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WO2018191800A1 - Dispositif pour l'application de biopolymères de fibrine - Google Patents

Dispositif pour l'application de biopolymères de fibrine Download PDF

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Publication number
WO2018191800A1
WO2018191800A1 PCT/BR2018/050099 BR2018050099W WO2018191800A1 WO 2018191800 A1 WO2018191800 A1 WO 2018191800A1 BR 2018050099 W BR2018050099 W BR 2018050099W WO 2018191800 A1 WO2018191800 A1 WO 2018191800A1
Authority
WO
WIPO (PCT)
Prior art keywords
components
biopolymer
fibrine
application device
biopolymers
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/BR2018/050099
Other languages
English (en)
Portuguese (pt)
Inventor
Moacyr RAMOS BIGHETTI
Ana Silvia SARTORI BARRAVIERA SEABRA FERREIRA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kaivo Pesquisa E Desenvolvimento Em Saude Ltda
Original Assignee
Kaivo Pesquisa E Desenvolvimento Em Saude Ltda
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.)
Filing date
Publication date
Application filed by Kaivo Pesquisa E Desenvolvimento Em Saude Ltda filed Critical Kaivo Pesquisa E Desenvolvimento Em Saude Ltda
Publication of WO2018191800A1 publication Critical patent/WO2018191800A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices 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
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/10—Polypeptides; Proteins
    • 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
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00495—Surgical glue applicators for two-component glue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/04—Liquids
    • A61M2202/0413—Blood
    • A61M2202/0445—Proteins
    • A61M2202/0447—Glycoproteins
    • A61M2202/045—Fibrin

