BRPI0805157A2

BRPI0805157A2 - method for obtaining a prosthesis from an animal biological structure and prosthesis obtained from an animal biological structure

Info

Publication number: BRPI0805157A2
Authority: BR
Inventors: Miguel Angel Maluf
Original assignee: Clinicar Servicos De Assistenc
Priority date: 2008-11-11
Filing date: 2008-11-11
Publication date: 2010-08-17

Abstract

MéTODO PARA OBTER UMA PRóTESE A PARTIR DE UMA ESTRUTURA BIOLóGICA ANIMAL E PRóTESE OBTIDA A PARTIR DE UMA ESTRUTURA BIOLóGICA ANIMAL. Sendo que o referido método compreende. essencialmente, as fases de: A) Obtenção do material; B) Coleta do material; C) Fase de fixação; D) Montagem da prótese; e E) Fase de conservação, ao passo que as próteses compreendem: a) uma Prótese Bivalvular Pulmonar Suma: b) um Conduto Valvulado Pulmonar Suíno; c) uma Prótese Pulmonar Suma; e d) uma Prótese Valvulada Pulmonar Suma com Flap. Todas as próteses são obtidas com material biológico que parte de estruturas biológicas sumas devidamente tratadas e montadas de modo a permitir que as mesmas possam ser adequadamente transplantadas para pacientes humanos em fase pediátrica.METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE AND PROSTHESIS OBTAINED FROM AN ANIMAL BIOLOGICAL STRUCTURE. Wherein said method comprises. essentially, the phases of: A) Obtaining the material; B) Material collection; C) Fixation phase; D) Assembly of the prosthesis; and E) Preservation phase, whereas the prostheses comprise: a) a Short Pulmonary Bivalvular Prosthesis: b) a Swine Pulmonary Valve Conduit; c) a short lung prosthesis; and d) a Flap Short Pulmonary Valve Prosthesis. All prostheses are obtained from biological material that is derived from properly treated and prepared biological biological structures to allow them to be adequately transplanted to human pediatric patients.

Description

"MÉTODO PARA OBTER UMA PRÓTESE A PARTIR DEUMA ESTRUTURA BIOLÓGICA ANIMAL E PRÓTESE OBTIDA A PARTIR DEUMA ESTRUTURA BIOLÓGICA ANIMAL"."METHOD FOR OBTAINING PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE AND PROSTHESIS OBTAINED FROM AN ANIMAL BIOLOGICAL STRUCTURE".

A presente invenção tem como um de seus objetivosprimordiais propor um método destinado a servir de modo de obtenção de umaprótese feita a partir de uma estrutura biológica animal a ser empregada emprocedimentos médicos (cirúrgicos) tais como os que visam a resolução deproblemas funcionais relacionados às malformações cardíacas que dão origemartérias pulmonares em pacientes humanos em Atresia pulmonar, definida comoa obstrução total das mencionadas artérias pulmonares ou nos casos deinsuficiência pulmonar, caracterizada pela ausência da valva pulmonar.The present invention has as one of its primary objectives to propose a method for obtaining a prosthesis made from an animal biological structure to be employed by medical (surgical) procedures such as the resolution of functional problems related to cardiac malformations. which give rise to pulmonary arteries in human patients with pulmonary atresia, defined as total obstruction of the aforementioned pulmonary arteries or in cases of pulmonary insufficiency, characterized by the absence of the pulmonary valve.

É também um dos objetivos da presente invenção a proteçãoà prótese obtida a partir de uma estrutura biológica animal, a qual apresentacaracterísticas desejáveis tais como compatibilidade com o organismo receptoralém de ser eficiente no sentido de cumprir a função biológica da estruturaanatômica natural a que se destina a substituir.It is also an object of the present invention to protect the prosthesis obtained from an animal biological structure which has desirable characteristics such as compatibility with the recipient organism in addition to being efficient in fulfilling the biological function of the natural anatomical structure to which it is intended to replace. .

A presente invenção busca viabilizar um método de produçãode próteses que permita a obtenção de uma prótese feita a partir de umaestrutura biológica animal que é caracterizada por um conduto valvuladobiológico que é cirurgicamente implantado entre o Ventrículo Direito e asartérias pulmonares do paciente visando-se assim a correção da Atresia,prótese esta preferencialmente indicada para uso pediátrico.The present invention seeks to enable a method of prosthesis production that allows the obtention of a prosthesis made from an animal biological structure that is characterized by a valvulobiological conduit that is surgically implanted between the right ventricle and the patient's pulmonary arteries, thus aiming at correction. of Atresia, prosthesis is preferably indicated for pediatric use.

