ES2914103T3 - Métodos y aparatos para realizar un tratamiento circunferencial no continuo de un lumen corporal - Google Patents
Métodos y aparatos para realizar un tratamiento circunferencial no continuo de un lumen corporal Download PDFInfo
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Abstract
Un aparato (300; 500) para el tratamiento circunferencial discontinuo de un lumen corporal de un paciente, que comprende: un dispositivo que comprende un catéter (302; 502) configurado para posicionarse dentro del lumen corporal, un elemento expandible (304), y al menos tres elementos de suministro de energía (307) acoplados al dispositivo, en donde los tres elementos de suministro de energía (307) están separados longitudinalmente y están desplazados angularmente entre sí alrededor de una longitud del dispositivo, en donde cada uno de los tres elementos de suministro de energía está configurado para suministrar energía a menos de una circunferencia completa del lumen corporal del paciente, y en donde los elementos de suministro de energía están acoplados al elemento expandible y en donde el elemento expandible está configurado para poner los elementos de suministro de energía en contacto con una pared del lumen corporal y está configurado para bloquear el flujo de fluido dentro del lumen corporal durante el suministro de energía.
Description
DESCRIPCIÓN
Métodos y aparatos para realizar un tratamiento circunferencial no continuo de un lumen corporal
Campo técnico
La presente invención se refiere a métodos y aparatos para realizar un tratamiento circunferencial no continuo dentro de un lumen corporal. Varias realizaciones de dichos métodos y aparatos están dirigidas a tratamientos circunferenciales del lumen corporal que aplican energía en una o más áreas de tratamiento discretas para formar una o más lesiones que no son contiguas o continuas alrededor de cualquier circunferencia completa de una corte transversal normal a un eje longitudinal del lumen corporal.
Antecedentes
Los solicitantes han descrito métodos y aparatos para tratar una variedad de enfermedades renales y cardiorrenales, tales como insuficiencia cardiaca, enfermedad renal, insuficiencia renal, hipertensión, nefropatía por contraste, fibrilación auricular e infarto de miocardio, mediante la modulación de fibras neurales que contribuyen a la función renal, por ejemplo, desnervando el tejido que contiene las fibras neurales que contribuyen a la función renal. Se espera que esto reduzca la actividad nerviosa simpática renal, lo que aumenta la eliminación de agua y sodio del cuerpo y devuelve la secreción de renina a niveles más normales. La secreción de renina normalizada hace que los vasos sanguíneos que irrigan los riñones asuman un nivel constante de dilatación/constricción, lo que proporciona un flujo sanguíneo renal adecuado. Véase, por ejemplo, el documento copendiente del solicitante Números de solicitud de patente de los Estados Unidos: (a) 10/408,665, presentada el 8 de abril de 2003, publicado como US2003/0216792; (b) 11/129,765, presentada el 13 de mayo de 2005, publicado como US2005/0288730 A1; (c) 11/189,563, presentada el 25 de julio de 2005, publicado como US2006/0041277 A1; (d) 11/363,867, presentada el 27 de febrero de 2006, publicado como US2007/0203549 A1; (e) 11/504,117, presentada el 14 de agosto de 2006, publicado como US2009/0221939 A1; así como Patente de los Estados Unidos No. 6,978,174.
Los solicitantes también han descrito previamente métodos y aparatos para la neuromodulación inducida por vía intravascular o la denervación de un vaso sanguíneo inervado en un paciente o cualquier fibra neural objetivo en la proximidad de un vaso sanguíneo, por ejemplo, para tratar cualquier trastorno neurológico u otra condición médica. Los nervios próximos a un vaso sanguíneo pueden inervar un órgano o tejido efector. La neuromodulación o denervación inducida por vía intravascular se puede utilizar para tratar una serie de trastornos neurológicos u otras afecciones médicas, incluidas, entre otras, las afecciones mencionadas anteriormente, como insuficiencia cardíaca e hipertensión, así como dolor y enfermedad oclusiva arterial periférica (por ejemplo, a través de mitigación del dolor). Los métodos y aparatos pueden usarse para modular señales nerviosas eferentes o aferentes, así como combinaciones de señales nerviosas eferentes y aferentes. Véase, por ejemplo, el documento copendiente del Solicitante Solicitud de Patente de los Estados Unidos No. 11/599,649, presentada el 14 de noviembre de 2006, publicado como US20070129760 A1, titulado Methods and Apparatus for Intravascularly-Induced Neuromodulation or Denervation (Expediente del abogado No. 57856.8018.US).
Aunque los métodos anteriores son útiles por sí mismos, un desafío de la neuromodulación y/o denervación intravascular es afectar suficientemente el tejido neural desde el interior del vaso. Por ejemplo, la neuromodulación intravascular debería evitar aumentar el riesgo de estenosis aguda y/o tardía. Por lo tanto, sería deseable proporcionar métodos y aparatos que aborden aún más estos desafíos.
Breve descripción de los dibujos
Varias realizaciones de la presente invención serán evidentes al considerar la siguiente descripción detallada, tomada junto con los dibujos adjuntos, en los que los mismos números de referencia se refieren a partes iguales en todo el texto, y en los que:
La Figura 1 es una vista detallada isométrica esquemática que muestra una ubicación común de las fibras neurales próximas a una arteria.
