ES2236446T3 - Adhesivo para fijar un material de refuerzo a un dispositivo de sujecion quirurgico. - Google Patents
Adhesivo para fijar un material de refuerzo a un dispositivo de sujecion quirurgico.Info
- Publication number
- ES2236446T3 ES2236446T3 ES02253133T ES02253133T ES2236446T3 ES 2236446 T3 ES2236446 T3 ES 2236446T3 ES 02253133 T ES02253133 T ES 02253133T ES 02253133 T ES02253133 T ES 02253133T ES 2236446 T3 ES2236446 T3 ES 2236446T3
- Authority
- ES
- Spain
- Prior art keywords
- staples
- adhesive
- tissue
- surgical stapling
- cartridge
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B17/07292—Reinforcements for staple line, e.g. pledgets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B17/1155—Circular staplers comprising a plurality of staples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00491—Surgical glue applicators
- A61B2017/00513—Tissue soldering
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
- A61B2017/07214—Stapler heads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
- Accommodation For Nursing Or Treatment Tables (AREA)
Abstract
Instrumento de grapado quirúrgico (20) para agarrar y grapar tejido que comprende: a. una empuñadura (25), un primero y un segundo miembros opuestos de agarre de tejido conectados a dicha empuñadura y amovibles entre una posición abierta, para recibir tejido entre ellos, y una posición cerrada para grapar tejido entre ellos, albergando al menos uno de dichos primer y segundo miembros de agarre una pluralidad de grapas (49) y b. una tira (60, 61) de material de refuerzo fijada de modo desprendible a, al menos, uno de dichos primer y segundo miembros de agarre de tejido mediante un adhesivo, estando dicho material de refuerzo dispuesto sobre dicho miembro de agarre de forma que dichas grapas (49) pueden fijar dicho material de refuerzo al tejido entre dichos miembros de agarre; caracterizado porque : el material de refuerzo esta fijado a dicho miembro de agarre mediante un adhesivo de aplicación fundido en caliente.
Description
Adhesivo para fijar un material de refuerzo a un
dispositivo de sujeción quirúrgico.
La presente invención se refiere, en general, al
campo de los dispositivos de sujeción quirúrgicos para aplicar una
pluralidad de medios de sujeción quirúrgicos dentro del tejido y,
más concretamente, a un procedimiento novedoso de fijar un material
de refuerzo sobre el dispositivo de sujeción quirúrgico con el fin
de crear una línea reforzada de medios de sujeción quirúrgicos
dentro del tejido.
Muchas intervenciones quirúrgicas implican la
resección de tejido. Una intervención de este tipo es la reducción
del volumen del pulmón, que reseca una porción de pulmón para tratar
el enfisema. Un problema con el que se tropieza durante la resección
de tejido corporal, especialmente en conjunción con el empleo de
grapas, es la cuestión de la hemostasia. Ciertos tipos de tejido
corporal son más propensos a la abertura de la hemostasia como por
ejemplo el tejido delgado friable que se encuentra en el pulmón, y
las circunstancias de la enfermedad pueden exacerbar los problemas.
Como medio para resecar el tejido pulmonar enfermo, se han
utilizado dispositivos mecánicos, como por ejemplo grapas
quirúrgicas y cortadoras lineales, tanto en intervenciones abiertas
como endoscópicas. Las grapas provocan la hemostasia de las
estructuras vasculares, y cuando se aplican al tejido pulmonar
proporcionan también un grado importante de neumostasia. Los
instrumentos de grapado quirúrgico tienen una pluralidad de grapas
dispuestas en múltiples filas situadas al tresbolillo dentro de un
cartucho reemplazable en par de mordazas opuestas de las cuales al
menos una es amovible. Los instrumentos de grapado quirúrgicos
comprimen el tejido pulmonar entre el cartucho y la mordaza, y las
grapas son disparadas en el tejido comprimido en íntima proximidad
a la porción enferma del pulmón que va a ser extirpada. Se pasa una
cuchilla longitudinalmente entre las filas más interiores de las
grapas conformadas, transeccionando el tejido. El dispositivo de
grapado quirúrgico es retirado del emplazamiento quirúrgico,
recargado con otro cartucho de grapado sin disparar, y el
procedimiento se repite hasta que la sección deseada del pulmón es
resecada y retirada. Un ejemplo de una cortadora lineal para
procedimientos abiertos se ofrece en la Patente estadounidense
5.415.334 transferida a Ethicon Endo-Surgery,
Cincinnati, Ohio del 16 de Mayo de 1995.
Un ejemplo de cortadora lineal para
procedimientos endoscópicos se ofrece en la Patente estadounidense
nº 5.597.107 transferida a Ethico Endo-Surgery,
Cincinnati, Ohio el 28 de Enero de 1997.
Un problema conocido en la utilización de grapas
quirúrgicas empleadas de esta manera ha sido la formación de fugas
de aire en el tejido pulmonar grapado. Las fugas pueden presentarse
en la línea de corte, y/o en los mismos orificios de las grapas.
Frecuentemente, el tejido pulmonar dañado es delgado y friable y
puede romperse al nivel de las grapas cuando los pulmones se
redistienden. Estas fugas de aire pueden ser resistentes y pueden
prolongar la estancia hospitalaria de un paciente durante semanas.
Como medio de aliviar estos problemas de fugas, los cirujanos
refuerzan la línea de grapado aplicando un material de refuerzo o
contención en el emplazamiento de grapado propuesto y grapando todo
el material de refuerzo. El material de refuerzo proporciona un
fortalecimiento del tejido friable. El tejido es comprimido contra
los agujeros de las grapas dando como resultado una neumostasia
incrementada. Esto reduce las posibilidades de que el tejido se
rompa al nivel de la línea de grapado, y reduce la salida de las
grapas del tejido friable.
