BRPI0606896B1 - material de sustentação de prendedor cirúrgico, combinação compreendendo um prendedor cirúrgico, aparelho para facilitar o alinhamento e aplicação de um material de sustentação em uma superfície de trabalho de um prendedor cirúrgico e kit cirúrgico para facilitar a aplicação de um artigo de material de sustentação nas superfícies de trabalho justapostas de um prendedor cirúrgico - Google Patents
material de sustentação de prendedor cirúrgico, combinação compreendendo um prendedor cirúrgico, aparelho para facilitar o alinhamento e aplicação de um material de sustentação em uma superfície de trabalho de um prendedor cirúrgico e kit cirúrgico para facilitar a aplicação de um artigo de material de sustentação nas superfícies de trabalho justapostas de um prendedor cirúrgico Download PDFInfo
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Abstract
MATERIAL DE SUSTENTAÇÃO DE PRENDEDOR CIRÚRGICO. A presente invenção refere-se a um material de sustentação de linha de grampo tendo uma superfície adesiva, embalada, e fornecida em forma pronto para uso, estéril. O material pode ser usado para reajustar grampeadores cirúrgicos para fornecer uma linha de grampo aperfeiçoada, e com, facilidade de uso aperfeiçoada.
Description
[001] A presente invenção refere-se a um prendedor cirúrgico, e a materiais de sustentação adaptados para serem usados em combinação com tais prendedores cirúrgicos .
[002] Prendedores cirúrgicos são comumente usados em cirurgias para realizar uma variedade de funções, por exemplo para remover partes de órgãos (por exemplo, para ressecar tecido), para cortar através de órgãos e tecidos (transsecção), e para criar conexões entre as estruturas (para criar anastomoses). Uma variedade de prendedores cirúrgicos estão atualmente em uso e incluem aplicadores de presilhas, grampeadores cirúrgicos e outros dispositivos.
[003] Os grampeadores cirúrgicos são comumente usados em uma variedade de procedimentos cirúrgicos incluindo cirurgias vascular, bariátrica, urológica, ginecológica, torácica e pediátrica. Por exemplo, tal procedimento torácico é a redução de volume de pulmão, que resseca uma parte do pulmão para tratar enfisema e outras condições. Também, tal procedimento bariátrico é o procedimento de desvio gástrico, que resseca uma parte do estômago para criar um estômago menor para ajudar na perda de peso.
[004] Grampeadores cirúrgicos são também fornecidos em muitas formas, incluindo grampeadores lineares, grampeadores circulares, e grampeadores contornados ou curvados. Os grampeadores cirúrgicos comumente incluem um par de superficies de trabalho justapostas. No caso de um grampeador linear, dois mordentes justapostos são fornecidos, um prendendo um cartucho de grampos e outro sendo um elemento de bigorna contra o qual os grampos estão para serem disparados. Quando o grampeador é disparado, emite simultaneamente uma pluralidade de fileiras de grampos estreitamente espaçados do cartucho, e através do próprio tecido do paciente.
[005] Em alguns casos, vazamentos de ar e/ou fluido e/ou sangramento excessivo na linha de grampos foram relatados. O termo "linha de grampo" é usado aqui para se referir a qualquer fileira de tecido grampeado, e a linha de grampo pode ser linear, circular ou curvada, dependendo do tipo de grampeador usado. Vazamentos podem ocorrer na linha de corte, e/ou nos furos de grampo propriamente ditos. Frequentemente no caso de procedimentos torácicos, o tecido de pulmão doente é fino e friável e pode lacerar nos grampos na medida em que os pulmões tornam a inflar. Estes vazamentos de ar podem ser persistentes e podem estender a estada hospitalar de um paciente por semanas. Como um meio de aliviar estes problemas de vazamento, os cirurgiões frequentemente reforçam a linha de grampos aplicando um material de sustentação ou bandagem no local de grampeamento desejado, e grampeando através do material de sustentação. O material de sustentação fornece reforço ao tecido friável na medida em que reduz as mudanças de laceração de tecido na linha de grampos, e reduz a saida de grampos no tecido friável. O material de sustentação também cria uma linha de grampos mais forte para aumentar a segurança contra vazamentos de ar e/ou fluido e/ou sangramento excessivo, ambos durante a cirurgia e nas semanas cruciais que seguem.
[006] Uma variedade de materiais foi descrita para uso como materiais de sustentação de linha de grampo, incluindo aqueles formados de tecido especialmente tratado (por exemplo tecido pericárdico bovino), alginato, feltro poliglicólico, e materiais de marca Teflon, no entanto somente uma pequena quantidade tem sido considerada adequada para uso comercial. Estes materiais de sustentação são tipicamente montados em uma maneira liberável nas superficies de trabalho de um grampeador cirúrgico tal que no disparo, o tecido do paciente é intercalado entre as tiras de material de sustentação.
[007] Os materiais de sustentação são montados tipicamente de modo liberável nas superficies de trabalho de um grampeador cirúrgico tanto por meios mecânicos e/ou químicos. Em alguns casos, um adesivo é aplicado em uma ou ambas as superficies do grampeador propriamente dito, ou a uma superficie de um a tira de material de sustentação, e a tira é então aplicada na superficie de trabalho correspondente. Por exemplo, no caso de grampeadores lineares, o material de sustentação é frequentemente fixado com um adesivo em cada mordente justaposto. Adesivos comuns são tipicamente géis biocompativeis, que são aplicados ao material de sustentação propriamente dito, a fim de hidratar o material e criar uma ligação temporária entre o material e o grampeador.
