WO2004054632A1 - Haemostatic wound dressing - Google Patents

Haemostatic wound dressing Download PDF

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Publication number
WO2004054632A1
WO2004054632A1 PCT/EP2003/014163 EP0314163W WO2004054632A1 WO 2004054632 A1 WO2004054632 A1 WO 2004054632A1 EP 0314163 W EP0314163 W EP 0314163W WO 2004054632 A1 WO2004054632 A1 WO 2004054632A1
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WO
WIPO (PCT)
Prior art keywords
composition according
bleeding
wound
acid
composition
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Application number
PCT/EP2003/014163
Other languages
German (de)
French (fr)
Inventor
Stefan Bertsch
Original Assignee
Langer, Hans-Georg
Priority date (The priority date 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 date listed.)
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Publication date
Application filed by Langer, Hans-Georg filed Critical Langer, Hans-Georg
Priority to EP03789254A priority Critical patent/EP1581269A1/en
Publication of WO2004054632A1 publication Critical patent/WO2004054632A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0066—Medicaments; Biocides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/0076—Sprayable compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/008—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0061—Use of materials characterised by their function or physical properties
    • A61L26/009—Materials resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/21—Acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/418—Agents promoting blood coagulation, blood-clotting agents, embolising agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/04—Materials for stopping bleeding

Definitions

  • the invention relates to a pharmaceutical composition which contains a lysine analog, preferably epsilon-aminocaproic acid (EACA), as a therapeutically active substance and which is suitable for the treatment of subsequent bleeding or bleeding bleeding on large, deep and / or deep-lying wounds.
  • a lysine analog preferably epsilon-aminocaproic acid (EACA)
  • EACA epsilon-aminocaproic acid
  • the balanced system of blood coagulation has the task of sealing small and large injuries to endothelia or entire tissue structures and thus to avoid a larger, possibly life-threatening blood loss.
  • the central process for blood coagulation is the proteolytic activation of prothrombin to thrombin.
  • the activation of the so-called "exogenous system” is induced by a lipoprotein, thromboplastin (III), which is released from the endoplasmic reticulum when tissue cells are destroyed.
  • thromboplastin thereby activates plasma factor VII, which combines with phospholipids and Ca 2+
  • This complex is largely responsible for the activation of factor X to Xa, a protease that ultimately converts prothrombin to thrombin.
  • factor X is activated via a cascade of plasma factors.
  • factor XII dissolved in the plasma has surfaces other than that If the endothelium comes into contact with the blood, it is activated (Xlla) and thus starts the so-called "endogenous system".
  • the plasma factors XI, XIa, IX, IXa, VIII, Ca 2+ and a platelet factor (TF3) are also part of the endogenous system involved, which ultimately induce the proteolytic conversion of prothrombin to thrombin by the activated factor Xa.
  • Thrombin then acts on fibrinogen, which is thereby first converted into monomeric soluble fibrin and subsequently polymerized to stable fibrin clots under the influence of factor XIII and Ca 2+ , thereby sealing off injuries.
  • sterile cloths, compresses or similar materials are applied to a wound in the form of bandages.
  • the absorbent capacity of the dressing material reduces the bleeding speed in the wound area so that the naturally occurring blood clotting is sufficient to close a wound.
  • wound coverings such as the TachoComb® wound cover (Hafslund Nycomed Pharma), which consists of a collagen matrix which is coated on one side or on all sides with coagulation-requiring substances, are used.
  • highly effective coagulant substances For example, thrombin obtained from bovine blood and fibrinogen obtained from human blood are used.
  • a decisive disadvantage of the known wound covers is also their inadequate adaptation to the individual surface structures or dimensions of a wound.
  • large or deep, oozing or bleeding wounds cannot be optimally treated with the known wound covers, which are defined in their structure. It is therefore an object of the invention to provide a pharmaceutical composition for wound care which does not contain any human or animal constituents and which enables individual care and coverage of large, deep or deep-lying wounds while at the same time preventing seepage or subsequent bleeding.
