ES2246215T3 - Espuma de refuerzo para grapadora quirurgica. - Google Patents
Espuma de refuerzo para grapadora quirurgica.Info
- Publication number
- ES2246215T3 ES2246215T3 ES00305509T ES00305509T ES2246215T3 ES 2246215 T3 ES2246215 T3 ES 2246215T3 ES 00305509 T ES00305509 T ES 00305509T ES 00305509 T ES00305509 T ES 00305509T ES 2246215 T3 ES2246215 T3 ES 2246215T3
- Authority
- ES
- Spain
- Prior art keywords
- foam
- lactide
- copolymer
- caprolactone
- adhesive
- 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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- 238000010304 firing Methods 0.000 description 6
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- ATJFFYVFTNAWJD-UHFFFAOYSA-N Tin Chemical compound [Sn] ATJFFYVFTNAWJD-UHFFFAOYSA-N 0.000 description 1
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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
- 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
- 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, 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Surgical Instruments (AREA)
Abstract
Una espuma biocompatible blanda de celdilla abierta que tenga un primer lado y un segundo lado conformado de forma que se ajuste a las mandíbulas de un aplicador de grapas, en la que la espuma bioabsorbible blanda está compuesta por un poliéster elastomérico alifático y en el que la espuma tiene al menos una superficie que se sellado esencialmente por calentamiento de la espuma.
Description
Espuma de refuerzo para grapadora quirúrgica.
Esta invención se refiere a un equipo para
aproximar tejidos, de manera más específica se refiere a un equipo
de engrapado que aplica un refuerzo de espuma quirúrgica
biocompatible al tejido corporal.
Durante los procedimientos quirúrgicos es
necesario aproximar tejidos de órganos con grapas quirúrgicas. Los
cirujanos usan a menudo dispositivos de engrapado con cortadora
lineal para suturar órganos y tejidos del cuerpo tales como pulmón,
esófago, estómago, duodeno y otros órganos del cuerpo. Dichos
dispositivos aplican varias hileras de grapas lateralmente separadas
sobre los lados opuestos de un corte de tejido.
Se describen en las Patentes de los Estados
Unidos N^{os} 4.633.861 y 4.892.244 ejemplos de dichas grapas
quirúrgicas. La engrapadora quirúrgica incluye un par de miembros en
forma de mandíbula elongados cooperativos. Uno de los miembros de la
mandíbula incluye un cartucho de grapas con al menos dos hileras de
grapas lateralmente separadas y otro miembro de la mandíbula incluye
un yunque con depresiones para el cierre de las grapas alineado con
las hileras de grapas en el cartucho. Un bloque de empuje se dirige
longitudinalmente a lo largo de las mandíbulas para eyectar de
manera secuencial las grapas desde los cartuchos, de manera que
empuja las grapas contra el yunque para formar hileras de grapas
lateralmente separadas a través de los tejidos que se aprisionan
entre las mandíbulas. Con el bloque de empuje se asocia una
cuchilla, que se mueve hacia delante a lo largo de las mandíbulas
para cortar el tejido a lo largo de la línea entre las hileras de
grapas anteriormente formadas.
Cuando se opera sobre tejido es deseable cerrar
los vasos sanguíneos abiertos (hemostasis) a lo largo de la línea de
corte. Y en procedimientos que implican aproximar el tejido del
pulmón es necesario sellar el pulmón para evitar la pérdida de aire
(pneumostasis). La Patente de los Estados Unidos Nº 5.263.629
describe un procedimiento y equipo para conseguir la hemostasis a lo
largo de la línea de grapas utilizando un material almohadillado
colocado adyacente a al menos una de las superficies del tejido. La
línea de grapas se forma de manera que se extiende a través del
tejido y del material almohadillado absorbible El material
almohadillado se selecciona de forma que distribuya la presión de
una manera esencialmente uniforme a lo largo de la línea de grapas,
y produzca por tanto la esencial hemostasis a lo largo del corte del
tejido. Los materiales preferidos para estos almohadillados son
tejidos herméticamente entrelazados, absorbibles y estériles. Los
almohadillados se pueden asegurar a la engrapadora por soldaduras
ultrasónicas separadas o enlaces adhesivos separados.
La presente invención proporciona un equipo de
engrapado quirúrgico mejorado en el que el material almohadillado o
refuerzo es un material de espuma blando, elástico, bioabsorbible
que es fácil de cortar y proporciona un sellado mejor para la
hemostasis y pneumostasis, que se puede adherir de forma despegable
al engrapador mediante un polímero bioabsorbible de bajo punto de
fusión, ó líquido.
La Fig. 1 es una vista en perspectiva del
despiece de una engrapadora quirúrgica que incorpora la espuma
biocompatible enlazada con un polímero de bajo punto de fusión, ó
líquido;
La Fig. 2 es una vista lateral en elevación del
dispositivo engrapador que se muestra en la Fig. 1 con sus
mandíbulas en una posición de grapado;
La Fig. 3 es una vista en perspectiva de un
cartucho de grapas que incluye un material de espuma de acuerdo con
la invención;
La Fig. 4 es una vista en sección tomada a través
de las mandíbulas de la engrapadora quirúrgica que muestra una grapa
que se está formando a través de las secciones de tejidos adyacentes
y el material de espuma situado adyacente a la superficie externa de
cada una de las secciones de tejido;
La Fig. 5 es una vista en sección longitudinal
que muestra las secciones de tejido adyacentes unidas juntas
mediante grapas y el material de espuma de acuerdo con la
invención;
La Fig. 6 es una vista en sección que muestra los
segmentos de órgano adyacentes unidos juntos mediante grapas y el
material de espuma de acuerdo con la invención;
La Fig. 7 es una vista en perspectiva de una
punta del yunque que incluye un material de espuma de acuerdo con la
invención;
La Fig 8 es una vista en planta superior de la
punta del yunque que se muestra en la Fig. 7;
La Fig. 9 es una vista en elevación lateral de la
punta del yunque que se muestra en la Fig. 7;
La Fig. 10 es una vista en planta inferior de la
punta del yunque que se muestra en la Fig. 7; y
La Fig. 11 es una vista del extremo de una punta
del yunque tomada a lo largo de la línea 11-11 de la
Fig. 9.
