ES2328087T3 - Montaje mezclador externo. - Google Patents
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- ES2328087T3 ES2328087T3 ES08002355T ES08002355T ES2328087T3 ES 2328087 T3 ES2328087 T3 ES 2328087T3 ES 08002355 T ES08002355 T ES 08002355T ES 08002355 T ES08002355 T ES 08002355T ES 2328087 T3 ES2328087 T3 ES 2328087T3
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- 239000000853 adhesive Substances 0.000 claims abstract description 28
- 230000001070 adhesive effect Effects 0.000 claims abstract description 28
- 239000012530 fluid Substances 0.000 claims abstract description 26
- 239000003364 biologic glue Substances 0.000 claims abstract description 7
- 108010049003 Fibrinogen Proteins 0.000 claims description 15
- 102000008946 Fibrinogen Human genes 0.000 claims description 15
- 108090000190 Thrombin Proteins 0.000 claims description 14
- 229940012952 fibrinogen Drugs 0.000 claims description 14
- 229960004072 thrombin Drugs 0.000 claims description 14
- 108010080379 Fibrin Tissue Adhesive Proteins 0.000 claims description 8
- 239000000243 solution Substances 0.000 description 25
- 206010052428 Wound Diseases 0.000 description 6
- 208000027418 Wounds and injury Diseases 0.000 description 6
- 208000032843 Hemorrhage Diseases 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 239000012460 protein solution Substances 0.000 description 5
- 239000000565 sealant Substances 0.000 description 5
- 230000000712 assembly Effects 0.000 description 4
- 238000000429 assembly Methods 0.000 description 4
- 230000000740 bleeding effect Effects 0.000 description 4
- 238000011109 contamination Methods 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 108010073385 Fibrin Proteins 0.000 description 3
- 102000009123 Fibrin Human genes 0.000 description 3
- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
- 230000009977 dual effect Effects 0.000 description 3
- 229950003499 fibrin Drugs 0.000 description 3
- 208000015181 infectious disease Diseases 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 238000006116 polymerization reaction Methods 0.000 description 3
- 235000018102 proteins Nutrition 0.000 description 3
- 102000004169 proteins and genes Human genes 0.000 description 3
- 108090000623 proteins and genes Proteins 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 235000004252 protein component Nutrition 0.000 description 2
- 239000003106 tissue adhesive Substances 0.000 description 2
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 240000007124 Brassica oleracea Species 0.000 description 1
- 235000003899 Brassica oleracea var acephala Nutrition 0.000 description 1
- 235000011301 Brassica oleracea var capitata Nutrition 0.000 description 1
- 235000001169 Brassica oleracea var oleracea Nutrition 0.000 description 1
- 239000004826 Synthetic adhesive Substances 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- 239000002671 adjuvant Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 229940030225 antihemorrhagics Drugs 0.000 description 1
- 229940064004 antiseptic throat preparations Drugs 0.000 description 1
- 239000013060 biological fluid Substances 0.000 description 1
- 239000003054 catalyst Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 230000015271 coagulation Effects 0.000 description 1
- 238000005345 coagulation Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000002874 hemostatic agent Substances 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
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Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05C17/00—Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces
- B05C17/005—Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes
- B05C17/00503—Details of the outlet element
- B05C17/00516—Shape or geometry of the outlet orifice or the outlet element
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05C—APPARATUS FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
- B05C17/00—Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces
- B05C17/005—Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes
- B05C17/00553—Hand tools or apparatus using hand held tools, for applying liquids or other fluent materials to, for spreading applied liquids or other fluent materials on, or for partially removing applied liquids or other fluent materials from, surfaces for discharging material from a reservoir or container located in or on the hand tool through an outlet orifice by pressure without using surface contacting members like pads or brushes with means allowing the stock of material to consist of at least two different components
-
- 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
- A61B2017/00495—Surgical glue applicators for two-component glue
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Mechanical Engineering (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Physics & Mathematics (AREA)
- Geometry (AREA)
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Abstract
Un sistema de suministro de fluido (100) para dispensar un adhesivo biológico multicomponente, sistema que comprende: un montaje de conductos (28) que tiene al menos un conducto (24, 26); un conjunto de reservorios (120) que tiene un primer reservorio (124) que contiene el primer componente adhesivo y un segundo reservorio (126) que contiene el segundo componente adhesivo, estando el primer y segundo reservorios en comunicación fluida con un conducto respectivo del al menos un conducto; y caracterizado por: un montaje deflector (40) que tiene una placa deflectora (44) para recibir el primer y el segundo componentes adhesivos desde el al menos un conducto y deflectar el primer y el segundo componentes adhesivos antes de dispensarlos a un sitio de aplicación.