[008] Em muitos casos, é em geral necessário alinhar e posicionar, de modo apropriado, a tira de material de sustentação nas superficies de trabalho do grampeador. Um material de sustentação alinhado de modo inapropriado frequentemente resulta em uma linha de grampos falhada. Os aparelhos que incluem um dispositivo de alinhamento foram desenvolvidos para ajudar um usuário a alinhar apropriadamente um material de sustentação nas superficies de trabalho de um grampeador. Por exemplo, tal aparelho é descrito na Patente U.S. N.° 5.752.965 do Requerente, o conteúdo interior da qual são incorporados aqui por referência.
[009] A invenção fornece um material de sustentação aperfeiçoado. Métodos correntes de posicionar o material de sustentação em uma superfície de trabalho de um grampeador envolvem tipicamente pelo menos duas etapas, uma etapa de aplicar um material adesivo no material de sustentação (ou a superfície de trabalho do grampeador cirúrgico) e então aplicar um material de sustentação na superfície de trabalho. A invenção torna possivel um método de uma etapa de aplicar um material de sustentação em uma superfície de trabalho de um grampeador. Também métodos correntes de alinhar o material de sustentação em uma superfície de trabalho de um grampeador não são a prova de falhas, mesmo com o uso de dispositivos de alinhamento. Frequentemente, quando um usuário aplica um adesivo tanto no material de sustentação quanto na peça de trabalho do grampeador, adesivo demais é aplicado. Este excesso de adesivo frequentemente faz a superfície de trabalho se tornar escorregadiça e o material de sustentação propriamente dito desliza ao longo da superfície e se torna desalinhado. Assim, a invenção também fornece um método de aplicar um material de sustentação em uma superfície de trabalho de um grampeador que reduz substancialmente os desalinhamentos resultantes da má aplicação do adesivo.
[0010] A figura 1 é uma vista em perspectiva mostrando um artigo de material de sustentação de acordo com uma modalidade da invenção.
[0011] A figura 2 é uma vista em perspectiva mostrando o método de engate entre um grampeador cirúrgico e dois artigos de material de sustentação de acordo com uma modalidade da invenção.
[0012] A figura 3a é uma vista parcialmente explodida de um aparelho de alinhamento adaptado para incorporar dois artigos de material de sustentação de acordo com uma modalidade da invenção.
[0013] A figura 3b é uma vista em seção transversal do aparelho na figura 3a tomado ao longo da linha 3B-3B.
[0014] A figura 4a é uma vista em perspectiva ilustrando o método de engate entre um grampeador cirúrgico e um aparelho de alinhamento que incorpora dois artigos de material de sustentação de acordo com uma modalidade da invenção.
[0015] A figura 4b é uma vista em seção transversal do aparelho da figura 4a tomada ao longo da linha 4B-4B.
[0016] Em algumas modalidades, a invenção fornece um material de sustentação de linha de sutura tendo pelo menos uma superficie adesiva, o material sendo embalado e fornecido em uma maneira que permite a superficie ser alinhada com e cobrir de modo liberável a superficie de trabalho de um prendedor cirúrgico. O termo "linha de sutura" é usado aqui para se referir a qualquer fileira de tecido suturado. A linha de sutura pode ser suturada usando grampos, presilhas e similares. Também, a linha de sutura pode ser linear, circular, curva ou de qualquer outro padrão ou desenho adequado dependendo do tipo de prendedor cirúrgico usado. O material de sustentação é adaptado para uso com qualquer prendedor cirúrgico conhecido na técnica. Nas modalidades preferidas, o prendedor cirúrgico de preferência compreende um grampeador cirúrgico, e mais preferivelmente compreende um grampeador linear.
[0017] Materiais de sustentação são frequentemente fornecidos na forma de uma tira ou outra configuração onde existem duas superficies maiores, uma superficie adaptada para entrar em contato com uma superficie de trabalho de um prendedor cirúrgico e a outra superficie adaptada para ser posicionada contra o tecido corporal. A superficie adesiva do material de sustentação é fornecida em uma superficie que entrará em contato com a superficie de trabalho do prendedor cirúrgico. O adesivo é também suficientemente pegajoso para permitir que o material, de preferência sem meios estranhos tais como luvas removíveis, cordões ou géis adicionados, sejam retidos na superficie de trabalho do prendedor cirúrgico durante o posicionamento do prendedor cirúrgico dentro do local cirúrgico, e então ser removido da superfície de trabalho na aplicação do prendedor cirúrgico.
[0018] Materiais de sustentação tendo pelo menos uma superfície adesiva fornecem várias vantagens, incluindo a habilidade de evitar a necessidade de uma etapa separada para aplicar um gel adesivo. Isto aperfeiçoa a facilidade de uso de carregar o material de sustentação dentro do prendedor cirúrgico porque os processos de carregamento de duas etapas correntemente usados são agora convertidos em um processo de carregamento de uma etapa. Além do mais, esta eliminação da segunda etapa ajuda a reduzir a má aplicação do adesivo pelo usuário.