  • This object is achieved by providing a liquid, gel-like or gelatinous pharmaceutical composition which accelerates blood coagulation by means of synthetic catalysts, in particular pharmaceutically acceptable acids, and which can be sprayed or foamed over the wound and / or into the wound.
  • the consistency of the composition is determined by the
  • Suitable carrier materials for the production are gelatin or collagen compounds, cellulose sulfate, calcium and / or calcium / sodium alginate, rubber and polymers based on ethylene, propene, butene, isobutylene, butadiene, isoprene, maleic acid, propylene hydrogen maleate and / or methyl acrylate , It is known to the person skilled in the art how to process these materials in order to set the desired consistency and thus to produce the composition according to the invention. Likewise, the person skilled in the art knows which gases or foaming agents are to be added in suitable dispensers or atomizers in order to be able to apply the composition according to the invention in a manner appropriate to the situation.
  • the initially liquid or at least mouldable consistency of the composition ensures that the coagulation-promoting catalysts are not only placed on the outside of the wound, but also that the coagulation-promoting factors are optimally provided at all points within the wound and thus blood coagulation can be catalyzed.
  • the spraying and / or foaming of the composition according to the invention in the wound or on the wound allows a significantly improved and thus individually better adapted wound care.
  • a thin layer of the composition according to the invention will be sprayed onto the wound. If the injury bleeds more heavily in partial areas, such partial areas can be sprayed more intensively, so that a thicker and therefore longer-lasting layer of the composition according to the invention covers the wound.
  • the composition according to the invention is placed in the wound in the form of a thick and, due to the spongy surface structure, also absorbent foam casing.
  • the blood then seeps away in the sponge-like foam shell, where it comes into contact with the coagulation-promoting catalyst everywhere.
  • the infiltration firstly provides a larger surface for the catalysis, but at the same time prevents the composition according to the invention from washing away.
  • the backing material or biopolymer is suitable for use in wounds or organ injuries lying inside preferably not immunogenic, but absorbable and biodegradable, so that it does not have to be removed after the bleeding has stopped, but rather is slowly decomposed.
  • a combination of absorbable, biodegradable, but also non-degradable synthetic, organic materials or polymers is preferably used for the treatment of external injuries. With such a combination, after the bleeding has stopped, the areas close to the wound dissolve, making the other constituents of the composition easy to remove.
  • injuries which have been treated with the composition according to the invention as soon as the protective film begins to harden and / or harden can be incorporated with conventional dressing materials.
  • composition according to the invention contains a coagulation-promoting, synthetic catalyst, in particular a pharmaceutically acceptable acid, which increases the pH in the wound area by 0.1 to 3.
  • Acids or lysine analogs e.g. which are also highly effective inhibitors of fibrinolysis, namely epsilon-aminocaproic acid (EACA), p-aminomethylbenzoic acid (PAMBA) or tranexamic acid (AMCHA) or similar substances.
  • the composition according to the invention can contain calcium donors, in particular CaCl 2 and / or substances which neutralize the action of heparin or vitamin K antagonists, in particular protamine sulfate, as further coagulation-promoting and thus advantageous components.
  • composition according to the invention is in the initial care of wounds in humans and animals after accidents or operations.
  • a simple spraying or foaming of the wound with the composition according to the invention stops or at least reduces creeping blood loss or bleeding on large or deep wounds.
  • Another preferred use of the 'composition according to the invention is given in and during surgery, to reduce a hemorrhaging the surgical site from injure tissues by spraying or foaming.
  • composition according to the invention is also preferably used in the aftercare of large, poorly healing, oozing, bleeding wounds in humans and animals.
  • composition according to the invention can be used to provide safe, sterile and hemostatic wound care both in primary care, during operations and in aftercare.

Abstract

The invention relates to a composition for the dressing of wounds in the form of a liquid and/or a gel, comprising a synthetic catalyst which promotes blood coagulation, selected from the group of pharmacologically-acceptable acids or lysin analogues, an air-hardening or and/or polymerising organic material and at least one pharmacologically-acceptable support or diluent.

