MX2013001317A - Reconfirmacion de colocacion de una punta de cateter asistida por ecg. - Google Patents
Reconfirmacion de colocacion de una punta de cateter asistida por ecg.Info
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- A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
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- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
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- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
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- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
- A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
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Abstract
Se divulga la reconfirmación de la posición de un catéter intravascularmente colocado con la asistencia de señales ECG del paciente, asistiendo de esta manera en la determinación del desplazo subsecuente del catéter dentro de la vasculatura del paciente. En una modalidad un método para reconfirmar una posición de un dispositivo médico interno dentro de un cuerpo de un paciente comprende primer colocar el dispositivo médico dentro del cuerpo del paciente usando señales ECG del paciente. Se almacena un primer perfil de señal ECG que se relaciona con una posición inicial del dispositivo médico interno después de la colocación inicial del dispositivo médico. Luego se adquiere un segundo perfil de señal ECG que se relaciona con la posición del dispositivo médico interno en un tiempo subsecuente a la colocación inicial del dispositivo médico. El primer perfil de señal ECG se compara con el segundo perfil de señal ECG para determinar si el desplazamiento del dispositivo médico interno se ha presentado.
Description
RECONFIRMACIÓN DE COLOCACIÓN DE UNA PUNTA DE CATÉTER ASISTIDA
POR ECG BREVE DESCRIPCIÓN
Brevemente resumidas, las modalidades de la presente invención se dirigen a la reconfirmación de una posición de un catéter u otro dispositivo interno que se ha colocado con la asistencia de señales ECG del paciente. El sistema y métodos descritos en la presente permiten que un médico confirme si la punta distante del catéter interno permanece posicionada en la misma ubicación como cuando el catéter se colocó inicialmente . Si se descubre que la punta ha migrado a otra posición, se pueden tomar pasos para regresarla a su posición apropiada.
En una modalidad un método para reconfirmar una posición de un dispositivo médico interno dentro de un cuerpo de un paciente comprende primero colocar el dispositivo médico dentro del cuerpo del paciente usando señales ECG del paciente. Se almacena un primer perfil de señal ECG que se relaciona con la posición inicial del dispositivo médico interno después de que se completa la colocación inicial del dispositivo médico. Luego se adquiere un segundo perfil de señal ECG con relación a una posición del dispositivo médico interno en un tiempo subsecuente a la colocación inicial del dispositivo médico. El primer perfil de señal ECG se compara con el segundo perfil de señal ECG para determinar si el desplazamiento del dispositivo médico interno se ha presentado después de la colocación inicial del dispositivo médico. Si el desplazamiento se ha presentado, el médico puede tomar los pasos necesarios para la reposición del catéter como sea necesario.
Estas y otras características de las modalidades de la presente invención serán más evidentes a partir de la siguiente descripción y las reivindicaciones adjuntas o se puede aprender por la práctica de las modalidades de la invención como se expone a partir de ahora.
BREVE DESCRIPCIÓN DE LOS DIBUJOS
Una descripción más particular de la presente invención se representará a manera de referencia a las modalidades específicas de la misma que se ilustran en los dibujos adjuntos. Se aprecia que estos dibujos representan solamente modalidades típicas de la invención y por lo tanto no se van a considerar limitantes de su alcance. Modalidades ejemplares de la invención se describirán y se explicarán con especificidad y detalles adicionales a través del uso de los dibujos acompañantes en los cuales:
la FIG. 1 es un diagrama de bloques que representa varios elementos de un sistema para colocación intravascular de un catéter, de acuerdo con una modalidad ejemplar de la presente invención;
la FIG. 2 es una vista simplificada de un paciente y un catéter que se inserta en el mismo con asistencia del sistema de la FIG. 1;
la FIG. 3 es una vista recortada parcial de una configuración de ruta conductiva dentro del catéter de la FIG. 2 de acuerdo con una modalidad;
la FIG. 4 es una vista en perspectiva de un sistema lector/codificador de tarjetas para el uso de acuerdo con una modalidad;
la FIG. 5 es una vista superior de una bifurcación de catéter que incluye un chip RFID de acuerdo con una modalidad;
la FIG. 6 es una vista superior simplificada de un lector/codificador RFID; y
la FIG. 7 es una captura de pantalla de la pantalla del sistema de la FIG. 2 que muestra una pluralidad de formas de onda ECG durante el uso del sistema en la confirmación de una posición de un catéter, de acuerdo con una modalidad.
DESCRIPCIÓN DETALLADA DE LAS MODALIDADES SELECCIONADAS
Se hará ahora referencia a las figuras en donde estructuras similares se proporcionarán con designaciones de referencia similares. Se entiende que los dibujos son representaciones diagramáticas y esquemáticas de modalidades ejemplares de la presente invención, ni se limitan tampoco se dibujan necesariamente a escala.
Para claridad se va a entender que la palabra "próxima" se refiere a una dirección relativamente más cercana a un médico que usa el dispositivo que se describe en la presente, mientras que la palabra "distante" se refiere a una dirección relativamente lejos del médico. Por ejemplo, extremo de un catéter colocado dentro del cuerpo de un paciente se considera un extremo distante del catéter, mientras que el extremo del catéter que permanece fuera del cuerpo es un extremo próximo del catéter. También, las palabras "que incluye", "tiene" y "que tiene", como se usan en la presente, incluyendo las reivindicaciones, tendrán el mismo significado como la palabra "que comprende".
