TWI599348B - 骶髂關節固著融合系統 - Google Patents
骶髂關節固著融合系統 Download PDFInfo
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Description
本國際專利合作條約專利申請案主張2010年1月13日申請之美國臨時專利申請案第61/335,947號之權利,該臨時專利申請案特此以全文引用的方式併入本文中。
一般而言,本發明係關於一種骶髂關節固著融合系統,其提供一種固著且融合骶髂關節之方法及一種在置放於骶髂關節之關節間隙內時有助於骶髂關節之穩定性及融合的骶髂關節植入物。
骶髂關節為在骨盆之骶骨與髂骨之間的由韌帶接合之關節。在人類中,骶骨支撐脊椎且又由每一側上之髂骨支撐。骶髂關節為具有關節軟骨及會產生兩骨之連鎖之不規則隆起及凹陷的滑動關節。
與骶髂關節相關之疼痛可由骨盆之創傷性骨折脫位、退化性關節炎、骶髂關節炎(sacroiliitis)(骶髂關節之一種發炎或退化病狀)、緻密性髂骨炎(osteitis condensansilii)或骶髂關節之其他退化病狀引起。當前,此等病狀之最為提倡之外科療法是骶髂關節融合。骶髂關節之融合可藉由若干不同習知方法達成,該等方法涵蓋前路方法、後路方法及側路方法,伴有或不伴有經皮螺釘或其他類型的植入物固著。然而,儘管此等方法之每一者在過去之數十年中皆已用於骶髂關節之固著及融合,但關於骶髂關節固著及融合之實質性問題仍未經解決。
伴隨用於固著且融合骶髂關節之某些習知方法(包括前路方法、後路方法或側路方法)之一個顯著問題可為外科醫師必須在皮膚及組織中產生實質性切口以直接接近所涉及之骶髂關節。此等侵襲性方法允許骶髂關節由外科醫師直接看見及觸及。常稱為「切開手術(open surgery)」之此等程序具有要求全身麻醉之相伴缺點且可由於由切開手術引起之廣泛軟組織損傷而涉及手術時間、住院期、疼痛及恢復時間增加。使用前路方法進行切開手術之一個危險可為對位於骶髂關節內側約2公分處之L5神經根的損傷或對主要血管的損傷。另外,此等程序典型地涉及藉由置放一或多個螺釘或藉由置放一或多個經髂植入物(如由圖1之非限制性實例所示)或藉由將植入物置放入S1椎引根(pedicle)及髂骨中來固著骶髂關節(使骶髂關節之關節面相對於彼此不動)。經髂及S1椎引根髂骨植入物之使用亦可涉及損傷腰骶神經血管元件之風險。因使用此等程序所致之腰骶神經血管元件損傷以及骶髂關節之延遲結合或不結合可能需要進行用以移除所有或部分植入物之翻修手術或關於此等併發症之重複手術。
伴隨利用侵襲性最小之小切開程序之習知程序的另一顯著問題可為由於需要雙平面螢光檢查骶髂關節之關節面及廣泛外科訓練及經驗,該等程序在技術上有難度。不管外科訓練及經驗之程度如何,始終常常發生對腰骶神經血管元件的損傷。另外,骶骨畸形可進一步導致植入物之不良置放,從而引起周圍結構損傷。另外,此等程序常在骶髂關節未融合之情況下進行,此不移除退化關節面且藉此不處理可能引起骶髂關節持續或復發性疼痛之骶髂關節退化病狀。
伴隨習知程序之另一顯著問題可為利用多個不包括有螺紋表面的經髂狹長植入物。此方法需要在骨盆及鄰近骶骨孔中產生經髂孔,其可具有相對較大尺寸且隨後用儀器進行拉削,其可導致骨被擠入骨盆及神經孔(neuroforamen)中。
產生經髂孔及隨後對孔進行拉削需要導銷,其可能會無意中進入骨盆或骶骨孔中,從而導致其他結構之損傷。另外,產生經髂孔、拉削、或置放狹長植入物可能導致腰骶神經血管元件損傷,如上所論述。另外,骶髂關節之關節部分可能無實際融合,此可能導致需要額外手術之持續或復發性疼痛。
伴隨習知程序之另一實質性問題可為置放如Stark之美國專利申請案第10/797,481號中之實例所述的後路關節外牽引融合植入物及骨移植物就移除關節面或預備皮質骨、植入物結構及固著骶髂關節而言可能不足夠。方法可能不會移除骶髂關節之足夠量之關節面或皮質面以減輕骶髂關節疼痛。對於充分固著或融合而言,所述植入物結構與骶髂關節之關節面或皮質骨的嚙合可能不足或無效。用Stark申請案所述之植入物結構及方法不能充分穩定且融合骶髂關節可能導致不能減輕所治療之骶髂關節病狀。另外,如Stark所述的驅動骶骨與髂骨分開之方法可能導致骶髂關節之不良對準及增加之疼痛。
本文所述之本發明髂融合系統處理與骶髂關節之固著及融合中使用之習知方法及裝置相關聯的問題。
因此,本發明之一廣泛目標可為提供用於固著且融合骶髂關節之本發明骶髂關節植入物。該骶髂關節植入物之具體實例可提供狹長本體,其可進一步包括自該狹長本體之縱軸徑向向外延伸一定距離,適於在骶髂關節之關節面之間進行非橫向置放的至少1個徑向部件或一對部件,且關於某些具體實例,其可進一步提供各自適於自該狹長本體之縱軸徑向向外延伸一定距離進入骶骨或髂骨之骨中的第三徑向部件及另外第四徑向部件。
本發明之另一廣泛目標可為提供利用本發明髂植入物的用於固著且融合骶髂關節之本發明方法。本發明方法包含進行侵襲性最小之後路手術的步驟,該手術允許接近骶髂關節之後路態樣以達成移除骶髂關節之關節面之間的可由上述髂植入物之具體實例置換之足夠部分的關節軟骨或組織。可移除骶髂關節之軟骨下骨之一部分以在骶髂關節平面中提供植入物接收間隙(非經髂),其經組態以允許狹長部件、或具有在植入物接收間隙之相對表面之間的至少第一徑向部件的狹長部件之干涉配合(interference fitting)。本發明方法可進一步包括提供具有一或多個切入骨(包括軟骨下骨、皮質骨或疏鬆骨之一或多者)中之徑向部件接收通道之植入物接收間隙,且藉此將一或多個徑向部件定位在骶骨之骨或髂骨之骨中的步驟。本發明方法避免習知的經髂置放由桿(rod)接合之固著元件或S1椎弓根及髂內螺釘,同時提供骶髂關節之即刻固著。
本發明之另一廣泛目標可為提供一或多個骨向內生長孔隙元件,其在一或多個徑向部件之相反表面之間或貫穿大體上線性之狹長本體連通,各元件具有允許骶骨及髂骨之骨生長入植入物中或貫穿植入物生長以有助於骶骨與髂骨融合及骶髂關節固著的組態。
本發明之另一廣泛目標可為提供沿植入物長度具有一定量之彎度之本發明固著融合植入物的特定具體實例,該彎度允許置放固著融合植入物之具有增加之表面積,保持或實質上保持在骶髂關節之關節部分內的具體實例。
本發明之另一廣泛目標在於提供植入骶髂關節植入物以固著骶髂關節之方法,其包含以下步驟:
a)接近該骶髂關節之肢接表面之間的關節間間隙;
b)在骶髂關節之肢接表面之間非橫向置放骶髂關節植入物;及
c)藉由骶髂關節之該等肢接表面對該骶髂關節植入物的相應嚙合來以實質上不動之關係安置該骶骨及該髂骨。
該方法進一步包含在骶髂關節之肢接表面之間產生植入物接收間隙之步驟。
在骶髂關節之該等肢接表面之間產生植入物接收間隙之步驟進一步包含移除在由該等關節面界定之區域內之骶髂關節之一部分的步驟。
該方法進一步包含用該骶髂關節植入物置換在由該等關節面界定之區域內的所移除的骶髂關節的該部分。
移除由該等關節面界定之區域內之骶髂關節之一部分的步驟包含自由以下組成之群移除骶髂關節之一部分:一定量之關節軟骨、該骶骨或該髂骨之一定量之皮質骨、該骶骨或該髂骨之一定量之疏鬆骨或其組合。
該方法進一步包含將徑向部件接收通道切入該骶髂關節之該等關節面之至少一者中的步驟。
該方法進一步包含將徑向部件接收通道切入該骶髂關節之該等關節面之每一者中的步驟。
該方法進一步包含將該骶髂關節植入物之整體實質上插入該植入物接收間隙之步驟。
該方法進一步包含藉由在骶髂關節之肢接表面之間非橫向置放該骶髂關節植入物來實質上避免改變該骶骨及該髂骨之位置關係的步驟。
該方法進一步包含將以實質上不動關係安置之該骶骨及該髂骨之位置關係實質上維持成如在骶髂關節之肢接表面之間非橫向置放該骶髂關節植入物之前所存在的位置關係的步驟。
該方法進一步包含在骶髂關節之肢接表面之間非橫向定位該骶髂關節植入物而不驅動該等關節面分開的步驟。
該方法進一步包含與該骶髂關節植入物相抵地壓迫肢接表面之步驟。
該方法進一步包含以與與骶髂關節植入物相應嚙合之該等關節面呈橫向關係地安置狹長部件的步驟。
該方法進一步包含藉由操作該狹長部件來與該骶髂關節固著元件相抵地牽引肢接表面的步驟。
該方法進一步包含提供貫穿該骶髂關節植入物之孔及使該狹長部件穿過該孔道來以與與骶髂關節植入物相應嚙合之該等關節面呈橫向關係地安置該狹長部件的步驟。
該方法進一步包含藉由在骶髂關節之肢接表面之間非橫向置放該骶髂關節植入物來以即刻不動關係安置該骶骨及該髂骨之步驟。
該方法進一步包含產生用以接近骶髂關節之肢接表面之間的該關節間間隙之孔道的步驟。
該方法進一步包含使骶髂關節植入物穿過該孔道以在骶髂關節之肢接表面之間非橫向置放該骶髂關節植入物的步驟。
該方法進一步包含經由該孔道推進一或多個導銷以定位於該骶髂關節之該等肢接表面之間的步驟。
該方法進一步包含在該一或多個導銷周圍滑動操作管狀鑽以自該骶髂關節之該等肢接表面之間移除該量之組織的步驟。
該方法進一步包含在該一或多個導銷周圍滑動操作髓針(broach)以自該骶髂關節之該等肢接表面之間移除該量之組織的步驟。
該方法進一步包含組態該髓針之外表面以產生該植入物接收間隙之相應組態的步驟。
該方法進一步包含將套管插入該孔道中以藉由穿過該套管之該一或多個導銷,鄰近該骶髂關節之後路態樣定位一端的步驟。
該方法進一步包含以與該骶髂關節呈固定關係安置該套管之步驟。