A presente invenção parte do estado da técnica quecontempla, por exemplo, próteses Aórticas Suínas montadas em suporte (parauso adulto); Válvula Pulmonar Suína junto a seu tronco pulmonar (para usopediátrico); Veia jugular Bovina com válvula (também para uso pediátrico); ePrótese de Pericárdio Bovino (também para uso adulto).O presente relatório descritivo trata de uma invenção queparte das técnicas conhecidas de aproveitamento de tecido pulmonar suíno,para prover o projeto e produção de próteses para a correção de malformaçãocardíaca em crianças, prevendo um primeiro modelo de prótese denominadocomo Prótese Bivalvular Pulmonar Suína; um segundo modelo denominadocomo Conduto Valvulado Pulmonar Suíno; um terceiro modelo denominadocomo Prótese Valvular Pulmonar Suína e um quarto e último modelodenominado como Prótese Valvular Pulmonar Suína com Flap1 os quais serãototalmente ilustrados e descritos.The present invention departs from the prior art which includes, for example, swivel-mounted Aortic prostheses (adult paraffin); Swine Pulmonary Valve near its pulmonary trunk (for pediatric use); Bovine jugular vein with valve (also for pediatric use); eBovine Pericardial Prosthesis (also for adult use). This descriptive report deals with an invention that departs from the known techniques of utilization of porcine pulmonary tissue, to provide the design and production of prostheses for the correction of cardiac malformation in children, providing for a first model. a prosthesis called as Swine Pulmonary Bivalvular Prosthesis; a second model called as porcine pulmonary valve conduit; a third model called as Swine Pulmonary Valve Prosthesis and a fourth and last model called Flap1 Swine Pulmonary Prosthesis which will be fully illustrated and described.

A presente invenção será descrita com referência às figurasabaixo relacionadas, nas quais:The present invention will be described with reference to the related figures below, in which:

As figuras 1 e 2 ilustram, respectivamente, duas fases demontagem da Prótese Bivalvular Pulmonar Suína;Figures 1 and 2 illustrate, respectively, two stages of swine pulmonary bivalvular prosthesis assembly;

As figuras 3, 4 e 5, ilustram, respectivamente, os doisestágios de montagem de um segundo modelo de prótese aqui descrito (figuras3 e 4), o qual é definido como um conduto valvulado pulmonar suíno, sendo quea figura 5 ilustra a referida prótese já finalizada;Figures 3, 4 and 5 illustrate, respectively, the two stages of assembly of a second prosthesis model described herein (figures 3 and 4), which is defined as a porcine pulmonary valve conduit, and which figure 5 illustrates said prosthesis. finished;

Já a figura 6 ilustra uma vista em perspectiva de uma prótesepulmonar suína, tal como a que também é tratada na presente invenção; eFigure 6 illustrates a perspective view of a swine prosthesis, such as that also treated in the present invention; and

As figuras 7, 8, 9 e 10 ilustram um último tipo da modalidadede prótese aqui descrita, a qual é definida como uma Prótese ValvuladaPulmonar Suína com Flap; sendo que na figura 7 é representado em linhapontilhada o recuo de 3 mm da borda do anel para a definição da linha de suturada prótese definida não figura 6.Figures 7, 8, 9 and 10 illustrate a last type of prosthesis embodiment described herein, which is defined as a Flap Swine Pulmonary Valve Prosthesis; In Figure 7, the 3 mm indentation of the rim of the ring for the definition of the suture line defined in Figure 7 is shown in dotted line.

De conformidade com o quanto ilustram as figuras acimarelacionadas, o objeto desta invenção prevê quatro modelos diferentes depróteses para emprego em correção de cardiopatias em pacientes pediátricos,sendo que, especificamente com relação às figuras 1 e 2, são retratados osdetalhes da Prótese Bivalvular Pulmonar Suína, a qual é obtida por um métodoque prevê as etapas de: A) Obtenção do material; B) Coleta do material; C) Fasede fixação; D) Montagem da prótese; e E) Fase de conservação.According to what the above figures illustrate, the object of this invention provides four different models for use in the correction of heart disease in pediatric patients. Specifically with respect to Figures 1 and 2, the details of the Swine Pulmonary Bivalvular Prosthesis are depicted. which is obtained by a method which provides for the steps of: A) Obtaining the material; B) Material collection; C) Fixing stage; D) Assembly of the prosthesis; and E) Conservation phase.

A obtenção do material (fase A) demanda a obtenção decorações de suínos abatidos em frigoríficos que são estabelecimentosespecialmente selecionados e credenciados, os quais passam por rigorososprocedimentos de fiscalização.Obtaining the material (phase A) requires the decoration of slaughtered pigs in refrigerators that are specially selected and accredited establishments, which undergo rigorous inspection procedures.