Estos materiales de refuerzo están generalmente
montados de manera desprendible en los miembros de mordaza de un
dispositivo de grapado quirúrgico, de forma que tras el disparo de
las grapas, el material de refuerzo queda grapado al tejido
pulmonar. El tejido pulmonar queda "emparedado"
satisfactoriamente entre dos capas de este material de
fortalecimiento. Alternativamente, pueden utilizarse materiales de
refuerzo en algunas intervenciones quirúrgicas de otro tipo, como
por ejemplo (no limitativo) una histerectomía ovárica, un by pass,
una anastomosis de tejido intestinal, u otra intervención
quirúrgica que requiera el fortalecimiento de una línea de grapado
o de una hemostasia incrementada de tejido.
La fijación de modo desprendible del material de
refuerzo a los miembros de mordaza del dispositivo de grapado
quirúrgico resulta ser un problema especial no resuelto. El
material de refuerzo debe quedar firmemente sujeto a las mordazas
del dispositivo de grapado quirúrgico, de forma que no caiga durante
su utilización normal, pero al mismo tiempo debe poder liberarse
fácilmente del dispositivo de grapado quirúrgico después de
disparar las grapas. Se conoce una diversidad de medios de fijación
adhesivos y mecánicos. A continuación se analizan los medios de
fijación tanto adhesivos como mecánicos y ambos presentan sus
deficiencias.
Un ejemplo de dispositivo que fija un material de
refuerzo a una cortadora lineal con un adhesivo se describe en la
Patente estadounidense nº 5.441.193 y por Gravener et al.
Este dispositivo fija materiales de refuerzo a un instrumento
quirúrgico con un adhesivo de cianoacrilato biocompatible. La unión
por adhesivo se aplica a lo largo de las porciones marginales del
material de refuerzo y unas líneas intermitentes de perforaciones
son situadas dentro del material de refuerzo (adyacentes a la línea
de pegado) de forma que la porción central sin adhesivo del
material de refuerzo puede desgarrarse de las porciones marginales
de pegado. Sin embargo, las porciones del material de refuerzo que
tienen aplicadas en ellas el adhesivo no son desprendibles del
adhesivo. Como consecuencia de ello, la retirada del refuerzo del
instrumento (después del disparo de las grapas) puede resultar
especialmente difícil, pues todo el material existente entre las
perforaciones debe desgarrarse simultáneamente para liberar el
tejido del dispositivo de grapado quirúrgico.
Se requiere un adhesivo que fije de forma
desprendible el material de refuerzo al dispositivo quirúrgico de un
modo que sea más fácil para el cirujano retirar el dispositivo
quirúrgico del emplazamiento quirúrgico después del disparo de las
grapas. La Patente estadounidense nº 5.752.965 de Francis et
al. da a conocer la fijación del material o de las tiras de
refuerzo a un dispositivo de grapado quirúrgico con un adhesivo
desprendible que puede aplicarse justo antes de su empleo. Un
accesorio de alineación se utiliza para alinear el par de tiras de
refuerzo, se aplica adhesivo a la superficie expuesta de cada tira
de refuerzo, y las mordazas del dispositivo de grapado quirúrgico
se cierran entonces sobre el adhesivo y sobre las tiras de
refuerzo. Cuando las mordazas se abren, el material de refuerzo
queda fijado a la mordaza y al cartucho del dispositivo de grapado
quirúrgico con el adhesivo líquido viscoso. El adhesivo líquido
viscoso que la patente da a conocer resulta estar compuesto de
celulosa de hidroxipropilmetilcelulosa, de polipropilenglicol y
agua. Aunque la fijación de esta forma de un material de refuerzo
puede ofrecer un adhesivo desprendible, los efectos adherentes del
adhesivo líquido viscoso son temporales. Además, el proceso de
fijación es retardatorio, y la etapa de fijación debe repetirse en
cada proceso de expulsión de las grapas. Por último, una vez que el
adhesivo viscoso se expone al aire, los elementos volátiles del
adhesivo comienzan a evaporarse. Esto limita la aplicación del
adhesivo viscoso justo antes o durante la intervención
quirúrgica.
Se necesita un dispositivo desprendible que no se
seque o degrade con el tiempo. Dicho adhesivo permitiría que el
material de refuerzo se fijara a dispositivo de grapado quirúrgico
en la planta de fabricación, y permitiría el ahorro de tiempo y
dinero. La solicitud de Patente europea EP 1064883A1 de Leslie
Hamilton et al. da a conocer un adhesivo desprendible de
polímeros esteralifáticos bioabsorbibles no tóxicos que son sólidos
semicristalinos o líquidos viscosos (o de consistencia como la
miel). El adhesivo se caracteriza porque puede fluidificarse a la
temperatura corporal (37ºC) y preferentemente fluidificarse a
temperatura ambiente (25ºC). Sin embargo, el adhesivo puede llegar
a ser más fluido a elevadas temperaturas (hasta 50ºC) que
frecuentemente pueden alcanzarse en camiones, contenedores de
transporte, vagones de ferrocarril y almacenes. Sometido a elevadas
temperaturas, el adhesivo puede migrar a otras partes del
instrumento o al embalaje del instrumento y la migración puede
reducir la resistencia de la unión por adhesivo.