Las modalidades de la presente invención se dirigen generalmente a la reconfirmación de una posición de un catéter u otro dispositivo interno que se ha colocado con la asistencia de señales ECG del paciente. Como se explica en la presente, el sistema y métodos descritos en la presente permiten particularmente que un médico confirme si la punta distante del catéter interno permanece posicionada en la misma ubicación como cuando el catéter se colocó inicialmente . Si se descubre que la punta ha migrado a otra posición, se pueden tomar pasos para regresarla a su posición apropiada .
La referencia primero se hace a las FIGS. 1 y 2, donde se muestra un ejemplo de un sistema de colocación y supervisión de catéter, designado generalmente en 10. El sistema 10 permite la visualización de un vaso subcutáneo de un vaso subcutáneo de un paciente 70 a través de la formación de imágenes con ultrasonido, seguido por la inserción, avanzado, y colocación final de un catéter 72 dentro de la vasculatura del paciente a través de la supervisión de señales ECG emitidas por el nodo SA del corazón del paciente. Un diagrama de bloques simplificado de componentes de hardware y otros del sistema 10 se muestra en la FIG. 1, mientras que la FIG. 2 representa el sistema de catéter 72 con relación al paciente 70. Como se muestra, el sistema 10 en una modalidad incluye generalmente una consola 20 que aloja una pantalla 30, una sonda de ultrasonido 40, y una unidad detectora 50 para la colocación en el pecho del paciente 70.
Con mayor detalle y como se menciona en lo anterior, la FIG. 2 muestra la relación general de los componentes del sistema 10 a un paciente 70 durante un procedimiento para colocar el catéter 72 en la vasculatura del paciente a través de un sitio e inserción de la piel 73. La FIG. 2 muestra que el catéter 72 incluye generalmente una porción próxima 74 que permanece exterior al paciente y una porción distante 76 que reside dentro de la vasculatura del paciente después de que se completa la colocación. El sistema 10 se emplea para posicionar finalmente una punta distante 76A del catéter 72 en una posición deseada dentro de la vasculatura del paciente. En una modalidad, la posición deseada para la punta distante del catéter 76A está próxima al corazón del paciente, tal como en la porción de un tercio inferior (1/3°) de la Vena Cava Superior ("SVC") . Por su puesto, el sistema 10 se puede emplear para colocar la punta distante del catéter en otras ubicaciones. La porción próxima del catéter 74 incluye además una bifurcación 74? que proporciona comunicación fluida entre el uno o más lúmenes del catéter 72 y uno o más extremos de extensión 74B que se extienden próximos desde el cubo. Cada extremo de extensión 74B incluye un conector de Luer 74C para la unión a los dispositivos médicos adecuados.
La consola 20 aloja varios componentes necesarios para la operación del sistema 10. Un procesador 22, incluyendo memoria no volátil tal como EEPROM para asistencia, se incluye en la consola 20 para controlar la función del sistema durante la operación del sistema 10, actuando de esta manera como un procesador de control. Un controlador digital/interfaz análoga 24 también se incluye con la consola 20 y está en comunicación con tanto el procesador 22 como los otros componentes del sistema para controlar la interconexión entre la zona de ultrasonido 40, el sensor 50 y otros componentes del sistema.
La consola 20 incluye además puertos 52 para la conexión con el sensor 50 y los componentes opcionales 54 incluyendo una impresora, medios de almacenamiento, teclado, etc. Los puertos 52 en una modalidad son puertos USB, aunque otros tipos de puertos o una combinación de tipos de puertos se pueden usar para estar y las otras conexiones de interfaces descritas en la presente. Una conexión de energía 56 se incluye con la consola 20 para permitir la conexión operable a un suministro de energía externo 58. Una batería interna 60 también se puede emplear, ya sea con o exclusiva de un suministro de energía externo. Los circuitos de manejo de energía 59 se incluyen con el controlador digital/interfaz análoga 24 de la consola para regular el uso y distribución de energía.
La pantalla 30 del sistema 10 en la presente modalidad está integrada en la consola 20 y se usa para mostrar información al médico durante el procedimiento de colocación del catéter, y como se observará, durante la reconfirmación de la posición de la punta distante del catéter de acuerdo con las modalidades que se describen posteriormente. Opcionalmente , la pantalla se puede separar de la consola. En una modalidad, un interfaz de botón de consola 32 y botones incluidos en la sonda 40 se pueden usar para controlar la funcionalidad del sistema 10 durante el procedimiento de colocación del catéter. De esta manera, se puede emplear una sola pantalla 30 de la consola del sistema 20 para la guía de ultrasonido en el acceso a la vasculatura de un paciente, confirmación basada en ECG de la colocación de la punta distante del catéter con respecto a un nodo del corazón del paciente, asi como también confirmación subsecuente de la posición de la punta distante del catéter como se observará a continuación. En una modalidad, la pantalla 30 es un dispositivo LCD.
