YINTONI I-BIOMATERIALS ?

I-Biomatariya nazo naziphi na izinto, zendalo okanye ezenziwe ngumntu, ezibandakanya ngokupheleleyo okanye inxalenye yesakhiwo esiphilayo okanye isixhobo sebhayoloji esenza, eyongeza, okanye ebuyisela umsebenzi wendalo. I-Biomaterials zizinto ezingenakusebenza ezisetyenziswa kwizixhobo zonyango, ngoko ke zenzelwe ukunxibelelana nenkqubo yezinto eziphilayo. Ezi zixhobo zilungiselelwe izicelo zonyango. I-Biomaterials inokuba nomsebenzi onobungozi, njengokusetyenziswa kwevalve yentliziyo. I-Biomatariyali zikwasetyenziswa kwizicelo zamazinyo, utyando, kunye nokuhanjiswa kweziyobisi (ulwakhiwo olunemveliso yoxubo lwamayeza olumiliselweyo lunokufakwa emzimbeni, oluvumela ukukhutshwa kwexesha elide kwechiza kwithuba elide lexesha). I-biomaterials ayithintelwanga kuphela kwizinto ezenziwe ngabantu ezenziwe ngesinyithi okanye i-ceramics. I-biomaterial isenokuba yi-autograft, i-allograft okanye i-xenograft esetyenziswa njengemathiriyeli yokutshintshwa.

Ezinye izinto ezisetyenziswayo zebhayomatariya zezi:

• Iipleyiti zethambo, iipleyiti ezidityanisiweyo, Isamente yethambo

• Imigqa yokwenziwa kunye nemisipha

• Ezinye izifakelo zamazinyo

• Iivalve zentliziyo

• Iiprothesi zemithambo yegazi

• Izixhobo zokulungisa ulusu

• Ukufakelwa kwebele

• Iilensi zokujonga

I-Biomaterials kufuneka ihambelane nomzimba, kwaye kuhlala kukho imiba ye-biocompatibility. Imiba enjalo yokungahambelani kufuneka isonjululwe phambi kokuba imveliso ibekwe emarikeni. Kukho iimfuno ezingqongqo zolawulo lwebhayomatariya. Iinkampani zokuvelisa ezisebenza ngebhayomatariya nazo ziyafuneka ukuba ziqinisekise ukulandeleka kwazo zonke iimveliso zazo ukuze ukuba kufunyaniswe imveliso enesiphene, ezinye zikwibhetshi enye zinokulandelelwa ngokukhawuleza.

 

I-Biocompatibility ye-biomaterials kwiindawo ezahlukeneyo phantsi kweekhemikhali ezahlukeneyo kunye neemeko zomzimba ziyimfuneko. I-Biocompatibility inokubhekisa kwiipropathi ezithile zemathiriyeli ngaphandle kokuchaza ukuba iza kusetyenziswa phi okanye njani imathiriyeli. Ngokomzekelo, izinto eziphathekayo zingenza impendulo encinci okanye ingabikho kwi-immune kwi-organism enikeziweyo, kwaye ingakwazi okanye ingakwazi ukudibanisa nohlobo oluthile lweseli okanye izicubu. Izixhobo zonyango kunye neeprostheses zihlala zenziwe ngezinto ezininzi, ngoko ke akunakuhlala kwanele ukuthetha malunga nokuhambelana kwebhayoloji yemathiriyeli ethile.

 

Kwakhona, imathiriyeli akufuneki ibe yityhefu ngaphandle kokuba yenziwe ngokukhethekileyo ukuba ibe njalo. Umzekelo ziinkqubo zokuhanjiswa kweziyobisi ezikrelekrele ezijolise kwiiseli zomhlaza kwaye zizitshabalalise. Ukuqondwa ngokucokisekileyo kwe-anatomy kunye ne-physiology yendawo yesenzo kubalulekile ukuze i-biomaterial isebenze. Ngoko ke kubalulekile, ngexesha loyilo, ukuqinisekisa ukuba ukuphunyezwa kuya kuncedisa kwaye kube nefuthe elinenzuzo kunye nommandla othile we-anatomical wesenzo.

