MXPA06002116A - Dispositivo para medicion no invasiva de presion de fluido en un dispositivo de restriccion ajstable. - Google Patents
Dispositivo para medicion no invasiva de presion de fluido en un dispositivo de restriccion ajstable.Info
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- MXPA06002116A MXPA06002116A MXPA06002116A MXPA06002116A MXPA06002116A MX PA06002116 A MXPA06002116 A MX PA06002116A MX PA06002116 A MXPA06002116 A MX PA06002116A MX PA06002116 A MXPA06002116 A MX PA06002116A MX PA06002116 A MXPA06002116 A MX PA06002116A
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- Prior art keywords
- restriction
- pressure
- working fluid
- fluid
- further characterized
- Prior art date
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- Measuring Fluid Pressure (AREA)
Abstract
Se describe un sistema de restricción, tal como una banda gástrica ajustable, para forma una restricción en un paciente, y comunicar no invasivamente datos de presión respecto a la restricción a un monitor externo; el sistema incluye un dispositivo de restricción para implantación en un paciente para formar una restricción; el sistema incluye además un orificio implantado conectado al dispositivo de restricción; el orificio contiene un fluido de trabajo para afectar el tamaño de la restricción; el sistema incluye además un sistema detector de presión en comunicación con el fluido de trabajo para la medición de la presión del fluido de trabajo, y transmitir datos de la medición de presión a un monitor externo.
Description
DISPOSITIVO PARA MEDICION NO INVASIVA DE PRESION DE FLUIDO EN UN DISPOSITIVO DE RESTRICCION AJUSTABLE
CAMPO DE LA INVENCION
La presente invención se refiere en general a dispositivos de restricción impiantables, en particular dispositivos de restricción llenos de fluido. La presente invención tiene aún más relación con dispositivos de restricción de ración alimenticia para el tratamiento de obesidad patológica.
ANTECEDENTES DE LA INVENCION
La obesidad está llegando a ser un asunto creciente, en particular en los Estados Unidos, ya que el número de personas obesas continúa aumentando, y más se aprende acerca de los efectos negativos que tiene la obesidad sobre la salud. La obesidad patológica, en la cual una persona está 45.5 kg o más arriba del peso corporal ideal, plantea en particular riesgos importantes por problemas severos para la salud. Por consiguiente, un gran cúmulo de atención se está enfocando en el tratamiento de los pacientes obesos. Un método para tratar la obesidad patológica, ha sido colocar un dispositivo de restricción, tal como una banda alargada, alrededor de la porción superior del estómago. La banda se coloca para que forme una pequeña bolsa gástrica arriba de la banda y una abertura reducida
del estoma en el estómago. El efecto de la banda es reducir el volumen disponible del estómago y, de esta manera, la cantidad de alimento que puede consumirse antes de que el estómago "se llene". Las bandas gástricas han comprendido típicamente un globo elastomérico lleno de fluido con puntos de extremo fijos que rodean al estómago apenas abajo de la unión gastroesofágica. Cuando se infunde fluido en el globo, la banda se expande contra el estómago, creando una restricción sobre la ración alimenticia o estoma en el estómago. Para disminuir esta restricción, se remueve fluido de la banda. Los dispositivos de restricción de alimento han comprendido también bandas ajustadas mecánicamente que asimismo rodean la porción superior del estómago. Estas bandas incluyen cualquier número de materiales elásticos o dispositivos de engranaje, así como miembros de accionamiento, para el ajuste de las bandas. Además, se han desarrollado bandas gástricas que incluyen elementos de accionamiento hidráulicos y mecánicos. Un ejemplo de dicha banda gástrica ajustable se describe en la patente de E.U.A. No. 6,067,991, titulada "Mechanical Food Intake Restriction Device", expedida en mayo 30 de 2000 e incorporada en la presente como referencia. Se sabe también que restringe el volumen de alimento disponible en la cavidad del estómago implantando un globo elastomérico inflable dentro de la cavidad misma del estómago. El globo se llena con un fluido que se expande contra las paredes del estómago, y disminuye de esta manera el volumen de alimento disponible dentro del estómago.
Con cada uno de los dispositivos de restricción de alimento descritos anteriormente, el tratamiento seguro y efectivo requiere que el dispositivo sea monitoreado y ajustado regularmente para hacer variar el grado de restricción aplicado al estómago. Con dispositivos de efecto de banda, la bolsa gástrica arriba de la banda aumentará sustancialmente en tamaño después de la implantación inicial. Por consiguiente, la abertura del estoma en el estómago debe hacerse inicialmente bastante grande para permitir que el paciente reciba nutrición adecuada, mientras que el estómago se adapta al dispositivo de efecto de banda. Puesto que la bolsa gástrica aumenta en tamaño, la banda puede ajustarse para hacer variar el tamaño del estoma. Además, es deseable hacer variar el tamaño del estoma para acomodar cambios en el régimen de tratamiento o cuerpo del paciente, o en un caso más urgente, para aliviar una obstrucción o dilatación esofágica severa. Tradicionalmente, el ajuste de una banda gástrica hidráulica requería la visita programada de un médico clínico, durante la cual se usaban una jeringa y aguja hipodérmica para permear la piel del paciente y añadir o remover fluido del globo. Más recientemente, se han desarrollado bombas implantables que permiten ajustes no invasivos de la banda. Un programador externo comunica con la bomba implantada usando telemetría que controla la bomba. Durante una visita programada, un médico coloca una porción portátil del programador cerca del implante gástrico, y transmite energía y ordena señales al implante. El implante ajusta a su vez los niveles de fluido en la banda, y transmite una orden de respuesta al programador.
