TR201612824A1 - A NEW TOPICAL HEMOSTATIC AGENT - Google Patents
A NEW TOPICAL HEMOSTATIC AGENT Download PDFInfo
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- TR201612824A1 TR201612824A1 TR2016/12824A TR201612824A TR201612824A1 TR 201612824 A1 TR201612824 A1 TR 201612824A1 TR 2016/12824 A TR2016/12824 A TR 2016/12824A TR 201612824 A TR201612824 A TR 201612824A TR 201612824 A1 TR201612824 A1 TR 201612824A1
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- Turkey
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- hemostatic agent
- diatomite
- topical
- topical hemostatic
- bleeding
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Landscapes
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Abstract
Bu buluş, cilt yarıkları, vücut dışı yaralanmalar, travmatik kesikler, kendiliğinden ya da cerrahi girişimler sonrası oluşan minör ve majör kanamaların durdurulması için kullanılacak işlenmiş diatomit bileşiklerinden elde edilen yeni ve özgün bir topikal hemostatik ajan ile ilgilidir.The present invention relates to a novel topical hemostatic agent obtained from treated diatomite compounds for use in the treatment of skin cleft, extracorporeal injuries, traumatic cuts, spontaneous or minor surgical bleeding.
Description
TARIFNAME YENI BIR TOPIKAL HEMOSTATIK AJAN Teknik Alan Bu bulus, cilt yariklari, vücut disi yaralanmalar, travmatik kesikler, kendiliginden ya da cerrahi girisimler sonrasi olusan minör ve majör kanamalarin durdurulmasi için kullanilacak islenmis diatomit bilesiklerinden elde edilen yeni ve özgün bir topikal hemostatik ajan ile ilgilidir. Önceki Teknik Kontrol edilemeyen kanamalar askeri alanda ölümlerin yaklasik yarisini olusturmaktadir. DESCRIPTION A NEW TOPICAL HEMOSTATIC AGENT Technical Area This invention can be used for skin punctures, extracorporeal injuries, traumatic cuts, spontaneous or surgical Processed to be used to stop minor and major bleeding after interventions It relates to a novel and unique topical hemostatic agent derived from diatomite compounds. Prior Art Uncontrollable bleeding accounts for about half of deaths in the military field.
Saglik alaninda travmaya bagli ölümlerin ise ikinci nedenidir. Kanamalar; travmaya bagli yaralanma, savas ve afet yaralanmalari, kesici deliei alet yaralanmalari, burun kanamalari, yanik sonrasi kanamalar, gastrointestinal sistem kanamalari olarak karsimiza çikmaktadir. It is the second cause of death due to trauma in the field of health. Bleedings; traumatic injuries, war and disaster injuries, stab wounds, nosebleeds, Bleeding after burns is seen as gastrointestinal system bleeding.
Boyutu, nedeni ve sekli ne olursa olsun kanamalarin erken durdurulmasi önemlidir. Cerrahi islemler sirasinda olusan kanamalar da benzer sekilde ivedilikle müdahale gerektirir. Regardless of its size, cause and form, it is important to stop bleeding early. Surgical Bleeding that occurs during procedures also requires immediate intervention.
Hemostazdaki yetersizlik degisik kanaina komplikasyonlarina neden olabilir. Operasyon yerinden sizinti seklinde kanamadan transfuzyon ihtiyacina varan hatta hemorajik sokla organ fonksiyonlarini bozan ve nihayetinde hasta kaybiyla sonuçlanan kanamalarla karsilasilabilir. Insufficient hemostasis may cause complications of different blood vessels. Operation Organ that needs transfusion without bleeding in the form of leakage from its place or even with a hemorrhagic shock. It may be encountered with bleeding that disrupts its functions and ultimately results in the loss of the patient.
Vücut disina kanamalar en yaygin kanama seklidir. ABD”de travmaya bagli alti milyon ölümün üçte birini kanamaya bagli Ölümler olusturmaktadir. Kontrol altina alinamayan kanamalarda ölen hastalarin yarisi hastaneye ulasamamaktadir. Saglik ve askeri alanda travma nedeniyle olan kanamalara zamaninda ve dogru müdahale etmek önemlidir. Bleeding outside the body is the most common form of bleeding. Six million deaths from trauma in the United States One third of deaths are due to bleeding. In uncontrolled bleeding Half of the patients who die cannot reach the hospital. Due to trauma in health and military field It is important to intervene in bleeding in a timely and correct manner.
Kanama durdurueu ajanlar tüm dünyada yaygin olarak kullanilmaktadir. Kanama durdurueu ajanlarin biyouyumlu olmasi ve toksik olmamasi kanama durdurulduktan sonraki takiplerinde önemlidir. Tüm dünyada kanama durdurueular üzerinde en çok çalisma yapilan alanlardan biridir. Literatürde bilinen ve ticari olarak kullanilan kanama durdurueular asagidaki Tablo l”de özetlenmistir. Bleeding stopping agents are widely used all over the world. Bleeding is stopped Biocompatibility and non-toxicity of the agents in the follow-up after bleeding is stopped is important. It is one of the most studied areas on hemorrhoids all over the world. is one. The known and commercially used hemorrhage stoppers in the literature are shown in Table 1 below. is summarized.
HEMOSTATIK AJANLAR Ilaç l Bilesimi l Mekanizmasi l Avantajlari l Dezavantajlari Kompresyon ve tampon amaçli kullanilanlar Bone wax (Ethicon) Balmumui Tikaç, tampon Ucuz, hizli, Emilimi yoktur. parafin hastaya bagimli Kemik birlesimini degil engeller. HEMOSTATIC AGENTS Drug Composition l Mechanism l Advantages l Disadvantages Used for compression and buffering Bone wax (Ethicon) Beeswax Plug, tampon Cheap, fast, No absorption. Paraffin patient dependent Bone junction not obstacles.
Ostene (Ceremed) Alkalin oksit Tikaç, tampon Hizli etkili, Sadece kemikte, polimeri hastaya bagimli Lokal etkili degil, yavas emilebilir. Ostene (Ceremed) Alkaline oxide Plug, buffer Fast acting, Bone only, polymer dependent on the patient Locally effective not slow absorbable.