Definitions

  • the present invention relates to a novel device for applying fibrin biopolymers, and more specifically for applying fibrin biopolymers consisting of two or more components that need to be mixed only at the time of use. More particularly, but not restrictively, the invented applicator device is intended for the application of fibrin biopolymers obtained exclusively from materials of animal origin, notably:. purified thrombin-like snake venom, or the use of the same component from its synthesis in the laboratory by methods known to science (produced by recombinant technology to extract its active synthetic form from from prokaryotic organisms, eg bacteria, or eukaryotes, eg fungi and yeast, or other methods for the same purpose); and //.
  • Said applicator device can be purchased commercially in pharmacies without the need for a prescription, and allows the user to apply the fibrin biopolymer topically without the assistance of a specialized medical professional.
  • some medicines are made up of two or more biological components which necessarily have to be mixed only at the time of application to achieve certain properties.
  • An example of such a medicine is fibrin biopolymers obtained from human blood, long known in the art. Said biopolymers are used in surgical procedures, with the purpose of reducing the bleeding and provide a firm grip between the tissues.
  • Fibrin is a natural biopolymer which has bioactivity, biocompatibility and biodegradability as characteristics. Because they provide excellent tissue sealing and bonding properties, such fibrin biopolymers have commonly been called fibrin "sealants” or "glues”.
  • fibrin biopolymers Since the 1970s, several new proposals for fibrin biopolymers have been developed, also involving the mixing of these two components (fibrinogen and thrombin), but only one of them continues to be extracted from humans (fibrinogen). , while human thrombin was replaced by bovine thrombin or snake venom purified thrombin.
  • fibrin biopolymer is that described in BR PI 9103724-7, published 30/03/1993, concerning a "COBRA POIS DERIVATED FIBRIN ADHESIVE FOR PREPARATION".
  • the fibrin glue consisted of two solutions, one consisting of a fibrinogen-rich cryoprecipitate obtained from fresh human plasma, and the other consisting of a fraction of lyophilized snake venom.
  • fibrin biopolymers already known in the art are those described in WO 2007/121748, published 11/01/2007, and US 9,446,166, published 7/24/2014.
  • fibrin biopolymer the fibrinogen-containing cryoprecipitate
  • the two components human fibrinogen and thrombin
  • the two components must be kept frozen at negative 20 ° C in order not to lose their properties, and at the time of use the biopolymer must be thawed and mixed .
  • applicator devices are also known in the art, formed either by two communicable chambers, or by two contiguous syringes, each comprising one of the biopolymer components, as well as by a mixing chamber capable of mix them when applying the biopolymer to the surface of the tissue or organ to be treated;
  • Such devices also need to be stored in freezers to keep frozen components inside.
  • these devices can only be handled by medical professionals (doctors or nurses) who are already used to operating surgical instruments.
  • fluidization is the process by which solid particles are transformed into liquid state by suspending them in a gas or liquid.
  • a carrier gas preferably carbon dioxide or nitrogen
  • a solution preferably water
  • such components are injected into a microtube, where the powder and liquid or gas come into contact and are mixed. The resulting mixture is then sprayed from the tip of the microtube to the body site to be treated.
  • Said fibrin biopolymers known in the art being obtained from human blood, present a number of problems.
  • One of them lies in the fact that human blood used in biopolymer production can contain contaminating factors, such as contagious viruses, among others, and can therefore be a potentially transmitting element of infectious diseases.
  • fibrin biopolymers are an expensive and scarce product that is handcrafted within laboratories on a very small scale, and which can be used only and only in hospital settings by skilled professionals in the field. doctor. Currently, this production only occurs in laboratories abroad, there is no production by the Brazilian national industry.
  • fibrin biopolymers to date have never been able to be a commercially available, commercially available end-consumer product that can be purchased as an over-the-counter (OTC) drug. , that is, a drug that could be purchased at points of sale (pharmacies and drugstores), without the need for medical prescription, or even prescription, but directly by the end consumer.
  • OTC over-the-counter
  • fibrin biopolymers because they are an extremely expensive and scarce product, are only available between the walls of hospital and university laboratories (and only produced abroad), where they are kept frozen, and only They are used when needed in major surgeries, in the hospital environment, where they are thawed shortly before their application by doctors or nurses during surgery.
  • fibrin biopolymer More recently, a fibrin biopolymer has been developed. in which not only thrombin but also fibrinogen came to be of animal origin. Such fibrin biopolymer is described in BR 10 2014 011436-0, published 23/02/2016, referring to a "FIBRINE SEALANT FOR TOPICAL USE, METHOD OF FORMATION OF THE SAME AND ITS USE".
  • the fibrin sealant provided therein is comprised of a serinoprotease purified from snake venom, a fibrinogen-rich cryoprecipitate extracted from large animals, preferably buffalo (buffalo), and a diluent. configured by calcium chloride.
  • a serinoprotease purified from snake venom a fibrinogen-rich cryoprecipitate extracted from large animals, preferably buffalo (buffalo)
  • a diluent. configured by calcium chloride.
  • the diluent is first injected into the vial containing serinoprotease and shaken and set aside. Using a syringe and needle, the whole contents of this vial (diluted serinoprotease) are aspirated. With another syringe and needle, aspirate the entire contents of the vial containing the cryoprecipitate. Topical application of the two components is then performed, with the two syringes in parallel and their respective bevels directed to the site to be treated, said components being polymerized "in situ" after being properly mixed.
  • Fibrin sealant described in that application BR 10 2014 01 1436-0 presents no risk of transmission of diseases transmitted by human blood, eliminating the disadvantage of conventional fibrin biopolymers being potential transmitters of infectious diseases.
  • the predicted fibrin sealant described in BR 10 2014 011436-0 has a highly coagulant effect, capable of clogging blood vessels, and thus stopping bleeding almost immediately, and still creates a skin film. It is transparent over the application site, which accelerates cell multiplication, facilitating tissue healing and recovery by stimulating the emergence of new blood vessels.
  • the fibrin sealant described in application BR 10 2014 011436-0 still requires that its components (serinoprotease purified from snake venom and cryoprecipitate (rich in fibrinogen extracted from large animals) are kept frozen until the time of use, thus continuing to limit the manufacture and use of the sealant solely and exclusively to hospital environments.
  • Such a device should have such features as to enable end-user acquisition of the biopolymer at the point of sale, without the need for medical prescription, and to enable the user to apply the biopolymer himself in a manner simple and easy without the assistance of any medical professional (doctor or nurse).
  • the Depositor has created this new "FIBRINE BIOPOLYMER APPLICATION DEVICE", which is configured by an adhesive bandage provided with a support element that is impregnated with one or more components of the biopolymer. Said support element is surmounted by an independent and watertight compartment, which houses a diluent liquid, whether or not equipped with one of the components of the biopolymer already diluted therein, which compartment is provided with appropriate release means capable of releasing the liquid outlet. contained in it.