Las Figuras 2A-2J son vistas laterales esquemáticas, parcialmente en sección, que ilustran un ejemplo de métodos y aparatos para un tratamiento circunferencial no continuo de un lumen corporal.
La Figura 3 es una vista lateral esquemática, parcialmente en sección, que ilustra una realización alternativa de los métodos y aparatos de las Figuras 2.
La Figura 4 es una vista lateral esquemática, parcialmente en sección, que ilustra otros métodos y aparatos alternativos para tratamientos circunferenciales no continuos.
Las Figuras 5A y 5B son vistas laterales esquemáticas, parcialmente en sección, que ilustran otros métodos y aparatos alternativos para tratamientos circunferenciales no continuos.
Descripción detallada
A. Resumen
Los solicitantes han descubierto que puede ser deseable realizar un tratamiento circunferencial de un lumen corporal para afectar positivamente una condición médica mediante la aplicación de energía a zonas discretas que no son continuas a lo largo de la circunferencia completa de una corte transversal radial generalmente normal a la pared del lumen. Por ejemplo, en el tratamiento de la fibrilación auricular, se puede lograr un tratamiento circunferencial formando una lesión circunferencial continua que sea continua completamente alrededor de una corte transversal radial de la vena pulmonar para interrumpir las señales eléctricas aberrantes. En el tratamiento de la insuficiencia cardiaca, puede lograrse un tratamiento circunferencial formando una lesión circunferencial continua similar que sea continua completamente alrededor de una corte transversal radial de una arteria renal para reducir la actividad neural simpática renal. Sin embargo, las lesiones circunferenciales continuas que se extienden continuamente alrededor de 360° completos de la circunferencia de una corte transversal radial normal a la lumen corporal o tejido en las proximidades del lumen corporal pueden aumentar el riesgo de formación de estenosis aguda y/o tardía dentro del vaso sanguíneo. Por lo tanto, muchas de las realizaciones descritas a continuación están dirigidas a formar lesiones discretas no continuas dentro de un lumen sin afectar negativamente al vaso.
Dichos tratamientos no continuos pueden, por ejemplo, llevarse a cabo desde una posición intravascular o intraluminal, que puede incluir el tratamiento que utiliza elementos pasados desde una ubicación intravascular a una ubicación extravascular, es decir, tratamiento intravascular a extravascular. Sin embargo, debe entenderse que también se pueden proporcionar aparatos y métodos de tratamiento extravascular de acuerdo con la presente invención.
Los tratamientos se pueden aplicar en relación con los nervios, incluido el tejido nervioso en el cerebro, u otras estructuras diana dentro o en las proximidades de un vaso sanguíneo u otro lumen corporal que se desplaza al menos en general en paralelo o a lo largo de una dimensión longitudinal del vaso sanguíneo (lumen corporal). Las estructuras diana pueden adicional o alternativamente comprender una orientación rotacional con respecto al vaso sanguíneo (lumen corporal). Varias realizaciones descritas de tratamientos circunferenciales no continuos pueden reducir el riesgo de formación de estenosis aguda y/o tardía al tratar la materia neural a lo largo de porciones de múltiples planos radiales o secciones transversales que están separadas a lo largo de la dimensión longitudinal del vaso sanguíneo (lumen corporal).
El área de tratamiento en cada plano radial o corte transversal define una zona de tratamiento que no es completamente continua a lo largo de una circunferencia, es decir, define una zona de tratamiento sin una lesión circunferencial continua. Sin embargo, la superposición de las múltiples zonas de tratamiento a lo largo de los múltiples planos radiales o secciones transversales define una zona de tratamiento circunferencial superpuesta no continua a lo largo de un segmento longitudinal del vaso sanguíneo (lumen corporal). En algunas realizaciones, esta zona de tratamiento superpuesta puede proporcionar un tratamiento no continuo, pero sustancialmente totalmente circunferencial, sin formación de una lesión circunferencial continua. En otras realizaciones, la zona de tratamiento superpuesta puede proporcionar un tratamiento circunferencial parcial no continuo.