Durante estos ajustes de la banda gástrica, ha sido difícil determinar cómo el ajuste está procediendo, y si el ajuste tendrá el efecto deseado. En un intento por determinar la eficacia de un ajuste, algunos médicos han usado fluoroscopía con un sumidero de bario conforme el ajuste se está llevando a cabo. Sin embargo, la fluoroscopía es costosa y no deseable debido a las pérdidas de radiación incurridas por el médico y el paciente. Otros médicos han instruido al paciente para que tome un vaso de agua durante o después del ajuste para determinar si el agua puede pasar a través del estoma ajustado. Sin embargo, este método asegura sólo que el paciente no esté sufriendo obstrucción alguna, y no provee información alguna sobre la eficacia del ajuste. Con frecuencia, un médico puede adoptar simplemente un método de "inténtelo conforme avanza" basado en su experiencia previa, y los resultados de un ajuste pueden no descubrirse hasta horas o días después, cuando el paciente experimenta una obstrucción completa de la cavidad del estómago, o la banda induce erosión del tejido del estómago. Por consiguiente, es deseable proveer un método efectivo para evaluar un ajuste de un dispositivo de restricción de ración alimenticia durante o inmediatamente después de un ajuste. En particular, es deseable proveer un dispositivo de restricción gástrica que incluya un sistema de medición de presión para la medición de la presión dentro del dispositivo de restricción y, por consiguiente, el tamaño del estoma. Además, es deseable proveer un método no invasivo para la medición de la presión de fluido durante un ajuste,
y comunicar la medición de presión a un monitor externo.
BREVE DESCRIPCION DE LA INVENCION
De conformidad con la presente invención, se provee un sistema de restricción, tal como una banda gástrica ajusíable, para formar una restricción en un paciente y comunicar no invasivamente datos de presión respecto a la restricción a un monitor externo. El sistema incluye un dispositivo de restricción para implantación en un paciente para formar una restricción. El sistema incluye además un orificio implantado conectado al dispositivo de restricción. El orificio contiene un fluido de trabajo para afectar el tamaño de la restricción. El sistema incluye además, un sistema detector de presión en comunicación con el fluido de trabajo para la medición de la presión del fluido de trabajo, y transmitir datos de medición de presión a un monitor externo.
BREVE DESCRIPCION DE LAS FIGURAS
La figura 1 es una ilustración esquemática de un dispositivo de restricción de ración alimenticia de la presente invención; la figura 2 es una vista en perspectiva más detallada de un ejemplo de porción implantable para el dispositivo de restricción de ración alimenticia de la figura 1 ; la figura 3 es una vista en perspectiva de la banda gástrica
ajustable de la figura 2, que muestra la banda posicionada alrededor de la unión gastroesofágica de un paciente; la figura 4 es una vista en sección de la banda gástrica ajustable de la figura 2, mostrada en una configuración desinflada; la figura 5 es una vista en sección de la banda gástrica ajustable de la figura 2, mostrada en una configuración inflada para crear una restricción sobre la ración alimenticia; la figura 6 es una vista lateral parcialmente en sección, del orificio de inyección mostrado en la figura 2; la figura 7 es una vista isométrica de la cubierta de retención mostrada en la figura 6; la figura 8 es una vista isométrica del sensor de presión mostrado en la figura 6; la figura 9 es una vista lateral en sección que ilustra una primera modalidad para el sistema detector de presión de la presente invención; la figura 10 es un esquema simplificado del circuito de resistencia variable de la primera modalidad; la figura 11 es una vista lateral en sección de una segunda modalidad para el sistema detector de presión de la invención; la figura 12 es un diagrama de bloque que representa un sistema de medición de presión asociado con la primera y segunda modalidades de la invención; la figura 13 es una vista lateral en sección de una tercera
modalidad para el sistema detector de presión de la invención; la figura 14 es un diagrama de bloque que representa un sistema de medición de presión asociado con la tercera modalidad de la invención; la figura 15 es una vista lateral en sección de una cuarta modalidad para el sistema detector de presión de la invención; la figura 16 es una vista lateral en sección de una quinta modalidad del sistema detector de presión de la invención; la figura 7 es un diagrama de bloque de un sistema de medición de presión asociado con la cuarta y quinta modalidades de la invención; la figura 18 es una gráfica que indica una señal de presión del sistema detector de presión, tal como puede aparecer en la presentación visual del monitor externo durante la interrogación por un usuario.
DESCRIPCION DETALLADA DE LA INVENCION
Con relación ahora a los dibujos en detalle, en donde números iguales indican los mismos elementos en todas las vistas, la figura 1 ilustra un sistema de restricción 30 de ración alimenticia. El sistema 30 comprende una primera porción, identificada en general como 32, implantada dentro de un paciente 34, y una segunda porción, identificada en general como 36, localizada fuera del paciente. La porción implantada 32 comprende una banda gástrica ajustable 38 posicionada sobre la porción superior del estómago 40 del paciente. La banda ajustable 38 puede incluir una cavidad hecha de
caucho de silicón, u otro tipo de material biocompatible, que se infla hacia dentro contra el estómago 40 cuando se llena con un fluido. En forma alternativa, la banda 38 puede comprender un dispositivo mecánicamente ajustable que tiene una cavidad de fluido que experimenta cambios de presión con ajustes de la banda, o una combinación de banda ajustable mecánica/hidráulica. Un orificio de inyección 42, que se describirá en mayor detalle a continuación, se implanta en una región del cuerpo accesible para señales de comunicación por telemetría y/o inyecciones por aguja. En la modalidad mostrada, el orificio de inyección 42 comunica con fluidez con la banda ajustable 38 mediante un catéter 44. Un cirujano puede posicionar e implantar permanentemente el orificio de inyección 42 dentro del cuerpo del paciente, para realizar ajustes de la restricción de la ración alimenticia o el estoma. Los expertos en la técnica reconocerán que los métodos quirúrgicos para la colocación de sistemas de banda gástrica tales como la porción implantable 32, han evolucionado ampliamente durante años recientes, de modo que el paciente puede derivar efecto terapéutico óptimo con complicaciones mínimas. En cirujano, por ejemplo, implanta típicamente el orificio de inyección 42 en la región subcostal lateral del abdomen del paciente bajo la piel y capas de tejido adiposo. El cirujano puede implantar también el orificio de inyección 42 sobre el esternón del paciente. La figura 2 ilustra un ejemplo de banda gástrica ajustable en mayor detalle. En esta modalidad, la banda 38 incluye una cavidad 46 de volumen variable que se expande o se contrae contra la pared exterior del