Como se desprende de la exposición anterior, la
fijación de un material de refuerzo a una grapadora quirúrgica con
un adhesivo puede presentar muchos problemas. En la técnica es
también conocida la fijación mecánica de material de refuerzo a un
dispositivo de grapado quirúrgico lo que evita los problemas
planteados con los adhesivos. Existen muchos procedimientos de
fijación mecánica, y uno habitual es el emplazamiento de un
manguito sobre los miembros de agarre del dispositivo de grapado
quirúrgico. Los manguitos pueden estar hechos de un tejido flexible
como material de refuerzo, o puede contener una tira desprendible
de material de refuerzo fijada a un tejido diferente. Muchos de
estos manguitos se describen en la Patente estadounidense nº
5.503.638 de Cooper et al, en la Patente estadounidense nº
5.702.409 de Rayburn et al., en la Patente estadounidense nº
5.810.855 de Rayburn et al., y en la Patente estadounidense
nº 5.964.774 de McKean et al. La Patente estadounidense nº
5.503.638 (o la Patente europea EP 0667119, el equivalente europeo)
divulga las características del preámbulo de la reivindicación
1.
Aunque los manguitos pueden eficazmente emplearse
para fijar el material de refuerzo al efector terminal del
dispositivo de grapado quirúrgico, los manguitos pueden causar
otras complicaciones durante la intervención quirúrgica. Por
ejemplo, si el manguito está conformado con un manguito sólido de
material de refuerzo, al disparar el dispositivo de grapado
quirúrgico se grapa el refuerzo y el tejido y se corta el manguito
de refuerzo y el tejido entre las líneas de grapado. Esta acción
deja las porciones de tejido (a ambos lados de la línea cortada)
unidas entre sí por una lámina de material de refuerzo. Esto
requiere que el cirujano tenga que ponerse a seccionar el manguito
cortado de material de refuerzo para separar el tejido seccionado,
y retirar cualquier porción no deseada del material de
refuerzo.
Se necesita un medio de fijar de forma
desprendible una tira de refuerzo de un dispositivo de grapado
quirúrgico, que siga siendo efectiva durante un largo periodo de
tiempo, permanezca operativa a todas las temperaturas a las que
probablemente pueda quedar sometido el producto, y que pueda
fácilmente desprenderse del dispositivo de grapado quirúrgico.
De acuerdo con la presente invención, se
proporciona un instrumento de grapado quirúrgico para agarrar y
grapar tejido. El instrumento tiene una empuñadura y unos primer y
segundo miembros de agarre de tejido opuestos conectados a la
empuñadura. Los miembros son amovibles entre una posición abierta
para recibir tejido entre ellos y una posición cerrada para grapar
tejido entre dichos miembros. Al menos uno de entre los primer y
segundo miembros de agarre alberga una pluralidad de grapas. El
dispositivo incluye también una tira de material de refuerzo fijada
de modo desprendible a al menos uno de los primer y segundo
miembros de agarre de tejido mediante un adhesivo de aplicación
fundido en caliente. El material de refuerzo está dispuesto sobre el
miembro de agarre de forma que las grapas puedan unir el material
de refuerzo al tejido prendido entre los miembros de agarre.
También de acuerdo con la presente invención, se
proporciona un cartucho de grapas para su fijación a un efector
terminal de un instrumento de grapado quirúrgico. El cartucho
incluye un miembro que alberga una pluralidad de grapas. El miembro
incluye un dispositivo para fijarse él mismo de forma separable a un
instrumento quirúrgico. El cartucho incluye así mismo una tira de
material de refuerzo fijada de forma desprendible al miembro
mediante un adhesivo de aplicación fundido en caliente.
Las características novedosas de la invención se
exponen particularmente en las reivindicaciones adjuntas. La
invención misma, sin embargo, en cuanto a la organización y
procedimientos operativos, junto con los objetos y ventajas
adicionales de la misma, pueden comprenderse de forma óptima con
referencia a la descripción que sigue, tomada en conjunción con los
dibujos que se acompañan, en los cuales:
La Fig. 1 es una vista isométrica de un
dispositivo de grapado quirúrgico que muestra un efector terminal
que tiene unas tiras de refuerzo fijadas de forma desprendible a una
primera superficie de agarre de un yunque y fijadas de forma
desprendible a una segunda superficie de agarre de un cartucho de
grapas mediante un adhesivo de aplicación fundido en caliente de
la presente invención;
la Fig. 2 es una vista isométrica de tamaño
ampliado del efector terminal del dispositivo de grapado quirúrgico
de la Fig. 1 con el yunque seccionado y rotado por razones de
claridad, mostrando la vista la etapa de aplicar el adhesivo de
aplicación fundido en caliente de la presente invención sobre las
primera y segunda superficies de agarre del efector terminal con un
aplicador;
la Fig. 3 es una vista isométrica de tamaño
ampliado del efector terminal del dispositivo de grapado quirúrgico
con el yunque seccionado y rotado por razones de claridad,
mostrando la vista la etapa de fijar una tira de material de
refuerzo sobre cada una de las superficies de agarre de tejido
colocando el material de refuerzo en contacto con el adhesivo de
aplicación fundido en caliente de la presente invención situado
sobre el mismo;
la Fig. 4 es una vista isométrica en despiece
ordenado de la etapa de enfriar el adhesivo de aplicación fundido en
caliente de la presente invención mas allá de un punto fijo,
convirtiendo en sólido el adhesivo desprendible y adhiriendo cada
una de las porciones de material de refuerzo a cada una de las
respectivas superficies de agarre de tejido;
la Fig. 5 es una vista isométrica de un
instrumento de grapado circular que muestra los anillos de refuerzo
situadas sobre el mismo antes de la etapa de aplicar el adhesivo
fundido de la presente invención en un yunque y en un cartucho de
grapas del instrumento de grapado circular para la fijación al mismo
de los anillos de refuerzo.