[0019] O material de sustentação tendo pelo menos uma superfície adesiva pode ser compreendido de um material único ou um composto de dois ou mais dos mesmos ou diferentes materiais. Nas modalidades preferidas, o material de sustentação inclui pelo menos um material tendo resistência mecânica suficiente para reforçar uma linha de sutura (daqui em diante "material reforçado"). O compósito de materiais pode ser fornecido como um laminado de materiais, uma mistura homogênea de materiais, uma mistura graduada de materiais ou como outras formações adequadas.
[0020] O material reforçado pode também ser formado a partir de tecido sintético ou natural. Em certas modalidades, o material reforçado é formado a partir de tecido animal natural. Em alguns casos, o tecido animal natural é uma membrana fibro-serosa ou serosa. Em casos preferidos, o tecido animal natural é uma membrana fibro- serosa compreendendo pericárdio, de preferência pericárdio bovino. Em algumas modalidades, o tecido animal natural pode ser um tecido do tipo descrito em qualquer uma das Patentes U.S do próprio Requerente N° . 5.503.638, 5.575.803, 5.549.628, 6.468.313, 6.312.474 e 6.652.594, os conteúdos inteiros de cada uma das quais são incorporados aqui por referência.
[0021] Em casos particularmente preferidos, o material reforçado compreende pericárdio bovino tratado disponível dos cessionários do requerente e vendidos sob sua marca comercial Peri-Strips Dry®. O uso deste tipo particular de material é vantajoso em que tem uma densidade muito maior de colágeno que a maioria de outros tecidos conectivos e é reticulado com glutaraldeido. A alta densidade do pericárdio bovino fornece integridade estrutural aumentada em torno da linha de sutura e a reticulação com glutaraldeido é vantajosa em que diminui a antigenicidade do tecido, desse modo resultando em pouca ou nenhuma reação inflamatória com o tecido corporal adjacente. Em outra modalidade preferida da invenção, o material reforçado compreende pericárdio bovino tratado disponível do cessionário do requerente e vendido sob sua marca comercial Veritas®. Enquanto a modalidade preferida da presente invenção emprega pericárdio bovino como biomaterial de sustentação, é para ser facilmente entendido que outro pericárdio ou dura-máter adequado pode ser empregado, incluindo, mas não limitado a, equino, porco- espinho, ovino e ser humano, bem como materiais sintéticos biocompativeis.
[0022] Em uma modalidade preferida da presente invenção, o material reforçado compreende uma membrana lisa, densa e não porosa. Um tecido de pericárdio bovino reticulado. Por exemplo material Peri-Strips Dry® é um exemplo de tal membrana densa. Em outras modalidades, o material reforçado resiste ou substancialmente resiste a degradação in vivo. Por exemplo, tal material reforçado de preferência sofre pouca ou nenhuma hidrólise uma vez em contato com fluido corpóreo ou solução salina. O pericárdio bovino reticulado, por exemplo, material Peri-Strips Dry® é também um exemplo de um material que resiste à degradação in vivo. Em outros casos, é fornecido um material remodelável que é integrado dentro do tecido corporal circundante com o tempo. De preferência, o material remodelável compreende tecido animal não reticulado, por exemplo pericárdio bovino. O material Veritas® é um exemplo de tal material remodelável.
[0023] Em modalidades adicionais, o material reforçado exibe resistência à tração superior, resistência ao vazamento e resistência a ruptura. Por exemplo, o material de preferência tem uma resistência à tração pré-implante em que a carga de pico é pelo menos cerca de 2000 gramas, mais preferivelmente pelo menos cerca de 3000 gramas e otimamente pelo menos cerca de 4000 gramas. Em outros casos, o material tem uma resistência à tração pré-implante que não diminui significantemente com o tempo uma vez implantado in vivo. A resistência à tração pré-implante de um material pode ser medida usando um aparelho deteste de tração uniaxial MTS Q45. O material reforçado também de preferência tem uma pressão de vazamento de pelo menos cerca de 90 mmHg, mais preferivelmente pelo menos cerca de 150 mmHg. Em outras modalidades, o material reforçado tem uma pressão de ruptura de pelo menos cerca de 90 mmHg, mais preferivelmente pelo menos cerca de 150 mmHg e otimamente pelo menos cerca de 200 mmHg. A pressão de vazamento e a pressão de ruptura pode ser podem ser medida introduzindo corante azul em um lado da linha de sutura a uma taxa constante e então introduzindo pressão. A pressão de vazamento é a pressão em que vazamento do corante azul através da linha de sutura é observado. A pressão de ruptura é registrada quando a pressão atinge um platô ou cai abruptamente na medida em que a linha de sutura rompe. Pericárdio bovino reticulado, por exemplo, material Peri-Strips Dry® é também um exemplo de um material que exibe resistência à tração superior, resistência a vazamento e resistência a ruptura.
[0024] O material de sustentação pode ser fornecido com uma superfície adesiva em uma variedade de maneiras. Em algumas modalidades, o material de sustentação inclui um material único tendo propriedades adesivas por si mesmo. O material único também de preferência tem resistência mecânica suficiente para reforçar uma linha de sutura. Por exemplo, um filme de hidrogel pode ser fornecido como o material único, em que o hidrogel é fornecido com resistência mecânica suficiente. Neste caso, qualquer superfície do material de sustentação poderia ser fornecida como a superfície adesiva a ser contatada com uma superfície de trabalho de um prendedor cirúrgico.
