ES2611284T3 - Aparato para tratamiento cutáneo y remodelación de tejido - Google Patents
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Abstract
Aparato para proporcionar energía a un tejido y para crear un patrón de zonas localizadas de daños térmicos en la dermis, comprendiendo el aparato una serie de agujas (350, 410, 415) fijadas a una base (310) donde las agujas están configuradas para penetrar en el tejido, una fuente de energía (320) conectada a la serie de agujas y un módulo de control (330) donde la separación media de las agujas está entre aproximadamente 1 mm y aproximadamente 2 cm, donde las agujas tienen una longitud de entre aproximadamente 1500 μm y aproximadamente 2000 μm, donde el módulo de control está configurado para controlar la fuente de energía generando patrones de zonas localizadas de daño térmico en la dermis ajustando la intensidad y la duración de la potencia trasmitida a las agujas individuales o a pares de agujas, donde la fuente de energía está configurada para proporcionar energía de entre 1 mJ aproximadamente y aproximadamente 100 mJ por aguja o par de agujas y donde la fuente de energía está configurada para calentar las puntas de dichas agujas individuales o pares de agujas produciendo el patrón de daño térmico alrededor de dichas puntas.
Description
DESCRIPCION
Aparato para tratamiento cutaneo y remodelacion de tejido 5 CAMPO DE LA INVENCION
La presente invencion se refiere a un aparato mejorado para el tratamiento de la piel. Mas espedficamente se refiere a un aparato configurado para producir herimiento fraccionado utilizando conjuntos de agujas para danar las zonas seleccionadas de la piel favoreciendo asf resultados beneficiosos como el estiramiento de la piel y la remodelacion 10 de los tejidos.
ANTECEDENTES DE LA INVENCION
La piel esta formada fundamentalmente por dos capas: la capa externa o epidermis que tiene un espesor de 15 aproximadamente 100 pm y la capa interna o dermis que tiene un espesor de aproximadamente 3000 pm desde la superficie externa de la piel y que esta fundamentalmente compuesta por una red de protema fibrosa conocida por colageno.
Existe una demanda creciente de reparacion de defectos cutaneos que se pueden producir por el envejecimiento, la 20 exposicion solar, las enfermedades dermatologicas, efectos traumaticos y similares. La piel que envejece tiende a perder su elasticidad derivando en una mayor formacion de arrugas y flacidez. Otras causas de las arrugas no deseadas en la piel incluyen una perdida de peso excesiva y el embarazo. Hay varias estrategias quirurgicas bien conocidas para mejorar el aspecto de la piel que suponen incisiones en la misma seguidas de la eliminacion de parte del tejido y la union del tejido restante. Estas estrategias quirurgicas incluyen estiramiento facial, levantamiento de 25 cejas, realce de busto y reduccion de abdomen. Estas estrategias tienen muchos efectos secundarios negativos incluyendo la formacion de cicatrices, penodos de curacion largos, desplazamiento de la piel con respecto a su posicion original relativa a la estructura osea subyacente y un estiramiento de la piel no uniforme.
Se han desarrollado muchos tratamientos que utilizan radiacion electromagnetica para mejorar los defectos 30 cutaneos produciendo lesiones termicas en la piel que derivan en una compleja respuesta curativa de la herida de la piel. Esto produce una reparacion biologica de la piel danada que puede ir acompanada de otros efectos deseables. En anos recientes se han introducido varias tecnicas que consiguen este objetivo. Las distintas tecnicas se pueden categorizar en general en dos grupos de modalidades de tratamiento: reestructuracion superficial de la piel mediante laser ablativo (LSR), y remodelacion de colageno no ablativa (NCR). El primer grupo de modalidades de tratamiento, 35 LSR, supone causar un dano termico bastante amplio en la epidermis y/o la dermis, mientras que el segundo grupo, NCR, esta disenado para evitar el dano termico de la epidermis.
La tecnica LSR se considera un tratamiento con laser eficaz para la reparacion de la piel. En el procedimiento LSR tfpico, mostrado esquematicamente en la figura 1, una zona de la epidermis 100 y una zona de la dermis 110 40 correspondiente por debajo de la misma se danan termicamente para favorecer la curacion de la herida. La energfa electromagnetica 120 se dirige hacia una zona de la piel, produce ablacion de la piel eliminando tanto el tejido epidermico como el dermico de la zona 130. La tecnica LSR con laser pulsado de CO2 o Er:YAG, que se conoce en el estado de la tecnica como reestructuracion superficial por laser o reestructuracion superficial ablativa se considera un tratamiento eficaz contra los signos de la piel fotoenvejecida, piel, piel con envejecimiento cronico, cicatrices, 45 lesiones pigmentadas, estnas y lesiones cutaneas superficiales. Sin embargo, los pacientes pueden sufrir serios inconvenientes despues de un tratamiento LSR, incluyendo edemas, secreciones o escozor durante los primeros 14 dfas despues del tratamiento. Estos serios inconvenientes son pueden resultar inaceptables para muchos pacientes. Otro problema del procedimiento LSR es que es relativamente doloroso y, por lo tanto, en general exige la utilizacion de una cantidad significativa de analgesicos. Mientras que el tratamiento LSR de areas relativamente pequenas se 50 puede hacer con anestesia local inyectando un producto anestesico, la tecnica LSR para zonas relativamente grandes normalmente se realiza con anestesia general o tras un bloqueo nervioso mediante inyecciones multiples de producto anestesico.