La Fig. 12 es una vista en perspectiva de una
forma de realización alternativa de la presente invención en la que
las mandíbulas superior, y de manera opcional la inferior, tienen
superficies contorneadas que se enganchan mediante material de
espuma.
Con referencia a la Fig. 1, se muestra una
engrapadora quirúrgica típica 10, generalmente del tipo descrito en
las Patentes de los Estados Unidos N^{os} 5.503.638; 4.633.681 y
4.892.244. La engrapadora quirúrgica 10 incluye una mandíbula
superior 20, un medio de disparo 30, una mandíbula inferior 40 y un
cartucho de grapas 50 que se acopla en el interior de la mandíbula
inferior 40,
El dispositivo de disparo 30 incluye un bloque de
empuje y un conjunto de resorte de disparo 32 y una cuchilla 34
localizada entre los anteriores. Los resortes de disparo se dirigen
a través de puertos longitudinales que se localizan en el cartucho
de grapas 50. El cartucho 50 se acopla de manera que se puede quitar
en el interior de un canal de la mandíbula inferior 44. Un botón de
disparo 42 activa el dispositivo de disparo 30 para mover los
resortes de disparo 32 a través del cartucho de grapas 50. A medida
que los resortes de disparo 32 pasan longitudinalmente a través del
cartucho, entran en contacto con los punzones de las grapas (no
mostrados), que eyectan a su vez las grapas 51 a través de los
orificios 53 del cartucho de grapas 50,
La mandíbula superior 20 está conectada de manera
que pueda pivotar con la mandíbula inferior 40 a través de un cierre
engranado 35 que se acopla al puerto 36 asociado con un miembro de
cierre 38 para cerrar los miembros de mandíbula conjuntamente en una
posición intermedia a lo largo de la longitud de la misma. El
movimiento del miembro de cierre 38 entre su posición de cierre, tal
como se muestra en la Fig. 2, y su posición no cerrada, tal como se
muestra en la Fig. 1, hace que las mandíbulas 20 y 40 se muevan
acercándose y separándose entre si.
Haciendo referencia a las Figuras 1 y 3 se
muestra una forma de realización preferida de un cartucho de grapas
desechable 50 que contiene varias grapas quirúrgicas 51, del tipo
general que se describe en las Patentes de los Estados Unidos
N^{os} 4.633.681 y 4.892.244. El cartucho 50 se proporciona
provisto, de forma preferible con dos líneas de grapas paralelas
separadas entre sí.
El cartucho 50 incluye una tira de material de
espuma bioabsorbible 52 unido de forma que se pueda separar al
anterior (mediante un polímero bioabsorbible líquido o de bajo punto
de fusión 54) interaccionando con una superficie superior 57 que
tiene orificios 53 a través de los cuales se eyectan las grapas de
acuerdo con una forma de realización preferida de la invención, la
tira de espuma se asegura a los bordes longitudinales del cartucho
de grapas del cartucho de grapas 50 mediante un recubrimiento
continuo de una variedad de enlaces que se pueden despegar
espaciados entre sí que proporciona el polímero bioabsorbible
líquido o de bajo punto de fusión 54.
Haciendo referencia a las Figuras 1 y
7-10, la parte frontal de la mandíbula superior 20
incluye una sección de yunque 60 que incluye filas longitudinales de
agujeros formadores de grapas uniformemente separados 63. Una punta
de yunque desechable 62 se monta de forma que se puede liberar en la
parte frontal de la sección de yunque 60 y se acopla de forma
reversible sobre la anterior. La punta del yunque 62 incluye un par
de paredes alargadas en la cara interna separadas entre sí 66 que se
extienden en la sección de yunque 60 y un par un par de paredes
alargadas en la cara externa separadas entre sí 68 que se extienden
a lo largo de la sección de yunque 60, Una tira de material de
espuma 52 se asegura de forma que se puede liberar (de manera
adhesiva o mecánica) a la punta del yunque 62 por diferentes medios
que permitan que la tira de material de espuma permanezca por detrás
de las grapas una vez que la engrapadora se ha retirado del
emplazamiento de engrapado. De acuerdo con formas de realización
preferidas de la invención, la tira de material de espuma se asegura
a la superficie inferior de las paredes laterales 68 mediante un
recubrimiento continuo de un adhesivo o varios enlaces separados
entre sí que se pueden liberar formados mediante un adhesivo que se
puede separar tal como un polímero bioabsorbible líquido o de bajo
punto de fusión 54.
De manera alternativa, tal como se ilustra en la
Fig. 12, el material de espuma 52, 52a, puede tener las
características 124, 124a para engranar la superficie contorneada de
la superficie del yunque 164 o la superficie contorneada de la
superficie del cartucho 157,
En una forma de realización adicional de la
presente invención, el material de espuma se puede proporcionar en
una funda que se acopla por encima de las mandíbulas 20 y 40 de la
engrapadora. Los diseños adecuados para las fundas se describen en
las Patentes de los Estados Unidos N^{os} 5.503.638,5.702.409 y
5.766.188. Sólo es necesario que se use el material de espuma en la
parte de la funda que permanecerá en el paciente para la hemostasis
o pneumostasis; el resto de las porciones de la funda se puede
fabricar con otros materiales adecuados.