[0025] Em outras modalidades, um material adesivo é pré-aplicado em uma superfície do material de sustentação (que pode incluir um material único ou composto de um ou mais materiais). Nestes casos, um ou mais materiais compreendendo material de sustentação em geral têm propriedades de reforço e sustentação em vez de propriedades adesivas, desde que um adesivo separado é pré-aplicado a uma superfície. No entanto, isto não é exigido e um ou mais materiais podem certamente incluir um material tendo propriedades adesivas. Neste caso, a superfície do reforço contendo adesivo pré-aplicado é fornecida como a superfície adesiva. O material adesivo é de preferência formado de uma superfície de uma camada de filme, embora outras configurações sejam também possíveis.
[0026] O adesivo pode ser pré-aplicado em uma ou mais superfícies do material de sustentação de acordo com qualquer um dos métodos conhecidos usando equipamento de revestimento e materiais convencionais. Métodos de revestimento adequados incluem, por exemplo, faca de ar, escova, calandra, fundição, cortina, imersão, extrusão, lâmina, faca, gravura, revestimento superficial ("kiss roll"), faca sobre cobertura ("knife over blanhet"), faca sobre rolo ("knife over roll"), gravura offset, rolo reverso, rolo de alisamento reverso, vareta, pulverizações, rolo de compressão, polimerização in vivo, e revestimento de resina em pó. Por sua vez, o material revestido pode estar em qualquer forma adequada, por exemplo, a forma de uma composição de resina em pó, treliça com base aquosa ou solvente, emulsão ou dispersão.
[0027] O adesivo pode ser aplicado em uma superfície, duas ou mais superfícies, ou a todas as superfícies do material de sustentação. Em casos onde o material de sustentação é poroso ou de outro modo capaz de ser saturado, o adesivo pode ser aplicado para saturar a sustentação inteira. De preferência, é aplicado hidrogel somente em um lado, com o lado oposto sendo deixado descoberto, ou tratado ou fornecido com um revestimento ou propriedades adequadas. O adesivo é de preferência aplicado a uma ou mais superficies como uma camada fina, por exemplo, entre cerca de 0,1 mm e cerca de 1,0 mm em espessura nominal, e mais preferivelmente entre cerca de 0,25 mm a cerca de 0,75 mm de espessura nominal
[0028] Uma variedade de materiais pode ser fornecida como o material adesivo. Em modalidades preferidas, o material adesivo compreende um gel biocompativel. Em modalidades particularmente preferidas, o material adesivo compreende um hidrogel, que pode também ser descrito como um gel polimérico contendo água. Hidrogéis adequados incluem aqueles baseados em hidrogéis naturais (por exemplo seda artificial, materiais celulósicos) e hidrogéis sintéticos, tais como estes metacrílico e acrilico, hidrogéis de acrilamida hidrogéis baseados em N- vinil-2-pirrolidona, hidrogéis complexos e carregados de polieletrólito, incluindo combinações, misturas e copolímeros dos mesmos. Os inventores descobriram que hidrogéis adequados fornecem uma combinação ótima de tais propriedades como adesão ao material de sustentação de escolha, adesão nas superficies de trabalho de um prendedor cirúrgico, flexibilidade, formação de contorno, biocompatibilidade, bioestabilidade, e habilidade de ser esterilizado.
[0029] Exemplos de hidrogéis adequados incluem aqueles disponíveis sob a marca registrada Aquatrix II® de Hydromer, Inc., uma corporação localizada em Branchburg, New Jersey. Em uma modalidade particularmente preferida, o hidrogel compreende um gel de poli(N-vinil lactam)quitosana. Tais géis são descritos nas Patentes U.S. N° . 6.379.702, 6.365.664, 6.121.375, 5.420.197, 5.258.421 e 5.156.601, os conteúdos inteiros de cada uma das quais são incorporados aqui por referência. Quitosana é uma quitina desacetilada, e é um polissacarideo linear de N-acetil-D-glucosamina desacetilada. Poli(N-vinil lactama)s tal como polivinilpirrolidona (PVP) têm sido usados em produtos farmacêuticos, em certos tipos de filmes, e em alguns produtos cosméticos. Podem ser usados para fornecer géis dermatologicamente compatíveis tendo uma propriedade absorvente hidrofilico e valores K de menos que 60. Tais materiais são de preferência géis hidrofilicos estáveis que compreendem uma combinação de quitosana neutralizada por ácido e um poli (N-vinil lactama) , com ou sem um plastificante, o poli(N-vinil lactama) tendo um valor K de menos que cerca de 60 e mais equivalentes de grupos ácidos de pelo menos cerca de 1,4.
[0030] Tais géis preferidos podem ser preparados misturando solução aquosa de poli(N-vinil lactama) e quitosana neutralizada por ácido em solução aquosa em uma relação de peso de poli(N-vinil lactama)/quitosana de cerca de 12/1 a cerca de 1/1, de preferência de cerca de 10/1 a cerca de 5/1, para formar uma combinação em cerca de 5% em peso a 40% em peso de concentração de polimero total, de preferência de cerca de 12,5%por peso a cerca de 25% em peso de concentração de polimero, e permitir que a combinação cure até que um gel seja formado.
