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WO2019162720A1 - Device for treating obesity - Google Patents

Device for treating obesity Download PDF

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Publication number
WO2019162720A1
WO2019162720A1 PCT/IB2018/051071 IB2018051071W WO2019162720A1 WO 2019162720 A1 WO2019162720 A1 WO 2019162720A1 IB 2018051071 W IB2018051071 W IB 2018051071W WO 2019162720 A1 WO2019162720 A1 WO 2019162720A1
Authority
WO
WIPO (PCT)
Prior art keywords
volume
stomach cavity
stomach
actuator
encapsulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2018/051071
Other languages
Spanish (es)
French (fr)
Inventor
Samuel ESCOBAR GONZÁLEZ
Simón VILLA ARANGO
Javier Enrique CAMACHO COGOLLO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Universidad EIA
Original Assignee
Universidad EIA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Universidad EIA filed Critical Universidad EIA
Priority to PCT/IB2018/051071 priority Critical patent/WO2019162720A1/en
Publication of WO2019162720A1 publication Critical patent/WO2019162720A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

  • the present invention is encompassed in the gastroenterological field of medicine, and more specifically in the systems used for weight loss.
  • Invasive devices currently used in weight loss treatments such as the balloon or gastric band, reduce the effective volume of the stomach cavity, thus creating a feeling of fullness or fullness to patients with a smaller amount of food, leading to These people eat less food and therefore a loss of weight is induced in these.
  • the devices currently used are admitted to patients either orally in the case of the gastric balloon, or by minimally invasive surgery when talking about the gastric band. Patients who undergo this treatment have a high probability of suffering constant episodes of vomiting, dyspepsia and / or reflux, among others, when eating food, due to the effect created by the elements mentioned above. In other words, the reduction in gastric volume available through these devices makes gastric filling easier, causing the aforementioned adverse effects and food rejection.
  • gastric balls or bands currently implemented that allow to change their internal volume implicitly require that this be changed in an invasive manner, as for example in the one disclosed in the patent document US20090149879-A1.
  • the volume and pressure they exert or exert on them is not fed back at any time to users or health care staff.
  • the present invention solves this problem, by presenting an electromechanical device that allows the modification of the volume available in the stomach cavity remotely without the need to intervene the patient for it.
  • the present invention consists of a device for the treatment of obesity.
  • the device is implanted inside the stomach cavity and can vary in a controlled way the volume it occupies inside the stomach, without the need for external intervention.
  • the device may have actuators or measuring elements, which can be used to perform different tasks within the patient's stomach.
  • Through a wireless communication the device of the present invention can communicate with an external device that allows the system to be checked, controlled or recalibrated without the need for invasive interventions to patients.
  • the device is designed to be displaced inside the stomach using magnetic fields generated from outside the patient. Additionally, a wireless charging system is implemented to replenish the battery or batteries that power the device.
  • the device for the treatment of obesity through its implantation in the stomach cavity of a patient, comprises the following elements:
  • a volume sensor that obtains information through optical, resistive, piezoelectric, piezoresistive or ultrasonic transducers, among others, configured to measure the volume of the expanded element.
  • the actuator configured to regulate said volume by controlling the volume of the expanded element.
  • the actuator is composed of an electromechanical element that allows the volume to be modified.
  • a control unit configured to receive said commands and proceed, depending on the information contained in said command and the information from the volume sensor, to control the volume of the expanded element by means of the actuator.
  • a source of energy storage for example one or more batteries, to power the electronic components of the device.
  • a wireless charging system that allows wireless charging of the energy storage source from outside the stomach cavity in a non-invasive manner.
  • the device may comprise a ferromagnetic element to allow the device to move from the outside of the stomach cavity in a non-invasive manner, for example by means of a magnet.
  • the device comprises light emitting means, implemented for example by one or more LEDs, to illuminate the stomach cavity, and one or several cameras housed in the encapsulation and configured to capture images of the stomach cavity.
  • the device can transmit these images abroad wirelessly, for review by a specialist.
  • the transmission of the images can be done either through a wireless module installed in the cameras themselves or using the device's wireless media.
  • the encapsulation may comprise a plurality of openings to house electronic or electromechanical elements of the device.
  • the device can comprise one or more sensors (acidity sensor, pressure sensor, etc.) housed in the openings for the measurement of one or several variables of interest inside the stomach cavity, such as the degree of heartburn
  • the device may comprise a medication dispenser configured to deposit drugs in a controlled manner inside the stomach cavity through one of the openings of the encapsulation.
  • the control unit may be configured to gradually increase the volume of the expanded element according to an established weight loss program.
  • the control unit may be configured, once the weight loss program is over, to gradually decrease the volume of the expanded element.
  • the main objective of the present invention is to provide a device that allows control over the available volume of the stomach cavity, an action performed remotely by wireless and non-invasive commands, allowing the patient a less aggressive treatment over the duration of this.
  • Another optional objective of the present invention is to make measurements, through different sensors housed in the device, of different variables (eg acidity, pressure, temperature, presence of substances of interest such as glucose or the concentration of a medicine, among others) within the stomach cavity to provide information of special interest to specialists about some of the events that occur inside the stomach and know the patient's condition.
  • variables eg acidity, pressure, temperature, presence of substances of interest such as glucose or the concentration of a medicine, among others
  • the device can incorporate the additional functionality of controlled dispensing of medications when the patient requires it, either when programmed temporarily or when any of the measured variables leave a set range.