De acuerdo con formas de realización preferidas
de la invención, las tiras de material de espuma 52 se fabrican de
forma preferible con un material de espuma bioabsorbible adecuado.
El material de espuma distribuye la presión de manera uniforme a lo
largo de la hilera de grapas para producir sustancial hemostasis o
pneumostasis a lo largo del corte de tejido. El material de espuma
también proporciona un medio para que las grapas se mantengan en
tejidos finos o enfermos. El material también absorbe el impacto y
reduce el trauma.
Los materiales de espuma adecuados para uso como
material de almohadillado necesitan ser blandos y plegables de forma
que la espuma pueda distribuir la carga compresiva y compensar las
variaciones en el espesor del tejido, actuando de esta forma como
una junta efectiva para la hemostasis y pneumostasis.
Las espumas adecuadas para uso en la presente
invención se preparan a partir de polímeros elastómeros
biocompatibles, de forma preferible este polímero será también
bioabsorbible. Se describen en la Patente de los Estados Unidos Nº
5,468,253 ejemplos de elastómeros bioabsorbibles adecuados. De forma
preferible, los elastómeros bioabsorbibles y biocompatibles están
basados en poliésteres alifáticos, entre los que se incluyen pero no
se limitan al grupo constituido por copolímeros elastoméricos de
\varepsilon-caprolactona y glicólido (de forma
preferible que tengan una relación molar de
\varepsilon-caprolactona a glicólido de
aproximadamente 35:65 a aproximadamente 65:35, de forma más
preferible 45:55 a 35:65), copolímeros elastoméricos de
\varepsilon-caprolactona y láctido, que incluyen
mezclas de L-láctido y D-láctido de
los mismos o copolímeros de ácido láctico (de forma preferible que
tengan una relación molar de
\varepsilon-caprolactona a láctido de
aproximadamente 35:65 a aproximadamente 65:35 y de forma más
preferible 45:55 a 30:70 o desde aproximadamente 95:5 a
aproximadamente 85:15), copolímeros elastoméricos de
p-dioxanona
(1,4-dioxan-2-ona) y
láctido que incluyen L-láctido,
D-láctido y ácido láctico (de forma preferible que
tengan una relación molar de p-dioxanona a láctido
de aproximadamente 40:60 a aproximadamente 60:40), copolímeros
elastoméricos de \varepsilon-caprolactona y
p-dioxanona (de forma preferible que tengan una
relación molar de \varepsilon-caprolactona a
p-dioxanona de aproximadamente 30:70 a
aproximadamente 70:30), copolímeros elastoméricos de
p-dioxanona y carbonato de trimetileno (de forma
preferible que tengan una relación molar de
p-dioxanona a carbonato de trimetileno de
aproximadamente 30:70 a aproximadamente 70:30), copolímeros
elastoméricos de carbonato de trimetileno y glicólido (de forma
preferible que tengan una relación molar de carbonato de trimetileno
a glicólido de aproximadamente 30:70 a aproximadamente 70:30),
copolímero elastomérico de carbonato de trimetileno y láctido que
incluyen mezclas de L-láctido,
D-láctido de los mismos o copolímeros de ácido
láctico (de forma preferible que tengan una relación molar de
carbonato de trimetileno a láctido de aproximadamente 30:70 a
aproximadamente 70:30) y mezclas de los mismos. Estos polímeros
elastoméricos tendrán una viscosidad inherente de aproximadamente
1,2 dL/g a aproximadamente 4 dL/g, de forma preferible una
viscosidad inherente de aproximadamente 1,2 dL/g a aproximadamente 2
dL/g y lo más preferible una viscosidad inherente de aproximadamente
1,4 dL/g a aproximadamente 2 dL/g según se determina a 25ºC en una
solución de polímero de 0,1 gramo por decilitro (g/dL) en
hexafluoroisopropanol (HFIP).
De forma preferible, los elastómeros mostrarán un
elevado porcentaje de elongación y un módulo bajo, a la vez que
poseen buena resistencia a la tracción y buenas propiedades de
recuperación. En las formas de realización preferidas de esta
invención, el elastómero a partir del cual se forman las espumas
presentará una elongación porcentual mayor de aproximadamente 200 de
forma preferible mayor de aproximadamente 500, también mostrará un
módulo (módulo de Young) menor de aproximadamente 80.000 psi (5,52 x
10^{8} N/m^{2}), de forma preferible menor de aproximadamente
40.000 psi (2,76 x 10^{8} N/m^{2}). Estas propiedades, que miden
el grado de elasticidad del elastómero bioabsorbible, se alcanzan a
la vez que se mantiene una resistencia a la tracción mayor de
aproximadamente 500 psi (3,45 x 10^{6} N/m^{2}), de forma
preferible mayor de aproximadamente 1.000 psi (6,60 x 10^{6}
N/m^{2}), y una resistencia al desgarro de mayor de
aproximadamente 50 lbs/pulgada (8,756 N/m), de forma preferible
mayor de aproximadamente 80 lbs/pulgada (41,010 N/m).
