人工骨產(chǎn)品展示

1、Medical Biomat（法國）/index.php/en該企業(yè)同類產(chǎn)品較多詳細(xì)可見 同類產(chǎn)品MEDICALBIOMAT 文件夾產(chǎn)品名產(chǎn)品照片組成及規(guī)格適用范圍備注Atlantik 人工骨由 70%羥基磷灰石和 30% -磷酸三鈣組成雙相合成人工骨。 因為由高純度合成材料組成，Atlantik 人工骨人骨礦物成份十分相同，從而含有非常理想生物相容性這種人工骨適適用于由外傷或外科手術(shù)中骨缺損填充，其中括：關(guān)節(jié)置換手術(shù)脊椎手術(shù)閉合骨折切骨術(shù)腫瘤切除術(shù)后填充上頜面手術(shù)牙科手術(shù)等產(chǎn)品性能Atlantik 人工骨有良好多孔性和最優(yōu)化表面處理，保障了快速骨再生和良好骨結(jié)合。Atlantik 人工骨結(jié)構(gòu)

2、包含兩種不一樣空隙，空隙之間完全鏈接保障宏觀孔隙中細(xì)胞滲透，微觀孔隙則增加了與生物體液接觸面。Atlantik 人工骨良好機(jī)械特征使它們能夠很好配合大多數(shù)臨床適應(yīng)癥。 在試驗測試中，動物植入試驗以及臨床結(jié)果顯示 Atlantik 人工骨有著十分理想骨結(jié)核效果。Antartik 磷酸三鈣Antartik TCP 是由貝塔磷酸三鈣 ( TCP)組成合成骨代替品。這種人工骨合成原料純度極高，非?？拷诠堑V物成份。所以ANTARTIK TCP 骨代替品含有完全生物兼容性。Antartik 醫(yī)用海綿Antartik Sponge 是由羥基磷灰石和磷酸三鈣，外加一類和三類膠原蛋白組成人工骨填充物。國食藥監(jiān)

3、械(進(jìn))字第3464652號第1頁Atlantik 含抗生素型人工骨可替換骨填充物與慶大霉素相結(jié)合人工骨系列Atlantik Genta 是由 70%羥基磷灰石和30%磷酸三鈣，外加慶大霉素合成人工骨。它適合用于外傷或外殼手術(shù)中骨缺損填充手術(shù)，其中包含： 關(guān)節(jié)置換術(shù) 脊椎手術(shù) 閉合手術(shù) 切骨術(shù) 腫瘤切除術(shù)后填充這款產(chǎn)品尤其推薦于抵制細(xì)菌對慶大霉素敏感出現(xiàn)風(fēng)險。產(chǎn)品性能Atlantik Genta 人工骨擁有優(yōu)化孔隙率和表面，促使快速骨再生和良好骨整合。我們?nèi)斯す遣牧辖Y(jié)構(gòu)擁有兩種不一樣孔隙率，兩種孔隙率之間完全連接使宏觀空隙促進(jìn)了細(xì)胞滲透，而微觀孔隙率增加與生物體液接觸面。Atlantik Ge

4、nta 人工骨顆粒狀能夠?qū)?fù)雜形態(tài)骨缺損空腔進(jìn)行填充，使外科醫(yī)生在手術(shù)中效率大大提升。Atlantik Genta 人工骨包含 150 毫克慶大霉素，在手術(shù)后數(shù)小時內(nèi)，慶大霉素將逐步擴(kuò)散到手術(shù)執(zhí)行區(qū)域。 釋放不少于 48 小時，以預(yù)防任何細(xì)菌產(chǎn)生耐藥性風(fēng)險。 慶大霉素常規(guī)治療劑量（3 毫克/千克）適合用于 50 千克以上體重患者。 釋放數(shù)劑量與均勻釋放率到達(dá)局部高效濃度（遠(yuǎn)高于細(xì)菌對慶大霉素感最低殺菌濃度*）。當(dāng)與血清混合后在使用期限內(nèi)產(chǎn)生峰值（圖 1）) *CMB：最低殺菌濃度載藥材料設(shè)計參考。第2頁Antartik Inject 50%磷酸三鈣和 50%羥基磷灰石組成，外加增塑劑。此產(chǎn)品由