Una limitacion de la tecnica LSR es que la reestructuracion superficial ablativa en las zonas no faciales 55 generalmente tiene un mayor riesgo de dejar cicatrices porque la recuperacion de la lesion cutanea en estas zonas no es muy eficaz. Ademas las tecnicas LSR son mas adecuadas para la correccion de los defectos de pigmentacion y lesiones pequenas que para reducir o eliminar arrugas.
En un intento de superar estos problemas asociados con los procedimientos LSR han aparecido varios tipos de
tecnicas NCR. Estas tecnicas se conocen en general en el estado de la tecnica como reestructuracion no ablativa, estructuracion subsuperficial no ablativa o remodelacion cutanea no ablativa. Las tecnicas NCR en general utilizan laseres no ablativos, lamparas de destellos o corrientes de radiofrecuencia para danar los tejidos dermicos pero sin danar los tejidos epidermicos. El concepto en el que se basan las tecnicas NCR es que el dano termico de los tejidos 5 termicos induce, segun se cree, la contraccion del colageno derivando en un estiramiento de la piel situada sobre el y la estimulacion de la curacion de la herida, lo que resulta en una reparacion biologica y la formacion de nuevo colageno dermico. Este tipo de curacion de heridas puede producir una disminucion de los danos estructurales relacionados con el fotoenvejecimiento. La evitacion del dano epidermico en las tecnicas NCR disminuye la gravedad y la duracion de los efectos secundarios relacionados con el tratamiento. En particular, las secreciones, la 10 formacion de costras, las alteraciones de pigmentacion y la incidencia de infecciones posteriores por la perdida prolongada de la funcion de barrera epidermica se pueden evitar normalmente utilizando las tecnicas NCR.
En el metodo NCR de tratamiento cutaneo, ilustrado esquematicamente en la figura 2, se calientan selectivamente zonas de tejido dermico 135 de la capa dermica 110 para inducir la curacion de la herida sin danar la epidermis 100 15 que esta por encima. El dano termico selectivo que deja sin danos la epidermis se puede conseguir enfriando la superficie de la piel y concentrando la energfa electromagnetica 120, que puede ser un haz laser, en la zona dermica 135 utilizando una lente 125. En los metodos de tratamiento NCR tambien se aplican otras estrategias basadas en el uso de laseres no ablativos para producir un dano en la dermis sin hacerlo en la epidermis. Los laseres no ablativos utilizados en los procedimientos NCR en general tienen una penetracion dermica mayor que los laseres ablativos 20 utilizados en los procedimientos LSR. Se pueden utilizar longitudes de onda del infrarrojo proximo, Estas longitudes de onda hacen que el laser no ablativo tenga una mayor penetracion que los laseres ablativos de absorcion muy superficial de Er:YAG y CO2. Algunos ejemplos de las tecnicas NCR y los aparatos que las aplican se divulgan en el documento de patente 2002/0161357.
25 Si bien se ha demostrado que estas tecnicas NCR pueden ayudar a evitar danos epidermicos uno de sus mayores inconvenientes es su eficacia limitada. La mejora de la piel fotoenvejecida o las cicatrices despues de un tratamiento con tecnicas NCR es significativamente menor que la conseguida con las tecnicas ablativas Ls. Incluso despues de multiples tratamientos la mejora clmica es a menudo bastante inferior a las expectativas del paciente. Ademas la mejora clmica generalmente se produce varios meses despues de aplicar los procedimientos de tratamiento. Las 30 tecnicas NCR son moderadamente eficaces para la eliminacion de arrugas y en general no son eficaces para la discroirna. Una ventaja de las tecnicas NCR es que no tienen los efectos secundarios no deseados que son caractensticos del tratamiento LSR como el riesgo de cicatrices o infecciones.
Otra limitacion de los procedimientos NCR se refiere al rango de los parametros de tratamiento aceptables para que 35 este sea seguro y eficaz contra las alteraciones cutaneas. Los procedimientos NCR en general se basan en la coordinacion optima de los parametros de energfa del laser y los parametros de enfriamiento lo que puede producir un perfil de temperatura no deseado en la piel derivando en que no se obtenga efecto terapeutico o en la formacion de cicatrices por sobrecalentamiento de un volumen relativamente grande de tejido.