Estos polímeros elastoméricos pueden formar
espuma mediante liofilización, espumado en solvente supercrítico (es
decir, como se describe en el Docuemnto EP 464.163 B1), extrusión
por inyección de gas, moldeo por inyección de gas, o colada con un
material extraíble (es decir, sales, azúcar, o cualquier otro
procedimiento conocido de aquellos expertos en la técnica). En la
actualidad se prefiere preparar elastómeros biocompatibles
bioabsorbibles mediante liofilización. Un procedimiento adecuado
para liofilizar polímeros elastoméricos para formar una espuma se
describe en el Ejemplo 2. Se pueden incorporar compuestos
farmacéuticamente activos al material de espuma para además tratar
al paciente, entre los que se incluyen pero no se limitan a,
antibióticos, agentes antifúngicos, agentes hemostáticos, agentes
antiinflamatorios, factores de crecimiento, y similares.
Los adhesivos adecuados bioabsorbibles que se
pueden despegar incluyen homopolímeros de ésteres alifáticos y
copolímeros fabricados a partir de polímeros de fórmula:
[-O-R^{11}-C(O)-]_{Y}
en la que R^{11} se selecciona
del grupo constituido por -CR^{12}H-,
-(CH_{2})_{3}-O-,
-CH_{2}-CH_{2}-O-CH_{2}-,
CR^{12}H-CH_{2},
-(CH_{2})_{4}-,
-(CH_{2})_{z}-O- y - (CH_{2})_{z}-C(O)-CH_{2}-; R^{12} es hidrógeno o metilo; z es un entero comprendido en el intervalo de 1 a 7; e y es un entero comprendido en el intervalo entre aproximadamente 10 a aproximadamente 20.000; mezclas de un PEG líquido viscoso y un PEG de bajo punto de fusión (sólido a temperatura ambiente que funde a menos de aproximadamente 60ºC); monosacáridos, disacáridos y polisacáridos biocompatibles (como pectina) que se pueden mezclar con un plastificante (como glicerina) para formar un adhesivo pegajoso y proteínas biocompatibles (tales como gelatina) que se pueden mezclar con un plastificante (como glicerina) para formar un adhesivo
pegajoso.
-(CH_{2})_{z}-O- y - (CH_{2})_{z}-C(O)-CH_{2}-; R^{12} es hidrógeno o metilo; z es un entero comprendido en el intervalo de 1 a 7; e y es un entero comprendido en el intervalo entre aproximadamente 10 a aproximadamente 20.000; mezclas de un PEG líquido viscoso y un PEG de bajo punto de fusión (sólido a temperatura ambiente que funde a menos de aproximadamente 60ºC); monosacáridos, disacáridos y polisacáridos biocompatibles (como pectina) que se pueden mezclar con un plastificante (como glicerina) para formar un adhesivo pegajoso y proteínas biocompatibles (tales como gelatina) que se pueden mezclar con un plastificante (como glicerina) para formar un adhesivo
pegajoso.
Se pueden usar muchos polímeros de ésteres
alifáticos bioabsorbibles no tóxicos que son sólidos semicristalinos
o líquidos pegajosos a temperatura ambiente como adhesivos que se
pueden despegar. El adhesivo que se puede despegar de esta invención
se caracteriza por lo general por ser fluido a la temperatura del
cuerpo (37ºC) y de forma preferible fluirá a temperatura ambiente
(25ºC). Lo más preferible, estos líquidos tendrán un bajo límite
elástico para evitar la migración del polímero. En la Patente de los
Estados Unidos con Número de Serie 08/746.180 presentada el 6 de
noviembre de 1996 se muestran ejemplos de copolímeros líquidos
pegajosos adecuados. De forma adicional, también se pueden usar
microdispersiones pegajosas como las que se describen en la Patente
de los Estados Unidos Nº 5.559.852. De forma particular, se
prefieren los copolímeros líquidos que están compuestos en el
intervalo de aproximadamente 65 en porcentaje molar a
aproximadamente 35 en porcentaje molar de
\varepsilon-caprolactona, carbonato de
trimetileno, éter de lactona (que a efectos de esta invención se
define como unidades repetidas de
1,4-dioxepan-2-ona y
1,5-dioxepan-2-ona)
o combinaciones de los mismos siendo el resto del polímero una
variedad de unidades repetidas de una segunda lactona. Las unidades
repetidas de una segunda lactona se seleccionarán del grupo
constituido por unidades repetidas de ácido glicólico, unidades
repetidas de ácido láctico, unidades repetidas de
1,4-dioxanona,
6,6-dialquil-1,4-dioxepan-2-ona,
combinaciones de los mismos y mezclas de los mismos. De forma
adicional, la \varepsilon-caprolactona, el
carbonato de trimetileno, o un éter de lactona se pueden
copolimerizar para proporcionar un copolímero líquido. Entre los
polímeros preferidos para uso como sólidos particulados están los
polímeros bioabsorbibles entre los que se incluyen homopolímeros de
poli(\varepsilon-caprolactona),
poli(p-dioxanona), o poli(carbonato de
trimetileno), copolímeros de
\varepsilon-caprolactona y carbonato de
trimetileno, copolímeros de
\varepsilon-caprolactona y varias unidades
repetidas de una segunda lactona. Las unidades repetidas de segunda
lactona pueden seleccionarse del grupo constituido por unidades
repetidas de ácido glicólico, unidades repetidas de ácido láctico,
unidades repetidas de 1,4-dioxanona, unidades
repetidas de
1,4-dioxepan-2-ona,
unidades repetidas de
1,5-dioxepan-2-ona y
combinaciones de los mismos. Los copolímeros de
\varepsilon-caprolactona estarán compuestos de
forma preferible de 99 en porcentaje molar a 70 en porcentaje molar
de \varepsilon-caprolactona siendo el resto del
polímero varias unidades repetidas de una segunda lactona. Los
polímeros pueden ser lineales, ramificados, o ramificados en forma
de estrella; copolímeros en bloque o terpolímeros; copolímeros
segmentados en bloque o terpolímeros. Estos polímeros se purificarán
también para eliminar de forma sustancial todos los monómeros que no
hayan reaccionado que puedan causar una reacción inflamatoria en los
tejidos.