該方法進一步包含組態該套管之內表面以滑動嚙合複數個夾具之外表面的步驟。
該方法進一步包含將具有一或多個鑽導子(drill guide)之鑽頭夾插入該套管內及操作該鑽導子內之該鑽以自該骶髂關節之該等肢接表面之間移除該量之組織的步驟。
該方法進一步包含組態該鑽導子以產生用以接收骶髂關節固著元件之該植入物接收間隙的步驟。
該方法進一步包含將具有髓針導子之髓針夾插入該套管內及操作該髓針導子內之該髓針以自該骶骨及該髂骨之該等肢接表面之間移除該量之組織的步驟。
該方法進一步包含組態該髓針導子以產生用以接收骶髂關節固著元件之該植入物接收間隙的步驟。
當然,貫穿本說明書、圖式、像片及申請專利範圍之其他區域揭示了本發明之其他目標。
一般而言,本發明係關於一種骶髂關節固著融合系統,其提供一種固著且融合骶髂關節之方法及一種在置放於骶髂關節之關節區域內時有助於骶髂關節之穩定性及融合的骶髂關節植入物。
現在主要參考圖1,其展示用於固著骶髂關節(1)之一種常用習知方法及器件。所示習知器件包含一或多個實質上線性之狹長部件(2),其可插入於相應尺寸之經髂骨孔(3)中,其中第一部分延伸入骶骨(4)之骨中且第二部分延伸入髂骨(5)之骨中,藉此跨越骶髂關節(1)延伸。呈經髂骨置放之一或多個實質上線性之狹長部件(2)(其可組態成可進一步包括一定量之錐度或進一步包括螺旋螺紋(spiral thread)的與外表面耦接的圓柱狀桿以避免需要產生經髂骨孔)可相對於骶骨(4)呈固定關係地定位髂骨(5)。然而,此等實質上線性之狹長部件(2)之此經髂骨置放可具有上述缺點。另外,經髂骨孔(3)及狹長部件(2)之習知置放可在由骶髂關節(1)之成對關節面(16)(亦通常稱為「耳狀面(auricular surface)」)之邊界界定之彼區域的外部,如以下進一步描述。
現在主要參考圖2-6,展示本發明骶髂關節植入物(6)之一具體實例,其可部分地包括具有縱軸(8)之狹長本體(7)。狹長本體(7)可具有尺寸足以避免在相對於骶骨(4)外科置放及固著髂骨(5)之正常力量下變形的組態。因此,儘管圖2-6中所示之骶髂關節植入物(6)之具體實例可為大體上圓柱狀或橫截面為圓形;但本發明不如此受限制,且狹長本體(7)可具有與下文描述的方法一致之眾多及變化之橫截面組態中的任一者,諸如橢圓形、三角形、矩形、正方形、菱形或其類似組態。作為一非限制性實例,視應用而定,圖2中所示之大體上圓柱狀之狹長本體(7)可具有在約0.5公分(「cm」)至約1 cm之範圍內之直徑及安置在第一植入物端(11)與第二端(12)之間的在約3 cm與約6 cm之範圍內的長度。
關於本發明之特定具體實例,狹長本體(7)可進一步包括定界在狹長本體(7)之第一植入物端(11)與第二植入物端(12)之間連通之軸向路徑(10)的軸孔(9)。軸孔(9)允許在軸向路徑(10)內置放導銷(13)(或其他導引部件),可圍繞該導銷導引骶髂關節植入物(6)之具體實例以插入及置放在骶髂關節(1)中,如以下進一步描述。
再次主要參考圖2-6,骶髂關節植入物(6)之具體實例可進一步包括與狹長本體(7)之外表面耦接之大體上沿縱軸(8)向外徑向延伸的第一徑向部件(14)。關於如圖中所示之骶髂關節植入物(6)之某些具體實例,第一徑向部件(14)可沿縱軸(8)在實質上狹長本體(7)之整個長度上延伸;然而,本發明不如此受限制,且本發明骶髂關節植入物(6)之具體實例可具有第一徑向部件(14),其可部分地或以複數個不連續部分形式沿縱軸(8)或狹長本體(7)延伸。
再次參考圖2-6,骶髂關節植入物(6)之具體實例可進一步包括第二徑向部件(15)。第一徑向部件(14)及第二徑向部件(15)之每一者可大體上以相反關係(圍繞狹長本體(7)之縱軸(8)分開約180度)自狹長本體(7)徑向向外延伸;然而,本發明不如此受限制,且第一徑向部件(14)及第二徑向部件(15)可圍繞狹長本體(7)間隔較大或較小度數。可使第一徑向部件(14)或第二徑向部件(15)之每一者(或兩者)之組態適於非橫向定位在骶髂關節(1)之關節面(16)之間來以實質上不動、不動或固定關係安置骶骨(4)及髂骨(5)。如本文所用之術語「非橫向(non-transversely)」意謂不佈放或延伸跨越骶骨(4)與髂骨(5)之間之關節且特定言之不包括骶髂關節植入物之如上所述且展示於圖1中之經髂骨置放。術語「關節面(articular surface)」包括在骶骨(4)及髂骨(5)之表面之間形成的兩對L形表面,其具有如例如圖25、27及29中所示之前側部分(87)及尾側部分(86)(斷線),且如本文所用,該術語不包括骶骨(4)或髂骨(5)的在關節面(16)之外部的結構或區域,諸如配對髂骨粗隆(iliac tuberosity)及骶骨窩(sacral fossa)。
第一徑向部件(14)及第二徑向部件(15)之每一者可各自提供分開一厚度(19A)而安置且具有由頂部邊緣(20)、一對側邊緣(21)(22)及底部邊緣(23)定界之區域之一對相反面(17)(18)。側邊緣對之第一者(21)可如上所述與狹長本體(7)連接,從而使第二側邊緣(22)自狹長本體(7)之縱軸(8)向外一距離地定位。作為一非限制性實例,第一徑向部件(14)及第二徑向部件(15)之每一者可實質上呈矩形組態,其在側邊緣對之第一者(21)與側邊緣對之第二者(22)之間的高度(28a)在約0.2 cm與約1 cm之範圍內。可理解地,直徑較小之狹長本體(7)可包括具有較大高度(28a)之第一徑向部件(14)及第二徑向部件(15)(或其他徑向部件),且直徑較大之狹長本體(7)可需要具有較小高度(28a)之第一徑向部件(14)及第二徑向部件(15)(或其他徑向部件)。
第一徑向部件(14)及第二徑向部件(15)之每一者之頂部邊緣(20)可實質上與狹長本體(7)之第一植入物端(11)對準地終止。第一徑向部件(14)及第二徑向部件(15)之底部邊緣(23)可實質上與狹長本體(7)之第二植入物端(12)對準地終止。關於某些具體實例,底部邊緣(23)可進一步包括角式元件(24),其自狹長本體(7)向外向第一植入物端(11)傾斜一距離、在第二植入物端(12)處開始且接合側邊緣對之第二者(22)。角式元件(24)可具有相對於縱軸(8)之垂線之在約15度至約30度範圍內的角度(25),如圖2中所示;然而,本發明不如此受限制且角式元件(24)可為半徑元件、錐形元件或使插入骶髂關節(1)中容易之其他元件。
再次主要參考圖2-6,骶髂關節植入物(6)之某些具體實例可進一步包括沿該狹長本體(7)之縱軸(8)延伸之適於延伸入髂骨(5)之皮質骨中的第三徑向部件(26)。某些具體實例可進一步包括沿該狹長本體(7)之縱軸(8)延伸之適於延伸入該骶骨(4)之皮質骨中的第四徑向部件(27)。可使第三徑向部件(26)及第四徑向部件(27)之某些具體實例適於分別延伸入骶骨(4)及髂骨(5)之骨中。
關於圖3中所示之骶髂關節植入物(6)之非限制性具體實例,第三徑向部件(26)及第四徑向部件(27)可大體上與狹長本體(7)之縱軸(8)成直線地連接。第三徑向部件(26)及第四徑向部件(27)之每一者可實質上與第一徑向部件(14)及第二徑向部件(15)呈相反關係(分開約180度)及呈垂直關係(約90度)自狹長本體(7)向外徑向延伸(亦參見圖8及9C);然而,本發明不如此受限制,且第三徑向部件(26)及第四徑向部件(27)(若具體實例包括第四徑向部件(27))可圍繞狹長本體(7)相對於彼此及相對於第一徑向部件(14)及第二徑向部件(15)間隔較大或較小度數,視應用及與骶骨(4)或髂骨(5)之骨之所要的嚙合量而定。
第三徑向部件(26)或第四徑向部件(27)之每一者之組態可根據需要變化以提供足以促進實質性不動、不動之可與骶骨(4)及髂骨(5)之骨嚙合的一定量之表面積,或在植入骶髂關節植入物(6)時相對於髂骨(5)固定骶骨(4)及進一步提供對骶髂關節植入物(6)在由骶髂關節(1)之肢接表面(16)定界之區域內的植入物位置處之旋轉或其他不合需要移動的阻力。因此,骶髂關節植入物(6)之具有第三徑向部件(26)及第四徑向部件(27)之具體實例可提供以分開一厚度(19b)安置之一對相反面(17)(18)且具有由頂部邊緣(20)、一對側邊緣(21)(22)及底部邊緣(23)以與以上關於第一徑向部件(14)及第二徑向部件(15)所述類似之組態定界之區域。側邊緣對之第一者(21)可如上所述與狹長本體(7)連接,從而使第二側邊緣(22)自狹長本體(7)之縱軸(8)向外一距離定位。作為一非限制性實例,第三徑向部件(26)及第四徑向部件(27)之每一者可具有實質上矩形組態,其在側邊緣對之第一者(21)與側邊緣對之第二者(22)之間的高度(28b)在約0.1 cm與約0.4 cm之範圍內。第三徑向部件(26)及第四徑向部件(27)之每一者之頂部邊緣(20)可實質上與狹長本體(7)之第一植入物端(11)對準地終止。第三徑向部件(26)及第四徑向部件(27)之底部邊緣(23)可實質上與狹長本體(7)之第二植入物端(12)對準地終止。關於某些具體實例,第三徑向部件(26)及第四徑向部件(27)之底部邊緣(23)可進一步包括角式元件(24),其使側邊緣對之第二者(22)向狹長本體(7)之第一植入物端(11)彎曲。角式元件(24)可具有相對於縱軸(8)之垂線之在約15度至約30度範圍內的角度(25);然而,本發明不如此受限制且就本發明之某些具體實例而言,可能無角式元件(24)或角式元件之角度可大於或小於約15度至約30度之範圍內的角度。另外,角式元件(24)可與圖中所示類似或在特定骶髂關節植入物(6)之徑向部件之間可不類似(視應用而定)。