40 Otra estrategia de estiramiento de la piel y eliminacion de arrugas supone la aplicacion de corriente electrica de radiofrecuencia al tejido dermico a traves de un electrodo enfriado colocado en la superficie de la piel. La aplicacion de una corriente de radiofrecuencia de esta forma no invasiva produce una zona calentada que se forma bajo el electrodo y que dana un volumen relativamente grande de la dermis; el dano epidermico se minimiza mediante un enfriamiento activo de la superficie del electrodo durante el tratamiento. Esta estrategia de tratamiento puede ser 45 dolorosa y derivar en hinchazon de poca duracion en la zona tratada. Y mas, debido al volumen relativamente grande de tejido tratado y la necesidad de encontrar el equilibrio entre la aplicacion de la corriente de radiofrecuencia y el enfriamiento de la superficie, esta estrategia de remodelacion de tejido no permite un control fino de los patrones de danos y el estiramiento de la piel subsiguiente. Este tipo de tecnica RF es monopolar basandose en la puesta a tierra remota del paciente para conducir en un bucle el flujo de corriente del unico electrodo. Esta corriente en 50 aplicaciones monopolares tiene que pasar a traves del cuerpo del paciente hasta la tierra remota lo que puede producir estimulacion electrica no deseada de otras partes del cuerpo. Por el contrario, los instrumentos bipolares conducen la corriente entre dos electrodos situados relativamente cerca a lo largo de un recorrido mas localizado.
El estiramiento de la piel y la eliminacion de arrugas aplicando radiofrecuencia mediante electrodos de aguja se 55 describe en los documentos de patente US 6277116 B1 y US2002/0128641 A1. Aplicando energfa las capas de la dermis se ven danadas por el calentamiento.
A la vista de las deficiencias de los metodos mencionados de tratamiento cutaneo y remodelacion de tejido existe la necesidad de proporcionar un procedimiento y un aparato que ofrezcan un tratamiento seguro y eficaz de
remodelacion de tejido, estiramiento de la piel y eliminacion de arrugas con efectos secundarios mmimos como incomodidad durante el procedimiento o despues del procedimiento, curacion larga o infecciones posteriores.
SUMARIO DE LA INVENCION 5
Por lo tanto, uno de los objetivos de la presente invencion definida en las reivindicaciones es proporcionar un aparato que ofrezca un tratamiento seguro y eficaz que mejore las alteraciones dermatologicas con mmimos efectos secundarios. Otro objetivo de la presente invencion es proporcionar un aparato que favorezca el estiramiento de la piel y la eliminacion de arrugas creando un patron de zonas localizadas pequenas de dano termico en la dermis. 10 Otro objetivo de la presente invencion es proporcionar un aparato para estiramiento de la piel u otras formas de remodelacion de tejidos utilizando un conjunto de agujas electrodo para aplicar de forma controlada energfa electrica o termica en lugares prefijados de la dermis u otro tejido.
Estos y otros objetivos se pueden conseguir con una realizacion de ejemplo del aparato de acuerdo con la presente 15 invencion, que somete a radiacion electromagnetica a zonas de un area objetivo del tejido, tal como pulsos de radiofrecuencia o energfa termica. La radiacion electromagnetica se dirige a zonas del area objetivo de la piel utilizando metodos de minima invasion produciendo herimiento fraccionado de las zonas del area objetivo. La radiacion electromagnetica la puede generar una fuente de radiacion electromagnetica configurada para suministrar calor, pulsos de radiofrecuencia, corriente electrica o similares a una serie de areas objetivo.
20
En otra realizacion de ejemplo de acuerdo con la presente invencion una fuente de radiacion electromagnetica esta configurada para generar radiacion electromagnetica y un dispositivo de aplicacion que comprende un conjunto de agujas, conectado con la fuerte de radiacion electromagnetica, esta configurado para penetrar en la piel hasta una profundidad deseada y aplicar la radiacion electromagnetica directamente en una serie de areas objetivo.
25
En otro aspecto alternativo de la invencion una o mas agujas del conjunto pueden ser huecas y utilizarse para aplicar pequenas cantidades de producto analgesico o anestesico en la zona de la piel que se este tratando. Estas agujas huecas pueden estar entremezcladas con agujas electrodo del conjunto y tambien pueden funcionar como electrodos.
30
En otra realizacion de la invencion las agujas electrodo tambien pueden estar conectadas a una segunda fuente de corriente electrica en el rango de los miliamperios. La deteccion de un nervio cercano a una cualquiera de las agujas insertadas del conjunto se consigue mediante aplicacion secuencial de pequenas corrientes a las agujas del conjunto y observacion de cualquier respuesta motriz visible. Si se detecta un nervio, la aguja o agujas proximas se 35 pueden desactivar durante la aplicacion subsiguiente de la corriente de radiofrecuencia a otras agujas electrodo del conjunto para evitar danar el nervio.
Se entendera mejor el principio de funcionamiento y las ventajas de la presente invencion haciendo referencia a las figuras en la siguiente exposicion.