Mikrofibiiier kolajen içerenler Avitene (Davol) Helistat Mikrofibril Pihtilasma çatisi, Biyouyumlu, Trombositopenilerde (Integra) Instat (Ethicon) kollajen trombosit nötr pH, az etkili, sadece toz aktivasyonu heparinden formunda olmasi etkilenmez, sislik kizariklik GeIFoam (Pharmacia & Hidrolize Pihtilasma Biyoemilim, Kompresyon ile Upjohnj edilmis aktivasyonu, nötral pH, sisme ve kizariklik jelatin tampon Trombin ile artiyor. köpügü kombine edilebilir. Containing microfibrillar collagen Avitene (Davol) Helistat Microfibril Coagulation framework, Biocompatible, In Thrombocytopenia (Integra) Instat (Ethicon) collagen platelet neutral pH, less effective, powder only activation in the form of heparin unaffected, puffy redness GeIFoam (Pharmacia & Hydrolyzed Coagulation Bioabsorption with Compression Upjohnjed activation, neutral pH, swelling and redness The gelatin buffer increases with Thrombin. foam combination can be done.
Surgicel (Ethicon) Oksitlenmis Pihtilasma Emilebilir, Asidik bozunma; selüloz ( aktivasyonu bükülebilir, çok olasi uzun vadeli kagit yönlü, komplikasyonlar hamuru) antimikrobiyal Kitin bazli ilaçlar HemCon (HemCon N Asetil Pihtilasma çatisi; Emilebilir, Alerjik riski fazla, Medical Tech nologiesl; Glukozamin vasokonstrüksiyon; Antimikrobiyal, hasta pihtilasma CeIOX (Celox Medicall; (kitinI pihtilasma çok yönlü, faktörlerine bagimli, Hemostat, mRDH (Marine kitosan) aktivasyonu stabil, gazli gazli bezin Polymer bezle kullanima emilebilir olmamasi Technologiesl;TraumaStat uygun (Ore-Medix) Mineral ajanlar QuickCIot, Combat Gauze Zeolit Sivi absorbsiyonu, Yaygin Ekzotermik ve (Z-Medicai (mikroporlara lokal pihtilasma kullanim, basit, yabanci cisim sahip faktörlerini artirir yeni bandaj reaksiyonu orani alüminyum formlari ile fazla, fibrozise silikati absorbsiyon neden olabilir. orani fazla WoundStat Kil (Silikat) Tampon, dolgu, Yaygin Yabanci cisim (TraumaCure) (bentOnit, pihtilasma Çatisi kullanim, basit, reaksiyonu, hasta kaolin, ekzotermik bagimli, 2009 Simektit) yilinda Amerika'da reaksiyon orduda kullanimi olmainasi birakilmis. Surgicel (Ethicon) Oxidized Coagulation Absorbable, Acidic decomposition; cellulose (activation is pliable, very likely long-term paper-sided, complications pulp) antimicrobial chitin-based drugs HemCon (HemCon N Acetyl Coagulation Roof; Absorbable, High Allergic Risk, Medical Technologies; Glucosamine vasoconstriction; Antimicrobial, patient coagulation CeIOX (Celox Medicall; (kitI coagulation versatile, dependent on factors, Hemostat, mRDH (Marine chitosan) activation stable, gauze gauze Non-absorbable for use with polymer cloth Technologiesl;TraumaStat suitable (Ore-Medix) mineral agents QuickCIot, Combat Gauze Zeolite Liquid Absorption, Diffuse Exothermic and (Z-Medicai (local coagulation use to micropores, simple, foreign body Increases new bandage reaction rate excess with aluminum forms, fibrosis silicate may cause absorption. over rate WoundStat Clay (Silicate) Buffer, padding, Common Foreign body (TraumaCure) (bentOnit, Coagulation Roof use, simple, reaction, patient kaolin, exothermic addict, 2009 Smectitis) in America in reaction use in the army it is not allowed.
Trombin ajanlari Thrombin JMI (King Sigir Trombin Basit kullanim Hasta pihtilasma Pharmaceuticalsl trombini aktivasyonu faktörleri gerekli, alerjik Evithrom (Ethicon) Insan Hasta pihtilasma plazmasi faktörleri gerekli, trombini plazmadan elde edilmesi Recothrom Insan Hasta pihtilasma (Zymogenetics) rekombinant faktörleri gerekli trombin FloSeal (Baxter) Insan plazma Trombin Sislik ve Hasta pihtilasma trombini + aktivasyonu+ pihtilasma faktörleri gerekli , jelatin pihtilasma Çatisi çatisi plazmadan elde problemleri edilmesi, sislik ve kizariklik komplikasyonlari Fibrinoj en içerenler BioGIue (CryoLife) Glutaraldehit Yara eki, Dokulara Bölgesel sinirler album In f ibrinojen, çapraz baglanir, üzerinde pihtilasma Çatisi hizli etkili, komplikasyon, sicaklik ve su Büyüyen dokuda Coseal (Baxter) Polietilen Yara eki, Dokulara Sisiik , kizariklik glukOl pihtilasma çatisi çapraz baglanir, polimerleri hizli etkili inflamasyon Crosseal (Ethiconl Insan plazma Gerçek fibrin tikaç Hastanin Yaygin kullanim fibrinoieni + pihtilasma alani yoktur. plazminojen durumuna bagli Arteryel inhibitörü degildir. kanamalarda Evicel (Ethiconl Insan plazma kullanilmaz, çok az Tisseel (Baxter) fibrinoieni + faktör 8 ihtiva eder. trombin Yapiskan bir matriks olustururlar Vitagel (Orthovitai M ikrofibriller Pihtilasma çatisi, Fibrin tikaç ve Hazirlamasi zordur, kollajen + fibrin tikaç, trombosit özellikle hasta plazmadan trombosit jel aktivasyonu plazma hazirlamasi trombin + karmasiktir. hastanin plazmasi Deney asamasinda olanlar Dry Fibrin Sealant Dondurulmus Insan pihtilasma Faktörlere karsi Pahali, plazmadan Dressing, DFSD fibrinojen + formasyonu+ defans, üretilmekte, az (American Red Cross) kuru fibrin çati lsavaslarda faktör 8 fibrinojen + basarili, aktivasyonu, trombin+ emilebilir kirilgan tasima poliglaktin Tachosil (Nycomed) Kollajen Pahali, plazmadan sünger+ üretilmekte, az fibrinolen+ faktör 8 aktivasyonu trombin Recombinant Hemostatic Rekombinant Emilebilir, fibrin Hizli ve güçlü Kullanimi karmasik Devices (University of insan tikaç, çapraz pihtilasma, bir ürün Nebraskal f ibrinojeni, baglanmis pihti faktörlere trombini olusumu defans yok, fibrinojen, tamami F8, polilaktid rekombinant örtü üretilmis, bükülebilir Diger ajanlar Hemostase (CryoLifel Bitki protein Fibrin