TWI428116B - 用於骨骼植入物之膠結材料增補物的裝置 - Google Patents

用於骨骼植入物之膠結材料增補物的裝置 Download PDF

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Publication number
TWI428116B
TWI428116B TW095106057A TW95106057A TWI428116B TW I428116 B TWI428116 B TW I428116B TW 095106057 A TW095106057 A TW 095106057A TW 95106057 A TW95106057 A TW 95106057A TW I428116 B TWI428116 B TW I428116B
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TW
Taiwan
Prior art keywords
hollow cylinder
bone
rear end
perforations
cement material
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Application number
TW095106057A
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English (en)
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TW200633676A (en
Inventor
Robert Frigg
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Synthes Gmbh
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Publication of TW200633676A publication Critical patent/TW200633676A/zh
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Publication of TWI428116B publication Critical patent/TWI428116B/zh

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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
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    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0069—Three-dimensional shapes cylindrical
    • A—HUMAN NECESSITIES
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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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    • A—HUMAN NECESSITIES
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    • 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
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

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Description

用於骨骼植入物之膠結材料增補物的裝置
本發明關於一種依據申請專利範圍第1項之概念的用於骨骼植入物之膠結材料增補的裝置。
已知在骨科手術中，膠結材料增補物早已使用了好多年。此種增補物被應用在骨質疏鬆的骨骼中，骨骼錨定機構(例如：螺絲釘(screw)、針(pin)、釘(nail)等等)並無法被穩固地錨定在該骨質疏鬆的骨骼中。
根據已知的技術，骨骼用膠結材料被***到骨骼中，並且適合做為一種用於後續***的植入物之錨定床(anchoring bed)。在骨骼用膠結材料的情況，據瞭解每一種骨骼用填充材料是可以藉由聚合物、液壓或依據其它的反應機構來硬化。這些骨骼用填充材料在該膠結材料硬化前被***，使得該膠結材料會附加到該等植入物上。此一已知技術的缺點是：骨骼用膠結材料使用複雜，並且很難判定該植入物是否正確定位到膠結複合材料之內。
為了解決這些難題，已經發展出來特殊的植入物，其容許當該植入物正橫臥時，使用膠結材料。為此，植入物及特別是螺絲釘已經被使用，其包括：一管子(cannulation)，該膠結材料透過該管子而可以被充填到骨骼內。此種技術需要一種高黏性的膠結材料，而其可以透過相當小的管子注入。再者，該膠結材料的注入量與在該骨骼內的位置不會受到充分地控制。具有較低黏性之骨骼用膠結材料(其相較於非吸收性並且在高溫下硬化的骨骼用膠結材料而言，具有顯著的生物上的優勢)並不適合與這些適宜的植入物結合。
例如，從“TRONZO”的專利DE－A－3 508 759中，此種髖部螺絲釘(hip screw)已知其提供有一中央貫穿孔，而該貫穿孔在一開放式螺絲釘尖端(open screw tip)中開孔，並且具有在該等螺紋壁之間的側向開孔。藉由這髖部螺絲釘，可以在某一側之上達成在骨骼內之大型與尖頭螺紋(oversized and pointed thread)的固定，而藉由注入骨骼用膠結材料通過該中央貫穿孔接著流出橫向開孔的方式，在另一側之上達成脆弱骨質的強化。此種技術所觀察到的主要缺點是：無任何一般的骨骼用膠結材料可以被使用，除了需要特製、昂貴與複雜的植入物(髖部螺絲釘)之外。
基於上述原因，本發明企圖提供補救措施。本發明是依據提供一種裝置，而藉由該裝置現存以及/或新穎的骨骼錨定機構(或其它的骨骼植入物)的膠結材料增補物可以被簡化。
本發明使用一種用於骨骼植入物之膠結材料增補物的裝置解決了該所造成的問題，而該裝置呈現出專利申請範圍第1項的特徵。
依據本發明的裝置將該特殊的增補物與該要被增補的植入物分隔，透過此係簡化了內部手術中處理作業(intra－operative handling)，同時增加此種治療技術的安全性。
在本發明的情況中，一預先充填骨骼用膠結材料之穿孔式中空圓筒被***該骨骼內。依據此種狀況，在該骨骼中用於該中空圓筒之基座必須被預備好。上述情況可以透過鑽孔以及/或擴孔來達到。一旦該中空圓筒被安裝後，對應該中空圓筒之該骨骼錨定元件(例如：骨骼用螺絲釘葉片(blade)、螺旋葉片(spiral blade)、骨骼用釘)被***在該中空圓筒之內，以此透過在該中空圓筒中之該等穿孔將該膠結材料移出到附近的骨骼中。該膠結材料的流出量等於該錨定機構的容積。該增補物可以在一所希望的區域中，依據在該中空圓筒中之穿孔位置與數目來達成。由於用於該植入物之該增補裝置的分離，一膠結材料增補物可以藉由使用一般市售的植入物來達成。
該膠結材料的應用在該骨骼中與已知的增補物的情況一樣實施上並不複雜，然係以一種在操作台上受控的方式被實施到該中空圓筒之內。一旦實施該充填作業之後，該中空圓筒可以被***到在該骨骼內該已預備好的基座中。
基本上，該中空圓筒可以被應用在該骨骼材料無法給予普通的錨定機構足夠的剛性的各狀況中，例如，在靠近一骨關節、該脊椎骨、頜骨、骨盆等等的區域處。
本發明所達成的各種優點如下：－從身體的外部施加該膠結材料i)該膠結材料的處理簡單ii)填充程序是可控制與可定量化的(doseable)；iii)無血液、液體與組織包含在該膠結材料中；－透過該穿孔的定向、位置、數目與尺寸，引導該膠結材料在結構上所希望的位置；－經過該骨骼錨定元件之體積，該中空圓筒的膠結材料露出量能夠受到控制；以及－避免在骨折區域中的大量膠結材料由於抵抗力不可控制的減少(在治療區域中自發性骨骼斷裂)，而有未受控制的損失之危險性，這是因為膠結材料露出量是經由一植入物的***來控制，而非經由一被施加抵抗該骨骼抗力的壓力來控制。