  • the device can also be used to implement a method of weight loss associated with a feedback system, through a programmed control that gradually increases the volume it occupies inside the stomach until reaching a desired value, then adapting to the patient's response until At the end of the treatment, its impact begins to decrease (by reducing the volume) also in a controlled manner and without external supervision.
  • Figure 1 shows a front view of the device.
  • Figure 2 shows a bottom plan view of the device.
  • Figure 3 shows a right side view of the device.
  • Figure 4 shows a left side view of the device.
  • the present invention relates to a device for the treatment of obesity, which is implanted within the stomach cavity.
  • Figure 1 shows a front elevation view of the device 1 for treatment of obesity, which comprises an expandable element 2, which changes volume within the stomach by the action of an actuator 7 comprising an electromechanical element that allows the volume to be modified according to be programmed to perform its therapeutic action.
  • an actuator 7 comprising an electromechanical element that allows the volume to be modified according to be programmed to perform its therapeutic action.
  • this expandable element 2 increases or decreases the stomach's ability to house food and therefore contributes to weight loss.
  • the device 1 also comprises an encapsulation 3 where the electronic and electromechanical components of the device are housed.
  • the encapsulation It has openings (4a, 4b, 4c) that can be used to locate the different types of electronic, mechanical or electromechanical elements.
  • the end of the expanded element 2 is fixed to the encapsulation 3, so that the upper base of the encapsulation 3 and the peripheral wall of the expanded element 2 generate a volume 12, controllable by the device itself.
  • the expanded element 2 is manufactured in a preferred embodiment by a flexible and soft material, for example silicone, which allows the control of said volume 12 by changing the pressure of a fluid, for example air, inside.
  • the expanding element 2 may be made of a rigid material, whereby the change in volume does not depend on the pressure inside it, but on the displacement of its peripheral walls by means of the action of the actuator 7.
  • a wireless charger or wireless charging system 5 an element that allows wireless charging of an energy storage source (eg one or several rechargeable batteries) located inside the device (not shown in the figure).
  • an energy storage source eg one or several rechargeable batteries located inside the device (not shown in the figure).
  • the actuator 7 is implemented by pneumatic volume control means for injecting or dislodging a fluid, for example air, in volume 12, and the sensors 6 include a pressure sensor for measuring the pressure of the fluid housed in the inside of volume 12.
  • Figure 2 represents a bottom view of the device 1 where you can see additional access ports or openings (8a, 8b) and a ferromagnetic element 9 (eg a magnet) used for the movement or relocation of the device 1 from the outside of non-invasive way.
  • a ferromagnetic element 9 eg a magnet
  • Figures 3 and 4 illustrate, respectively, a right and left side view of the device 1, where a port or cavity can be seen on both sides of the encapsulation 3 of the device for locating in each of them a camera (10a, 10b) responsible for transmitting images of the inside of the stomach in case a timely review of the stomach cavity is needed.
  • Light emitting elements or means (1 1 a, 1 1 b) are placed around the chamber that allow the stomach cavity to be illuminated when examinations are to be performed.
  • a single camera is used, instead of two, to increase autonomy and reduce size, complexity and cost.
  • ferromagnetic element 9 located at the base of the device 1, in other possible embodiments more ferromagnetic elements can be incorporated in the contour of the package 3, for example on its sides, to allow more degrees of freedom and greater control of the rotation of the device 1, performed externally by means of one or more magnets. In this way, you can have greater control of the orientation of the device 1 and the rotation of the cameras (10a, 10b).
  • the device 1 After implantation in the stomach, the device 1 can change the volume it occupies remotely without having to intervene the patient.
  • the device 1 communicates wirelessly, using a wireless communications module (for example, using Bluetooth low energy), with a device external to the patient with which an exchange of data between the two parties can be made.
  • the control unit housed or supported in the package 3 can receive remote commands for the control of the volume of the expandable element 2.
  • the control unit proceeds to regulate the volume 12 of the expandable element 2 , depending on the information contained in said command and the information coming from the sensors 6 by means of the actuator 7.
  • the control unit is constantly reading variables of interest within the stomach captured by the different sensors of device 1, which can be stored in an internal memory of the control unit or sent to the external unit for further analysis.
  • the control unit can be implemented, for example, by a microcontroller.
  • the actuator 7 of the device 1 comprises an electromechanical element that, by controlling the volume of the expandable element 2, allows it to change its shape to occupy more or less space within the stomach cavity.
  • the wireless charging system 5 allows to receive the necessary energy, transferred from an external system, to recharge an internal energy storage source (e.g. one) of the device.
  • the device 1 has on the periphery of its package 3 different access ports or openings (4a, 4b, 4c, 8a, 8b) where additional electronic or electromechanical elements, such as actuators or sensors, among others, can be located.
  • the ferromagnetic element 9 implemented for example by means of a magnet, allows the relocation or movement of device 1 into the stomach cavity. Said relocation is achieved by using an external electromagnetic field, which moves the device 1 in the desired direction.
  • the actuator 7 is an electromechanical element responsible for making the change in the volume occupied by the expandable element 2, thereby modifying the volume available in the stomach cavity.
  • the volume change can be done in different ways, such as pneumatically or hydraulically. Due to the location of the device 1 within the organism, all the materials used that may come into contact with the patient are biocompatible and implantable grade.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention relates to a device for treating obesity by means of implantation in the stomach cavity, which comprises: a capsule (3); an expandable element (2) that defines a closed volume (12); a pressure sensor (6); an actuator (7) for controlling the volume (12) of the expandable element (2); a wireless communication module; a control unit that wirelessly receives remote commands for controlling the volume of the expandable element (2) by means of the actuator (7); a battery; and a wireless charging system (5) for charging the battery. The device (1) can include cameras (10a, 10b) and light emitters (11a, 11b) for wirelessly capturing and transmitting images of the inside of the stomach cavity. The device provides the patient with a non-invasive treatment by means of the remote control of the useful volume of the stomach cavity.