çati Bilinmiyor Bilinmiyor aktivasyonu Haempatch (Venomics) Yilan Fibrin çati Bilinmiyor Asiri alerjik prothrombinase (Factor venomundan olusumu reaksiyon Xa mimetic) (compare to kollajen FIoSeal, GelFoam) (Hemostasis LLC] Amilopektin Bilinmiyor Allerjik reaksiyon pudrasi Arista AH; TraumaDex Mikro Trombosit ve Bilinmiyor Bilinmiyor (Medafor): gözenekli serum polisakkarit proteinlerinin küreler konsantre olmasini Alüminyum Klorür, Alüminyum Fibrin çati Lokal Bilinmiyor Alüminyum sülfat, Klorür, olusumu, uygulamada Ferrik sülfat Alüminyum pihtilasma basarili, kisa sülfat, Ferrik aktivasyonu etkili, dis sülfat ilaçlar içerisinde farkli oranlarda bulunabilir. tedavilerinde Tablo 1: Literatürde bilinen hemostatik ajanlar Son yillarda en yaygin kullanilan lokal kanama durdurucu ajanlardan biri kitosandir. Kitosan okyanuslarda bulunan istiridye kabuklari fosillerinden olusan tuzlardan üretilen dogal bir biyoinalzeinedir. Kitosandan farkli olarak, “QuikClot” (QC) ticari ismi ile bilinen sentetik bir ürün kanama durdurucu olarak piyasada bilinmektedir. QC zeolitlerden elde edilen bir kanama durdurucudur. Alüminyum, silikon dioksit ve sodyum hidroksitin isitilmasi yoluyla elde edilir. thrombin agents Thrombin JMI (King Bovine Thrombin Simple use Patient coagulation Pharmaceuticalsl thrombin activation factors required, allergic Evithrom (Ethicon) Human Patient Coagulation plasmacy factors required, obtaining thrombin from plasma to be made Recothrom Human Patient Coagulation (Zymogenetics) recombinant factors required thrombin FloSeal (Baxter) Human plasma Thrombin Swelling and Patient Coagulation thrombin + activation + coagulation factors required, roof of gelatin coagulation derived from plasma problems, swelling and redness complications Containing fibrinogen BioGIue (CryoLife) Glutaraldehyde Wound attachment, To Tissues Regional nerves album In fibrinogen, cross-linked, on Coagulation Roof fast-acting, complication, temperature and water in growing tissue Coseal (Baxter) Polyethylene Wound Supplement, Tissue Squeeze, redness glukOl coagulation roof is cross-linked, fast acting polymers inflammation Crosseal (Ethiconl Human plasma Real fibrin plug Patient's Widespread use There is no fibrinoine + coagulation area. Arterial due to plasminogen status It is not an inhibitor. in bleeding Evicel (Ethiconl Human plasma is not used, very little It contains Tisseel (Baxter) fibrinogen + factor 8. thrombin A sticky matrix they form Vitagel (Orthovitai Microfibrillar Coagulation framework, Fibrin plug and Difficult to prepare, collagen + fibrin plug, platelet especially sick platelet gel activation from plasma plasma preparation thrombin + complex. of the patient plasma Those in the experimental stage Dry Fibrin Sealant Frozen Human Coagulation Factors Expensive, from plasma Dressing, DFSD fibrinogen + formation + defense, produced, little (American Red Cross) factor 8 in dry fibrin roof surveys fibrinogen + successful, activation, thrombin+ absorbable fragile transport polyglactin Tachosil (Nycomed) Collagen Expensive, from plasma sponge+ being produced, less fibrinolen+ factor 8 activation thrombin Recombinant Hemostatic Recombinant Absorbable, fibrin Fast and powerful Complex to use Devices (University of human plug, cross coagulation, a product Nebrascal fibrinogen bound to clotting factors thrombin formation no defense, fibrinogen, whole F8, polylactide recombinant cover produced pliable other agents Hemostase (CryoLifel Plant protein Fibrin roof Unknown Unknown activation Haempatch (Venomics) Snake Fibrin roof Unknown Extremely allergic prothrombinase (reaction formed from Factor venom Xa mimetic) (compare to collagen FIoSeal, GelFoam) (Hemostasis LLC] Amylopectin Not known Allergic reaction powder Arista AH; TraumaDex Microplatelet and Unknown Unknown (Medafor): porous serum of polysaccharide proteins spheres to concentrate Aluminum Chloride, Aluminum Fibrin Roof Local Unknown Aluminum sulfate, Chloride, formation, application Ferric sulfate Aluminum coagulation successful, short sulfate, Ferric activation effective, dis sulfate drugs in different in proportions can be found. in their treatment Table 1: Hemostatic agents known in the literature Chitosan is one of the most widely used local astringent agents in recent years. chitosan It is a natural product produced from salts formed from oyster shell fossils found in the oceans. is a bioinalzeine. Unlike chitosan, it is a synthetic product known by the trade name "QuikClot" (QC). The product is known in the market as an astringent. A hemorrhage from QC zeolites is a stopper. Aluminum is obtained by heating silicon dioxide and sodium hydroxide.
Zeolitlerden pudra haline getirilmis formu savas yaralanmalarmda önerilinistir. Temel etkisi sivi absorbsiyonu ve trombositlerin aktivasyonu ile kanama durdurmada etkilidir. Ancak QC°nin kaolinden üretilmesi nedeniyle önemli yan etkilerinin oldugu sonucuna varilmistir. QC daha sonraki üretim asamalarinda mikropartiküllere ayristirilarak cerrahi malzemelerle birlikte kullanilmaya baslanmistir. Powdered form of zeolites is recommended for war injuries. Basic effect It is effective in stopping bleeding by fluid absorption and activation of platelets. However It was concluded that QC° has significant side effects because it is produced from kaolin. QC In the next production stages, it is decomposed into microparticles and together with surgical materials. has been put into use.