在本發明的一較佳實施例中，該中空圓筒至少部分地使用尚未硬化的骨骼用膠結材料來充填。
在另一實施例中，該中空圓筒與該骨骼錨定元件相互配合，使得當該骨骼錨定元件***到該中空圓筒內時，該尚未硬化的骨骼用膠結材料透過在該中空圓筒的殼體之中的該至少一穿孔流出來。
在本發明的另一實施例中，該中空圓筒在其前方端部位置是封閉的。據此所達成的優點為，該膠結材料僅僅側向地流出，該側向處是最合適的，因為在該中空圓筒的前方，膠結材料之一硬化群集(hardened cluster)可能會有不利的情況，這是由於當進一步螺固到該植入物之內時，膠結材料群集可能會穿透入在其之前的皮層(corticalis)。例如，在“TRONZO”的情況中，該膠結材料於硬化之後，該骨骼錨定元件不會在徑向上朝前方被螺固，因為透過該開放式尖端外流出來並且硬化的該膠結材料不允許如此。如果該中空圓筒使用在一骨關節附近的話，該前方端部位置封閉的中空圓筒之一額外的優點被達成。
在另一實施例中，該中空圓筒的後方端部被構形成一用於連接骨骼用膠結材料之注射器的耦接器。特別是，該中空圓筒的後方端部可以是一用於適配器(adapter)之插座式連接(plug－in connection)，該適配器是用於與一骨骼用膠結材料之注射器耦接。這種非滲透性的連接在某一側上防止壓力損失，而在另一側上防止骨骼用膠結材料在該中空圓筒的後方端部位置非所希望的外流。
在另一實施例中，該中空圓筒的後方端部被構形成一具有一內螺紋的鑽孔。該骨骼錨定元件特別是可以被構形成一種具有外螺紋的骨骼用螺絲釘，而該外螺紋與該中空圓筒的內螺紋配合。
在另一實施例中，該中空圓筒的後方端部被提供有一具有骨骼植入物橫剖面之孔洞，例如：一螺紋或一用於一葉片之溝槽的形式。
在另一實施例中，該中空圓筒具有一全長L，該等穿孔距離前方端部最大值為L/2，較佳為距離前方端部L/3。此種骨骼用膠結材料僅僅該中空圓筒的前方區域外流出來，即其所提供的最顯著的優點。在該後方部分所外流出來的骨骼用膠結材料在臨床上相當不利的。
在另一實施例中，該中空圓筒的後方端部被構形成一具有橫剖面為多邊形的腔室或一TORX式腔室，其容許接受一個別的多邊形螺絲起子(polygonal screw driver)或TORX型螺絲起子。
該等穿孔的直徑典型上是介於0.9mm與3.3mm的範圍之內。穿孔的數目典型上至少是20個，較佳為至少40個。穿孔的數目典型上最大值是100個，最大值較佳為60個。較佳地，在該中空圓筒的外直徑(以mm單位量測)與該等穿孔的總出口面積F(以mm2 單位量測)之間的D/F比值是介於0.19與0.36mm－ 1 的範圍之間。
該中空圓筒的壁厚(外徑D減去內徑d)較佳是介於0.1與2.0mm的範圍之間。
對於材料而言，該等一般的植入物材料例如鋼或鈦金屬是很合適的，但是合成的材料如聚醚醚酮(PEEK)或可再吸收性或不可再吸收性聚合物同樣也可以被使用。該中空圓筒可以製造成一網狀物、一編結物(braiding)或一完全或部分的穿孔式管件。藉由穿孔的位置、直徑與數目，膠結材料的外流可以依據位置與量值來控制，及對被使用的該膠結材料做調整。
該前方端部的表面會依據需要而開啟或封閉。該封閉狀態的實施例防止該膠結材料的表面外流，其對於某些應用(應用在一骨關節附近)來說是重要的。
本發明額外較佳的實施例具有的特徵描述在專利申請範圍的附屬項中。
本發明與本發明額外的構形以更詳細的方式，參照數個實施例的部分圖式的說明來解釋。
圖1所顯示的實施例主要包括：一中空圓筒1，其具有一前方端部3、一後方端部4與一縱長軸2。該中空圓筒1具有一平行於該縱長軸2延伸之全長L與一被相對於該縱長軸2垂直量測之外徑D。該中空圓筒1的腔室9具有一內徑d，該內徑d被相對於該縱長軸2垂直量測。該中空圓筒1的腔室9藉由一沿著該全長L之殼體5圍住，該殼體5藉此部分地被提供有數個穿孔6。所有穿孔6總數達到一小於該殼體5的表面積之總排出口面積F。