Los copolímeros líquidos preferidos para uso como
el adhesivo que se puede despegar están compuestos en el intervalo
de aproximadamente un 65 en porcentaje molar a aproximadamente 35 en
porcentaje molar de \varepsilon-caprolactona o una
unidad repetida éter de lactona siendo el resto del copolímero
unidades repetidas de carbonato de trimetileno. Entre los ejemplos
de terpolímeros adecuados están los terpolímeros que se seleccionan
del grupo constituido por poli(glicólido-co-
\varepsilon-caprolactona-co-p-dioxanona)
y poli(láctido-co-
\varepsilon-caprolactona-co-p-dioxanona)
en la que el porcentaje molar de las unidades repetidas de
\varepsilon-caprolactona es desde aproximadamente
35 a aproximadamente 65 en porcentaje molar.
Se prefieren los terpolímeros que estén
comprendidos en el intervalo de un 40 a 60 en porcentaje molar
unidades repetidas de \varepsilon-caprolactona.
Entre los ejemplos de copolímeros líquidos para uso como el adhesivo
que se puede despegar pueden seleccionarse del grupo constituido por
poli(\varepsilon-caprolactona-co-carbonato
de trimetileno),
poli(láctido-co-carbonato de
trimetileno),
poli(\varepsilon-caprolactona-co-p-dioxanona),
poli(carbonato de
trimetileno-co-p-dioxanona),
poli(\varepsilon-caprolactona-co-láctido),
poli(láctido-co-1,5-dioxepan-2-ona),
y
poli(1,5-dioxepan-2-ona-co-p-dioxanona),
poli(láctido-co-1,4-dioxepan-2-ona),
y
poli(1,4-dioxepan-2-ona-co-p-dioxanona).
El porcentaje molar de las unidades repetidas de
\varepsilon-caprolactona, carbonato de trimetileno
o éter de lactona en estos polímeros debería estar en el intervalo
de aproximadamente 35 a aproximadamente 65 en porcentaje molar y de
forma preferible en el intervalo de 40 a 60 en porcentaje molar. Lo
más preferible es que estos polímeros líquidos sean copolímeros
aleatorios desde el punto de vista estadístico. Estos polímeros se
purificarán también para eliminar de forma sustancial todos los
monómeros que no hayan reaccionado que puedan causar una reacción
inflamatoria en los tejidos.
Los polímeros usados como el adhesivo que se
puede despegar beberían tener una viscosidad inherente determinada
en una solución de hexafluoroisopropanol de 0,1 g/dL (HFIP) a 25ºC
comprendida desde aproximadamente 0,1 dL/g a aproximadamente 0,8
dL/g, de forma preferible desde aproximadamente 0,1 dL/g a
aproximadamente 0,6 dL/g, y lo más preferible desde 0,15 dL/g a 0,25
dL/g para polímeros líquidos.
De forma adicional se pueden usar mezclas de
polietilén glicoles (PEG) líquidos y sólidos como el adhesivo que se
puede despegar. El PEG líquido puede tener un peso molecular desde
aproximadamente 200 a aproximadamente 600, El PEG sólido puede tener
un peso molecular desde aproximadamente 3400 a aproximadamente
10.000, Por lo general esto es una teoría, que en forma alguna
limita el alcance de esta invención, que el PEG líquido de bajo peso
molecular plastifica el PEG sólido para volver pegajoso el PEG
sólido. Por consecuencia, la mayoría de la composición debe ser el
PEG sólido, y de forma preferible, entre aproximadamente 50 y
aproximadamente 80 como porcentaje en peso de la composición será
PEG sólido. Por ejemplo, un polietilén glicol líquido con un peso
molecular de 400 (PEG 400) se puede mezclar con un polietilén glicol
sólido con un peso molecular de aproximadamente 2.000 (PEG 2000). La
relación de PEG 400 a PEG 2000 puede variar desde aproximadamente
40:60 a aproximadamente 30:70, Estas mezclas se pueden formar
mezclando el PEG líquido y el PEG sólido con agitación constante en
un baño de agua caliente hasta que el sólido funda y se forme una
solución transparente. Una vez que se deja enfriar estas soluciones,
se puede ensayar la adhesividad de la mezcla resultante y se usa en
la presente invención si se ha obtenido la adhesividad deseada.
De manera alternativa se pueden usar
monosacáridos, disacáridos, polisacáridos o proteínas biocompatibles
con un plastificante biocompatible tal como glicerina para formar
películas pegajosas en presencia de agua. Estos materiales se pueden
aplicar a la superficie del material de almohadillado y activarlos
aplicando agua antes de ponerlo en contacto con el aplicador de
grapas.
La cantidad de adhesivo que se puede despegar que
se aplicará depende de varios factores, tales como el adhesivo que
se puede despegar usado, el grado deseado de resistencia para que la
espuma se despegue y la geometría de su aplicación. Aquellos
expertos en la técnica serán fácilmente capaces de determinar la
cantidad apropiada de adhesivo que se puede despegar a aplicar para
conseguir el perfil de despegado deseado.