Literatürde karsilasilan zeolit tabanli diger çalismalarda zeolitlerin kanama durdurmada basarili oldugu gösterilmistir. Li Jing ve arkadaslarinin domuzlar üzerinde yaptiklari çalismada; kasik yaralanmalarinda ölüm oranini %100 oranda azalttiklari sonucuna varilmistir (Li et al., 2013). In other zeolite-based studies encountered in the literature, zeolites were successful in stopping bleeding. has been shown. In the study of Li Jing and his friends on pigs; groin It was concluded that they reduced the death rate by 100% in injuries (Li et al., 2013).
Yapilan baska bir in vitro çalisma modeli olan tromboelastografi testlerinde kanama durdurmada etkinligi oldugu, in vivo yapilan testlerde ise kanama durdurmada etkinligi ile birlikte antibakteriyel özelliginin oldugu tespit edilmistir. Zeolitlerin kafes seklindeki yapisi, iyon degisimi ve kimyasal reaksiyonlar için genis iç ve dis yüzey alani olusturmaktadir. Içindeki gözenekler hacininin %50”sini kaplar. Bu gözenekler moleküler elek islevi görürler. Zeolitler dogal olarak negatif yüklüdür ve yüksek iyon degistirme kapasitesine sahiptir. Gözenekli yapisi ve yüksek iyon degistirme kapasitesi sayesinde birçok çesit gazi ve kokuyu; suyu ve nemi; petrokimyasal maddeleri. düsük düzeyde radyoaktif elementleri, amonyumu, toksinleri, agir metalleri ve pek çok solüsyonu tutma ve sogurma özelligine sahiptir. Bir baska çalismada Eryilmaz ve arkadaslarinin zeolit bazli QC ile yaptiklari çalismada zeolitin kanamaya bagli kan kaybini azaltma egilimi gösterdigi ancak tam olarak durduramadigi tespit edilmistir(EryIImaZ et al., 2009). Ayni Çalismada klinik testlerin yetersizligi vurgulanmistir. Zeolit çesitlerinden bentonit ile yapilan ilk çalismalarda kanama durdurucu olarak etkili olabilecegi sonucuna varilmistir. Alavi ve arkadaslarinin bentonit ile yaptigi çalismada kanamayi ve kanama zamanini azaltmakla birlikte yara bakiminda da etkili olabilecegi sonucuna varmislardir(A|aVi et al., 2014]. Ancak çalisma konusu olan bentonit bir zeolit türevidir. sepiyolit ve izole edilmis zeolitten seçilen izole edilmis bir kil içeren hemostatik bir içerisindeki kalsiyum miktari ayarlanabilir zeolitin kanama durdurucu olarak kullanilmasi açiklanmaktadir. Benzer sekilde kitosan tabanli bir çok malzemenin kan durdurueu olarak Birlesik Devletler patent basvurusunda, bilinen farkli kari damari daraltici (vasoconstrictor) aj anin biyobozunur kitosan üzerine enkapsüle ya da immobilize edilmesi ile elde edilen bir kan basvurusunda ise, hidrofobik olarak modifiye edilmis kitosandan, yüksek molekül agirligina sahip polivinil alkolden ve iyonik bir çapraz baglayicidan olusan bir hemostatik ajan tanimlanmistir. Bleeding in thromboelastography tests, which is another in vitro study model. It has been shown to be effective in stopping bleeding, in in vivo tests, it has been shown to be effective in stopping bleeding. It has also been found that it has antibacterial properties. The cage-shaped structure of zeolites, It creates a large internal and external surface area for ion exchange and chemical reactions. in pores occupy 50% of their volume. These pores function as molecular sieves. Zeolites It is naturally negatively charged and has a high ion exchange capacity. porous structure and many kinds of gases and odors thanks to its high ion exchange capacity; water and moisture; petrochemicals. low levels of radioactive elements, ammonium, toxins, heavy It has the property of holding and absorbing metals and many solutions. In another study In the study of Eryılmaz et al. with zeolite-based QC, zeolite It has been determined that it tends to reduce the loss but cannot completely stop it (EryIImaZ et al., 2009). In the same study, the inadequacy of clinical tests was emphasized. Zeolite varieties In the first studies conducted with bentonite, it was concluded that it can be effective as a hemorrhage. has arrived. In the study of Alavi et al. with bentonite, bleeding and bleeding concluded that it can be effective in wound care as well as reducing the time (A|aVi) et al., 2014]. However, bentonite, which is the subject of the study, is a zeolite derivative. A hemostatic material containing an isolated clay selected from sepiolite and isolated zeolite. The use of zeolite, the amount of which can be adjusted in calcium, as an astringent is explained. Similarly, many chitosan-based materials are used as blood stoppers. In the United States patent application, different known vasoconstrictor A blood obtained by encapsulating or immobilizing an agent on biodegradable chitosan. In its application, it is made of hydrophobically modified chitosan to high molecular weight. A hemostatic agent consisting of polyvinyl alcohol with an ionic cross-linker has been defined.