Description
Montaje mezclador externo.
La descripción se refiere a un sistema de
suministro de fluido para selladores, hemostáticos y adhesivos
biológicos así como sintéticos y, más particularmente a un montaje
mezclador externo para mezclar y suministrar selladores,
hemostáticos y adhesivos biológicos y/o sintéticos biocompatibles a
tejidos u órganos para sellar heridas, detener hemorragia y
similares.
Se usan selladores, hemostáticos y adhesivos
derivados biológicamente así como sintéticos para tratar heridas en
casos en los que no son totalmente eficaces los apósitos externos ni
las suturas. Un tratamiento común obtiene ventajas de la
polimerización rápida que sucede cuando una solución de factores de
coagulación proteómicos, tal como fibrinógeno, se pone contacto con
una solución de un catalizador proteómico, tal como trombina, para
formar un complejo que actúa como agente hemostático y como adhesivo
de tejido. Esta polimerización rápida comienza típicamente dentro
de los dos segundos después de que las soluciones se ponen
inicialmente en contacto una con otra, y alcanza típicamente una
solidificación blanda dentro de diez segundos de contacto. Un nombre
común para un complejo de este tipo es cola de fibrina o sellador
de fibrina.
Los componentes de proteínas de fibrinógeno y
trombina que, junto con una diversidad de adyuvantes conocidos,
forman un sellador de fibrina se derivan típicamente del plasma
humano y se someten a procedimientos de eliminación de virus. Los
componentes son típicamente deshidratados individualmente y se
almacenan en viales separados como polvos estériles.
Debido a la rápida polimerización tras la íntima
interacción de fibrinógeno y trombina, es importante mantener
separadas estas dos proteínas sanguíneas hasta que se apliquen en el
sitio de aplicación. Estas soluciones de proteínas se suministran
generalmente mediante sistemas de suministro de fluidos, tales como
un aparato de jeringa dual, en el que cada solución está confinada
dentro de una jeringa separada antes del mezclado.
Un aparato de jeringa dual para aplicar adhesivo
de tejido a base de fibrinógeno se describe en el documento de
patente de EE.UU. Nº 4.359.049 de Redl y col. Redl y col. describen
un mecanismo en el que dos jeringas normalizadas de una vía se
mantienen en un soporte teniendo un medio de accionamiento común. El
extremo dispensador de cada jeringa se inserta en un colector de
recogida en el que se mezclan los dos componentes. A continuación
se dispensan los componentes a través de una aguja común capaz de
cubrir un área limitada del sitio de aplicación. A menudo es
deseable o necesario cubrir un área extensa de una herida, ya sea
para detener una hemorragia, para fijar un tejido o para prevenir
una infección. También es deseable prevenir que los dos componentes
se mezclen dentro del dispositivo dispensador.
Además, todos los dispositivos conocidos para
dispensar soluciones de fibrinógeno y trombina requieren la adición
de estas proteínas en forma de polvo al cuerpo de la jeringa. Esto
hace a las proteínas susceptibles de contaminación por impurezas
que pueden entrar en el cuerpo de la jeringa. Aún más, el uso del
cuerpo de la jeringa para mezclar las proteínas con agua para crear
las soluciones de proteínas puede provocar que las soluciones
tengan fugas tanto desde el extremo dispensador de cada jeringa como
desde el extremo proximal del cuerpo de la jeringa. Adicionalmente,
un aparato de jeringa dual para la aplicación de soluciones de
fibrinógeno y trombina a un sitio de aplicación generalmente
contiene varias piezas, tales como un émbolo de jeringa, un
conector de colector en "Y", una aguja dispensadora, un soporte
de jeringa, agujas de jeringa, y conductos para transportar las
soluciones a la aguja dispensadora. Por lo tanto, los sistemas o
aplicadores de suministro de selladores de fibrina conocidos, tales
como los que se describen la patente de EE.UU. de Redl y col.
anteriormente descrita, y en las patentes de EE.UU. N^{os}
4.874.368 de Millar y col. y 4.979.942 de Wolf y col. son difíciles
de reutilizar. El rellenado de los componentes de proteínas requiere
típicamente retirar un gancho que sujeta el émbolo de la jeringa,
retirar el émbolo de la jeringa, separar las jeringas del conector
en "Y", retirar las jeringas del soporte, insertar nuevas
jeringas, fijar las jeringas al conector en "Y", y añadir
fibrinógeno a una jeringa y trombina a la otra jeringa, añadir agua
estéril a cada jeringa, volver a colocar el émbolo de la jeringa,
volver a colocar el gancho del émbolo, y mezclar las soluciones. En
una aplicación en la que el tiempo es esencial, un procedimiento de
rellenado tan largo no es práctico y es engorroso.