estómago para formar un estoma ajustable para restringir en forma controlable la ración alimenticia en el estómago. Un médico puede disminuir el tamaño de la abertura del estoma añadiendo fluido a la cavidad 46 de volumen variable o, en forma alternativa, puede aumentar el tamaño del estoma extrayendo fluido de la cavidad. Puede añadirse o retirarse fluido insertando una aguja en el orificio de inyección 42. En forma alternativa, puede transferirse fluido en una forma no invasiva entre la banda 38 y el orificio de inyección 42 usando señales de órdenes por telemetría. El fluido puede ser, pero no se restringe a, una solución salina a 0.9%. La figura 3 muestra la banda gástrica ajustable 38 de la figura 2 aplicada alrededor de la unión gastroesofágica de un paciente. Como se muestra en la figura 3, la banda 38 encierra por lo menos sustancialmente la porción superior del estómago 40 cerca de la unión con el esófago 48. La figura 4 es una vista en sección de la banda 38, que muestra la banda en una configuración desinflada. En esta vista, la banda 38 contiene poco a ningún fluido, aumentando de esta manera al máximo el tamaño de la abertura del estoma en el estómago 40. La figura 5 es una vista en sección transversal de la banda 38 y el estómago 40, similar a la figura 4, mostrando la banda 38 en una configuración inflada llena de fluido. En esta vista, la presión de la banda 38 contra el estómago 40 se incrementa debido al fluido dentro de la banda, disminuyendo de esta manera la abertura del estoma, para crear una restricción sobre la ración alimenticia. La figura 5 ilustra también esquemáticamente la dilatación del esófago 48 arriba de la banda 38 para
formar una bolsa superior 50 bajo el músculo 52 del diafragma del paciente. Volviendo ahora a la figura 1 , la porción externa 36 del sistema de restricción de alimento 30 comprende un dispositivo de lectura de presión 60 conectado eléctricamente (en esta modalidad mediante un ensamble de cables eléctricos 62) a una caja de control 64. La caja de control 64 incluye un monitor 66, uno o más conmutadores de control 68, y un módulo de control externo, que se explicarán en más detalle a continuación. La caja de control 64 puede configurarse para su uso, por ejemplo, en una sala de reconocimiento o consultorio del médico. Algunas formas de montar la caja de control 64, incluyen colocación sobre un escritorio, unión a una mesa de reconocimiento, o colgando sobre un pedestal portátil. La caja de control 64 puede configurarse también para que se lleve en la bolsa de la bata del médico, se sostenga con la mano, o se coloque sobre la mesa de reconocimiento o el asiento reclinable del paciente. El ensamble de cables eléctricos 62 puede conectarse en forma que se pueda separar, a la caja de control 64 o el dispositivo de lectura de presión 60 para facilitar la limpieza, mantenimiento, uso y almacenamiento de la porción externa 36 del sistema 30. El dispositivo de lectura de presión 60 mide no invasivamente la presión del fluido dentro de la porción implantada 32 aún cuando el orificio de inyección 42 sea implantado bajo tejido adiposo subcutáneo grueso (de por lo menos más de 10 cm). El médico puede sostener el dispositivo de lectura de presión 60 contra la piel del paciente cerca del sitio del orificio de inyección 42 en el paciente, y observar la lectura de presión en el monitor 66 de la caja de
control 64. El dispositivo de lectura de presión 60 puede unirse también en forma que se pueda remover al paciente, tal como durante un reconocimiento prolongado, usando correas, adhesivos y otros métodos bien conocidos. El dispositivo de lectura de presión 60 opera a través de la ropa o campos quirúrgicos de papel convencionales, y puede incluir también una cubierta desechable (no mostrada) que puede reemplazarse para cada paciente. Volviendo ahora a la figura 6, se muestra una vista lateral parcialmente seccionada del orificio de inyección 42 que contiene un sistema detector de presión para medir no invasivamente la presión de fluido dentro de la porción implantada 32. Como se muestra en la figura 6, el orificio de inyección 42 comprende un alojamiento rígido 70 que tiene una pestaña anular 72 que contiene una pluralidad de agujeros de unión 74 para la sujeción del orificio de inyección al tejido en un paciente. Un cirujano puede unir el orificio de inyección 42 al tejido, tal como la facia que cubre un músculo abdominal, usando cualquiera de numerosos sujetadores quirúrgicos que incluyen filamentos de sutura, grapas y broches. El orificio de inyección 42 comprende además un tabique 76 hecho típicamente de un caucho de silicón, y retenido por compresión en el alojamiento 70. El tabique 76 es penetrable por una aguja de Huber, o un tipo similar de instrumento de inyección, para añadir o retirar fluido del orificio. El tabique 76 se sella por sí mismo tras el retiro de la aguja de la jeringa para mantener el volumen de fluido dentro del orificio de inyección 42. El orificio de inyección 42 comprende además un depósito 80 para retener un fluido de trabajo y el conector 82 de un catéter. El