Description

Blutungsstillende Wundversorgung Bleeding wound care
Beschreibungdescription
Die Erfindung betrifft eine pharmazeutische Zusammensetzung, welche als therapeutisch aktiven Wirkstoff ein Lysinanalogon, vorzugsweise Epsilon-Aminocapronsäure (EACA) enthält und die zur Behandlung von Nachblutungen oder Sickerblutungen an großflächigen, tiefen und/oder tiefliegenden Wunden geeignet ist.The invention relates to a pharmaceutical composition which contains a lysine analog, preferably epsilon-aminocaproic acid (EACA), as a therapeutically active substance and which is suitable for the treatment of subsequent bleeding or bleeding bleeding on large, deep and / or deep-lying wounds.
Im physiologisch gesunden Organismus hat das ausgewogene System der Blutgerinnung die Aufgabe kleinere und größere Verletzungen von Endothelien oder ganzen Gewebestrukturen abzudichten und somit einen größeren, möglicherweise lebensbedrohlichen Blutverlust zu vermeiden.In the physiologically healthy organism, the balanced system of blood coagulation has the task of sealing small and large injuries to endothelia or entire tissue structures and thus to avoid a larger, possibly life-threatening blood loss.
Der zentrale Vorgang für die Blutgerinnung ist die proteolytische Aktivierung von Prothrombin zu Thrombin. Bei Gewebeverletzungen wird die Aktivierung des sogenannten „exogenen Systems" durch ein Lipoprotein, Thromboplastin (III), das bei der Zerstörung von Gewebezellen aus dem endoplasmatischen Reticulum freigesetzt wird, induziert. Thromboplastin aktiviert dabei den Plasmafaktor VII, der mit Phospholipiden und Ca2+ einen Komplex bildet. Dieser Komplex ist maßgeblich für die Aktivierung des Faktors X zu Xa verantwortlich, einer Protease, welche schließlich Prothrombin in Thrombin umwandelt .The central process for blood coagulation is the proteolytic activation of prothrombin to thrombin. In the case of tissue injuries, the activation of the so-called "exogenous system" is induced by a lipoprotein, thromboplastin (III), which is released from the endoplasmic reticulum when tissue cells are destroyed. Thromboplastin thereby activates plasma factor VII, which combines with phospholipids and Ca 2+ This complex is largely responsible for the activation of factor X to Xa, a protease that ultimately converts prothrombin to thrombin.
Bei kleineren Endotheldefekten erfolgt die Aktivierung des Faktors X über eine Kaskade von Plasmafaktoren. Sobald der im Plasma gelöste Faktor XII mit anderen Oberflächen als dem Endothel der Gefäße in Berührung kommt, wird er aktiviert (Xlla) und startet damit das sogenannte „endogene System". Am endogenen System sind im Weiteren die Plasmafaktoren XI, XIa, IX, IXa, VIII, Ca2+ sowie ein Thrombozytenfaktor (TF3) beteiligt, die schließlich die proteolytische Umwandlung von Prothrombin zu Thrombin durch den aktivierten Faktor Xa induzieren.In the case of smaller endothelial defects, factor X is activated via a cascade of plasma factors. As soon as the factor XII dissolved in the plasma has surfaces other than that If the endothelium comes into contact with the blood, it is activated (Xlla) and thus starts the so-called "endogenous system". The plasma factors XI, XIa, IX, IXa, VIII, Ca 2+ and a platelet factor (TF3) are also part of the endogenous system involved, which ultimately induce the proteolytic conversion of prothrombin to thrombin by the activated factor Xa.
Thrombin wirkt dann auf Fibrinogen ein, welches dadurch zunächst in monomeres lösliches Fibrin umgewandelt wird und nachfolgend unter dem Einfluss von Faktor XIII und Ca2+ zu stabilen Fibringerinnseln polymerisiert und dabei Verletzungen abdichtet.Thrombin then acts on fibrinogen, which is thereby first converted into monomeric soluble fibrin and subsequently polymerized to stable fibrin clots under the influence of factor XIII and Ca 2+ , thereby sealing off injuries.
Der gesamte Vorgang der Blutgerinnung dauert im ungestörten System 3 bis 5 Minuten und damit zu lange, um bei großflächigen oder stark blutenden Wunden tatsächlich einen erhöhten Blutverlust zu vermeiden.The entire process of blood coagulation takes 3 to 5 minutes in the undisturbed system and thus too long to actually prevent increased blood loss in large-area or heavily bleeding wounds.