Description

DISPOSITIVO PARA TRATAMIENTO DE LA OBESIDAD  DEVICE FOR TREATMENT OF OBESITY

DESCRIPCIÓN DESCRIPTION

Campo de la invención Field of the Invention

La presente invención se engloba en el campo gastroenterológico de la medicina, y más concretamente en los sistemas utilizados para la pérdida de peso.  The present invention is encompassed in the gastroenterological field of medicine, and more specifically in the systems used for weight loss.

Antecedentes de la invención Background of the invention

Los dispositivos invasivos utilizados actualmente en tratamientos de pérdida de peso, como el balón o la banda gástrica, reducen el volumen efectivo de la cavidad estomacal, creándole así una sensación de saciedad o de llenura a los pacientes con una cantidad menor de comida, llevando a estas personas a ingerir menos alimento y por ende se induce una pérdida de peso en estos.  Invasive devices currently used in weight loss treatments, such as the balloon or gastric band, reduce the effective volume of the stomach cavity, thus creating a feeling of fullness or fullness to patients with a smaller amount of food, leading to These people eat less food and therefore a loss of weight is induced in these.

Los dispositivos utilizados actualmente son ingresados a los pacientes ya sea vía oral en el caso del balón gástrico, o por cirugía mínimamente invasiva cuando se habla de la banda gástrica. Los pacientes que se someten a este tratamiento tienen una alta probabilidad de sufrir episodios constantes de vómito, dispepsia y/o de reflujo, entre otros, cuando se ingiere comida, debido al efecto creado por los elementos mencionados anteriormente. En otras palabras, la reducción en el volumen gástrico disponible por medio de estos dispositivos hace que el llenado gástrico se dé con mayor facilidad, ocasionando los efectos adversos antes mencionados y el rechazo del alimento. The devices currently used are admitted to patients either orally in the case of the gastric balloon, or by minimally invasive surgery when talking about the gastric band. Patients who undergo this treatment have a high probability of suffering constant episodes of vomiting, dyspepsia and / or reflux, among others, when eating food, due to the effect created by the elements mentioned above. In other words, the reduction in gastric volume available through these devices makes gastric filling easier, causing the aforementioned adverse effects and food rejection.

