TWI452994B - 脊椎穩定用的桿件總成及模組式桿件系統 - Google Patents

脊椎穩定用的桿件總成及模組式桿件系統 Download PDF

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TWI452994B
TWI452994B TW097138482A TW97138482A TWI452994B TW I452994 B TWI452994 B TW I452994B TW 097138482 A TW097138482 A TW 097138482A TW 97138482 A TW97138482 A TW 97138482A TW I452994 B TWI452994 B TW I452994B
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rod system
adapter
end section
modular
core
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TW097138482A
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TW200916047A (en
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Lutz Biedermann
Wilfried Matthis
Jurgen Harms
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Biedermann Technologies Gmbh
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    • 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
    • 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
    • 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
    • A61B17/7049—Connectors, not bearing on the vertebrae, for linking longitudinal elements together
    • A61B17/705—Connectors, not bearing on the vertebrae, for linking longitudinal elements together for linking adjacent ends of longitudinal elements
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • 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
    • A61B17/7004—Longitudinal elements, e.g. rods with a cross-section which varies along its length
    • 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

Description

脊椎穩定用的桿件總成及模組式桿件系統
本發明係關於一種脊椎穩定用的桿件總成，包括撓性管狀元件和配置在撓性管狀元件內之核心，以及在撓性管狀元件至少一側之承接器。承接器使管狀元件可連接到脊椎穩定裝置之其他桿件部份或其他桿件總成。核心之至少一端可自由運動。延伸進入承接器之一部份內，後者本身延伸入管狀元件，因而提供精巧設計。本發明又關於脊椎穩定用之模組式桿件系統。