再次主要參考圖2-6,且不限於前述,第三徑向部件(26)及第四徑向部件(27)可具有小於第一徑向部件(14)及第二徑向部件(15)之高度(28b)。儘管第三徑向部件(26)及第四徑向部件(27)之結構似乎與第一徑向部件(14)及第二徑向部件(15)類似,但功能可實質上不同。第一徑向部件(14)及第二徑向部件(15)具有一組態(高度、長度、厚度、表面積、及相對於狹長本體(7)之外表面之位置,如上所述),其能夠或允許非橫向置放在關節面(16)之間(且不跨越)或在如以下進一步描述用手術藉由移除骶髂關節(1)之一部分在由關節面(16)定界之區域內產生的植入物接收間隙(29)內,在置放於關節面(16)之間或植入物接收間隙(29)內時能夠使骶髂關節(1)實質上不動或不動。
相對比地,第三徑向部件(26)及關於具有第四徑向部件(27)之彼等具體實例可具有一組態(高度、長度、厚度、表面積、及在狹長本體(7)之外表面上之位置,如上所述),其能夠在非橫向定位骶髂關節植入物(6)於骶髂關節(1)之關節面(16)之間時被強制推動入骶骨(4)或髂骨(5)之皮質骨或疏鬆骨中一定深度或被置放在植入物接收間隙(29)之徑向部件接收通道(74)內。第三徑向部件(26)及第四徑向部件(27)之高度可足以對抗植入之骶髂關節植入物(6)之旋轉以允許疏鬆骨骨融合於髂植入物(6)或穿過與第一徑向部件(14)及第二徑向部件(15)類似之第三徑向部件(26)或第四徑向部件(27)或兩者的孔隙。現在主要參考圖2,自狹長本體(7)向外延伸之每一徑向部件(14)(15)(26)(27)可終止於相對於徑向部件之表面實質上垂直安置的徑向部件隔條(98)。
再次主要參考圖2-6,骶髂關節植入物(6)之特定具體實例可進一步包括一或多個孔隙元件(31),其在第一徑向部件(14)或第二徑向部件(15)或兩者之相反面(17)(18)之間連通。孔隙元件(31)之開口間隙之量可由可具有眾多及變化之組態的孔隙周邊(32)界定,該等組態之尺寸足以允許髂骨(5)或骶骨(4)(或兩者)之表面鄰近於骶髂關節植入物(6)之第一徑向部件(14)或第二徑向部件(15)(或兩者)以向孔隙元件(31)中或穿過孔隙元件(31)生長一定距離或在孔隙元件(31)內融合或融合入置放在孔隙元件內之材料,該材料可包括:可骨整合、骨誘導性、骨傳導性、成骨材料或生物活性劑、或其組合及排列。作為一非限制性實例,孔隙周邊(32)可通常具有橢圓形組態,從而產生位於第一徑向部件(14)或第二徑向部件(15)(或兩者)中(或視具體實例而定位於其他徑向部件中)之橢圓形孔隙元件(31),其中橢圓形孔隙元件(31)之長度與第一徑向部件(14)或第二徑向部件(15)之長度對準且為徑向部件之長度之約四分之一至約三分之二,且橢圓形孔隙元件(31)之寬度定位於第一徑向部件(14)或第二徑向部件(15)之側面(21)(22)之間且為高度(28a)之約四分之一至約三分之二。另外,狹長本體(7)可進一步包括孔隙元件(31),其在徑向部件(14)(15)(26)(27)之間在外表面之間連通。
再次主要參考圖2-7,骶髂關節植入物(6)之具體實例可進一步包括與狹長本體(7)之第一植入物端(11)耦接的抗遷移元件(33)。抗遷移元件(33)可採用狹長本體(7)之第一端之增大末端部分的形式(如圖2-6中所示),一或多個徑向部件之高度(28)增加(諸如如圖7中所示向外張口)鄰近狹長本體(7)之第一植入物端(11)。作為一非限制性實例,抗遷移元件(33)可採用具有大體上圓形組態之端帽(34)之形式,其中中心實質上與狹長部件(7)之縱軸(8)對準且徑向向外延伸一足夠距離以防止在植入物接收間隙(29)中進行植入之後,骶髂關節植入物(6)之第二植入物端(12)前進而進一步進入骶髂關節(1)中。儘管所示端帽(34)大體上為圓形組態,但端帽(34)可具有界定適用於固定骶髂關節植入物(6)相對於骶髂關節(1)之位置之橢圓形、正方形、矩形或其他組態的端帽周邊(35)。另外,抗遷移元件(33)可具有足以進一步包括一或多個孔(36)之尺寸,該等孔在抗遷移元件(33)之相反表面(37)(38)之間連通且經定尺寸以接收可經驅動或旋轉以使機械扣件之一部分與骶骨(4)或髂骨(5)嚙合的機械扣件(39)(諸如有螺紋部件、有缺口部件、鎖定部件或其類似物)。現在主要參考圖2,抗遷移元件(33)亦可採用在一部分或全部外表面上之錐形元件的形式,該等錐形元件自表面向外漸尖,從而允許插入骶髂關節植入物(6)之具體實例但對抗反向行進。現在主要參考圖7,抗遷移元件(33)可採用骶髂關節植入物(6)之錐形末端(33/99)之形式,該錐形末端阻止骶髂關節植入物(6)的正向或反向行進。
上述狹長本體(7)以及骶髂關節植入物(6)之其他元件可自複數件或呈單一件形式之尺寸適合粒子、薄片或其他結構形式之生物相容材料或生物相容及可生物降解材料的組合、或經適合黏合或成形或模製以提供根據本發明之組態之可成形或可模製材料製造或形成。
現在主要參考圖8及9,骶髂關節植入物(6)之具體實例可進一步包括耦接、產生或整合於骶髂關節植入物(6)之所有或一部分外表面之塗層(40)。塗層(40)可為可與骶髂關節植入物(6)耦接之能夠與髂骨(5)及骶骨(4)之骨進行生物相容骨整合之任何組成物,諸如純氧化鋁、二氧化鈦、羥基磷灰石、三磷酸鈣或其類似物。作為一非限制性實例,塗層(40)可藉由用電漿炬、電漿調變器或電漿槍進行電漿噴射來塗覆。或者,塗層(40)可藉由噴砂、珠粒噴擊、模製或其類似操作產生骶髂關節植入物(6)之表面粗糙度、孔隙率或不規則性來達成。塗層(40)可具有在約40 μm與約100 μm之範圍內之厚度。此外,骶髂關節植入物(6)之具體實例可組態成具有貫穿之互連孔之材料,諸如可購自Zimmer(P.O. Box 708,1800 West Center Street,Warsaw,Indiana 46581-0708)之TRABECULAR METAL;或金屬發泡體,諸如可購自National Research Council Canada(1200 Montreal Road,Bldg. M-58,Ottawa,Ontario,Canada)之鈦發泡體;或經完全工程改造之多孔鈦結構,諸如可購自Tecomet(115 Eames Street,Wilmington,MA 01887)之TRABECULITE。
再次主要參考圖2及圖3-6,本發明之具體實例可進一步包括一或多種生物活性劑(41),其可直接施用於骶髂關節植入物(6)之外表面或可與可施用於骶髂關節植入物(6)之外表面或另外組成骶髂關節植入物之一部分的生物相容材料或生物相容可生物降解材料或生物相容可骨整合材料(共同用數字指標(100)表示)混合。關於固著融合植入物(6)之特定具體實例,生物活性劑(41)可與一定量之生物相容可生物降解材料或可骨整合材料(100)混合且定位於一或多個孔隙元件(31)內。
出於本發明之目的之「生物相容」意謂任何材料執行本發明之具體實例之預定功能而不引發對接受者之任何非所要局部或全身性影響的能力,且可包括非可生物降解材料,諸如:陶瓷、金屬或鋼(諸如鈦合金)或硬質聚合材料或硬質層壓材料或複合物(其包括分散在硬質層壓材料內之尺寸適合之金屬粒子或鋼粒子)、經適合黏合或成形以提供組態之生物相容材料之適合大小的粒子、聚胺基甲酸酯、聚異丁烯、乙烯-α-烯烴共聚物、丙烯酸聚合物及共聚物、乙烯基鹵化物聚合物及共聚物、聚乙烯酯、聚氯亞乙烯、聚丙烯腈、聚乙烯酮、聚乙烯芳族化合物(諸如聚苯乙烯)、乙烯系單體與烯烴之共聚物(諸如乙烯-甲基丙烯酸甲酯共聚物)、丙烯腈-苯乙烯共聚物、ABS樹脂、乙烯-乙酸乙烯酯共聚物、聚醯胺(諸如耐綸66(Nylon 66)及聚己內酯)、醇酸樹脂、聚碳酸酯、聚氧化乙烯、聚醯亞胺、聚酯、環氧樹脂、嫘縈-三乙酸酯、塞璐芬(cellophane)、聚醚醚酮(PEEK)、聚醚酮酮(PEKK)、可購自Istituto di Scienza e Tecnologia dei Mareriali Ceramici(Faenza,Italy)之來自木料之骨(bone-from-wood)、或其類似物;或可生物降解材料,如本文所述。
出於本發明之目的之「可生物降解」意謂任何生物相容材料在骶髂關節之生理環境內藉由一或多個物理、化學或細胞過程以符合以可藉由選擇聚合物或聚合物之混合物(亦稱為聚合材料)控制的治療含量提供骶髂關節病狀之治療之速率分解的能力,包括(但不限於):聚乳酸交酯聚合物(PLA)、乳酸與乙醇酸之共聚物(PLGA)、聚乳酸-聚氧化乙烯共聚物、聚(ε-己內酯-共-L-乳酸)(PCL-LA)、甘胺酸/PLA共聚物、涉及聚氧化乙烯(PEO)之PLA共聚物、乙醯化聚乙烯醇(PVA)/聚己內酯共聚物、羥基丁酸酯-羥基戊酸酯共聚物、聚酯(諸如(但不限於)天冬胺酸及不同脂族二醇)、聚(酒石酸烷二酯)及其與聚胺基甲酸酯之共聚物、具有各種酯內含物及具有化學或酶促可降解鍵之聚麩胺酸酯、其他可生物降解非肽聚醯胺、胺基酸聚合物、聚酸酐藥物載體(諸如(但不限於)聚(癸二酸)(PSA)、脂族-芳族均聚物及聚(酸酐-共-醯亞胺)、藉由基質或側位傳遞系統之聚(磷酸酯)、聚(磷氮烯)、聚(亞胺基碳酸酯)、交聯聚(原酸酯)、羥基化聚酯-胺基甲酸酯、或其類似物。