5、兩種不一樣結(jié)構(gòu)混合而成（液體狀和粉末狀）使用時操作視頻：/index.php/zh/liste-des-produits/substituts-osseux-synthetiques/antartikinject注射材料設(shè)計參考。骨水泥使用設(shè)計詳見：MEDICALBIOMAT AntartikInjectableEN-CN第3頁Bi-Ostetic Slow Resorbtion Bone FillerBi-Ostetic is a cost-effective synthetic bone filler tailored for slow resorbtion. Based on Trica

6、lcium Phosphate (TCP) and Hydroxyapatite (HAP), its composition mimics that of human bone. Berkeley Advanced Biomaterials, Inc. formulates the chemistry and microstructure of Bi-Ostetic to enhance bone regeneration. This formulation provides optimal osteo-conduction. The spongy Bi-Ostetic bioceramic

7、 granules with true interconnected porosity resemble cancellous bone chips. The structure enhances osteo-conduction and ensures complete bone in-growth.Common use of Bi-OsteticDefect filling in total hip revisionSpinal fusionHand and foot surgeryFracture repairJoint reconstruction優(yōu)點(diǎn)：Safe and Biocomp

8、atibleEasy to use100% Synthetic Scaffold (composed of 60% HA and 40% -TCP)100% Resorbable and EffectiveOsteoconductive and biocompatibleRadiopaque（不透射線）Safe, sterilized by Gamma irradiation有很完整臨床試驗圖片能夠參考，詳見鏈接網(wǎng)址。/Berkeley Advanced Biomaterials, Inc.(美國)/國食藥監(jiān)械(進(jìn))字第3463438號第4頁Bi-Ostetic Foam Excellent

9、BiocompatibilityBi-Ostetic Foam is a sterile bone graft composed of highly purified fibrillar Type I bovine collagen and Bi-Ostetic resorbable 60% hydroxyapatite and 40 % tricalcium phosphate granules. Bi-Ostetic Foam is safe and has excellent biocompatibility. After it is implanted, it resorbs and

10、is later replaced by natural bone. Bi-Ostetic Foam is a safe choice for sparing patients the trauma of autograft harvesting. Common Use of Bi-Ostetic FoamTreatment of bone fractures and traumatic osseous defects in:Extremities of the skeletal systemSpinePelvis（盆骨）Safe and BiocompatibleEasy to UseCol

11、lagen and Synthetic ScaffoldResorbable and EffectiveOsteoconductive and BiocompatibleBiodegradableRadiopaqueSafe, Sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美國)/第5頁Cem-OsteticOptimal Bone GenerationCem-Ostetic is a neutral pH bone putty that contains calcium-based biocompati

12、ble calcium salts that have been used for decades in orthopedic surgery. These materials are often used to provide an additional source of bone to help the patient heal faster. Berkeley Advanced Biomaterials, Inc. formulates the chemistry and microstructure to enhance bone regeneration, provide opti

13、mal osteo-conduction and reduce the time for the bone to regain its full health. Cem-Ostetics unique putty formula sets up quickly with marginal exothermic reaction (less than 4C).Cem-Ostetic is available in Putty, Injection Kit, Granules and Block. Common use of Cem-OsteticJoint reconstructionSpina

14、l fusionHand and foot surgeryFracture repairSafe and BiocompatibleEasy to use Quick to prepare (5 minutes)100% Synthetic (Calcium Salts Scaffold, including nanocrystalline hydroxyapatite)100% Resorbable and Effective (three to four months in animal tests and clinical studies)Osteoconductive, biocomp

15、atible and neutral pHSafe, sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美國)/第6頁GenerOsFor a complete bone in-growthGenerOs is an osteoconductive bone void filler composed of -tri-calcium phosphate (TCP). Once implanted, GenerOs provides a scaffold that stimulates the formation

16、 of the bone. GenerOs then resorbs and is later replaced by natural bone.GenerOs is provided in granules which porosity resembles the patients bone. Its structure enhances osteoconduction and ensures complete bone in-growth.Common use of GenerOsDefect filling in total hip revisionSpinal fusionHand a