Como se menciona en lo anterior, la sonda de ultrasonido 40 se emplea en relación con la visualización basada en ultrasonido ("US") de un vaso subcutáneo, tal como una vena, en la preparación para la inserción del catéter 72 en la vasculatura. Tal visualización da una guia de ultrasonido en tiempo real para introducir el catéter en la vasculatura del paciente (a través del sitio de inserción 73) y ayuda en la reducción de complicaciones asociadas típicamente con tal introducción, incluyendo función arterial inadvertida, hematoma, neumotorax, etc.
La sonda portátil 40 incluye un alojamiento de cabeza de un arreglo piezoeléctrico para producir pulsos ultrasónicos y para recibir ecos del mismo después de la reflexión por el cuerpo del paciente cuando la cabeza se coloca contra la piel del paciente próxima al sitio de inserción prospectivo 73. La sonda 40 puede incluir además una pluralidad de botones de control para controlar el sistema 10, eliminando de esta manera la necesidad de que el médico alcance el campo esférico, que se establece alrededor del sitio de inserción del paciente antes de la colocación el catéter, para controlar la funcionalidad del sistema.
Como tal, en una modalidad un médico emplea la modalidad de ultrasonido del sistema 10 para determinar un sitio de inserción adecuado y establecer el acceso vascular, tal como con una aguja o introductor, luego con el catéter. El médico luego puede cambiar fácilmente, a través de pulsaciones de botón en los botones incluidos en la sonda 40, a una modalidad de guia de punta de catéter basada en ECG (descrita a continuación) , sin tener que alcanzar el campo estéril. En esta forma, el sistema 10 ayuda al médico en la guia de la punta distante- del catéter 72 a través de la vasculatura hacia una destinación propuesta.
La FIG. 1 muestra que la sonda 40 incluye además un controlador de botón y memoria 42 para controlar la operación del botó y sonda. El controlador de botón y memoria 42 puede incluir memoria no volátil, tal como EEPROM, en una modalidad. El controlador de botón y memoria 42 está en comunicación operable con una interfaz de sonda 44 de la consola 20, que incluye un piezocomponente de entrada/salida 44A para interactuar con el arreglo piezoeléctrico de sonda y un componente de entrada/salida de botón y memoria 44B para interconectarse con el controlador de botón y memoria 42.
Como se menciona, el sistema 10 incluye la funcionalidad en donde la determinación de la proximidad de la punta distante del catéter 76A relativa con uno nodo emisor de impulsos sino-atrial ("SA") u otro eléctrico del corazón del paciente 70 se puede determinar, proporcionando de esta manera capacidad mejorada para colocar con precisión la punta distante del catéter en una ubicación deseada próxima al nodo. También referido en la presente como "ECG" o "confirmación de punta basada en ECG", esta modalidad del sistema 10 permite la detección de señales ECG del nodo SA a fin de colocar la punta distante de catéter en una ubicación deseada dentro de la vasculatura del paciente. Observar que las modalidades US y ECG se combinan fácilmente en la presente invención 10, y se pueden emplear en conjunto o individualmente para ayudar en la colocación del catéter. Además, otras modalidades, tal como ubicación de la punta de catéter basada en elemento magnético, también se pueden incluir en el sistema 10. En una modalidad, se entiende que la modalidad ECG como se describe en la presente se puede incluir en un sistema dependiente sin la inclusión del US u otras modalidades. De esta manera, los entornos en los cuales las modalidades se describen en la presente se entienden como entornos simplemente ejemplares y no se consideran limitantes de la presente descripción. Observar también que otros sistemas de guia/supervisión basados en ECG se pueden emplear en conexión con las modalidades de reconfirmación de la punta distante descritas a continuación adicionalmente .
Las FIGS. 1 y 2 muestran un estilete 130 predispuesto removiblemente dentro del lumen del catéter 72 que se inserta en el paciente 70 a través del sitio de inserción 73. El estilete 130 incluye un componente detector, es decir, un electrodo próximo a su extremo distante para detectar señales ECG producidas por el nodo SA. El estilete 130 incluye una correa 134 que se extiende desde su extremo próximo que se conecta operablemente al sensor 50· En resumen, la correa del estilete 134 proporciona una ruta conductiva que permite que las señales ECG detectadas por el electrodo ECG incluido en una porción distante del estilete 130 se transporten al sensor 50 durante el avance del catéter .
Los electrodos cutáneos ECG de referencia y de tierra 138 se unen a la superficie de la piel del paciente 70 y se unen operablemente al sensor 50 para permitir que el sistema filtre actividad eléctrica de alto nivel no relacionada con la actividad eléctrica del nodo SA del corazón, permitiendo de esta manera la funcionalidad de confirmación de la punta basada en ECG. Junto con las señales de referencia y de tierra recibidas de los electrodos cutáneos ECG 138 colocados sobre la piel del paciente, las señales ECG detectadas por el electrodo de estilete se reciben por el sensor 50 colocados sobre el pecho del paciente u otro componente designado del sistema 10. El sensor 50 y/o procesador de consola 22 pueden procesar los datos de la señal ECG para producir una forma de onda de electrocardiograma en la pantalla 30. En el caso donde el sensor 50 procesa los datos de la señal ECG, un procesador se incluye en el mismo para llevar a cabo la funcionalidad propuesta. Si la consola 20 procesa los datos de la señal ECG, el procesador 22, controlador 24, u otro procesador se pueden usar en la consola para procesar los datos.