  • the support member of said bandage is preferably impregnated with powder components. More particularly, the support member of said bandage is impregnated with two powdered components which may be serinoprotease purified from snake venom and fibrinogen rich cryoprecipitate extracted from large animals.
  • the applicator device is more specifically intended for the application of fibrin biopolymers consisting of components of animal origin only, notably:.
  • serinoprotease purified from snake venom or the use of the same component from its synthesis in the laboratory by methods known to science (produced by recombinant technology to extract its active synthetic form from from prokaryotic organisms, eg bacteria, or eukaryotes, eg fungi and yeast, or other methods for the same purpose); and //. the fibrinogen-rich cryoprecipitate extracted from large animals), said device thus lending more particularly, but not restrictively, to the application of the fibrin sealant described in BR 10 2014 011436-0.
  • said bandage is fixed over the wound to be treated, matching the support element already impregnated with the two components of the wound. biopolymer; Using the release means provided in the compartment above the support element, the diluent liquid contained therein is released to the said support, which upon contact with the components already provided. impregnated to the carrier causes the desired mixing of all components.
  • the diluent liquid is already released with one of the powdered components diluted therein to on said support, which liquid, upon contact with the other powder component already impregnated with the support element, also causes the desired mixing of all components.
  • fibrin compounds consisting of components of animal origin only (notably serinoprotease purified from snake venom and fibrinogen-rich cryoprecipitate extracted from large animals, components of fibrin sealant object of BR 10 2014 011436-0) .
  • the new applicator device will for the first time allow the supply of fibrin biopolymers in the form of an end product itself which can be manufactured on an industrial scale at low cost without requiring the freezing of its components, a product that will be commercially available at points of sale (pharmacies and drugstores), and which may be purchased and used by the consumer himself, outside the hospital, without the need for medical prescription, and without the presence of a specialized medical professional.
  • This product may be applied to general injuries, from minor cuts resulting from simple household accidents (knife cuts, razor blades, scratches, bruises, etc.) to large wounds, It is a highly effective product for stopping bleeding and accelerating tissue healing by stimulating the emergence of new blood vessels. DESCRIPTION OF DRAWINGS
  • Figure 1 is a schematic perspective view of the now-innovated fibrin biopolymer applicator device in a first embodiment
  • Figures 1A, 1B and 1C illustrate said device respectively through top view, side view and bottom view
  • Figure 2 is a schematic perspective view of the now-innovated fibrin biopolymer applicator device in a second embodiment
  • Figures 2A, 2B and 2C illustrate said device respectively through top view, side view and bottom view
  • Figure 3 is a schematic perspective view of the now innovated fibrin biopolymer applicator device in a third embodiment.
  • Figures 3A, 3B and 3C illustrate said device respectively through top view, side view and bottom view.
  • the present invention relates to a "FIBRINE BIOPOLYMER APPLICATION DEVICE", which device (1) is formed by an adhesive bandage (2) of any suitable shape, including rectangular (as shown in Figure 1), square (as shown in Figure 2), circular (as shown in Figure 3), or the like, provided with an appropriate lower adhesive area, duly covered by one or more protective strips (3), said adhesive area surrounding a central support element (4) (for example a pad), which is impregnated with one or more fibrin biopolymer components, which components are preferably powdered.
  • an adhesive bandage (2) of any suitable shape, including rectangular (as shown in Figure 1), square (as shown in Figure 2), circular (as shown in Figure 3), or the like, provided with an appropriate lower adhesive area, duly covered by one or more protective strips (3), said adhesive area surrounding a central support element (4) (for example a pad), which is impregnated with one or more fibrin biopolymer components, which components are preferably powdered.
  • a compartment independent, watertight (5) in which a diluent liquid is provided, whether or not provided with one of the biopolymer components, also preferably in powder, already diluted therein, with a partition (5) provided with appropriate release (6) which, when actuated, release the release of said liquid and its deposition onto said support member (4).
  • said diluent liquid release means (6) stored in said compartment (5) are configured by a sealing seal that seals a predicted opening between said partitioned (5) and the support member ( 4), which seal, when ruptured, causes the pressure liquid to be expelled onto said support member (4) already impregnated with one or more biopolymer components, and, consequently, the removal of all components.
  • the support element (4) is impregnated with two powdered components, namely serinoprotease purified from snake venom and fibrinogen-rich cryoprecipitate extracted from large animals (components of the fibrin sealant object of document BR 10 2014 011436-0).
  • said support member (4) is impregnated with only one of the two with powdered components (the fibrinogen-rich cryoprecipitate extracted from large animals), while the other with a powdered component.
  • the powder (serinoprotease purified from snake venom) is diluted in the diluent liquid retained in the housing (5) disposed above said support member (4).
  • the protective strips (3) of the adhesive bandage (2) are first removed and the latter attached to the user's skin using the lower adhesive area provided therein, and the central support member (4) disposed with one or more of the fibrin biopolymer components just above of the wound to be treated.
  • the release means (6) provided in the compartment (5) above the support member (4) the outlet of the diluent liquid contained therein, whether or not provided or not, shall be released. of one of said components of the biopolymer already diluted therein, which liquid is deposited on said support element (4) already impregnated with one or more of the components, and then the mixture takes place between all the components.
  • the support element (4) is impregnated with both components of the fibrin sealant object of BR 10 2014 011436-0, namely serinoprotease purified from snake venom and fibrinogen-rich cryoprecipitate extracted from large animals, the mixture with components caused by the release of the diluent liquid on them causes the formation of a sealing and transparent film which, disposed over the wound, stops bleeding and accelerates tissue healing and recovery by stimulating the emergence of new blood vessels.
  • the support element (4) is impregnated with only one of said components, namely the brynogen-rich cryoprecipitate extracted from large animals, upon release of the diluent liquid with the another with a component already diluted in it, that is, serinoprotease purified from snake venom, also occurs between them with components, obtaining the same sealant and transparent film over the wound, capable of stopping the bleeding immediately , accelerating tissue healing and recovery by stimulating the emergence of new blood vessels.
  • said components namely the brynogen-rich cryoprecipitate extracted from large animals
  • the new applicator device more particularly is obtained the mixing and deposition of the components of fibrin biopolymers consisting exclusively of components of animal origin, with which it was possible for the first time to provide such biopolymers in the form of a final product itself, manufactured on an industrial scale, at a low cost, commercially available at points of sale (pharmacies and drugstores), and can be purchased and used by the consumer himself without the need for medical prescription, outside the hospital environment and without the presence of a specialized medical professional.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