[0031] Em algumas modalidades, a superfície adesiva tem uma resistência de adesivo predeterminada ou viscosidade, a resistência de adesivos predeterminada sendo reduzida quando a superfície adesiva é hidratada. Os termos "viscosidade" e "resistência de adesivo" são usados aqui para descrever a aderência do adesivo. A viscosidade de um adesivo é tipicamente a resistência de tração (medida em dinas) exercida pelo adesivo aderindo completamente nas duas superficies sendo separadas. Quanto maior a resistência de tração, maior a viscosidade do adesivo. Assim, quando o material adesivo está fora do corpo e em uma forma seca, tem viscosidade suficiente para evitar que o material de sustentação seja removido ou realinhado ao longo das superficies de trabalho do prendedor cirúrgico. Portanto, em casos preferidos, a superfície adesiva é embalada e fornecida em uma maneira que tem viscosidade suficiente para ser aplicada firmemente em uma superfície de trabalho de um prendedor cirúrgico, esta viscosidade sendo reduzida quando a superfície adesiva é posicionada dentro do local cirúrgico.
[0032] Em modalidades preferidas, o material adesivo desta invenção pode ser usado para distribuir um ou mais agentes bioativos, incluindo localmente no local de colocação, ou mais amplamente, incluindo sistematicamente através do paciente. Tais agentes bioativos podem servir para aperfeiçoar a função do adesivo propriamente dito e/ou podem servir a funções relacionadas ou não relacionadas dentro do corpo. Em uma modalidade, por exemplo, o adesivo pode ser usado grandemente como um dispositivo de distribuição bioativo, com sua função como um material de sustentação sendo auxiliar àquele. Em casos preferidos, são fornecidos um ou mais agentes bioativos que aperfeiçoariam a cura de tecidos grampeados ou de outro modo suturados. Exemplos de agentes bioativos de cura adequados incluem, mas não são limitados a antibióticos, agentes antiinflamatórios, fatores de crescimento, e citoquinas. Coagulantes podem também ser fornecidos para reduzir o sangramento, e sementes radiativas podem ser fornecidas para monitorar a localização do material de sustentação dentro do corpo.
[0033] Em algumas modalidades, a invenção também fornece combinações cirúrgicas, que incluem um material de sustentação de acordo com qualquer uma das modalidades já descritas. Por exemplo, em alguns casos, uma combinação incluindo um prendedor cirúrgico e pelo menos um artigo de material de sustentação é fornecido. Qualquer prendedor cirúrgico conhecido na técnica pode ser usado com esta combinação. Em modalidades preferidas, o prendedor cirúrgico de preferência compreende um grampeador cirúrgico, e mais preferivelmente compreende um grampeador linear. Em outros casos, uma combinação incluindo um aparelho para equipar um prendedor cirúrgico com um material de sustentação e pelo menos um artigo de material de sustentação é fornecido. Aparelhos adequados para equipar um prendedor cirúrgico com um material de sustentação são descritos nas Patentes U.S. N°. 5.752.965 e 6.656.193 e nas Publicações U.S. N° . 20040093029, 20030120284 e 20020165563, os conteúdos inteiros de cada um são aqui incorporados por referência. Tais aparelhos são úteis para dispor um ou mais artigos de material de sustentação em fixação liberável com as superficies de trabalho de um prendedor cirúrgico tal que os artigos são automaticamente alinhados com aquelas superficies. O pelo menos um artigo do material de sustentação pode ser fornecido como instalado dentro de um material de sustentação ou como um componente separado que é parte de um kit cirúrgico em que o material de sustentação é inserido dentro do aparelho no local cirúrgico.
[0034] Em certas modalidades, a invenção fornece métodos cirúrgicos de usar o material de sustentação. Os materiais de sustentação da invenção podem ser usados em uma variedade de cirurgias, incluindo cirurgias vascular, bariátrica, urológica, ginecologia, torácica e pediátrica. As cirurgias bariátricas comuns incluem desvio gástrico e curvatura gástrica. As cirurgias de desvio gástrico também incluem os seguintes tipos de cirurgias: desvio gástrico roux-en-y (RYGB), gastroplastia com faixas vertical, e diversão bilio-pancreática. As cirurgias torácicas comuns incluem blebectomias, bulectomias, resseção em cunha, segmentectomias, lobectomia, pneumonectomia, cirurgia de redução de volume de pulmão, e outras ressecções do pulmão e brônquio.
[0035] Um método cirúrgico da invenção em geral inclui fornecer um ou mais artigos de material de sustentação a uma superfície de trabalho de um prendedor cirúrgico, posicionar o prendedor cirúrgico em torno de uma seção do tecido corporal, e aplicar o prendedor para formar uma linha de sutura reforçada. Em casos onde o material adesivo prende a resistência adesiva quando hidratado in vivo, é desejável posicionar o prendedor cirúrgico em torno de uma seção do tecido corporal por um periodo de tempo longo bastante para hidratar o material adesivo de modo que os artigos de material de sustentação serão facilmente liberados das superficies de trabalho de prendedor cirúrgico.
[0036] O uso de material de sustentação desta invenção, será agora descrito com respeito a uma modalidade preferida da invenção que é ilustrada pelas figuras. A figura 1 ilustra um artigo de material de sustentação 100 tendo uma camada de material adesivo 105 pré-aplicada em uma superfície 103 do material reforçado 108. 0 material adesivo 105 compreende qualquer material adesivo adequado e o material reforçado 108 compreende qualquer material reforçado adequado. O material de sustentação 100 é dimensionado e configurado para ser posicionado e alinhado em um mordente de grampeador linear, com a superfície 103 contendo o adesivo 105 estando em contato direto com a superfície de mordente.