Adicionalmente, los sistemas conocidos de
suministro de fluido para dispensar un adhesivo biológico requieren
el empleo manual de una fuerza sobre los componentes de proteínas de
modo que puedan ser dispensados desde el sistema de suministro de
fluido. Típicamente, se emplea una fuerza manual sobre los
componentes por medio del émbolo en la jeringa estándar de una vía.
Este tipo de disposición se muestra en las patentes de EE.UU.
N^{os} 4.359.049 anteriormente descrita, y 4.631.055 de Redl y
col. Emplear manualmente una fuerza sobre un émbolo situado en el
extremo proximal del sistema de suministro de fluido puede hacer
difícil la aplicación del adhesivo. Por ejemplo, el usuario es
incapaz de ver claramente el sitio de aplicación cuando sostiene el
sistema de suministro de fluido perpendicularmente al sitio de
aplicación. Además, una disposición de este tipo provoca que entre
aire a las jeringas, provocando dificultad para emplear una fuerza
por la vía del émbolo de la jeringa.
Los documentos EP 0 648 510 y WO 00/56221 se
citaron como descripciones de la técnica anterior relevantes,
durante el examen de esta patente. El preámbulo de la reivindicación
1 está basado en la EP 0 648 510.
Así pues, existe necesidad en la técnica de un
sistema de suministro de fluido para aplicar un adhesivo de tejido
en el que el adhesivo cubra un área extensa de la herida, ya sea
para detener una hemorragia, para fijar un tejido o para prevenir
una infección. También existe necesidad de un sistema de suministro
de fluido en el que los componentes adhesivos no sean susceptibles
de contaminación y los componentes adhesivos no se entremezclen
dentro del sistema de suministro de fluido. Además, existe necesidad
de un sistema de suministro de fluido en el que las soluciones
componentes se rellenen fácilmente. También existe necesidad de un
sistema de suministro de fluido que sea autolimpiante y
reutilizable con diferentes soluciones componentes. Además, existe
necesidad de un sistema de suministro de fluido que sea económico de
fabricar para que permita que el sistema de suministro de fluido
sea desechado después de uso. Adicionalmente, existe necesidad de un
sistema de suministro de fluido que evite desperdiciar solución
adhesiva y permita que se vea claramente por el usuario el sitio de
aplicación cuando se aplican las soluciones componentes
perpendiculares al sitio de aplicación.
La reivindicación 1 define un sistema de
suministro de fluido según la presente invención.
Se describe un sistema de suministro de fluido
al que se hace referencia en este documento como montaje mezclador
externo. El montaje mezclador externo mezcla y suministra
externamente un primer y un segundo componente de un adhesivo
biológico a tejidos u órganos para sellar heridas, detener
hemorragia y similares. Los componentes primero y segundo se
mezclan inmediatamente después de salir de orificios de salida
separados que se disponen en comunicación de fluido con reservorios
de componentes.
En una realización preferida, el montaje
mezclador externo incluye una carcasa que tiene una cabeza de
carcasa para incluir en la misma un primer reservorio que contiene
el primer componente, y un segundo reservorio que contiene el
segundo componente. La carcasa incluye además una boquilla de
descarga que define un eje longitudinal para incluir en la misma un
montaje de conductos que tiene un primer y un segundo conducto en
comunicación con el primer y segundo reservorios, respectivamente.
Se conecta un montaje deflector a la boquilla de descarga. El
montaje deflector incluye una placa deflectora para proporcionar un
espacio para la mezcla inicial del primer y segundo componentes. Se
prevé que la boquilla de descarga y el montaje deflector puedan
estar conformados en diversas configuraciones para proporcionar
mezcla y dispensación adecuadas de los componentes primero y
segundo.
