滿，其中要注意，該現有穿孔（5)，(8)也 宜用對X射線不透明的塡充劑充塡。 --------------------訂·— (請先閱讀背面之注意事項再填寫本頁) 線% 本紙張尺度國國家標準（CNS)A4規格（21〇 X 297公爱）

Claims (1)

  1. A8B8C8D8 1236368 κ、申請專利範圍 $來6.如_申請專利範_第1或第2項的骨植入物，其中： (請先閲讀背面之注意事項再填寫本頁) 0透過輻射線的材料用纖維補強，且宜用碳纖維，玻璃纖 維，或PEEK纖維。 一 7.如申請專利範_第1或第2項的骨植入物，其中： β冃植入物的總體積V與該空心體（1)的體積v之間的比例 V ··"在1:〜2.3之間、。 8.如申請專利範園第1或第2項的骨植入物，其中： 其表面至少部分地設有一個可透過X射線的覆層或一個對 X射線的透過性幾乎無影響的薄層。 9·如申請專利範圍第9項的骨植入物，其中：該覆層 由一種金屬構成，且宜爲鈦、金、或鉑。 10.如申請專利範圍第9項的骨植入物，其中：該覆層 由一種陶瓷材料構成，且宜由羥基磷灰石或二磷酸三鈣構 成。 線_ 11·如申請專利範圍第i或第2項的骨植入物，其中： 該空心體（1)至少部分地用一種塡充劑充塡，該塡充劑由磷 酸銘構成’且宜由羥基磷灰石或二磷酸三鈣構成。 12·如申請專利範圍第1或第2項的骨植入物，其中： 該空心體（1)至少部分地用一種塡充劑充塡，該塡充劑由硫 酸銘、除礦物骨、自體骨、或珊瑚骨構成。 13. 如申請專利範圍第1或第2項的骨植入物，其中·· 該空心體至少部分地用一種由一可吸收的聚合物構成的塡 充劑充塡，該聚合物宜爲多孔隙者。 14. 如申請專利範圍第4項的骨植入物，其中：該可能 本紙張尺度適用中國國家標準（CNS)A4規格(210 X 297公釐) 1236368 A8 B8 C8 D8 六、申請專利範圍 存在的穿孔（5)(8)至少邰分地用對X射線不透明的壚充劑 充塡。 15·—種製造如申請專利範圍第1項的骨植入物的方法 ’其中：該環形空心體（1)利用射出成形-、熱成形-、 壓f吴技術製造。 (請先閱讀背面之注意事項再填寫本頁〕 2έτ: 本紙張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐）
TW090131611A 2001-01-30 2001-12-20 Bone implantate, particularly intervertebral implantate TWI236368B (en)

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