TWI473592B - 尤指脊骨動態穩定用之桿狀植入體 - Google Patents

尤指脊骨動態穩定用之桿狀植入體 Download PDF

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TWI473592B
TWI473592B TW98114301A TW98114301A TWI473592B TW I473592 B TWI473592 B TW I473592B TW 98114301 A TW98114301 A TW 98114301A TW 98114301 A TW98114301 A TW 98114301A TW I473592 B TWI473592 B TW I473592B
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rod
shaped implant
shaped
flexible
implant
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TW200946074A (en
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Lutz Biedermann
Wilfried Matthis
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Biedermann Technologies Gmbh
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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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
    • A61B17/7029—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form the entire longitudinal element being flexible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
    • A61B17/7028—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form the flexible part being a coil spring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032—Screws or hooks with U-shaped head or back through which longitudinal rods pass
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped

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Description

尤指脊骨動態穩定用之桿狀植入體
本發明係關於一種桿狀植入體，尤指供脊骨動態穩定用。桿狀植入體包括至少一部份是由撓性第一種材料製成，形成矩陣，內嵌撓性結構，包括至少一種纖維，由第二種材料製成。
脊椎柱動態穩定用之塑膠材料製桿狀植入體，參見例如US 2007/0093820 A1、US 2007/0161999 A1和US 2007/0270843 A1。
US 2006/0142758 A1記載一種脊椎固設系統之連結元件，由聚合性材料製之至少部份支持體，和實質上與支持體共軸之桿(無論彎曲與否)組成。桿係例如由蝸形彈簧製成，其軸線和圈匝至少部份嵌入聚合物料製之支持體內。蝸形彈簧係例如為金屬或合金製成。連結元件之結構得以壓縮和搖動，以容許脊骨動態穩定。
本發明之目的，在於提供一種脊骨動態穩定用之桿狀植入體，使得利用植入體在界定方向穩定之脊椎運動截面得以運動，同時防止或抑制在其他方向運動。
此目的係由申請專利範圍第1項之桿狀植入體解決。本發明進一步發展，列於申請專利範圍附屬項。
本發明桿狀植入體具撓性，視以植入體加以穩定的椎骨間之作用力方向而定。對桿施以扭力時，顯示特別剛性行為，而對植入體施以軸向壓力和拉力時，又容許軸向伸縮。
桿狀植入體之屈曲性質可特別按照臨床需要設計，藉選擇纖維所形成適當撓性結構為之。
本發明其他特點和優點，由如下參照附圖所示具體例之詳述，即可明白。
第1至3圖表示桿狀植入體第一具體例之簡略側視圖、斷面圖和透視圖。桿狀植入體1實質上呈圓筒形，外徑D。由嵌入聚合性材料3矩陣內之撓性結構2構成。聚合性材料顯示屈曲性，以彈料為佳。適當彈料性材料之例有，生理相容性聚胺酯或聚碳酸酯胺酯(PCU)。桿狀植入體之外徑D設計成，桿狀植入體可固設於例如梗釘之容納件內。聚合物材料之屈曲性係等方性(各向同性)。為使桿狀植入體具有方向依賴性之特殊屈曲性，設有撓性結構2。尤其從第2和4a至5b圖可見，第一具體例之撓性結構2，包括內結構2a和外結構2b。內結構2a包括四個螺旋2a1,2a2,2a3,2a4，與桿狀植入體之縱向軸線L共軸配置。內結構2a的第一直徑d1 ，是全部四個螺旋相同。螺旋2a1和2a4彼此轉動90°。第一內結構2a因而形成空心圓筒形網狀結構。
由第5a和5b圖可見，外結構2b同樣包括四個螺旋2b1,2b2,2b3,2b4，亦與縱向軸線L共軸配置，彼此轉動90°。外結構的螺旋直徑d2 比內結構的螺旋直徑d1 大，但比桿狀植入體1的外徑D小。外結構2b相對於內結構2a轉動180°。外結構2b亦形成空心圓筒形網狀結構。由第6a、6b和1至3圖可見，外結構2b包圍桿狀植入體內之內結構2a。
螺旋係纖維製成，在纖維延伸方向具有高強度。彈簧般性能(像纖維之拉力強度和壓縮強度)係以纖維之幾何形狀界定。因此，螺旋匝數和距離、纖維厚度，以及直徑d1 和d2 ，界定螺旋亦即全部撓性結構2之屈曲特性。
