JPS6211459A - Composite implant material - Google Patents
Composite implant materialInfo
- Publication number
- JPS6211459A JPS6211459A JP60149332A JP14933285A JPS6211459A JP S6211459 A JPS6211459 A JP S6211459A JP 60149332 A JP60149332 A JP 60149332A JP 14933285 A JP14933285 A JP 14933285A JP S6211459 A JPS6211459 A JP S6211459A
- Authority
- JP
- Japan
- Prior art keywords
- composite implant
- implant material
- hydroxyapatite
- powder
- observed
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000463 material Substances 0.000 title claims description 14
- 239000002131 composite material Substances 0.000 title claims description 12
- 239000007943 implant Substances 0.000 title claims description 12
- 229910052588 hydroxylapatite Inorganic materials 0.000 claims description 12
- 239000000203 mixture Substances 0.000 claims description 12
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 claims description 12
- 229920002050 silicone resin Polymers 0.000 claims description 5
- 239000002245 particle Substances 0.000 claims description 4
- 229920002379 silicone rubber Polymers 0.000 description 10
- 206010061218 Inflammation Diseases 0.000 description 8
- 230000004054 inflammatory process Effects 0.000 description 8
- 239000000843 powder Substances 0.000 description 7
- 239000004945 silicone rubber Substances 0.000 description 6
- 210000004872 soft tissue Anatomy 0.000 description 5
- 238000002627 tracheal intubation Methods 0.000 description 5
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 4
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 3
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 2
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 2
- 239000003462 bioceramic Substances 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- AXCZMVOFGPJBDE-UHFFFAOYSA-L calcium dihydroxide Chemical compound [OH-].[OH-].[Ca+2] AXCZMVOFGPJBDE-UHFFFAOYSA-L 0.000 description 2
- 239000000920 calcium hydroxide Substances 0.000 description 2
- 229910001861 calcium hydroxide Inorganic materials 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 150000002500 ions Chemical class 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000005498 polishing Methods 0.000 description 2
- 238000005245 sintering Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 210000001226 toe joint Anatomy 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 208000033809 Suppuration Diseases 0.000 description 1
- 210000001015 abdomen Anatomy 0.000 description 1
- 230000003187 abdominal effect Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 229910052586 apatite Inorganic materials 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- WUKWITHWXAAZEY-UHFFFAOYSA-L calcium difluoride Chemical compound [F-].[F-].[Ca+2] WUKWITHWXAAZEY-UHFFFAOYSA-L 0.000 description 1
- 229910001634 calcium fluoride Inorganic materials 0.000 description 1
- 210000000845 cartilage Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 239000000460 chlorine Substances 0.000 description 1
- 229910052801 chlorine Inorganic materials 0.000 description 1
- -1 chlorine ions Chemical class 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 238000010562 histological examination Methods 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- VSIIXMUUUJUKCM-UHFFFAOYSA-D pentacalcium;fluoride;triphosphate Chemical compound [F-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O VSIIXMUUUJUKCM-UHFFFAOYSA-D 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
Landscapes
- Materials For Medical Uses (AREA)
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】
本発明は、生体組織、特に軟骨組織を含む、軟組織の代
替物、あるいは生体内外を連結する挿管(Cannul
a)として使用される複合インプラント材に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention provides a substitute for living tissue, particularly soft tissue including cartilage tissue, or a cannula that connects the inside and outside of a living body.
Relating to a composite implant material used as a).
一般に生体材料として用いられるバイオセラミックは生
体親和性にすぐれており、長期間、生体の代替物として
埋設が可能である。バイオセラミックの中でも特にハイ
ドロキシアパタイトは生体に対する物性面で親和性にす
ぐれている。しかし、生体組織に比べ高度が非常に高く
、しかも弾力性、柔軟性がないため軟組織や挿管として
不適である。Bioceramics, which are generally used as biomaterials, have excellent biocompatibility and can be implanted as a substitute for living organisms for a long period of time. Among bioceramics, hydroxyapatite in particular has excellent affinity for living organisms in terms of physical properties. However, it is very high in altitude compared to living tissue, and has no elasticity or flexibility, making it unsuitable for soft tissue or intubation.
