TWI516292B - 具抗菌性塗覆滑動表面的義肢元件 - Google Patents

具抗菌性塗覆滑動表面的義肢元件 Download PDF

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TWI516292B
TWI516292B TW100134968A TW100134968A TWI516292B TW I516292 B TWI516292 B TW I516292B TW 100134968 A TW100134968 A TW 100134968A TW 100134968 A TW100134968 A TW 100134968A TW I516292 B TWI516292 B TW I516292B
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sliding surface
prosthetic component
prosthetic
coating
surface coating
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羅格 索爾
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華迪瑪琳克股份有限公司
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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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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
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    • A61F2310/00856—Coating or prosthesis-covering structure made of compounds based on metal nitrides
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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Description

具抗菌性塗覆滑動表面的義肢元件
本發明係關於一種關節體內義肢的義肢元件。該義肢元件包含一滑動表面，其經設計以與抗衡的滑動表面形成一滑動關節。該抗衡的滑動表面可為另一個義肢元件之表面或該關節或軟組織之骨抗衡軸承。
當將義肢插入人體中時，會重覆地發生問題，此係因為身體在接受義肢時會有併發症發生。所謂的生物膜(其在移植後，於表面上由細菌形成，其亦呈植入狀態)時常係此併發症的理由。已經顯示出此不僅有與義肢其呈植入狀態且直接毗連身體組織的表面區域相關的風險，而且亦有與想要與其它義肢元件交互作用之此等表面區域相關的風險。特別是，這些表面區域包括義肢元件的滑動表面，其與其它義肢元件交互作用以再現出天然關節的功能性。在這些區域中的表面生物膜大大超過身體之防禦機制可及的範圍。該生物膜存在的風險係其會從滑動表面區域重覆地將微生物釋放至週圍區域。因為該滑動表面連續遭遇到移動的事實，微生物本身從滑動表面區域散佈進週圍區域中之趨勢進一步提高。
義肢的滑動表面遭遇到與剩餘表面區域相當不同的應力。若合適的話，當以人體的幾乎全部重量乘以加速力之函數落在義肢的滑動表面上時，在關節中發生相對移動。在這些環境下，難以防止微生物散佈。
考慮到此先述技藝，構成本發明的基礎之問題係呈現出用來減低在插入人體期間發生併發症的機率之義肢元件。此問題係由申請專利範圍第1項的特徵解決。根據本發明，該義肢元件提供一種具有抗菌效力的滑動表面塗層。優良的具體實例係描述在相依的申請專利範圍中。
初始解釋幾個用字。具有抗菌效力的塗層其自身可由具有降低微生物的生存能力或複製能力之潛力的事實來辨別。通常來說，此係藉由該塗層釋放出一具有對抗微生物的效力之物質達成。
義肢的滑動關節係由第一義肢元件之滑動表面與第二義肢元件之相應的抗衡滑動表面形成。在移動程序期間，可在該滑動表面的不同區域中，於滑動表面與抗衡的滑動表面間製得接觸。用字”滑動表面”包括在義肢中於關節移動期間可與該抗衡的滑動表面接觸之全部表面區域。
若在主體上沉積一塗層時，將額外的材料加入至該主體。在該主體的表面上產生一全部由新加入的材料組成之塗層。不排除根據本發明的塗層亦可沉積在該義肢元件除了該滑動表面外之表面區域上。但是，其它表面區域時常無塗層，以便該塗層僅有在該滑動表面上。
根據本發明之塗層，將抗菌效應引進該滑動表面的區域中，因此引進不受身體的防禦系統影響之區域中。在滑動表面的區域中沒有抗菌活性，微生物本身可於此定居及反復地繁殖。根據本發明的抗菌塗層扮演對抗微生物，因此減低併發症的風險。
就此而論，在義肢表面上的抗菌塗層已知，參見例如EP 2 036 517。但是，迄今為止它們僅意欲讓義肢的此等表面區域曝露至低機械應力。
特別合適於應用在身體中的滅菌劑係銀。從塗層釋放出的銀顆粒對座落於塗層表面之微生物具有好的對抗效力。若從塗層顯露出的銀顆粒沒有遇到微生物，它們在身體中會與電解質結合成氯化銀(AgCl)及可從身體以此形式排泄。然後，銀在其它身體細胞上不具有損害效應。因此，該滑動表面塗層以包含銀為較佳。銀從該滑動表面塗層以各別的銀離子形式釋放出為較佳。