該中空圓筒1的前方端部3可以是開啟或封閉的，而該封閉狀態的實施例係為有利的，因為可以避免膠結材料在該中空圓筒1的前方群集。在該中空圓筒1的後方端部位置，該中空圓筒1被提供有一於該腔室9中開孔之鑽孔7，使得其適合做為骨骼用膠結材料的入口。在另一實施例中，該鑽孔7可以被提供有一內螺紋8(圖3)。
顯示在圖2中的該實施例包括：一中空圓筒1，其具有一被提供有穿孔之殼體5，其更具有一前方端部3與一後方端部4。一鑽孔7從該前方端部3處穿過該中空圓筒1，該鑽孔7易於從一膠結材料注射器40(以縱長剖面表示)使該骨骼用膠結材料20***到該中空圓筒1的腔室9。
圖3包括：一被充填有骨骼用膠結材料20的中空圓筒1，而該中空圓筒1具有一封閉的前方端部3。在該後方端部4位置，該鑽孔7在該中空圓筒1中被提供有一內螺紋8。該骨骼植入物10於此中被構形成一以骨骼用螺絲釘形式呈現的骨骼錨定元件15。該內螺紋8與該骨骼錨定元件15的外螺紋配合，使得該骨骼錨定元件15是可螺固到該中空圓筒1之內。因為該殼體5被提供有穿孔6，所以藉由該骨骼錨定元件15，一部分的骨骼用膠結材料20被徑向地擠壓通過該等穿孔6從該中空圓筒1而出。
顯示在圖4中的該實施例描述一通過依據圖1之該空的中空圓筒1之縱長剖面，而該中空圓筒1的前方端部3被封閉，並且該鑽孔7在該後方端部4的位置被提供有一內螺紋8。該中空圓筒1具有一外徑D與一內徑d。該中空圓筒1的殼體5被提供有在一部分的長度X(X<L)之上的穿孔6，而該部分長度X從該前方端部3位置量起。
圖5顯示一通過被充填有骨骼用膠結材料20的該中空圓筒1之縱長剖面，且該中空圓筒1具有一封閉的前方端部3與一在該後方端部4的位置之鑽孔7。此外，圖5描述一通過被充填有骨骼用膠結材料20的一骨骼用膠結材料之注射器40的縱長剖面。
圖6描述一通過被充填有骨骼用膠結材料20的該中空圓筒1之縱長剖面，而該中空圓筒1具有一封閉的前方端部3與一後方端部4，該後方端部4被提供有一鑽孔7。一骨骼錨定元件15被***到在該後方端部4的位置的該鑽孔7之內，該骨骼錨定元件15被提供有一外螺紋11，該外螺紋11與在該鑽孔7之內的內螺紋8配合。藉由***該骨骼錨定元件15，該骨骼用膠結材料20被擠壓通過該等穿孔6而從該中空圓筒1出來到該包圍的骨骼30之內。
在下文中，用於依據本發明的該骨骼錨定元件之手術技術被簡短地描述如下：a)該中空圓筒的基座被預備在該骨骼中。此種情況例如是藉由將該骨骼擴孔的方法達成；b)依據其長度與直徑選定的該中空圓筒係以一般的方式，從病人身體的外部被骨骼用膠結材料充填；c)為了防止該骨骼用膠結材料透過該中空圓筒之殼體的該等穿孔外流，該中空圓筒例如可以被***到一具有對應鑽孔的管座中；d)該預先被充滿的中空圓筒被***該骨骼中；e)該骨骼錨定元件(例如是：一骨骼用螺絲釘)通過該中空圓筒的後方端部被***該中空圓筒之中。在該程序作業期間，該骨骼用膠結材料被擠壓通過該等穿孔到包圍該中空圓筒的該骨骼結構；f)在該骨骼用膠結材料已經硬化之後，該骨骼用膠結材料產生一單元，該單元包括：該骨骼、該中空圓筒與該骨骼錨定機構。
D．．．外徑
d．．．內徑
L．．．全長
x．．．長度
1．．．中空圓筒
2．．．縱長軸
3．．．前方端部
4．．．後方端部
5．．．殼體
6．．．穿孔
7．．．鑽孔
8．．．內螺紋
9．．．腔室
10．．．骨骼植入物
11．．．外螺紋
20．．．骨骼用膠結材料
30．．．包圍的骨骼
40．．．注射器
圖1是一用於依據本發明的裝置之中空圓筒的立體圖；圖2是一依據圖1的中空圓筒之立體圖，以及一通過膠結材料的注射器之縱長剖面，而該膠結材料的注射器用於擠壓骨骼用膠結材料到該中空圓筒之中；圖3是一依據圖1充填骨骼用膠結材料的中空圓筒之立體圖，藉此一骨骼用螺絲釘被***，該骨骼用螺絲釘將一部分骨骼用膠結材料擠壓到附近的骨骼；圖4是一通過依據圖1之空的中空圓筒之縱長剖面；圖5是一通過依據圖1充填骨骼用膠結材料的中空圓筒與一膠結材料的注射器之縱長剖面；以及圖6是一通過依據圖1充填骨骼用膠結材料的中空圓筒之縱長剖面與一***該中空圓筒之骨骼用螺絲釘，該骨骼用螺絲釘將一部分骨骼用膠結材料擠壓到附近的骨骼。