40
BREVE DESCRIPCION DE LAS FIGURAS
La siguiente descripcion detallada, a modo de ejemplo, pero no limitativa de la invencion solo a las realizaciones espedficas descritas se puede entender mejor conjuntamente con las figuras adjuntas en las que:
45
- la figura 1 es una figura esquematica de una seccion transversal de un tejido tratado con el metodo ASR
- la figura 2 es una figura esquematica de una seccion transversal de un tejido tratado con el metodo NSR
- la figura 3 es una ilustracion esquematica de un aparato para realizar la remodelacion de tejidos utilizando energfa
electromagnetica de acuerdo con una realizacion de la presente invencion
50 - la figura 4 es una ilustracion esquematica de partes de un aparato para realizar la remodelacion de tejido de acuerdo con una realizacion de la presente invencion
En las figuras se utilizan los mismos numeros y sfmbolos de referencia, a menos que se indique otra cosa, para identificar las mismas caractensticas, elementos, componentes o partes de las realizaciones ilustradas. Ademas, si 55 bien la presente invencion se describira en detalle haciendo referencia a las figuras, se hace en relacion con las realizaciones ilustrativas y no esta limitada por las realizaciones particulares ilustradas en las figuras.
DESCRIPCION DETALLADA DE LA INVENCION
La presente invencion se refiere a un aparato para mejorar los defectos de la piel, incluyendo no limitativamente, arrugas, estnas y celulitis. En una realizacion el estiramiento de la piel o la remodelacion de tejido se consigue creando una distribucion de zonas de necrosis, fibrosis u otros danos en el tejido que se trata. Los danos en el tejido se consiguen aplicando corrientes localizadas que se convierten en calor en el entorno de las puntas de las agujas 5 del electrodo. La produccion de zonas de danos termicos locales en la dermis ocasiona una contraccion inmediata del colageno derivando en una respuesta beneficiosa de estiramiento de la piel. Ademas el dano termico tiende a estimular la formacion de nuevo colageno que rellena el tejido cutaneo local y que gradualmente deriva en un estiramiento de la piel adicional y la reduccion de las arrugas.
10 En una realizacion de ejemplo de la presente invencion el aparato de tratamiento de tejidos 300 mostrado en la figura 3 se puede utilizar para crear zonas de danos en el tejido que se trata. El aparato de remodelacion de tejido puede comprender una serie de agujas 350 fijadas a la base 3l0. La base esta fijada a la carcasa 340 o conformada como parte integral de dicha carcasa. Una fuente de corriente de radiofrecuencia 320 esta conectada a cada una de las agujas 350. Un modulo de control 330 permite variar las caractensticas de la corriente electrica de 15 radiofrecuencia que se puede suministrar individualmente a una o mas agujas. Opcionalmente, la fuente de energfa 320 y/o el modulo de control 330 puede estar situado fuera de la carcasa.
En otra realizacion de ejemplo la fuente de energfa 320 es un dispositivo de radiofrecuencia capaz de producir senales de frecuencias dentro de un intervalo deseado. En otra realizacion de ejemplo la fuente de energfa es capaz 20 de producir una corriente electrica alterna o continua. El modulo de control 330 proporciona una configuracion espedfica para la aplicacion a la fuente de energfa 320. La fuente de energfa 320 recibe esta configuracion y genera una corriente dirigida a y recibida desde las agujas especificadas durante un tiempo, intensidad o secuencia prefijados o seleccionables basandose en dicha configuracion.
25 En otra realizacion de la presente invencion puede incluirse un sustrato de separacion 315 que contiene un patron de agujeros pequenos a traves de los que sobresalen las agujas del conjunto, dicho sustrato situado entre la base 310 y la superficie de la piel 306. Este sustrato de separacion se pueden utilizar para conferir estabilidad mecanica a las agujas. Opcionalmente este sustrato puede estar fijado a la base 310 o a la carcasa 340 pero ser movil y resultar ajustable con respecto a la base 310 y ademas soportar el conjunto de agujas para controlar lo que sobresalen 30 dichas agujas por la superficie inferior 316 del sustrato de separacion 315 y, por tanto, controlando la profundidad a la que se insertan las agujas en la piel.
A la hora de ejecutar el metodo los extremos distantes agudos de las agujas 350 perforan la superficie 306 del tejido cutaneo 305 penetrando en el tejido hasta que la superficie inferior 316 del sustrato de separacion 315 (o la 35 superficie inferior 311 de la base 310 si no se utiliza un sustrato de separacion 315) toca la superficie 306 de la piel 305. Esta configuracion permite una insercion fiable del conjunto de agujas hasta una profundidad prefijada en el tejido que se trata. El modulo de control 330 se configura para aplicar cantidades controladas de corriente de radiofrecuencia a una o mas agujas 350.
40 La base 310 y/o el sustrato de separacion 315, si se utiliza, pueden ser planos o pueden tener una superficie inferior con un contorno que siga la forma de la zona del tejido que se esta tratando. Esto permite la penetracion del conjunto de agujas hasta una profundidad uniforme dentro del tejido objetivo incluso si la superficie de la piel no es plana, por ejemplo, a lo largo de las orbitas de los ojos.
45 En otra realizacion, la base 310 y/o un sustrato de separacion 315, si se utiliza, se puede/n enfriar con medios adecuados, por ejemplo, conductos internos que contengan un refrigerante circulante o un dispositivo Peltier para enfriar la superficie de la piel cuando el conjunto de agujas penetra en la misma, para reducir o eliminar el dolor. La zona superficial de la piel que se esta tratando y/o las agujas en sf tambien se pueden preenfriar con medios aparte, incluyendo medios convectivos, conductivos antes de que el conjunto de agujas penetre en la piel.