17、nd foot surgeryFracture repairJoint reconstructionCyst treatmentLimb salvage Safe and BiocompatibleEasy to use100% Synthetic Scaffold100% Resorbable and EffectiveOsteoconductive and biocompatibleRadiopaqueSafe, sterilized by Gamma irradiationBerkeley Advanced Biomaterials, Inc.(美國)/GenerOsGranules -

18、 Instruction for UseMaterialsGenerOs is composed of beta-tricalcium phosphate (TCP). TCP has been the topic of extensive clinical studies for several decades. GenerOs is safe and has excellent biocompatibility. After it is implanted, the implant resorbs and is later replaced by natural bone. GenerOs

19、 is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission.Indications-For-UseGenerOs is an osteoconductive bone substitute shaped as granules (can

20、cellous, cortical or cortico-cancellous) that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium.The granules may be pressed into the void or into the surgical

21、site by hand. The GenerOs granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. GenerOs is biocompatible and resorbs in the body as bone ingrowth occurs.第7頁D

22、emineralized Bone MatrixQuick revascularizationDemineralized Bone Matrix (DBM) is produced from ground cortical bone and contains osteoinductive proteins. It is intended to be used to fill bone defects and cavities.The increased activity of DBM is assumed to be attributed to the osteoinductive prote

23、ins activity.DBM can be used to augment autologous cancellous or corticocancellous grafts.It may also be an alternative for a patient who has no autologous bone available for use as a graft or for a patient who does not wish to undergo an extensive open procedure or for whom open procedure carries a

24、 very high risk.Common use of Demineralized Bone MatrixCranio-facial surgerySpinal fusionHand and foot surgeryFracture repairJoint reconstructionCase StudiesThese Case Studies (D1, D2 and D3) introduce the treatment using DBM and the postoperative results in patients presenting back pain, lumbar sco

25、liosis and lumbar radiculopathy. Those cases demonstrate the potential for use of DBM as a bone graft substitute: after few months, the use of DBM demonstrate that spine fusion is safe and effective.SafeEasy to use and quick to prepare (rehydrated in 5 minutes)Safe, sterilized by gamma irradiationDo

26、nor tissue recovered, processed and distributed by TBI/Tissue Banks International National Processing Center (an AATB-accredited tissue bank). Berkeley Advanced Biomaterials, Inc.(美國)/第8頁NovaBone（美國）并未公布組成/NB/orthopedic.htmlNovaBone PariculateThe particulate formulation provides users with a small (

27、90-710m) granular graft that readily mixes with local bone or blood, forming a slurry that can be packed into a defect.As new bone generation occurs, the material is resorbed by the body.ENGINEERED BONE REGENERATION特點(diǎn)：NovaBone Particulate Formulated for Small Graft AreasMixes easilyExceptional handl

28、ing and placementIdeal for smaller voids（空隙） and defectsNovaBone PuttyNovaBone Putty is a versatile bone graft substitute that is ready to use out of the package with exceptional handling characteristics that will save time and improve placement.The specially formulated consistency means it can be p

29、acked into any size or shape void without sticking to surgical gloves. The binder resists migration during irrigation allowing the bioactive component to stay as placed.Exceptional Handling CharacteristicsHighly malleable（可塑性）, easy to mold and pack into any defectStays at the surgical siteWill not

30、migrate during irrigationReady to use out of the packageDoes not stick to surgical gloves國食藥監(jiān)械(進(jìn))字第3632317號不過用于非口腔并未被引進(jìn)口腔用生物玻璃人工骨(商品名：倍骼生)第9頁NovaBone Bioactive StripNovaBone Bioactive Strip is a sterile bone graft composed of purified fibrillar collagen and resorbable bioactive calcium phospho- sili

31、cate granules. The open structure allows for rapid vascularization and mineralization and permits complete device absorption and replacement by new bone. NovaBone is the only graft that signals and recruits osteo progenitor cells while controlling the cell cycle to favor proliferation and differenti