WO 03/047442 A1記載一種用於脊椎穩定之阻尼元件，包括外彈簧、內彈簧，以及在內、外彈簧任一側之承接器。內彈簧靠近兩側承接器之末端，故在一端不能自由運動。
US 2005/0085815 A1記載一種脊椎穩定桿，包括核心，容納於撓性管狀桿內，在軸向有公差。
US 2007/0049937 A1記載一種脊椎穩定桿，包括撓性管狀部和在撓性管狀部任一側之剛性端部，以及延伸貫穿撓性部和剛性端部至少一部份之核心。核心可固定於一側，並在另一側自由運動。
US 2005/0154390 A1記載一種撓性元件，包括核心和二桿狀承接器，可連接於撓性元件之各端。核心不延伸進入承接器內。
第1圖簡略表示脊椎，連同骨骼固定元件100，固定於例如椎骨101的梗節。通常骨骼固定元件是經由脊椎穩定桿連接，後者可為剛性(筆直或彎曲)或撓性至某種程度。可見二骨骼固定元件間之桿所跨越距離，在較高胸椎區為25－30mm之譜，而在中腰椎區降到20－25mm，以迄下腰椎區大約10－15mm。在特殊的臨床應用上，必須以不同方式把脊椎的不同部份穩定，例如在不同位置必須用到剛性以及撓性穩 定。甚至在脊椎的不同位置，例如右側和左側，必須使用不同撓性程度的撓性穩定，考慮到在脊椎的下腰椎部份或在脊椎的頸椎部份之骨骼固定元件間距離小，便亟需有精巧形狀和小維度的穩定桿或桿件。
是故，本發明之目的，在於提供一種脊椎穩定用之桿件總成，可以模組方式使用，有簡易而多樣用途。此外，旨在提供一種小維度之桿件總成。最後，提供脊椎穩定用之模組式桿件系統。
此目的是以申請專利範圍第1項的桿件總成，和申請專利範圍第9項的模組式桿件系統解決。進一步發展列於申請專利範圍附屬項內。
本發明之優點是桿件總成可藉撓性管狀元件之各種組合預組成，形成撓性桿件和承接器，以便與其他桿件總成或剛性桿件連接。此模組式設計得以最適合患者特殊臨床需要之方式，處理脊椎脫序。
由於設計精巧，桿件總成可用於脊椎之所有區域，即亦可用在所用骨骼固定元件彼此距離很小之區域，諸如下腰椎區或頸椎區。
本發明其他特點和優點，由參照附圖所示具體例之詳述，即可明白。
如第2－5圖所示，第一具體例之桿總成包括管狀元件2，有第一端段2a，和第一端段相反對之第二端段2b。圖示具體例中管狀元件之內徑，從第一端段2a至第二端段2b一定不變。管狀外徑在第一端段和第二端段，較二端段間之部份為小。管狀元件包括撓性段，對管狀元件提供彎曲和壓縮彈性。
撓性段最好由凹部3形成，以螺狀方式延伸越過管狀元 件2全長。凹部3對管狀元件2施以壓縮和彎曲彈性。螺狀凹部3的維度和螺距，以及管狀元件2的壁厚，要能得所需彈性。凹部3不需有連續螺狀，亦可形成級進方式，包含與管狀元件縱向平行的部份。螺距可沿長度變化。
管狀元件宜由形狀記憶性合金形成，顯示形狀記憶效果和超彈性。尤其是，管狀元件由鈦鎳合金製成，諸如鎳鈦諾(nitinol)。
桿件總成又包括連接至第一端段2a之第一承接器4，和連接至第二端段2b之第二承接器5。詳見第5圖，第一承接器4包括連接至管狀元件2第一端段2a之第一段4a，和在第一段4a相反面的第二段4b，第二段4b供連接脊椎穩定裝置的其他元件。第一段4a外徑大約相當於管狀元件2第一端段2a之內徑。如第5圖所示，第一承接器的第一段4a具有多面形外表面，例如八面形。第二段4b的外表面結構，可與其他元件結合，在圖示具體例中，包括螺紋6。第一段4a和第二段4b，彼此以環形肩部4c分開，其外徑相當於第一端段2a的外徑。第一承接器4又包括共軸腔孔7，從第一端延伸貫穿至第二端。
第一承接器4以生理相容性金屬製成為佳，例如鈦。在組合狀態時，第一承接器4利用壓套接合，連接至管狀元件之第一端段2a。第一承接器的第一段外表面多面形，導致接合兼具形式鎖定或積極套接以及摩擦接合。八面形的型式，是按照所需接合強度選擇。具體而言，若管狀元件包括鎳鈦諾，當管狀元件在冷態，即材料主要呈麻田散體狀態，即建立壓套接合。在麻田散體狀態，比在沃斯田鐵狀態，更易變形。所以，承接器的多面形產生積極套接，使管狀元件的端段內壁變形。