關節義肢的滑動表面將曝露至高機械應力。滑動表面的高耐久性可藉由使用硬材料塗層製得該滑動表面塗層達成。較佳的是，該滑動表面塗層包括以耐火金屬為基礎的氮化物、氧氮化物或氧化物。有利的是，銀亦包含在滑動表面塗層中及可從塗層釋放。耐火性金屬係第四、第五及第六次族之高熔點的非貴重金屬。在第四次族中所包含者係鈦、鋯及鉿，在第五次族中係釩、鈮及鉭，及在第六次族中係鉻、鉬及鎢。特別合適於體內義肢元件的塗層之耐火性金屬係鈦、鋯、鈮及鉭。用字”以耐火金屬為基礎的氮化物、氧氮化物或氧化物”指為耐火金屬的離子與氧及/或氮作為反應性氣體所形成之化合物。然而，這些化合物本身可由大的硬度辨別。若該滑動表面塗層額外包含銀時，則不僅耐火金屬的離子與反應性氣體被包含於所產生的氮化物、氧氮化物或氧化物中，而且其亦額外包含銀離子。銀離子被併入欲產生的塗層中。
在包含銀的硬材料塗層之情況中，抗菌效力隨著銀含量而增加。若將該塗層設計成主要留意在具有高抗菌效力時，將選擇在該硬材料塗層中的銀含量約25重量%。但是，機械耐久性則顯著降低(與不包含銀的硬材料塗層比較)。在本發明的上下文中，因此應該在該硬材料塗層中選擇較低的銀含量(以重量計)。該含量(以重量計)以在2%至15%間為較佳，以在3%至10%間為更佳。已經顯示出隨著此低銀含量，在機械耐久性與抗菌效應間達成好的妥協。
該滑動表面塗層應該配製成銀主要係以各別的銀離子形式且不以較大的顆粒形式釋放。各別的銀離子可在滑動表面間活化而沒有發展出相關於滑動表面之磨損效應。
該義肢元件的主體可由金屬或金屬合金組成。特別合適的材料係鈦及鈦合金。
根據本發明之滑動表面塗層可例如藉由PVD方法(物理氣相沉積)沉積在該義肢元件的主體上。為這目的，提供晚後可被移出以形成塗層的材料標靶。可提供的各別標靶係包含耐火金屬和銀。但是，亦可提供數個標靶，其中第一標靶包含耐火金屬及其中第二標靶包含銀。
為了移出離子的目的，例如，可在電極與標靶間產生電弧，其將足夠的能量局部輸送至標靶以便移出離子。另一種將足夠的能量局部輸送至標靶之可能性可由將雷射束瞄準在標靶處組成。此外，即使非常昂貴，亦可藉由電子束傳遞能量。
將游離的離子引導到該義肢元件之主體上。為此目的，可在標靶與主體間施加電壓，藉此在主體的方向上加速該等離子。含有標靶與主體的反應容器包括反應性氣體，諸如例如氧或氮或氧與氮之混合物。耐火金屬的離子和銀及/或銅的離子與該反應性氣體反應。根據本發明之滑動表面塗層係藉由在主體表面上發生的反應而形成。該反應可在真空下發生，以在高真空下為較佳。
若欲避免在該義肢元件除了滑動表面外的其它表面區域上形成塗層，可在塗層製程期間覆蓋這些表面區域。例如，可以一溫度安定的材料覆蓋這些表面區域。若一材料在電漿塗佈製程期間所顯現之條件下安定時，其標記為溫度安定。該溫度安定材料特別可為金屬。
為了在移動期間於滑動表面與抗衡的滑動表面間保持最小磨損，該滑動表面應該儘可能平滑。較佳的是，該滑動表面之平均粗糙度Ra小於0.05微米，如根據DIN EN ISO 4288及3274測量。
本發明進一步關於一種關節體內義肢，其具有一根據本發明設計之第一義肢元件及一第二義肢元件。該第二義肢元件包含一抗衡的滑動表面，其與該第一義肢元件之滑動表面形成滑動關節。
圖式簡單說明
在接下來中，本發明藉由優良具體實例的實施例且參照所附上的圖形來說明。其係顯示在下列中：第1圖係按照本發明所配備的髋義肢；第2圖係來自第1圖的放大部分；及第3圖係按照本發明所配備的膝義肢。
顯示在第1圖中的髋義肢包含一股骨元件10及一髖臼元件11。該股骨元件10包含一幹12，其插入股骨13的骨髓隙中。接著該幹12係一義肢頸14，其轉變成關節頭15。將髖臼元件11引進髖骨16中及置換於此的天然髖臼。髖臼元件11包含一殼17，其係由金屬製得；和一由高密度聚乙烯組成的插入物18。
在植入狀態下，關節頭15係以關節頭15與聚乙烯插入物18一起形成滑動關節之此方式置於聚乙烯插入物18中。因此，關節頭15的表面與聚乙烯插入物18的抗衡滑動表面26一起作用為滑動表面19。該滑動表面之平均粗糙度Ra小於0.03微米。
股骨元件10係從鈦合金製造。在滑動表面19的區域中，如第2圖以明顯放大的表示顯示出，滑動表面塗層20係沉積在關節頭15上。該滑動表面塗層20係藉由PVD方法製造及具有厚度約3微米。滑動表面塗層20由附上銀原子21的氮化鈦組成，其中銀原子未呈比例地表示出。滑動表面塗層20具有銀原子含量約5重量%。
銀係以各別的原子形式且不以較大的顆粒形式被包含在滑動表面塗層20中。在義肢之使用期間，各別的銀離子從滑動表面塗層20顯露出。銀離子在滑動關節的區域中具有抗菌效應。各別的銀離子如此小，使得它們在聚乙烯插入物18上不具有磨損效應。
在第3圖中顯示出一膝義肢，其裝備有一根據本發明的滑動表面塗層。該膝義肢包含一股骨元件22及一脛骨元件23。該股骨元件22的滑動表面24與脛骨元件23的聚乙烯插入物25一起作用，及形成一模擬天然膝的功能之滑動關節。
該股骨元件22及脛骨元件23由傳統的鉻-鈷合金組成。抗菌滑動表面塗層20(如在第2圖中闡明)係沉積在股骨元件22的滑動表面24上。
在第3圖的膝義肢之情況中，於聚乙烯插入物25的頂端上那時，該滑動表面24僅有小的表面區域置於任何點處。各別的表面區域係根據膝義肢的動作狀態而改變。滑動表面塗層20擴展在整個滑動表面24上，此意謂著在可與聚乙烯插入物25接觸的整個表面區域上擴展。從滑動表面塗層20顯露出之銀離子對處於此的微生物具有抗菌效應。
10．．．股骨元件
11．．．髖臼元件
12．．．幹
13．．．股骨
14．．．義肢頸
15．．．關節頭
16．．．髖骨
17．．．殼
18．．．插入物
19．．．滑動表面
20．．．滑動表面塗層
21．．．銀原子
22．．．股骨元件
23．．．脛骨元件
24．．．滑動表面
25．．．插入物
26．．．抗衡滑動表面
第1圖係按照本發明所配備的髋義肢；
第2圖係來自第1圖的放大部分；及
第3圖係按照本發明所配備的膝義肢。
10．．．股骨元件
11．．．髖臼元件
12．．．幹
13．．．股骨
14．．．義肢頸
15．．．關節頭
16．．．髖骨
17．．．殼
18．．．插入物
19．．．滑動表面
26．．．抗衡滑動表面