出於本發明之目的之「生物活性劑」意謂種類或量可變化以提供有效介導骨、軟骨、腱之形成或癒合,或降低、抑制或防止在骶髂關節(1)內置放固著融合植入物之一具體實例之後出現骶髂關節病狀之症狀(諸如感染或疼痛)之治療含量的彼等藥劑或藥劑混合物,且可不加限制地包括影響骨生長之藥劑、去礦化骨基質、幹細胞、同種異體移植物、自體移植物、異種移植物、成骨蛋白(無論天然存在、合成或重組)、生長因子、細胞激素、骨形態發生蛋白2、骨形態發生蛋白7、止痛劑、麻醉劑、消炎劑、抗細菌劑、抗病毒劑、抗真菌劑、抗原蟲藥、抗感染藥物、抗生素(諸如胺基糖苷,諸如慶大黴素(gentamicin)、康黴素(kanamycin)、新黴素(neomycin)及萬古黴素(vancomycin))、醯胺醇(諸如氯黴素(chloramphenicol))、頭孢菌素(cephalosporin)(諸如頭孢唑林(cefazolin)鹽酸鹽)、青黴素(penicillin)(諸如安比西林(ampicillin)、青黴素、卡本西林(carbenicillin)、苯唑西林(oxycillin)、二甲氧苯青黴素(methicillin))、林可醯胺(lincosamide)(諸如林可黴素(lincomycin))、多肽抗生素(諸如多黏菌素(polymixin)及桿菌肽(bacitracin))、四環素(tetracycline)(諸如四環素、二甲胺四環素(minocycline)及多西環素(doxycycline))、喹諾酮(quinolone)(諸如環丙沙星(ciprofloxacin)、莫西沙星(moxifloxacin)、加替沙星(gatifloxacin)及左氧氟沙星(levofloxacin))、抗病毒藥物(諸如阿昔洛韋(acyclovir)、更昔洛韋(gancyclovir)、阿糖腺苷(vidarabine)、疊氮胸苷(azidothymidine)、二去氧肌苷(dideoxyinosine)、二去氧胞苷(dideoxycytosine))、止痛劑(諸如可待因(codeine)、嗎啡(morphine)、酮洛酸(ketorolac)、萘普生(naproxen))、麻醉劑、利多卡因(lidocaine)、大麻鹼(cannabinoid)、抗真菌劑(諸如兩性黴素(amphotericin))、抗血管生成化合物(諸如阿奈可他乙酸鹽(anecortave acetate))、類視黃素(retinoid)(諸如他紮羅汀(tazarotene))、類固醇消炎劑(諸如21-乙醯氧基妊烯醇酮(21-acetoxypregnenolone)、阿氯米松(alclometasone)、阿爾孕酮(algestone)、安西奈德(amcinonide)、倍氯米松(beolomethasone)、倍他米松(betamethasone)、布地奈德(budesonide)、氯潑尼松(chloroprednisone)、氯倍他索(clobetasol)、氯倍他松(clobetasone)、氯可托龍(clocortolone)、氯潑尼醇(cloprednol)、皮質酮(corticosterone)、可的松(cortisone)、可的伐唑(cortivazol)、地夫可特(deflazacort)、地奈德(desonide)、去羥米松(desoximetasone)、地塞米松(dexamethasone)、二氟拉松(diflorasone)、二氟可龍(diflucortolone)、二氟潑尼酯(difluprednate)、甘草次酸(enoxolone)、氟紮可特(fluazacort)、氟氯奈德(flucloronide)、雙氟美松(flumethasone)、氟尼縮松(flunisolide)、氟新諾龍丙酮(fluocinolone acetonide)、氟西奈德(fluocinonide)、氟考丁酯(fluocortin butyl)、氟可龍(fluocortolone)、氟米龍(fluorometholone)、氟培龍乙酸鹽(fluperolone acetate)、氟潑尼定乙酸鹽(fluprednidene acetate)、氟潑尼龍(fluprednisolone)、氟氫縮松(flurandrenolide)、丙酸氟替卡松(fluticasone propionate)、福莫可他(formocortal)、哈西奈德(halcinonide)、氯倍他索丙酸鹽(halobetasol propionate)、鹵米松(halometasone)、鹵潑尼松乙酸鹽(halopredone acetate)、氫可他酯(hydrocortamate)、氫皮質酮(hydrocortisone)、氯替潑諾(loteprednol etabonate)、馬潑尼酮(mazipredone)、甲羥松(medrysone)、甲潑尼松(meprednisone)、甲潑尼龍(methylprednisolone)、莫米松呋喃甲酸鹽(mometasone furoate)、帕拉米松(paramethasone)、潑尼卡酯(prednicarbate)、潑尼龍(prednisolone)、潑尼龍25-二乙基胺基-乙酸鹽、潑尼龍磷酸鈉(prednisolone sodium phosphate)、潑尼松(prednisone)、潑尼松龍戊酸酯(prednival)、潑尼立定(prednylidene)、利美索龍(rimexolone)、替可的松(tixocortol)、曲安西龍(triamcinolone)、曲安奈德(triamcinolone acetonide)、苯曲安奈德(triamcinolone benetonide)、己曲安奈德(triamcinolone hexacetonide))、或含有活間質幹細胞之同種異體移植細胞基質(諸如可購自NuVasive公司(7475 Lusk Blvd.,San Diego,CA 92121 USA)之OSTEOCEL PLUS)、及任何其衍生物(以單獨或以其組合形式)。
關於本發明固著融合植入物(6)之特定具體實例,生物活性劑(41)可貫穿生物相容或生物相容可生物降解材料(或生物相容材料之混合物或生物相容可生物降解可生物降解材料之混合物)分散,此係藉由將生物活性劑(41)混合入熔融的生物相容或生物可降解聚合物中且接著藉由冷卻使所得材料凝固,從而使生物活性劑(41)實質上均一地分散於每一處來達成。可生物降解材料或生物相容材料或其混合物可經選擇以具有低於生物活性劑(41)變為反應性或降解之溫度的熔點。或者,可藉由溶劑澆鑄而使生物活性劑(41)分散在生物相容或可生物降解材料中每一處,在溶劑澆鑄中,生物相容或可生物降解材料溶解於溶劑中,且生物活性劑(41)溶解或分散於溶液中。接著蒸發溶劑,從而使生物活性劑(41)留在生物相容或可生物降解材料之基質中。溶劑澆鑄需要生物相容或可生物降解材料可溶於有機溶劑中。或者,固著融合植入物(6)可置放於溶解有一定濃度之生物活性劑(41)的溶劑中且其中位於孔隙元件中或施用於外表面之固著融合植入物(6)或生物相容或生物相容可生物降解材料會膨脹。固著融合植入物(6)或其部分之膨脹會吸引一定量之生物活性劑(41)。可接著蒸發溶劑,從而使生物活性劑(41)留在生物相容或生物相容可生物降解材料內。關於使生物活性劑(41)貫穿固著融合植入物(6)之或與固著融合植入物耦接之生物相容或可生物降解生物相容材料分散的每一方法,治療含量之生物活性劑(41)可包括在生物相容可生物降解材料中以向骶髂關節(1)提供治療有效含量之生物活性劑以治療特定骶髂關節病狀。
其他非活性劑(42)可出於多種目的包括在生物相容可生物降解材料中。舉例而言,可採用緩衝劑及防腐劑。可使用之防腐劑包括(但不限於)亞硫酸氫鈉、硫酸氫鈉、硫代硫酸鈉、氯化苯甲烴銨、氯丁醇、硫柳汞、乙酸苯汞、硝酸苯汞、對羥基苯甲酸甲酯、聚乙烯醇及苯基乙醇。可採用之緩衝劑之實例包括(但不限於)如由FDA或美國或外國之其他適當機構針對所要投藥途徑所核準的碳酸鈉、硼酸鈉、磷酸鈉、乙酸鈉、碳酸氫鈉及其類似物。諸如氯化鈉及氯化鉀之電解質亦可包括在調配物中。
作為一非限制性實例,具有含用於治療骶髂關節(1)之生物活性劑(41)之生物相容可生物降解部分的固著融合植入物(6)之具體實例可藉由將生物活性劑(41)分散於如上所述之生物相容可生物降解材料中以提供在治療含量下之生物活性劑(41)釋放特性來製備。如下所述在骶髂關節(1)中植入固著融合植入物(6)時,固著融合植入物(6)之生物相容可生物降解部分可實質上連續釋放生物活性劑(41)以在約1毫克至約4毫克之治療含量下提供局部量之骨形態發生蛋白2以有助於骨再生長。應瞭解提供傳遞一定量之骨形態發生蛋白2以有助於骨再生長的固著融合植入物(6)之一具體實例之此特定實例不意欲具有限制性,且固著融合植入物(6)之具體實例可用於傳遞呈個別或組合形式之眾多及變化之活性劑(41)以在植入固著融合植入物(6)之具體實例之後治療骶髂關節(1)之廣泛範圍的病狀。