50
En una realizacion preferida de la presente invencion las espigas de las agujas conductoras 350 estan aisladas electricamente excepto la zona de las agujas cerca de sus puntas. En el aparato de la figura 3, la aplicacion de la corriente de radiofrecuencia a las agujas 350 causa calentamiento en la zona de la punta expuesta, produciendo zonas de danos termicos 370 alrededor de la punta de cada aguja. Las zonas de danos termicas 370 son el 55 resultado del funcionamiento del aparato en su configuracion monopolar en la que el electrodo de puesta a tierra remoto, no mostrado en la figura 3, esta fijado a una parte remota del cuerpo del paciente para cerrar el circuito electrico que proporciona electricidad a las agujas 350 gracias a la fuente de energfa 320. En esta configuracion monopolar la corriente de radiofrecuencia provoca el calentamiento de la zona de la punta de las agujas 350 causando danos termicos en las zonas de tejido 370 adyacentes a las puntas de las agujas que son
aproximadamente esfericas o algo alargadas.
En una realizacion de la invencion la corriente se puede proporcionar simultaneamente a todas las agujas del conjunto para producir un patron de danos termicos alrededor de la punta de cada aguja. En realizaciones 5 alternativas el modulo de control 330 y la fuente de energfa 320 pueden estar configurados para proporcionar una corriente electrica a agujas particulares, a grupos espedficos de agujas del conjunto o a cualquier combinacion de agujas particulares siguiendo la secuencia temporal que se desee. La corriente proporcionada a las distintas agujas en distintos instantes durante el tratamiento (en lugar de calentar todas las agujas del conjunto de una vez) puede ayudar a evitar las interacciones electricas o termicas locales potenciales entre las agujas que puedan causar danos 10 locales excesivos.
En otra realizacion de la presente invencion uno o mas medios vibratorios tales como un transductor piezoelectrico o un pequeno motor con un peso excentrico fijado al eje pueden estar acoplados mecanicamente a la carcasa 340 y/o a la base 310 que soporta el conjunto de agujas 350. Las vibraciones inducidas por conduccion en las agujas 350 15 por dichos medios vibratorios pueden facilitar que las puntas de las agujas perforen la piel y la insercion subsiguiente de dichas agujas en el tejido. Los medios vibratorios pueden tener una amplitud de vibracion en un intervalo de aproximadamente 50-500 pm o mas preferiblemente de aproximadamente 100-200 pm. La frecuencia de las vibraciones inducidas puede estar entre aproximadamente 10 Hz y aproximadamente 10 kHz, mas preferiblemente entre aproximadamente 500 Hz y aproximadamente 2 kHz y aun mas preferiblemente alrededor de 1 kHz. Los 20 parametros de vibracion particulares elegidos pueden depender del tamano y material de las agujas, el numero de agujas del conjunto y la separacion media de las agujas. Los medios vibratorios pueden comprender ademas un controlador opcional capaz de ajustar la amplitud y/o la frecuencia de las vibraciones.
Otros detalles y realizaciones adicionales de la presente invencion se muestran en la figura 4. Las agujas 25 conductoras 410 y 415 se muestran fijadas a la base 310. El aislamiento 420 cubre la espiga de las agujas 410 y 415 sobresaliendo de la base 310 excepto en la zona cerca de la punta inferior, aislando electricamente cada espiga de aguja conductora del tejido circundante 305.
Los conductores electricos 430 y 431, que pueden ser cables o similares, se extienden desde la zona superior de las 30 agujas 410 y 415 respectivamente y estan conectados con la fuente de energfa (no mostrada). Los materiales de aislamiento adecuados para el aislamiento 420 incluyen, no limitativamente, teflon®, polfmeros, vidrios y otros revestimientos no conductores. Un material en particular se puede elegir como aislador para facilitar la penetracion y la insercion de las agujas 410 y 415 en el tejido 305.
35 Las agujas 410 y 415 se muestran funcionando en modo bipolar en otra realizacion de la presente invencion. La aguja 410 es el electrodo positivo que proporciona la radiofrecuencia u otra corriente a la zona de la punta de la aguja desde la fuente de energfa a traves del conductor 430. La aguja 415 hace de electrodo de puesta a tierra conectado a la tierra de la fuente de energfa a traves del conductor 431. En esta configuracion la corriente aplicada pasara a traves del tejido entre las puntas de las agujas 410 y 415 generando una zona alargada de dano termico 40 425 alrededor y entre las puntas de las dos agujas.
Una zona alargada de tejido danado 425 se puede crear entre dos agujas adyacentes o proximas del conjunto con la configuracion adecuada del modulo de control 330 y de la fuente de energfa 320. En una realizacion de la presente invencion las zonas de danos alargadas 425 se forman entre varios pares de agujas del conjunto de agujas 45 consiguiendose el patron de danos deseado en el tejido 305. Las zonas de danos termicos 325 creadas con funcionamiento bipolar del aparato pueden formarse simultaneamente o, alternativamente, secuencialmente utilizando cualquier combinacion de agujas proximas del conjunto para definir cada zona. Una amplia variedad de patrones de danos termicos se pueden crear utilizando un conjunto unico de agujas mediante la configuracion adecuada de la fuente de energfa 320 y el modulo de control 330 para proporcionar cantidades prefijadas de 50 corriente entre pares de agujas seleccionadas. Este aparato por lo tanto permite la creacion de patrones de danos complejos en el tejido 305 que pueden ser alargados macroscopicamente segun direcciones preferidas para producir una contraccion y una remodelacion anisotropica.
