ES2748926T3 - Fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas - Google Patents

Fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas Download PDF

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ES2748926T3
ES2748926T3 ES05810430T ES05810430T ES2748926T3 ES 2748926 T3 ES2748926 T3 ES 2748926T3 ES 05810430 T ES05810430 T ES 05810430T ES 05810430 T ES05810430 T ES 05810430T ES 2748926 T3 ES2748926 T3 ES 2748926T3
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surgical
surgical fixation
crown
legs
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Frank Viola
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0643—Surgical staples, i.e. penetrating the tissue with separate closing member, e.g. for interlocking with staple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective

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  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
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  • Surgical Instruments (AREA)

Abstract

Una fijación quirúrgica (100, 200) para usar en combinación con un aparato de aplicación de fijaciones quirúrgicas, comprendiendo la fijación quirúrgica (100, 200): un par de patas (102, 104, 204); una corona (106) que interconecta el par de patas (102, 104, 204); un material de tratamiento de heridas que cubre al menos una parte de las patas (102, 104, 204) y/o de la corona (106); y siendo el material de tratamiento de heridas un sellador para sellar el tejido para minimizar la pérdida de líquido y retardar el sangrado del tejido, caracterizada por que el sellador está curado de antemano en al menos una porción de una superficie de las patas (102, 104, 204) y/o de la corona (106) por exposición a luz ultravioleta antes de su suministro a un sitio quirúrgico.

Description

DESCRIPCIÓN
Fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas
Antecedentes
Campo técnico
La presente divulgación se refiere a fijaciones quirúrgicas y más particularmente a fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas.
Descripción de la técnica relacionada
En general, los recubrimientos para dispositivos médicos son útiles para crear un recubrimiento lubricante y absorbente de agua para instrumentos quirúrgicos, para biomateriales internos como stents, tornillos y férulas internas, y para tubos, catéteres, guías de alambre y similares. Tales recubrimientos minimizan el trauma del contacto del dispositivo médico con tejidos y fluidos biológicos. En particular, se han usado recubrimientos para proporcionar un recubrimiento resbaladizo y lubricante para reducir el coeficiente de rozamiento de una superficie de un dispositivo médico para facilitar el movimiento y la maniobrabilidad del dispositivo. Los recubrimientos lubricantes hechos de polímeros hidrófilos son bien conocidos en la técnica.
Dispositivos médicos como fijaciones quirúrgicas y las grapas han reemplazado a la sutura para unir o anastomosar diversas estructuras corporales, como, por ejemplo, el intestino o los bronquios. Los dispositivos de grapado quirúrgico empleados para aplicar estas grapas generalmente están diseñados para cortar y sellar simultáneamente un segmento extendido de tejido en un paciente, reduciendo así enormemente el tiempo y los riesgos de tales procedimientos.
Los cirujanos emplean dispositivos de grapado quirúrgico lineal o anular para aplicar secuencial o simultáneamente una o más filas lineales de fijaciones quirúrgicas — por ejemplo, grapas o fijaciones de dos partes— al tejido corporal con el fin de unir segmentos de tejido corporal y/o para la creación de anastomosis. Los dispositivos de grapado quirúrgico lineal generalmente incluyen un par de mordazas o estructuras en forma de dedo entre las cuales se coloca el tejido corporal que ha de ser unido. Cuando el dispositivo de grapado quirúrgico es accionado y/o “disparado”, barras de disparo se mueven longitudinalmente y entran en contacto con los elementos impulsores de grapas en una de las mordazas, y las grapas quirúrgicas son empujadas a través del tejido corporal y al interior o contra un yunque en la mordaza opuesta, cerrando así las grapas al plegarlas. Se puede proporcionar una cuchilla para cortar entre las filas/líneas de grapas. Ejemplos de tales dispositivos de grapado quirúrgico lineal son los instrumentos “GIA™”, “Endo GIA™” y “Premium Multi-fire TA™” disponibles en United States Surgical, una división de Tyco Health-Care Group, LP, Norwalk, Connecticut y divulgados, entre otros, en la patente estadounidense n° 5.465.896 de Allen et al., en la patente estadounidense n° 6.330.965 de Milliman et al. y en la patente estadounidense n° 6.817.508 de Racenet et al.