Con referencia ahora a las figuras, en las cuales
las mismas referencias numerales indican los mismos elementos a lo
largo de las vistas, la Fig. 1 muestra un dispositivo de grapado
quirúrgico 20 fabricado de acuerdo con la presente invención. El
dispositivo 20 tiene un efector terminal 35 con una primera tira de
refuerzo 60 y una segunda tira de refuerzo 61 fijadas en aquél con
un adhesivo de aplicación fundido en caliente de la presente
invención. El dispositivo de grapado quirúrgico 20 mostrado es una
cortadora para procedimientos endoscópicos y es bien conocida en la
técnica para agarrar, grapar, y cortar tejido corporal.
Alternativamente, el dispositivo de grapado 20 puede pertenecer a
un grupo de dispositivos diferentes de sujeción o grapado capaces
de un único o múltiples disparos. Las grapas o medios de sujeción
pueden contenerse dentro de un cartucho de grapas conformado de
manera integral con el dispositivo de grapado quirúrgico, o dentro
de un cartucho de grapas desmontable que puede dispararse y
sustituirse posibilitando múltiples disparos con el mismo
dispositivo de sujeción quirúrgico.
El dispositivo de grapado quirúrgico 20 tiene una
empuñadura 25 para ser sujetada por el operador, un eje alargado 30
que se extiende distalmente desde la empuñadura 25 y un efector
terminal 35 que se extiende distalmente desde el eje 30. El efector
terminal 35 tiene unos primer y segundo miembros de agarre de
tejido amovibles entre una posición abierta para recibir tejido
entre ellos y una posición cerrada para grapar tejido entre los
mismos. El primer miembro de agarre de tejido tiene un canal fijo
31 que se extiende desde el eje 30 y un cartucho de grapas
separable 45 montado en su interior. El segundo miembro de agarre
de tejido es un yunque amovible 40 situado opuesto al primer miembro
de agarre de tejido. El cartucho 45 de grapas se muestra colocado
dentro del canal fijo 31 y contiene una pluralidad de grapas 49
alojadas en su interior. El yunque amovible 40 está fijado de forma
operativa a un gatillo de cierre 26 que se extiende desde la
empuñadura 25 y se desplaza en respuesta al movimiento del gatillo
de cierre 26. El desplazamiento del gatillo de cierre 26 desde la
posición abierta mostrada en la Fig. 1 en dirección a un asidero 27
de la empuñadura 25 desplaza el yunque 40 desde la posición abierta
de la Fig. 1 hasta la posición cerrada adyacente al cartucho de
grapas separable 45 (no mostrado). El desplazamiento de un gatillo
de disparo 28 en dirección al gatillo de cierre 26 (cuando el
gatillo de cierre 26 y el yunque están en la posición cerrada,
expulsa la pluralidad de grapas 49 contenidas dentro del cartucho
separable 45. Las grapas 49 son impulsadas desde el cartucho de
grapas separable 45, a través de las tiras de refuerzo 60 y 61, y
son liberadas en configuraciones compactas en forma de "B" (no
mostradas) contra el yunque 40. Un ejemplo del dispositivo de
grapado quirúrgico 20 es el TSB35 Endopath^{TM} ETS Endoscopic
Linear Cutter by Ethicon-Endo Surgery, 4545 Creek
Road, Cincinnati, OH. El dispositivo de grapado quirúrgico 20 y el
cartucho de grapas separable 45 son descritos ampliamente en la
Patente estadounidense nº 5.597.107 transferida de la forma
legalmente establecida.
Como se muestra en la Fig. 1, la primera y una
segunda tira de refuerzo 60 y 61 están fijadas de manera
desprendible a una primera superficie 46 de agarre de tejido del
cartucho de grapas separable 45 y a una segunda superficie de
agarre 41 del yunque 40. Las tiras de refuerzo 60 y 61 pueden estar
conformadas con una amplia variedad de materiales de refuerzo que
incluyen VICRYL ®, fabricado por Ethicon, Inc., Somerville New
Jersey, ``DEXON ®, fabricado por Sherwood-Davis and
Geck, St. Louis, Missouri, y TEFLON ®, fabricado por E.I. DuPont de
Nemours & Co., Wilmington, Delaware. Adicionalmente, otros
materiales incluyen materia animal como por ejemplo pericardio de
bovino curtido, elastómeros biocompatibles tales como
\varepsilon-caprolactona glicolido fabricado por
Ethicon, Inc. Margrave, England, o uno cualquiera de algunos
materiales de refuerzo adecuados. De especial interés son
determinados materiales o espumas adecuadas de
\varepsilon-caprolactona glicolido y se describen
en la Patente estadounidense nº 5.468.253. Es un objeto de la
presente invención fijar de modo desprendible las tiras 60 y 61 a al
menos de una porción de dispositivo de grapado quirúrgico 20
durante largos periodos de tiempo, hasta dos o más años.
Las Figs. 2 a 4 muestran las etapas de fijar las
tiras de refuerzo 60 y 61, respectivamente, a las primera y segunda
superficies 46, 41 de agarre de tejido del efector terminal 35, con
un adhesivo sólido 65 de la presente invención. El adhesivo sólido
65, es sólido a temperatura ambiente (25ºC), sólido a temperatura
corporal (37º), y fusible a elevadas temperaturas. Los adhesivos de
este tipo son llamados adhesivos de aplicación fundido en caliente
son aplicados como un adhesivo fundido 26 durante el proceso de
pegado. Cuando el adhesivo fundido 66 se enfría vuelve al estado
del adhesivo sólido 65 constituyendo un aglutinante adhesivo. Las
Figs. 2 a 4 el efector terminal 35 del dispositivo de grapado
quirúrgico 20 se muestra en tamaño ampliado, y el yunque 40 se
muestra seccionado y rotado por razones de claridad.