[0037] A figura 2 ilustra um grampeador cirúrgico linear genérico 46 tendo um mordente de suporte de cartucho de grampos 48 e um mordente de suporte de bigorna 50 se estendendo a partir de um cabo de duas partes, que por sua vez inclui uma parte móvel 52 e uma parte estacionária 54 que é pivotante e articulada de maneira removível em 56 na parte móvel. 0 mordente de suporte de cartucho 48 prende um corpo de cartucho (não mostrado) contendo uma pluralidade de grampos dispostos em fileiras orientados longitudinalmente ao mordente 48 em oposição a uma bigorna (não mostrada) suportada pelo mordente 50 quando os elementos 48 e 50 estão em sua posição fechada Dois artigos de material de sustentação 100a e 100b são fornecidos, dimensionados e formatados para montagem nas superficies de trabalho das parte 52 e 54 do dispositivo cirúrgico 46. Como ilustrado, o artigo 100a é posicionado de modo que sua camada de material adesivo pré-aplicado 105 é orientada para cima de modo a aderir na superfície de trabalho do mordente de suporte de cartucho 48. Igualmente, o artigo 100b é posicionado de modo que sua camada de material adesivo pré- aplicado 105 é orientada descendentemente de modo a aderir na superficie de trabalho do mordente de suporte de bigorna 50 .
[0038] As figuras 3a-3b mostram um aparelho 10 para equipar um prendedor cirúrgico com um material de sustentação. O aparelho é adaptado para incorporar artigos de material de sustentação 100a e 100b de acordo com uma modalidade particularmente preferida. Nesta modalidade, o aparelho 10 é configurado para uso com um grampeador linear.
[0039] Referindo-se coletivamente às figuras 3a-3b, o aparelho 10 inclui uma estrutura de alinhamento 18 e um elemento de equalização de pressão internamente disposta 20. A estrutura de desalinhamento 18 pode ser configurada de qualquer maneira de modo a reter artigos 100a e 100b de material de sustentação em fixação liberável dentro da estrutura de alinhamento 18 tal que os artigos 100a e 100b serão automaticamente alinhados com os elementos de mordente justapostos do grampeador linear. Na modalidade ilustrada, a estrutura de alinhamento 18 inclui uma parte de bainha em geral planar 22, um primeiro canal de guia 24 e um segundo canal de guia 26. A parte de bainha 22 inclui uma área de recepção disposta internamente 40. O elemento de equalização de pressão 20 é internamente disposto dentro da área de recepção 40 e é de preferência construído a partir de um substrato resiliente deformável, tal como espuma de plástico, borracha e/ou qualquer número de materiais adequados tendo propriedades similares. Fornecendo tal distribuição de pressão uniforme, o elemento de equalização de pressão 20 assegura que os artigos 100a e 100b se conformarão mais facilmente ao formato e contorno das superficies de trabalho justapostas durante a etapa de fechamento do grampeador cirúrgico em torno do aparelho 10. A resiliência do elemento de equalização de pressão 20 é também vantajosa em que serve para orientar de modo liberável os artigos 100a e 100b dentro da área de recepção 40 da estrutura de alinhamento 18.
[0040] O primeiro canal de guia 24 e o segundo canal de guia 26 são dimensionados para regular o engate das superficies de trabalho justapostas de um grampeador cirúrgico e o aparelho de alinhamento. Os artigos 100a e 100b são desenhados para serem posicionados dentro da área de recepção 40 de modo a estar em geral em linha com os primeiro e segundo canais de guia 24, 26, respectivamente. Os canais de guia 24, 26 direcionarão automaticamente os mordentes justapostos de um grampeador cirúrgico em contato com a superfície adesiva 105 de cada material de sustentação 100a e 100b quando o grampeador cirúrgico é preso no aparelho 10 .
[0041] Com referência agora às figuras 4a e 4b, o aparelho 10 é mostrado completamente preparado para uso com um grampeador cirúrgico 46. Nesta modalidade, uma combinação incluindo artigos de material de sustentação, os artigos 100a e 100b, e um aparelho 10 para equipar um prendedor cirúrgico com um material de sustentação são fornecidos. O aparelho 10 desta modalidade inclui uma estrutura de alinhamento 18, um primeiro artigo de material de sustentação 100a e um segundo artigo de material de sustentação 100b. Os artigos 100a e 100b são dispostos de modo liberável dentro da área de recepção 40 de modo a estar em geral alinhado com os primeiro e segundo canais de guia 24, 26, respectivamente.
[0042] A fim de equipar um grampeador cirúrgico para produzir uma linha de grampos reforçada, as superficies de trabalho justapostas do grampeador cirúrgico são posicionadas dentro dos primeiro e segundo canais de guia 24, 26 respectivamente, e presos em contato com as camadas adesivas 105 dos artigos 100a e 100b. O grampeador cirúrgico é mantido nesta posição fechada por um dado periodo de tempo e então separado da estrutura de alinhamento 18 para remover o meio de equalização de pressão 20, com os artigos de material de sustentação 100a e 100b de dentro da área de recepção 40. A camada adesiva 105 forma uma ligação suficiente entre os artigos 100a e 100b e as superficies de trabalho justapostas do grampeador cirúrgico tal que, quando o grampeador cirúrgico é aberto a partir da posição previamente presa, os artigos 100a e 100b permanecem fixados de modo liberável nas superficies de trabalho justapostas do grampeador cirúrgico e o elemento de equalização de pressão 20 pode ser removido de entre os artigos 100a e 100b. O grampeador cirúrgico é então completamente equipado com artigos 100a e 100b tal que as superficies de trabalho justapostas do mesmo podem ser posicionadas em torno de uma seção de tecido corporal para formar uma linha de grampos reforçada de acordo com a presente invenção.