A fase de coleta do material parte do ponto em que, após tersido removido o coração suíno dentro de critérios de assepsia, compreende-se:o estágio de limpeza, definido por uma primeira lavagem com água, tanto emtermos externos, quanto internos ao órgão; o estágio de transporte, onde oscorações coletados são acondicionados em um recipiente contendo soluçãohipertônica de NaCI, no qual é transportado para o laboratório a umatemperatura de 4o Centígrados, onde permanece por um período de não maiorque quatro horas.The material collection phase starts from the point where, after having removed the swine heart within aseptic criteria, it is understood: the cleaning stage, defined by a first wash with water, both external and internal to the organ; The transport stage, where the collected hearts are packed in a container containing NaCI hypertonic solution, where it is transported to the laboratory at a temperature of 4 ° C, where it remains for a period of no more than four hours.

No laboratório ocorre o estágio de tratamento do tecido ondeé realizada a retirada do tronco pulmonar junto à sua válvula, extraindo-a doinfundíbulo do ventrículo direito, preservando-se a fina camada de músculopresente ao redor do anel fibroso.In the laboratory there is the stage of treatment of the tissue where the pulmonary trunk is removed next to its valve, extracting it from the right ventricular infundibulum, preserving the thin layer of muscle present around the fibrous ring.

Na etapa de fixação, todo o material preparado é submetido auma solução de glutaraldehido a 0,5%, visando assim curtir o tronco pulmonar,mantendo o alinhamento ou paralelismo dos feixes colágenos, de modo a nãopermitir o estiramento ou alteração da sua ondulação natural. Dessa forma otecido tem a devida elasticidade mecânica necessária para o seu corretofuncionamento dentro da estrutura da prótese.In the fixation stage, all prepared material is submitted to a 0.5% glutaraldehyde solution, thus aiming to shorten the pulmonary trunk, maintaining the alignment or parallelism of the collagen bundles, so as not to allow stretching or alteration of their natural undulation. Thus the fabric has the proper mechanical elasticity necessary for its proper functioning within the prosthesis structure.

A fase de montagem é realizada em ambiente apropriado,mediante emprego de técnica estéril, onde, tal como o retratado nas figuras 1 e2, são: a) utilizados dois segmentos de tronco pulmonar, um com uma válvula(indicado pela referência numérica 1) e outro sem válvula (indicado pelareferência numérica 2), sendo que ambos apresentam a mesma medida dediâmetro: b) em ambos os casos os enxertos são abertos longitudinalmente,sendo que o enxerto que tem válvula (indicado como 1) tem ressecado umsegmento de parede junto à válvula; c) de forma análoga é ressecado osegmento de parede do outro enxerto (indicado como 2), guardando as mesmasproporções; d) o enxerto bi-valvulado aberto é submetido à inclusão de umalinha de sutura 3 no segmento valvulado, mediante emprego de fio dePolipropileno 5-0, seguindo a borda de inserção das duas válvulas no anel, nasua fase cônica, tal como está melhor retratado na figura 1; e) sendo que omesmo ocorre também através da inclusão da linha de sutura 4 efetuada na faseconvexa, tal como pode ser melhor entendido através da observação da figura 2;e f) é previsto então que o enxerto (identificado pelo seu diâmetro inicial), sejaconservado em formaldehido ou outro agente anticalcificante, sendo destinado àembalagem.The assembly phase is carried out in an appropriate environment using a sterile technique, where, as shown in figures 1 and 2, a) two pulmonary trunk segments are used, one with a valve (indicated by numerical reference 1) and another without valve (indicated by numerical reference 2), both of which have the same measurement of diameter: b) in both cases the grafts are opened longitudinally, and the graft that has valve (indicated as 1) has resected a wall segment near the valve; c) analogously resects the wall segment of the other graft (indicated as 2), keeping the same proportions; d) the open bi-valve graft is subjected to the inclusion of a suture line 3 in the valve segment, using 5-0 Polypropylene thread, following the insertion edge of the two valves in the ring, in its conical phase, as best shown. in figure 1; e) whereas the same also occurs through the inclusion of the suture line 4 made in the faseconvex, as can be better understood from the observation of figure 2, and f) it is then predicted that the graft (identified by its initial diameter) will be preserved in formaldehyde or other anti-calcifying agent and is intended for packaging.

A etapa de conservação prevê o tratamento do tecido comuma solução oxidante especial, para retirar substâncias antigênicas, impurezas,resíduos celulares, além de aumentar a sua resistência. Em seguida, os tecidossão submetidos a uma solução conservadora de formaldehido a 4% ou outroagente anticalcificante.The preservation stage provides for the treatment of the tissue with a special oxidizing solution to remove antigenic substances, impurities, cellular debris and increase its resistance. The tissues are then subjected to a conservative 4% formaldehyde solution or other anti-calcifying agent.