A la hora poner en practica la presente invencion las agujas pueden tener una anchura de aproximadamente 50055 1000 pm o preferiblemente de aproximadamente 700-800 pm. Las agujas de un diametro inferior a 500 pm se pueden utilizar tambien si tienen suficiente resistencia mecanica. Las agujas de mayor diametro que 1000 pm aproximadamente pueden no ser adecuadas por la dificultad de hacer que penetren en la piel y por su mayor propension a causar dolor y cicatrices. La longitud de las agujas que penetra en la piel dependera de la profundidad objetivo de dano en el tejido. Una profundidad tfpica para el colageno objetivo de la dermis es de aproximadamente
1500- 2000 pm. Las agujas de un unico conjunto puede sobresalir longitudes distintas de la base 310 o del sustrato de separacion 315. Esto hara que las puntas de las agujas queden a diferentes profundidades en el tejido que se trate, permitiendo la creacion de tejido danado a mas de una profundidad. Esta variacion de la profundidad de las agujas puede conseguir que se formen tejidos danados en un volumen mayor en el tejido que se trata.
5
Los conjuntos de agujas pueden tener cualquier geometna adecuada para el tratamiento deseado que se realice. La separacion entre agujas adyacentes es mayor que 1 mm aproximadamente, y puede ser de hasta 2 cm aproximadamente. La separacion entre agujas de un conjunto no hace falta que sea uniforme y puede ser inferior en zonas en las que se desee un control mas preciso del dano en el area objetivo del tejido. En una realizacion el 10 conjunto de agujas puede comprender pares de agujas separados de pares adyacentes por distancias mayores. Esta geometna puede ser adecuada para producir danos en modo bipolar entre pares de agujas. Las agujas tambien pueden estar situadas formando triangulos o cuadrilateros regulares o casi regulares. En cualquier geometna de conjunto, el patron de danos y la remodelacion de tejido resultante se controla con alguna precision ajustando sentencias y la duracion de la potencia transmitida a cada aguja individual o a cada par de agujas.
15
La cantidad de energfa dirigida a una aguja dada vana dependiendo del tejido que se trate y la extension deseada del dano a producir. Para las separaciones de agujas tfpicas mencionadas, la fuente de energfa debe configurarse para proporcionar aproximadamente 1-100 mJ por aguja o par de agujas del conjunto. Puede ser preferible utilizar inicialmente cantidades inferiores de energfa realizando dos o mas tratamientos en la misma area objetivo para 20 controlar mejor los patrones de danos y la extension de la remodelacion.
En otra realizacion de la presente invencion una o mas agujas del conjunto pueden ser huecas, como la aguja 440 de la figura 4. El canal central 450 se puede usar para proporcionar un analgesico local tal como solucion de lidocama 2% desde una fuente (no mostrada) situada dentro del contorno o por encima de la base 310 25 introduciendolo en el tejido 305 para reducir o eliminar el dolor causado por el proceso de dano termico.
En otra realizacion de la presente invencion la aguja hueca 440 es bifuncional, capaz de conducir una corriente de radiofrecuencia u otra energfa a traves del conductor 432 y tambien capaz de proporcionar analgesico local o similar a traves del canal central 450. Analogamente a las agujas 410 y 415, la aguja bifuncional 440 tiene un aislamiento 30 445 que cubre la espiga extendiendose desde la base 310, excepto en la zona cercana a la punta inferior. El analgesico se puede suministrar al tejido bien antes o durante la aplicacion de radiofrecuencia u otra corriente a la aguja 450.
En una realizacion de la invencion una o mas agujas del conjunto pueden ser bifuncionales como la aguja 440. 35 Alternativamente una o mas agujas pueden ser huecas y opcionalmente no conductoras, adecuadas solo para proporcionar analgesico local o similar. Este conjunto de agujas utilizado para una aplicacion dada puede comprender cualquier combinacion de electrodos macizos, agujas bifuncionales o agujas no conductoras huecas. Por ejemplo, un tipo de conjunto de agujas puede comprender paredes de agujas electrodo funcionando en modo bipolar con una aguja hueca situada entre cada par. En esta configuracion la aguja hueca puede proporcionar el 40 analgesico al tejido entre las puntas de las agujas electrodo antes de la aplicacion de la corriente a los electrodos y la produccion de dano termico en el tejido anestesiado.