 

Ii-Biopolymers ziveliswa kwizinto eziphilayo. I-cellulose kunye nesitashi, iiprotheni, i-peptides, kunye ne-DNA kunye ne-RNA yimizekelo ye-biopolymers, apho iiyunithi ze-monomeric, ngokulandelanayo, zishukela, i-amino acids, kunye ne-nucleotides. I-cellulose yeyona nto ixhaphakileyo ye-biopolymer kunye neyona khompawundi ixhaphakileyo emhlabeni. Ezinye ii-biopolymers ziyakwazi ukubola. Oko kukuthi, badityaniswe phantsi kwi-CO2 kunye namanzi ngama-microorganisms. Ezinye zezi biopolymers zebhayoloji ziyavundiswa, zinokufakwa kwinkqubo yokwenziwa komgquba kwimizi-mveliso kwaye ziya kuhla nge-90% kwiinyanga ezi-6. Ii-Biopolymers ezenza oku zinokumakishwa ngesimboli "esivundisiweyo". Ukupakishwa okuphawulwe ngolu simboli kunokufakwa kwiinkqubo zokwenziwa komgquba kwimizi-mveliso ukuze kuphulwe kwiinyanga ezi-6 okanye ngaphantsi. Umzekelo wepolymer evundisiweyo yifilimu ye-PLA phantsi kobunzima obuthile. Iifilimu ze-PLA ezityebileyo kunoko azifaneleki ukuba zivundiswe, nangona zinokonakala. Umgquba wasekhaya unokwenza ukuba abathengi bakwazi ukulahla iipakethe ngqo kwimfumba yabo yomgquba.

 

IINKONZO ZETHU

Sinikezela ngoyilo, uphuhliso, uhlalutyo kunye neenkonzo zovavanyo ezixhasa uphuhliso kunye nolwamkelo lwentengiso yezixhobo zonyango kunye nendibaniselwano yesixhobo samachiza, ukubonisana, ubungqina obuchwephesha kunye neenkonzo zokumangalela.

 

Uyilo kunye noPhuhliso lweBiomaterials

Uyilo lwethu lwe-biomaterials kunye neenjineli zophuhliso kunye neenzululwazi zinobuchule bokuyila kunye nokuvelisa i-biomaterials kubenzi abakhulu be-IVD abaneziphumo eziqinisekisiweyo kwiikiti zokuxilonga. Izicubu zebhayoloji zilungelelaniswe ngaphakathi kwizikali ezininzi, zenza imisebenzi emininzi yesakhiwo kunye neyomzimba. I-biomaterials isetyenziselwa ukufaka indawo yezicubu zebhayoloji kwaye ngoko ke kufuneka ziyilwe ngendlela efanayo. Iingcali zethu zezifundo zinolwazi kunye nobuchule kwiinkalo ezininzi zenzululwazi zezi zinto zinzima kunye nokusetyenziswa okubandakanya ibhayoloji, i-physiology, i-mechanics, ukulinganisa amanani, i-chemistry yomzimba ... njl. Ubudlelwane babo obusondeleyo kunye namava ngophando lweklinikhi kunye nokufikelela ngokulula kwiimpawu ezininzi kunye nobuchule bokubonwayo zizinto zethu ezixabisekileyo.