Alternativamente el adhesivo de aplicación fundido en caliente 65
puede fundirse mediante un disolvente y emplearse para adherir las
tiras de refuerzo 60,61 al dispositivo de grapado quirúrgico 20.
Cuando el disolvente se evapora del adhesivo fundido 66, retorna al
estado de adhesivo sólido 65 de aplicación fundido en caliente y
fija las tiras de refuerzo 60, 61 al dispositivo de grapado
quirúrgico 20.
La Fig. 2 muestra la primera etapa de aplicar el
adhesivo fundido 66 a las primera y segunda superficies de agarre
46,41 con un aplicador 70. El aplicador 70 tiene una empuñadura 72,
una boquilla distal 71 para la descarga del adhesivo fundido 66, un
dispositivo calefactor con resistencia caliente 75 contenido dentro
de la empuñadura 72 para fundir el extremo distal del adhesivo
sólido 75, un gatillo 63 del aplicador, y un cable eléctrico 74. La
conexión del cable eléctrico 74 a una fuente de energía conecta con
el dispositivo calefactor con resistencia caliente 75 (no
mostrado). La empuñadura 72 tiene unas ranuras de refrigeración 77
adyacentes al dispositivo calefactor con resistencia caliente 75
para evitar el sobrecalentamiento. Este tipo de aplicadores de
adhesivo son bien conocidos en la técnica como pistolas de pegado
para aplicación fundido en caliente y son fácilmente disponibles
para uso comercial o doméstico. Un ejemplo excelente de pistola de
pegamento por termoimpregnacion o aplicador de adhesivo 70 es la
pistola de pegado SHURE BONDER® Pro 9000 fabricada por FPL
Corporation, Wauconda, IL, 60084.
En la Fig. 2, aparece insertada una barra de
adhesivo sólido 65 dentro de una abertura practicada en el extremo
proximal de la empuñadura 72. Cuando la barra de adhesivo sólido 65
es insertada, conecta operativamente con un mecanismo de
alimentación (no mostrado) que está operativamente acoplado al
gatillo 73 del aplicador. El accionamiento del gatillo del aplicador
desplaza la barra de adhesivo sólido 75 distalmente dentro de la
empuñadura hasta que contacta con el dispositivo calefactor con
resistencia caliente 75 y funde la porción distal de la barra de
adhesivo sólido 65. La aplicación de una presión adicional sobre el
gatillo 73 del aplicador fuerza la salida del adhesivo fundido 66
por un orificio 76 de la boquilla 71 y desplaza la barra de
adhesivo sólido 65 distalmente dentro del aplicador 70. Aunque la
pistola o aplicador 70 de pegado de aplicación fundido en caliente
es el procedimiento preferente de aplicar el adhesivo sólido 65,
puede también disponerse de otros aplicadores adhesivos
alternativos. Estos aplicadores adhesivos alternativos incluyen pero
no se limitan a un dispensador de pegamento fundido presurizado que
aplica una cinta fundida de adhesivo, un nebolizador que aplica un
pulverizador de gotículas fundidas, y un rodillo caliente que
aplica una película de adhesivo fundido.
En la Fig. 2, el aplicador 70 se muestra
aplicando varias líneas de adhesivo fundido 66 sobre las primera y
segunda superficies 46,41 de agarre de tejido del yunque 40 y del
cartucho 45. El adhesivo fundido es aplicado a estas superficies
antes de la etapa de aplicar las tiras de refuerzo 60 y 61.El
adhesivo fundido 66 se muestra siendo aplicado sobre la segunda
superficie de agarre 41 de tejido entre los receptáculos 42 de las
grapas embutidos en su interior. Las dos líneas de adhesivo fundido
66 se mantienen cercanas sobre la segunda superficie 41 de agarre
de tejido y proporcionan la suficiente fuerza de retención para
fijar la primera tira de refuerzo 60 sobre la segunda superficie 41
de agarre de tejido, pero permite que la primera tira de refuerzo
60 sea fácilmente desprendida.
Las dos filas más largas de adhesivo fundido 66
se muestran situadas sobre la primera superficie de agarre 46 del
cartucho de grapas retirable 45, entre las filas longitudinales de
las ranuras 47 de las grapas. Cada ranura 47 de las grapas tiene un
propulsor 48 de las grapas a modo de pistón (no mostrado)
desplazable desde una primera posición retraída en el fondo del
interior del cartucho 45 retirable de las grapas hasta una segunda
porción que se extiende desde una primera superficie 46 de agarre
de tejido. En las Figs. 2 y 3 los propulsores 48 de las grapas
están en la primera posición retraída en el fondo del interior de
las ranuras 47 de las grapas del cartucho 45 de las grapas
retirable. Una grapa en forma de "U" 49 (no mostrada) está
situada dentro de cada ranura 47 de las grapas, en la parte
superior de los propulsores 48 de las grapas retraídos en su
interior. El desplazamiento de los propulsores 48 de las grapas
hacia la segunda posición expulsa las grapas 49 del cartucho
retirable 4. En estas Figs., los propulsores 48 de las grapas y las
grapas 49 están retraídas dentro de las ranuras 47 de las grapas y
no pueden verse. Los cartuchos 45 de las grapas y el desplazamiento
de los propulsores 48 de las grapas y las grapas 49 son bien
conocidos en la técnica y pueden encontrarse en la patente
estadounidense nº 5.415.334 de Williamson, IV et al.