De forma adicional, puede desearse que las
espumas porosas se procesen posteriomente para evitar el
deslizamiento del adhesivo en el interior de la espuma. Para evitar
o minimizar el deslizamiento del adhesivo que se puede despegar al
interior de la espuma porosa es deseable sellar la superficie de la
espuma porosa. Existen muchos procedimientos que se pueden usar para
sellar la superficie. Por ejemplo, recubrir la parte superficial de
la espuma con un material biocompatible de bajo punto de fusión
antes de aplicar el adhesivo que se puede despegar. De manera
alternativa, la espuma porosa se puede recubrir por su parte
superior con una capa de película. Además, la espuma porosa se puede
tratar con una solución de solvente para colapsar la capa externa de
poros y formar una piel. Se puede conseguir un efecto similar
aplicando una superficie caliente a la espuma porosa para reducir de
forma sustancial la porosidad de la superficie de la espuma.
El (los) poli(éster)s alifáticos se
preparan por los general mediante una polimerización de bucle
abierto con las proporciones deseadas de uno o más monómeros de
lactona en presencia de un catalizador organometálico y un iniciador
a temperatura elevada. El catalizador organometálico es de forma
preferible un catalizador basado en estaño, por ejemplo, octoato
estannoso, y está presente en la mezcla de monómeros con una
relación molar de monómero a catalizador que oscila desde
aproximadamente 15.000/1 a aproximadamente 80.000/1. El iniciador es
típicamente un alcanol (tal como 1-dodecanol), un
poliol (tal como 1,2-propanodiol,
1,3-propanodiol, dietilén glicol, o glicerol,
poli(etilén glicol)s, poli(propilén
glicol)s y
poli(etilén-co-propilén
glicol)s), un hidroxiácido o una amina, y está presente en la
mezcla de monómeros en una relación molar de monómero a iniciador
que oscila desde aproximadamente 100/1 a aproximadamente 5000/1. La
polimerización se lleva normalmente a cabo en un intervalo de
temperatura comprendido desde aproximadamente 80 a aproximadamente
220ºC, de forma preferible 160 a 190ºC, hasta que se consigue el
peso molecular y la viscosidad deseados.
El procedimiento para conseguir hemostasis a lo
largo de un corte de tejido que tenga vasos sanguíneos abiertos de
acuerdo con la invención se discutirá a continuación con una
descripción del funcionamiento del dispositivo engrapador 10, El
tejido o paredes de las secciones del órgano a engrapar y cortar se
colocarán y aprisionarán entre la mandíbula superior 20 y la
mandíbula inferior 40 y el cierre 38 en su posición cerrada tal como
se muestra en la Fig. 2. Se proporciona a al menos uno, y de forma
preferible tanto al cartucho 50 como a la punta del yunque 62 una
tira de material de espuma 52 según se ha descrito anteriormente.
Por ejemplo, tal como se muestra en la Fig. 4, los segmentos de
tejido 70 y 72 se muestran colocados y unidos entre las mandíbulas
20 y 40.
Una vez que los segmentes de tejido se han
juntado entre los miembros de mandíbula, se dispara la grapa 10
haciendo avanzar el botón de disparo 42 para activar el bloque de
empuje y el conjunto de cuchilla de corte 30, Los resortes de
disparo 32 avanzan distalmente a través del cartucho de grapas 50
hasta enganchar con los puertos de grapas para empujar de forma
secuencial las grapas 51 a través de los orificios 53 en dos líneas
de grapas paralelas separadas entre sí. Las grapas 51 entran en
contacto con el correspondiente hueco formador de grapas asociado
con la sección de yunque 60 para formar una grapa, por lo general
con configuración en B o plana. Haciendo referencia a la Figura 4,
las grapas se extienden a través de las secciones de tejido 70 y 72
y las tiras de material de espuma 52. A la vez, la cuchilla de corte
34 avanza distalmente a través de una abertura longitudinal formada
en la sección de yunque 60 y cartucho de grapas 50 para cortar las
secciones de tejido engrapadas entre las secciones de mandíbula
entre las dos líneas de grapas paralelas separadas entre sí.
Una vez que los resortes de disparo 32 están
completamente avanzados para formar todas las grapas del cartucho
50, el bloque de empuje y conjunto de cuchilla cortadora 30 vuelven
a su posición de partida por retracción del botón de disparo 42. El
miembro de cierre 38 puede moverse a continuación a su posición no
cerrada, separando las mandíbulas 20 y 40, de forma que permite que
el dispositivo 10 se desenganche y retire de las secciones de tejido
liberando las tiras del material de espuma de la punta del yunque 62
y/o el cartucho 50,
Tal como se muestra en las Figuras 5 y 6, las
grapas 51 se extienden a través de las tiras de material de espuma
52 y los segmentos de tejido 70 y 72 quedan empaquetados entre las
anteriores. Las tiras de material de espuma 52 distribuyen la
presión de manera uniforme a lo largo de la hilera de grapas, y por
tanto dan lugar a una hemostasis y pneumostasis sustancial a lo
largo de las patas de las grapas. La naturaleza absorbible del
material a partir del cual se fabrican las tiras del material de
espuma hace que las tiras se puedan dejar en el cuerpo y se elimina
la posibilidad de que se puedan producir reacciones a cuerpos
extraños si las espumas no fueran bioabsorbibles.
De acuerdo con la forma de realización más
preferida de la invención el material de espuma se coloca adyacente
a las superficies de las secciones de tejido que entran en contacto
tanto con el cartucho de grapas 50 como con la punta del yunque 62.
Sin embargo, la invención contempla que el material de espuma pueda
colocarse adyacente sólo a una de estas superficies, de forma
preferible la superficie adyacente a la punta del yunque 62. Además,
se prefiere que se extiendan un par de hileras paralelas de grapas a
través de cada una de las secciones de tejido adyacente al corte del
tejido.