 

Enye indawo enkulu yoyilo, "i-Biointerfaces" ibaluleke kakhulu kulawulo lwempendulo yeseli kwi-biomaterials. Iimpawu ze-Biochemical kunye ne-physico-chemicals ze-biointerfaces zilawula ukunamathela kweeseli kwi-biomaterials kunye nokuthathwa kwe-nanoparticles. Iibhrashi zePolymer, amatyathanga epolymer ancanyatheliswe kwelinye icala kuphela kwi-substrate engaphantsi zizinto zokwaleka ukulawula ezo ntlobo ze-biointerfaces. Ezi zogquma zivumela ukuthungwa kweempawu zephysico-chemical of biointerfaces ngokulawula ukutyeba kwazo, ukuxinana kwetsheyini kunye nekhemistry yeeyunithi zazo eziphindaphindayo kwaye zinokusetyenziswa kwisinyithi, iiseramikhi kunye neepholima. Ngamanye amazwi, zivumela ukulungiswa kweepropathi ze-bioactive zoluhlu olubanzi lwemathiriyeli, nokuba zingakanani na kunye nekhemistri yomphezulu. Iinjineli zethu ze-biomaterial ziye zafunda ukunamathela kwiprotheyini kunye nokusebenzisana kwiibhrashi zepolymer, ziye zaphanda iimpawu ze-biofunctional ze-biomolecules ezidityaniswe neebrashi ze-polymer. Izifundo zabo ezinzulu ziye zaba luncedo kuyilo lweengubo zokufakelwa, iisistim zenkcubeko ye-in vitro cell kunye noyilo lokuhambisa imfuza.

 

Ijometri elawulwayo luphawu lwendalo lwezicubu kunye namalungu kwi-vivo. Ubume bejometri yeeseli kunye nezicubu kwizikali zobude obuninzi zibalulekile kwindima kunye nomsebenzi wazo, kunye nophawu lwezifo ezinjengomhlaza ngokunjalo. I-In vitro, apho iiseli ziyinkcubeko kwizitya zeplastiki zovavanyo, olu lawulo lwejometri luhlala lulahlekile. Ukwakhiwa kwakhona kunye nokulawula ezinye iimpawu zejometri zeenkqubo zebhayoloji kwi-vitro kubalulekile kuphuhliso lwe-scaffolds yobunjineli bezicubu kunye noyilo lwee-assays ezisekelwe kwiiseli. Kuya kuvumela ulawulo olungcono lwe-phenotype yeseli, ukwakhiwa kweqondo eliphezulu kunye nomsebenzi, oyimfuneko ekulungisweni kwezicubu. Oku kuya kuvumela ubungakanani obuchanekileyo ngakumbi beseli kunye nokuziphatha kwe-organoid kwi-vitro kunye nokumiselwa kokusebenza kwamachiza kunye nonyango. Iinjineli zethu ze-biomaterials ziye zaphuhlisa ukusetyenziswa kwezixhobo zepateni kwimilinganiselo yobude obuhlukeneyo. Ezi ndlela zokwenza iipateni kufuneka zihambelane ngokupheleleyo nekhemistri ye-biomaterials apho la maqonga asekelwe khona, kunye neemeko ezifanelekileyo zenkcubeko yeeseli.

 

Mininzi eminye imiba yoyilo kunye nophuhliso eziye zasebenza iinjineli zethu zebhayiloji kuyo yonke imisebenzi yazo. Ukuba ungathanda ulwazi oluthile malunga nemveliso ethile nceda uqhagamshelane nathi.

 