En una realización preferida, la boquilla de
descarga incluye una cara distal que tiene una configuración
angular. La placa deflectora se orienta en relación generalmente
paralela yuxtapuesta distal a la cara distal de la boquilla de
descarga. Sin embargo, se prevé que la placa deflectora se disponga
abierta o cerrada en cierta medida en relación con la cara distal
de la boquilla de descarga dependiendo de las necesidades
quirúrgicas particulares. El tamaño y configuración de la placa
deflectora pueden variar. También se contempla que la cara distal
de la boquilla de descarga pueda ser también sustancialmente
perpendicular al eje longitudinal de la boquilla de descarga. Los
componentes primero y segundo son preferiblemente fibrinógeno y
trombina que se entremezclan para formar un sellador de
fibrina.
En este documento se describen diversas
realizaciones con referencia a los dibujos, en los que:
Fig. 1 es una imagen, vista en perspectiva de un
montaje mezclador externo según una realización de la presente
descripción;
Fig. 2 es una vista posterior de la imagen de la
realización ilustrada en Fig. 1, que muestra porciones del extremo
proximal de la boquilla de descarga;
Fig. 3 es una vista en sección transversal de la
realización ilustrada en Fig. 2, tomada a lo largo de la línea
3-3;
Fig. 4 es una vista en sección transversal de la
realización ilustrada en Fig. 2, tomada a lo largo de la línea
4-4;
Fig. 5 es una vista en perspectiva de un montaje
mezclador externo según otra realización de la presente
descripción;
Fig. 6 es una vista frontal de la realización
ilustrada en Fig. 5, que muestra porciones del extremo distal de la
punta de la boquilla y la placa deflectora; y
Fig. 7 es una vista en sección transversal de la
realización ilustrada en Fig. 6, tomada a lo largo de la línea
7-7.
Con referencia a las Figs. 1-4,
se ilustra un montaje mezclador externo según una realización de la
presente descripción. El montaje que se designa generalmente por el
número 100 incluye una carcasa 102 que tiene una cabeza de carcasa
104 y una boquilla de descarga 120 que definen un eje longitudinal.
Aunque la cabeza de carcasa 104 se muestra con una forma
particular, se entiende que se pueden usar otras formas que
contribuyan a la facilidad de manejo y control del montaje
mezclador 100.
Se proporciona una punta de boquilla 106 en un
extremo distal o cara 108 de la boquilla de descarga 120. La punta
de boquilla 106 incluye dos orificios dispensadores 110a, 110b en
los que cada orificio dispensador está en comunicación de fluido
con un respectivo conducto 112a, 112b de un montaje de conductos 114
dentro de la boquilla de descarga 120 para dispensar componentes
biológicos contenidos dentro de la cabeza de carcasa 104.
Preferiblemente, los componentes biológicos son una solución de
fibrinógeno y una solución de trombina que se intermezclan para
formar un sellador de fibrina. Sin embargo, se ha de entender que se
pueden sustituir con otros fluidos biológicos, dependiendo de la
elección de la mezcla que se ha de dispensar.
La carcasa 102 se forma preferiblemente a partir
de semisecciones de carcasa moldeadas que se forman con particiones
internas configuradas para alinear apropiadamente unos con respecto
a otros los componentes internos del montaje 100 y para prevenir el
movimiento de un primer reservorio 150 y un segundo reservorio 152
que almacena cada uno un componente biológico cuando los
reservorios 150a, 150b se ajustan dentro de conductos de reservorios
124 y 126, como se muestra mediante FIGS. 3 y 4. Los componentes
internos principales del montaje 100 incluyen el montaje de
conductos 114 y un montaje de reservorios 130. Los dos montajes 114,
130 se interrelacionan entre sí para dispensar los componentes
biológicos almacenados dentro de los reservorios primero y segundo
150a, 150b vía los dos orificios dispensadores 110a, 110b.
El montaje 100 incluye adicionalmente un montaje
deflector 140 conectado a la carcasa 102 y a la boquilla de
descarga 120 por la vía de los soportes 148 y 149. Se contempla que
los soportes 148 y 149 se pueden sustituir por uno o más diferentes
tipos de estructura de conexión como se conocen en la técnica. El
montaje deflector 140 incluye una carcasa deflectora cilíndrica 142
que aloja la boquilla de descarga 120 cuando el montaje deflector
140 se conecta a la carcasa 102 y a la boquilla de descarga 120.
Una placa deflectora 144 se extiende desde un
extremo distal de la carcasa deflectora 142. La placa deflectora
144 está desplazada una distancia relativamente corta de la cara
distal 108 de la boquilla de descarga 120 para proporcionar espacio
para la mezcla inicial de los componentes biológicos dispensados
desde los dos orificios dispensadores 110a, 110b.