桿件總成1又包括核心8，在圖示具體例中呈圓筒形狀，其直徑可利用壓套接合連接於第一承接器4。核心8即 牢固連接於第一承接器4，亦即管狀元件2之第一端段2a。從第一承接器4末端延伸至第二端段2b之大約末端。因此，延伸完全貫穿管狀元件2之彈性段。核心8長度使管狀元件2在完全壓縮狀態時，其自由端不會碰到第二承接器5。核心的自由端9不固定，故可在管狀元件2內自由運動。核心8最好由形狀記憶性合金製成，諸如鈦鎳合金，例如鎳鈦諾。尤其是可由鎳鈦諾線。
由第2和5圖可見，第二承接器5有第一段5a和第二段5b。第一段5a外徑大約相當於管狀元件第二端段2b內徑，在此具體例內具有多面形狀。第二段5b外徑相當於管狀元件第二段2b外徑。第二段5b包括結構可與骨骼穩定裝置的其他元件結合。在圖式具體例中，包括螺紋腔孔10，可與螺紋桿件或承接器接合。第二承接器5又包括共軸腔孔11，從第一段5a的自由端延伸至螺紋腔孔10底部。共軸腔孔11內徑比核心8外徑大。當第二連接器5連接於管狀元件2時，核心8延伸貫穿腔孔11之一部份。
第二承接器5係由生理相容性材料製成，例如鈦。
詳見第2和3b圖，在第二承接器第一部份5a和核心8之間，配置套筒12。套筒12有第一部12a，利用壓套接合，連接到第二承接器之第一段5a。意即第一部份12a內的套筒12外徑，大約和共軸腔孔11的內徑相同。第一部份12a的末端毗連腔孔11的末端。第二部份12b的直徑，比管狀元件的內徑稍小。套筒內徑比核心8外徑稍大，故核心8可在套筒內滑動。套筒長度使得撓曲時，核心不會滑出套筒外。套筒以方便核心8滑動的材料製成。例如，可由聚醚醚酮(PEEK)、碳纖強化之聚醚醚酮(CRF PEEK)、聚四氟乙烯(PTFE)，或適合軸承的其他生理相容性材料製成。亦可使用生理相容性塗料，以改進軸承性能。
核心8用來加強彈性管狀元件。例如，若無核心8，管 狀元件2在某負載狀況下會扭曲。核心8可防止此類扭曲。
選用桿件總成的材料維度和元件性能，使特殊桿件總成在承接器彈性和設計方面，具有特別需要之特性。
由於核心8應在一側可自由運動，故必須有空間讓核心運動。把核心的活動端配置於第二承接器之至少一部份內，即可縮短桿件總成的總長度。又可縮短桿件總成撓性部份之長度。如此即用於例如脊椎之下腰椎部份。
上述具體例可有各種修飾。第6圖表示第二具體例，其中管狀元件2'有末端段2a'和2b'，其外徑與撓性段相同。例如，管狀元件2'外徑為5.5mm，而第一具體例的管狀元件2，其撓性段外徑為7.5mm，末端段外徑為5mm。
第7a至7c圖表示承接器之各種修飾例。承接器5'是第二承接器5型式。同樣組件以同樣參考數字標示。承接器5'包括螺紋腔孔10，供連接骨骼穩定裝置之其他組件。承接器第一段5a'可以各種方式造型。第7a圖表示四邊形外表面，有平坦邊緣，第7b圖表示八面形外表面，而第7c圖為圓筒形外表面。選擇第一段外表面形狀，利用形式套合(或積極套合)兼摩擦套接，達成所需接合強度。第二段5b'外徑相當於管狀元件第二段2b'之外徑。
第8圖表示第6圖之管狀元件2'，各側有承接器。承接器5'相當於第7a至7c圖所示承接器之一，而承接器4相當於第2至5圖所示承接器。
第9圖表示之承接器，其型式像承接器5,5'，另像承接器4。由第9圖可見，承接器4的陽螺紋7可與承接器5螺紋腔孔10的陰螺紋結合。此舉可把若干桿件總成組合於骨骼穩定裝置組合。尤其是可提供某種長度之脊椎穩定桿，分成不同段，有不同的撓曲性能，相當於各桿件總成之撓曲性能。
第10a至10d圖表示各種剛性桿部20,21,22,23，各在一 端有螺紋腔孔20a,21a,22a,23a，而在相反端有螺紋凸部20b,21b,22b,23b。剛性桿部可有不同長度，如第10a至10c所示，或具有曲率，如第10d圖所示。螺紋腔孔20a至23a與桿件總成的第一承接器之螺紋7結合，而螺紋凸部20b至23b與第二承接器5之螺紋腔孔10結合。剛性桿部係由生理相容性材料製成，例如鈦或不銹鋼。