Aunque se describe más arriba en unión con una
engrapadora quirúrgica 10 concreta, a efectos de ejemplo, se
contempla que los principios de la presente invención se pueden usar
de forma similar en unión de otras tijeras y engrapadoras
quirúrgicas. Por ejemplo, se puede modificar de forma adecuada una
engrapadora circular del tipo que se describe en la Patente de los
Estados Unidos 5.104,025, con el fin de proporcionar material de
espuma sobre el cartucho de grapas y el yunque. Se puede modificar
de forma adecuada una cortadora endoscópica abandonada en la
actualidad del tipo que se describe en la Patente de los Estados
Unidos con número de Serie 779.436, publicada el 18 de octubre de
1991, con el fin de proporcionar material de espumas sobre la
protección del yunque y el conjunto del cartucho de grapas.
El procedimiento y equipo de la invención, en sus
aspectos más amplios, no se limitan a los detalles específicos que
se muestran y se describen, y se pueden hacer modificaciones a las
formas de realización preferidas de la invención descritas sin
separarse de los principios de la invención.
Se añadieron 57,07 gramos de
\varepsilon-caprolactona (0,5 moles), 58,04 gramos
de glicólido (0,5 moles), 5,68 mL (60 mmoles/moles) de dietilén
glicol, y 67 \mul (relación monómero/ catalizador 45K/1) de 0,33M
solución de octoato estannoso en tolueno a un matraz de fondo
redondo y una sola boca de 250 ml, limpio y secado a la llama, en
una cámara de nitrógeno. El contenido del matraz se secó durante
toda la noche en vacío completo a temperatura ambiente. Tras secado
durante toda la noche, se equipó el matraz con un agitador mecánico
de acero inoxidable secado a la llama, se secó a vacío durante 30
minutos más, se purgó con nitrógeno gas, y se mantuvo bajo manto de
nitrógeno gas durante la polimerización. El matraz se colocó en un
baño de aceite. La temperatura del baño de aceite se aumentó hasta
80ºC y se mantuvo a 80ºC durante 1/2 hora hasta disolver
completamente el glicólido. La temperatura del aceite se aumentó
entonces hasta 190ºC y se mantuvo durante 18 horas. Se retiró el
matraz del baño de aceite y se dejó enfriar hasta temperatura
ambiente. Se eliminaron los volátiles del copolímero tras sustituir
el agitador mecánico por un agitador magnético durante 16 horas a
80ºC bajo vacío completo. El copolímero finalizado se caracterizó
mediante ^{1}H RMN y la viscosidad inherente en HFIP (a 25ºC y una
concentración de 0,1g/dL). Los resultados de la RMN fueron
poliglicólido 47,3%, policaprolactona 52,3%, monómero de glicólido
residual menos del 0,2%, monómero de caprolactona residual menos del
0,2%. La IV fue 0,19.
Este ejemplo describe un procedimiento preferido
para fabricar espuma liofilizada a partir de copolímeros de
caprolactona-glicólido.
Solución de formación. Una cantidad apropiada
(16,5 g) de polímero (nominal 40/60 CAP/GLY fabricada de forma
similar a los procedimientos que se describen en la Patente de los
Estados Unidos 5.468.253) se colocó en el solvente
1,4-dioxano (148 ml) y se agitó a aproximadamente
50ºC durante aproximadamente 5 horas hasta disolución (para tener
una disolución al 10% en peso). La solución se filtró en frío a
través de un filtro de poro extra grueso (Kimble, embudo Buchner
Kimax con placa fritada Kimflow, 150 ml de capacidad, porosidad
extra gruesa o equivalente) para eliminar el polímero no
disuelto.
Liofilización: Una cantidad apropiada de solución
(31,0 g con un espesor de aproximadamente 0,030'' (0.076 cm) se
colocó en un vidrio de reloj de fondo plano especialmente fabricado
(construido a partir de tubo y fondo "ópticamente" plano) con
aproximadamente 8,5'' (21,6) de diámetro. La placa se limpió con
cáustico y se silanizó antes de uso. El disco que contenía la
solución se colocó en la bandeja de un liofilizador preenfriado
mantenido a 20ºC. A continuación, la solución se dejó congelar
ajustando la temperatura de la bandeja a -5ºC.
Después de 30 minutos se practicó un vacío (en un
caso, durante una hora). Se necesitaron dos horas de secado primario
a -5ºC bajo vacío para eliminar la mayor parte del
1,4-dioxano. Al final de esta fase de secado,
típicamente el nivel de vacío alcanzó aproximadamente 10 mTorr
(1.333 N/m^{2}) o menos. A continuación se llevó a cabo la segunda
fase del secado en dos etapas bajo vacío de 10 mTorr (1.333
N/m^{2}). En primer lugar, la temperatura de la bandeja se aumentó
hasta 5ºC y se mantuvo durante 1 hora, a continuación, la
temperatura aumentó hasta 20ºC y se mantuvo durante 1 hora más.
Al final de la segunda fase de secado, la cámara
se puso a temperatura ambiente y se eliminó el vacío con nitrógeno.
Se retiraron las espumas de los platos y se colocaron en bolsas de
plástico, y se almacenaron bajo nitrógeno.
La duración total del ciclo de liofilización fue
de aproximadamente 4,5 horas. Se determinó que las espumas
fabricadas mediante este procedimiento tenían < 0,2 ppm de
dioxano residual mediante análisis de headspace.
Claims (10)
1. Una espuma biocompatible blanda de celdilla
abierta que tenga un primer lado y un segundo lado conformado de
forma que se ajuste a las mandíbulas de un aplicador de grapas, en
la que la espuma bioabsorbible blanda está compuesta por un
poliéster elastomérico alifático y en el que la espuma tiene al
menos una superficie que se sellado esencialmente por calentamiento
de la espuma.