Zur Versorgung von blutenden Wunden werden daher verschiedenen Methoden und Substanzen eingesetzt.Various methods and substances are therefore used to treat bleeding wounds.
In der einfachsten Form werden sterile Tücher, Kompressen oder ähnliche Materialien in Form von Verbänden auf eine Wunde aufgebracht. Durch die Saugfähigkeit des Verbandmaterials wird dabei die Blutungsgeschwindigkeit im Wundbereich verringert, sodass die natürlich einsetzende Blutgerinnung ausreicht, um eine Wunde zu verschließen.In its simplest form, sterile cloths, compresses or similar materials are applied to a wound in the form of bandages. The absorbent capacity of the dressing material reduces the bleeding speed in the wound area so that the naturally occurring blood clotting is sufficient to close a wound.
Bei stark blutenden Wunden kommen Wundabdeckungen, wie z.B. die TachoComb® Wundabdeckung (Hafslund Nycomed Pharma) , die aus einer Kollagenmatrix, welche mit gerinnungsfordernden Substanzen einseitig oder allseitig beschichtet ist, besteht, zum Einsatz. Als hochwirksame gerinnungsfordernde Substanzen werden z.B. das aus Rinderblut gewonnene Thrombin und das aus menschlichen Blut gewonnene Fibrinogen eingesetzt.In the case of heavily bleeding wounds, wound coverings, such as the TachoComb® wound cover (Hafslund Nycomed Pharma), which consists of a collagen matrix which is coated on one side or on all sides with coagulation-requiring substances, are used. As highly effective coagulant substances For example, thrombin obtained from bovine blood and fibrinogen obtained from human blood are used.
Da jedoch die Verwendung von menschlichen Bestandteilen wegen einer erhöhten Gefahr der Krankheitsübertragung als gravierender Nachteil betrachtet wird, gab es Bestrebungen fibrinogen-freie Wundabdeckungen herzustellen.However, since the use of human components is considered a serious disadvantage due to an increased risk of disease transmission, efforts have been made to produce fibrinogen-free wound covers.
Aus US 5,645,849 ist z.B. eine solche fibrinogen-freie Wundabdeckung, bestehend aus einer biologisch abbaubaren und absorbierbaren Matrix bekannt, die nur mit Thrombin und einem Hemmstoff der Fibrinolyse, Epsilon-Aminocapronsäure (EACE) , beschichtet ist. Diese Wundabdeckung eignet sich für stark bis pulsierend blutenden Wunden, denn US 5,645,849 gibt als eine weitere Funktion der EACA an, dass durch Erhöhung des pH- Wertes die Aktivierung des verfügbaren Thrombins in der Wundablage beschleunigt wird.From US 5,645,849 e.g. such a fibrinogen-free wound covering, consisting of a biodegradable and absorbable matrix, which is coated only with thrombin and an inhibitor of fibrinolysis, epsilon-aminocaproic acid (EACE). This wound covering is suitable for wounds that bleed heavily to pulsating, because US 5,645,849 specifies as a further function of the EACA that the activation of the available thrombin in the wound deposit is accelerated by increasing the pH.
Nach wie vor ist bei solchen Wundabdeckungen die Verwendung von tierischen Bestandteilen, z.B. Thrombin, problematisch. Zum einen besteht das erhebliche Risiko der Übertragung von für den Menschen gefährlichen Krankheiten wie z.B. BSE (Bovine Spongiforme Encephalitis) , zum anderen ist die Gewinnung von Blutgerinnungsfaktoren aus tierischem Material aufwendig und teuer. Ein weiterer Nachteil ist, dass Wundabdeckungen, die tierisches Thrombin enthalten, besonders gelagert werden müssen, um ein vorzeitiges Verderben zu verhindern.The use of animal constituents, e.g. Thrombin, problematic. On the one hand, there is a considerable risk of transmission of diseases that are dangerous to humans, e.g. BSE (Bovine Spongiform Encephalitis), on the other hand, the extraction of blood coagulation factors from animal material is complex and expensive. Another disadvantage is that wound coverings containing animal thrombin must be specially stored to prevent premature spoilage.