De esta manera, se realiza un tratamiento circunferencial discontinuo sobre un segmento longitudinal del vaso sanguíneo (lumen corporal), en comparación con un tratamiento circunferencial continuo en una única corte transversal longitudinal o plano radial. Las estructuras diana que se desplazan sustancialmente a lo largo de la dimensión longitudinal del vaso sanguíneo (lumen corporal) se ven afectadas circunferencialmente de forma discontinua sin formación de la lesión circunferencial continua a lo largo de cualquier corte transversal o plano radial del vaso sanguíneo (lumen corporal). Esto puede reducir el riesgo de formación de estenosis aguda o tardía dentro del vaso sanguíneo (lumen corporal). Por lo tanto, un tratamiento circunferencial discontinuo puede comprender un tratamiento realizado en múltiples posiciones alrededor de la dimensión longitudinal de un lumen corporal, donde la zona de tratamiento en cualquier posición longitudinal no comprende una lesión circunferencial continua completamente alrededor de un plano radial, pero donde una superposición de la las zonas de tratamiento en todas o algunas de las posiciones longitudinales pueden definir una zona de tratamiento circunferencial superpuesta. El tratamiento circunferencial discontinuo puede lograrse opcionalmente a través de un aparato colocado dentro de un lumen corporal en la proximidad de las fibras neurales diana para la aplicación de energía a las fibras neurales diana. El tratamiento puede ser inducido, por ejemplo, a través de la aplicación de energía eléctrica y/o magnética, a través de la aplicación de energía térmica (ya sea calefacción o refrigeración), a través de la aplicación de energía mecánica, a través de la aplicación de energía química, a través de la aplicación de energía nuclear o de radiación, a través de la aplicación de energía fluida, etc. Dicho tratamiento puede lograrse, por ejemplo, a través de un campo eléctrico térmico o no térmico, a través de un campo eléctrico continuo o pulsado, a través de un campo eléctrico de estimulación, a través de la administración localizada de fármacos, a través de ultrasonidos enfocados de alta intensidad, a través de técnicas térmicas, a través de técnicas atérmicas, combinaciones de las mismas, etc. Tal tratamiento puede, por ejemplo, efectuar electroporación o electrofusión irreversible, necrosis y/o inducción de apoptosis, alteración de la expresión génica, bloqueo o atenuación del potencial de acción, cambios en la regulación positiva de citoquinas, ablación y otros condiciones en las fibras neurales diana. Opcionalmente, todo o una parte del
aparato puede pasarse a través de una pared del lumen corporal hasta una ubicación extraluminal para facilitar el tratamiento. El lumen corporal puede, por ejemplo, comprender un vaso sanguíneo, y el aparato puede colocarse dentro del vaso sanguíneo mediante técnicas percutáneas bien conocidas.
El tratamiento puede lograrse mediante la alteración directa de las estructuras diana (por ejemplo, estructuras neurales diana) o, al menos en parte, mediante la alteración de las estructuras vasculares u otras que soportan las estructuras diana o el tejido circundante, como arterias, arteriolas, capilares, venas. o vénulas. En algunas realizaciones, el tratamiento se puede lograr mediante la aplicación directa de energía al objetivo o a las estructuras de soporte. En otras realizaciones, el tratamiento puede lograrse a través de la generación y/o aplicación indirecta de la energía, tal como a través de la aplicación de un campo eléctrico o de ultrasonido enfocado de alta intensidad que provoca calentamiento resistivo en el objetivo o estructuras de soporte. También se pueden utilizar técnicas térmicas alternativas.
En algunas realizaciones, se pueden proporcionar métodos y aparatos para el control en tiempo real del tratamiento y sus efectos sobre las estructuras diana o de soporte, y/o en el tejido no diana. Asimismo, se puede proporcionar un control en tiempo real del aparato de suministro de energía. La potencia o la energía total suministrada, la impedancia y/o la temperatura, del tejido diana o no diana o del aparato, adicional o alternativamente, pueden monitorizarse.
Cuando se utiliza un campo eléctrico para lograr el tratamiento circunferencial deseado, los parámetros del campo eléctrico se pueden alterar y combinar en cualquier combinación, según se desee. Dichos parámetros pueden incluir, entre otros, voltaje, potencia, intensidad de campo, ancho de pulso, duración de pulso, forma del pulso, número de pulsos y/o intervalo entre pulsos (por ejemplo, ciclo de trabajo), etc. Por ejemplo, las intensidades de campo adecuadas pueden ser de hasta aproximadamente 10 000 V/cm y pueden ser continuas o pulsadas. Formas adecuadas de la forma de onda eléctrica incluyen, por ejemplo, formas de onda de CA, ondas sinusoidales, ondas de coseno, combinaciones de ondas de seno y coseno, formas de onda de CC, formas de onda de CA con desplazamiento de CC, formas de onda de RF, ondas cuadradas, ondas trapezoidales, ondas que decaen exponencialmente o combinaciones del mismo.
Cuando se utiliza un campo eléctrico pulsado, los anchos de pulso adecuados pueden ser de cualquier intervalo deseado, por ejemplo, hasta aproximadamente 1 segundo. El campo incluye al menos un pulso y, en muchas aplicaciones, el campo incluye una pluralidad de pulsos o se aplica continuamente, por ejemplo, durante varios minutos. Los intervalos de impulsos adecuados incluyen, por ejemplo, intervalos inferiores a unos 10 segundos. Estos parámetros se proporcionan como ejemplos adecuados y de ninguna manera deben considerarse limitantes. Cuando se utilizan mecanismos térmicos para lograr el tratamiento deseado, se pueden proporcionar opcionalmente elementos protectores para proteger el tejido no diana, como las células del músculo liso, del daño térmico durante el tratamiento circunferencial discontinuo inducido térmicamente. Por ejemplo, cuando se calientan nervios objetivo o estructuras de soporte, se pueden proporcionar elementos de enfriamiento protectores, tales como elementos de enfriamiento por convección, para proteger el tejido no objetivo. Asimismo, cuando se enfrían los nervios objetivo o las estructuras de soporte, se pueden utilizar elementos de calentamiento protectores, tales como elementos de calentamiento por convección, para proteger el tejido no objetivo. La energía térmica se puede aplicar directa o indirectamente durante un período de tiempo breve o sostenido para lograr, por ejemplo, la neuromodulación o denervación deseada. La retroalimentación, tal como la temperatura detectada a lo largo del tejido objetivo o no objetivo o a lo largo del aparato, puede usarse opcionalmente para controlar y monitorear el suministro de la energía térmica.