現在主要參考圖10-15及30,本發明之特定具體實例可進一步在固著融合植入物(6)之第一植入物端(11)與第二植入物端(12)之間包括一定量之彎度(43)。彎度(43)之量可在固著融合植入物(6)之具體實例與具體實例之間變化,視在實質上線性狹長本體(7)之間的應用而定,該狹長本體係如上所述以包括一定量之彎度(43),其界定有助於在骶髂關節(1)之關節面(16)之間的前側部分(87)及尾側部分(86)中或在相應植入物接收間隙(29)中進行置放的半徑。作為一非限制性具體實例,半徑可在約2 cm及約6 cm之範圍內。
現在主要參考圖15,具有一定量之彎度之本發明的某些具體實例可以複數個植入物區段(101)(102)(103)提供,該等區段可藉由下述方法個別地植入如圖25、27或29中所示之關節區域(44)內。
另外,骶髂關節植入物(6)之具體實例可經組態以收容骨生長刺激器(105)。適用之可植入生長刺激器可直接嚙合電池組之陽極及在骶髂關節植入物(6)內或極鄰近骶髂關節植入物處植入之單一或雙重鈦陰極導線。陰極導線可向宿主骨、骨移植物或器件之部分中安置一定距離,較佳使陰極端接觸活骨及/或錨定入活骨中。本發明之具體實例可包括具有隔熱材料(諸如PEEK)以防止陰極-金屬接觸,同時允許陰極-骨接觸之金屬植入物。電池組可置放於筋膜外皮下袋中以達成可移除之置放。適合生長刺激器可購自Biomet Trauma 100 Interpace Pkwy#1(Parsippany,NJ 07054-1149)。
可理解地,無論單獨或呈接合關係、無論為相同或不同具體實例之複數個本發明骶髂關節植入物(6)可與本文關於固著且融合骶髂關節(1)所述之習知或本發明植入方法一起加以利用。作為一實例,複數個狹長本體(7)可以固定、實質上固定或可移動關係接合以提供骶髂關節植入物(6)之一具體實例。
現在主要參考圖16-24,其為接近骶髂關節(1)之肢接表面(16)之間的關節區域(44)且在骶髂關節(1)之關節區域(44)內之肢接表面(16)之間非橫向置放骶髂關節植入物(6)以藉由骶髂關節(1)之肢接表面(16)對骶髂關節植入物(6)之相應嚙合來以實質上不動關係安置骶骨(4)及髂骨(5)的一非限制性方法。所述方法之特定實例足以使一般技術者能夠利用骶髂關節植入物(6)之具體實例且不意欲關於步驟順序,或使用所有或任何步驟或將一或多個步驟組合成為單一步驟,或進行作為子步驟之任一步驟、或其他類似等效或習知步驟以將骶髂關節植入物之具體實例植入骶髂關節(1)內而具有限制性。
現在主要參考圖16,方法之一具體實例可包括使在鎮靜狀態下之患者伏臥在半透明手術台(或其他適合表面)上之步驟。骶髂關節(1)可經局部麻醉以允許在螢光檢查指導下將射線照相對比劑(46)(作為一非限制性實例,Isoview 300射線照相對比劑)注射入骶髂關節(1)之下路態樣中以描繪骶髂關節(1)之關節面(16)的輪廓。在骶髂關節(1)內注射射線照相對比劑(46)可利用具有可在骶髂關節(1)之肢接表面(16)之間前進之第一管狀部件端(48)且具有以可移除方式與套節(50)耦接之第二管狀部件端(49)的管狀部件(47)(諸如注射針)達成。套節(50)可經組態以按可移除方式與注射筒(51)(或欲含有且傳遞一定量之射線照相對比劑(46)之其他器件)耦接。在注射筒(51)之實例中,注射筒(51)可具有能夠接收足以描繪骶髂關節(1)之側關節面(16)之輪廓的一定量之射線照相對比劑(46)之內容積。柱塞(52)可以滑動方式接收於筒(51)內以穿過管狀部件(47)將射線照相對比劑(46)傳遞入骶髂關節(1)中。管狀部件(47)可具有在約第16型號及約第20型號之範圍內之型號且可進一步在外表面上以增加方式標記以允許確定第一針端(48)已在骶髂關節(1)內前進之深度。當第一針端(48)前進入骶髂關節(1)中時,放射照相染料(46)可自注射筒(51)內傳遞入骶髂關節(1)中以允許觀測骶髂關節(1)及在骶髂關節(1)內定位管狀針(47)。
現在主要參考圖17,一旦第一管狀部件端(48)已經充分推進入骶髂關節(1)中且骶髂關節(1)之關節面(16)已經充分觀測,就可自管狀部件(47)移除套節(50),從而使管狀部件(47)固定在骶髂關節(1)內以作為隨後用於在骶髂關節(1)之肢接表面(16)之間非橫向定位或置放骶髂關節植入物(6)或移除由關節面(16)界定之區域內之骶髂關節(1)之一部分以產生植入物接收間隙(29)之工具的初始導件。或者,一或多個導銷(13)可沿管狀部件(47)之實質上相同路徑插入以達成骶髂關節(1)內之固定嚙合且在隨後步驟中用作導件。
現在主要參考圖18,可在骶髂關節(1)之後上路(或關於某些具體實例為下路)態樣處之皮膚中產生小切口,其沿骶髂關節(1)之線在管狀部件(47)之近端及遠端延伸以提供接近骶髂關節(1)之肢接表面(16)之間之關節間間隙的孔道。管狀探針(53)可與自骶髂關節(1)向外延伸之管狀部件(47)(或導銷(13))滑動嚙合(儘管骶髂關節在圖中出於說明目的可展示為實質上線性,但應瞭解骶髂關節之通常不規則特徵未被移除)。管狀探針(53)可具有大體上圓柱狀之探針本體(54),其終止於在推進入骶髂關節(1)中之末端處的匙狀尖端(55)。可移除管狀探針柄(56)與探針本體(54)之相反端耦接。匙狀尖端(55)可沿管狀針(47)(或導線(13))經引導入骶髂關節(1)之後部中且在側部螢光觀測下經推進至骶髂關節(1)之前部。管狀探針柄(56)可接著經移除,從而提供穿過在皮膚中產生之切口自骶髂關節(1)向外延伸之大體上圓柱狀的探針本體(54)。
現在主要參考圖19,自切口至骶髂關節(1)之孔道可藉由將套管(57)插入切口中產生。具有平端(59)之軟組織擴張器(58)或複數個尺寸遞增之軟組織擴張器可經探針本體(54)推進直至軟組織擴張器(58)之平端(59)及相應套管端(45)接觸骶髂關節(1)之後路態樣。可自套管(57)內移除軟組織擴張器(58)。套管(57)之外表面可與周圍組織充分嚙合以避免使組織位於套管(57)之中空內部。套管(57)之一非限制性具體實例提供具有實質上平行之相反側壁之管狀體,該等側壁在複數個不同夾具可插入其中之兩端(菱形)處以一半徑終止。
現在主要參考圖20A-20C,套管對準夾具(60)可經探針本體(54)(或導銷(13))推進且經接收在套管(57)內。實質上,相同十字絲(63)(64)可安置在上夾具表面(65)及下夾具表面(66)上。十字絲(63)(64)在x射線下與骶髂關節(1)的對準可證實套管(57)具有相對於骶髂關節(1)之成對關節面(16)之適當定向。可接著藉由將扣件穿過套管(57)置放入骶骨(4)或髂骨(5)中來使與成對關節面(16)呈適當定向之套管(57)與骶髂關節呈固定關係地安置。
現在參考圖21A及21B,第一鑽頭夾(67)可經探針本體(54)(或導銷(13))推進且接收在套管(57)內。自骶髂關節(1)向外延伸之探針本體(54)(或導銷(13))穿過第一鑽頭夾(67)之鑽導孔(68)(或複數個導銷(13)可穿過相應複數個導銷孔(69)延伸)。鑽導孔(68)可採用如圖中所示之圓形孔、槽、或限制鑽頭(62)在鑽頭夾(60)內的移動且為鑽頭(62)提供相對於骶髂關節(1)之引導之其他組態的形式。
現在參考圖22,管狀鑽頭(70)可經探針本體(54)及在第一鑽頭夾(67)之鑽導孔(68)內推進。在螢光檢查引導下,管狀鑽頭(70)可推進入骶髂關節(1)之肢接表面(16)之間的關節間區域(44)中以產生至經確定深度之第一孔(71)(用斷線展示)。關於方法之某些具體實例,可移除來自骶髂關節(1)之關節面(16)之間之一定量的關節軟骨或其他組織,該等關節面應足以允許植入骶髂關節植入物(6)之具體實例以置換移除之關節軟骨或組織。因為方法移除骶髂關節(1)之關節面(16)之間的退化關節軟骨或組織,所以骶髂關節(1)之關節面(16)可保持完整或實質上完整,從而允許在骶髂關節(1)之關節面(16)之間非橫向定位骶髂關節植入物(6)。可理解地,其他儀器可單獨或與管狀鑽頭(62)組合利用來移除關節面(16)之間之關節軟骨或組織,該等儀器諸如:起釘鏨、圓頭銼(bur)、孔鋸、刮匙、雷射器(諸如CO2、釹/YAG(釔-鋁-石榴石)、氬氣及紅寶石)、採用電磁能之電手術設備(切割電極可為精細顯微針、柳葉刀、小刀、導線或帶環、鉉圈套器(snare)、通電手術刀(energized scalpel)或其類似物),其中傳輸之能量可為單極或雙極的且以例如在約300kHz與約1000 kHz之範圍內之高頻電流操作,無論以「峰值因數(crest factor)」可恆定在每正弦波形約1.4且電壓峰值為約300 V以允許實現「純」截割效應,同時具有可能之最小凝聚效應的純正弦電流波形形式,或以峰值因數在1.5與8之間變化(其中遞減峰值因數會提供較小凝聚效應)的調幅電流波形形式。可設置電手術波形以促進兩種類型之組織效應,即凝聚(細胞內溫度上升,接著該等細胞脫水且收縮)或切割(細胞水之加熱快速發生以致細胞破裂)。凝聚的細胞與切割的細胞之比例可變化,從而產生「摻合」或「混合」效應。另外,完全整流電流、或部分整流電流、或產生較大量或側向熱量之閃耀電流可用於發現關節之關節面且幫助將探針或導線推進入肢接表面之間的位置中。此等電流可有效降解軟骨且允許推進入關節中而不明顯地穿透到軟骨外很多。