Iinkonzo zoVavanyo lweBiomaterials

Ukuyila, ukuphuhlisa nokuvelisa iimveliso ze-biomaterial ezikhuselekileyo nezisebenzayo, ngelixa uhlangabezana neemfuno zolawulo logunyaziso lokuthengisa, uvavanyo lwebhubhoratri eyomeleleyo luyafuneka ukuze kuqondwe imiba enxulumene nokhuseleko lwemveliso, njengokutyekela kweemveliso ze-biomaterial zokukhupha izinto ezivuzayo, okanye ukusebenza. iikhrayitheriya, ezifana neempawu zoomatshini. Sinokufikelela kuluhlu olubanzi lwezakhono zokuhlalutya ukuze siqonde ubuni, ukucoceka, kunye nokhuseleko lwebhayoloji yenani elikhulayo lezinto eziphilayo ezisetyenziswa kwiimveliso zonyango ngokusebenzisa umzimba, imichiza. , oomatshini, kunye neendlela zokuvavanya i-microbiological. Njengenxalenye yomsebenzi wethu sinceda abavelisi bavavanye ukhuseleko lwezixhobo ezigqityiweyo kunye nokuxhasa ukubonisana nge-toxicological. Sinikezela ngeenkonzo zokuhlalutya ukuxhasa uphuhliso lwemveliso kunye nolawulo lomgangatho wemathiriyeli ekrwada kunye neemveliso ezigqityiweyo. Sinamava ngeentlobo ezininzi zezinto eziphilayo ezifana nolwelo, iijeli, iipolima, isinyithi, iiseramikhi, i-hydroxyapatite, i-composites, kunye nezinto ezifumaneka kwibhayoloji ezifana necollagen, chitosan, peptide matrices, kunye nealginates. Olunye uvavanyo olukhulu esinokuluqhuba lu:

• Ubume bekhemikhali kunye nohlalutyo olusisiseko lwe-biomaterials ukufikelela ukuqonda okubanzi kwemveliso yokungeniswa kolawulo kunye nokuchongwa okanye ubungakanani bezinto ezingcolisayo okanye iimveliso ezithotyiweyo. Sinofikelelo kwiilebhu ezixhotyiswe ngoluhlu olubanzi lobuchule bokumisela ukwakheka kweekhemikhali, ezinje nge-infrared spectroscopy (FTIR, ATR-FTIR) uhlalutyo, i-nuclear magnetic resonance (NMR), ubungakanani bokungabandakanywa kwechromatography (SEC) kunye neplasma edityanisiweyo. i-spectroscopy (ICP) ukuchonga kunye nokulinganisa ukubunjwa kunye nokulandelela izinto. Ulwazi olusisiseko malunga nomphezulu we-biomaterial lufunyenwe yi-SEM / EDX, kunye nezixhobo ezininzi nge-ICP. Obu buchule bunokuqaqambisa ubukho besinyithi esinokuba yityhefu efana nelothe, imekyuri kunye nearsenic ngaphakathi nakwibiomaterials.

• Ukubonakaliswa kokungcola kusetyenziswa i-laboratory-scale scale kunye noluhlu lwechromatography okanye i-mass spectrometry iindlela ezifana ne-MALDI-MS, i-LC-MSMS, i-HPLC, i-SDS-PAGE, i-IR, i-NMR kunye ne-fluorescence ... njl.

• Uhlalutyo lwepolymer yeBioomaterial ukubonisa isambuku semathiriyeli yepolymer kunye nokumisela iintlobo ezongezelelweyo ezifana neplastiki, imibala, i-anti-oxidants kunye nezihluzi, ukungcola okufana ne-monomers kunye ne-oligomers ezingaphendulwanga.

• Ukumiselwa kweentlobo zebhayoloji ezinomdla ezifana ne-DNA, i-Glycoaminoglycans, isiqulatho seprotheyini iyonke…njl.

• Uhlalutyo lwezinto ezisebenzayo ezifakwe kwii-biomaterials. Siqhuba izifundo zokuhlalutya ukuchaza ukukhutshwa okulawulwayo kwezi molekyuli ezisebenzayo ezifana ne-antibiotics, i-antimicrobials, i-polymers zokwenziwa kunye neentlobo ze-inorganic ezivela kwi-biomaterials.

• Siqhuba izifundo zokuchongwa kunye nobungakanani bezinto ezinokutsalwa kunye nezinokuvuza ezivela kwi-biomaterials.