[0043] Enquanto uma modalidade preferida da presente invenção foi descrita, deve ser entendido que várias mudanças, adaptações e modificações podem ser feitas na mesma sem se afastar do espirito da invenção e do escopo das reivindicações anexas.
Claims (19)
1. Material de sustentação de prendedor cirúrgico (100), tendo uma superficie adesiva (105), o material sendo embalado e fornecido de uma maneira que permite a superficie adesiva (105) ser alinhada com e cobrir de modo liberável uma superficie de trabalho de um prendedor cirúrgico (46), caracterizado pelo fato de que a superficie adesiva (105) tem uma resistência adesiva predeterminada quando retida na superficie de trabalho de um prendedor cirúrgico (46), a resistência adesiva sendo reduzida quando a superficie adesiva (105) é posicionada e hidratada in vivo.
2. Material, de acordo com a reivindicação 1, caracterizado pelo fato de que o material de sustentação (100) é embalado e fornecido de uma maneira que permite a superficie adesiva (105) ser alinhada com e cobrir de modo liberável uma superficie de trabalho de um prendedor cirúrgico em um processo de carregamento de uma etapa.
3. Material, de acordo com a reivindicação 1, caracterizado pelo fato de que a superficie adesiva (105) tem uma resistência adesiva suficiente para permitir o material, sem meio externo, ser retido na superficie de trabalho do prendedor cirúrgico (46) durante o posicionamento do prendedor cirúrgico (46) dentro do local cirúrgico e, então, ser removido da superficie de trabalho na aplicação do prendedor cirúrgico (46).
4. Material, de acordo com a reivindicação 1, caracterizado pelo fato de que a superficie adesiva é uma superficie que compreende um material adesivo pré-aplicado.
5. Material, de acordo com a reivindicação 4, caracterizado pelo fato de que o material adesivo pré- aplicado compreende um hidrogel pré-aplicado.
6. Material, de acordo com a reivindicação 5, caracterizado pelo fato de que o material adesivo pré- aplicado inclui adicionalmente um ou mais agentes bioativos.
7. Material, de acordo com a reivindicação 1, caracterizado pelo fato de que o material de sustentação (100) inclui pelo menos um material reforçado (108) tendo resistência mecânica suficiente para reforçar uma linha de sutura de prendedor cirúrgico.
8. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que o material de sustentação (100) inclui um composto de dois ou mais materiais, com pelo menos um dos materiais sendo um material reforçado.
9. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que pelo menos um material reforçado (108) resiste à degradação quando implantado in vivo.
10. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que pelo menos um material reforçado (108) tem uma resistência à tração pré-implante tendo uma carga de pico de pelo menos 2000 gramas.
11. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que pelo menos um material reforçado (108) tem uma resistência à tração pré-implante e o pelo menos um material reforçado mantem sua resistência à tração pré-implante quando implantado in vivo.
12. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que pelo menos um material reforçado (108) tem uma pressão de vazamento ou pressão de ruptura de pelo menos 90 mmHg.
13. Material, de acordo com a reivindicação 7, caracterizado pelo fato de que pelo menos um material reforçado (108) também tem uma resistência adesiva suficiente para permitir o material, sem meio externo, ser retido na superfície de trabalho do prendedor cirúrgico (46) durante o posicionamento do prendedor cirúrgico (46) dentro do local cirúrgico, e então ser removido da superfície de trabalho na aplicação do prendedor cirúrgico (46) .
14. Combinação compreendendo um prendedor cirúrgico (46), caracterizada por compreender pelo menos uma superfície de trabalho e um material de sustentação (100), do tipo definido na reivindicação 1, posicionado na pelo menos uma superfície de trabalho.
15. Combinação, de acordo com a reivindicação 14, caracterizada pelo fato de que o prendedor cirúrgico compreende um grampeador cirúrgico (46).
16. Aparelho (10) para facilitar o alinhamento e aplicação de um material de sustentação (100) em uma superfície de trabalho de um prendedor cirúrgico (46), caracterizado pelo fato de que o aparelho incorpora um material de sustentação (100) do tipo definido na reivindicação 1.
17. Aparelho, de acordo com a reivindicação 16, caracterizado pelo fato de que compreender adicionalmente uma estrutura de alinhamento (18) que retém um ou mais artigos do material de sustentação (100) em fixação liberável com a estrutura de alinhamento (18) tal que um ou mais artigos serão automaticamente alinhados com as superficies de trabalho justapostas de um prendedor cirúrgico (46).
18. Kit cirúrgico para facilitar a aplicação de um artigo de material de sustentação (100) nas superficies de trabalho justapostas de um prendedor cirúrgico (46), caracterizado pelo fato de incluir um ou mais artigos de material de sustentação (100), do tipo definido na reivindicação 1, e um aparelho de alinhamento (10).