Los dispositivos de grapado quirúrgico anular generalmente incluyen un conjunto de cartucho de grapas anular que incluye una pluralidad de filas anulares de grapas, normalmente dos, un conjunto de yunque asociado operativamente con el conjunto de cartucho anular y una cuchilla anular dispuesta internamente de las filas de grapas.
Otro tipo de grapadora quirúrgica es una grapadora de anastomosis término-terminal. Un ejemplo de tal dispositivo es un instrumento modelo “EEA™” disponible en United States Surgical, una división de Tyco Health-Care Group, LP, Norwalk, Connecticut y divulgado, entre otros, en la patente estadounidense n° 5.392.979 de Green et al. En general, una grapadora de anastomosis de extremo a extremo coloca normalmente una serie de grapas en las secciones aproximadas de los intestinos de un paciente u otros órganos tubulares. La anastomosis resultante contiene una sección invertida del intestino que contiene numerosas grapas en forma de “B” para mantener una conexión segura entre las secciones aproximadas del intestino.
Los documentos WO 03/071962, US 2004/0167572 y US 5.550.172 divulgan fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas, siendo selladores los materiales de tratamiento de heridas.
Además del uso de grapas quirúrgicas, se pueden aplicar selladores, por ejemplo, selladores biológicos, al sitio quirúrgico para evitar fugas. Normalmente, los selladores biológicos son aplicados manualmente a la superficie externa de la línea de grapas por un médico rociando, cepillando, frotando o cualquier combinación de los mismos. Esta aplicación manual de sellador biológico puede conducir a una falta de uniformidad del grosor del sellador en la línea de grapado y/u omitir una parte del área de cobertura prevista debido a la imposibilidad de ver o alcanzar la ubicación deseada.
Existe la necesidad de fijaciones quirúrgicas y similares para suministrar material de tratamiento de heridas a un sitio quirúrgico diana sin agregar etapas o complicaciones adicionales al procedimiento quirúrgico.
Compendio
La presente invención proporciona una fijación quirúrgica como se define en la reivindicación 1 adjunta. En las reivindicaciones dependientes se definen realizaciones preferidas.
La presente divulgación se refiere a fijaciones quirúrgicas y más particularmente a fijaciones quirúrgicas recubiertas con materiales de tratamiento de heridas.
Según un aspecto de la presente divulgación, se proporciona una fijación quirúrgica para usar en combinación con un aparato de aplicación de fijaciones quirúrgicas. La fijación quirúrgica incluye un par de patas, una corona que interconecta el par de patas, y un material de tratamiento de heridas que cubre al menos una parte de las patas y/o de la corona.
El material de tratamiento de heridas según la invención es un sellador. En una realización, la fijación quirúrgica es una grapa. En otra realización, la fijación quirúrgica es una fijación de dos partes.
Las patas y la corona de la fijación quirúrgica pueden fabricarse de al menos uno de un material no absorbible y bioabsorbible. Se prevé que el material no absorbible sea al menos uno de acero inoxidable y titanio. El material bioabsorbible puede ser al menos uno de homopolímeros, copolímeros y una mezcla de monómeros seleccionados del grupo constituido por glicólido, ácido glicólico, lactida, ácido láctico, p-dioxanona, a-caprolactona y carbonato de trimetileno. El material bioabsorbible también puede ser al menos uno de ácido poliglicólico (PGA) y ácido poliláctico (PLA).
El material de tratamiento de heridas puede ser un sellador seleccionado del grupo constituido por acrilato, hidrogeles funcionales de metacrilato en presencia de un fotoiniciador biocompatible, cianoacrilatos alquílicos, macrómeros con funcionalidad isocianato con o sin macrómeros con funcionalidad amina, macrómeros con funcionalidad de éster succinimidílico con macrómeros funcionales de amina o sulfhidrilo, macrómeros funcionales epoxi con macrómeros funcionales amina, mezclas de proteínas o polipéptidos en presencia de reticuladores de aldehídos, genipina, carbodiimidas hidrosolubles, polisacáridos aniónicos en presencia de cationes polivalentes.