De esta manera, conforme el catéter 72 se hace avanzar a través de la vasculatura del paciente, la pantalla 30 representa una forma de onda de electrocardiograma ECG producida como un resultado de actividad eléctrica del corazón del paciente como se detecta por el electrodo del estilete 130. Con mayor detalle, la actividad eléctrica ECG del nodo SA, incluyendo una porción de onda P de la forma de onda, se detecta por el electrodo del estilete 30 y se envía al sensor 50 y a la consola 20. La actividad eléctrica ECG luego se procesa para la representación en la pantalla 30. Un médico que coloca el catéter luego puede observar los datos ECG, incluyendo la representación de la onda P, para determinar la colocación óptima de la punta distante 76A del catéter 72, tal como el nodo SA nodo en una modalidad.
Observar que la forma de onda ECG y su cambio de onda P conforme el electrodo del estilete 130 se mueve relativo con el nodo SA del corazón del paciente. Por ejemplo, la onda P de la forma de onda ECG se incrementará generalmente en amplitud conforme el electrodo se aproxime al nodo SA y disminuirá generalmente conforme el electrodo retrocede del nodo SA. Como se menciona, en una modalidad la consola 20 incluye los componentes electrónicos, tal como el procesador 22, necesario para recibir y procesar las señales ECG detectadas por el electrodo de estilete. En otra modalidad, el sensor 50 puede incluir los componentes electrónicos necesarios para procesar las señales ECG. Detalles adicionales con respecto al sistema de colocación del catéter descritos en la presente y su uso se pueden encontrar en la publicación de solicitud de patente norteamericana No. 2010/0036227, presentada el 10, 2009, y titulada "Apparatus and Display Methods Relating to Intravascular Placement of a Catheter", que se incorpora en la presente a manera de referencia en su totalidad. Por su puesto, se aprecia que el sistema de colocación del catéter basado en ECG descrito en lo anterior es un ejemplo de un monitor ECG que se puede usar para practicar las modalidades divulgadas en la presente; de hecho, también se pueden emplear otros sistemas de supervisión y colocación basados en ECG.
Observar que el electrodo del estilete 130 en la presente modalidad incluye una porción distante del alambre de estilete conductor tal que las señales ECG se detectan y se transmiten a través del alambre del estilete a la correa 134 y el sensor 50. Se observa, sin embargo, que un electrodo usado para detectar señales ECG intravasculares se puede configurar en muchas formas diferentes. Como tal, "electrodo" como se usa en la presente se puede referir generalmente a cualquier estructura que se pueda usar para detectar señales ECG del corazón del paciente. Como se observará, un electrodo en otras modalidades puede incluir una porción de una columna de solución conductora colocada en un lumen del catéter, entre otras configuraciones de electrodo posibles.
Como se describe adicionalmente en lo anterior, la supervisión de los cambios en la señal ECG detectada emitida por el nodo SA del electrodo (s) de estilete que se hace avanzar dentro de la vasculatura permite que el médico coloque el catéter para determinar cuando la punta distante del catéter 72 se coloca como se desee dentro de la vasculatura. Nuevamente, un ejemplo de una posición de punta distante de catéter deseable incluye la colocación de la misma en el 1/3° inferior de la Vena Cava Superior ("SVC") . Después de que se completa la colocación el catéter 72, el estilete 130 se remueve del lumen del catéter 72 y el catéter se prepara para uso inicial. La forma de onda ECG detectada cuando la punta distante 76A del catéter 72 se coloca inicialmente en su posición deseada dentro de la vasculatura del paciente también es referido en la presente como el primer perfil de señal ECG.
Es frecuentemente deseable reconfirmar la posición de la punta distante de catéter 76A en un tiempo posterior después de la colocación inicial del catéter para asegurar gue no se haya presentado inadvertidamente mal posición o desplazamiento de la punta distante. A su vez, esto asegura que los medicamentos u otras soluciones administradas al paciente a través del catéter se suministren a la región deseada de la vasculatura. El sistema 10 u otro sistema de supervisión ECG adecuados se puede emplear en la reconfirmación de la colocación de la posición de la punta distante del catéter apropiada.
En una modalidad, tal reconfirmación de la colocación de la punta distante del catéter se puede lograr al medir la forma de onda ECG - también referida en la presente como un segundo perfil de señal ECG - detectada en o cerca de la punta distante del catéter colocado en su lugar a través de un electrodo adecuadamente colocado, luego comparar el segundo perfil ECG con el primer perfil ECG tomado cuando el catéter 72 se colocó inicialmente usado el sistema 10.
A fin de medir las señales ECG en la punta distante del catéter interno y adquirir de esta manera el segundo perfil ECG, una ruta conductiva adecuada debe estar presente en el catéter 72 para permitir que las señales ECG con respecto a la punta distante del catéter se detecten y se transmitan al sistema 10 u otro monitor ECG adecuado. En una modalidad, un alambre conductivo temporalmente dispuesto en el catéter se usa como el medio conductivo, con su extremo distante que sirve como un electrodo para la detección de señal ECG. El alambre conductivo se puede insertar a través de uno de los conectores de Luer 74C y su extremo de extensión respectivo 74B, luego a través distalmente de un lumen del catéter 72. Sabiendo la longitud del catéter colocado en su lugar 72, el alambre se hace avanzar hasta su extremo distante que está próximo a o co-terminal con la punta distante 76A del catéter.