Diger kompresyon ve tikaç etkisi olan hemostatik ajanlar ise etkilerini sadece basi sonrasi damara mekanik olarak etkiyle gösterebilmektedir. Sözü geçen bu ajanlar kanama durdurueu özellige sahip degildirler. Anostomik yapistiricilar grubundan olan jelatin grubu ilaçlar kan proteini ile temas edince jelatin formu siser. trombin ve mekanik etkisi ile beraber pihtilasmayi Ancak, yukarida özetlenen, literatürde bilinen, ticari olarak halihazirda kullanilan ve patent basvurularina konu olan mevcut tüm kan durdurueu ajanlarda iki temel problem ile karsilasilmaktadir. Bu problemlerden biri ve en önemlisi bilinen kan durdurueu ajanlarin sivi ve/veya su ile temas ettiginde yara bölgesinden kolayca temizlenememesi ve uzaklastirilamamasidir. Diger çözüm bekleyen problem ise, mevcut hemostatik ajanlarin kan durdurueu etkinliginin düsük ve sürdürülebilir olmamasidir. Tüm bu problemlerin çözümü ve mevcut hemostatik aj anlara bir alternatif olarak bulus konusu dogal diatomit bilesenlerinden ve bunlarin hemostatik etkiyi güçlendireeek ajan ve/veya bu ajanlarin belli oranda karisimlarinin yüklü oldugu formlarindan elde edilen topikal hemostatik ajan tanimlanmistir. Benzersiz yapisal özelliklerinden dolayi yara yerinden temizlenmesi ve uzaklastirilrnasi esnasinda çok önemli avantaj saglayacak, yukarida ifade edilen en büyük problem yönelik çözüm alternatiflerinden biri olacaktir. Ayrica, proje konusu topikal hemostatik ajaninin kapsüler ve gözenekli özelliginden dolayi mevcut hemostatik ajanlara göre kanama durdurma etkinliginin daha yüksek olmasi beklenmcktedir. Ayrica, genis yüzey alanina sahip gözenekli yapisi sayesinde yara yerinde hizli sivi absorbsiyonuna olanak saglayarak fibrin çatiya mekanik destek saglayacaktir. Other hemostatic agents with compression and plugging effects are effective only after compression. It can show the vein by mechanical effect. The aforementioned agents stop bleeding. they don't have the feature. Gelatin group drugs from the anastomic adhesives group When it comes into contact with the protein, the gelatin form swells. coagulation with thrombin and its mechanical effect However, the above summarized, known in the literature, commercially used and patented There are two main problems in all existing blood-stopping agents that are the subject of their applications. are compared. One of these problems, and the most important, is the lack of known blood-stopping agents. and/or inability to be easily cleaned from the wound area when in contact with water and cannot be removed. Another unsolved problem is that the existing hemostatic agents are Its stopping efficiency is low and not sustainable. The solution to all these problems and As an alternative to existing hemostatic agents, the subject of the invention consists of natural diatomite components and agents that strengthen their hemostatic effect and/or certain mixtures of these agents. A topical hemostatic agent obtained from its loaded forms has been defined. Unique Due to its structural properties, it is very important during cleaning and removal from the wound site. solution for the biggest problem mentioned above, which will provide a significant advantage will be one of the alternatives. In addition, the topical hemostatic agent of the project is capsular and Due to its porous feature, the bleeding stopping efficiency compared to existing hemostatic agents is expected to be higher. In addition, its porous structure with a large surface area It provides mechanical support to the fibrin roof by allowing rapid fluid absorption at the wound site. it will provide.
Bulusun kisa açiklamasi Bu bulusun amaci, mevcut kan durdurueu ajan ve ürünlere göre kan durdurueu etkinligi arttirilmis ve morfolojik özelliklerinden dolayi yara bölgesinden kolayca temizlenecek ve uzaklastirilacak yeni ve özgün bir topikal hemostatik ajanin elde edilmesidir. Brief description of the invention The aim of this invention is to determine the blood-stopping efficacy according to the available blood-stopping agents and products. Due to its increased and morphological features, it will be easily cleaned from the wound area and is to obtain a new and unique topical hemostatic agent to be removed.
Bu bulusun bir diger amaci, yüksek absorbsiyon kapasitesine ve nötr pH°a sahip, yara bölgesinde gaz alisverisine olanak saglayan ve toksik olmayan yeni ve özgün bir topikal heinostatik ajanin elde edilmesidir. Another object of the present invention is to have a high absorption capacity and a neutral pH. A new and unique non-toxic topical that allows gas exchange in the obtaining the heinostatic agent.
Bu bulusun bir baska amaci kolay ve ucuz üretilebilir ve steril edilebilir yeni ve özgün bir topikal hemostatik ajanin elde edilmesidir. Another object of this invention is to produce a new and unique product that can be easily and inexpensively produced and sterilized. obtaining a topical hemostatic agent.
Bulusun ayrintili açiklamasi Diatomit, algler sinifindan su canlilari olan diatomelerin silisli kabuklarinin birikimiyle olusmus fosil karakterli bir sedimanter kayadir. Diatome içinde yasadigi çevre suyundan temin ettigi silisten yapilmis kabuk veya kavki içinde yerlesmis çok küçük bir protoplazmadir. Genis ve sig havzalar, çok miktarda suda erimis silis ve teiniz sular, gelismesini saglayan ve hizlandiran faktörlerdir. Sayilari 16.000 e ulasan farkli diatome çesitleri tatli sularda, denizlerde veya hafif tuzlu sularda gelismektedirler. Ölen diatomelerin dibe çöken kabuklari birikerek diatomit yataklarini olusturmaktadir. Çok aktif diatome kolonileri yilda birkaç milimetre kalinlik yaratacak bir çökelme hizina ulasabilmektedirler. Diatomeler ilk defa 65-135 milyon yil önce Kretase çaginda çok büyük iniktarlara ulasmislar ve bugün tieari degeri olan yataklarin çogunu ise Miyosen çaginda (7-27 inilyon yil önce) meydana getirrnislerdir. Diatomeler bugün de denizlerde ve göllerde yasamlarini sürdünnektedirler. Detailed description of the invention Diatomite is formed by the accumulation of siliceous shells of diatoms, which are aquatic creatures of the algae class. It is a fossilized sedimentary rock. Obtaining from the environmental water in which Diatome lives. It is a very small protoplasm located in a shell or shell made of silica. Wide and shallow basins, large amounts of dissolved silica and clear waters, which support its development and accelerating factors. Different types of diatoms, the number of which reaches up to 16.000, are found in fresh waters and seas. or grow in slightly salty waters. The shells of the dying diatoms, which collapsed to the bottom, were accumulated. form diatomite deposits. Very active diatom colonies a few millimeters per year they can reach a precipitation rate that will create a thickness. Diatoms 65-135 million for the first time years ago, in the Cretaceous period, they reached very large amounts and today the beds that have a valuable value are Most of them are formed in the Miocene epoch (7-27 million years ago). Diatoms today They also live in seas and lakes.
Yurdumuzda oldukça bol ve kaliteli ham diatomit rezervleri mevcuttur. Tespit edilebilen yataklarimizin bulundugu iller sunlardir. Afyon, Ankara, Aydin, Balikesir, Bingöl, Çanakkale, Çankiri, Denizli, Eskisehir, Kayseri, Konya; Kütahya, Nigde, Sivas ve Van'dir. Kayseri-Hirka diatomit yatagi 50 milyon ton rezervi ile Türkiye”nin en büyük yatagidir. There are abundant and high quality raw diatomite reserves in our country. detectable These are the provinces where our beds are located. Afyon, Ankara, Aydin, Balikesir, Bingol, Canakkale, Cankiri, Denizli, Eskisehir, Kayseri, Konya; Kütahya, Nigde, Sivas and Van. Kayseri-Hirka The diatomite deposit is Turkey's largest deposit with 50 million tons of reserves.