La placa deflectora 144 se configura para
facilitar tanto el mezclado como el direccionamiento de los
componentes. La placa deflectora 144 se orienta preferiblemente en
relación paralela general con la cara distal 108 de la boquilla de
descarga 120. Se contempla que la placa deflectora 144 se pueda
disponer en una relación abierta o cerrada en cierta medida con
relación a la cara distal 108 de la boquilla de descarga 120
dependiendo de la aplicación específica. También se contempla que
la placa deflectora 144 se pueda conectar a la carcasa deflectora
142 de modo que pueda pivotar mediante un mecanismo de trinquete
para pivotar y bloquear la placa deflectora 144 en una o varias
posiciones con respecto a la cara distal 108 de la boquilla de
descarga 120 según las necesidades quirúrgicas particulares.
El tamaño y configuración de la placa deflectora
144, y el hueco que deja con la cara distal 108 de la boquilla de
descarga 120, se pueden variar. Las posiciones y orientaciones de
los orificios de descarga 110a, 110b, con relación a la placa
deflectora 144, también se pueden variar en función de las
necesidades quirúrgicas cambiando la alineación de los conductos
112a, 112b con respecto al eje longitudinal de la boquilla de
descarga 120. Esto es, uno o ambos conductos 112a, 112b pueden
tener una o más curvas, los conductos 112a, 112b pueden estar en
orientación divergente, convergente o paralela de uno con respecto
al otro, los conductos 112a, 112b se pueden juntar en la proximidad
de la cara distal 108 de la boquilla de descarga 120 para formar un
conducto, etc.
Como se sabe en la técnica, los reservorios
primero y segundo 150a, 150b incluyen un cuerpo principal o
perforación pasante central 152 para almacenar los componentes
biológicos. Se usa una tapa 154 para sellar al vacío la perforación
pasante central 152 para prevenir la contaminación de los
componentes biológicos. La tapa 154 incluye preferiblemente una
superficie de silicona 156 capaz de ser penetrada por una aguja de
jeringa para añadir un líquido, preferiblemente agua estéril,
dentro de los reservorios 150a, 150b para que se entremezcle con
los componentes biológicos para formar soluciones de proteínas. Las
soluciones de proteínas se dispensan en el sitio de aplicación como
se ha descrito anteriormente. El montaje del conducto 114 incluye
los dos conductos 112a, 112b. Preferiblemente, cada conducto
incluye una punta proximal biselada 60 para penetrar en la tapa 154
respectiva de los reservorios primero y segundo 150a, 150b.
Preferiblemente, los reservorios primero 150a,
150b y segundo son idénticos para contener una cantidad volumétrica
igual de su respectiva solución de proteína en comparación con el
otro reservorio. Se contempla proporcionar un color diferente para
cada reservorio 150a, 150b para reconocer fácilmente el reservorio
que contiene fibrinógeno y el reservorio que contiene trombina. Se
contempla adicionalmente proporcionar una forma diferente para cada
reservorio y cambiar la forma de uno o de ambos conductos de
reservorios 124, 126 consecuentemente con la misma finalidad, es
decir, reconocer fácilmente el reservorio que contiene fibrinógeno y
el reservorio que contiene trombina. Sin embargo, la cantidad
volumétrica almacenada dentro del primer reservorio 150a debería
ser igual a la cantidad volumétrica almacenada dentro del segundo
reservorio 150b para mantener una relación previamente determinada
de solución de fibrinógeno a trombina, que es típicamente una
relación 1:1.
Los reservorios primero y segundo 150a, 150b se
construyen preferiblemente de un material flexible y contienen los
componentes biológicos primero y segundo, respectivamente. Se
contempla que las semisecciones de la carcasa sean completamente o
parcialmente transparentes, así como los reservorios primero y
segundo 150a, 150b para permitir que el usuario vea la cantidad de
solución y determine si la solución se ha entremezclado
suficientemente antes de que sea dispensada en el sitio de
aplicación. Se contempla adicionalmente proporcionar marcas de
calibración en el reservorio primero 150a y en el segundo 150b.
Con referencia a Figs. 5-7, se
muestra un montaje mezclador externo según una realización
alternativa de la presente descripción, y se designa generalmente
con la referencia numérica 10. Generalmente, el montaje mezclador
externo 10 es similar al montaje mezclador externo 100 si la carcasa
102 que aloja el montaje reservorio 130 se quita y solamente quedan
la boquilla de descarga 120 y el montaje deflector 140.