conector 82 se une al catéter 44, mostrado en la figura 2, para formar un circuito hidráulico cerrado entre el depósito 80 dentro del orificio de inyección 42 y la cavidad 46 dentro de la banda ajustable 38. El fluido del depósito 80 puede usarse para expandir el volumen de la cavidad 46 de la banda. En forma alternativa, puede removerse fluido de la cavidad 46, y puede retenerse en el depósito 80, para disminuir temporalmente el volumen de la cavidad 46. El alojamiento 70 y el conector 82 pueden moldearse integralmente a partir de un polímero biocompatible, o pueden construirse de un metal tal como titanio o acero inoxidable. Se provee un sistema detector de presión en el orificio de inyección 42, que mide la presión de fluido dentro del circuito hidráulico cerrado de la porción implantada 32. La presión dentro del circuito corresponde a la cantidad de restricción aplicada por la banda ajustable 38 al estómago del paciente. Por consiguiente, la medición de la presión de fluido le permite al médico evaluar la restricción creada por el ajuste de la banda. La presión de fluido puede medirse antes, durante y/o después de un ajuste, para verificar que la banda sea ajustada adecuadamente. En la modalidad mostrada en la figura 6, el sistema detector de presión comprende un sensor 84 posicionado en el fondo del depósito de fluido 80 dentro del alojamiento 70. Una cubierta de retención 86 se extiende arriba del sensor de presión 84 para separar sustancialmente la superficie del sensor del depósito 80, y proteger al sensor de la penetración de la aguja. La cubierta de retención 86 puede hacerse de un material cerámico tal como, por ejemplo, alúmina, que resiste a
la penetración de la aguja, y sin embargo no interfiere con las comunicaciones electrónicas entre el sensor de presión 84 y el dispositivo de lectura de presión 60. La cubierta de retención 86 incluye un respiradero 90 que permite que el fluido dentro del depósito 80 fluya hacia la superficie del sensor de presión 84, e impacte sobre la misma. La figura 7 es una vista ¡sométrica de la cubierta de retención 86 que ilustra el respiradero 90 en la superficie inferior de la cubierta. La figura 8 es una vista isométrica del exterior del sensor de presión 84. Como se muestra en la figura 8, el exterior del sensor de presión 84 incluye un elemento de deformación que tiene una superficie deformable. En la modalidad mostrada, el elemento de deformación es un diafragma 92. El diafragma 92 puede formarse adelgazando una sección de una pared en el depósito de titanio 80. El diafragma 92 puede hacerse de titanio u otro material similar, y tiene un espesor entre 0.001" y 0.002". Aunque las modalidades muestran un diafragma como el elemento de deformación, la presente invención puede construirse también y puede ponerse en práctica usando otros elementos de deformación que conviertan la presión de fluido a un desplazamiento mecánico. Ejemplos de otros elementos de deformación adecuados incluyen, pero no están limitados a, tubos de Bourdon y ensambles de fuelle. El sensor de presión 84 está sellado herméticamente dentro del alojamiento 94 para prevenir que el fluido se infiltre y efectúe la operación del sensor. El alojamiento 94 está sellado al alojamiento 70 del orificio, para prevenir la pérdida de fluido del orificio de inyección 42. El diafragma 92 está
sellado herméticamente al alojamiento 94 del sensor para prevenir que el fluido pase alrededor de los bordes del diafragma y en los componentes internos del sistema de detección. Conforme fluye fluido a través del respiradero 90 en el depósito 80, el fluido impacta sobre la superficie del diafragma 92. El flujo de fluido a través del respiradero 90 permite que el diafragma 92 responda a cambios de presión de fluido dentro del circuito hidráulico, y convierta los cambios de presión en un desplazamiento mecánico. La figura 9 es una vista lateral en sección del sensor de presión 84, tomada a lo largo de la línea A-A de la figura 8, que ilustra una primera modalidad 88 para la medición de la presión de fluido. En la modalidad mostrada en la figura 9, el desplazamiento mecánico del diafragma 92 es convertido a una señal eléctrica por un par de medidores de deformación de silicio 96, 98 de resistencia variable. Los medidores de deformación 96, 98 están unidos al diafragma 92 en el lado opuesto del fluido de trabajo en el depósito 80. El medidor de deformación 96 está unido a una porción central del diafragma 92 para medir el desplazamiento del diafragma. El segundo medidor de deformación 98 acoplado está unido cerca del borde exterior del diafragma 92. Los medidores de deformación 96, 98 pueden unirse al diafragma 92 mediante adhesivos, o pueden difundirse en la estructura del diafragma. Conforme la presión de fluido dentro de la banda 38 cambia, la superficie del diafragma 92 se deforma hacia arriba o hacia abajo dentro de la superficie del alojamiento 94. Esta deformación del diafragma 92 produce un
cambio de resistencia en el medidor de deformación central 96. Como se muestra en la figura 10, los medidores de deformación 96, 98 forman los dos elementos de resistencia superiores de un circuito de puente de Wheatstone 100 semicompensado. Conforme el medidor de deformación 96 reacciona a las deformaciones mecánicas del diafragma 92, la resistencia cambiante del medidor cambia el potencial a través de la porción superior del circuito del puente. El medidor de deformación 98 está acoplado al medidor de deformación 96, y atermaliza el circuito de puente de Wheatstone. Amplificadores diferenciales 102, 104 están conectados al circuito 100 del puente para medir el cambio en potencial dentro del circuito del puente debido a los medidores de deformación de resistencia variable. En particular, el amplificador diferencial 102 mide el voltaje a través del circuito del puente entero, mientras que el amplificador diferencial 104 mide el voltaje diferencial a través de la mitad del medidor de deformación del circuito 00 del puente. Cuanto mayor es la diferencial entre los voltajes del medidor de deformación, para un voltaje fijo a través del puente, mayor es la diferencia de presión. Si se desea, podría usarse también un circuito de puente de Wheatstone totalmente compensado para aumentar la sensibilidad y precisión del sistema detector de presión. En un circuito de puente totalmente compensado, cuatro medidores de deformación están unidos a la superficie del diafragma 92, más que sólo dos medidores de deformación como se muestra en la figura 9. Las señales de salida de los amplificadores diferenciales 102,