Un extremo próximo del alambre conductivo que se extiende más allá del extremo próximo del catéter 72 y fuera del extremo de extensión 74B a través del cual los alambres se extienden se conecta operablemente al sistema 10 en una manera similar a aquella del estilete 130 y la correa 134 de la FIG. 2. Esta configuración permite que las señales ECG emitidas por el nodo SA, es decir, el segundo perfil ECG, se detecte en o cerca del extremo distante del alambre conductivo y se transmita a través del alambre conductivo al sistema 10, informando al médico que el perfile ECG de la punta distante 76A del catéter 72 está en su posición correcta .
Como se menciona, el alambre conductivo configurado como se plantee inmediatamente en lo anterior es similar al estilete 130 mostrado en la FIG. 2. De hecho, en una modalidad del estilete 130 usado para la colocación inicial del catéter se puede usar expulsado nuevamente subsecuente a la colocación inicial para reconfirmar la ubicación de la punta distante del catéter al insertarla en el lumen del catéter 72 y conectarla operablemente al sistema 10 a través de la correa 134 como se muestra en la FIG. 2 para que se adquiera el segundo perfil ECG de la punta distante délo catéter en su ubicación actual. Además, otro estilete adecuado u otro alambre guia se puede emplear para proporcionar la ruta conductiva descrita en lo anterior de la punta distante del catéter al sistema.
La FIG. 3 muestra detalles de otra configuración para proporcionar una ruta conductiva entre un electrodo en o cerca del extremo distante del catéter interno 76A y el sistema 10 para la reconfirmación de la posición de la punta. En particular, la ruta conductiva incluye una solución conductiva 200 colocada en el extremo de extensión respectivo 74B y el lumen del catéter 72 para extenderse a la punta distante 76A del mismo. La solución conductiva 200 incluye solución salina, u otra solución biocompatible y eléctricamente conductiva. De esta manera configurada, la solución conductiva 200 sirve como un electrodo y una porción e una ruta conductiva para detectar señales ECG en la punta distante 76A del catéter 72. Una tapa 202 se conecta al conector de Luer 74C del extremo de extensión rellenado con fluido respectivo 74B.
Además de la solución conductiva 200, la ruta conductiva de la modalidad de la FIG. 3 incluye además un alambre conductivo 208 que pasa a través de la tapa 202 y se extiende distantemente a través del extremo de extensión respectivo 74B tal que un extremo distante 208B del mismo se sumerge en la solución conductiva. Una porción próxima del alambre conductivo 208 que termina en un extremo próximo 208A se extiende desde la tapa 202. Un sujetador de caimán 210 u otro conector eléctrico adecuado se une a la porción próxima del alambre conductivo 208. El sujetador 210 se conecta operablemente a una correa 234, que se conecta al sensor 50 del sistema 10, similar a la manera de conexión de la correa 134 en la FIG. 2, conectando de esta manera operablemente la columna de la solución conductiva 200 colocado en el catéter 72 al sistema y permite que las señales ECG detectadas por la solución conductiva sean transmitidas al sistema. En esta forma, el segundo perfil de señal ECG que representa la posición de la punta distante 76A del catéter 72 dentro de la vasculatura se puede adquirir. Además para aquellas descritas en relación con las FIGS . 2 y 3, observar que las otras configuraciones de ruta conductivas se pueden emplear en otras modalidades. De esta manera, estas soluciones de ruta conductivas se deben considerar como no limitantes.
A fin de comparar el primer perfil de señal ECG adquirido en el tiempo de la colocación de la punta distante del catéter inicial con un segundo perfiles ECG subsecuente medido en el tiempo de la reconfirmación de la posición de la punta distante, es necesario un componente de almacenamiento para el almacenamiento del primer perfil de señal ECG en el tiempo de la colocación inicial. En una modalidad, esto se logra al ajusfar el sistema 10 u otro sistema monitor de ECG adecuado con un lector/codificador de tarjetas 250, un ejemplo del cual se muestra en la FIG. 4 como es unido a la consola 20. De esta manera, cuando el catéter 72 se coloca inicialmente usando el sistema 10, se puede codificar una tarjeta de datos del paciente 254 por el sistema 10 al deslizar la tarjeta a través del lector/codificador 250, que codifica y almacena sobre una tira magnética 256 de la tarjeta de varios datos con respecto a la colocación del catéter inicial, incluyendo el primer perfil de señal ECG en el tiempo de la colocación inicial. La tarjeta 254 luego se da al paciente o de otra manera se guarda con seguridad.
Después, cuando la reconfirmación de la posición de la punta distante 76A del catéter previamente colocado 72 (FIG. 1) se desea, el catéter se conecta operablemente al sistema 10 en una de las configuraciones descritas en lio anterior en relación con las FIGS. 2, 3, o por otra manera adecuada para proporcionar una ruta conductiva de la punta distante 76A del catéter al sistema. La tarjeta 254, codificada en el tiempo de la colocación inicial del catéter luego se desliza a través del lector/codificador 250 del sistema 10 para ser leída en consecuencia. Esto proporciona al sistema 10 el primer perfil de señal ECG de la posición de la punta distante del catéter distal en el tiempo de la colocación inicial. El primer perfil de señal ECG incluye por ejemplo una forma de onda ECG como es detectada por el electrodo en o cerca del extremo distante 76A del catéter 72 en el tiempo de la colocación inicial, se puede representar en la pantalla 30 de la consola del sistema 20 (FIG. 1) , o de otra manea transportado al médico.