L'invention concerne un dispositif pour l'application de biopolymères de fibrine, ces biopolymères étant constitués par deux ou plusieurs constituants qui ne doivent être mélangés qu'au moment de l'utilisation, ledit dispositif (1) étant constitué par un ruban adhésif (2) dont la zone inférieure adhésive, recouverte d'une ou plusieurs bandes protectrices (3), entoure un élément de support central (4) imprégné d'un ou de plusieurs constituants du biopolymère. Un compartiment indépendant et étanche (5) est prévu sur ledit élément de support central (4), ce compartiment renfermant un liquide diluant doté ou non de l'un desdits constituants du biopolymère y dilué, ledit compartiment (5) étant pourvu de moyens de libération appropriés (6) qui, lorsqu'ils sont actionnés, permettent la sortie dudit liquide et son dépôt sur l'élément de support (4).
PCT/BR2018/050099 2017-04-18 2018-04-12 Dispositif pour l'application de biopolymères de fibrine Ceased WO2018191800A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BR102017008024-2A BR102017008024B1 (pt) 2017-04-18 2017-04-18 Dispositivo para aplicação de biopolímeros de fibrina
BRBR102017008024-2 2017-04-18

Publications (1)

Publication Number Publication Date
WO2018191800A1 true WO2018191800A1 (fr) 2018-10-25

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Application Number Title Priority Date Filing Date
PCT/BR2018/050099 Ceased WO2018191800A1 (fr) 2017-04-18 2018-04-12 Dispositif pour l'application de biopolymères de fibrine

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BR (1) BR102017008024B1 (fr)
WO (1) WO2018191800A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4407787A (en) * 1980-10-03 1983-10-04 Dr. Ruhland Nachf. Gmbh Collagenous dressing
DE3409372A1 (de) * 1984-03-14 1985-09-19 Dr. Ruhland Nachf. GmbH, 8425 Neustadt Material zum vitalisieren von implantatoberflaechen
WO2008019126A2 (fr) * 2006-08-04 2008-02-14 Stb Lifesaving Technologies, Inc. Procédé de production de pansement solide pour le traitement de lésion tissulaire

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4407787A (en) * 1980-10-03 1983-10-04 Dr. Ruhland Nachf. Gmbh Collagenous dressing
DE3409372A1 (de) * 1984-03-14 1985-09-19 Dr. Ruhland Nachf. GmbH, 8425 Neustadt Material zum vitalisieren von implantatoberflaechen
WO2008019126A2 (fr) * 2006-08-04 2008-02-14 Stb Lifesaving Technologies, Inc. Procédé de production de pansement solide pour le traitement de lésion tissulaire

Also Published As

Publication number Publication date
BR102017008024A2 (pt) 2018-10-30
BR102017008024B1 (pt) 2022-10-04

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