104 se aplican a un microcontrolador 106. El microcontrolador 106 está integrado en el tablero de circuito 110 dentro del alojamiento 94. Un sensor de temperatura 112 mide la temperatura dentro del orificio implantado, y envía una señal de temperatura al microcontrolador 106. El microcontrolador 106 usa la señal de temperatura del sensor 112 para compensar las variaciones en la temperatura corporal y los errores de temperatura residuales no explicados por el medidor de deformación 98. La compensación de la señal de medición de presión para variaciones en la temperatura corporal, aumenta la precisión del sistema detector de presión. Además, una bobina de TET/telemetría 114 se localiza dentro del alojamiento 94. La bobina 1 4 está conectada a un capacitor 116 que forma un circuito de tanque resonante para recibir energía de la porción externa 36, y transmitir la medición de presión al dispositivo de lectura de presión 60. La figura 11 es una vista lateral en sección similar a la figura 9, que muestra una segunda modalidad 118 para el sistema detector de presión de la presente invención. En la segunda modalidad 118, se provee un sensor de MEMS 120 dentro del alojamiento 94 que mide la deformación mecánica del diafragma 92 y produce una señal eléctrica proporcional a la presión dentro de la banda ajustable 38. Una cámara de aceite de silicón sellada 122 está provista entre el diafragma 92 y el sensor de MEMS 120. La cámara de aceite 122 protege al sensor de MEMS 120, y transfiere los desplazamientos mecánicos del diafragma 92 al sensor. El sensor de MEMS 120 genera una señal eléctrica para el microcontrolador 106, indicativa de la presión de fluido
en el depósito 80. El microcontrolador 106 envía la señal del sensor de MEMS 120 y una señal de temperatura del sensor de temperatura 12, y calcula la medición de presión. La medición de presión es transmitida al dispositivo de lectura de presión 60 en la porción externa 36 usando señales de telemetría, como se describirá en más detalle a continuación. La figura 12 es un diagrama de bloque de un sistema de medición de presión para la' primera y segunda modalidades 88, 118 de la invención. Como se muestra en la figura 12, un módulo de control externo 126 del sistema incluye una bobina de TET primaria 130 para transmitir una señal de energía al módulo de control interno, indicado en general como 132. La bobina de TET primaria 130 se localiza en el dispositivo de lectura de presión 60 mostrado en la figura 1. Un circuito de accionamiento de TET 134 controla la aplicación de una señal de energía a la bobina de TET primaria 130. El circuito de accionamiento de TET 134 es controlado por un microprocesador 136 que tiene una memoria asociada 138. Una interfaz gráfica de usuario 140 está conectada al microprocesador 136 para controlar los datos mostrados en el monitor 66. El módulo de control externo 126 incluye también un transceptor de telemetría primario 142 para trasmitir órdenes de interrogación y recibir datos de respuesta, que incluyen lecturas de presión de fluido, a partir del módulo de control 132 del implante. El transceptor primario 142 está conectado eléctricamente al microprocesador 136 para enviar y recibir señales de datos y de órdenes. El transceptor primario 142 resuena en una frecuencia de comunicación de RF seleccionada para generar un campo magnético
alterno descendente 146 que transmite datos de órdenes al módulo de control 132 del implante. Una fuente de energía 150 suministra energía al módulo de control externo 126 para accionar el sistema 30. Un sensor de presión ambiental 152 está conectado al microprocesador 136. El microprocesador 136 usa la señal del sensor de presión ambiental 152 para ajustar la lectura de presión para variaciones en presión atmosférica debidas, por ejemplo, a variaciones en condiciones barométricas o altitud, para aumentar la precisión de la medición de presión. La figura 12 ilustra también el módulo de control interno 132 implantado bajo la piel 154 del paciente. El módulo de control interno 132 se localiza dentro del alojamiento 94 del orificio de inyección 42. Como se muestra en la figura 12, una bobina de TET/telemetría secundaria 156 en el módulo de control interno 132 recibe señales de comunicación y energía del módulo de control externo 126. La bobina 156 forma un circuito de tanque resonante que está acoplado inductivamente con la bobina de TET primaria 130 para accionar el implante, o bobina de telemetría primaria 144 para recibir y transmitir datos. Un transceptor de telemetría 158 controla el intercambio de datos con la bobina 156. Además, el módulo de control interno 132 incluye un regulador de energía/rectificador 160, el microcontrolador 106 descrito anteriormente, una memoria 162 asociada con el microcontrolador, un sensor de temperatura 112, un sensor de presión 84 y un circuito de acondicionamiento de señales 164, para amplificar la señal del sensor de presión. El módulo de control interno 132 transmite la medición de presión
ajustada por la temperatura, del sensor de presión 84 al módulo de control externo 126. En el módulo externo 126, la señal de medición de presión recibida es ajustada para cambios en presión ambiental, y mostrada en el monitor 66. La figura 13 es una vista lateral en sección que muestra una tercera modalidad 170 para la medición de la presión de fluido de conformidad con la invención. En la tercera modalidad 170, el módulo de control interno 32 es accionado por una fuente de energía interna ta! como, por ejemplo, una batería 172. La batería 172 reemplaza a las bobinas de TET primaria y secundaria 130, 156 para accionar el microcontrolador 106 y los otros componentes internos. En esta modalidad, el sistema detector de presión incluye un par de medidores de deformación 96, 98 como en la primera modalidad 88, para la medición de las deformaciones mecánicas del diafragma 92 que corresponden a cambios de presión en la banda 38. Los medidores de deformación 96, 98 están incorporados en un circuito de puente balanceado térmicamente compensado para la medición de diferenciales de presión dentro del circuito de fluido cerrado del implante. La figura 14 es un diagrama de bloque del sistema de medición de presión de la invención de conformidad con la tercera modalidad 170 mostrada en la figura 13. En la modalidad 170, una fuente de energía interna se usa para accionar el módulo de control interno 176 más que un sistema de energía de TET como en la primera modalidad. La fuente de energía para la porción implantada 32, es una batería 172 más que la bobina primaria de TET