32、ation of cells that generate new bone. NovaBonedemonstrated equivalent rates of bone growth when compared to autograft in clinical studiesCompression resistant formable Bioactive Bone Graft.Bioactive Synthetic Granules activating chemistry promotes bone formation and creates a highly Osteoconductive

33、 Matrix for new bone growth.Type I Collagen provides sites for cell and protein binding.Optimal composition and pore size designed to mimic cancellous bone.Hydrates rapidly in bone marrow aspirate.Ability to visualize bone graft placementNovaBone 企業(yè)幾款產(chǎn)品比較有參考價值，能夠重點(diǎn)參閱一下相關(guān)文件第10頁meta-biomed（韓國）/eng/Bon

34、eMedik第11頁meta-biomed（韓國）/eng/NT-Ceram第12頁meta-biomed（韓國）/eng/NT-Cem第13頁meta-biomed（韓國）/eng/DM-Bone第14頁meta-biomed（韓國）/eng/DM-Bone第15頁GENOSS（韓國）/ORTHOPEDIC OSTEON合成骨移植替換材料GenossORTHOPEDIC OSTEON具與人體骨骼類似結(jié)構(gòu)，是一個具骨傳導(dǎo)性合成骨骼，由Hydroxyapatite(HA)和-tricalcium phosphate (-TCP)組成。因為生物活性優(yōu)異且生物降解速度慢，HA scaffold從結(jié)構(gòu)

35、上可長時間支撐。在HA scaffold上涂一層生物活性及吸收性優(yōu)異-TCP，從而實現(xiàn)早期骨融合及長久支撐作用。適用范圍：在進(jìn)行骨損壞、損失、矯正等骨科手術(shù)時，移植所需骨部位，并促進(jìn)骨骼再生。-填充并重組骨折造成骨損壞部位- 依據(jù)假關(guān)節(jié)有沒有骨缺失部位- 進(jìn)行脛骨骨折手術(shù)時-進(jìn)行關(guān)節(jié)整形術(shù)、矯正術(shù)或其它特定部位矯正術(shù)時- 使用于關(guān)節(jié)穿刺、口腔頜面外科、牙周科等ORTHOPEDIC OSTEON II合成骨移植替換材料GenossORTHOPEDIC OSTEON II為高-TCP含量骨傳導(dǎo)性合成骨移植材料。結(jié)構(gòu)上與海綿骨類似，經(jīng)過提升-TCP含量幫助快速吸收，從而促進(jìn)新骨形成。第16頁GENO

36、SS（韓國）主要是人工骨和再生膜/ORTHOPEDIC OSTEONII Collagen合成骨移植替換材料Orthopedic OSTEON II Collagen是為修復(fù)或再生骨缺失部位而開發(fā)骨移植生物材料，由具優(yōu)異骨傳導(dǎo)性合成骨材料OSTEON II和Type I膠原蛋白組成。適用范圍：在進(jìn)行骨損壞、損失、矯正等外科手術(shù)時，移植所需骨部位，并促進(jìn)骨骼再生。-填充并重組骨折造成骨損壞部位- 依據(jù)假關(guān)節(jié)有沒有骨缺失部位- 進(jìn)行脛骨骨折手術(shù)時-進(jìn)行關(guān)節(jié)整形術(shù)、矯正術(shù)或其它特定部位矯正術(shù)時使用于關(guān)節(jié)穿刺（E.N.T）、口腔頜面外科等特點(diǎn)：- 涂有一層膠原蛋白，易于操作， 并可縮短手術(shù)時間-在濕潤

37、狀態(tài)下可變形為各種形狀- 在提升早期操作簡易度后，膠原蛋白將吸收到人體內(nèi)- 空間保持功效及新骨形成功效優(yōu)異- 止血作用國械注進(jìn)3461730第17頁GENOSS（韓國）/OSTEON合成骨移植材料- 100% 合成骨移植材料 = 涂有-TCPHA支架- OSTEON = HA 70% + -TCPOSTEON合成骨移植材料IIHA和-TCP之比為30:70合成骨移植材料第18頁第19頁GENOSS（韓國）/NEWBONE 合成骨移植材料GENOSS NEWBONE為具骨傳導(dǎo)性合成骨移植材料，由20%Hydroxyapatite (HA)和80%-tricalcium phosphate (-T