Como se muestra en la Fig. 3 una vez que el
adhesivo fundido 66 es aplicado, la segunda etapa es aplicar las
tiras de refuerzo 60 y 61 sobre la respectivas superficies 46,41 de
agarre de tejido. Las primera y segunda tiras de refuerzo 60 y 61
se muestran desplazándose hacia las primera y segunda superficies
46,41 de agarre de tejido y hacia el adhesivo fundido 66. La Fig. 4
muestra la última etapa del proceso de pegado en la que las tiras de
refuerzo 60 y 61 son situadas en posición y colocadas sobre las
respectivas superficies de agarre 4, 41. Cuando las tiras de
refuerzo 60, 61 son presionadas en posición, el adhesivo fundido 66
es comprimido entre las tiras de refuerzo 61 y las superficies de
agarre 46,41, dejándose que se enfríen hasta adoptar el estado
adhesivo sólido 65, fijando los refuerzos 60,61 al dispositivo de
grapado quirúrgico 20.
El disparo del dispositivo de grapado quirúrgico
20 desplaza los propulsores 48 de las grapas desde la primera
posición dentro del cartucho 45 hasta la segunda posición, esto es,
la posición extendida desde la primera superficie 46 de agarre de
tejido. Esta acción simultáneamente levanta y conforma las grapas
46 contra el yunque 40 y levanta la primera tira de refuerzo 60
hacia arriba y lejos de la primera superficie 46 de agarre de
tejido del cartucho 45. El movimiento hacia arriba de la primera
tira de refuerzo 60 rompe el ligamen adhesivo entre la primera tira
de refuerzo 60 y la primera superficie 46 de agarre de tejido,
liberando la primera tira de refuerzo 61 del cartucho 45 de las
grapas.
Alternativamente, la tira de agarre 61 puede
estar adherida al cartucho 45 aplicando genéricamente el adhesivo
fundido 66 dentro de las ranuras 47 de las grapas y fijando la
primera tira de refuerzo 60 sobre el cartucho 45. El adhesivo
fundido puede situarse dentro de las ranuras 47 de las grapas de dos
formas diferentes. En primer lugar, la masa caliente fundida puede
inyectarse directamente dentro de las ranuras 47 de las grapas con
la pistola de pegado de aplicación fundido en caliente adhiriendo
la tira de refuerzo 60 a la ranura 47 (no mostrada) de las grapas.
En segundo lugar, el adhesivo fundido 66 puede introducirse en los
receptáculos 48 de las grapas colocando el adhesivo fundido 66
sobre la primera superficie 46 de agarre de tejido adyacente a la
ranura 47 de las grapas (Fig. 3) y forzandolo hacia el interior de
los receptáculos 48 de las grapas presionando la primera tira de
refuerzo 60 contra la primera superficie de agarre 46. La acción de
presionar determina que una parte del adhesivo fundido 66 salga de
la primera superficie 46 de agarre de tejido y penetre en las
ranuras 47 de las grapas, adhiriendo el refuerzo 61 tanto a las
ranuras 47 de las grapas como a la primera superficie 46 de agarre
de tejido (no mostrada). Cuando el adhesivo sólido 65 está dentro
de las ranuras 47 de las grapas y el dispositivo de grapado
quirúrgico 20 es disparado, los propulsores 48 de las grapas y las
grapas 49 se desplazan hacia arriba dentro de las ranuras 47 de las
grapas y contactan con el adhesivo sólido 65 alojado en su interior.
El contacto con los propulsores 48 de las grapas en desplazamiento
y las grapas 49 expulsan el adhesivo sólido 65 de las ranuras 47 y
rompe la ligadura del adhesivo entre la primera tira de refuerzo 60
y el cartucho de las grapas retirable 45.
Así, el adhesivo sólido 65 de la presente
invención se convierte en un adhesivo desprendible cuando el disparo
del instrumento de grapado quirúrgico 20 se utiliza para romper la
ligadura del adhesivo entre el cartucho 45 de las grapas y la
primera tira de refuerzo 60. Es importante destacar que el empleo de
la acción de disparo del dispositivo de grapado 20 para romper la
ligadura no depende de la composición del adhesivo. Es decir,
puede liberarse una diversidad de adhesivos de las formas
anteriormente descritas. Además de los adhesivos de aplicación
fundido en caliente, pueden aplicarse otros adhesivos a temperatura
ambiente y pueden incluirse adhesivos tipo compuestos
elastoméricos, siliconas de RTV, gomas naturales y sintéticas,
compuestos anaeróbicos, compuestos obturadores, compuestos
moldeables como por ejemplo compuestos para cerramientos dentales,
o materias maleables como por ejemplo ceras. Adicionalmente, pueden
utilizarse otros adhesivos como por ejemplo acrílicos,
cianoacrilatos, epoxis y similares pueden utilizarse con un
inhibidor de la ligadura. Los inhibidores de la ligadura actúan
como barrera para reducir la resistencia de la ligadura del
adhesivo y pueden incluir aceites, grasas, ceras, desmoldeadores,
Teflon®, siliconas o cualquier otra superficie contaminante que
inhiba la resistencia de la ligadura del adhesivo.
La eyección de las grapas 49 desde el cartucho 45
de las grapas retirable libera también la segunda tira de refuerzo
61 respecto de la segunda superficie 41 de agarre de tejido y
conforma las grapas configuradas en forma de "U" 49,
configurándolas en forma de "B". Las grapas configuradas en
forma de "U" 49 son conformadas en configuraciones en forma de
"B" propulsándolas a través de la segunda tira de refuerzo 62
fijada a la segunda superficie 41 de agarre de tejido y contra los
receptáculos 42 de las grapas situadas dentro del yunque 40. Cuando
el alambre de la grapa 49 es propulsado dentro del receptáculo 42 de
las grapas, los extremos del alambre de la grapa se incurvan
adoptando la configuración de "B", y desalojan el adhesivo
sólido 65 de los receptáculos 42 de las grapas y de la segunda
superficie 41 de agarre de tejido. Esta acción separa la segunda
tira de refuerzo 71 del yunque 40 (no mostrado).