130 y bobina secundaria 156 mostradas en la figura 12. En la modalidad mostrada en la figura 14, la bobina secundaria implantada 156 se usa solamente para comunicación de datos entre los módulos de control externo e interno. Se provee un regulador de energía 174 que controla la energía de la batería 172 para conservar y extender la vida de la batería. La figura 15 ilustra una cuarta modalidad 180 para la medición de la presión de fluido dentro de la banda ajustable 38, en la cual se usa un sistema pasivo para la medición de cambios de presión dentro del fluido de trabajo. En esta cuarta modalidad 180, una capacitancia variable 182 está unida al diafragma 92 para medir las deformaciones mecánicas del diafragma. La capacitancia variable 182 incluye una primera placa 184 unida cerca del centro del diafragma 92 sobre el depósito de fluido 80 del lado opuesto. Una segunda placa 186 del capacitor es fijada en posición dentro del alojamiento 94 por montaje 188 del capacitor. Cada una de las placas 184, 186 del capacitor está conectada a una bobina de inductancia 190, como se muestra mediante las líneas 192, para formar un circuito resonante. Cuando la presión de fluido dentro del depósito 80 aumenta o disminuye debido, por ejemplo, a cambios en la presión peristáltica contra la banda 38, la posición de la placa 184 del capacitor varía con la deformación del diafragma 92. Conforme aumenta la presión de fluido, el diafragma 92 acerca más la primera placa 84 del capacitor a la segunda placa 186 del capacitor, aumentando de esta manera la capacitancia, y disminuyendo la frecuencia resonante. Asimismo, cuando la presión hidráulica disminuye dentro del circuito cerrado del
implante, la primera placa 184 del capacitor se aleja con el diafragma 92 en una dirección opuesta a la segunda placa 186, disminuyendo de esta manera la capacitancia dentro del circuito resonante, y aumentando la frecuencia resonante. La figura 16 muestra una quinta modalidad 196 para la medición de la presión de fluido de conformidad con la presente invención. La quinta modalidad 196 es una modalidad alternativa para un sistema detector de presión pasivo, en el cual una bobina de inductancia variable 200 convierte las deformaciones mecánicas del diafragma 92 en una señal de medición de presión. Como se muestra en la figura 16, la bobina de inductancia 200 es una bobina plana separada bajo el diafragma 92. Una capacitancia fija 202 está conectada a la bobina de inductancia 200, como se muestra mediante las líneas 204, para formar un circuito resonante de LC 206. Conforme el diafragma 92 se deforma hacia arriba y hacia abajo en respuesta a variaciones de presión en el fluido de trabajo, la inductancia de la bobina 200 varía. Conforme la presión de fluido aumenta, el diafragma 92 se deforma en la dirección de la bobina 200, disminuyendo de esta manera la inductancia de la bobina 200 debido al acoplamiento de la corriente de contraflujo entre el diafragma de metal y la bobina. A la inversa, cuando la presión de fluido disminuye, el diafragma 92 se deforma lejos de la bobina 200, disminuyendo de esta manera el acoplamiento de la corriente de contraflujo, y aumentando la inductancia de la bobina. Por consiguiente, la inductancia de la bobina 200 es inversamente proporcional a la presión del fluido de trabajo. Conforme la
¡nductancia de la bobina 200 cambia, la frecuencia resonante del circuito de LC 206 cambia. La figura 17 es un diagrama de bloque de un sistema de medición de presión para la cuarta y quinta modalidades 180, 196 de la invención. En este sistema, el microprocesador 136 controla un circuito 208 de bobina de inducción y bobina de inducción 210. El microprocesador 136 hace variar la frecuencia de la bobina de inducción 210 para acoplar magnéticamente la bobina con el circuito de LC 206 en la porción implantada 32, como se indica mediante la línea 212. La frecuencia a la cual las bobinas interna y externa se acoplan, variará con la frecuencia resonante del circuito de LC implantado 206. La frecuencia resonante del circuito de LC implantado variará con la presión de fluido dentro de la banda 38. La variación en la frecuencia resonante es medida por el microprocesador 136 a través del circuito 208 de bobina de inducción. Una vez detectada, la frecuencia resonante puede compararse con presiones conocidas a frecuencias designadas para determinar la presión de fluido dentro de la banda 38. Una interfaz gráfica de usuario 140 en el módulo externo 214, presenta visualmente la presión de fluido medida en el monitor 66. La figura 18 es una representación gráfica de una señal de presión 216 del sistema detector de presión de la invención, tal como puede aparecer en el monitor 66 durante la interrogación por un usuario. En el ejemplo mostrado en la figura 18, la presión de fluido es medida inicialmente por el dispositivo de lectura de presión 60, mientras el paciente está estable,
resultando en una lectura de presión estable como se muestra. Después, se aplica un ajuste a la banda 38 para disminuir el tamaño del estoma. Durante el ajuste de la banda, el sistema detector de presión continúa midiendo la presión de fluido y transmite las lecturas de presión a través de la piel del paciente al dispositivo 60. Como se observa en la gráfica de la figura 18, la lectura de presión aumenta ligeramente después del ajuste de la banda. En el ejemplo mostrado, se le pide entonces al paciente que beba un líquido para verificar la precisión del ajuste. Conforme el paciente bebe, el sistema detector de presión continúa midiendo las espigas de presión debidas a la presión peristáltica de la ingestión del líquido, y transmite las lecturas de presión al módulo externo 36 para presentación visual. Al medir y describir visualmente la carga del dispositivo de restricción contra el movimiento peristáltico del estómago durante y después de un ajuste, la presente invención le provee al médico una visualización precisa en tiempo real de la respuesta del paciente al ajuste. Esta presentación visual activa instantánea de los datos de presión registrados, le permite al médico realizar ajustes más precisos de la banda. Los datos pueden presentarse visualmente con el tiempo para proveer un precedente de presión contra tiempo. Además de su uso durante los ajustes, el sistema detector de presión de la invención puede usarse también para medir variaciones de presión en el dispositivo de restricción a varios intervalos durante el tratamiento. Las lecturas de presión periódicas permiten que el sistema detector de presión funcione como una herramienta de diagnóstico, que