第11a至11c圖表示不同脊椎穩定桿之例，由上述若干元件組成。第11a圖表示脊椎穩定裝置組合之前，包括剛性桿部23、特定長度和特定彈性之桿件總成，又一剛性桿部20，和特定與第一桿件總成1不同之第二桿件總成1'。在穩定裝置末端，設有圓蓋25，與桿件總成末端結合。當然，端蓋可有其他設計。第11b圖表示第11a圖骨骼穩定裝置之組合狀態。第11c圖表示第11a和11b圖類似之骨骼穩定裝置。唯一不同的是，第二桿件總成1'改用桿件總成1"，外徑較第一桿件總成1為小，故與剛性桿段20表面齊平。
可進一步改變。桿件總成和剛性桿部間之螺合，可改用其他接合，諸如壓套接合。在又一變化例中，承接器有一部份延伸到管狀元件的末端段，並固定於此。例如利用壓套接合。不同具體例之各種元件可以彼此組合。
核心8可有非圓形斷面，例如長方形斷面，以定向方式增進堅性。此外，核心8可由形狀記憶性合金以外的材料製成。例如可由生理相容性塑膠材料製成。
使用時，提供一組桿件總成，有各種外徑、各種彈性或撓性、各種長度和各種連接機構。又提供不同類型的一組承接器，以及不同長度和/或曲率之剛性桿部。桿件總成、承接器和剛性桿部，形成模組式桿件系統。外科醫師可由此模組式系統選用適當元件，組合於脊椎穩定桿，連接到骨骼固定元件，如第1圖所示。尤其是可顧及不同的解剖情形，例如在脊椎左側或右側，或脊椎的不同區域，選用和組合適當 元件以供矯正。
100‧‧‧骨骼固定元件
101‧‧‧椎骨
1,1',1"‧‧‧桿件總成
2,2'‧‧‧管狀元件
2a,2a'‧‧‧第一端段
2b,2b'‧‧‧第二端段
3‧‧‧螺狀凹部
4‧‧‧第一承接器
4a,5a,5a'‧‧‧第一段
4b,5b,5b'‧‧‧第二段
4c‧‧‧環形肩部
5,5'‧‧‧第二承接器
6‧‧‧螺紋
7‧‧‧共軸腔孔
8‧‧‧核心
9‧‧‧核心自由端
10‧‧‧螺紋腔孔
11‧‧‧共軸腔孔
12‧‧‧套筒
12a‧‧‧第一部份
12b‧‧‧第二部份
20,21,22,23‧‧‧剛性桿部
20a,21a,22a,23a‧‧‧螺紋腔孔
20b,21b,22b,23b‧‧‧螺紋凸部
25‧‧‧圓蓋
第1圖為脊椎簡圖；第2圖為桿件總成沿桿件軸線之斷面圖；第3a圖為桿件總成沿第2圖A－A線之斷面圖；第3b圖為第1圖桿件總成之元件透視圖；第4圖為第2圖桿件總成之側視圖；第5圖為第2圖桿件總成之透視分解圖；第6圖為桿件總成管狀元件之第二具體例；第7a至7c圖為第6圖管狀元件所用承接器之變化例；第8圖為桿件總成之第三具體例；第9圖為第8圖桿件總成所用二承接器之透視圖；第10a至10d圖表示本發明桿件總成所用剛性桿件承接器之各種具體例；第11a至11c圖為桿件總成和承接器之各種組合。
1‧‧‧桿件總成
2‧‧‧管狀元件
2a‧‧‧第一端段
2b‧‧‧第二端段
3‧‧‧螺狀凹部
4‧‧‧第一承接器
5‧‧‧第二承接器
5a‧‧‧第一段
5b‧‧‧第二段
6‧‧‧螺紋
7‧‧‧共軸腔孔
8‧‧‧核心
9‧‧‧核心自由端
10‧‧‧螺紋腔孔
11‧‧‧共軸腔孔
12a‧‧‧第一部份
12b‧‧‧第二部份

Claims (18)

  1. 一種模組式桿件系統，包含至少一第一桿件總成，和另一桿部或脊椎穩定用的另一桿件總成，該第一桿件總成包括：一撓性管狀元件(2,2')，有一第一端段(2a)和一第二端段(2b)；一承接器(4,5)，連接於該第二端段(2b)，該承接器(5)有一結合結構(10,6)，供連接於該脊椎穩定裝置之該另一桿部或另一桿件總成，該結合結構(10,6)包括該第一桿件總成和該另一桿部或另一桿件總成間之螺紋接合(10,6)或壓套接合；其中該承接器(4,5)至少一部份延伸入或至該第二端段(2b)；一縱向核心(8)，延伸貫穿該管狀元件；該核心有一第一端，延伸貫穿該第一端段(2a)之至少一部份；和一第二端(9)，延伸進入該承接器之該部份，並可在其內自由運動者。