O método acima descrito viabiliza a obtenção de uma prótese,a qual compreende um enxerto bivalvulado pulmonar porcino, o qual é, emessência, formado por dois segmentos, tronco pulmonar, um com válvula 1 eoutro sem válvula 2, de mesmos diâmetros, abertos longitudinalmente, sendoque ambos têm um dos segmentos da parede ressecado, o segmento valvulado1 tendo ressecamento junto de uma das válvulas, sendo suturados um ao outroem ambas as fases e seguindo a borda de inserção das duas válvulas no anel,de modo a compor duas fases, que são: uma côncava contendo as duasválvulas inseridas num anel fibro muscular e suturado 3 ao segmento proximal,que apresenta as mesmas dimensões em largura e comprimento e uma faseconvexa que mostra a linha de sutura 4 na junção da porção próxima e distai.The method described above makes it possible to obtain a prosthesis, which comprises a porcine bivalvular pulmonary graft, which is formed by two segments, pulmonary trunk, one with valve 1 and one without valve 2, of the same diameter, longitudinally open, both of which have one of the segments of the parched wall, the valve segment1 having dryness next to one of the valves, being sutured to each other in both phases and following the insertion edge of the two valves in the ring, in order to compose two phases, which are : a concave containing the two valves inserted into a fibro muscular ring and sutured 3 to the proximal segment, which has the same dimensions in width and length and a convex shaft showing the suture line 4 at the junction of the proximal and distal portion.

Já as figuras 3, 4 e 5 da presente invenção retratam oconduto valvulado pulmonar suíno, o quai é obtido pelo mesmo métodoanteriormente descrito com relação à prótese bivalvular pulmonar suína, ondesão previstas as etapas de: A) Obtenção do material; B) Coleta do material; C)Fase de fixação; D) Montagem da prótese; e E) Fase de conservação.Figures 3, 4 and 5 of the present invention depict the porcine pulmonary valve conduit, which is obtained by the same method previously described with respect to the porcine pulmonary bivalvular prosthesis, where the steps of: A) Obtaining the material; B) Material collection; C) Fixation phase; D) Assembly of the prosthesis; and E) Conservation phase.

No caso do segundo modelo de prótese tratado na presenteinvenção, a fase de montagem é realizada em ambiente apropriado, com técnicaestéril e, no caso do conduto valvulado pulmonar suíno (figuras 3 a 5),compreende: a) o uso de dois segmentos de tronco pulmonar, sendo um dotadocom válvula de diâmetro conhecido 5 e outro sem válvula 6, sendo que esteúltimo de diâmetro de 2 a 4 mm maior que o do primeiro segmento: b) no enxertosem válvula 6, é evertida a borda do enxerto de maior diâmetro 7 e telescopadono anel fibro muscular 8 do enxerto valvulado, tal como o retratado na figura 3;c) empregando fio Polipropileno 5-0, é feita uma primeira sutura interna 9englobando a borda evertida de um segmento por um lado e o anel valvular pelooutro, tal como o retratado na figura 4; e finalmente, a borda evertida édesdobrada sendo suturados os dois enxertos com sutura externa 10, tal como odemonstrado na figura 4.In the case of the second prosthesis model treated in the present invention, the assembly phase is performed in an appropriate environment with sterile technique and, in the case of the porcine pulmonary valve conduit (Figures 3 to 5), it comprises: a) the use of two trunk segments one with a valve of known diameter 5 and one without a valve 6, the latter having a diameter of 2 to 4 mm larger than that of the first segment: b) in the graft without valve 6, the edge of the largest diameter graft is everted 7 and telescoping in the fibro muscular ring 8 of the valve graft, as depicted in Figure 3, c) employing 5-0 Polypropylene thread, a first internal suture 9 engaging the everted edge of one segment on one side and the valve ring on the other as as depicted in figure 4; and finally, the everted edge is unfolded and the two external suture grafts 10 are sutured, as shown in figure 4.

A fase de conservação, tal como o verificado no caso daprimeira prótese, é feito colocando-a em solução de formaldehido a 4% ou outroagente anticalcificante.The preservation phase, as in the case of the first prosthesis, is done by placing it in a 4% formaldehyde solution or other anti-calcifying agent.