El montaje mezclador externo 10 incluye una
boquilla de descarga 20 y un montaje deflector 40 conectado a un
extremo distal de la boquilla de descarga 20. La boquilla de
descarga 20 incluye un cuerpo de boquilla 22 que define dos
orificios de salida longitudinales 24 y 26 en el mismo con
comunicación de fluido con sus respectivos reservorios de
componentes (que no se muestran). El cuerpo de boquilla 22 incluye
una punta de boquilla 28 en una porción del extremo distal de la
misma, que se configura preferiblemente como un cilindro que tiene
una cara distal en ángulo. Se prevé que los reservorios de
componentes pueden ser similares a los reservorios 150a, 150b
descritos anteriormente, o diferentes.
El montaje deflector 40 incluye una porción de
conexión 42 en un extremo proximal del mismo para conectarse con el
extremo distal del cuerpo de boquilla 22. El montaje deflector 40
incluye adicionalmente una placa deflectora 44 en un extremo distal
del mismo, que está desplazada una corta distancia de la cara distal
de la punta de la boquilla 28 para proporcionar un espacio para la
mezcla inicial de los componentes biológicos. La placa deflectora
44 se configura para facilitar tanto el mezclado como el
direccionamiento de los componentes. La placa deflectora se orienta
preferiblemente en relación general paralela con la cara distal de
la boquilla de descarga 28.
Se contempla que la placa deflectora 44 se pueda
disponer en una relación abierta o cerrada en cierta medida con
relación a la cara distal de la punta de la boquilla 28 dependiendo
de la aplicación específica. También se contempla que la placa
deflectora 44 se pueda conectar a la porción de conexión 42 de modo
que pueda pivotar mediante un mecanismo de trinquete para pivotar y
bloquear la placa deflectora 44 en una o varias posiciones con
respecto a la cara distal de la punta de la boquilla 28 según las
necesidades quirúrgicas particulares.
El tamaño y configuración de la placa deflectora
44 y el hueco que deja con la cara distal de la punta de la
boquilla 28, se pueden variar. Las posiciones y orientaciones de los
orificios de salida 24 y 26, con relación a la placa deflectora 44,
también se pueden variar en función de las necesidades quirúrgicas
cambiando la alineación de los orificios de salida 24 y 26 con
respecto al eje longitudinal de la boquilla de descarga 20. Esto
es, uno o ambos orificios de salida 24 y 26 pueden tener una o más
curvas, los orificios de salida 24 y 26 pueden estar en orientación
divergente, convergente o paralela de uno con respecto al otro, los
orificios de salida 24 y 26 se pueden juntar en la proximidad de la
cara distal de la punta de la boquilla 28 para formar un orifico de
salida, etc.
Los montajes mezcladores externos según la
presente descripción son capaces de aplicar un adhesivo de tejido
en el que el adhesivo cubre un área extensa de una herida, ya sea
para detener una hemorragia, para fijar un tejido o para prevenir
una infección. Los montajes mezcladores externos según la presente
descripción previenen que los componentes adhesivos sean
susceptibles de contaminación y que se entremezclen los componentes
adhesivos externamente.
Además, el montaje mezclador externo de la
primera realización permite que las soluciones componentes se
rellenen fácilmente retirando los reservorios gastados de los
conductos de reservorios y reemplazándolos con reservorios nuevos.
Adicionalmente los montajes mezcladores externos según la presente
descripción evitan desperdiciar solución adhesiva y permiten que se
vea claramente por el usuario el sitio de aplicación cuando se
aplican las soluciones componentes perpendiculares al sitio de
aplicación.
Se contempla que todas las realizaciones que se
describen en este documento sean desechables o tengan uno o más
componentes desechables. También se contempla que todas las
realizaciones que se describen en este documento puedan ser
esterilizadas para reutilizarlas.
Por lo tanto, se entiende que se pueden hacer
diversas modificaciones a las realizaciones que se describen en
este documento. Por ejemplo, aun cuando se han descrito con detalle
realizaciones específicas del montaje mezclador externo, también se
pueden usar estructuras que llevan a cabo sustancialmente la misma
función sustancialmente de la misma manera para conseguir
sustancialmente el mismo resultado. Asimismo, además de aplicar un
sellador de fibrina, el montaje mezclador externo se puede usar
para llevar a cabo procedimientos quirúrgicos humanos o
veterinarios que incluyen aplicar antisépticos, medicación y otros
procedimientos similares. Por lo tanto, la descripción anterior no
se debe entender como limitante, sino simplemente como
ejemplificaciones de realizaciones preferidas. Los expertos en la
técnica preverán otras modificaciones dentro del alcance de las
reivindicaciones anexas.