一方生体内の軟組織に適用されるものとして、整形外科
で使われているシリコーンゴム組成物がある。これはハ
イドロキシアパタイトに比べ、高い柔軟性、弾力性を有
し、挿管として広く用いられている他、乳房や男性器な
どへの代替物として用いること等、幅広い用途があるこ
とは周知である。On the other hand, silicone rubber compositions used in orthopedic surgery are applicable to soft tissues in living organisms. It is well known that it has higher flexibility and elasticity than hydroxyapatite, and has a wide range of uses, including being widely used for intubation and as a substitute for breasts, male genitals, etc.
しかし、シリコーンゴム組成物はあくまで生体にとって
異物に他ならず、体質によっては、炎症を起こし、化膿
することも少なくはなく、長時間使用することは不可能
な場合もある。特に生体内外を連結する挿管等にあって
は、接続部分に対する細菌の感染の危険性が甚だ高く、
長時間の使用は到底絶えられないものであった。However, silicone rubber compositions are nothing but foreign substances to living organisms, and depending on their constitution, they often cause inflammation and suppuration, making it impossible to use them for a long time. In particular, in cases such as intubation that connect the inside and outside of a living body, there is an extremely high risk of bacterial infection at the connecting part.
It was unbearable to use it for a long time.
上記に鑑み本発明は、生体内で長期間、代用物としての
機能果たし、炎症等を防ぐもので、柔軟性、弾力性を有
し、しかも生体親和性が優れた複合インプラント材を提
供することを目的とする。In view of the above, an object of the present invention is to provide a composite implant material that functions as a substitute for a long period of time in the body, prevents inflammation, etc., has flexibility and elasticity, and has excellent biocompatibility. With the goal.
以下、本考案複合インプラント材の剤組成及び製造、形
状乃至構造、使用の態様等につぎ詳細に分脱する。Hereinafter, the composition, production, shape and structure, mode of use, etc. of the composite implant material of the present invention will be discussed in detail.
材料組成・製法
本発明に於ける“ハイドロキシアパタイト”とはその化
学組成がCa、。(PO4)6(OH)2で表わされる
純粋品のみならず、OHイオンのかわりに1〜10%の
カーボネート(CO3)イオンや7ツソ、塩素イオンを
含むこともある。また、これを主成分とするも焼結性、
強度、細孔度等を向上すべくこれにCa=(PO4)2
、MgO1Na20.’に20.CaF2、A12O−
1Si○2、CaOSCaO5Fe20−1、ZnO,
C,5rO1PbO,BaO、TiO2、Zr02等々
の周知の各種添加物を添加混合したものをも包含する。Material composition/manufacturing method "Hydroxyapatite" in the present invention has a chemical composition of Ca. Not only is it a pure product represented by (PO4)6(OH)2, but it may also contain 1 to 10% of carbonate (CO3) ions, carbonate, and chlorine ions instead of OH ions. In addition, although this is the main component, it has sinterability,
Ca=(PO4)2 is added to this to improve strength, porosity, etc.
, MgO1Na20. ' to 20. CaF2, A12O-
1Si○2, CaOSCaO5Fe20-1, ZnO,
It also includes mixtures of various well-known additives such as C, 5rO1PbO, BaO, TiO2, Zr02, etc.
上記成分を持つハイドロキシアパタイト焼結粒体は、ハ
イドロキシアパタイト粉末を700〜1300℃程度の
温度で焼結処理して得られるものである。予め硬化剤を
10%程度混合したシリコーンエラストマー(信越化学
製)を所望の量で充分に混合攪拌し、所望の形状を有す
る金型に流し込み約150℃、約15分、約200kg
/cII+2で過熱圧縮することによって脱泡し、再度
、同条件で過熱圧縮し、重合成形体とする。尚、挿管、
カテーテル等のような管状体を形成する場合は、上記金
型に代えて、押し出し型金型を用いるものである。The hydroxyapatite sintered granules having the above components are obtained by sintering hydroxyapatite powder at a temperature of about 700 to 1300°C. A desired amount of silicone elastomer (manufactured by Shin-Etsu Chemical Co., Ltd.) pre-mixed with about 10% of a curing agent is thoroughly mixed and stirred, poured into a mold having a desired shape, and heated at about 150°C for about 15 minutes to produce about 200 kg.