Ham diatomitin sadece kurutulmasi ve içindeki yabanci maddelerin kaba olarak ayrilmasiyla dogal ürün elde edilir. Diatomit olusturan bilesikler içinde büyük oranini olusturmak üzere Bilesiklerin oranlari diatom'itin bulundugu bölge göre degisiklikler gösterebilir. By only drying the raw diatomite and coarsely separating the impurities in it. natural product is obtained. To make up the majority of diatomite-forming compounds. The proportions of the compounds may vary according to the region where diatomite is found.
Bulus konusu topikal hemostatik ajamn üretilmesi için Kayseri, Nigde ve Nevsehir bölgesinde yer alan rezervlerden dogal diatomit bilesikleri temin edilmistir. Temin edilen diatomit bilesiklerinden topikal hemostatik ajanin eldesi için öncelikle islenmistir. Diatomit bilesenlerinin isleme basamaklari sirasiyla asagida gibidir: - hidrojen peroksit ile yikanmasi (l ÜÜmI/IÜÜÜgr ], - 35 °C derecede 2 saat kurutulmasi, - 24 saat sulu ortamda karistirilmasi ve kurutulmasi, - kurutma sonrasi tozlarin ve yabanci maddelerin ayristirilmasi, - 700 °C”da kalsinasyona tabi tutulmasi, - sogutmanin ardindan 35 °C derecede 6 saat kurutulmasi, - pH”nm 5,5-9,0 olacak sekilde ayarlanmasi, - steril edilmesi Isleme sonrasi diatomit bilesenlerinin yapisi X-Ray Floresan (XRF) ile yapilari aydinlatilmis, asagidaki tabloda sunulmustur. islenmis diatomit bilesiklerinin yapisinin agirlikça %91,37- 0,06 oraninda MnO Oldugu belirlenmistir. Bulus konusu topikal hemostatik ajanm eldesi için kullanilan diatomit bilesenlerinin yüzey alani BET sonuçlarina göre 16.0385 mZ/g olarak bulunmustur. In order to produce the topical hemostatic agent which is the subject of the invention, in Kayseri, Nigde and Nevsehir regions Natural diatomite compounds were obtained from the reserves in the area. The supplied diatomite It is primarily processed to obtain the topical hemostatic agent from its compounds. diatomite The processing steps of the components are as follows, respectively: - washing with hydrogen peroxide (l ÜmI/IÜÜÜgr ], - Drying at 35 °C for 2 hours, - Mixing and drying in aqueous medium for 24 hours, - separation of powders and foreign matter after drying, - Subjecting to calcination at 700 °C, - drying at 35 °C for 6 hours after cooling, - Adjusting the pH to be 5.5-9.0, - sterilizing After processing, the structure of the diatomite components was illuminated with X-Ray Fluorescent (XRF), presented in the table below. 91.37% by weight of the structure of the processed diatomite compounds It was determined that it was 0.06 MnO. For obtaining the topical hemostatic agent of the invention The surface area of the diatomite components used was 16.0385 mZ/g according to the BET results. has been found.
XRF Sonuçlari Bilesik Adi Agirlikça Yüzde (W/W, AI203 3,02-4,42 Fe203 2,76-5,50 P205 0,74 -0,88 Na20 0,11-0,15 K20 0,06-0,15 TiOz (LOS-0,32 Tablo 2: Diatomit bilesiklerinin XRF sonuçlari Bunun yani sira, islenmis diatomit bilesenlerinin SEM fotograflari çekilmistir (Resim1,2,3). XRF Results Compound Name by Weight Percent (W/W, AI203 3.02-4.42 Fe2O3 2.76-5.50 P205 0.74 -0.88 Na20 0.11-0.15 K20 0.06-0.15 TiO2 (LOS-0.32 Table 2: XRF results of diatomite compounds In addition, SEM photographs of the processed diatomite components were taken (Picture1,2,3).
Sekil standartlarina uymadigi düsünüldügü için asagidaki mikroskop görüntülerine, bulusun daha net anlasilabilmesi adina tarifnamede yer verilmistir. The microscope images below are considered to be non-compliant with the figure standards. It is included in the description for a clearer understanding.
Mag : 200 K X Detector = SE1 1.45 "V Mag : 20.00 KX Deteclur = SE1 Resim 2: Elektron mikroskobunda Mikro kapsül ve nano tasiyici sistem iç duvar yapisi ölçüleri Resim 3 : Mikro kapsül dis görünüsü. A: Mikrokapsül Sekillerin Açiklamalari Pa 1: Mikro kapsül uzun eksen boyutu Pa 2: Mikro kapsül kisa eksen boyutu ve kapsül katmanlari görüntüsü Dal : Mikro kapsül Elek seklindeki nanometrik gözenek boyutu Da2 : Mikro kapsül elek seklindeki nanometrik küçük gözenek boyutu Pa R 2: Iskelet stünlari arasi boyutu Elde edilen fotograflardan diatomit bilesiklerinin morfolojik özellikleri belirlenmistir. Bulus konusu topikal hemostatik ajaninin eldesinde kullanilan diatomit bilesiklerinin mikro ve nano kapsüllerinin uzunluklari ortalama 77 um (Pa2) ve enleri ortalama 19 um (PaR2) olarak tespit edilmistir. Ayrica, kapsüllerin ortalama 6-12 kattan olustugu gözlenmistir (Pa2). Her bir mikrokapsül iskeletinde ortalama 30 adet kolon (PaR2) benzeri yapi ile her bir iskelet kolonunda ortalama 20 adet (Dal) dört çekirdekli gözenek (Da2) bulunmaktadir. Iskelet kolonlari arasindaki mesafeler ortalama 1,45 um, gözeneklerin sayisi her bir katmanda elek seklinde yaklasik 1200 adet gözenek ve gözenekler ortalama 20-600 nm boyutlarinda oldugu gösterilmistir. Sahip oldugu bu benzersiz yapisi sayesinde bulus konusu topikal hemostatik ajaninin mikro organizmalar için önemli bariyer özelligi ile yavas salinim açisindan önemli avantaj saglayacaktir. Ayrica, yara yerinin kuru olmasi, mikroorganizmalarin ürememesi ve kanama kontrolü yara yeri iyilesmesi için önemli parametrelerdir. Bulus konusu topikal hemostatik ajanin sahip oldugu nanometre boyutundaki gözenekleri yara yerini kaplayacak sekilde yerlestirildi ginde mikroorganizmalarin bu bölgeye geçisi için bariyer görevi saglarken, gaz alis-verisine ise olanak saglayacaktir. Mag : 200 K X Detector = SE1 1.45"V Mag : 20.00 KX Deteclur = SE1 Figure 2: Microcapsule and nanocarrier system inner wall structure measurements in electron microscope Figure 3: Microcapsule outer view. A: Microcapsule Descriptions of Figures Pa 1: Microcapsule long axis size Pa 2: Image of microcapsule short axis size and capsule layers Branch : Microcapsule Sieve-shaped nanometric pore size Da2 : Nanometric small pore size in the form of microcapsule sieve