El material de tratamiento de heridas también puede ser un sellador seleccionado del grupo constituido por prepolímeros de uretano hidrófilos con terminación de isocianato derivados de poliisocianatos orgánicos y dioles o polioles basados en oxietileno; adhesivos a base de polímeros reticulados biocompatibles formados a partir de precursores hidrosolubles que tienen grupos electrofílicos y nucleófilos capaces de reaccionar y reticularse in situ; sistemas adhesivos de dos partes que incluyen los basados en cadenas principales de óxido de polialquileno sustituidas con uno o más grupos isocianato en combinación con compuestos de diamina bioabsorbibles, o cadenas principales de óxido de polialquileno sustituidas con uno o más grupos amina en combinación con compuestos de diisocianato bioabsorbibles; y prepolímeros de uretano hidrófilos con terminación de isocianato derivados de diisocianatos y polioles aromáticos.
En una realización, el material de tratamiento de heridas puede impregnarse en las patas y la corona. En otra realización, el material de tratamiento de heridas cubre completamente las patas y la corona.
Se prevé que cada pata incluya un extremo distal afilado. Se prevé además que la corona sea lineal o no lineal.
Breve descripción de los dibujos
La figura 1 es una vista en perspectiva de una fijación quirúrgica según una realización de la presente divulgación; la figura 2 es una vista en sección transversal longitudinal de la fijación quirúrgica de la figura 1;
la figura 3 es una vista en sección transversal longitudinal de una fijación quirúrgica según otra realización de la presente divulgación;
la figura 4 es una vista en sección transversal longitudinal de una fijación quirúrgica según otra realización más de la presente divulgación; y
la figura 5 es una vista en perspectiva de una fijación ejemplar de dos partes construida según la presente divulgación.
Descripción detallada de las realizaciones
Ahora se describirán en detalle realizaciones de las fijaciones quirúrgicas aquí divulgadas con referencia a las figuras de los dibujos, en las que números de referencia similares identifican elementos similares o idénticos. Según se usa en este documento y como es tradicional, el término “distal” se refiere a la porción más alejada del usuario, mientras que el término “proximal” se refiere a la porción más cercana al usuario.
Con referencia a las figuras 1 y 2, se muestra como 100, en general, una fijación quirúrgica en forma de grapa quirúrgica. Las grapas quirúrgicas de la presente divulgación normalmente incluyen cualquier grapa metálica usada para unir partes de tejido y/o tejidos adyacentes. Las grapas quirúrgicas 100 pueden estar hechas de metal, tal como, por ejemplo, acero inoxidable o titanio, o de cualquier otro material conocido por un experto en la materia. Por ejemplo, las grapas quirúrgicas 100 también pueden fabricarse de material bioabsorbible o similar.
Los materiales bioabsorbibles utilizados para las grapas quirúrgicas 100 incluyen, sin limitación, los fabricados a partir de homopolímeros, copolímeros o mezclas obtenidas de uno o más monómeros seleccionados del grupo constituido por glicólido, ácido glicólico, lactida, ácido láctico, p-dioxanona, a-caprolactona y carbonato de trimetileno. Otros materiales bioabsorbibles incluyen, sin limitación, ácido poliglicólico (p Ga ) y ácido poliláctico (PLA).
Con referencia continuada a las figuras 1 y 2, la grapa quirúrgica 100 incluye un par de patas 102, 104 que están interconectadas entre sí mediante una corona o tramo posterior 106 que se extiende entre los primeros extremos 102a, 104a, respectivamente, de los mismos. Como se ve en las figuras 1 y 2, la corona 106 es sustancialmente perpendicular a las patas 102, 104. Sin embargo, se prevé que la corona 106 pueda adoptar cualquier forma según sea necesario y/o se desee y pueda tener cualquier orientación con respecto a las patas 102, 104. Por ejemplo, la corona 106 puede incluir dos secciones que se extienden angularmente desde las patas 102, 104 y están conectadas en un vértice (no mostrado).
Como se ve en las figuras 1 y 2, los respectivos extremos distales 102b, 104b de las patas 102, 104 están afilados para facilitar la penetración de las patas 102, 104 en el tejido o similar.
Según la presente descripción, la grapa quirúrgica 100 está recubierta con un material de tratamiento de heridas “W”. Se prevé que el material de tratamiento de heridas “W” se pueda aplicar a la totalidad de la grapa quirúrgica 100 (como se ve en las figuras 1 y 2), o se pueda aplicar a cualquier área específica de la grapa quirúrgica 100 que entrará en contacto con tejido de similares. Por ejemplo, el material de tratamiento de heridas “W” puede aplicarse únicamente a las patas 102, 104 (véase la figura 3); únicamente a una de las patas 102, 104 (no mostrado); únicamente a la corona 106 (no mostrado); o cualquier porción de las mismas. Se prevé además que el material de tratamiento de heridas “W” se pueda impregnar en las patas 102, 104 y la corona 106 de la grapa quirúrgica 100, como se ve en la figura 4.