/cII+2 to degas the mixture, and then heat and compress it again under the same conditions to obtain a polymerized product. In addition, intubation,
When forming a tubular body such as a catheter, an extrusion mold is used instead of the mold described above.
次に上記重合成形体の表面を磨粉を用いて研磨し、アパ
タイト粒子を露出させる。Next, the surface of the polymerized body is polished using polishing powder to expose the apatite particles.
形状乃至構造
本発明複合インプラント材の形態は軟組織に応じて、あ
るいは使用目的に応じて所望のものとなし得るものであ
るが、シリコーン樹脂とハイドロキシアパタイト焼結体
の混合比は、ハイドロキシアパタイト焼結体が50%以
上であることが好ましく、特に50%がシリコーン樹脂
の生体に対する毒性を量的に中和し、しかも複合インプ
ラントの柔軟性はシリコーンゴムだけのものと同程度の
柔軟性が発揮され好適である。仕上げにおける研磨にお
いても、ハイドロキシアパタイト焼結体が表面に露出す
る程度で行なえばよい。Shape or Structure The shape of the composite implant material of the present invention can be made into a desired shape depending on the soft tissue or purpose of use, but the mixing ratio of the silicone resin and the hydroxyapatite sintered body It is preferable that the silicone resin accounts for 50% or more, and in particular, 50% quantitatively neutralizes the toxicity of the silicone resin to living organisms, and the flexibility of the composite implant is comparable to that of silicone rubber alone. suitable. Finishing polishing may also be performed to the extent that the hydroxyapatite sintered body is exposed on the surface.
宋歇■上
ハイドロキシアパタイトの粉末は、0.5モル/1水酸
化カルシウムと0.3モル/1リン酸溶液を徐々に滴下
し、37℃で、1日反応させて合成し、これを濾過乾燥
して得た。この合成粉末を1250℃で1時間焼結処理
して、ハイドロキシアパタイト焼結体の粉末を得た。Song Wei■ Upper hydroxyapatite powder is synthesized by gradually dropping 0.5 mol/1 calcium hydroxide and 0.3 mol/1 phosphoric acid solution, allowing the reaction to occur at 37°C for one day, and filtering it. Obtained by drying. This synthetic powder was sintered at 1250° C. for 1 hour to obtain a hydroxyapatite sintered powder.
この粉末を50重量%、シリコーンエラストマー50重
量%で充分に混合攪拌し、200gの混合物を金型に充
填し、150℃で約15分間200kg/cm2で圧縮
しながら過熱した。50% by weight of this powder and 50% by weight of silicone elastomer were thoroughly mixed and stirred, 200g of the mixture was filled into a mold, and heated at 150° C. for about 15 minutes while being compressed at 200kg/cm 2 .
上記複合インプラント材を雑種成犬前足指関節の代替と
して成形し、植設した後、経時観察した。The above composite implant material was molded as a replacement for the front toe joint of an adult mongrel dog, and after implantation, it was observed over time.
結果、植設後2力月経っても炎症反応をおこさず異常所
見は何ら認められなかった。As a result, even 2 months after implantation, no inflammatory reaction occurred and no abnormal findings were observed.
また、通常の組織学的検索でも炎症反応などの異常所見
は何ら認められなかった。Furthermore, no abnormal findings such as inflammatory reactions were observed in routine histological examination.
一方シリコーンゴムのみで形成した成形体を、雑種成犬
前足指関節に植設したところ、植設後3力月目に植設部
分の皮膚表面が盛り上がり、発熱が認められた。On the other hand, when a molded body made only of silicone rubber was implanted in the front toe joint of an adult mongrel dog, the skin surface of the implanted area bulged three months after implantation, and fever was observed.
実験例■
実験例Iと同様、ハイドロキシアパタイト焼結体の粒体
50重量%、シリコーンエラストマー50重量%の混合
物を形成と、150’Cで15分、200 kg/am
2で過熱圧縮し、縦10關、高さ1+aa+の長方体を
した複合インプラント材による成形体を得た。Experimental Example ■ As in Experimental Example I, a mixture of 50% by weight of hydroxyapatite sintered body particles and 50% by weight of silicone elastomer was formed and heated at 150'C for 15 minutes at 200 kg/am.