纖維材料以聚合物為佳，例如聚丙烯或類似材料。惟碳或kevlar纖維亦可用。內結構和外結構螺旋之材料可相同，亦可不同，以提供特殊性能。纖維和聚合物矩陣的彈性模數間相差，比金屬彈簧與聚合物矩陣間之差異小。所以，加載時，聚合物矩陣內纖維鬆弛危機小，或根本不存在。
桿狀植入體1之製造，例如先組裝內結構和外結構，再把聚合物矩陣在全撓性結構2周圍噴射成型，使撓性結構2內嵌於聚合物矩陣3。
第7至9圖表示桿狀植入體固設於單軸式梗釘內。梗釘5包括螺紋幹部6，和螺紋幹部6一端形成之容納件7。容納件7實質上為圓筒形，包括U形凹部8，從自由端，按螺紋幹部方向延伸，因而形成二自由股部，設有陰螺紋9。在U形凹部底設有結合結構10，呈肋條狀，橫越桿狀植入體的縱軸線L延伸。為固設起見，設有固設螺釘11，可旋入容納件7之陰螺紋9內。固設螺釘11包括結合結構12，朝U形植入體1的側面，有環形突部，見第8和9圖。
使用時，把二梗釘5旋入相鄰椎骨內，將桿狀植入體1插入，以固設螺釘加以固設。容納件之結合結構10和固設螺釘之結合結構12，壓住桿狀植入體1，因而將聚合物矩陣3表面變形，使結合結構和聚合物矩陣間發生部份形式套合連接，保持桿狀植入體安全定位。結合結構之維度設計，使得固設螺釘11旋緊時，桿狀植入體1之撓性結構不變形。
第10至12圖表示桿狀植入體固設於多軸式梗釘內。多軸式梗釘15包括螺釘構件16，有螺紋幹部和球形頭部16a，以及容納件17。容納件17呈實質上圓筒形，包括U形凹部18和共軸徑孔19，斜縮入開口20內，螺釘構件16a保持於其內，可相對於容納件17樞動。利用U形凹部18，形成二自由股部，包括陰螺紋21。設有壓力構件22，藉此對頭部16a施壓，把頭部16a固設。壓力構件22可插入徑孔19內，設計來容納桿狀植入體1。設有固設螺釘23，在朝向桿狀植入體1之側面，包括結合結構24。
使用時，把至少二梗釘旋入相鄰椎骨內，將容納件17對準，容納桿狀植入體，再以固設螺釘23固設之。對壓力構件22施壓力，即可將頭部16a固設於定位。同時，也把桿狀植入體固設於容納件內。
第13至15圖表示桿狀植入體1，固設於已固定在彼此之間包圍椎間盤103之相鄰椎骨101,102梗節內的二多軸式梗釘15,15'。第13圖表示在中性位置。在此位置，桿狀植入體之撓性結構2和聚合物矩陣，即未壓縮，亦未伸長。第14圖表示脊椎屈曲狀態，其中梗節間，亦即梗釘間之距離，變得比在中性位置時還大。作用於桿狀植入體之拉力，造成內、外結構2a,2b連同周圍聚合物矩陣延伸。第15圖表示脊椎伸長狀態，梗節彼此趨近，使梗節問之距離比在中性位置時為小。此項壓縮力造成內結構和外結構連同聚合物矩陣壓縮在一起，致桿狀植入體變短。
第16圖表示桿狀植入體的長度大約在中性位置，而第17圖表示桿狀植入體長度壓縮和縮短。當撓性結構以軸向力F壓縮時，內結構和外結構的直徑會變大。由於聚合物矩陣是彈料性材料，會遵循撓性結構2之壓縮或伸長。
當扭力F作用於桿狀植入體之縱向軸線周圍，如第18圖所示，撓性結構2抵擋此扭力，故實際上不會發生桿狀植入體扭動。由於內結構和外結構彼此相對轉動180°，可提供高度扭轉剛性。桿狀植入體之扭轉剛性可藉選擇性結構之屈曲性能，特別設計之。
由於纖維強度，桿狀植入體不會發生捲曲。
第19a至19c圖表示桿狀植入體的撓性結構第二具體例。與第1至8圖所示第一具體例不同的是，外結構的直徑和內結構相同。內、外螺旋連接成網狀結構。
第20a和20b圖表示撓性結構之進一步變化。撓性結構包含單一內螺旋2a'和單一外螺旋2b'，外螺旋直徑比內螺旋大，且相對於內螺旋轉動180°。
可構想其他變化。螺旋之匝距可在單一螺旋或不同螺旋間變化。撓性結構不一定由螺旋構成。亦可為纖維製成之另一網狀結構，例如，布料般結構，有菱形開口，或任何其他網狀結構，可容許延長和壓縮，同時提供轉動剛性。
梗釘亦可改用其他骨骼固定裝置。
1．．．桿狀植入體
2．．．撓性結構
3．．．聚合物矩陣
D．．．桿狀植入體的外徑
2a．．．內結構
2b．．．外結構
2a1,2a2,2a3,2a4．．．螺旋
2b1,2b2,2b3,2b4．．．螺旋
d1 ．．．內結構的螺旋直徑
d2 ．．．外結構的螺旋直徑
5．．．梗釘
6．．．螺紋幹部
7,17．．．容納部
8,18．．．U形凹部
9,21．．．陰螺紋
10．．．容納件之結合結構
11,23．．．固設螺釘
12．．．固設螺釘之結合結構
L．．．桿狀植入體之縱向軸線
15,15'．．．多軸式梗釘
16．．．螺釘構件
16a．．．球形頭部
19．．．共軸徑孔
20．．．開口
22．．．壓力構件
24．．．結合結構
101,102．．．椎骨
103．．．椎間盤
F．．．扭力
2a'．．．內螺旋
2b'．．．外螺旋
第1圖為桿狀植入體第一具體例簡略側視圖；
第2圖為第1圖植入體垂直於桿軸線之簡略斷面圖；
第3圖為第1圖植入體之簡略透視圖；
第4a圖為第1圖桿狀植入體撓性內結構第一例之透視圖；
第4b圖為第4a圖撓性內結構之側視圖；
第5a圖為第1圖桿狀植入體撓性外結構第一例之透視圖；
第5b圖為第5a圖撓性外結構之側視圖；
第6a圖為第4a至5b圖組合內、外結構之透視圖；
第6b圖為第6a圖組合內、外結構之側視圖；
第7圖為第1至6b圖桿狀植入體連同單軸式梗釘之分解圖；
第8圖為第7圖桿狀植入體和單軸式螺釘呈組裝狀態取自對桿軸線垂直之斷面圖；
第9圖為第7圖桿狀植入體和單軸式螺釘呈組裝狀態取自沿桿軸線之斷面圖；
第10圖為第1至6b圖桿狀植入體與多軸式梗釘一同呈組裝狀態取自對桿軸線垂直之斷面圖；
第11圖為桿狀植入體和多軸式螺釘沿桿軸線之斷面圖；
第12圖為第10和11圖多軸式螺釘呈組裝狀態之透視圖；
第13至15圖分別表示桿狀植入體連同二梗釘固設於相鄰椎骨將脊椎運動截段穩定於椎骨中性位置、屈曲和伸長之狀態；
第16圖為桿狀植入體在中性位置之簡略側視圖；
第17圖為桿狀植入體在軸向壓縮力作用下之簡略側視圖；
第18圖為桿狀植入體在扭力作用下之狀態；
第19a至19c圖分別表示修飾具體例的撓性結構之透視圖、斷面圖和側視圖；
第20a和20b圖分別表示又一修飾具體例的撓性結構之透視圖和側視圖。
1．．．桿狀植入體
5．．．梗釘
6．．．螺紋幹部
7．．．容納部
8．．．U形凹部
9．．．陰螺紋
10．．．結合結構
11．．．固設螺釘
L．．．桿狀植入體之縱向軸線