Los párrafos numerados que siguen, son las
reivindicaciones 1 a 15 del documento WO 02/067785 que es la
solicitud que se presentó originalmente. Se incluyen pues son parte
de la descripción original.
1. Un sistema de suministro de fluido para
dispensar un adhesivo biológico multicomponente, comprendiendo el
sistema:
una carcasa configurada para recibir una
pluralidad de reservorios;
una boquilla de descarga que aloja un montaje de
conductos que tiene una pluralidad de conductos con un extremo
proximal de los mismos en comunicación de fluido respectiva con
separados de dichos reservorios, un extremo distal de dichos
conductos que define al menos un orificio de salida; y
un montaje deflector proporcionado en dicha
carcasa que tiene una placa deflectora en alineación yuxtapuesta
con dicho al menos un orifico de salida, orientada dicha placa
deflectora para deflectar dichos componentes después de la salida
de dicho al menos un orificio de salida.
2. El sistema de 1, en el que cada uno de dicha
pluralidad de reservorios incluye un orificio sellable configurado
para ser penetrado por un extremo proximal de uno de los conductos
respectivos de dicha pluralidad de conductos.
3. El sistema de 1, en el que dicha placa
deflectora está orientada en general paralela en relación a una
cara distal de dicha boquilla de descarga.
4. El sistema de 1, en el que un primero de
dicho al menos un orificio de salida y un segundo de dicho al menos
un orificio de salida son independientes, de tal manera que dichos
componentes primero y segundo se deflectan y entremezclan
externamente a dicha boquilla de descarga contra dicha placa
deflectora
5. El sistema de 1, en el que dicho primer
componente es una solución de trombina, y dicho segundo componente
es una solución de fibrinógeno, con lo que dicho adhesivo biológico
es un sellador de fibrina.
6. El sistema de 1, en el que dicho adhesivo
biológico comprende una relación determinada previamente de dicho
primer componente a dicho segundo componente.
7. El sistema de 1, en el que dicha carcasa
incluye una cabeza de carcasa para almacenar en ella dicha
pluralidad de reservorios.
8. Un sistema de suministro de fluido para
dispensar un primer y un segundo componente de un adhesivo
biológico, comprendiendo el sistema:
un montaje de boquilla que tiene al menos un
conducto dispensador para dispensar el primer componente y el
segundo componente; y
un montaje deflector conectado al conjunto de
boquilla y que tiene una placa deflectora para deflectar dichos
primer y segundo componentes después de dispensarlos desde al menos
una salida distal de dicho al menos un conducto dispensador,
estando dicha placa deflectora en alineación yuxtapuesta con dicha
al menos una salida distal.
9. El sistema de 8, que además comprende una
carcasa configurada para recibir una pluralidad de reservorios que
almacenan el primer y el segundo componente.
10. El sistema de 9, en el que cada uno de dicha
pluralidad de reservorios incluye un orificio sellable configurado
para ser penetrado por un extremo proximal de el al menos un
conducto dispensador.
11. El sistema de 8, en el que dicha placa
deflectora está orientada en general paralela en relación a una
cara distal de dicho montaje de boquilla.
12. El sistema de 8, en el que un primero de
dicho al menos un conducto dispensador y un segundo de dicho al
menos un conducto dispensador son independientes, de tal manera que
dichos componentes primero y segundo se deflectan y entremezclan
externamente a dicho montaje de boquilla contra dicha placa
deflectora.
13. El sistema de 8, en el que dicho primer
componente es una solución de trombina, y dicho segundo componente
es una solución de fibrinógeno, con lo que dicho adhesivo biológico
es un sellador de fibrina.
14. El sistema de 8, en el que dicho adhesivo
biológico comprende una relación determinada previamente de dicho
primer componente a dicho segundo componente.
15. El sistema de 9, en el que dicha carcasa
incluye una cabeza de carcasa para almacenar en ella una pluralidad
de reservorios, almacenando cada uno de dicha pluralidad de
reservorios uno del primer y el segundo componente.