El tejido no diana puede protegerse opcionalmente durante, por ejemplo, la neuromodulación o la denervación, utilizando el flujo sanguíneo como sumidero térmico conductor y/o convectivo que absorbe el exceso de energía térmica (caliente o fría). Por ejemplo, cuando el flujo de sangre no está bloqueado, la sangre circulante puede proporcionar un medio de temperatura relativamente constante para eliminar el exceso de energía térmica del tejido no diana durante el procedimiento. El tejido no diana adicional o alternativamente puede protegerse enfocando la energía térmica (u otra) en el objetivo o las estructuras de soporte, de modo que la intensidad de la energía sea insuficiente para inducir el daño térmico en el tejido no diana distante del tejido diana o estructuras de soporte. Se pueden utilizar métodos y aparatos adicionales y alternativos para lograr un tratamiento circunferencial discontinuo sin formación de una lesión circunferencial continua, como se describe a continuación. Para comprender mejor las estructuras de los dispositivos de la presente invención y los métodos de uso de tales dispositivos para el tratamiento circunferencial discontinuo, es instructivo examinar una anatomía neurovascular común en humanos. B. Resumen de anatomía neurovascular
La Figura 1 ilustra una disposición anatómica común de las estructuras neurales en relación con los lúmenes corporales o las estructuras vasculares, normalmente las arterias. Las fibras neurales N generalmente pueden extenderse longitudinalmente a lo largo de la dimensión longitudinal L de una arteria A en una gama relativamente pequeña de posiciones a lo largo de la dimensión radial r, a menudo dentro de la adventicia de la arteria. La arteria A
tiene células de músculo liso SMC que rodean la circunferencia arterial y generalmente giran en espiral alrededor de la dimensión angular 0 de la arteria, también dentro de un rango relativamente pequeño de posiciones a lo largo de la dimensión radial r. Por consiguiente, las células de músculo liso de la arteria tienen una dimensión longitudinal o más larga que generalmente se extiende de forma transversal (es decir, no paralela) a la dimensión longitudinal del vaso sanguíneo. La desalineación de las dimensiones longitudinales de las fibras neurales y las células del músculo liso se define como "desalineación celular".
La desalineación celular de los nervios N y las células del músculo liso SMC puede aprovecharse para afectar selectivamente a las células nerviosas con un efecto reducido sobre las células del músculo liso. Más específicamente, se puede lograr un tratamiento circunferencial discontinuo superponiendo tratamientos realizados a lo largo de múltiples planos transversales o radiales de la arteria A que están separados a lo largo de la dimensión longitudinal L de la arteria, en lugar de realizar un tratamiento circunferencial continuo a lo largo de un único plano radial o corte transversal de la arteria. De esta manera, debido a la desalineación celular, las fibras neurales orientadas longitudinalmente pueden experimentar un tratamiento circunferencial discontinuo completo, mientras que las células del músculo liso orientadas angularmente pueden experimentar solo un tratamiento circunferencial parcial. Los elementos de control pueden utilizarse opcionalmente para evaluar la extensión del tratamiento inducido en los nervios y/o en las células del músculo liso, así como para ajustar los parámetros del tratamiento para lograr el efecto deseado.
C. Realizaciones de aparatos y métodos para el tratamiento circunferencial no continuo de un lumen corporal
Las Figuras 2 a 5 ilustran ejemplos de sistemas intravasculares y métodos para realizar tratamientos circunferenciales no continuos. Los solicitantes han descrito sistemas intravasculares e intra-a-extravasculares para neuromodulación o denervación, por ejemplo, en Solicitud de patente de Estados Unidos No. 11/129,765, presentada el 13 de mayo de 2005; y 11/363,867, presentada el 27 de febrero de 2006. Los solicitantes también han descrito sistemas extravasculares para neuromodulación o denervación (ver, por ejemplo, Solicitud de patente de Estados Unidos No. 11/189,563, presentada el 25 de julio de 2005), y debe entenderse que los tratamientos circunferenciales discontinuos pueden realizarse utilizando sistemas extravasculares (o extraluminales), además de sistemas intravasculares (intraluminales) o intra-a-extravasculares (intra-a-extraluminales). Los solicitantes también han descrito previamente sistemas térmicos para neuromodulación o denervación, por ejemplo, en Solicitud de patente de Estados Unidos No. 11/504,117, presentada el 14 de agosto de 2006.
Con referencia ahora a las Figuras 2A-2J, la realización no cubierta por las reivindicaciones, de un aparato 300 comprende un catéter 302 que tiene un elemento de posicionamiento opcional 304 (por ejemplo, un globo, una cesta de alambre expandible, otros expansores mecánicos, etc.) y elemento de electrodo expandible 306 posicionado a lo largo del eje del catéter e ilustrativamente ubicado sobre el elemento de posicionamiento. El elemento de electrodo 306 puede tener uno o más electrodos 307 acoplados eléctricamente a un generador de campo 50 para suministrar un campo eléctrico a las fibras neurales objetivo. En una realización alternativa no cubierta por las reivindicaciones, uno o más de los electrodos 307 del elemento de electrodo 306 pueden comprender electrodos Peltier para calentar o enfriar las fibras neurales diana para modular las fibras. El(los) electrodo(s) 307 opcionalmente pueden asignarse individualmente y pueden utilizarse de forma bipolar, y/o pueden utilizarse de forma monopolar con una almohadilla de conexión a tierra externa unida al exterior del paciente.