Ein entscheidender Nachteil der bekannten Wundabdeckungen ist auch ihre mangelhafte Anpassung an die individuellen Oberflächenstrukturen bzw. Ausdehnungen einer Wunde. Insbesondere großflächige oder tiefe, nässende oder nachblutende Wunden können nicht optimal mit den bekannten, in ihrer Struktur festgelegten Wundabdeckungen versorgt werden. Es ist daher Aufgabe der Erfindung, eine pharmazeutische Zusammensetzung zur Wundversorgung bereitzustellen, die keine menschlichen oder tierischen Bestandteile enthält und eine individuelle Versorgung und Abdeckung großflächiger, tiefer oder tiefliegender Wunden bei gleichzeitiger Hemmung von Sicker- oder Nachblutungen ermöglicht.A decisive disadvantage of the known wound covers is also their inadequate adaptation to the individual surface structures or dimensions of a wound. In particular, large or deep, oozing or bleeding wounds cannot be optimally treated with the known wound covers, which are defined in their structure. It is therefore an object of the invention to provide a pharmaceutical composition for wound care which does not contain any human or animal constituents and which enables individual care and coverage of large, deep or deep-lying wounds while at the same time preventing seepage or subsequent bleeding.
Diese Aufgabe wird durch das Bereitstellen einer flüssigen, gelartigen oder gelatinösen pharmazeutischen Zusammensetzung erreicht, welche die Blutgerinnung mittels synthetischer Katalysatoren, insbesondere pharmazeutisch annehmbarer Säuren, beschleunigt und welche sich flächig über die Wunde und/oder in die Wunde sprühen oder schäumen lässt.This object is achieved by providing a liquid, gel-like or gelatinous pharmaceutical composition which accelerates blood coagulation by means of synthetic catalysts, in particular pharmaceutically acceptable acids, and which can be sprayed or foamed over the wound and / or into the wound.
Die Konsistenz der Zusammensetzung wird dabei durch dieThe consistency of the composition is determined by the
Verwendung eines an Luft aushärtenden und/oder polymerisierenden organischen Trägermaterials oder Biopolymers bestimmt .Use of an air-curing and / or polymerizing organic carrier material or biopolymer determined.
Geeignete Trägermaterialien zur Herstellung sind dabei Gelatine- oder Collagenverbindungen, Zellulose-Sulfat, Calzium- und/oder Calzium/Sodium-Alginat, Kautschuk sowie auf Äthylen, Propen, Buten, Isobutylen, Butadien, Isopren, Maleinsäure, Propylenhydrogenmaleat und/oder Methylacrylat basierende Polymeren. Es ist dem Fachmann bekannt, wie diese Materialien zu verarbeiten sind, um die gewünschte Konsistenz einzustellen und so die erfindungsmäßige Zusammensetzung herzustellen. Ebenso ist dem Fachmann bekannt, welche Gase oder Schäummittel in geeigneten Dispensern oder Zerstäubern zuzusetzen sind, um die erfindungsmäßige Zusammensetzung situationsgerecht applizieren zu können. Durch die zunächst flüssige oder zumindest formbare Konsistenz der Zusammensetzung wird gewährleistet, dass die gerinnungsfördernden Katalysatoren nicht nur außen auf die Wunde aufgelegt werden, sondern auch an allen Stellen innerhalb der Wunde eine optimale Bereitstellung der gerinnungsfördernden Faktoren und damit Katalyse der Blutgerinnung möglich wird.Suitable carrier materials for the production are gelatin or collagen compounds, cellulose sulfate, calcium and / or calcium / sodium alginate, rubber and polymers based on ethylene, propene, butene, isobutylene, butadiene, isoprene, maleic acid, propylene hydrogen maleate and / or methyl acrylate , It is known to the person skilled in the art how to process these materials in order to set the desired consistency and thus to produce the composition according to the invention. Likewise, the person skilled in the art knows which gases or foaming agents are to be added in suitable dispensers or atomizers in order to be able to apply the composition according to the invention in a manner appropriate to the situation. The initially liquid or at least mouldable consistency of the composition ensures that the coagulation-promoting catalysts are not only placed on the outside of the wound, but also that the coagulation-promoting factors are optimally provided at all points within the wound and thus blood coagulation can be catalyzed.