Pa R 2: Inter-skeletal pillar size Morphological properties of diatomite compounds were determined from the photographs obtained. Meet Micro and nanoparticles of diatomite compounds used in the production of the topical hemostatic agent The average length of the capsules was 77 µm (Pa2) and the average width was 19 µm (PaR2). has been made. In addition, it was observed that the capsules consisted of an average of 6-12 layers (Pa2). Each Each skeleton with an average of 30 columnar (PaR2)-like structures in the microcapsule skeleton column has an average of 20 (Branch) quadruple-core pores (Da2). Skeleton The distances between the columns are on average 1.45 µm, the number of pores is sieve in each layer. in the form of approximately 1200 pores and the pores are approximately 20-600 nm in size. shown. Thanks to its unique structure, the subject of the invention is topical hemostatic agent is important in terms of slow release with its important barrier feature for micro-organisms. will provide an advantage. In addition, if the wound site is dry, microorganisms do not grow and Bleeding control is an important parameter for wound healing. The subject of the invention is topical The nanometer-sized pores of the hemostatic agent will cover the wound site. When placed in such a way, it provides a barrier for the passage of microorganisms to this region, and it will enable gas exchange.
Pihtilasmanin ilk asamasinda, hasarli damardan trombositler damar disina çiktiginda trombosit aktivatörleriyle etkileserek etki gösterirler. Trombosit aktivatörleri; özellikle von Willebrand faktörü ile beraber kollajen, trombin, tromboksan A2, ADP, konvulksin olarak bilinmektedir. In the first stage of coagulation, platelets become extravasated from the damaged vessel. They act by interacting with activators. Platelet activators; especially von Willebrand It is known as collagen, thrombin, thromboxane A2, ADP, convulxin together with the factor.
Normal saglikli bireyde trombositler damar disi ve doku faktörleri ile temas sonrasi bu aktivatörleri tetikler. Böylece pihti olusumu baslar. Trombosit aktivatörleri ni n tetiklenmesinde Ca++ önemli role sahip oldugu bilinmektedir. XRF sonuçlarina göre, bulus konusu topikal hemostatik ajanin bilesiminde agirlikça %1552-2,52 CaO oldugu gösterilmis, Ca++ iyonlari pihtilasmanin baslamasi için trombosit aktivatörlerini tetikleyecegi degerlendirilmistir. Ayrica, diatomit bilesimindeki AlzOg, Fazog, MgO, Nazo, KzO, TIOz ve Pzos bilesiklerinde bulunan anyonik ve katyonik pozitif yüklü moleküllerin baglama özelligi ile tüin kirinizi kan hücrelerinin negatif yüklü elektrik alanlarini manyetik katalizör olarak yapistirir. Anyonik ve katyonik etkilesim sonucu trombin aktif hale gelir. Aktive trombinler ise fibrin pihtisinin en hizli sekilde olusmasini tetikler. After contact with extravascular and tissue factors, platelets in a normal healthy individual triggers activators. Thus, clot formation begins. In triggering platelet activators Ca++ is known to have an important role. According to the XRF results, the subject of the invention is topical. It has been shown that the composition of the hemostatic agent is 1552-2.52% CaO by weight, Ca++ ions It has been evaluated that it will trigger platelet activators for the initiation of coagulation. Moreover, found in AlzOg, Fazog, MgO, Nazo, KzO, TIOz and Pzos compounds in the diatomite composition. With the binding feature of anionic and cationic positively charged molecules, It attaches the negatively charged electric fields of its cells as magnetic catalysts. anionic and Thrombin is activated as a result of cationic interaction. Activated thrombins are the most important part of the fibrin clot. triggers its rapid formation.
Bunun yani sira, bulus konusu topikal hemostatik ajaninin yapisinda oldugu gösterilen silika nanopartikülleri protrombin (PT) ve parsiyel tromboplastin zamanini (PTT) uzattigi, FX aktivasyonunu artirdigi ve kismen de trombosit aktivasyonunu artirdigi literatürde bilinmektedir. Bulus konus topikal hemostatik ajaninin ayni mekanizma ile pihtilasmayi tetikler. In addition, silica, which has been shown to be in the structure of the topical hemostatic agent of the invention The nanoparticles prolong prothrombin (PT) and partial thromboplastin time (PTT), FX It has been reported in the literature that it increases the activation of platelets and partially increases the activation of platelets. known. Coagulation of the topical hemostatic agent of the invention by the same mechanism triggers.
Bulus konusu topikal hemostatik ajanin sentez etme asamalarinda, diatomit türlerinin farkli bilesik konsantrasyonlarinda ve farkli renklerde oldugu sonucuna ulasilmistir. Buna göre, topikal hemostatik ajan yapiminda kullanilan toprak kirmizi renk ile kahverengi renk arasinda olup; kullanilan diatomit bilesiklerinin XRF sonuçlarina göre alüminyum ve demirden zengindir. Diatomitin kaolin ve diger yabanci bilesiklerden saflastirilmasi sonrasi açik kahverengi ile sari renk arasi bir renge dönüstügü görülmüstür. Alüminyum sülfat ve ferrik sülfat kanama durdurmada tüm dünyada yaygin kullanilan heinostatik etkili ajanlar arasindadir. In the synthesis stages of the topical hemostatic agent, which is the subject of the invention, different types of diatomite are used. It has been concluded that it is in compound concentrations and in different colors. According to this, The soil used in making a topical hemostatic agent is between red and brown in color. is; According to the XRF results of the diatomite compounds used, aluminum and iron he is rich. Open after purification of diatomite from kaolin and other foreign compounds It was observed that it turned into a color between brown and yellow. Aluminum sulfate and ferric Sulfate is among the heinostatic agents that are widely used all over the world to stop bleeding.