El generador de campo 50, así como cualquiera de las realizaciones de electrodos descritas en el presente documento, puede utilizarse con cualquier realización de la presente invención para suministrar un campo eléctrico con los parámetros de campo deseados. El generador de campo 50 puede ser externo al paciente. Debe entenderse que los electrodos de las realizaciones descritas a continuación pueden conectarse eléctricamente al generador aunque el generador no se muestre o describa explícitamente con cada realización. Además, el generador de campo puede colocarse opcionalmente en el interior del paciente, y los electrodos y/o el generador de campo pueden implantarse opcionalmente de manera temporal o permanente dentro del paciente.
El elemento de posicionamiento 304 puede posicionar opcionalmente o impulsar de otro modo el(los) electrodo(s) 307 en contacto con la pared del vaso. El elemento de posicionamiento 304 también puede comprender un elemento que altera la impedancia que altera la impedancia dentro del vaso durante la terapia para dirigir el campo eléctrico a través de la pared del vaso. Esto puede reducir la energía requerida para lograr la neuromodulación o denervación deseada y puede reducir el riesgo de lesiones en tejidos no diana. Los solicitantes han descrito previamente el uso de un elemento que altera la impedancia, por ejemplo, en Solicitud de patente de Estados Unidos con número de serie 11/266,993, presentada el 4 de noviembre de 2005. Cuando el elemento de posicionamiento 304 comprende un globo inflable, como en las Figuras 2A-J, el globo puede servir como elemento de centrado y/o expansión para el elemento de electrodo expandible 306, y como aislante eléctrico que altera la impedancia para dirigir un campo eléctrico. administrado a través del (de los) electrodo(s) 307 dentro o a través de la pared del vaso para la modulación de las fibras neurales diana. El aislamiento eléctrico proporcionado por el elemento 304 puede reducir la magnitud de la energía aplicada u otros parámetros del campo eléctrico necesarios para lograr la modulación deseada de las fibras objetivo, hasta e incluyendo la denervación total del tejido que contiene las fibras objetivo.
Además, el elemento 304 puede utilizarse opcionalmente como elemento térmico. Por ejemplo, se puede inflar con un fluido frío que sirve como disipador de calor para eliminar el calor del tejido que entra en contacto con el elemento. A la inversa, el elemento 304 se puede inflar con un fluido calentado que calienta el tejido en contacto con el elemento. El fluido térmico dentro del elemento puede circular y/o intercambiarse opcionalmente dentro del elemento de posicionamiento 304 para facilitar una transferencia de calor por conducción y/o convección más eficiente. Los fluidos térmicos también se pueden usar para lograr la neuromodulación térmica a través de mecanismos de calentamiento o enfriamiento térmico, como se describe con mayor detalle a continuación.
El(los) electrodo(s) 307 pueden ser electrodos individuales (es decir, contactos independientes), un electrodo segmentado con contactos conectados comúnmente, o un solo electrodo continuo. Además, el(los) electrodo(s) 307 pueden configurarse para proporcionar una señal bipolar, o el(los) electrodo(s) 307 pueden usarse juntos o individualmente junto con una almohadilla de tierra del paciente separada para uso monopolar. Como alternativa o además de la colocación del(de los) electrodo(s) 307 a lo largo del elemento de electrodo expandible 306, como en las Figuras 2, el o los electrodos 307 pueden unirse al elemento de posicionamiento 304 de modo que entren en contacto con la pared de la arteria al expandirse el elemento de posicionamiento. En tal variación, el(los) electrodo(s) pueden, por ejemplo, fijarse a la superficie interior, superficie exterior o al menos parcialmente incrustados dentro de la pared del elemento de posicionamiento (véanse las Figuras 5A y 5B). En otra realización no cubierta por las reivindicaciones, el o los electrodos no hacen contacto con la pared del vaso y pueden colocarse en cualquier ubicación deseada dentro del vaso.
El(los) electrodo(s) 307 o cualquier otra parte del aparato 300, como el catéter 302 o el elemento 304, adicional o alternativamente puede comprender uno o más sensores, como termopares 310, para monitorear la temperatura u otros parámetros del tejido objetivo, el tejido no objetivo, los electrodos, el elemento de posicionamiento y/o cualquier otra parte del aparato 300 o de la anatomía del paciente. El régimen de tratamiento puede controlarse utilizando el o los parámetros medidos como retroalimentación. Esta retroalimentación se puede usar, por ejemplo, para mantener el(los) parámetro(s) por debajo de un umbral deseado, por ejemplo, un umbral que puede causar lesiones en los tejidos no objetivo. Por el contrario, la retroalimentación se puede usar para mantener los parámetros en o por encima de un umbral deseado, por ejemplo, un umbral que puede inducir un efecto deseado en los tejidos objetivo, como la neuromodulación de las fibras neurales objetivo o la denervación de tejidos inervados por las fibras neurales diana. Además, la retroalimentación se puede usar para mantener el(los) parámetro(s) dentro de un rango que inducirá el efecto deseado en los tejidos objetivo sin dañar los tejidos no objetivo. Múltiples parámetros (o los mismos o múltiples parámetros en múltiples ubicaciones) pueden usarse opcionalmente como retroalimentación de control para asegurar los efectos deseados mientras se mitigan los efectos no deseados.