1．．．中空圓筒
3．．．前方端部
4．．．後方端部
6．．．穿孔
7．．．鑽孔
8．．．內螺紋
10．．．骨骼植入物
11．．．外螺紋
20．．．骨骼用膠結材料
30．．．包圍的骨骼

Claims (15)

  1. 一種用於骨骼植入物的膠結材料增補物之裝置，具有：A)一適合接受一尚未硬化的骨骼用膠結材料(20)的中空圓筒(1)，該中空圓筒(1)具有一縱長軸(2)、一內螺紋(8)、一適合***一骨骼(30)中之前方端部(3)、一後方端部(4)與一具有至少一穿孔(6)之殼體(5)；以及B)一螺絲釘(10)，其具有外螺蚊(11)，且可從該後方端部(4)***該中空圓筒(1)內，該外螺紋(11)對應於中空圓筒(1)的內螺紋(8)；其特徵在於：該螺絲釘係為一骨骼用螺絲釘，其適用於控制從中空圓筒(1)處經由其穿孔擠出至骨骼之中的膠結材料(20)的體積量；以及該中空圓筒(1)具有全長L，其中殼體(5)設有該至少一穿孔(6)，穿孔(6)位於從該前方端部(3)開始測量的最大值L/2的部分長度上；其中，在該中空圓筒(1)的外直徑D(以mm單位量測)與該等穿孔(6)的總出口面積F(以mm2 單位量測)之間D/F的比值是介於0.19與0.36mm-1 的範圍之間。
  2. 如申請專利範圍第1項之裝置，其中，該中空圓筒(1)至少部分地被充填有未硬化的骨骼膠結材料(20)。
  3. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)與該螺絲釘(10)相互配合，使得當該螺絲釘 (10)***到該中空圓筒(1)時，該未硬化的骨骼用膠結材料(20)穿透過在該中空圓筒(1)的殼體(5)中之至少一穿孔(6)。
  4. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)在其前方端部(3)位置是封閉的。
  5. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)的後方端部(4)被構形成一連接骨骼用膠結材料之注射器(40)的耦接器。
  6. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)的後方端部(4)被構形成一用於一適配器之插座式連接，該適配器是用於與一骨骼用膠結材料之注射器(40)耦接。
  7. 如申請專利範圍第1項之裝置，其中，該中空圓筒(1)的後方端部(4)被構形成一具有內螺紋(8)的鑽孔(7)。
  8. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)的後方端部(4)被提供有一開孔，而該開孔對應該骨骼植入物(10)的橫剖面。
  9. 如申請專利範圍第1項或第2項之裝置，其中，該等穿孔(6)具有一離該前方端部(3)的最大值為L/3的距離。
  10. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)的後方端部(4)被構形成多邊形腔室或一TORX型腔室，其容許接受個別的多邊形螺絲起子或TORX型螺絲起子。
  11. 如申請專利範圍第1項或第2項之裝置，其中，該等穿孔(6)的直徑是介於0.9與3.3mm的範圍之間，較佳 是介於1.5與2.5mm的範圍之間。
  12. 如申請專利範圍第1項或第2項之裝置，其中，穿孔(6)的數目合計至少20個，較佳為至少40個。
  13. 如申請專利範圍第1項或第2項之裝置，其中，穿孔(6)的數目合計的最大值為100個，最大值較佳為60個。
  14. 如申請專利範圍第1項或第2項之裝置，其中，該中空圓筒(1)的壁厚(外徑減去內徑)是介於0.1與2.0mm的範圍之間。
  15. 如申請專利範圍第1項或第2項之裝置，其中，該等穿孔(6)具有一種網格狀的形式。
TW095106057A 2005-03-24 2006-02-23 用於骨骼植入物之膠結材料增補物的裝置 TWI428116B (zh)

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