Darüber hinaus erlaubt das Aufsprühen und/oder Aufschäumen der erfindungsgemäßen Zusammensetzung in der Wunde bzw. auf die Wunde eine deutlich verbesserte und damit individuell besser angepasste Wundversorgung.In addition, the spraying and / or foaming of the composition according to the invention in the wound or on the wound allows a significantly improved and thus individually better adapted wound care.
Bei leichteren Blutungen oder nässenden Wunden wird hierbei eine dünne Schicht der erfindungsgemäßen Zusammensetzung auf die Wunde aufgesprüht werden. Falls die Verletzung in Teilbereichen stärker blutet, können solche Teilbereiche intensiver besprüht werden, sodass eine dickere und damit länger haltbare Schicht der erfindungsgemäßen Zusammen-setzung die Wunde abdeckt.In the case of lighter bleeding or oozing wounds, a thin layer of the composition according to the invention will be sprayed onto the wound. If the injury bleeds more heavily in partial areas, such partial areas can be sprayed more intensively, so that a thicker and therefore longer-lasting layer of the composition according to the invention covers the wound.
Für intensive Blutungen oder tiefe Verletzungen wird die erfindungsgemäße Zusammensetzung in Form einer dicken und aufgrund der schwammartigen Oberflächenstruktur auch saugfähigen Schaumhülle in die Wunde gelegt. Das Blut versickert so zunächst in der schwammartigen Schaumhülle, wobei es überall mit dem gerinnungsfördernden Katalysator in Berührung kommt. Durch das Versickern wird zum einen eine größere Oberfläche für die Katalyse bereitgestellt, gleichzeitig aber auch ein Wegschwemmen der erfindungsgemäßen Zusammensetzung verhindert.For intensive bleeding or deep injuries, the composition according to the invention is placed in the wound in the form of a thick and, due to the spongy surface structure, also absorbent foam casing. The blood then seeps away in the sponge-like foam shell, where it comes into contact with the coagulation-promoting catalyst everywhere. The infiltration firstly provides a larger surface for the catalysis, but at the same time prevents the composition according to the invention from washing away.
Für den Einsatz bei im Innenbereichen liegenden Wunden oder Organverletzungen ist das Trägermaterial oder Biopolymer vorzugsweise nicht immunogen, jedoch absorbierbar und biologisch abbaubar, sodass es nachdem die Blutung gestillt ist, nicht entfernt werden muss, sondern langsam zersetzt wird.The backing material or biopolymer is suitable for use in wounds or organ injuries lying inside preferably not immunogenic, but absorbable and biodegradable, so that it does not have to be removed after the bleeding has stopped, but rather is slowly decomposed.
Für die Behandlung von äußeren Verletzungen kommt vorzugsweise eine Kombination aus absorbierbarem, biologisch abbaubarem, aber auch nicht-abbaubarem synthetischen, organischen Materialen oder Polymeren zum Einsatz. Bei einer solchen Kombination lösen sich, nachdem die Blutung gestillt ist, die wundnahen Bereiche vermehrt auf, wodurch die übrigen Bestandteile der Zusammensetzung leicht zu entfernen sind.A combination of absorbable, biodegradable, but also non-degradable synthetic, organic materials or polymers is preferably used for the treatment of external injuries. With such a combination, after the bleeding has stopped, the areas close to the wound dissolve, making the other constituents of the composition easy to remove.
Optional können Verletzungen, die mit der erfindungsgemäßen Zusammensetzung behandelt wurden, sobald der Schutzfilm beginnt sich zu festigen und/oder auszuhärten, mit herkömlichen Verbandsmaterialien eingebunden werden.As an option, injuries which have been treated with the composition according to the invention as soon as the protective film begins to harden and / or harden can be incorporated with conventional dressing materials.