asegura que el dispositivo de restricción de ración alimenticia esté operando efectivamente. En particular, el sistema detector de presión puede usarse para detectar una condición de falta de presión dentro de la banda, indicando una fuga de fluido. En forma alternativa, el sistema puede usarse para detectar espigas de presión excesivas dentro de la banda, indicando una falla en el catéter 44, o un bloqueo dentro del estoma. El sistema detector de presión de la invención permite también que el paciente siga él curso de su propio tratamiento, usando un monitor externo, tal como el dispositivo externo 36, en casa. Mediante el uso del dispositivo externo, el paciente puede descargar habitualmente lecturas de presión al consultorio de su médico, reduciendo de esta manera el número, de visitas al consultorio requeridas para monitorear el tratamiento del paciente. Además, el paciente podría hacer lecturas de presión en casa, y notificar a su médico cuando la presión de la banda disminuye abajo de una línea de referencia especificada, indicando la necesidad de un ajuste del dispositivo. El sistema detector de presión de la invención tiene de esta manera beneficios como una herramienta de diagnóstico y de monitoreo durante el tratamiento del paciente con un dispositivo bariátrico. Llegará a ser fácilmente evidente para los expertos en la técnica, que la invención anterior tiene igual aplicación a otros tipos de bandas implantables. Por ejemplo, se usan bandas para el tratamiento de incontinencia fecal. Una de dichas bandas se describe en la patente de E.U.A. No. 6,461 ,292, la cual se incorpora en la presente como referencia. Pueden
usarse también bandas para el tratamiento de incontinencia urinaria. Una de dichas bandas se describe en la solicitud de patente de E.U.A. 2003/0105385, la cual se incorpora en la presente como referencia. Pueden usarse también bandas para tratar acidez y/o reflujo de ácido. Una de dichas bandas se describe en la patente de E.U.A. No. 6,470,892, la cual se incorpora en la presente como referencia. Pueden usarse también bandas para tratar impotencia. Una de dichas bandas se describe en la solicitud de patente de E.U.A. 2003/0114729, la cual se incorpora en la presente como referencia. Aunque la presente invención se ha ilustrado mediante la descripción de varias modalidades, no es la intención del solicitante restringir o limitar el espíritu y alcance de las reivindicaciones anexas a dicho detalle. Numerosas otras variaciones, cambios y sustituciones se le ocurrirán a los expertos en la técnica, sin que se aparten del alcance de la invención. Por ejemplo, el dispositivo y método de la presente invención se ha ilustrado con relación a proveer el sensor de presión dentro del orificio de inyección. En forma alternativa, el sensor podría posicionarse dentro de una porción llena de fluido de la banda, para medir cambios de presión dentro de la banda. Además, el sensor de presión podría asociarse con un globo elastomérico implantado dentro de la cavidad del estómago para medir la presión de fluido dentro del globo. La estructura de cada elemento asociado con la presente invención puede describirse en forma alternativa como un medio para proveer la función realizada por el elemento. Se entenderá que la descripción anterior se provee a manera de ejemplo, y que pueden ocurrir otras modificaciones
para los expertos en la técnica, sin que se aparten del alcance y espíritu
las reivindicaciones anexas.
Claims (19)
1.- Un sistema de restricción para formar una restricción en un paciente y comunicar no invasivamente datos de presión respecto a la restricción a un monitor externo, el sistema comprendiendo: a. un dispositivo de restricción para implantación en un paciente para formar una restricción en el mismo; b. un orificio implantado conectado a dicho dispositivo de restricción, dicho orificio conteniendo un fluido de trabajo para afectar el tamaño de la restricción; y c. un sistema detector de presión en comunicación con dicho fluido de trabajo para la medición de la presión de dicho fluido de trabajo y transmitir datos de medición de presión a un monitor externo.
2. - El sistema de restricción de conformidad con la reivindicación 1, caracterizado además porque la presión de dicho fluido de trabajo es proporcional al grado de restricción formado.
3. - El sistema de restricción de conformidad con la reivindicación 1 , caracterizado además porque dicho sistema detector de presión incluye una superficie mecánicamente deformable en contacto con dicho fluido de trabajo, y en donde dicha superficie se deforma en proporción a la presión de dicho fluido de trabajo.
4. - El sistema de restricción de conformidad con la reivindicación 3, caracterizado además porque dicha superficie mecánicamente deformable tiene deformaciones mecánicas sobre la misma que se convierten en una señal eléctrica indicativa de la presión dentro de dicho fluido de trabajo.
5.- El sistema de restricción de conformidad con la reivindicación 4, caracterizado además porque dicho sistema detector de presión comprende dos o más elementos de resistencia variable unidos a dicha superficie deformable, la resistencia de los elementos variando en respuesta a deformaciones mecánicas de la superficie; y en donde los elementos de resistencia están conectados en un circuito eléctrico, en donde la salida del circuito provee una medición de presión de dicho fluido de trabajo.
6.- El sistema de restricción de conformidad con la reivindicación 1 , caracterizado además porque dicho dispositivo de restricción es una banda gástrica ajustable.
7. - El sistema de restricción de conformidad con la reivindicación 4, caracterizado además porque dicho sistema detector de presión incluye un capacitor de capacitancia variable, la capacitancia de dicho capacitor variando en respuesta a cambios de presión en el fluido de trabajo, la variación en la capacitancia proveyendo una medición de presión de dicho fluido de trabajo.
8. - El sistema de restricción de conformidad con la reivindicación 4, caracterizado además porque dicho fluido de trabajo es transferible entre dicho orificio y dicho dispositivo de restricción en un circuito de fluido cerrado para afectar el tamaño de la restricción.
9. - El sistema de restricción de conformidad con la reivindicación 4, caracterizado además porque dicho sistema detector de presión mide la presión de dicho fluido de trabajo, y transmite datos de dicha medición de presión a dicho monitor externo durante un ajuste de dicho dispositivo de restricción.
10.- El sistema de restricción de conformidad con la reivindicación 4, caracterizado además porque dicho sistema detector de presión incluye una bobina de ¡nductancia variable adyacente a dicha superficie deformable, la inductancia de dicha bobina variando en respuesta a cambios de presión en dicho fluido de trabajo, dicha variación en inductancia proveyendo una medición de presión de dicho fluido de trabajo.