Claims (7)

  1. 一種具有滑動表面的關節體內義肢之義肢元件，其經設計以與另一個義肢元件的抗衡滑動表面或與關節或軟組織的骨抗衡軸承形成一滑動關節，其特徵為該滑動表面係由一沉積在該義肢元件的主體上之滑動表面塗層形成，及其中該滑動表面塗層具有抗菌效應；其中該滑動表面塗層含銀；其中該滑動表面塗層包含以耐火金屬為基礎的氮化物、氧氮化物或氧化物；以及其中該滑動表面塗層中的銀含量以重量計係在2%至15%間。
  2. 如申請專利範圍第1項之義肢元件，其特徵為該耐火金屬係鈦。
  3. 如申請專利範圍第1項之義肢元件，其特徵為在該滑動表面塗層中的銀含量以重量計係在3%至10%間。
  4. 如申請專利範圍第1項之義肢元件，其特徵為該滑動表面塗層具有厚度在0.5微米至5微米間。
  5. 如申請專利範圍第1項之義肢元件，其特徵為該滑動表面塗層可藉由PVD方法獲得。
  6. 如申請專利範圍第1項之義肢元件，其特徵為該滑動表面之平均粗糙度Ra小於0.05微米。
  7. 一種關節體內義肢，其具有一如申請專利範圍第1至6項之任何一項般所設計的第一義肢元件，及一具有抗衡的滑動表面之第二義肢元件，其中該第一義肢元件的滑動表面與該第二義肢元件的抗衡滑動表面形成一滑動關節。
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