現在參考圖23,關於本發明之某些具體實例,可自套管(57)內移除第一鑽頭夾(67)且第二鑽頭夾(72)可經探針本體(54)推進且經接收在套管(57)內;然而,本發明不限於任何特定數目之鑽頭夾且關於方法之某些具體實例,第一鑽頭夾(67)可包括所有所需鑽導孔(68)(或槽或鑽導子之其他組態)且關於方法之其他具體實例,可以連續順序利用複數個鑽頭夾以提供所有鑽導孔(68)。關於由圖展示之本發明的特定具體實例,第一鑽頭夾(67)可提供一或多個額外鑽導孔(68),其相對於第一孔(71)引導具有相同或不同組態之第二或更多管狀鑽(62)插入骶髂關節(1)內且推進入骶髂關節(1)中以在骶髂關節(1)內產生第二孔(73)(通常用斷線以71/73顯示)或以預定樣式間隔開之複數個孔以允許自骶髂關節(1)之關節間間隙移除足夠關節軟骨(16)或其他組織以用於在由骶髂關節(1)之成對關節面(16)界定且在其之間的區域內置放骶髂關節植入物(6)之具體實例。關於本發明之某些方法,可以連續順序利用第一鑽頭夾(67)或第二鑽頭夾(72)或複數個鑽頭夾來移除骶髂關節(1)之一部分以產生植入物接收間隙(29)。就方法之此等具體實例而言,可自骶髂關節(1)之關節面(16)之間移除足以允許置放骶髂關節植入物(6)之某些具體實例的關節軟骨或其他組織及足夠軟骨下骨,且一或多個徑向部件接收通道(74)可切入該骶髂關節(1)之至少1個足以接收髂植入物(6)之其他具體實例的關節面(16)中。一或多個徑向部件接收通道(74)可切入骶骨(4)或髂骨(5)之軟骨下皮質骨或疏鬆骨中一定深度。
現在主要參考圖24,在隨後步驟中,可自套管(57)內移除連續呈現之鑽頭夾(67)(72)中之最後一個且髓針夾(75)可經探針本體(54)推進以定位在套管(57)內。髓針夾(75)可包括髓針導孔(76),其接收經探針本體(54)推進之管狀髓針(78)的第一髓針端(77)。第一髓針端(77)可具有可推進入骶髂關節(1)中之組態。關於方法之某些具體實例,可使第一髓針端(77)適於自骶髂關節(1)之關節區域(44)內之關節面(16)之間移除一定量之關節軟骨及其他組織以非橫向置放具有狹長本體(7),或具有狹長本體(7)及第一徑向部件(14),或具有在骶髂關節(1)之關節面(16)之間具有第一及第二徑向部件(14)(15)之狹長本體(7)的骶髂關節植入物(6)。關於方法之其他具體實例,管狀髓針(78)可移除足夠之一部分骶髂關節(1)以產生植入物接收間隙(29)來接收骶髂關節植入物(6)之具有狹長本體(7)、狹長本體(7)及至少1個適於在關節面(16)之間非橫向置放之徑向部件(14)或至少1個適於延伸入骶骨(4)或髂骨(5)之骨中之徑向部件(26)的具體實例。作為一非限制性實例,圖24展示髓針(78),其經組態以移除骶髂關節(1)之一部分來產生植入物接收間隙(29)以接收骶髂關節植入物(6)之具體實例,該等具體實例具有狹長本體(7)(第一徑向部件(14)及第二徑向部件(15)以適於定位在骶髂關節(1)之關節面(16)之間之實質上相反關係沿狹長本體(7)之縱軸(8)向其延伸)且進一步具有以適於相應延伸入骶骨(4)及髂骨(5)之骨中之實質上相反關係沿狹長部件(7)之縱軸(8)延伸的第三徑向部件(26)及第四徑向部件(27)。
現在主要參考圖25及26A、26B及26C,植入物接收間隙(29)及骶髂關節植入物(6)可經組態而具有相關尺寸關係,以使得在植入物接收間隙(29)內置放骶髂關節植入物(6)會以實質上不動關係安置骶骨(4)及髂骨(5)且實質上避免骶骨(4)及髂骨(5)之位置關係自正常狀態改變,或避免將骶骨(4)與髂骨(5)驅動到一起或分開而偏離或實質上偏離正常位置關係。選擇骶髂關節植入物(6)及植入物接收間隙(29)之組態之意圖是使骶骨(4)相對於髂骨(5)不動同時維持骶髂關節(1)呈實質上正常或實質上正常位置關係,或使骶髂關節(1)返回至實質上正常位置關係以矯正骶髂關節(1)之退化病狀。
作為一非限制性實例,植入物接收間隙(29)之組態允許骶髂關節植入物(6)之具體實例非橫向置放於骶髂關節(1)之關節面(16)的尾側部分(86)之間。儘管骶髂關節植入物(6)之某些具體實例可能僅提供定位於經相應組態之植入物接收間隙(29)內以嚙合髂骨(5)之骨的至少一部分的狹長本體(7);但本發明不如此受限制,且可進一步包括至少第一徑向部件或第一及第二徑向部件,第一徑向部件(14)之至少一部分外表面嚙合骶骨(4)及髂骨(5)之骨(73)的一部分。關於骶髂關節植入物(6)之具有第三徑向部件(26)及第四徑向部件(27)之彼等具體實例,植入物接收間隙(29)可進一步包括另一徑向部件接收通道(74),其相應地允許第三及第四徑向部件(26)(27)延伸入骶骨(4)或髂骨(5)之骨(無論軟骨下骨、皮質骨、疏鬆骨或其類似骨)中,或骶髂關節植入物(6)壓入無徑向部件接收通道(74)之植入物接收間隙(29)中可強制推動徑向部件(26)(27)進入骶骨(4)及髂骨(5)之骨中。機械扣件(39)(諸如有花紋部件)可穿過孔(36)插入於抗遷移元件(33)中及進入骶骨(4)及髂骨(5)中以固定固著融合植入物(6)在植入物接收間隙(29)內之位置。
現在參考圖27及28A、28B及28C,作為第二非限制性實例,植入物接收間隙(29)之組態允許藉由與以上關於切開及產生到達骶髂關節(1)之上路關節部分之孔道所述類似之程序或步驟將骶髂關節植入物(6)之具體實例非橫向置放在骶髂關節(1)之關節面(16)的前側部分(86)之間。
現在參考圖29及30,植入物接收間隙(29)之組態允許藉由與以上關於切開及產生到達骶髂關節(1)之下路關節部分之孔道所述類似之程序或步驟將骶髂關節植入物(6)之具體實例非橫向置放在骶髂關節(1)之關節面(16)的前側部分(87)與尾側部分(86)之間。
現在主要參考圖31,其展示骶髂關節植入物(6)之一具體實例,該具體實例具有適於與對準工具(79)之一部分固定配合之軸孔(9)的一部分。對準工具(79)可具有固定或以可調方式固定之組態,其使管狀對準導件(80)與穿過骶髂關節植入物(6)的孔(36)中之一者對準。插入工具(81)可與管狀對準導件(80)滑動嚙合。狹長部件(85)可以可移除方式與鄰近骶髂關節植入物(6)中之孔(36)的第一插入工具端(82)固定附接。第二插入工具端(83)可被強制推進於管狀對準導件(80)中以推進狹長部件(81)穿過孔(36),以相對於與骶髂關節植入物(6)相應嚙合之該等關節面(16)呈橫向關係地安置狹長部件(81)。作為一非限制性實例,狹長部件(81)可具有與外表面耦接之螺旋螺紋(84)且藉由旋轉插入工具(81)之第二端(83),狹長部件(85)可被相對於與骶髂關節植入物(6)相應嚙合之該等關節面(16)呈橫向關係地牽引穿過骶髂關節植入物(1)之孔(36)。藉由進一步操作狹長部件(85),可與骶髂關節植入物(6)之外表面相抵地牽引骶髂關節(1)之關節面(16)。
現在主要參考圖32,本發明之具體實例可進一步包含與骶髂關節植入物(6)之第一端(11)連接之耦接元件(87)。作為一非限制性實例,耦接元件(87)可藉由螺紋嚙合扣件部分(88)而相對於骶髂關節植入物(6)之第一端(11)以固定關係安置;然而,本發明不如此受限制且扣件部分(88)可藉由諸如熔接、旋轉熔接、黏著或其類似方法之任何方法與骶髂關節植入物(6)之第一端(11)連接。耦接元件(87)可進一步提供經組態以與懸跨部件(90)之眾多及廣泛多種橫截面幾何結構接合的耦接部分(89)。作為一非限制性實例,耦接部分(89)可組態成與扣件部分(88)樞接之圓柱狀杯(91)。螺旋螺紋可與圓柱狀杯(91)之內表面耦接以可旋轉地接收螺旋螺紋化本體(92)。圓柱狀杯(91)之側壁(93)可包括可接收懸跨部件(90)之一部分的穿通元件(94)。可藉由螺旋螺紋化本體(92)之旋轉嚙合而使懸跨部件(90)之接收於穿通元件(94)內的一部分與圓柱狀杯(91)呈固定關係地置放。
現在主要參考圖33,作為另一非限制性實例,一對骶髂關節(1)中之每一者可接收各自具有與第一端(11)耦接之耦接元件(87)之上述骶髂關節植入物(6)的一具體實例。耦接元件(87)之每一者可接收懸跨部件(90)之相反端(95)。另外,與骶髂關節植入物(6)呈固定關係之懸跨部件(90)可與複數個額外懸跨部件(96)連接,作為一非限制性實例,該等額外懸跨部件可與脊柱(97)呈位置關係而置放以允許支撐可錨定在脊椎之間之額外植入物。
現在主要參考圖34,作為另一非限制性實例,第一耦接元件(87)可與如上所述之骶髂關節植入物(6)之一具體實例的第一端(11)接合且第二耦接元件(87)之扣件部分(88)可直接安置入骶骨(4)或髂骨(5)或兩者之骨中。呈平板形式之懸跨元件(90)之相反端(95)可為或可提供耦接元件(87)之扣件部分(88)可穿過的孔隙(96)。耦接部分(89)之外表面之相應部分與懸跨部件(90)可嚙合以固定懸跨部件(90)之位置,從而允許藉由複數個固著元件將腰脊椎與經穩定骨盆耦接以進一步增加穩定性。
方法可進一步採用手術中神經生理監測以降低患者神經系統(特定言之周邊神經)之醫原性損傷之風險,或向外科醫師提供功能指導。
實施例1
在直接觀測下及在輔助側部螢光檢查下,將具有實質上如圖3-6所示及如上所述之組態的本發明骶髂關節植入物之一具體實例插入患者中。進行該程序以達成評估在實際付諸實施中在實質上如圖25中所示之骶髂關節之關節面的下路部分或尾側部分之間安全植入本發明骶髂關節植入物之能力的目的,以確認將骶髂關節植入物植入實質上如上所述經組態之植入物接收間隙中會起到使骶髂關節不動的作用。植入骶髂關節之下路(尾側)部分中之如上所述的骶髂關節植入物證明會即刻使骶髂關節不動。