2 to obtain a molded body of the composite implant material having a rectangular shape of 10 squares in length and 1+aa+ in height.
軌惣寒敦
次にこれを成犬腹部、皮膚組織内2〜5mmに埋設とだ
処、術後2週問経っても炎症反応は見られなかった。一
方、この成犬はシリコーン樹脂のみで形成された成形体
を腹部皮下2〜51III11に埋設した処3ケ月後に
炎症を起こした。Atsushi Kisokan then implanted this into the abdomen of an adult dog, 2 to 5 mm deep into the skin tissue, and no inflammatory reaction was observed even two weeks after the surgery. On the other hand, this adult dog developed inflammation 3 months after the molded body made only of silicone resin was implanted under the abdominal skin 2-51III11.
実験例■
ハイドロキシアパタイトの粉末は、0.5モル/1水酸
化カルシウム0.3モル/1、リン酸溶液を徐々に滴下
し、37℃で1日反応させて合成し、これを100メツ
シユに整粒、濾過、乾燥して得た。この合成粉末を12
50℃で1時間焼結処理して、ハイドロキシアパタイト
焼結体の粉末を得た。この粉末を50重量%、シリコー
ンエラストマー50重量%で充分に混合攪拌し、200
gの混合物とする。これを押し出し金型で外径10龍内
径6mmの管状体を形成し、150℃で15分間過熱、
200 kg/am2で圧縮し管状体である複合インプ
ラント材による成形体を得た。Experimental example ■ Hydroxyapatite powder was synthesized by gradually dropping 0.5 mol/1 calcium hydroxide 0.3 mol/1 phosphoric acid solution and reacting at 37°C for one day.This was synthesized into 100 meshes. Obtained by sizing, filtering, and drying. 12 hours of this synthetic powder
Sintering treatment was performed at 50° C. for 1 hour to obtain a powder of hydroxyapatite sintered body. This powder was thoroughly mixed and stirred with 50% by weight and 50% by weight of silicone elastomer.
A mixture of g. This was extruded into a tubular body with an outer diameter of 10 mm and an inner diameter of 6 mm, heated at 150°C for 15 minutes,
It was compressed at 200 kg/am2 to obtain a molded body of the composite implant material in the form of a tubular body.
動隻求数
次にこれを成犬胸部に深さ10mmまで刺通埋設し、そ
の一部が生体外に露出した状態と゛したが生体外の開口
部は密閉した処、約2週間口でも炎症反応は認められず
、1力月後でも同様であった。Next, this was inserted into the chest of an adult dog to a depth of 10 mm, and a part of it was exposed outside the body. However, the opening outside the body was sealed, and inflammation occurred even in the mouth for about 2 weeks. No reaction was observed, even after 1 month.
一方、シリコーンゴム製の管状体においては3力月後に
炎症性の発赤が認められ、5力月目には炎症が進行し、
化膿し始め、8力月目1こ脱落した。On the other hand, in the silicone rubber tubular body, inflammatory redness was observed after 3 months, and the inflammation progressed by the 5th month.
It started to suppurate and one fell off in the 8th month.
以上の実施例から明らかなようにハイドロキシアパタイ
ト焼結体とシリコーンゴムとの混和物である複合インプ
ラント材は柔軟でしかも、生体に対し、常に安定した状
態を保持することができる軟組織代替物として、又挿管
として長期間使用できる材料である等、使用上広範囲に
わたって絶大なる効果を奏効するものである。As is clear from the above examples, the composite implant material, which is a mixture of sintered hydroxyapatite and silicone rubber, is flexible and can be used as a soft tissue substitute that can always maintain a stable state in the living body. In addition, it is a material that can be used for a long period of time as an intubation, and has great effects over a wide range of uses.
Claims (2)
の混合物より成ることを特徴とする複合インプラント材
。(1) A composite implant material comprising a mixture of hydroxyapatite particles and silicone resin.