• Iinkonzo ze-GCP kunye ne-GLP ze-bioanalytical ezixhasa zonke izigaba zophuhliso lwamachiza kunye ne-non-GLP yokufumanisa ngokukhawuleza isigaba se-bioanalysis

• Uhlalutyo olusisiseko kunye novavanyo lokulandelela isinyithi ukuxhasa uphuhliso lwamayeza kunye nokuveliswa kwe-GMP

• Izifundo zokuzinza kwe-GMP kunye nokugcinwa kwe-ICH

• Uvavanyo lwePhysical and morphological and characterization of biomaterials ezifana nobukhulu bepore, pore geometry kunye nokusabalalisa ubukhulu bepore, interconnectivity, kunye neporosity. Ubuchwephesha obufana ne-microscopy yokukhanya, i-electron microscopy (SEM) yokuskena, ukumiselwa kweendawo ezingaphezulu ngeBET zisetyenziselwa ukubonakalisa iimpawu ezinjalo. Iindlela ze-X-Ray diffraction (XRD) zisetyenziselwa ukufunda iqondo lecrystallinity kunye neentlobo zesigaba kwizinto. 

• Uvavanyo lomatshini kunye ne-thermal kunye nokuchazwa kweempawu ze-biomaterial kubandakanya uvavanyo lwe-tensile, uxinzelelo-uxinzelelo kunye nokusilela kovavanyo lokudinwa ngokuhamba kwexesha, ukubonakaliswa kweepropathi ze-viscoelastic (eziguqukayo zoomatshini) kunye nezifundo zokuhlola ukubola kweepropathi ngexesha lokuthotywa.

• Uhlalutyo lokungaphumeleli kwesixhobo sonyango, ukumiselwa konobangela

 

Iinkonzo zokucebisa

Sinokukunceda ukuhlangabezana neemfuno zempilo, zokusingqongileyo kunye nolawulo, ukwakha ukhuseleko kunye nomgangatho kwinkqubo yoyilo kunye nemveliso, kunye nokulungelelanisa iinkqubo zokuvelisa. Iinjineli zethu ze-biomaterials zinobuchule kuyilo, uvavanyo, imigangatho, ulawulo lwekhonkco lokubonelela, itekhnoloji, ukuthotyelwa kwemithetho, i-toxicology, ulawulo lweprojekthi, ukuphuculwa komsebenzi, ukhuseleko kunye nokuqinisekiswa komgangatho. Iinjineli zethu zokubonisana zinokumisa imiba ngaphambi kokuba zibe ziingxaki, zincede ukulawula kunye nokuvavanya imingcipheko kunye neengozi, zibonelele ngezisombululo ezitsha kwimiba entsonkothileyo, zicebise iindlela ezizezinye zoyilo, ziphucule iinkqubo kunye nokuphuhlisa ezona nkqubo zilungileyo zokuphucula ukusebenza kakuhle.

 

 

Iinkonzo zeeNgcali zamangqina kunye neeNkonzo zamaTyala

I-AGS-Engineering biomaterials iinjineli kunye nezazinzulu zinamava ekuboneleleni ngovavanyo lwelungelo elilodwa lomenzi wechiza kunye neentshukumo ezisemthethweni zetyala. Baye babhala i-Rule 26 yeengxelo zeengcali, bancedise ekwakhiweni kwebango, bafaka ubungqina kwi-deposition kunye novavanyo kwiimeko ezibandakanya iipolymers, izinto eziphathekayo, kunye nezixhobo zonyango ezinxulumene namatyala omabini kunye neemfanelo zemveliso.

 

Ukufumana uncedo ngoyilo, uphuhliso kunye novavanyo lwebhayomatariya, iingcebiso, ubungqina obuchwephesha kunye neenkonzo zesimangalo, qhagamshelana nathi namhlanje kwaye abaphandi bethu bebhayoloji bayakuvuyela ukukunceda.

 

Ukuba ubukhulu becala unomdla kubuchule bethu bokuvelisa ngokubanzi endaweni yobunjineli bobunjineli, sicebisa ukuba undwendwele indawo yethu yokwenza isikohttp://www.agstech.net

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I-FDA yethu kunye neemveliso zonyango ezivunyiweyo ze-CE zinokufumaneka ku imveliso yethu yezonyango, izinto ezisetyenziswayo kunye nesixhobo sendawo.http://www.agsmedical.com