A prótese obtida compreende um conduto valvulado pulmonarsuíno formado por dois segmentos de tronco pulmonar, um indicado pelareferência numérica 5, dotado com válvula, e outro, indicado pela referêncianumérica 6, sem tal válvula, sendo que este último conta com diâmetroligeiramente maior que o diâmetro do outro; uma sutura interna 9 que liga, porum lado, borda do enxerto de maior diâmetro do segundo não valvulado e, pelooutro lado, o anel valvular 8 do segmento valvulado 5; uma sutura externa 10que liga os dois enxertos, de forma a definir uma prótese tubular, com discretacurvatura, formada por terço proximal com extremo proximal biselado e diâmetrodiscretamente maior ao próprio anel, terço médio onde se encontra o anel e aválvula, cujo diâmetro é uso para identificar a prótese e terço distai queacompanha o diâmetro do anel dotado de extremo distai biselado.The prosthesis obtained comprises a pulmonary pulmonary valve conduit formed by two pulmonary trunk segments, one indicated by numerical reference 5, with valve, and another, indicated by numerical reference 6, without such valve, the latter having a diameter slightly larger than the diameter of the other; an internal suture 9 that connects, on the one hand, the edge of the larger diameter graft of the second non-valve and, on the other hand, the valve ring 8 of the valve segment 5; an external suture 10 that connects the two grafts to define a discreturvature tubular prosthesis, formed by a proximal third with a beveled proximal end and a slightly larger diameter to the ring itself, the middle third where the ring and valve are located, whose diameter is used to identify the prosthesis and distal third that matches the diameter of the beveled distal ring.

A figura 6 ilustra a Prótese Valvular Pulmonar Suína, a qual éum dos tipos de prótese abordada por esta invenção.Figure 6 illustrates the Swine Pulmonary Valve Prosthesis, which is one of the types of prosthesis addressed by this invention.

A prótese Valvular Pulmonar Suína é utilizada na substituiçãoda válvula pulmonar humana quando a continuidade Ventrículo direito - válvulapulmonar (via de saída do ventrículo direito) é uniforme, não havendo estenose(estreitamento).The Swine Pulmonary Valve prosthesis is used to replace the human pulmonary valve when the continuity Right ventricle - pulmonary valve (right ventricular outflow tract) is uniform, with no stenosis (narrowing).

A prótese da figura 6 pode ser utilizada nas seguintessituações: a) ausência de válvula pulmonar; b) procedimentos cirúrgicos parasubstituir uma prótese danificada, calcificadas, com trombose ou com infecção.The prosthesis of figure 6 can be used in the following situations: a) absence of pulmonary valve; b) surgical procedures to replace a damaged, calcified, thrombotic or infected prosthesis.

No caso da presente prótese, em não havendo bocasanastomóticas e apenas a implantação da prótese no próprio anel pulmonar dopaciente, haverá menor chance de estenose (estreitamento), na sua evoluçãoem médio prazo.In the case of the present prosthesis, if there are no mouths and only the implantation of the prosthesis in the patient's own pulmonary ring, there will be less chance of stenosis (narrowing) in its evolution in the medium term.

A prótese da figura 6 corresponde à porção do anel valvularda artéria pulmonar suína 11, constituída por um anel fibroso 12; válvulas 13inseridas no referido anel; parede 14 da artéria pulmonar com seu extremoventricular e o extremo pulmonar 15.The prosthesis of Figure 6 corresponds to the portion of the porcine pulmonary artery valvulard ring 11, consisting of a fibrous ring 12; valves 13 inserted in said ring; pulmonary artery wall 14 with its extremoventricular and pulmonary extremity 15.

A montagem da presente prótese compreende a sutura deuma fita de pericárdio bovino 16, a qual é fixada por uma linha de sutura 17 aoanel 12 da prótese, em forma da aba, o qual tem como objetivo servir de apoioaos pontos de sutura que são utilizados para o seu implante no anel dopaciente.The assembly of the present prosthesis comprises suturing a bovine pericardium tape 16 which is fixed by a suture line 17 to the flap-shaped prosthesis ring 12 which is intended to support the suture points that are used to your implant in the patient ring.

A prótese da figura 6 é obtida pelas mesmas etapasnecessárias e descritas com relação aos dois primeiros modelos, ou seja, A)Obtenção do material; B) Coleta do material; C) Fase de fixação; D) Montagemda prótese; e E) Fase de conservação.The prosthesis of figure 6 is obtained by the same steps required and described in relation to the first two models, that is, A) Obtaining the material; B) Material collection; C) Fixation phase; D) Prosthesis assembly; and E) Conservation phase.

Com relação à etapa de coleta o material biológico (coraçãosuíno) é acondicionado em um recipiente contendo solução hipertônica de NaCI,tal como o verificado nas duas primeiras próteses, porém com acréscimo deMgSO4 - 8 milimols, solução essa tamponada em um pH de 7,4, com tampãofosfato 0,13 M, no qual é transportado para o laboratório a uma temperatura de4o Centígrados, onde permanece por um período de não maior que quatrohoras.Regarding the collection stage, the biological material (heart) is placed in a container containing hypertonic NaCI solution, as verified in the first two prostheses, but with an addition of MgSO4 - 8 millimols, a buffered solution with a pH of 7.4. , with 0.13 M phosphate buffer, which is transported to the laboratory at a temperature of 40 ° C, where it remains for a period of no more than four hours.