En una realización, las grapas quirúrgicas 100 pueden fabricarse a partir de un material bioabsorbible que idealmente se impregna con material de tratamiento de heridas “W”. En consecuencia, en uso, el componente de material de tratamiento de heridas de las grapas quirúrgicas 100 puede funcionar, a manera de sellador, retardando cualquier sangrado que pueda ocurrir desde el tejido y asegurando el tejido aproximado entre sí, a manera de adhesivo. La bioabsorbibilidad de las grapas quirúrgicas 100 permite que al menos una parte de las grapas quirúrgicas 100 sea absorbida por el cuerpo después de una cantidad de tiempo predeterminada. Por ejemplo, las grapas quirúrgicas 100 pueden permanecer en su lugar en el cuerpo durante aproximadamente 2-3 semanas para que la anastomosis se cure lo suficiente antes de que las grapas quirúrgicas 100 sean absorbidas por el cuerpo.
Según se mencionó anteriormente y como se muestra en la figura 3, se prevé que las grapas quirúrgicas 100 puedan impregnarse con un material de tratamiento de heridas “W” que sea un adhesivo o sellador curado de antemano. El sellador o adhesivo curado de antemano reaccionará con la humedad y/o el calor del tejido corporal para activar de ese modo las propiedades de sellado y/o adhesivas del sellador o adhesivo. Se prevé que el sellador o adhesivo curado de antemano pueda ser un hidrogel o similar.
Se contempla que el material de tratamiento de heridas “W” es cualquier material para unir, curar, sellar o tratar de otro modo el tejido. En una realización preferida, según la invención, el material de tratamiento de heridas es un sellador biocompatible, que incluye selladores que curan tras la exposición a la luz ultravioleta (UV). En una realización, se contempla que tales selladores sean curables. Por ejemplo, los selladores pueden tener un tiempo de curado de aproximadamente 10 a 15 segundos. En realizaciones preferidas, el sellador es un material bioabsorbible y/o biorresorbible. En otra realización, se contempla que se pueda usar un sellador que tenga un tiempo de curado de aproximadamente 30 segundos. Se prevé además que el material de tratamiento de heridas “W” pueda ser un adhesivo o sellador curado de antemano.
En ciertas realizaciones preferidas, el material de tratamiento de heridas “W” comprende un sellador. Tal sellador es idealmente un material a base de PEG. Los ejemplos de clases de materiales útiles como sellador y/o adhesivo incluyen hidrogeles funcionales de acrilato o metacrilato en presencia de un fotoiniciador biocompatible, cianoacrilatos alquílicos, macrómeros funcionales de isocianato con o sin macrómeros funcionales de amina, macrómeros funcionales de éster succinimidílico con macrómeros funcionales de amina o sulfhidrilo, macrómeros funcionales epoxi con macrómeros funcionales amina, mezclas de proteínas o polipéptidos en presencia de reticuladores de aldehídos, genipina, carbodiimidas hidrosolubles, polisacáridos aniónicos en presencia de cationes polivalentes, etc.
Algunos materiales específicos que pueden utilizarse incluyen prepolímeros de uretano hidrófilos con terminación de isocianato derivados de poliisocianatos orgánicos y dioles o polioles basados en oxietileno, incluidos los divulgados en las patentes estadounidenses nos 6.702.731 y 6.296.607 y la solicitud de patente estadounidense publicada n° 2004/0068078; adhesivos a base de alfa-cianoacrilato, incluidos los divulgados en la patente estadounidense n° 6.565.840; adhesivos de cianoacrilato basados en éster alquílico, incluidos los divulgados en la patente estadounidense n° 6.620.846; adhesivos basados en polímeros reticulados biocompatibles formados a partir de precursores hidrosolubles que tienen grupos electrofílicos y nucleófilos capaces de reaccionar y reticularse in situ, incluidos los divulgados en la patente estadounidense n° 6.566.406; sistemas adhesivos de dos partes que incluyen aquellos basados en cadenas principales de óxido de polialquileno sustituidas con uno o más grupos isocianato en combinación con compuestos de diamina bioabsorbibles, o cadenas principales de óxido de polialquileno sustituidas con uno o más grupos amino en combinación con compuestos de diisocianato bioabsorbibles como se describe en la solicitud de patente estadounidense publicada n° 2003/0032734; y prepolímeros de uretano hidrófilos con terminación de isocianato derivados de diisocianatos y polioles aromáticos como se describe en la solicitud de patente estadounidense publicada n° 2004/0115229.