Una nueva medición de señal ECG, usando un electrodo colocado en o cercan de la punta distante 76A del catéter 72 y la ruta conductiva adecuada que interconecta el electrodo con el sistema 10, luego se toma para producir un segundo perfil de señal ECG con relación a la posición de la punta distante del catéter actual dentro de la vasculatura. El segundo perfil de señal ECVG puede, similar al primer perfil de señal ECG también se ha representado en la pantalla 30 de la consola del sistema 20. Los dos perfiles de señal ECG se pueden superponer como formas de onda uno encima del otro y comparados en una manera adecuada (por ejemplo, medición de los valores de voltaje absoluto de onda P) para determinar si la punta distante 76A del catéter 72 se ha desplazado indeseablemente. Si es asi, se pueden someter a procedimientos apropiados por el médico para reposicionar adecuadamente la punta distante del catéter 76A. Si no se ha desplazado, el catéter 72 se puede usar como se propone. Observar que el orden especifico del proceso descrito en lo anterior puede variar en otras modalidades. Por ejemplo, la adquisición del segundo perfil de señales ECG se puede llevar a cabo antes de ingresar el primer perfil de señal ECG en el sistema, en una modalidad.
La FIG. 5 muestra otro componente de almacenamiento posible para permitir almacenamiento y exceso a la colocación inicial del primer perfil de señal ECG y otros datos, en donde un chip RFID 270 se incrusta en una porción del catéter 72 mismo, tal como la bifurcación 74A (ver también la FIG. 2). Un codificador/lector RFID 274 que incluye una antena 280 y se asocia con los circuitos 282, como se muestra en la FIG. 6, se puede incluir con el sistema 10 u otro supervisor ECG adecuado para permitir que el primer perfil de señal ECG con relación la posición de la punta distante de catéter 76A en el tiempo de la colocación inicial se codifique y se almacene en el chip RFID del catéter 270. En una modalidad, el chip RFID 270 es un chip programable en el campo, incluyendo tanto memoria de solo lectura para identificación única del chip mismo asi como también una mejoría no volátil que es programable por el codificador/lector RFID 274 para almacenar el primer perfil de señal ECG ene 1 momento de la colocación inicial .
Además del primer perfil de señal ECG, se pueden almacenar otros datos en el chip RFID 270 (o la tarjeta 254 de la FIG. 4 u otro componente de almacenamiento adecuado) incluyendo el nombre del paciente, fecha y ubicación de la colocación inicial, longitud final del catéter después del recorte, registro de inyecciones de potencia previas, creatinina u otros conteos sanguíneos, etc. En una modalidad, se almacena la longitud de la porción del PICC que permanece externo al sitio de inserción después de que se completa la colocación. En otra modalidad, la información del portal de la red se puede almacenar para dirigir a un usuario a un sitio de la red donde se proporciona información útil u otra asistencia. Observar que el chip RFID 270 puede ser ya sea activo o pasivo. Observar además que otros componentes de almacenamiento son posibles para almacenar el primer y/o segundo perfiles de seña ECG, incluyendo una ubicación de memoria dentro del sistema 10 mismo y almacenamiento fuera del sitio remoto en el supervisor de señal ECG puede acceder a los perfiles inalámbricamente, tal como a través de WiFi u otro protocolo inalámbrico adecuado.
La FIG. 7 muestra un ejemplo posible de una captura de pantalla 300 para la representación en el monitor 30 del sistema 10 durante la reconfirmación de la posición de la punta distante del catéter, de acuerdo con una modalidad. Como se muestra, la captura de pantalla 300 muestra formas de onda ECG 310, incluyendo una forma de onda 310A que corresponde al primer perfil de señal ECG en el momento de colocación inicial del catéter y una forma de onda 310B que corresponde al segundo perfil de señal ECG en el momento de la reconfirmación de la colocación de la punta distante, descrito en lo anterior. Las dos formas de onda 310A y 310B se pueden calibrar por el sistema 10 y superponer encima del otro en una modalidad para permitir que se haga una comparación entre las mismas. En una modalidad, por ejemplo, una onda P 312A de la forma de onda inicial 310A se puede comparar con una onda P 312B de la forma de onda actual 310B para determinar si el desplazamiento de la punta distante de catéter 76A con respecto al nodo SA se ha presentado.
El lado derecho de la captura de pantalla 300 también muestra datos adicionales 314 con respecto al paciente, tipo de catéter, longitud del catéter etc. Por su puesto, la señal ECG y otros datos representados en este punto pueden tomar uno o más de muchas formas y formatos. De hecho, el contenido de datos puede variar de acuerdo con el deseo o necesidad, como es apreciado por una persona experta en el campo. En una modalidad, por ejemplo, tanto la magnitud de onda P pico durante la colocación inicial del catéter, así como también la magnitud de onda P después de que el catéter se extrae para el posicionamiento de la punta distante final durante la colocación inicial, se almacenan para comparación exterior con magnitudes similares tomadas en el momento de la reconfirmación de la punta.