2. La espuma de la reivindicación 1, en la que el
poliéster elastomérico alifático se selecciona del grupo constituido
por un copolímero de \varepsilon-caprolactona y
glicólido, un copolímero de
\varepsilon-caprolactona y láctido (que incluyen
L-láctido, D-láctido, mezclas de los
mismos o ácido láctico), un copolímero de
p-dioxanona y láctido (que incluyen
L-láctido, D-láctido, mezclas de los
mismos o ácido láctico), un copolímero de
\varepsilon-caprolactona y
p-dioxanona, un copolímero de
p-dioxanona y carbonato de trimetileno, un
copolímero de carbonato de trimetileno y glicólido, un copolímero de
carbonato de trimetileno y láctido (que incluyen
L-láctido, D-láctido, mezclas de los
mismos o ácido láctico) y mezclas de los mismos.
3. La espuma de la reivindicación 1 o la
reivindicación 2, que tiene un adhesivo biocompatible que se puede
despegar en el primer lado.
4. La espuma de la reivindicación 3, en la que el
adhesivo biocompatible que se puede despegar es un copolímero de
\varepsilon-caprolactona y carbonato de
trimetileno, un copolímero de
\varepsilon-caprolactona y un éter de lactona, un
copolímero de carbonato de trimetileno y un éter de lactona, un
copolímero compuesto en el intervalo del 65 en porcentaje molar al
35 en porcentaje molar de unidades repetidas de
\varepsilon-caprolactona, carbonato de
trimetileno, éter de lactona o combinaciones de los mismos, siendo
el resto del polímero varias unidades repetidas de segunda lactona;
en la que las unidades repetidas de segunda lactona son unidades
repetidas de glicólido, unidades repetidas de láctido, unidades
repetidas de1,4-dioxanona,
6,6-dialquil-1,4-dioxepan-2-ona,
o una combinación de los mismos o una mezcla de los mismos.
5. La espuma de la reivindicación 3, en la que el
adhesivo bioabsorbible que se puede despegar es una mezcla de un
líquido y polietilén glicoles de bajo punto de fusión; o un sacárido
y un plastificante; o una proteína y un plastificante.
6. La espuma de una cualquiera de las
reivindicaciones 3 a 5, en la que el adhesivo que se puede despegar
es una microdispersión pegajosa
7. La espuma de una cualquiera de las
reivindicaciones 1 a 6, que contiene una cantidad efectiva de un
compuesto farmacéuticamente activo.
8. El equipo que comprende un cartucho de grapas
que contiene varias grapas quirúrgicas que se proporcionan en dos
hileras separadas entre sí que tiene una superficie superior con una
apertura a través de la cual se pueden eyectar dichas grapas, dicha
superficie superior tiene unida a ella de forma que se pueda
despegar una espuma como se ha definido en cualquiera de las
reivindicaciones 1 a 7.
9. El equipo de la reivindicación 8, en el la
espuma es una espuma de celdilla abierta que tiene al menos una
superficie que se ha sellado esencialmente, y en el que dicha
superficie sellada está en contacto con la superficie superior del
cartucho.
10. El equipo de la reivindicación 8 ó 9, en el
que dicha espuma tiene sobre sí dicho adhesivo que se puede despegar
y dicha espuma está unida de forma que se pueda separar a la
superficie superior del cartucho de grapas mediante dicho adhesivo
bioabsorbible que se puede despegar.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/345,093 US6325810B1 (en) | 1999-06-30 | 1999-06-30 | Foam buttress for stapling apparatus |
| US345093 | 1999-06-30 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2246215T3 true ES2246215T3 (es) | 2006-02-16 |
Family
ID=23353482
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES00305509T Expired - Lifetime ES2246215T3 (es) | 1999-06-30 | 2000-06-29 | Espuma de refuerzo para grapadora quirurgica. |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US6325810B1 (es) |
| EP (1) | EP1064883B1 (es) |
| JP (1) | JP4173273B2 (es) |
| AU (1) | AU771060B2 (es) |
| CA (1) | CA2313064A1 (es) |
| DE (1) | DE60021961T2 (es) |
| ES (1) | ES2246215T3 (es) |
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-
1999
- 1999-06-30 US US09/345,093 patent/US6325810B1/en not_active Expired - Lifetime
-
2000
- 2000-06-29 DE DE60021961T patent/DE60021961T2/de not_active Expired - Lifetime
- 2000-06-29 JP JP2000195886A patent/JP4173273B2/ja not_active Expired - Lifetime
- 2000-06-29 EP EP00305509A patent/EP1064883B1/en not_active Expired - Lifetime
- 2000-06-29 CA CA002313064A patent/CA2313064A1/en not_active Abandoned
- 2000-06-29 ES ES00305509T patent/ES2246215T3/es not_active Expired - Lifetime
- 2000-06-30 AU AU43759/00A patent/AU771060B2/en not_active Expired
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| EP1064883B1 (en) | 2005-08-17 |
| US6325810B1 (en) | 2001-12-04 |
| EP1064883A1 (en) | 2001-01-03 |
| JP4173273B2 (ja) | 2008-10-29 |
| AU771060B2 (en) | 2004-03-11 |
| DE60021961T2 (de) | 2006-07-06 |
| JP2001037763A (ja) | 2001-02-13 |
| DE60021961D1 (de) | 2005-09-22 |
| AU4375900A (en) | 2001-01-04 |
| CA2313064A1 (en) | 2000-12-30 |
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