La Fig. 5 muestra el adhesivo fundido 66 cuando
se utiliza para fijar materiales de refuerzo a una grapadora
circular 85. Los anillos de refuerzo 86 se muestran en despiece
ordenado, separados de una primera y una segunda superficies de
compresión circular 87,88, justo antes de la etapa de impregnar con
pegamento los anillos de refuerzo 86 en las superficies de
compresión circulares 88,87 con adhesivo fundido 66. En la Fig. 5
el adhesivo fundido 66 es aplicado sobre la primera superficie de
compresión 87 y está escondido.
El adhesivo sólido 65 puede ser uno cualquiera de
entre una diversidad de adhesivos de termoimpregnación
comercialmente disponibles. Es preferente que el adhesivo de
termoimpregnación sea biocompatible con el tejido corporal y puede
ser natural o sintético. Pueden utilizarse como adhesivos de
termoimpregnación polímeros biológicos naturales, y en particular
algunas proteínas biológicas. Estas proteínas pueden incluir
colágeno, gelatina, ciprina, fibronectina, fibrinógeno, elastina,
albúmina sérica, hemoglobina, ovoalbúmina y similares o cualquier
combinación de las mismas. Adicionalmente, pueden emplearse, solas o
en combinación con otras sustancias, polisacáridos tales como ácido
hialurónico, sulfato de condroitina, almidón de hidroxietilo,
hidroixetilcelulosa, hidroxipropil-celulosa,
carboxietilcelulosa, quitana/quitosana, azarosa y alginato. Las
sustancias sintéticas pueden incluir poli (ácido láctico),
poli(ácido glicólico) poli (hidroxibutirato),
poli(fosfatina), poliéster, polietilenglicol, óxido de
politelino, poliacrilamina, polihidroxietilmetaliacrilato,
polivinilpirrolidona, alcohol poliviníco, ácido poliacrílico,
poliacetato, policaprolactona, polipropileno, nailon y similares.
Así mismo, también pueden incluirse, sin que suponga limitación,
adecuados polímeros bioabsorbibles, biocompatibles seleccionados a
partir del grupo compuesto por poliésteres alifáticos,
poli(aminoácidos), copoli (eterésteres), oxalatos de
polialquileno, poliamidas, policarbonatos derivados de la tirosina,
poli(iminocarbonatos), poliortoésteres, polioxaésteres,
poliaminoésteres, polioxaésteres con grupos de amina,
poli(anhídridos), polifosfacenos, biomoléculas (esto es,
biopolímeros como por ejemplo colágeno, elastina, almidones
bioaborbibles, etc.) y mezclas de las mismas.
De especial interés respecto del adhesivo sólido
65 es un copolímero sólido a temperaturas genéricamente por debajo
de los 40ºC. El copolímero preferente es un copolímero de
\varepsilon-caprolactona o carbonato de
trimitileno y glicólido. Como máxima preferencia, el copolímero es
un copolímero de \varepsilon-caprolactona y
glicólido. La cantidad de
\varepsilon-caprolactona puede situarse entre 30 y
45 por ciento molar siendo el resto glicolido. La combinación
teóricamente perfecta para el copolímero sería de 36:64 (mol/mol)
[poli(\varepsilon-caprolactona-coglicolido)].
El copolímero es un elastómero con menos de un uno por cien de
monómero no reaccionado de acuerdo con lo determinado por la
espectrografía NMR (resonancia magnética nuclear) de protones. La
viscosidad inherente se determina en una solución de 0,1 g/dl de
hexafluoroisopropanol (HFIP) a 25ºC, y puede oscilar entre,
aproximadamente 0,8 g/dl, y, aproximadamente 3,2 g/dl,
preferentemente de, aproximadamente 0,6 g/dl a, aproximadamente,
2,4 g/dl y como máxima preferencia de, aproximadamente
1,6 g/dl.
1,6 g/dl.
En una forma de realización especialmente
preferente, tanto el adhesivo sólido preferente como el material de
refuerzo preferente pueden estar constituidos por el mismo material
biocompatible, \varepsilon-caprolactona
glicólido.
El adhesivo sólido 65 puede caracterizarse como
un sólido a temperaturas hasta los 40ºC, y se funde sin degradación
a elevadas temperaturas entre 40,1ºC y 600ºC. Más preferentemente
los adhesivos sólidos indicados con la referencia numeral 65 pueden
fundirse sin degradación a elevadas temperaturas entre 120ºC y 240ºC
y como máxima preferencia a 180ºC. El copolímero anteriormente
descrito puede prepararse de acuerdo con las descripciones
suministradas en las Patentes estadounidenses n^{os}. 5.486.253,
5.133.739 y 4.605.730.
Aunque se han mostrado y descrito formas de
realización concretas de lapresente invención, pueden efectuarse
modificaciones en el dispositivo sin apartarse del ámbito de la
invención según se define en las reivindicaciones adjuntas a la
presente memoria.