如可由前述所容易瞭解,本發明之基本概念可以多種方式來體現。本發明涉及包括骶髂關節植入物之骶髂關節融合系統及植入骶髂關節植入物之方法(包括提供骶髂關節之固著及融合之最佳模式)之眾多及變化的具體實例。
因而,由本說明書揭示或伴隨本申請案之圖或表中所示之本發明的特定具體實例或元件不意欲具有限制性,而意欲例示由本發明一般性涵蓋之眾多及變化之具體實例或關於其任何特定元件的所涵蓋之等效物。此外,本發明之單一具體實例或元件之特定描述可能不明確描述所有可能之具體實例或元件;許多替代物係由本說明書及圖隱含地揭示。
應瞭解裝置之各元件或方法之各步驟可由裝置術語或方法術語描述。當需要使本發明所享有權利之隱含廣泛覆蓋範圍明確時,此等術語可經替換。僅舉例而言,應瞭解方法之所有步驟皆可揭示為動作、進行彼動作之手段、或引起彼動作之元件。類似地,裝置之各元件皆可揭示為實體元件或彼實體元件所促成之動作。僅舉例而言,揭示「一植入物」應理解成涵蓋揭示「植入」之動作--無論是否明確論述--,且反之,若實際上揭示了「植入」之動作,則該種揭示應理解成涵蓋揭示「一植入物」及甚至「植入部件之手段」。各元件或步驟之此等替代性術語應理解成明確包括在本說明書中。
此外,關於所用之各術語,應瞭解除非其在本申請案中之利用與此等解釋不一致,否則普通辭典定義應理解成包括在對如Random House Webster's Unabridged Dictionary,第二版中所含的各術語之描述中,各定義特此以引用的方式併入本文中。
出於本發明之目的,範圍在本文中可表述為自「約」一特定值至「約」另一特定值。當表述該種範圍時,另一具體實例包括自一特定值至另一特定值。類似地,當藉由使用先行詞「約」以近似值形式表述值時,應瞭解特定值形成另一具體實例。應進一步瞭解每一範圍之端點相對於另一端點及獨立於另一端點均有效。此外,術語「約」意謂關於任何數值的在彼數值附近至多10%之偏差。
此外,出於本發明之目的,術語「一」實體係指一或多個彼實體;舉例而言,「一部件」或「一狹長部件」係指一或多個部件或至少1個部件。因而,術語「一」、「一或多個」及「至少1個」在本文中可互換使用。
因此,應瞭解申請人主張至少:i)如本文中揭示及描述之骶髂關節植入物,ii)揭示及描述之相關方法,iii)此等器件及方法之每一者之類似、等效及甚至隱含變化形式,iv)達成所展示、揭示或描述之功能之每一者的彼等替代性具體實例,v)達成展示為對於達成揭示及描述之彼功能而言為隱含性之功能之每一者的彼等替代性設計及方法,vi)展示為單獨及獨立發明物之各特徵、組件及步驟,vii)由揭示之各種系統或組件增強之應用,viii)由此等系統或組件產生之所得產品,ix)實質上如上文所述及參考任何隨附實例之方法及裝置,x)先前揭示之元件之每一者的各種組合及排列。
本專利申請案之先前技術章節提供對本發明所屬之努力領域的陳述。此章節亦可併入有或含有某些美國專利、專利申請案、公開案之釋義;或所主張發明之適用於關聯關於本發明所屬技術狀態之資訊、問題或關切事件的標的物。不意欲將本文中引用或併入有之任何美國專利、專利申請案、公開案、陳述或其他資訊解釋為、理解為或視為欲承認為關於本發明之先前技術。
本說明書中闡述之申請專利範圍(若存在)特此以引用的方式併入作為本發明說明書之一部分,且申請人明確保留使用此等申請專利範圍之此併入內容之所有或一部分作為支援任何或所有申請專利範圍請求項或其任何要素或組件之額外描述的權利,且申請人進一步明確保留必要時將此等申請專利範圍請求項或其任何要素或組分之併入內容之任何部分或全部自本說明書移動入申請專利範圍中或反之亦然以界定本申請案或任何隨後申請案或其接續案、分割案或部分接續申請案所尋求保護之標的物,或以符合任何國家或條約之專利法律、規則或法規的權利,且以引用的方式併入之此內容在本申請案(包括其任何隨後接續案、分割案或部分接續申請案)之整個待審期或隨後任何再頒予或延長期間將繼續存在。
本說明書中闡述之申請專利範圍(若存在)進一步意欲描述有限數目之本發明較佳具體實例之邊界及界限且不應解釋為本發明之最廣泛具體實例或可能主張之本發明之具體實例的完全清單。申請人不放棄基於以上闡述之本說明書產生其他申請專利範圍作為任何接續案、分割案、或部分接續案或類似申請案之一部分的任何權利。
1...骶髂關節/骶髂關節植入物
2...狹長部件
3...經髂骨孔
4...骶骨
5...髂骨
6...骶髂關節植入物/髂植入物/固著融合植入物
7...狹長本體/狹長部件
8...縱軸
9...軸孔
10...軸向路徑
11...第一植入物端/第一端
12...第二端/第二植入物端
13...導銷/導線
14...第一徑向部件/徑向部件
15...第二徑向部件/徑向部件
16...配對關節面/關節面/肢接表面/側關節面/關節軟骨
17...相反面
18...相反面
19a...厚度
19b...厚度
20...頂部邊緣
21...側邊緣/側邊緣對之第一者/側面
22...側邊緣/第二側邊緣/側邊緣對之第二者/側面
23...底部邊緣
24...角式元件
25...角度
26...第三徑向部件/徑向部件
27...第四徑向部件/徑向部件
28...高度
28a...高度
28b...高度
29...植入物接收間隙
31...孔隙元件
32...孔隙周邊
33...抗遷移元件
34...端帽
35...端帽周邊
36...孔
37...相反表面
38...相反表面
39...機械扣件
40...塗層
41...生物活性劑/活性劑
42...非活性劑
43...彎度
44...關節區域/關節間區域
46...射線照相對比劑/放射照相染料
47...管狀部件/管狀針
48...第一管狀部件端/第一針端
49...第二管狀部件端
50...套節
51...注射筒/筒
52...柱塞
53...管狀探針
54...探針本體
55...匙狀尖端
57...套管
58...軟組織擴張器
59...平端
60...套管對準夾具/鑽頭夾
62...鑽頭/管狀鑽頭/管狀鑽
63...十字絲
64...十字絲
65...上夾具表面
66...下夾具表面
67...第一鑽頭夾/鑽頭夾
68...鑽導孔
69...導銷孔
70...管狀鑽頭
71...第一孔
72...第二鑽頭夾/鑽頭夾
73...第二孔/骨
74...徑向部件接收通道
75...髓針夾
76...髓針導孔
77...第一髓針端
78...管狀髓針/髓針
79...對準工具
80...管狀對準導件
81‧‧‧插入工具/狹長部件
83‧‧‧第二插入工具端/第二端
84‧‧‧螺旋螺紋
85‧‧‧狹長部件
86‧‧‧尾側部分/前側部分
87‧‧‧前側部分/耦接元件/第一耦接元件/第二耦接元件
88‧‧‧扣件部分
89‧‧‧耦接部分
90‧‧‧懸跨部件/懸跨元件
91‧‧‧圓柱狀杯
92‧‧‧螺旋螺紋化本體
93‧‧‧側壁
94‧‧‧穿通元件
95‧‧‧相反端
96‧‧‧懸跨部件/孔隙
97‧‧‧脊柱
98‧‧‧徑向部件隔條
100‧‧‧生物相容可生物降解材料或可骨整合材料
101‧‧‧植入物區段
102‧‧‧植入物區段
103‧‧‧植入物區段
105‧‧‧骨生長刺激器
圖1為骨盆區域及用於穩定骶髂關節之習知方法及器件之前視圖。
圖2為骶髂關節植入物之特定具體實例之透視圖。
圖3為骶髂關節植入物之特定具體實例之第一側視圖。
圖4為骶髂關節植入物之特定具體實例之第一植入物端視圖。
圖5為骶髂關節植入物之特定具體實例之第二植入物端視圖。
圖6為圖3中所示之骶髂關節之特定具體實例的關於縱軸旋轉約90度的第二側視圖。
圖7為骶髂關節植入物之第二特定具體實例之透視圖。
圖8為具有塗佈材料之固著融合植入物之另一特定具體實例的第一側視圖,該塗佈材料有助於固著融合植入物與骨之骨整合。
圖9為固著融合植入物之彼特定具體實例之如圖8中所示的橫截面8-8。
圖10為沿縱軸具有一定量之彎度之骶髂關節植入物之一具體實例的透視圖。
圖11為圖10中所示之固著融合植入物之特定具體實例的第一側視圖。
圖12為圖11中所示之固著融合植入物之特定具體實例的第一植入物端視圖。
圖13為圖11中所示之固著融合植入物之特定具體實例的第二植入物端視圖。
圖14為圖11中所示之固著融合植入物之特定具體實例的關於縱軸旋轉約90度的第二側視圖。
圖15為以複數個可植入零件形式產生之圖10中所示之骶髂關節植入物之具體實例的側視圖。
圖16為貫穿骶髂關節之橫截面圖,其說明植入骶髂關節植入物之一具體實例之方法,步驟包括將針插入骶髂關節之關節平面中以注射放射照相染料以允許螢光觀測骶髂關節。
圖17為貫穿骶髂關節之橫截面圖,其說明植入骶髂關節植入物之具體實例之方法,步驟包括將管狀針以導線形式固定在骶髂關節內。
圖18為貫穿骶髂關節之橫截面圖,其說明植入骶髂關節植入物之一具體實例之方法,步驟包括沿固定在骶髂關節中之針將管狀探針之本體推進至在骶髂關節前部的固定位置。
圖19為貫穿骶髂關節之橫截面圖,其說明植入骶髂關節植入物之一具體實例之方法,步驟包括沿固定在骶髂關節中之管狀探針之本體推進組織擴張器以允許與骶骨及髂骨之表面相抵地置放套管來暴露骶髂關節。