Die erfindungsgemäße Zusammensetzung enthält einen gerinnungsfördernden, synthetischen Katalysator, insbesondere eine pharmazeutisch annehmbare Säure, welche den pH-Wert im Wundbereich um 0.1 bis 3 heraufsetzt. Vorzugsweise werden hierfür Säuren oder Lysinanaloga z.B. die auch hochwirksame Hemmstoffe der Fibrinolyse sind, nämlich Epsilon- Aminocapronsäure (EACA) , p-Aminomethylbenzoesäure (PAMBA) oder Tranexamsäure (AMCHA) oder analoge Substanzen, eingesetzt.The composition according to the invention contains a coagulation-promoting, synthetic catalyst, in particular a pharmaceutically acceptable acid, which increases the pH in the wound area by 0.1 to 3. Acids or lysine analogs, e.g. which are also highly effective inhibitors of fibrinolysis, namely epsilon-aminocaproic acid (EACA), p-aminomethylbenzoic acid (PAMBA) or tranexamic acid (AMCHA) or similar substances.
Im Rahmen der Erfindung durchgeführte Untersuchungen haben ergeben, dass selbst stärker blutende Wunden erfolgreich mit der erfindungsgemäßen Zusammensetzung versorgt und abgedeckt werden können, da die Zugabe von pharmazeutisch annehmbaren Säuren, insbesondere von EACA, ein Wegschwemmen der aufgesprühten Zusammensetzung beträchtlich vermindert. Gemäß weiterer Ausführungsformen kann die erfindungsgemäße Zusammensetzung als weitere gerinnungsfördernde und damit vorteilhafte Komponenten Calziumdonatoren, insbesondere CaCl2 und/oder Substanzen, welche die Wirkung von Heparin oder Vitamin-K-Antagonisten neutralisieren, insbesondere Protaminsulfat, enthalten.Studies carried out within the scope of the invention have shown that even heavily bleeding wounds can be successfully treated and covered with the composition according to the invention, since the addition of pharmaceutically acceptable acids, in particular EACA, considerably reduces washing away of the sprayed-on composition. According to further embodiments, the composition according to the invention can contain calcium donors, in particular CaCl 2 and / or substances which neutralize the action of heparin or vitamin K antagonists, in particular protamine sulfate, as further coagulation-promoting and thus advantageous components.
Eine bevorzugte Verwendung der erfindungsgemäßen Zusammensetzung ist in der Erstversorgung von Wunden bei Mensch und Tier nach Unfällen oder Operationen. Hier besonders zur Abdeckung und Ausgleich von Organdefekten, bei welchen dies mit körpereigenem Gewebematerial nicht möglich ist und besonders das Risiko der Nachblutung besteht.A preferred use of the composition according to the invention is in the initial care of wounds in humans and animals after accidents or operations. Here, in particular, to cover and compensate for organ defects where this is not possible with the body's own tissue material and where there is a particular risk of subsequent bleeding.
Ein einfaches Aufsprühen oder Einschäumen der Wunde mit der erfindungsgemäßen Zusammensetzung stoppt oder verringert wenigstens dabei einen schleichenden Blutverlust oder Blutungen an großflächigen oder tiefen Wunden.A simple spraying or foaming of the wound with the composition according to the invention stops or at least reduces creeping blood loss or bleeding on large or deep wounds.
Eine weitere bevorzugte Verwendung der ' erfindungsgemäßen Zusammensetzung ist bei und während Operationen gegeben, um ein Einbluten des Operationsortes aus verletzen Geweben durch Einsprühen oder Einschäumen zu verringern.Another preferred use of the 'composition according to the invention is given in and during surgery, to reduce a hemorrhaging the surgical site from injure tissues by spraying or foaming.
Schließlich wird die erfindungsgemäße Zusammensetzung auch bevorzugt in der Nachversorgung von großflächigen, schlecht heilenden, nässenden, nachblutenden Wunden bei Mensch und Tier eingesetzt .Finally, the composition according to the invention is also preferably used in the aftercare of large, poorly healing, oozing, bleeding wounds in humans and animals.