No laboratório é realizada a retirada do tronco pulmonar juntoà sua válvula, extraindo-a do infundíbulo do ventrículo direito, preservando-se afina camada de músculo presente ao redor do anel fibroso.In the laboratory, the pulmonary trunk is removed near its valve, extracting it from the right ventricular infundibulum, preserving the thin layer of muscle around the fibrous ring.

A montagem da prótese retratada na figura 6 obedece aosmesmos requisitos e segue as mesmas fases relatadas com respeito aos doismodelos precedentes, sendo que a borda do anel da prótese nesse casoapresenta-se 3mm acima, conforme representado em linha pontilhada na figura 7.The assembly of the prosthesis depicted in Figure 6 meets the same requirements and follows the same phases reported with respect to the two preceding models, with the edge of the prosthesis ring in this case being 3mm above, as shown in a dotted line in Figure 7.

As figuras 7, 8, 9 e 10 ilustram o quarto modelo de próteseproposto por esta Patente de Invenção, o qual é uma Prótese ValvuladaPulmonar Suína com Flap, a qual parte de dois segmentos de tronco pulmonar,um dotado com válvula 18 e outro sem tais válvulas, indicado pela referêncianumérica 19.Figures 7, 8, 9 and 10 illustrate the fourth model of prosthesis proposed by this invention, which is a Flap Swine Pulmonary Valve Prosthesis, which starts from two pulmonary trunk segments, one provided with valve 18 and the other without such. valves, indicated by reference number 19.

Na presente prótese a mensuração do anel valvular é feitacom um dilatador de Hegar, sendo necessário, para a montagem da prótese,que o segmento valvulado tenha uma medida de diâmetro de 4 a 6 milímetrosmaior do que o segmento não valvulado.In the present prosthesis the measurement of the valve annulus is made with a Hegar dilator, being necessary, for the prosthesis assembly, that the valve segment has a diameter measurement of 4 to 6 millimeters larger than the non-valve segment.

Tal como o retratado na figura 8 a prótese valvulada dotadacom flap é constituída por telescopagem dos dois segmentos de troncopulmonar suíno, um deles tendo as já citadas válvulas, que são indicadas pelareferência numérica 20, sendo que a junção dos dois troncos é feita pelos seusextremos proximais e após everter-se a borda 22 do segmento não valvulado 19,efetua-se a sutura interna 21 com chuleio de pontos passados com fio depolipropileno 5-0, tal como o retratado na figura 8.As shown in Figure 8, the flap valve prosthesis is made by telescoping the two swine trunk segments, one of which has the aforementioned valves, which are indicated by the numerical reference 20, and the joining of the two trunks is made by their proximal ends. and after changing the edge 22 of the non-valved segment 19, the internal suture 21 is made with stitching with 5-0 polypropylene thread, as shown in Figure 8.

A figura 9 ilustra o estágio onde a borda evertida 22 édesdobrada, momento em que é realizada a sutura externa 23, permitindo assimque a mesma fique adequadamente hemostática.Figure 9 illustrates the stage where the everted edge 22 is unfolded, at which time the external suture 23 is performed, thus allowing it to be properly hemostatic.

A figura 10 retrata o estágio acabado da prótese, onde osflaps 24 são feitos em cada um dos segmentos de tronco pulmonar 18 e 19,sendo um flap executado no extremo proximal e outro no extremo distai daprótese, os quais são aproveitados para uma anastomose mais ampla ao níveldo tronco pulmonar e parede livre do ventrículo direito, evitando-se assimestenose da boca anastomótica.Figure 10 depicts the finished stage of the prosthesis, where flaps 24 are made in each of the pulmonary trunk segments 18 and 19, one flap being performed at the proximal end and the other at the distal end of the prosthesis, which are used for a wider anastomosis. at the level of the pulmonary trunk and free wall of the right ventricle, thus avoiding anastomotic mouth stenosis.

A prótese retratada nas figuras 7, 8, 9 e 10 apresentam, emrelação ao conduto valvulado a vantagem de contar com os flaps 24 no extremopulmonar e ventricular, os quais permitem, tal como já informado, a realizaçãode uma boca anastomótica ampla, além de apresentar menor chance dedesenvolvimento de estenose (estreitamento), que ocorre com relativafreqüência na evolução a médio prazo nos condutos valvulados.The prosthesis depicted in figures 7, 8, 9 and 10 show, in relation to the valve conduit, the advantage of having flaps 24 in the pulmonary and ventricular extremities, which, as already informed, allow the accomplishment of a wide anastomotic mouth, besides presenting lower chance of development of stenosis (narrowing), which occurs with relative frequency in the medium term evolution in the valvular conduits.