De esta manera, de acuerdo con una modalidad se divulga un método para reconfirmar una posición de un catéter u otro dispositivo médico interno dentro de un cuerpo de un paciente. El método incluye colocar el dispositivo médico dentro del cuerpo del paciente usando señales ECG del paciente, luego almacenar un primer perfil de señal ECG que se relaciona con una posición inicial del dispositivo médico interno después de que completa la colocación inicial del después de que se completa la colocación inicial del dispositivo médico. Como se menciona, el primer perfil de señal ECG se puede almacenar en una tarjeta del paciente, un chip REID, en la memoria del sistema, escribir o imprimir los datos de señal ECG, u otro componente de almacenamiento adecuado. El método incluye además adquirir un segundo perfil de señal ECG que se relaciona con una posición de dispositivo médico interno en un tiempo después de la colocación inicial del dispositivo médico, y al comparar el primer perfil de señal ECG con el segundo perfil de señal ECG para determinar si el desplazamiento del dispositivo médico interno se ha presentado después de la colocación inicial del dispositivo médico. Observar que la comparación de los perfiles se puede llevar a cabo directamente por un médico que observa las formas de onda representadas en la pantalla de consola 30 o automáticamente por algoritmos adecuados ejecutables por el procesador 22 de la consola 20.
Las modalidades de la invención se pueden incorporar en otras formas especificas sin apartarse del espíritu de la presente descripción. Las modalidades descritas se van a considerar en todos los aspectos solamente como ilustrativas, no restrictivas. El alcance de las modalidades es, por lo tanto, indicado por las reivindicaciones adjuntas antes que por la descripción anterior. Todos los cambios que entran dentro del significado e intervalo de equivalencia de las reivindicaciones se van a abarcar dentro de su alcance.
Claims (29)
1. Un método para reconfirmar una posición de un dispositivo médico interno dentro del cuerpo de un paciente, el método caracterizado porque comprende: colocar el dispositivo médico dentro del cuerpo del paciente usando señales ECG del paciente; almacenar un primer perfil de señal ECG que se relaciona con una posición inicial del dispositivo médico interno después de que completa la colocación inicial del dispositivo médico; adquirir un segundo perfil de señal ECG que se relaciona con una posición del dispositivo médico interno en un tiempo subsecuente a la colocación inicial del dispositivo médico; y i comparar el primer perfil de señal ECG con el segundo perfil de señal ECG para determinar si el desplazamiento del dispositivo médico interno se ha presentado después de la colocación inicial del dispositivo médico.
2. El método para reconfirmación de conformidad con la reivindicación 1, caracterizado porque el dispositivo médico incluye un catéter y en donde el desplazamiento del dispositivo médico se determina relativo en la punta distante del catéter.
3. El método para reconfirmación de conformidad con la reivindicación 1, caracterizado porque el almacenamiento del primer perfil de señal ECG incluye almacenar el primer perfil de señal ECG en un componente asociado con el dispositivo médico o el paciente.
4. El método para reconfirmación de conformidad con la reivindicación 3, caracterizado porque el almacenamiento del primer perfil de señal ECG incluye almacenar el primer perfil de señal ECG en una tarjeta leíble por un lector de tarjetas.
5. El método para reconfirmación de conformidad con la reivindicación 3, caracterizado porque el almacenamiento del primer perfil señal ECG incluye almacenar el primer perfil de señal ECG en el dispositivo médico mismo.
6. El método para reconfirmación de conformidad con la reivindicación 5, caracterizado porque el dispositivo médico incluye un catéter y en donde el almacenamiento del primer perfil ECG incluye almacenar el primer perfil de señal ECG en un chip RFID incluido con el catéter.
7. El método para reconfirmación de conformidad con la reivindicación 1, caracterizado porque el almacenamiento del primer perfil de señal ECG incluye almacenar el primer perfil de señal ECG remotamente del dispositivo médico.
8. El método para reconfirmación de conformidad con la reivindicación 1, caracterizado porque el almacenamiento del primer perfil de señal ECG además incluye enviar las señales ECG desde un electrodo asociado con el dispositivo médico hasta un monitor de ECG a través de una ruta conductiva establecida entre el electrodo y el monitor de ECG.
9. El método para reconfirmación de conformidad con la reivindicación 8, caracterizado porque la comparación del primer perfil de señal ECG con el segundo perfil de señal ECG incluye representar el primer y segundo perfiles de señal ECG como formas de onda en una pantalla del monitor de ECG.
10. El método para reconfirmación de conformidad con la reivindicación 9, caracterizado porque la comparación del primero y segundo perfiles de señales ECG incluye comparar los componentes de onda P del primero y segundo perfiles de señal ECG.
11. El método para reconfirmación de conformidad con la reivindicación 10, caracterizado porque el almacenamiento del primer perfil de señal ECG incluye almacenar el primer perfil de señal ECG en una memoria del monitor de señal ECG.
12. Un sistema para reconfirmar la posición de un catéter dentro de un paciente, el catéter que está colocado en proximidad a un nodo productor de señal ECG del corazón del paciente, el sistema caracterizado porque comprende: por lo menos un electrodo para adquirir un primer perfil de señal ECG, el primer perfil de señal ECG que se relaciona con una posición inicial de una punta distante de catéter dentro del paciente, el por lo menos un electrodo también para adquirir un segundo perfil de señal ECG que se relaciona con una posición subsecuente de la punta distante del catéter dentro del paciente: un componente de almacenamiento para almacenar por lo menos el primer perfil de señal ECG; y un monitor de señales ECG que recibe el primer perfil de señal ECG del componente de almacenamiento y también recibe el segundo perfil de señal ECG, el monitor de señales ECG que transporta datos que se relacionan con el primero y segundo perfiles de señal ECG para permitir la determinación de si la posición subsecuente de la punta distante de catéter difiere de la posición inicial.
13. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el por lo menos un electrodo para adquirir el primer perfil de señal ECG se incluye con el catéter dentro del cuerpo del paciente, y en donde el por lo menos un electrodo se conecta operablemente al monitor de señal ECG por una ruta conductiva.
14. El sistema para reconfirmar de conformidad con la reivindicación 13, caracterizado porque el por lo menos un electrodo incluye un estilete colocado dentro de un lumen del catéter, y en donde la ruta conductiva incluye una correa conectada operablemente al por lo menos un electrodo.
15. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el por lo menos un electrodo y la ruta conductiva incluye una solución conductiva colocada dentro de un lumen del catéter.
16. El sistema para reconfirmar de conformidad con la reivindicación 15, caracterizado porque un alambre conductivo se coloca parcialmente en la solución conductiva, el alambre conductivo que se extiende desde el catéter y que se conecta operablemente al monitor de señal ECG.
17. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el componente de almacenamiento incluye un chip RFID incluido en el catéter, y en donde el monitor de señal ECG un codificador/lector RFID para codificar y leer el primer perfil de señal ECG del chip RFID.
18. El sistema para reconfirmar de conformidad con la reivindicación 17, caracterizado porque el chip RFID es un chip programable en el campo.
19. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el componente de almacenamiento se coloca remotamente con respecto al catéter.
20. El sistema para reconfirmar de conformidad con la reivindicación 19, caracterizado porque el componente de almacenamiento incluye una tarjeta que incluye una tira magnética programable, y en donde el monitor de señal ECG incluye un codificador/lector de tarjetas.
21. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el monitor de señal ECG recibe inalámbricamente el primer perfil de señal ECG de una ubicación remota.
22. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque al menos uno del primero y segundo perfiles de señal ECG incluye datos que se relacionan con por lo menos uno de una longitud de la porción del catéter que permanece externa al cuerpo del paciente después de la colocación y un portal de la red donde se puede adquirir información adicional
23. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque el monitor de señal ECG incluye por lo menos un electrodo colocado interno al paciente y por lo menos dos electrodos para la colocación sobre la piel del paciente.
24. El sistema para reconfirmar de conformidad con la reivindicación 12, caracterizado porque un primer electrodo se emplea en adquirir el primer perfil de señal ECG y un segundo electrodo se emplea en adquirir el segundo perfil de señal ECG.
25. Un método para reconfirmar una posición de una punta distante de un catéter dentro de una vasculatura de un paciente, el método caracterizado porque comprende: colocar un catéter dentro de la vasculatura del paciente usando señales ECG del paciente; almacenar un primer perfil de señal ECG que se relaciona con una posición inicial de la punta distante de catéter después de que se completa la colocación inicial del catéter; adquirir un segundo perfil de señal ECG que se relaciona con una posición de la punta distante del catéter en un tiempo después de la colocación inicial del catéter; y comparar el primer perfil de señal ECG con el segundo perfil de señal ECG para determinar si el desplazamiento del catéter dentro de la vasculatura se ha presentado después de la colocación inicial del catéter.
26. El método para reconfirmación de conformidad con la reivindicación 25, caracterizado porque la comparación del primero y segundo perfiles de señal ECG incluye observar visualmente la primera y segunda formas de onda ECG detectadas mediante por lo menos un electrodo colocado dentro del paciente.
27. El método para reconfirmación de conformidad con la reivindicación 26, caracterizado porque la comparación del primero y segundo perfiles de señal ECG incluye comparar los componentes de onda P de la primera y segunda formas de onda ECG, la primera y segunda formas de onda ECG representadas en una forma superpuesta sobre una pantalla de un monitor de señales ECG.
28. El método para reconfirmación de conformidad con la reivindicación 25, caracterizado porque la comparación del primero y segundo perfiles de señal ECG lleva a cabo automáticamente por un monitor de señal ECG que recibe el primer y segundo perfiles de señal ECG.
29. El método para reconfirmación de conformidad con la reivindicación 25, caracterizado porque el almacenamiento del primer perfil de señal ECG incluye: adquirir el primer perfil de señal ECG a través de por lo menos un electrodo intravascular ; y almacenar el primer perfil de señal ECG en un componente de almacenamiento, el componente de almacenamiento es codificable por un codificador incluido con un monitor ECG.
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MX2013001317A MX338127B (es) | 2010-08-20 | 2011-08-19 | Reconfirmacion de colocacion de una punta de cateter asistida por ecg. |
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2011
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WO2012024577A2 (en) | 2012-02-23 |
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JP5845260B2 (ja) | 2016-01-20 |
WO2012024577A3 (en) | 2013-09-06 |
EP2605699A2 (en) | 2013-06-26 |
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US20120046562A1 (en) | 2012-02-23 |
KR101856267B1 (ko) | 2018-05-09 |
US20150080716A1 (en) | 2015-03-19 |
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