Ohne dass Verbände nötig sind, kann mit der erfindungsgemäßen Zusammensetzung eine sichere, sterile und blutungsstillende Wundversorgung sowohl in der Erstversorgung, während Operationen als auch in der Nachversorgung bereitgestellt werden. Without the need for bandages, the composition according to the invention can be used to provide safe, sterile and hemostatic wound care both in primary care, during operations and in aftercare.

Claims

Ansprüche Expectations
1. Zusammensetzung zur Wundversorgung in Form einer Flüssigkeit und/oder eines Gels enthaltend einen synthetischen Katalysator, welcher die1. Composition for wound care in the form of a liquid and / or a gel containing a synthetic catalyst, which the
Blutgerinnung fördert und welcher ausgewählt ist aus der Gruppe der pharmazeutisch annehmbaren Säuren und/oder Lysinanaloga; ein an Luft aushärtendes und/oder polymerisierendes organisches Material; sowie wenigstens einen pharmazeutisch annehmbarenPromotes blood clotting and which is selected from the group of pharmaceutically acceptable acids and / or lysine analogs; an air-curing and / or polymerizing organic material; and at least one pharmaceutically acceptable one
Träger oder Verdünner.Carrier or thinner.
2. Zusammensetzung nach Anspruch 1, wobei die Flüssigkeit und/oder das Gel sprühbar und/oder schäumbar ist.2. Composition according to claim 1, wherein the liquid and / or the gel is sprayable and / or foamable.
3. Zusammensetzung nach Anspruch 1 oder 2, wobei das organische Material nicht immunogen, aber absorbierbar und biologisch abbaubar oder nicht abbaubar ist.3. The composition of claim 1 or 2, wherein the organic material is not immunogenic, but is absorbable and biodegradable or non-degradable.
4. Zusammensetzung nach einem der Ansprüche 1 bis 3, wobei der synthetische Katalysator eine pharmazeutisch annehmbare Säure ist, die den pH Wert im Wundbereich um 0,1 - 3 anhebt.4. The composition according to any one of claims 1 to 3, wherein the synthetic catalyst is a pharmaceutically acceptable acid that raises the pH in the wound area by 0.1-3.
5. Zusammensetzung nach einem der Ansprüche 1 bis 4, wobei der synthetische Katalysator Epsilon-Aminocapronsäure (EACA) , p-Aminomethylbenzoesäure (PAMBA) und/oder Transexamsäure (AMCHA) ist.5. Composition according to one of claims 1 to 4, wherein the synthetic catalyst is epsilon-aminocaproic acid (EACA), p-aminomethylbenzoic acid (PAMBA) and / or transexamic acid (AMCHA).
6. Zusammensetzung nach einem der Ansprüche 1 bis 5, wobei 0.1 bis 300 mg/ml Epsilon-Aminocapronsäure (EACA) eingesetzt werden. 6. Composition according to one of claims 1 to 5, wherein 0.1 to 300 mg / ml epsilon-aminocaproic acid (EACA) are used.
7. Zusammensetzung nach einem der Ansprüche 1 bis 6 enthaltend einen Calciumdonator, vorzugsweise Calciumclorid.7. Composition according to one of claims 1 to 6 containing a calcium donor, preferably calcium chloride.
8. Zusammensetzung nach einem der Ansprüche 1 bis 7 enthaltend Protaminsulfat und/oder Substanzen, welche die Wirkung von Heparin und Vitamin K-Antagonisten neutralisieren.8. Composition according to one of claims 1 to 7 containing protamine sulfate and / or substances which neutralize the action of heparin and vitamin K antagonists.
9. Zusammensetzung nach einem der Ansprüche 1 bis 8 als Arzneimittel oder Medizinprodukt zur Behandlung von Blutungen, Nachblutungen oder Sickerblutungen.9. Composition according to one of claims 1 to 8 as a medicament or medical product for the treatment of bleeding, post-bleeding or seepage bleeding.
10. Dispenser oder Zerstäuber enthaltend die Zusammensetzung nach einem der Ansprüche 1 bis 9. 10. Dispenser or atomizer containing the composition according to one of claims 1 to 9.
PCT/EP2003/014163 2002-12-16 2003-12-12 Haemostatic wound dressing WO2004054632A1 (en)

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