En otra realizacion de la presente invencion una o mas agujas del conjunto pueden estar conectadas ademas a un aparato de deteccion electronico y realizar una funcion adicional como sonda para detectar la presencia de un nervio 45 cercano a la punta. El aparato de deteccion electronico puede comprender una fuente de corriente electrica en el orden de los miliamperios y medios de control para enviar corrientes pequenas del orden de los miliamperios a agujas espedficas del conjunto. La deteccion de un nervio proximo a una cualquiera de las agujas insertadas del conjunto se realiza mediante aplicacion secuencial de corrientes pequenas a las agujas del conjunto y la observacion de cualquier respuesta motriz visible. Si se detecta un nervio el modulo de control 330 puede estar 50 configurado para desactivar la aguja o agujas proximas al nervio durante el tratamiento subsiguiente para evitar danar el nervio. Un metodo de deteccion de nervios basados en principios similares a los descritos en este documento se divulga en el artfculo de Umey y col. publicado en la revista Regional Anesthesia and Pain Medicine 27:3 (mayo-junio) 2002, pags. 261-267.
55 En otra realizacion, una o mas agujas pueden ser huecas insertandose una fibra optica o una grna de luz en la aguja hueca de modo que un extremo de la misma llegue hasta o sobresalga ligeramente de la punta de la aguja. El otro extremo de la fibra optica o grna de luz estara conectado a una fuente de energfa optica. La energfa optica suministrada a la punta de la grna de luz o fibra optica se puede utilizar entonces para calentar la punta, que a su vez calienta el tejido circundante, es decir, el area objetivo, produciendo herimiento fraccionado en la zona de la
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punta de la aguja. Un conjunto de agujas utilizado de acuerdo con la presente invencion puede comprender una mezcla de agujas electrodo y agujas gmas de luz. Alternativamente cada aguja puede tener una gma de luz y toda la energfa utilizada para producir el dano termico lo puede generar la fuente de energfa optica en lugar de utilizar una corriente de radiofrecuencia u otra corriente electrica. Una zona de la gma de luz o de la fibra optica, como la zona de la punta de la aguja, se puede configurar para absorber la energfa y facilitar la conversion de la energfa optica en calor. En estas realizaciones la fuente de energfa optica puede comprender, no limitativamente, un laser de diodo, un laser bombeado por diodos de estado solido, un laser Er:YAG, un laser Nd:YAG, un laser de ion argon, un laser He-Ne, un laser de dioxido de carbono, un laser exdmero o un laser de rubu La energfa optica transmitida por la gma de luz o fibra optica puede ser adicionalmente continua o pulsada.
Los tratamientos realizados se pueden utilizar para aplicarlos al colageno de la dermis. Esto puede producir un estiramiento inmediato de la piel y la reduccion de las arrugas por encima del tejido danado producida por la contraccion del colageno calentado. Con el tiempo los danos termicos tambien favoreceran la formacion de nuevo colageno que servira para alisar la piel aun mas.
Una aplicacion alternativa de la presente invencion puede ser reducir o eliminar la celulitis. Para conseguir esto los conjuntos de agujas estan configurados para aplicarse a la dermis y opcionalmente a la capa superior de grasa subcutanea directamente. Creando patrones dispersos de zonas de dano termico pequenas en estas capas se puede estirar la estructura de colageno interconectada y eliminar el afloramiento de grasa subcutanea en el tejido dermico que provoca la celulitis.
Cualquier dano termico y remodelacion de tejido se puede realizar en un tratamiento unico o en varios tratamientos ejecutados bien sucesivamente durante una sesion o espaciandolos mas en sesiones multiples. Los tratamientos individuales o multiples de una zona dada de tejido se pueden utilizar para conseguir el dano termico adecuado y los efectos cosmeticos deseados.
Claims (19)
- REIVINDICACIONESI. Aparato para proporcionar energfa a un tejido y para crear un patron de zonas localizadas de danos termicos en la dermis, comprendiendo el aparato una serie de agujas (350, 410, 415) fijadas a una base (310) donde5 las agujas estan configuradas para penetrar en el tejido, una fuente de energfa (320) conectada a la serie de agujas y un modulo de control (330) donde la separacion media de las agujas esta entre aproximadamente 1 mm y aproximadamente 2 cm, donde las agujas tienen una longitud de entre aproximadamente 1500 pm y aproximadamente 2000 pm, donde el modulo de control esta configurado para controlar la fuente de energfa generando patrones de zonas localizadas de dano termico en la dermis ajustando la intensidad y la duracion de la 10 potencia trasmitida a las agujas individuales o a pares de agujas, donde la fuente de energfa esta configurada para proporcionar energfa de entre 1 mJ aproximadamente y aproximadamente 100 mJ por aguja o par de agujas y donde la fuente de energfa esta configurada para calentar las puntas de dichas agujas individuales o pares de agujas produciendo el patron de dano termico alrededor de dichas puntas.15 2. Aparato de acuerdo con la reivindicacion 1 donde dos o mas agujas son electricamente conductoras yla fuente de energfa esta configurada para proporcionar una corriente de radiofrecuencia individualmente a una o mas agujas.
- 3. Aparato de acuerdo con la reivindicacion 2 donde al menos uno, la fuente de energfa o el modulo de 20 control, esta ubicado fuera de la carcasa (340) que encierra la serie de las agujas.