圖20A為骨盆區域之後視圖,其展示內部已插入有套管對準夾具之套管相對於骶髂關節的固定置放。
圖20B為具有十字絲(cross hair)之圖20A中所示之套管夾具插入物的透視圖。
圖20C為內部插入有套管對準夾具之圖20B中所示之套管的透視圖,該套管對準夾具具有可對準之十字絲。
圖21A為骨盆區域之後視圖,其展示內部具有第一鑽頭夾的套管相對於骶髂關節的固定置放。
圖21B為內部具有第一鑽頭夾的圖21A之套管的透視圖。
圖22為貫穿骶髂關節之橫截面圖,其說明植入固著融合植入物之一具體實例之方法,步驟包括用接收管狀鑽之第一鑽頭夾置換組織擴張器以產生實質上沿骶髂關節之關節平面的第一鑽孔。
圖23為貫穿骶髂關節之橫截面圖,其說明植入髂植入物之一具體實例之方法,步驟包括用第二鑽頭夾置換第一鑽頭夾,該第二鑽頭夾允許相對於第一鑽孔產生各自實質上沿骶髂關節之關節平面的額外鑽孔。
圖24為貫穿骶髂關節之橫截面圖,其說明植入固著融合植入物之一具體實例之方法,步驟包括用髓針夾置換第二鑽頭夾(或視方法而定,第一鑽頭夾),該髓針夾接收可推進入骶髂關節中以產生植入物接收間隙之管狀髓針。
圖25為骨盆區域之側視圖,其展示定位在骶髂關節之尾側關節面(用斷線顯示)之間之骶髂關節植入物的一具體實例。
圖26A提供骶髂關節之剖視圖,其展示固著融合植入物之一特定具體實例在藉由圖16-24中說明之方法產生之植入物接收間隙中的置放。
圖26B為圖26A之一部分之放大視圖,其展示固著融合植入物之一特定具體實例在藉由圖16-24中說明之方法產生之植入物接收間隙中的置放。
圖26C為圖26B中所示之橫截面圖26C-26C,其展示藉由圖16-25中說明之方法產生之植入物接收間隙及植入其中之固著融合植入物之一特定具體實例的組態。
圖27提供骨盆之側視圖,其展示定位在骶髂關節之關節平面內之前側關節面(用斷線顯示)之間之髂植入物的一具體實例。
圖28A提供骶髂關節之剖視圖,其展示固著融合植入物之一特定具體實例在藉由圖16-24中說明之方法產生之植入物接收間隙中的置放。
圖28B為圖26A之一部分之放大視圖,其展示固著融合植入物之一特定具體實例在藉由圖16-24中說明之方法產生之植入物接收間隙中的置放。
圖28C為圖28B中所示之橫截面圖28C-28C,其展示藉由圖16-24中說明之方法產生之植入物接收間隙及植入其中之固著融合植入物之一特定具體實例的組態。
圖29提供骨盆之側視圖,其中固著融合植入物之一具體實例實質上定位在前側關節面與尾側關節面(用斷線顯示)之間且在有限程度上安置在骶髂關節之關節外。
圖30提供骨盆之側視圖,其中固著融合植入物之一具體實例定位於骶髂關節之關節平面內前側關節面與尾側關節面(用斷線顯示)之間。
圖31為貫穿骶髂關節之橫截面圖,其說明可與植入之骶髂關節植入物附接之使狹長部件對準以穿過骶髂關節植入物的對準工具。
圖32為貫穿骶髂關節之橫截面圖,其說明與植入之骶髂關節植入物之第一端接合的耦接元件。
圖33為骨盆區域之後視圖,其展示與一對相應耦接元件接合之懸跨部件(spanning member),該等耦接元件相應地與一對植入之骶髂關節植入物之第一端接合。
圖34為骨盆區域之後視圖,其展示與一對相應耦接元件接合之懸跨部件,該等耦接元件相應地與植入之骶髂關節植入物接合且直接與骶骨嚙合。
6...骶髂關節植入物/髂植入物/固著融合植入物
7...狹長本體/狹長部件
8...縱軸
9...軸孔
10...軸向路徑
11...第一植入物端/第一端
12...第二端/第二植入物端
14...第一徑向部件/徑向部件
15...第二徑向部件/徑向部件
17...相反面
18...相反面
19a...厚度
19b...厚度
20...頂部邊緣
21...側邊緣/側邊緣對之第一者/側面
22...側邊緣/第二側邊緣/側邊緣對之第二者/側面
23...底部邊緣
24...角式元件
25...角度
26...第三徑向部件/徑向部件
27...第四徑向部件/徑向部件
28a...高度
28b...高度
31...孔隙元件
32...孔隙周邊
33...抗遷移元件
34...端帽
35...端帽周邊
36...孔
37...相反表面
38...相反表面
39...機械扣件
41...生物活性劑/活性劑
42...非活性劑
98...徑向部件隔條
100...生物相容可生物降解材料或可骨整合材料
105...骨生長刺激器
Claims (21)
- 一種用於固著骶髂關節的系統,包含骶髂關節由骶骨和髂骨形成的關節面,該系統包含:一骶髂關節植入物,該骶髂關節植入物包含一狹長本體,該狹長本體包含一第一端、一第二端、設在第一端和第二端之間的長度,以及一對部件,其大體上垂直於彼此設置,並且延伸該狹長本體至少一部分的長度,該狹長本體適於非橫向定位在該骶髂關節之中以實質上穩固該骶髂關節,當該狹長本體被推進骶髂關節中時,藉由該對部件的其中一部件延伸進入並且保持在骶骨或髂骨之中,該狹長本體適於抵抗骶髂關節中的旋轉;一狹長部件;以及一對準工具,其包含一部分、一對準導件以及一插入工具,該對準工具的該部分包含一末端,其建構成配合該骶髂關節植入物,該對準導件結合至對準工具的該部分,且該插入工具與對準導件嚙合,其中該插入工具與對準導件的嚙合係使得當該狹長部件經由插入工具被推進時,該狹長部件以相對於該關節面以及骶髂關節植入物的狹長本體之橫向關係通過,同時對準工具的該部分的末端與骶髂關節植入物配合,且該骶髂關節植入物係位於骶髂關節中。
- 如申請專利範圍第1項所述之系統,其中:該骶髂關節植入物包含一個或多個孔道,其橫向地通過該狹長部件的長度延伸,且孔道之尺寸為容許該狹長部件以相對於該關節面之橫向關係通過;且該插入工具與對準導件的嚙合係使得當該狹長部件經由插入工具被推進時,該狹長部件 被接收在一個或多個孔道之中,使得狹長部件以相對於該關節面之橫向關係通過,同時對準工具的該部分的末端與骶髂關節植入物配合,且該骶髂關節植入物係位於骶髂關節中。
- 如申請專利範圍第2項所述之系統,其中該對準工具包含固定或以可調方式固定的構造,其使對準導件與該一個或多個孔道對準。
- 如申請專利範圍第1項所述之系統,其中該骶髂關節植入物進一步包含一軸孔,其與該狹長本體之第一端連通,該對準工具的該部分的末端建構成與該軸孔固定地配合。
- 如申請專利範圍第1項所述之系統,其中該狹長部件包含螺旋螺紋,其建構成與狹長部件的外表面耦接。
- 如申請專利範圍第1項所述之系統,其中該對準導件包含一管狀對準導件。
- 如申請專利範圍第6項所述之系統,其中該插入工具可與該管狀對準導件滑動嚙合。
- 如申請專利範圍第2項所述之系統,其中該對部件包含一第一部件和大體上垂直於第一部件設置的一第二部件,該第一部件適於非橫向定位在該關節面之間,該第二部件適於延伸進入髂骨之中。
- 如申請專利範圍第8項所述之系統,其中該第二部件為平坦狀且設置在一平面中,且一旦該狹長部件以相對於該骶髂關節以及骶髂關節植入物的狹長本體之橫向關係通 過時,該狹長部件適於被定位成大體上平行於該平面。
- 如申請專利範圍第8項所述之系統,其中該狹長本體進一步包含一第三部件和一第四部件,第三部件和第四部件大體上垂直於彼此設置,並且延伸該狹長本體的至少一部分長度,該第三部件適於非橫向定位在該關節面之間,該第二部件適於延伸進入骶骨之中。
- 如申請專利範圍第10項所述之系統,其中該第一部件和第三部件大體上彼此平行,且其中該第二部件和第四部件大體上彼此平行。
- 如申請專利範圍第11項所述之系統,其中該狹長本體的第一部件、第二部件、第三部件和第四部件形成十字狀的剖面。
- 如申請專利範圍第1項所述之系統,其中建構成與骶髂關節植入物配合的該末端包含該部分的一遠端,該部分包含相對於該遠端的一近端,該對準導件在遠離該部分的近端的位置結合至該對準工具的該部分。
- 如申請專利範圍第1項所述之系統,其中建構成與骶髂關節植入物配合的該末端包含該部分的一遠端,該部分包含相對於該遠端的一近端,以及延伸於該近端和遠端之間的一軸,該部分的近端比該部分的軸為寬。
- 如申請專利範圍第1項所述之系統,其中該狹長本體進一步包含在第一端和第二端之間的一定量之彎度。
- 如申請專利範圍第1項所述之系統,進一步包含一耦接元件,其建構成連接至骶髂關節植入物,以及一懸跨 部件,其可固定至該耦接元件,並且建構成容許將腰脊椎與骨盆耦接。
- 如申請專利範圍第16項所述之系統,其中該耦接元件包含一扣件部分,其建構成被接收於骶髂關節植入物之中,以及耦接部分,其係可樞轉地耦接至扣件部分,並且建構成連接至該懸跨部件。
- 如申請專利範圍第1項所述之系統,其中該系統建構成容許耦接一對骶髂關節植入物。
- 如申請專利範圍第1項所述之系統,其中該對準工具的該部分的該末端適於螺合地耦接該骶髂關節植入物以及分離。
- 如申請專利範圍第1項所述之系統,其中該對部件包含一第一部件和大體上垂直於第一部件設置的一第二部件,該第一部件適於非橫向定位在該關節面之間,該第二部件適於延伸進入髂骨之中。
- 如申請專利範圍第20項所述之系統,其中該第二部件為平坦狀且設置在一平面中,且一旦該狹長部件以相對於該骶髂關節以及骶髂關節植入物的狹長本體之橫向關係通過時,該狹長部件適於被定位成大體上平行於該平面。
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