Claims (11)

  1. 一種脊骨動態穩定用之桿狀植入體，至少一部份是由撓性第一種材料構成，形成矩陣(3)，內嵌撓性結構(2)，包括至少一纖維，係由第二種材料製成，其中撓性結構(2)包括共軸網狀內結構(2a)和共軸網狀外結構(2b)，外結構配置成包圍內結構者。
  2. 如申請專利範圍第1項之桿狀植入體，其中第一種材料是聚合物，尤指彈料性材料者。
  3. 如申請專利範圍第1項之桿狀植入體，其中第二種材料係合成材料，尤指聚丙烯者。
  4. 如申請專利範圍第1、2或3項之桿狀植入體，其中撓性結構(2)係由至少二螺旋形纖維構成，彼此轉動某一角度者。
  5. 如申請專利範圍第4項之桿狀植入體，其中該角度為180°者。
  6. 如申請專利範圍第4項之桿狀植入體，其中螺旋形纖維具有同樣直徑者。
  7. 如申請專利範圍第4項之桿狀植入體，其中螺旋形纖維具有不同直徑者。
  8. 如申請專利範圍第1、2或3項之桿狀植入體，其中網狀結構(2a,2b)，增進桿狀植入體(1)之扭力剛性者。
  9. 如申請專利範圍第1、2或3項之桿狀植入體，其中內結構(2a)包括四個螺旋(2a1,2a2,2a3,2a4)，而外結構(2b)包括四個螺旋(2b1,2b2,2b3,2b4)者。
  10. 如申請專利範圍第9項之桿狀植入體，其中內結構之螺旋彼此轉動90°，而外結構之螺旋彼此轉動90°者。
  11. 如申請專利範圍第9項之桿狀植入體，其中內結構(2a)和外結構(2b)彼此轉動180°者。
TW98114301A 2008-05-06 2009-04-30 尤指脊骨動態穩定用之桿狀植入體 TWI473592B (zh)

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