- 4. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-3 donde la fuente de energfa es un dispositivo de radiofrecuencia capaz de producir senales de frecuencias dentro de un intervalo deseado.25 5. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-3 donde la fuente de energfa escapaz de producir corriente electrica continua o alterna.
- 6. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-5 donde el modulo de control proporciona configuraciones espedficas de aplicacion a la fuente de energfa y donde la fuente de energfa recibe la30 configuracion y genera una corriente dirigida y opcionalmente recibida desde las agujas especificadas durante un tiempo, con unas intensidades y secuencias prefijados o seleccionables basandose en la configuracion.
- 7. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-6 donde las agujas comprenden unos extremos distantes agudos capaces de perforar la superficie del tejido de la piel y penetrar en el tejido hasta35 que la base toque la superficie de la piel.
- 8. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-7 donde el modulo de control esta configurado para proporcionar cantidades controladas de corriente de radiofrecuencia a una o mas agujas.40 9. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-8 que comprende ademas unacarcasa, donde la base esta fijada a al menos una zona de la carcasa.
- 10. Aparato de acuerdo con la reivindicacion 9, que comprende ademas un separador (315) fijado la baseque contiene un patron de agujeros a traves de los que sobresalen las agujas, donde al menos dos de las agujas 45 sobresalen longitudes diferentes del espaciador.II. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-10 donde la base es plana o tiene una superficie inferior cuyo contorno sigue la forma de la zona del tejido que se trata.50 12. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-11 donde la base ademascomprende medios de enfriamiento configurados para enfriar una superficie de la piel para reducir o eliminar el dolor cuando la serie de agujas perfora la superficie de la piel.
- 13. Aparato de acuerdo con la reivindicacion 12 donde dichos medios de enfriamiento comprenden 55 conductos internos que contienen un refrigerante circulante o dispositivo Peltier.
- 14. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-13 donde dicho aparato esta configurado para proporcionar energfa de radiofrecuencia a una o mas agujas en una configuracion monopolar.
- 15. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-13 donde dicho aparato esta configurado para proporcionar energfa de radiofrecuencia a dichas agujas en configuracion bipolar.
- 16. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-15 que comprende medios 5 vibratorios conectados a la base, donde dichos medios vibratorios comprenden un dispositivo piezoelectrico o unmotor que tiene un peso excentrico fijado a su eje.
- 17. Aparato de acuerdo con la reivindicacion 16 donde la frecuencia de vibracion de dichos medios vibratorios esta entre aproximadamente 10 Hz y aproximadamente 10 kHz, entre aproximadamente 500 Hz y10 aproximadamente 2 kHz o es de aproximadamente de 1 kHz.
- 18. Aparato de acuerdo con la reivindicacion 17 donde la amplitud de vibracion de dichos medios vibratorios esta entre aproximadamente 50 pm y 500 pm o entre aproximadamente 100 pm y 200 pm.15 19. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-18 donde la fuente de energfa y elmodulo de control estan configurados para proporcionar energfa a la serie de pares de agujas en modo bipolar.
- 20. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-19 donde el diametro de las agujas esta entre aproximadamente 500 pm y 1000 pm o aproximadamente entre 700 pm y 800 pm.20
- 21. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-20 donde las agujas no estan separadas uniformemente.
- 22. Aparato de acuerdo con una cualquiera de las reivindicaciones 1-21 donde una o mas agujas son 25 huecas y estan configuradas para proporcionar un analgesico local al tejido que rodea la punta de la aguja.
- 23. Aparato de acuerdo con una de las reivindicaciones 1-22 que comprende ademas un dispositivo de deteccion electronica conectado electricamente con una o mas agujas, configurado para detectar la presencia de un nervio cerca de la punta de una o mas de las agujas.30
- 24. Aparato de acuerdo con la reivindicacion 23 donde el dispositivo de deteccion esta conectado con el modulo de control y el modulo de control esta configurado para evitar que la fuente de energfa proporcione energfa a cualquier aguja si se ha detectado un nervio cerca de esa aguja.35 25. Aparato de acuerdo con cualquiera de las reivindicaciones 1-24 que comprende ademas una fuente deenergfa optica y una o mas agujas huecas que contienen fibras opticas o grnas de luz, donde el aparato esta configurado para proporcionar una cantidad controlada de energfa electromagnetica a traves de la fibra optica o la grna de luz al tejido que rodea las puntas de las agujas huecas.40 26. Aparato de acuerdo con la reivindicacion 25 donde la fuente de energfa optica comprende un diodolaser, un laser bombeado por diodos de estado solido, un laser Er:YAG, un laser Nd:YAG, un laser de ion-argon, un laser He-Ne, un laser de dioxido de carbono o un laser de rub y donde la energfa electromagnetica trasmitida por la fibra optica o la grna de luz es continua o pulsada.45 27. Aparato de acuerdo con la reivindicacion 1 donde la fuente de energfa comprende una fuente deenergfa de radiofrecuencia.
- 28. Aparato de acuerdo con la reivindicacion 1 donde la fuente energfa comprende una fuente de energfaoptica y donde las, al menos dos, agujas comprenden una grna de luz configurada para dirigir la energfa optica al 50 tejido.
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