19. Kit cirúrgico, de acordo com a reivindicação 18, caracterizado pelo fato de que um ou mais artigos de material de sustentação (100) são adaptados para serem carregados no aparelho de alinhamento (10)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US11/047,477 US20060173470A1 (en) | 2005-01-31 | 2005-01-31 | Surgical fastener buttress material |
| US11/047,477 | 2005-01-31 | ||
| PCT/US2006/003121 WO2006083748A1 (en) | 2005-01-31 | 2006-01-27 | Surgical fastener buttress materials |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BRPI0606896A2 BRPI0606896A2 (pt) | 2009-07-21 |
| BRPI0606896B1 true BRPI0606896B1 (pt) | 2020-10-27 |
| BRPI0606896B8 BRPI0606896B8 (pt) | 2021-06-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0606896A BRPI0606896B8 (pt) | 2005-01-31 | 2006-01-27 | material de sustentação de prendedor cirúrgico, combinação compreendendo um prendedor cirúrgico, aparelho para facilitar o alinhamento e aplicação de um material de sustentação em uma superfície de trabalho de um prendedor cirúrgico e kit cirúrgico para facilitar a aplicação de um artigo de material de sustentação nas superfícies de trabalho justapostas de um prendedor cirúrgico |
Country Status (11)
| Country | Link |
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| US (3) | US20060173470A1 (pt) |
| EP (1) | EP1848346B1 (pt) |
| JP (2) | JP5173439B2 (pt) |
| CN (1) | CN101111196A (pt) |
| AT (1) | ATE529050T1 (pt) |
| AU (1) | AU2006211147B2 (pt) |
| BR (1) | BRPI0606896B8 (pt) |
| CA (1) | CA2596254C (pt) |
| ES (1) | ES2375975T3 (pt) |
| MX (1) | MX2007009179A (pt) |
| WO (1) | WO2006083748A1 (pt) |
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| US12432790B2 (en) | 2021-10-28 | 2025-09-30 | Cilag Gmbh International | Method and device for transmitting UART communications over a security short range wireless communication |
| US12089841B2 (en) | 2021-10-28 | 2024-09-17 | Cilag CmbH International | Staple cartridge identification systems |
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| CN115281764B (zh) * | 2022-08-24 | 2023-03-24 | 安徽百诺佳医疗科技有限公司 | 一种手术吻合器 |
| US12419648B2 (en) | 2022-09-26 | 2025-09-23 | Covidien Lp | Two-part fasteners for surgical clip appliers and surgical clip appliers for deploying the same |
| CN120360626B (zh) * | 2025-06-23 | 2025-09-23 | 上海欣吉特生物科技有限公司 | 一种吻合口加固装置及其制备方法与应用 |
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-
2005
- 2005-01-31 US US11/047,477 patent/US20060173470A1/en not_active Abandoned
-
2006
- 2006-01-27 WO PCT/US2006/003121 patent/WO2006083748A1/en not_active Ceased
- 2006-01-27 EP EP06719810A patent/EP1848346B1/en not_active Expired - Lifetime
- 2006-01-27 CA CA2596254A patent/CA2596254C/en not_active Expired - Lifetime
- 2006-01-27 CN CNA2006800036952A patent/CN101111196A/zh active Pending
- 2006-01-27 JP JP2007553306A patent/JP5173439B2/ja not_active Expired - Lifetime
- 2006-01-27 ES ES06719810T patent/ES2375975T3/es not_active Expired - Lifetime
- 2006-01-27 MX MX2007009179A patent/MX2007009179A/es active IP Right Grant
- 2006-01-27 AU AU2006211147A patent/AU2006211147B2/en not_active Expired
- 2006-01-27 BR BRPI0606896A patent/BRPI0606896B8/pt active IP Right Grant
- 2006-01-27 AT AT06719810T patent/ATE529050T1/de not_active IP Right Cessation
-
2010
- 2010-03-22 US US12/728,993 patent/US20100234861A1/en not_active Abandoned
-
2012
- 2012-02-06 US US13/366,998 patent/US20120197272A1/en not_active Abandoned
- 2012-02-16 JP JP2012031735A patent/JP2012106026A/ja not_active Withdrawn
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|---|---|
| US20120197272A1 (en) | 2012-08-02 |
| US20060173470A1 (en) | 2006-08-03 |
| JP2008528203A (ja) | 2008-07-31 |
| AU2006211147B2 (en) | 2012-07-19 |
| JP5173439B2 (ja) | 2013-04-03 |
| BRPI0606896B8 (pt) | 2021-06-22 |
| EP1848346A1 (en) | 2007-10-31 |
| JP2012106026A (ja) | 2012-06-07 |
| AU2006211147A1 (en) | 2006-08-10 |
| EP1848346B1 (en) | 2011-10-19 |
| ES2375975T3 (es) | 2012-03-07 |
| CA2596254A1 (en) | 2006-08-10 |
| CA2596254C (en) | 2014-01-07 |
| ATE529050T1 (de) | 2011-11-15 |
| WO2006083748A1 (en) | 2006-08-10 |
| MX2007009179A (es) | 2007-09-21 |
| CN101111196A (zh) | 2008-01-23 |
| US20100234861A1 (en) | 2010-09-16 |
| BRPI0606896A2 (pt) | 2009-07-21 |
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