Se prevé y está dentro del alcance de la presente divulgación que el material de tratamiento de heridas “W” pueda incluir uno o una combinación de adhesivos, hemostáticos, selladores o cualquier otro material de tratamiento de tejidos o de heridas. Los materiales quirúrgicos biocompatibles para el tratamiento de heridas “W”, que pueden usarse según la presente descripción, incluyen adhesivos cuya función es unir o sujetar órganos, tejidos o estructuras, selladores para evitar fugas de líquido y hemostáticos para detener o prevenir el sangrado. Ejemplos de adhesivos que pueden emplearse incluyen materiales adhesivos a base de aldehidos derivados de proteínas; por ejemplo, los materiales de albúmina/glutaraldehído disponibles comercialmente vendidos bajo la designación comercial BioGlue™ por Cryolife, Inc., y materiales a base de cianoacrilato vendidos bajo las designaciones comerciales Indermil™ y Derma Bond™ de Tyco Healthcare Group, LP y Ethicon Endosurgery, Inc., respectivamente. Ejemplos de selladores que pueden emplearse incluyen selladores de fibrina y selladores de tejidos a base de colágeno y polímeros sintéticos. Ejemplos de selladores disponibles comercialmente son materiales sintéticos de hidrogel a base de polietilenglicol vendidos bajo la designación comercial CoSeal™ por Cohesion Technologies y Baxter International, Inc. Ejemplos de materiales hemostáticos que pueden emplearse incluyen hemostáticos tópicos a base de fibrina, a base de colágeno, a base de celulosa regenerada oxidada y a base de gelatina, así como alumbre de aluminio (es decir, alumbre amoniacal o sulfato de aluminio y amonio). Ejemplos de materiales hemostáticos disponibles comercialmente son los materiales combinados de fibrinógeno y trombina vendidos bajo las designaciones comerciales CoStasis™ de Tyco Healthcare Group, LP y Tisseel™ vendidos por Baxter International, Inc. Los hemostáticos del presente documento incluyen astringentes —por ejemplo, sulfatos de aluminio— y coagulantes. Otro ejemplo de hemostático incluye “Quick Clot™”, disponible comercialmente en Z-Medica, Inc., Newington, Connecticut.
El medicamento puede incluir una o más sustancias útiles desde el punto de vista médico y quirúrgico, como fármacos, enzimas, factores de crecimiento, péptidos, proteínas, colorantes, pigmentos, agentes de diagnóstico o agentes de hemostasia, anticuerpos monoclonales o cualquier otro producto farmacéutico utilizado en la prevención de la estenosis. El medicamento puede disponerse en la estructura 100 o impregnarse en la estructura 100.
El material de tratamiento de heridas “W” puede incluir materiales formadores de película viscoelástica, agentes reactivos de reticulación y adhesivos curables por energía. Se prevé que el material de tratamiento de heridas “W”, y en particular, el adhesivo se pueda curar con la aplicación de agua y/o glicerina (1,2, 3 - pranatetriol, también conocido como glicerol o glicerina) al mismo. De esta manera, el agua y/o la glicerina curan el adhesivo e hidratan la herida.