38、CP)組成。0.22.0mm大小范圍多空型粒子包裝于小瓶或注射器中，經(jīng)伽馬射線滅菌后供給。第20頁STRYKERhttp:/en-us/products/Orthobiologicals/index.htm#該企業(yè)產(chǎn)品較多，其中Vitoss Strip能夠重點(diǎn)參考一下。不過并未公布產(chǎn)品組成信息，能夠參考其參考文件，了解一下第21頁Wright/healthcare-professionals/biologics第22頁Allosource/ALLOFUSE DBM GEL & PUTTYAlloFuse DBM Gels, Pastes and Putties are unique bone

39、graft substitutes composed of demineralized bone matrix in a reverse phase medium. This distinctive reverse phase medium becomes more viscous at warm temperatures to provide exceptional handling characteristics. AlloFuse DBM Gel and Putty are available in a variety of sizes第23頁Iso Tis/family/isotis/

40、IsoTis Mozaik MorselsOur IsoTis Mozaik morsels form a moldable putty when hydrated with bone marrow aspirate. -TCP granules are larger than those in our putty configuration, adding additional volume.Key FeaturesAdvanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified

41、 -TCP, the matrix was developed to resemble the composition and pore structure of natural human bone. The resorption rate is consistent with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins tha

42、t play an important role in bone formation.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第24頁Iso Tis/family/isotis/IsoTis Mozaik PuttyOur IsoTis

43、Mozaik putty is a compression-resistant, osteoconductive scaffold composed of purified collagen and -TCP. The matrix readily hydrates with bone marrow aspirate.Key FeaturesAdvanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified -TCP, the matrix was developed to rese

44、mble the composition and pore structure of natural human bone. The resorption rate is consistent with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins that play an important role in bone format

45、ion.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第25頁Iso Tis/family/isotis/IsoTis Mozaik StripOur IsoTis Mozaik strip is a compression-resistant

46、, osteoconductive scaffold composed of purified collagen and -TCP. The matrix readily hydrates with bone marrow aspirate.Key FeaturesClinical Evidence - Equivalent fusion performance to autograft has been demonstrated in a retrospective study on posterolateral lumbar fusion. The study found 100% fus

47、ion in all one- and two-level procedures, with an overall fusion rate of 90%.Advanced Engineering - With a blend of 20% type 1 bovine collagen and 80% highly purified -TCP, the matrix was developed to resemble the composition and pore structure of natural human bone. The resorption rate is consisten

48、t with the formation of new bone.Carrier for Cells and Proteins - An interconnected pore structure absorbs bone marrow aspirate, which contains cells and proteins that play an important role in bone formation.Compression Resistance - A matrix with compression resistance has an increased ability to r

49、etain bone marrow aspirate within the matrix.Radiographic Visualization - The -TCP component provides radiographic visualization of graft placement.Terminal Sterilization - As the last step in manufacturing, the scaffold is terminally sterilized.第26頁Regeneration Technologies/en_us/products/category/

50、cardiothoracic參考文件：Ahn, E. & Webster, T. Enhanced Osteoblast & Osteoclast Function on nanOss a Calcium Phosphate Nanotechnology. . *Research and Development, Pioneer Surgical Technology, Greenville, NC & Woburn, MA. Study sponsored by Pioneer Surgical.*C. Lauryssen MD*, S. Robbins MD* & M. Songer MD

51、*. Lumbar Spinal Fusion Results Using nanOss: One Year Follow-Up. *Served as clinical evaluator/consultant of nanOss in posterolateral spine fusion and compensated for time summarizing patient oucomes, also were shareholders or option holders of Pioneer Surgical stock at the time they authored the s