  2. 如申請專利範圍第1項之模組式桿件系統，其中該承接器(5)包括一管狀部(5a)，延伸進入該管狀元件之該第二端段(2b)內者。
  3. 如申請專利範圍第1或2項之模組式桿件系統，其中該核心的該第二端(9)周圍，設有一套筒(12)，方便該核心之該第二端(9)滑動者。
  4. 如申請專利範圍第3項之模組式桿件系統，其中該套筒包括聚醚醚酮(PEEK)，或碳纖強化聚醚醚酮(CFR PEEK)者。
  5. 如申請專利範圍第1或2項之模組式桿件系統，其中該核心的該第一端固定於該第一端段(2a)者。
  6. 如申請專利範圍第1或2項之模組式桿件系統，其中連 接於該第二端段(2b)之該承接器(5)為一第二承接器，又其中連接於該第一端段(2a)者為一第一承接器(4)。
  7. 如申請專利範圍第6項之模組式桿件系統，其中該第一承接器(4)包括一管狀部(4a)，延伸進入該管狀元件(2)之該第一端段(2a)內者。
  8. 如申請專利範圍第2項之模組式桿件系統，其中連接於該第二端段(2b)之該承接器(5)為一第二承接器(5)，而該第二承接器(5)之該管狀部(5a)具有一圓筒形或一多面形外表面者。
  9. 如申請專利範圍第7項之模組式桿件系統，其中該第一承接器之該管狀部(4a)具有一圓筒形或一多面形表面者。
  10. 如申請專利範圍第1或2項之模組式桿件系統，其中該承接器(4,5)係利用一壓套接合，連接於該管狀元件(2,2')者。
  11. 如申請專利範圍第1或2項之模組式桿件系統，其中該承接器(4,5)，分別在該第一端段(2a)或該第二端段(2b)相反側，具有該一螺紋部者。
  12. 如申請專利範圍第11項之模組式桿件系統，其中該螺紋部係一陰螺紋(10)或一陽螺紋(6)者。
  13. 如申請專利範圍第1或2項之模組式桿件系統，其中設有一第三承接器(20,21,22,23)，把該承接器(4,5)連接至該另一桿件總成(1,1',1")之承接器(5)者。
  14. 如申請專利範圍第6項之模組式桿件系統，其中該核心(8)係利用一壓套接合，固定於該第一承接器(4)者。
  15. 如申請專利範圍第1或2項之模組式桿件系統，其中該核心(8)係由一形狀記憶性合金，尤其是鎳鈦諾(nitinol)製成者。
  16. 如申請專利範圍第1或2項之模組式桿件系統，其中該管狀元件(2,2')係由一形狀記憶性合金，尤其是鎳鈦諾製 成者。
  17. 如申請專利範圍第1或2項之模組式桿件系統，其中該管狀元件(2,2')壁上具有一連續性或級進螺形凹部(3)，以提供彈性者。
  18. 如申請專利範圍第1或2項之模組式桿件系統，其中該承接器(4,5)和該管狀元件(2,2')具有同樣最大外徑或不同最大外徑者。
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EP2047810A1 (en) 2009-04-15
US20090163953A1 (en) 2009-06-25
CN101416901A (zh) 2009-04-29
CN101416901B (zh) 2013-06-05
ES2417013T3 (es) 2013-08-05
KR20090037314A (ko) 2009-04-15
JP2009090117A (ja) 2009-04-30
TW200916047A (en) 2009-04-16
US9089369B2 (en) 2015-07-28
EP2364656A1 (en) 2011-09-14
JP5151887B2 (ja) 2013-02-27
EP2047810B1 (en) 2011-09-28
EP2364656B1 (en) 2013-04-03

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