Como se ve en la Figura 2A, el catéter 302 puede administrarse en un sitio de tratamiento dentro de la arteria A (o dentro de una vena o cualquier otro vaso cercano a las fibras neurales objetivo) en una configuración de administración de bajo perfil, por ejemplo, a través del catéter guía. o vaina 303. Alternativamente, los catéteres se pueden colocar en múltiples vasos para la neuromodulación, por ejemplo, dentro de una arteria y una vena. Las técnicas de vasos múltiples para la neuromodulación del campo eléctrico se han descrito anteriormente, por ejemplo, en el documento en trámite del solicitante. Solicitud de patente de Estados Unidos No. 11/451,728, presentada el 12 de julio de 2006
Una vez posicionado dentro de la vasculatura como se desee, el elemento de posicionamiento opcional 304 puede expandirse para expandir el elemento de electrodo 306 y poner los electrodos 307 en contacto con una pared interior del vaso, como se ve en la Figura 2B. Entonces, el generador de campo 50 puede generar un campo eléctrico, transferirlo a través del catéter 302 al elemento de electrodo 306 ya los electrodos 307, y administrarlo a través de los electrodos 307 a través de la pared de la arteria. El campo eléctrico modula la actividad a lo largo de las fibras neurales dentro de la pared de la arteria o en las proximidades de la arteria, por ejemplo, desnerva al menos parcialmente tejido u órgano(s) inervado(s) por las fibras neurales. Esto puede lograrse, por ejemplo, mediante ablación o necrosis o mediante lesión no ablativa u otros cambios en las fibras neurales diana o estructuras de soporte. El campo eléctrico también puede inducir electroporación en las fibras neurales.
Como se ve en la vista en corte transversal de la Figura 2C tomada a lo largo del plano radial I--I de la Figura 2B, el aparato 300 ilustrativamente comprende cuatro electrodos 307 igualmente espaciados alrededor de la circunferencia del elemento de electrodo 306 y el elemento de posicionamiento 304. Como se ve en la Figura 2D, cuando se utiliza de forma monopolar en combinación con una conexión a tierra externa (no mostrada; per se conocida), los segmentos circunferenciales tratados por cada electrodo se superponen para formar zonas de tratamiento discretas TZi que no son continuas completamente alrededor de la circunferencia. de la arteria en un plano radial normal a la pared del vaso. Como resultado, existen zonas discretas no tratadas UZi alrededor de la circunferencia de la arteria.
Como se ve en la Figura 2E, el elemento de electrodo 306 puede colapsarse sobre la dimensión radial r de la arteria de modo que los electrodos 307 no entren en contacto con la pared del vaso, por ejemplo, colapsando el elemento de posicionamiento 304. El elemento de electrodo 306 se puede girar alrededor de la dimensión angular 0 de la arteria para reposicionar angularmente los electrodos 307 (se muestra mejor en la Figura 2G). Esta rotación se puede lograr, por ejemplo, rotando angularmente el catéter 302. En la Figura 2E, el elemento de electrodo se ha girado ilustrativamente aproximadamente 45° alrededor de la dimensión angular de la arteria. En la realización del
aparato 300 que se muestra en las Figuras 2A-D, los electrodos están igualmente espaciados alrededor de la circunferencia del aparato, de modo que una rotación angular de 45° reposiciona los electrodos aproximadamente a medio camino entre las posiciones iniciales de los electrodos que se muestran en la Figura 2D.
Además del reposicionamiento angular de los electrodos, los electrodos pueden reposicionarse a lo largo de la dimensión longitudinal L de la arteria, que también se muestra en la Figura 2E como el desplazamiento longitudinal entre los electrodos 307 y el plano radial II. Dicho reposicionamiento longitudinal puede ocurrir antes, después o al mismo tiempo que el reposicionamiento angular de los electrodos. Como se ve en la Figura 2F, una vez reposicionado tanto en la dimensión longitudinal como en la angular, el elemento de electrodo 306 puede volver a expandirse sobre la dimensión radial para contactar los electrodos 307 con la pared del vaso. Entonces, se puede suministrar un campo eléctrico a través de los electrodos 307 reposicionados angular y longitudinalmente.
En la Figura 2G, el tratamiento a lo largo del plano radial II—II de la Figura 2F crea la zona de tratamiento TZ ii y la zona no tratada UZii. Al igual que con la zona de tratamiento TZi de la Figura 2D, la zona de tratamiento TZii de la Figura 2G no es continua alrededor de la circunferencia completa de la arteria. Las Figuras 2H y 2I permiten la comparación de la zona de tratamiento TZi y la zona de tratamiento TZii. El aparato 300 no se muestra en las Figuras 2H y 2I, por ejemplo, el aparato puede haber sido retirado del paciente para completar el procedimiento.
Como se muestra, las zonas no tratadas UZi y UZii a lo largo de los planos radiales I--I y II-M, respectivamente, están desplazadas angularmente entre sí. Como se ve en la Figura 2J, al superponer las zonas de tratamiento TZi y TZii, que se colocan a lo largo de diferentes secciones transversales o planos radiales de la arteria A, se forma una zona de tratamiento compuesta TZi-ii que proporciona una zona no continua, sin embargo, un tratamiento sustancialmente circunferencial sobre un segmento longitudinal de la arteria. Esta zona de tratamiento superpuesta no crea una lesión circunferencial continua a lo largo de ningún plano radial individual o corte transversal normal a la arteria, lo que puede reducir el riesgo de formación de estenosis aguda o tardía, en comparación con los tratamientos circunferenciales anteriores que crean una lesión circunferencial continua.