Claims (5)
1. Un sistema de suministro de fluido (100) para
dispensar un adhesivo biológico multicomponente, sistema que
comprende:
un montaje de conductos (28) que tiene al menos
un conducto (24, 26);
un conjunto de reservorios (120) que tiene un
primer reservorio (124) que contiene el primer componente adhesivo
y un segundo reservorio (126) que contiene el segundo componente
adhesivo, estando el primer y segundo reservorios en comunicación
fluida con un conducto respectivo del al menos un conducto; y
caracterizado por:
un montaje deflector (40) que tiene una placa
deflectora (44) para recibir el primer y el segundo componentes
adhesivos desde el al menos un conducto y deflectar el primer y el
segundo componentes adhesivos antes de dispensarlos a un sitio de
aplicación.
2. El sistema de la reivindicación 1, en el que
el montaje de conductos y el montaje de reservorios están
soportados dentro de una carcasa simple.
3. El sistema de la reivindicación 1 ó 2, en el
que dicha placa deflectora está orientada en general paralela en
relación a una cara distal de dicho montaje de conductos.
4. El sistema de la reivindicación 1, 2 ó 3, en
el que un primero de dicho al menos un conducto y un segundo de
dicho al menos un conducto son independientes, de tal manera que
dichos primer y segundo componentes adhesivos se entremezclan
externamente a dicho montaje de conductos.
5. El sistema de la reivindicación 1, 2, 3 ó 4
en el que dicho primer componente adhesivo es una solución de
trombina, y dicho segundo componente adhesivo es una solución de
fibrinógeno, con lo que dicho adhesivo biológico multicomponente es
un sellador de fibrina.
Applications Claiming Priority (2)
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|---|---|---|---|
| US27179301P | 2001-02-27 | 2001-02-27 | |
| US271793P | 2001-02-27 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2328087T3 true ES2328087T3 (es) | 2009-11-06 |
Family
ID=23037104
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| Application Number | Title | Priority Date | Filing Date |
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| ES02704461T Expired - Lifetime ES2296895T3 (es) | 2001-02-27 | 2002-02-27 | Montaje mezclador extremo. |
| ES08002355T Expired - Lifetime ES2328087T3 (es) | 2001-02-27 | 2002-02-27 | Montaje mezclador externo. |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES02704461T Expired - Lifetime ES2296895T3 (es) | 2001-02-27 | 2002-02-27 | Montaje mezclador extremo. |
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| US (1) | US7018357B2 (es) |
| EP (2) | EP1372488B1 (es) |
| AU (1) | AU2002238143B2 (es) |
| CA (2) | CA2766682A1 (es) |
| DE (2) | DE60224990T2 (es) |
| ES (2) | ES2296895T3 (es) |
| WO (1) | WO2002067785A2 (es) |
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-
2002
- 2002-02-27 DE DE60224990T patent/DE60224990T2/de not_active Expired - Lifetime
- 2002-02-27 WO PCT/US2002/006142 patent/WO2002067785A2/en not_active Ceased
- 2002-02-27 ES ES02704461T patent/ES2296895T3/es not_active Expired - Lifetime
- 2002-02-27 CA CA2766682A patent/CA2766682A1/en not_active Abandoned
- 2002-02-27 ES ES08002355T patent/ES2328087T3/es not_active Expired - Lifetime
- 2002-02-27 CA CA2438858A patent/CA2438858C/en not_active Expired - Fee Related
- 2002-02-27 DE DE60232926T patent/DE60232926D1/de not_active Expired - Lifetime
- 2002-02-27 US US10/085,150 patent/US7018357B2/en not_active Expired - Fee Related
- 2002-02-27 AU AU2002238143A patent/AU2002238143B2/en not_active Ceased
- 2002-02-27 EP EP02704461A patent/EP1372488B1/en not_active Expired - Lifetime
- 2002-02-27 EP EP09164775A patent/EP2105096A1/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| CA2438858C (en) | 2012-05-01 |
| DE60232926D1 (de) | 2009-08-20 |
| WO2002067785A3 (en) | 2003-01-09 |
| DE60224990T2 (de) | 2009-02-05 |
| EP1372488B1 (en) | 2008-02-13 |
| WO2002067785A2 (en) | 2002-09-06 |
| CA2438858A1 (en) | 2002-09-06 |
| DE60224990D1 (de) | 2008-03-27 |
| US7018357B2 (en) | 2006-03-28 |
| CA2766682A1 (en) | 2002-09-06 |
| EP1372488A2 (en) | 2004-01-02 |
| US20020179641A1 (en) | 2002-12-05 |
| AU2002238143B2 (en) | 2006-06-01 |
| EP2105096A1 (en) | 2009-09-30 |
| ES2296895T3 (es) | 2008-05-01 |
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