A prótese com flaps apresenta ainda a vantagem de terpropiciar menor turbilhonamento do fluxo sangüíneo, com redução do "stress" deabertura e fechamento da válvula, além de apresentar uma expectativa de maiordurabilidade, menor incidência de ruptura e menor chance de ocorrência detrombose.The flap prosthesis also has the advantage of having less blood flow whirling, reducing the stress of opening and closing the valve, as well as having an expectation of greater flexibility, lower incidence of rupture and lower chance of occurrence of thrombosis.

Claims

1. "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE", characterized by the fact that it comprises the phases of: A) Obtaining the material; B) Material collection; C) Fixation phase; D) Assembly of the prosthesis; and E) Conservation phase.

2 .- "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE", as claimed in 1, characterized by the fact that the phase of obtaining the material (phase A) requires obtaining hearts of swine slaughtered in refrigerators that are specially established. selected and accredited, which undergo rigorous inspection procedures; The material collection phase (phase B) starts from the point where, after the heart has been removed within aseptic criteria, the stages of: cleaning defined by a first wash with water, both externally and internally, are understood. ; transport stage, where the collected hearts are adequately packed for transport to the laboratory, where the appropriate treatment occurs, and for this stage, the use of NaCl hypertonic solution, maintenance of adequate pH 7.4 parameters and 4-centigrade temperature; tissue treatment stage, where the pulmonary trunk, together with its valve, is removed from the heart, drying the pulmonary ring, inserted into the RVOT musculature; the material fixation phase (phase C) is carried out in 0.5% glutaraldehyde and anti-calcifying agent prior to assembly; the prosthesis assembly phase (phase D) is performed in an appropriate environment, using a sterile technique, where: a) pulmonary trunk segments are used, one with a valve (1) and one without a valve (2), both of which have the same diameter measurement; b) in both cases the grafts are opened longitudinally, with the valve-grafted graft (i1) having a wall segment resected near the valve; c) analogously, the wall segment of the other graft (2) is resected, keeping the same proportions; d) the open bivalved graft is subjected to the inclusion of a suture line (3) in the valve segment, using 5-0 Polypropylene thread, following the insertion edge of the two valves in the ring in its conical phase; e) the same also occurs through the inclusion of suture line (4) made in the convex phase; and (f) it is then envisaged that the graft, which is identified by its initial diameter, will be preserved in formaldehyde and intended for packaging; The Conservation phase (phase E) foresees the use of 4% formaldehyde after the prosthesis assembly.

3. - "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE" as claimed in 1 and 2. characterized by the fact that the method for obtaining a prosthesis from an animal biological structure is used to enable obtaining a bivalvular prosthesis. swine lung.

4. "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE" as claimed in 1 and 2, characterized in that the method for obtaining a prosthesis from an animal biological structure is used to obtain a porcine pulmonary conduction valve.

5. - "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE", as claimed in 2, and 4, characterized by the fact that in the case of the second model of prosthesis which is constituted as a porcine pulmonary valve conduit, Assembly is carried out in an appropriate environment using a sterile technique and comprises: a) The use of two pulmonary trunk segments, one with a known diameter valve (5) and the other without a valve (6), the latter having a diameter between 2 4 mm larger than that of the first segment: b) a valve-free graft (6), the edge of the larger diameter graft (7) and a screwed on the fibro muscle ring (8) of the valve graft is c), using a polypropylene fiode 5- 0, a first internal suture (9) comprising the reversed edge of one segment on one side and the valve annulus on the other is performed, and finally, the everted edge is unfolded and the two grafts with external suture (10) are sutured;It is made by placing the prosthesis in 4% deformed solution or other anti-calcifying agent.

6. "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE" as claimed in 1, characterized in that the method for obtaining a prosthesis from an animal biological structure comprises the steps of: A) obtaining the material ; B) material collection; C) fixing phase; D) prosthesis assembly; and E) preservation phase, being used to enable the obtention of the PulmonarySuine Prosthesis, where the prosthesis corresponds to the portion of the valvular ring of the porcine pulmonary artery (11), consisting of a fibrous ring (12); valves (13) inserted in said ring; pulmonary artery wall (14) with its ventricular end and the pulmonary end (15); The assembly of the present prosthesis comprises suturing a bovine pericardium tape (16), which is fixed by a suture line (17) to the ring (12) of the prosthesis, in the shape of the flap, which acts as a support to the suture points. that are used for its implant in the patient's ring; In the present method, in relation to the collection stage of the biological material (phase A), the swine heart is packed in a container containing the hypertonic NaCI solution, but with MgS04 - 8 millimols added, a buffered solution with a pH of 7.4, with 0.13 M phosphate buffer, which is transported to the laboratory at a temperature of 4 ° C, where it remains for a period not exceeding four hours; In the laboratory, the pulmonary trunk is removed from its valve, extracting it from the right ventricular infundibulum, preserving the thin layer of muscle present around the fibrous ring; In the fixation stage, all the prepared material is submitted to a 0.5% glutaraldehyde solution, aiming at shortening the pulmonary trunk, maintaining the alignment or parallelism of the beam-collagen so as not to allow the stretching or alteration of its natural undulation; The preservation stage (phase E) provides for the treatment of tissue with an oxidizing solution, which removes antigenic substances, impurities, cellular residues, in addition to increasing its resistance; The tissues are then subjected to a 4% conservative solution of formaldehyde or other anticalifying agent.