Se contempla además que el material de tratamiento de heridas “W” pueda incluir, por ejemplo, composiciones y/o compuestos que aceleran o modifican beneficiosamente el proceso de curación cuando las partículas de la composición y/o el compuesto se aplican o se exponen a un sitio de reparación quirúrgica. Por ejemplo, el material de tratamiento de heridas “W” puede ser un agente terapéutico que se deposite en el sitio de reparación. El agente terapéutico se puede elegir por sus propiedades antimicrobianas, su capacidad para promover la reparación o la reconstrucción y/o el crecimiento de tejido nuevo. Por ejemplo, el material de tratamiento de heridas “W” puede comprender “SilvaSorb™”, disponible comercialmente en AcryMed, Inc, Portland, Oregón. Los agentes antimicrobianos como un antibiótico de amplio espectro (sulfato de gentamicina, eritromicina o glucopéptidos derivatizados) que se liberan lentamente en el tejido pueden aplicarse de esta manera para ayudar a combatir infecciones clínicas y subclínicas en un sitio de reparación de tejidos. Para promover la reparación y/o el crecimiento del tejido, el material de tratamiento de heridas “W” puede incluir uno o varios factores promotores del crecimiento; por ejemplo, factor de crecimiento de fibroblastos, factor de crecimiento óseo, factor de crecimiento epidérmico, factor de crecimiento derivado de plaquetas, factor de crecimiento derivado de macrófagos, factor de crecimiento de derivación alveolar, factor de crecimiento de derivación monocítica, magainina, etcétera. Algunas indicaciones terapéuticas son: glicerol con activador de plasminógeno tisular o renal para causar trombosis, superóxido dimutasa para eliminar los radicales libres que dañan los tejidos, factor de necrosis tumoral para terapia contra el cáncer o factor estimulante de colonias e interferón, interleucina-2 u otra linfocina para potenciar el sistema inmunológico.
Se prevé además, y está dentro de la presente divulgación, que el material de tratamiento de heridas “W” incluya cualquier agente microbiano, analgésico, factor de crecimiento y agente antiinflamatorio conocido por un experto en la técnica o cualquier combinación de los mismos.
Los expertos en la materia reconocerán que el tratamiento con éxito de la superficie de la grapa quirúrgica 100, antes de la aplicación del material de tratamiento de heridas “W”, puede incluir la limpieza previa de la grapa quirúrgica 100 y controlar la humedad en la superficie de la grapa quirúrgica 100 para asegurar el recubrimiento completo y/o apropiado de la grapa quirúrgica 100. Por lo tanto, se pueden utilizar operaciones de limpieza y secado en varias etapas para proporcionar una superficie limpia y controlar la humedad. Una vez que se trata la superficie de la grapa quirúrgica 100, como se describió anteriormente, se aplica a la grapa quirúrgica tratada 100 una solución que contiene material de tratamiento de heridas “W”.
Se contempla y está dentro del alcance de la presente divulgación que cualquiera de las grapas quirúrgicas 100 descritas en el presente documento se use en conexión con grapadoras quirúrgicas de tipo lineal, grapadoras quirúrgicas de tipo no lineal, grapas quirúrgicas de tipo anular, grapadoras quirúrgicas de tipo endoscópico, grapadoras quirúrgicas de tipo cutáneo y similares.
Se contempla además, y está dentro del alcance de la presente divulgación, que cualquiera de las grapas quirúrgicas 100 divulgadas en el presente documento tenga patas de igual longitud, patas de distinta longitud, una corona relativamente corta en comparación con la longitud de las patas, una corona relativamente larga en comparación con la longitud de las patas, un perfil de sección transversal simétrica en al menos una de las patas y la corona, y un perfil de sección transversal asimétrica en al menos una de las patas y la corona. Por ejemplo, cada pata y/o la corona pueden tener un perfil de sección transversal que sea poligonal, tal como triangular, rectangular, hexagonal, cualquier combinación de las mismas o similares. Además, cada pata y/o la corona pueden tener un perfil de sección transversal que sea circular, ovalado o similar. Se prevé, además, que la corona pueda ser lineal o no lineal.
También se contempla y está dentro del alcance de la presente divulgación que cualquiera de las grapas quirúrgicas 100 divulgadas en el presente documento incluya patas que no se encuentren en el mismo plano la una de la otra. En otras palabras, una pata y la corona de la grapa quirúrgica 100 definen un primer plano, y la otra pata de la grapa quirúrgica 100 se encuentra en un segundo plano que no es coplanaria, o es transversal al primer plano.
Como se ve en la figura 5, se muestra como 200, en general, una fijación quirúrgica, en forma de una fijación de dos partes. En la patente estadounidense n° 4.534.352 se muestra y se describe la estructura física de una fijación quirúrgica ejemplar 200. Generalmente, la fijación quirúrgica 200 incluye un miembro 210 de retención y un miembro 202 de fijación, que tiene dos puntas o patas 204 que son pasadas a través del tejido (no mostrado) para enganchar las aberturas 212 en el miembro 210 de retención. Cada una de las puntas 204 incluye una lengüeta 206 unida a un vástago 208.