Como se discutió anteriormente, el tratamiento circunferencial no continuo, colocando electrodos en diferentes orientaciones angulares a lo largo de múltiples ubicaciones longitudinales puede afectar preferentemente estructuras anatómicas que se propagan sustancialmente a lo largo de la dimensión longitudinal de la arteria. Tales estructuras anatómicas pueden ser fibras neurales y/o estructuras que soportan las fibras neurales. Además, dicho tratamiento circunferencial discontinuo puede mitigar o reducir los efectos potencialmente indeseables inducidos en estructuras que se propagan alrededor de la dimensión angular de la arteria, como las células del músculo liso. La orientación angular o circunferencial de las células del músculo liso en relación con la arteria puede explicar, al menos parcialmente, por qué las lesiones circunferenciales continuas pueden aumentar el riesgo de estenosis aguda o tardía.
Aunque en las Figuras 2A-J el elemento de electrodo 306 se expande a través del elemento de posicionamiento 304, debe entenderse que los elementos de electrodo expandibles o los electrodos de acuerdo con la presente invención pueden configurarse adicional o alternativamente para autoexpandirse en contacto con la pared del vaso. Por ejemplo, los electrodos pueden autoexpandirse después de retirar una vaina o un catéter guía 303 restringiendo los electrodos en una configuración de entrega reducida. Los electrodos o elementos de electrodos pueden, por ejemplo, fabricarse a partir de (o acoplarse a) elementos con memoria de forma que están configurados para autoexpandirse. Las realizaciones autoexpandibles pueden colapsarse opcionalmente para recuperarlas del paciente mediante el reposicionamiento de una vaina o catéter restrictivo sobre los elementos autoexpandibles.
La Figura 3 ilustra una realización alternativa no cubierta por las reivindicaciones, del aparato 300 que tiene un elemento de electrodo autoexpandible 306'. El elemento de posicionamiento 304 se ha retirado del aparato. En uso, el aparato 300 avanza a un sitio de tratamiento dentro de la vaina o catéter guía 303. Se retira la vaina y el elemento 306' se autoexpande para poner los electrodos 307 en contacto con la pared del vaso. Ventajosamente, la sangre continúa fluyendo a través de la arteria A durante la formación de la zona de tratamiento TZ1. El elemento 306' puede colapsarse parcial o completamente (por ejemplo, dentro de la vaina 303), girar angularmente en relación con el vaso, reposicionarse lateralmente en relación con el vaso y volver a expandirse en contacto con la pared del vaso a lo largo de un plano radial o corte transversal diferente. El tratamiento puede continuar en la nueva ubicación y en la nueva orientación angular en presencia de flujo sanguíneo, por ejemplo, para formar una zona de tratamiento superpuesta TZ1 que completa una zona de tratamiento circunferencial discontinua TZ1-11 cuando se superpone con la zona de tratamiento TZ|. A continuación, el elemento 306' puede volver a colapsarse y el aparato 300 puede retirarse del paciente para completar el procedimiento.
Con referencia ahora a la Figura 4, puede ser deseable lograr un tratamiento circunferencial discontinuo sin reposicionamiento angular y/o longitudinal de electrodos u otros elementos de suministro de energía. Con este fin, en otra realización no cubierta por las reivindicaciones, un aparato 400 comprende un catéter 402 que tiene una cesta de alambre 404 activamente expandible o autoexpandible que tiene electrodos proximales 406 y electrodos distales 408 separados longitudinalmente de los electrodos proximales. Los electrodos proximales 406 y los electrodos distales 408 también están separados radialmente alrededor de la canasta de alambre y eléctricamente acoplados al generador de campo 50 (ver Figura 2A). Los electrodos proximales 406 se pueden colocar a lo largo de
diferentes alambres de la cesta de alambre que los electrodos distales. En consecuencia, los electrodos proximal y distal están desplazados angular y lateralmente entre sí.
Los electrodos proximales pueden operarse independientemente de los electrodos distales, y/o los electrodos proximales y distales pueden operarse todos con la misma polaridad, por ejemplo, de forma monopolar como electrodos activos en combinación con una tierra externa. Como alternativa o adicionalmente, los electrodos proximales pueden utilizarse de forma bipolar entre sí y/o los electrodos distales pueden utilizarse de forma bipolar entre sí. Los electrodos proximal y distal preferiblemente no se utilizan juntos de forma bipolar. Tratando con los electrodos distales 408, la zona de tratamiento TZi de la Figura 2H puede formarse alrededor de la arteria. El tratamiento con los electrodos proximales 406 puede crear la zona de tratamiento TZii de la Figura 2I, que está desplazada angularmente con respecto a la zona de tratamiento TZi. La superposición de las zonas de tratamiento TZi y TZii crea la zona de tratamiento circunferencial discontinua TZui sobre un segmento longitudinal de la arteria. Los electrodos proximal y distal pueden utilizarse opcionalmente al mismo tiempo para formar al mismo tiempo las zonas de tratamiento TZi y TZii. Alternativamente, los electrodos pueden operarse secuencialmente en cualquier orden deseado para formar secuencialmente las zonas de tratamiento. Como otra alternativa más, las zonas de tratamiento pueden formarse parcialmente mediante tratamiento concurrente y parcialmente mediante tratamiento secuencial.