Claims (9)
1. Instrumento de grapado quirúrgico (20) para
agarrar y grapar tejido que comprende:
a. una empuñadura (25), un primero y un segundo
miembros opuestos de agarre de tejido conectados a dicha empuñadura
y amovibles entre una posición abierta, para recibir tejido entre
ellos, y una posición cerrada para grapar tejido entre ellos,
albergando al menos uno de dichos primer y segundo miembros de
agarre una pluralidad de grapas (49) y
b. una tira (60,61) de material de refuerzo
fijada de modo desprendible a, al menos, uno de dichos primer y
segundo miembros de agarre de tejido mediante un adhesivo, estando
dicho material de refuerzo dispuesto sobre dicho miembro de agarre
de forma que dichas grapas (49) pueden fijar dicho material de
refuerzo al tejido entre dichos miembros de agarre;
caracterizado porque:
el material de refuerzo esta fijado a dicho
miembro de agarre mediante un adhesivo de aplicación fundido en
caliente.
2. El instrumento de grapado quirúrgico (20) de
la reivindicación 1, incluyendo dicho primer medio de agarre la
pluralidad de grapas (49) dispuestas en su interior a lo largo de
dos filas separadas sustancialmente paralelas, comprendiendo dicho
segundo miembro de agarre un yunque (40) para formar dichas grapas;
en el que dicho adhesivo está dispuesto dentro de un receptáculo
(48) de las grapas situado en dicho al menos un miembro de
agarre.
3. El instrumento quirúrgico de grapado (20) de
la reivindicación 2 comprendiendo adicionalmente una cuchilla fijada
a dicha empuñadura (25), siendo dicha cuchilla deslizable entre
dichas dos filas de grapas (49) para seccionar el tejido y el
material de refuerzo situado en su interior.
4. El instrumento quirúrgico de grapado (20) de
una cualquiera de las reivindicaciones 1 a 3, incluyendo
adicionalmente un cartucho separable (45) para disponer dicha
pluralidad de grapas (49) sobre al menos uno de dichos primer y
segundo miembros de agarre.
5. Cartucho (45) de grapas para su fijación a un
efector terminal de un instrumento de grapado quirúrgico (20),
comprendiendo dicho cartucho (45):
a. un miembro que alberga una pluralidad de
grapas (49), incluyendo dicho miembro un dispositivo para su propia
fijación, de manera separable, a un instrumento quirúrgico (20) y
caracterizado porque una tira (60,61) de material de
refuerzo está fijada de manera desprendible a dicho miembro mediante
un adhesivo de aplicación fundido en caliente.
6. El instrumento quirúrgico de grapado (20) de
una cualquiera de las reivindicaciones 1 a 4 o el cartucho (45) de
grapas de la reivindicación 5, en el que dicho adhesivo de
aplicación fundido en caliente es un sólido por debajo de 40
grados centígrados.
7. El instrumento quirúrgico de grapado (20) de
una cualquiera de las reivindicaciones 1 a 6 o el cartucho (45) de
grapas de la reivindicación 5 o de la reivindicación 6, en el que
dicho adhesivo de aplicación fundido en caliente muestra una
viscosidad inherente entre 0,6 g/dl y 2,5 g/dl, preferentemente
entre 1,3 g/dl y 1,8 g/dl, en una solución de hexaflouroisopropanol
(HFIP) de 0,1 g/dl a 25ºC.
8. El instrumento quirúrgico de grapado (20) de
una cualquiera de las reivindicaciones 1 a 7 o el cartucho (45) de
grapas de una cualquiera de las reivindicaciones 5 a 7 en el que
dicho adhesivo de aplicación fundido en caliente es un copolímero
de entre 30 a 45 por ciento molar preferentemente, aproximadamente,
un 36 por ciento molar de
\varepsilon-caprolactona, siendo el resto
glicólido.
9. El instrumento quirúrgico de grapado (20) de
una cualquiera de las reivindicaciones 1 a 8 o el cartucho (45) de
grapas de una cualquiera de las reivindicaciones 5 a 8 e el que
dicho material de refuerzo es un copolímero de
\varepsilon-caprolactona y glicólido.
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Application Number | Priority Date | Filing Date | Title |
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US850369 | 2001-05-07 | ||
US09/850,369 US6592597B2 (en) | 2001-05-07 | 2001-05-07 | Adhesive for attaching buttress material to a surgical fastening device |
US09/850,374 US6656193B2 (en) | 2001-05-07 | 2001-05-07 | Device for attachment of buttress material to a surgical fastening device |
Publications (1)
Publication Number | Publication Date |
---|---|
ES2236446T3 true ES2236446T3 (es) | 2005-07-16 |
Family
ID=68069418
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES02253133T Expired - Lifetime ES2236446T3 (es) | 2001-05-07 | 2002-05-03 | Adhesivo para fijar un material de refuerzo a un dispositivo de sujecion quirurgico. |
ES02253132T Expired - Lifetime ES2278875T3 (es) | 2001-05-07 | 2002-05-03 | Dispositivo para fijar un material de refuerzo a una grapadora quirurgica. |
ES06076509T Expired - Lifetime ES2318657T3 (es) | 2001-05-07 | 2002-05-03 | Dispositivo para la sujecion de un material de refuerzo en un dispositivo quirurgico de fijacion. |
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ES02253132T Expired - Lifetime ES2278875T3 (es) | 2001-05-07 | 2002-05-03 | Dispositivo para fijar un material de refuerzo a una grapadora quirurgica. |
ES06076509T Expired - Lifetime ES2318657T3 (es) | 2001-05-07 | 2002-05-03 | Dispositivo para la sujecion de un material de refuerzo en un dispositivo quirurgico de fijacion. |
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US (2) | US6592597B2 (es) |
EP (3) | EP1256318B1 (es) |
JP (2) | JP4248803B2 (es) |
CN (2) | CN1301685C (es) |
AU (2) | AU784619B2 (es) |
CA (2) | CA2384950A1 (es) |
DE (3) | DE60230460D1 (es) |
ES (3) | ES2236446T3 (es) |
MX (2) | MXPA02004507A (es) |
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