Según la presente divulgación, la fijación quirúrgica 200, que incluye el miembro 210 de retención y el miembro de 202 de fijación, puede construirse de cualquiera de los materiales divulgados anteriormente, ya sea de forma idéntica (construidos a partir de los mismos materiales) o de manera individual (es decir, construidos a partir de diferentes materiales) entre sí.
Debe entenderse que pueden realizarse diversos cambios en la forma, el detalle y la aplicación de las estructuras de soporte de la presente divulgación sin apartarse del alcance de la presente divulgación.

Claims (11)

REIVINDICACIONES
1. Una fijación quirúrgica (100, 200) para usar en combinación con un aparato de aplicación de fijaciones quirúrgicas, comprendiendo la fijación quirúrgica (100, 200):
un par de patas (102, 104, 204);
una corona (106) que interconecta el par de patas (102, 104, 204);
un material de tratamiento de heridas que cubre al menos una parte de las patas (102, 104, 204) y/o de la corona (106); y
siendo el material de tratamiento de heridas un sellador para sellar el tejido para minimizar la pérdida de líquido y retardar el sangrado del tejido, caracterizada por que el sellador está curado de antemano en al menos una porción de una superficie de las patas (102, 104, 204) y/o de la corona (106) por exposición a luz ultravioleta antes de su suministro a un sitio quirúrgico.
2. La fijación quirúrgica (100, 200) según la reivindicación 1 en la que el sellador se selecciona del grupo constituido por acrilato; hidrogeles funcionales de metacrilato en presencia de un fotoiniciador biocompatible; cianoacrilatos alquílicos; macrómeros funcionales de isocianato con o sin macrómeros funcionales de amina; macrómeros funcionales de éster succinimidílico con macrómeros funcionales de amina o sulfhidrilo; macrómeros funcionales epoxi con macrómeros funcionales amina; mezclas de proteínas o polipéptidos en presencia de reticuladores de aldehidos; genipina; carbodiimidas hidrosolubles; polisacáridos aniónicos en presencia de cationes polivalentes; prepolímeros de uretano hidrófilos con terminación de isocianato derivados de poliisocianatos orgánicos y dioles o polioles basados en oxietileno; adhesivos a base de polímeros reticulados biocompatibles formados a partir de precursores hidrosolubles que tienen grupos electrofílicos y nucleófilos capaces de reaccionar y reticularse in situ; sistemas adhesivos de dos partes que incluyen los basados en cadenas principales de óxido de polialquileno sustituidas con uno o más grupos isocianato en combinación con compuestos de diamina bioabsorbibles, o cadenas principales de óxido de polialquileno sustituidas con uno o más grupos amina en combinación con compuestos de diisocianato bioabsorbibles; y prepolímeros de uretano hidrófilos con terminación de isocianato derivados de diisocianatos y polioles aromáticos.
3. La fijación quirúrgica (100, 200) según la reivindicación 1 o 2 en la que las patas (102, 104, 204) y la corona (106) están fabricadas de al menos uno de un material no absorbible y un material bioabsorbible.
4. La fijación quirúrgica (100, 200) según la reivindicación 3 en la que el material no absorbible es al menos uno de acero inoxidable y titanio.
5. La fijación quirúrgica (100, 200) según la reivindicación 3 en la que el material bioabsorbible se selecciona del grupo constituido por homopolímeros, copolímeros, y una mezcla de monómeros seleccionados del grupo constituido por glicólido, ácido glicólico, lactida, ácido láctico, p-dioxanona, [alfa]-caprolactona y carbonato de trimetileno.
6. La fijación quirúrgica (100, 200) según la reivindicación 3 en la que el material bioabsorbible es al menos uno de ácido poliglicólico (PGA) y ácido poliláctico (PLA).
7. La fijación quirúrgica (100, 200) según la reivindicación 1 en la que el material de tratamiento de heridas cubre completamente las patas (102, 104, 204) y la corona (106).
8. La fijación quirúrgica (100, 200) según la reivindicación 1 en la que cada pata (102, 104, 204) incluye un extremo distal afilado (102b, 104b, 206).
9. La fijación quirúrgica (100, 200) según la reivindicación 1 en la que la corona (106) es lineal.
10. La fijación quirúrgica (200) según la reivindicación 1 en la que la fijación quirúrgica (200) comprende una fijación de dos partes que tiene un miembro (210) de retención y el miembro (202) de fijación.
11. La fijación quirúrgica (100, 200) según la reivindicación 1 en la que el sellador curado de antemano es un hidrogel.
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