が露出していることを更に特徴とする特許請求の範囲第
(1)項に記載の前記複合インプラント材。(2) The composite implant material according to claim (1), further characterized in that hydroxyapatite particles are exposed on a required surface of the material.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP60149332A JPS6211459A (en) | 1985-07-09 | 1985-07-09 | Composite implant material |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP60149332A JPS6211459A (en) | 1985-07-09 | 1985-07-09 | Composite implant material |
Publications (1)
Publication Number | Publication Date |
---|---|
JPS6211459A true JPS6211459A (en) | 1987-01-20 |
Family
ID=15472792
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP60149332A Pending JPS6211459A (en) | 1985-07-09 | 1985-07-09 | Composite implant material |
Country Status (1)
Country | Link |
---|---|
JP (1) | JPS6211459A (en) |
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS57132675A (en) * | 1981-02-06 | 1982-08-17 | Sumitomo Metal Mining Co Ltd | Silver peroxide cell |
JPS57132674A (en) * | 1981-02-06 | 1982-08-17 | Sumitomo Metal Mining Co Ltd | Silver peroxide cell |
JPS63183069A (en) * | 1987-01-27 | 1988-07-28 | 旭光学工業株式会社 | Implant materials and their manufacturing methods |
JPH02243160A (en) * | 1988-12-12 | 1990-09-27 | Bio Plasty Inc | Microscopic implant substance |
US5041138A (en) * | 1986-11-20 | 1991-08-20 | Massachusetts Institute Of Technology | Neomorphogenesis of cartilage in vivo from cell culture |
US5736372A (en) * | 1986-11-20 | 1998-04-07 | Massachusetts Institute Of Technology | Biodegradable synthetic polymeric fibrous matrix containing chondrocyte for in vivo production of a cartilaginous structure |
US5741685A (en) * | 1995-06-07 | 1998-04-21 | Children's Medical Center Corporation | Parenchymal cells packaged in immunoprotective tissue for implantation |
US5804178A (en) * | 1986-11-20 | 1998-09-08 | Massachusetts Institute Of Technology | Implantation of cell-matrix structure adjacent mesentery, omentum or peritoneum tissue |
US6309635B1 (en) | 1986-11-20 | 2001-10-30 | Children's Medical Center Corp. | Seeding parenchymal cells into compression resistant porous scaffold after vascularizing in vivo |
US6432437B1 (en) | 1992-02-11 | 2002-08-13 | Bioform Inc. | Soft tissue augmentation material |
US7060287B1 (en) | 1992-02-11 | 2006-06-13 | Bioform Inc. | Tissue augmentation material and method |
US7968110B2 (en) | 1992-02-11 | 2011-06-28 | Merz Aesthetics, Inc. | Tissue augmentation material and method |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS53144194A (en) * | 1977-05-20 | 1978-12-15 | Kureha Chemical Ind Co Ltd | Compound implanted material and making method thereof |
JPS6055965A (en) * | 1983-09-06 | 1985-04-01 | 株式会社アドバンス | Living body terminal for drug treating system |
-
1985
- 1985-07-09 JP JP60149332A patent/JPS6211459A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS53144194A (en) * | 1977-05-20 | 1978-12-15 | Kureha Chemical Ind Co Ltd | Compound implanted material and making method thereof |
JPS6055965A (en) * | 1983-09-06 | 1985-04-01 | 株式会社アドバンス | Living body terminal for drug treating system |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS57132674A (en) * | 1981-02-06 | 1982-08-17 | Sumitomo Metal Mining Co Ltd | Silver peroxide cell |
JPS57132675A (en) * | 1981-02-06 | 1982-08-17 | Sumitomo Metal Mining Co Ltd | Silver peroxide cell |
US6309635B1 (en) | 1986-11-20 | 2001-10-30 | Children's Medical Center Corp. | Seeding parenchymal cells into compression resistant porous scaffold after vascularizing in vivo |
US5041138A (en) * | 1986-11-20 | 1991-08-20 | Massachusetts Institute Of Technology | Neomorphogenesis of cartilage in vivo from cell culture |
US5736372A (en) * | 1986-11-20 | 1998-04-07 | Massachusetts Institute Of Technology | Biodegradable synthetic polymeric fibrous matrix containing chondrocyte for in vivo production of a cartilaginous structure |
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