7. "METHOD FOR OBTAINING A PROSTHESIS FROM AN ANIMAL BIOLOGICAL STRUCTURE" as claimed in 1, characterized in that the method for obtaining a prosthesis from an animal biological structure comprises the phases of: the phases of: A ) obtaining the material; B) material collection; C) fixing phase; D) prosthesis assembly; and E) preservation phase, being used to enable the obtaining of Flap1 Swine Pulmonary Valve Prosthesis which part of two segments of trunk, one with valve (18) and one without such valves, indicated by numerical reference (19); In the present prosthesis, the measurement of the annular valve is made with a Hegar dilator. For the assembly of the prosthesis, it is necessary that the valve segment has a diameter measurement between 4 and 6 mm larger than the non-valve segment; The flap-valved prosthesis is made by telescoping the two segments of the swine trunk, one of them having the aforementioned valves, which are indicated by numerical reference (20), where the joining of the two trunks is made by their proximal extremities and after ever changing. the edge (22) of the non-valvular segment (19), the internal suture (21) is made with the stitching of 5-0 polypropylene thread; the stage where the everted edge (22) is unfolded is the moment the external suture is performed (23), thus allowing the same to be properly hemostatic, the finished stage of the prosthesis is provided, where the flaps (24) are made in each one. of the trunk segments (18) and (19), with a flap performed at the proximal end and another at the distal end of the prosthesis, which are used for a wider anastomosis at the level of the pulmonary trunk and free wall of the right ventricle.

8. - "Prosthesis obtained from an animal structure", said prosthesis being a Swine BivalvularPulmonary Prosthesis obtained from a treated animal biological structure, which is characterized by the fact that it is structured from two truncopulmonary segments, one with one valve (1) and one without valve (2), both of which have the same diameter measurement; the valve graft (1) has dried a wall segment near the valve; the graft (2) has resected its wall segment; The open bivalvular graft has the inclusion of a suture line (3) in the valve segment, using 5-0 Polypropylene thread, following the insertion edge of the two valves in the ring, in its conical phase. prediction of the suture alignment (4) performed in the convex phase

9 .- 'PROSTHESIS OBTAINED FROM AN ANIMAL STRUCTURE', said prosthesis being a Swine Pulmonary Valve Conduit obtained from a treated animal biological structure, which is characterized by the fact that it is structured from the use of two segments of the pulmonary trunk, one having a valve of known diameter (5) and another without valve (6), the latter having a diameter of 2 to 4 mm larger than that of the first segment, the graft without valve (6) has everted the edge of the larger diameter graft. (7) and being telescoped into the muscular fibro ring (8) of the valve graft, it has a first internal suture (9) made with 5-0 polypropylene thread, encompassing the everted edge of one segment on one side and the valve ring on the other; The present prosthesis has its everted edge unfolded and the two grafts with external suture sutured (10).

10. - "Prosthesis obtained from an animal structure", said prosthesis being a Swine Pulmonary Prosthesis obtained from a treated animal biological structure, which is characterized by the fact that it is structured from the portion of the valve ring of the porcine pulmonary artery ( 11) consisting of a fibrous ring (12); valves (13) inserted in said ring; pulmonary artery wall (14) with its ventricular end and the pulmonary end (15); A bovine pericardium tape (16) is provided, which is fixed by a suture line (17) to the flap ring (12) of the prosthesis, which is intended to support the suture points that are used for the your implant in the patient's ring.

11.- "PROSTHESIS OBTAINED FROM AN ANIMAL STRUCTURE", said prosthesis being a Flap Swine Pulmonary Valve Prosthesis obtained from a treated animal biological structure which is characterized by being structured from two segments of pulmonary trunk, one endowed with valve (18) and one without such valves, indicated by the numerical reference (19), the valve segment having a diameter of 4 to 6 millimeters larger than the non-valve segment; The flap valve prosthesis is made by telescoping the porcine pulmonary trunk dissegments, one of them having the aforementioned valves, which are indicated by the numerical reference (20), and the junction of the doistroncos is made by their proximal extremities and after everting the edge (22) of the non-valved segment (19) is incorporated into the internal suture (21) with flattening of stitches passed with 5-0 polypropylene thread; the everted edge (22) is unfolded, at which time the external suture is performed (23); the prosthesis has flaps (24) which are made in each of the pulmonary trunk segments (18) and (19), one flap being performed at the proximal end and the other at the extremity of the prosthesis.