11.- Un sistema de restricción para formar una restricción en un paciente y comunicar no invasivamente datos de presión respecto a la restricción a un monitor externo, el sistema comprendiendo: a. un dispositivo de restricción para implantación en un paciente para formar una restricción en el mismo, dicho miembro de restricción teniendo un volumen de fluido variable para crear una restricción; b. un control conectado operativamente a dicho miembro de restricción para hacer variar el volumen de dicho miembro de restricción; y c. un sistema detector de presión para la medición de la presión de fluido dentro de dicho miembro de restricción, y comunicar no invasivamente la presión medida a dicho monitor externo, la presión medida siendo proporcional al grado de restricción formado en el estómago.
12.- El sistema de restricción de conformidad con la reivindicación 1 , caracterizado además porque dicho sistema detector de presión incluye una superficie mecánicamente deformable en contacto con dicho fluido de trabajo, y en donde dicha superficie se deforma en proporción a la presión de dicho fluido de trabajo.
13. - El sistema de restricción de conformidad con la reivindicación 12, caracterizado además porque dicha superficie mecánicamente deformable tiene deformaciones mecánicas sobre la misma que se convierten en una señal eléctrica indicativa de la presión dentro de dicho fluido de trabajo.
14. - El sistema de restricción de conformidad con la reivindicación 13, caracterizado además porque dicho sistema detector de presión comprende dos o más elementos de resistencia variable unidos a dicha superficie deformable, la resistencia de los elementos variando en respuesta a deformaciones mecánicas de la superficie; y en donde los elementos de resistencia están conectados en un circuito eléctrico, en donde la salida del circuito provee una medición de presión de dicho fluido de trabajo.
15. - El sistema de restricción de conformidad con la reivindicación 11 , caracterizado además porque dicho dispositivo de restricción es una banda gástrica ajustable.
16. - El sistema de restricción de conformidad con la reivindicación 13, caracterizado además porque dicho sistema detector de presión incluye un capacitor de capacitancia variable, la capacitancia de dicho capacitor variando en respuesta a cambios de presión en el fluido de trabajo, la variación en la capacitancia proveyendo una medición de presión de dicho fluido de trabajo.
17. - El sistema de restricción de conformidad con la reivindicación 13, caracterizado además porque dicho fluido de trabajo es transferible entre dicho orificio y dicho dispositivo de restricción en un circuito de fluido cerrado para afectar el tamaño de la restricción.
18. - El sistema de restricción de conformidad con la reivindicación 13, caracterizado además porque dicho sistema detector de presión mide la presión de dicho fluido de trabajo, y transmite datos de dicha medición de presión a dicho monitor externo durante un ajuste de dicho dispositivo de restricción.
19. - El sistema de restricción de conformidad con la reivindicación 13, caracterizado además porque dicho sistema detector de presión incluye una bobina de inductancia variable adyacente a dicha superficie deformable, la inductancia de dicha bobina variando en respuesta a cambios de presión en dicho fluido de trabajo, dicha variación en inductancia proveyendo una medición de presión de dicho fluido de trabajo.
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- 2005-02-24 US US11/065,410 patent/US7699770B2/en not_active Expired - Fee Related
-
2006
- 2006-02-10 AU AU2006200583A patent/AU2006200583B2/en not_active Ceased
- 2006-02-14 SG SG200600977A patent/SG125209A1/en unknown
- 2006-02-21 CA CA2537562A patent/CA2537562C/en not_active Expired - Fee Related
- 2006-02-22 RU RU2006105524/14A patent/RU2430687C2/ru not_active IP Right Cessation
- 2006-02-23 JP JP2006047202A patent/JP4841968B2/ja not_active Expired - Fee Related
- 2006-02-23 MX MXPA06002116A patent/MXPA06002116A/es active IP Right Grant
- 2006-02-23 EP EP06250968A patent/EP1704833B1/en not_active Not-in-force
- 2006-02-23 EP EP10177843A patent/EP2305174B1/en not_active Not-in-force
- 2006-02-23 AT AT06250968T patent/ATE504259T1/de not_active IP Right Cessation
- 2006-02-23 DE DE602006021090T patent/DE602006021090D1/de active Active
- 2006-02-24 CN CNB2006100582243A patent/CN100539956C/zh not_active Expired - Fee Related
- 2006-02-24 BR BRPI0600550-0A patent/BRPI0600550A/pt not_active Application Discontinuation
- 2006-02-24 KR KR1020060018047A patent/KR20060094492A/ko not_active Application Discontinuation
- 2006-04-06 US US11/398,940 patent/US8016745B2/en not_active Expired - Fee Related
- 2006-11-29 HK HK06113082.6A patent/HK1092349A1/xx not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
CA2537562C (en) | 2013-12-10 |
EP2305174A1 (en) | 2011-04-06 |
US20060189888A1 (en) | 2006-08-24 |
CN1839765A (zh) | 2006-10-04 |
US20060199997A1 (en) | 2006-09-07 |
US8016745B2 (en) | 2011-09-13 |
EP1704833A2 (en) | 2006-09-27 |
RU2430687C2 (ru) | 2011-10-10 |
CN100539956C (zh) | 2009-09-16 |
KR20060094492A (ko) | 2006-08-29 |
AU2006200583A1 (en) | 2006-09-07 |
RU2006105524A (ru) | 2007-09-10 |
DE602006021090D1 (de) | 2011-05-19 |
SG125209A1 (en) | 2006-09-29 |
JP2006231061A (ja) | 2006-09-07 |
AU2006200583B2 (en) | 2012-06-28 |
CA2537562A1 (en) | 2006-08-24 |
ATE504259T1 (de) | 2011-04-15 |
EP1704833A3 (en) | 2008-05-28 |
HK1092349A1 (en) | 2007-02-09 |
BRPI0600550A (pt) | 2006-10-17 |
EP1704833B1 (en) | 2011-04-06 |
EP2305174B1 (en) | 2013-01-02 |
JP4841968B2 (ja) | 2011-12-21 |
US7699770B2 (en) | 2010-04-20 |
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