Las Figuras 5A y 5B describen aparatos y métodos adicionales para el tratamiento circunferencial discontinuo sin tener que cambiar la posición de los electrodos u otros elementos de suministro de energía. Como se ve en las Figuras 5A y 5B, el aparato 300 tiene un elemento de electrodo 306" que comprende un circuito flexible acoplado o colocado alrededor del elemento de posicionamiento 304. El circuito flexible está eléctricamente acoplado al generador de campo 50 mediante cables que se extienden a lo largo del catéter 302 o de forma inalámbrica. En la Figura 5A, el circuito flexible comprende un cilindro colapsable colocado alrededor del elemento de posicionamiento 304. En la Figura 5B, el circuito flexible comprende conexiones eléctricas individuales para cada electrodo 307, lo que puede facilitar el colapso del circuito flexible para la entrega y recuperación. Al igual que con los electrodos del aparato 400 de la Figura 4, los electrodos 307 de la Figura 7 están espaciados en múltiples posiciones longitudinales con respecto al elemento de posicionamiento y el vaso sanguíneo. Los electrodos se pueden operar como se describió anteriormente para lograr un tratamiento circunferencial discontinuo. Como los electrodos 307 se colocan ilustrativamente en tres posiciones longitudinales diferentes, el tratamiento circunferencial discontinuo puede formarse, por ejemplo, mediante la superposición de tres zonas de tratamiento (una en cada posición longitudinal dentro del vaso sanguíneo).
Las Figuras 2 a 5 describen ilustrativamente métodos y aparatos eléctricos para el tratamiento circunferencial sin formación de una lesión circunferencial. Sin embargo, debe entenderse que pueden utilizarse modalidades de energía alternativa, que incluyen magnética, térmica, química, nuclear/radiación, fluida, etc., para lograr el tratamiento circunferencial deseado sin lesión circunferencial. Además, aunque las Figuras 2 a 5 ilustran de forma ilustrativa el posicionamiento totalmente intravascular del aparato, debe entenderse que la totalidad o una parte del aparato puede colocarse extravascularmente, opcionalmente a través de un enfoque intravascular a extravascular. Durante la entrega del campo eléctrico (o de otra energía), la sangre dentro del vaso puede actuar como un sumidero térmico (ya sea frío o caliente) para la transferencia de calor por conducción y/o convección para eliminar el exceso de energía térmica del tejido no objetivo (como la pared interior del vaso), protegiendo así el tejido no diana. Este efecto puede mejorarse cuando el flujo sanguíneo no se bloquea durante el suministro de energía, como en las realizaciones de las Figuras 3 y 4. Se espera que el uso de la sangre del paciente como sumidero térmico facilite la administración de tratamientos más prolongados o de mayor energía con un riesgo reducido de daño al tejido no objetivo, lo que puede mejorar la eficacia del tratamiento en el tejido objetivo, por ejemplo, en el objetivo. fibras neurales.
Además o como alternativa a la utilización de la sangre del paciente como sumidero térmico, se puede inyectar un fluido térmico (frío o caliente) en el vaso, por ejemplo, aguas arriba de los electrodos u otro elemento de suministro de energía, para eliminar el exceso de calor. energía y proteger los tejidos no diana. El termofluido puede, por ejemplo, inyectarse a través del catéter del dispositivo o a través de un catéter guía. Además, este método de usar un fluido térmico inyectado para eliminar el exceso de energía térmica de los tejidos no objetivo para proteger los tejidos no objetivo del daño térmico durante el tratamiento terapéutico de los tejidos objetivo puede utilizarse en lúmenes corporales distintos de los vasos sanguíneos.
Aunque las variaciones ilustrativas preferidas se describen anteriormente, será evidente para los expertos en la técnica que se pueden realizar varios cambios y modificaciones en el mismo. Por ejemplo, aunque en las realizaciones descritas de las Figuras 2 a 4, el tratamiento circunferencial discontinuo se logra mediante la superposición del tratamiento en dos ubicaciones, debe entenderse que el tratamiento en más de dos ubicaciones puede superponerse para lograr el tratamiento circunferencial, como se describe con respecto a las Figuras 5A y 5B.
Claims (1)
1. Un aparato (300; 500) para el tratamiento circunferencial discontinuo de un lumen corporal de un paciente, que comprende:
un dispositivo que comprende un catéter (302; 502) configurado para posicionarse dentro del lumen corporal,
un elemento expandible (304), y
al menos tres elementos de suministro de energía (307) acoplados al dispositivo,
en donde los tres elementos de suministro de energía (307) están separados longitudinalmente y están desplazados angularmente entre sí alrededor de una longitud del dispositivo, en donde cada uno de los tres elementos de suministro de energía está configurado para suministrar energía a menos de una circunferencia completa del lumen corporal del paciente,
y en donde los elementos de suministro de energía están acoplados al elemento expandible y en donde el elemento expandible está configurado para poner los elementos de suministro de energía en contacto con una pared del lumen corporal y está configurado para bloquear el flujo de fluido dentro del lumen corporal durante el suministro de energía.
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