Bu ajanlar diatomit bilesimlerinde fazla miktarda olmasi sonucunda bulus konusu topikal hemostatik ajanin kanama durdurucu etkinligine katki saglayacaktir. As these agents are present in large amounts in diatomite compositions, the subject of the invention is topical. It will contribute to the hemostatic agent's hemostatic effect.
Kanamayi durdurucularin çogunlugu ekstravasküler ve lokal olarak kullanilmaktadir. Bulus konusu topikal hemostatik ajanin eldesi için kullanilan islenmis diatomit benzer sekilde ekstravasküler ve lokal kullanilacak bir malzemedir. Islenmis diatomitin kanamayi durdurucu etkileri hali hazirda kullanilan diger toz seklindeki topikal heinostatik ajanlarda oldugu gibidir. Most of the hemorrhage stoppers are used extravascularly and locally. Meet The processed diatomite used to obtain the topical hemostatic agent is similarly It is an extravascular and local material to be used. Treated diatomite as an astringent Its effects are the same as with other powdered topical heinostatic agents currently used.
Kanama bölgesine dis basinç uygulanmasi sonucunda fiziksel etki ile kanamanin durmasina katki saglar. Bu lokal hemostatik ajanlarda mevcut olan bir etkidir. Böylelikle daha fazla kan kaybi azaltilabilir. Fiziksel olarak kanamanin durdurulmasina kanama ve yara bölgesindeki sivinin absorbsiyonu özelligi katki saglar. Islenmis diatomit bilesiklerinin benzersiz gözenek yapisi sayesinde hasar bölgesindeki sivinin absorbsiyonu ile; yara yerinin kurumasina, fibrin tikaç ve fibrin çati olusumu ve devamliligina katki saglar. As a result of applying external pressure to the bleeding area, the bleeding stops with physical effect. contributes. This is an effect present in local hemostatic agents. Thus, more blood loss can be reduced. It helps to stop the bleeding physically and in the wound area. It contributes to the absorption feature of the liquid. The unique porosity of machined diatomite compounds with the absorption of the liquid in the damaged area thanks to its structure; wound dryness, fibrin It contributes to the formation and continuity of the plug and fibrin roof.
Diger bir fiziksel etki ise islenmis diatomit bilesikleri, sahip oldugu gözeneklerinin çapindan daha büyük olan ve pihtilasmada önemli fonksiyonel hücrelerin hasar yerindeki konsantrasyonunu artirir. Diatomit içindeki gözeneklerin çapi nanometre uzunlugunda iken, kandaki en küçük hücre olan trombosit (1-2x5 pm) ve eritrositlerin (7.5x2.0 um) çaplari ise mikrometre uzunlugundadir. Bu üstün özelligi sayesinde, kanin sivi kisini absorbe edilirken, hücrelerin geçisi engellenerek o bölgede pihtilasmada etkili kan elemanlarinin konsantrasyonunu arttirilir. Sonuç olarak bulus konusu topikal hemostatik ajan, pihtilasmada etkili kan elemanlari için elek ve filtrasyon görevi yaparken, kanama bölgesinde biriken eritrositler ve plateletler fibrin çatiyi destekleyecektir. Benzer sekilde, bulus konusu topikal büyük moleküllerin kanin sivi kismindan absorbe edilmesi ile konsantrasyonu artarak daha yogun bir fibrin yapi veya fibrin çati olusturabilirler. Another physical effect is the processed diatomite compounds from the diameter of their pores. at the site of injury of functional cells that are larger and important in coagulation increases concentration. While the diameter of the pores in the diatomite is nanometer long, The diameters of platelets (1-2x5 pm) and erythrocytes (7.5x2.0 um), which are the smallest cells in the blood, are micrometer in length. Thanks to this superior feature, while the blood's liquid is absorbed, By preventing the passage of cells, blood elements that are effective in coagulation in that region concentration is increased. As a result, the topical hemostatic agent of the invention is effective in coagulation. While it acts as a sieve and filtration for effective blood elements, it accumulates in the bleeding area. erythrocytes and platelets will support the fibrin roof. Similarly, the subject of the invention is topical With the absorption of large molecules from the blood liquid part, their concentration increases and becomes more intense. They can form a dense fibrin structure or fibrin roof.
Bulusun bir uygulamasinda, islenmis diatomit bilesikleri içerisine traneksamik asit (TA), tannik asit (Tn), Alüminyum klorür (AK), Alüminyum sülfat (AS), Epinefrin hidroklorür (EHC), Ferrik sülfat (FS), Trombin (TRB), J elatin (J L), fibrin, oksitlenmis selüloz, kalsiyum, eriyebilir jelatin, pamuklu jelatin ve benzeri diger hemostatik ajanlardan birinin ya da bunlarin belirli oranlarda karisimlari yüklenerek kan durdurucu olarak kullanilabilir. In one embodiment of the invention, tranexamic acid (TA) is mixed with tannic acid into processed diatomite compounds. acid (Tn), Aluminum chloride (AK), Aluminum sulfate (AS), Epinephrine hydrochloride (EHC), Ferric sulfate (FS), Thrombin (TRB), Gelatin (J L), fibrin, oxidized cellulose, calcium, soluble gelatin, cotton gelatin and other similar hemostatic agents or certain It can be used as a blood stopper by loading mixtures in proportions.
Bulusun bir diger uygulamasinda, bulus konusu topikal hemostatik ajan sentez, sterilizasyon ve kullanim asamasinda zarar görmemesi için literatürde bilinen hemostatik ajanlardan biri ile ya da bunlarinin belli oranda karisimlari ile kaplanarak kullanilabilir. In another application of the invention, the topical hemostatic agent of the invention is used for synthesis, sterilization and In order to avoid damage during use, it can be used with one of the hemostatic agents known in the literature. It can also be used by covering them with a certain amount of mixtures.
Bulusun bir baska uygulamasinda, bulus konusu topikal hemostatik ajan yara temizlemesinde kullanilan malzemeler ile birlikte kullanilabilir. In another application of the invention, the topical hemostatic agent of the invention is used for wound cleaning. It can be used with the materials used.
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| TR2016/12824A TR201612824A1 (en) | 2016-09-08 | 2016-09-08 | A NEW TOPICAL HEMOSTATIC AGENT |
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