52、tudy. 第27頁BioAlpha Inc. （韓國）/intro/idea.asp主要產(chǎn)品特點(diǎn)是：三維網(wǎng)狀結(jié)構(gòu)、高孔隙率、骨傳導(dǎo)國食藥監(jiān)械(進(jìn))字第3460914號(更)第28頁北京奧精醫(yī)藥科技有限企業(yè)/cn/index.aspx產(chǎn)品名注冊號組成及規(guī)格適用范圍備注人工骨修復(fù)材料國食藥監(jiān)械(準(zhǔn))字第3461579號該產(chǎn)品主要由I型膠原蛋白和羥基磷灰石組成,形狀為圓柱體、長方體、梯形體或顆粒狀。該產(chǎn)品經(jīng)射線滅菌,一次性使用。人工骨材料是一個新型生物礦化骨修復(fù)材料，國內(nèi)首創(chuàng)、國際領(lǐng)先，臨床中與骨髓混合，成骨愈合效果與自體骨相同。礦化膠原是骨組織主要成份之一，能為鈣化組織結(jié)構(gòu)提供必不可少三維結(jié)構(gòu)，

53、并為成骨細(xì)胞黏附、增殖及發(fā)揮成骨作用提供良好微環(huán)境，人工骨修復(fù)材料模仿了天然骨成份和微結(jié)構(gòu)特征，使其本身具備了與骨鍵合能力，使其在新骨形成過程中被吸收轉(zhuǎn)化為新骨主要成份。人工骨修復(fù)材料適用范圍：骨科、齒科和神經(jīng)外科。骼金第29頁上海瑞邦生物材料有限企業(yè)/瑞邦同類產(chǎn)品較多，可做參考第30頁一、產(chǎn)品性能上海瑞邦生物材料有限企業(yè)自固化型磷酸鈣人工骨產(chǎn)品（瑞邦骨泰），又稱CPC，是國際上八十年代中期開始臨床應(yīng)用非陶瓷型羥基磷灰石類人造骨材料。它由磷酸鈣粉末和固化液兩部分組成，使用時將二者按一定百分比調(diào)和后呈膏體狀，填充于骨缺損處，并可依據(jù)骨缺損處解剖要求隨意修整，到達(dá)準(zhǔn)確修復(fù)骨缺損目標(biāo)。它克服了羥基磷

54、灰石（HAP）陶瓷燒結(jié)、修整困難缺點(diǎn)，防止了陶瓷與骨之間密接性差，易于造成纖維組織介入生長而影響界面結(jié)合強(qiáng)度不足。同時CPC硬化過程基本不放熱，不會引發(fā)周圍組織損傷。利用特定百分比固化液調(diào)和后漿體優(yōu)良流動性，可用注射器將其注射到待填充修復(fù)部位，實現(xiàn)在填充部位原位固化。固化后其最終成份轉(zhuǎn)化為人體無機(jī)成份羥基磷灰石。二、物理性能凝結(jié)時間：15-18min固化體抗壓強(qiáng)度：35MPa內(nèi)部孔徑：10m孔隙率：40%三、產(chǎn)品規(guī)格注射型骨泰3.8克，7.6克四、使用方法CPC用于椎體，可采取常規(guī)切開注射及經(jīng)皮微創(chuàng)注射（PVP、PKP詳細(xì)操作參見后面附文）等 方法：常規(guī)手術(shù)前準(zhǔn)備；將穿刺針預(yù)置于待注射椎體（P

55、VP需在C臂機(jī)或CT導(dǎo)引下定位）；依據(jù)缺損部位大小，選擇適當(dāng)包裝劑量；將粉末同固化液按已配好百分比（一包粉末配一支固化液）在20ml消毒注射器內(nèi)充分調(diào)和成較牙膏略稀漿體，再轉(zhuǎn)注入1ml或2ml小注射器中備用；將注滿CPC漿體注射器與穿刺針相連接，隨即遲緩加壓，將漿體注射到待填充部位，充填滿意后停頓并統(tǒng)計，通常椎體一側(cè)注射6-10ml（PVP需在C臂機(jī)或CT監(jiān)視下進(jìn)行）；充填部位內(nèi)壓較高時，可選取加壓注射器，應(yīng)在注射前對充填部位預(yù)作處理；注射前應(yīng)排空注射器內(nèi)空氣。第31頁自固化磷酸鈣人工骨粉末產(chǎn)品使用方法：（10克可填充約4立方厘米）使用前先檢驗產(chǎn)品（粉末及固化液）有沒有破損。使用調(diào)和器材有否嚴(yán)

56、格無菌消毒，凡不合格者切勿使用。填充前，將粉末及固化液充分混合后調(diào)成軟硬適中面團(tuán)狀。普通一袋粉末配一包固化液，若固化液浪費(fèi)，則調(diào)和糊狀物過干過硬，須開啟備用固化液，酌量加入，防止過稀不成形。對待填充部位降低滲血滲液，如用紗布填塞，纖維蛋白酶止血劑或明膠海綿等。用含40-45生理鹽水?dāng)Q干熱紗布敷蓋15分鐘，在此時間內(nèi)調(diào)換2-3次以維持溫度，加速材料固化。關(guān)閉傷口前，用紗布敷蓋人工骨，清洗創(chuàng)面。關(guān)閉創(chuàng)面，滲血滲液多區(qū)域用負(fù)壓引流管引流，降低創(chuàng)面滲液和積留對材料固化影響。自固化磷酸鈣人工骨粉末一、產(chǎn)品性能上海瑞邦生物材料有限企業(yè)自固化型磷酸鈣人工骨產(chǎn)品（瑞邦骨泰），又稱CPC，是國際上八十年代中期開

57、始臨床應(yīng)用非陶瓷型羥基磷灰石類人造骨材料。它由磷酸鈣粉末和固化液兩部分組成，使用時將二者按一定百分比調(diào)和后呈膏體狀，填充于骨缺損處，并可依據(jù)骨缺損處解剖要求隨意修整，到達(dá)準(zhǔn)確修復(fù)骨缺損目標(biāo)。它克服了羥基磷灰石（HAP）陶瓷燒結(jié)、修整困難缺點(diǎn)，防止了陶瓷與骨之間密接性差，易于造成纖維組織介入生長而影響界面結(jié)合強(qiáng)度不足。同時CPC硬化過程基本不放熱，不會引發(fā)周圍組織損傷。二、物理性能凝結(jié)時間：315min固化體抗壓強(qiáng)度：35Mpa內(nèi)部孔徑：10m孔隙率：30%三、產(chǎn)品規(guī)格粉末型骨泰：2克，5克，10克第32頁一、產(chǎn)品性能上海瑞邦生物材料有限企業(yè)自固化型磷酸鈣人工骨產(chǎn)品（瑞邦骨泰），又稱CPC，是國

58、際上八十年代中期開始臨床應(yīng)用非陶瓷型羥基磷灰石類人造骨材料。它由磷酸鈣粉末和固化液兩部分組成，使用時將二者按一定百分比調(diào)和后呈膏體狀，填充于骨缺損處，并可依據(jù)骨缺損處解剖要求隨意修整，到達(dá)準(zhǔn)確修復(fù)骨缺損目標(biāo)。它克服了羥基磷灰石（HAP）陶瓷燒結(jié)、修整困難缺點(diǎn)，防止了陶瓷與骨之間密接性差，易于造成纖維組織介入生長而影響界面結(jié)合強(qiáng)度不足。同時CPC硬化過程基本不放熱，不會引發(fā)周圍組織損傷。利用特定百分比粉末，抗生素與固化液調(diào)和后制成載藥型骨泰，填充于病灶區(qū)域，遲緩釋放藥品，維持病灶區(qū)藥品高濃度，最終有效控制與治愈感染，同時CPC可有效傳導(dǎo)成骨。使用方法方法一：粉末加藥：是在手術(shù)過程中，用CPC粉末現(xiàn)場調(diào)制成CPC載藥顆粒。詳細(xì)操作方法以下：第一步，依據(jù)病灶腔大小，取適量CPC粉末，倒在調(diào)試皿上，按5%百分比混合藥品粉末；第二步，計量注入固化液，調(diào)和，制成CPC載藥顆粒（做載藥顆粒是為了增加顆粒表面積，有利藥品釋放），并將制好載藥顆粒用40左右溫紗布包裹2