Los balones o bandas gástricas implementados actualmente que permiten cambiar su volumen interno requieren implícitamente que este sea cambiado de manera invasiva, como por ejemplo en el divulgado en el documento de patente US20090149879-A1 . Además, el volumen y presión que estos ejercen o que se ejerce sobre ellos no es retroalimentado en ningún momento a los usuarios o al personal de atención en salud. The gastric balls or bands currently implemented that allow to change their internal volume implicitly require that this be changed in an invasive manner, as for example in the one disclosed in the patent document US20090149879-A1. In addition, the volume and pressure they exert or exert on them is not fed back at any time to users or health care staff.

La presente invención resuelve este problema, al presentar un dispositivo electromecánico que permite la modificación del volumen disponible en la cavidad estomacal de manera remota sin la necesidad de intervenir al paciente para ello. The present invention solves this problem, by presenting an electromechanical device that allows the modification of the volume available in the stomach cavity remotely without the need to intervene the patient for it.

Descripción de la invención Description of the invention

La presente invención consiste en un dispositivo para el tratamiento de la obesidad. El dispositivo se implanta dentro de la cavidad estomacal y puede variar de manera controlada el volumen que ocupa dentro del estómago, sin necesidad de intervención externa. El dispositivo puede tener actuadores o elementos de medición, los cuales pueden ser utilizados para realizar diferentes tareas dentro del estómago del paciente. Por medio de una comunicación inalámbrica el dispositivo de la presente invención puede comunicarse con un dispositivo externo que permita revisar, controlar o recalibrar el sistema sin necesidad de intervenciones invasivas a los pacientes. El dispositivo está diseñado para ser desplazado dentro del estómago haciendo uso de campos magnéticos generados desde el exterior del paciente. Adicionalmente se implementa un sistema de carga inalámbrica para reabastecer la batería o baterías que alimentan el dispositivo. The present invention consists of a device for the treatment of obesity. The The device is implanted inside the stomach cavity and can vary in a controlled way the volume it occupies inside the stomach, without the need for external intervention. The device may have actuators or measuring elements, which can be used to perform different tasks within the patient's stomach. Through a wireless communication the device of the present invention can communicate with an external device that allows the system to be checked, controlled or recalibrated without the need for invasive interventions to patients. The device is designed to be displaced inside the stomach using magnetic fields generated from outside the patient. Additionally, a wireless charging system is implemented to replenish the battery or batteries that power the device.

El dispositivo para tratamiento de la obesidad, mediante su implantación en la cavidad estomacal de un paciente, comprende los siguientes elementos: The device for the treatment of obesity, through its implantation in the stomach cavity of a patient, comprises the following elements:

- Un encapsulado para soporte y alojamiento de los componentes del dispositivo. - An encapsulation for support and housing of the device components.

- Un elemento expandióle sujeto al encapsulado para definir un volumen cerrado.- An expanded element subject to encapsulation to define a closed volume.

- Un sensor de volumen que obtiene información por medio de transductores ópticos, resistivos, piezoeléctricos, piezoresistivos o ultrasónicos, entre otros, configurado para medir el volumen del elemento expandióle. - A volume sensor that obtains information through optical, resistive, piezoelectric, piezoresistive or ultrasonic transducers, among others, configured to measure the volume of the expanded element.

- Un actuador configurado para regular dicho volumen mediante el control del volumen del elemento expandióle. El actuador está compuesto por un elemento electromecánico que permite modificar el volumen.  - An actuator configured to regulate said volume by controlling the volume of the expanded element. The actuator is composed of an electromechanical element that allows the volume to be modified.

- Medios de comunicación inalámbrica configurados para recibir de forma remota comandos para el control del volumen del elemento expandióle.  - Wireless media configured to remotely receive commands to control the volume of the expanded item.

- Una unidad de control configurada para recibir dichos comandos y proceder, en función de la información contenida en dicho comando y de la información procedente del sensor de volumen, al control del volumen del elemento expandióle por medio del actuador.  - A control unit configured to receive said commands and proceed, depending on the information contained in said command and the information from the volume sensor, to control the volume of the expanded element by means of the actuator.

- Una fuente de almacenamiento de energía, por ejemplo una o varias baterías, para alimentar los componentes electrónicos del dispositivo.  - A source of energy storage, for example one or more batteries, to power the electronic components of the device.

- Un sistema de carga inalámbrica que permite la carga inalámbrica de la fuente de almacenamiento de energía desde el exterior de la cavidad estomacal de manera no invasiva.  - A wireless charging system that allows wireless charging of the energy storage source from outside the stomach cavity in a non-invasive manner.

El dispositivo puede comprender un elemento ferromagnético para permitir el desplazamiento del dispositivo desde el exterior de la cavidad estomacal de manera no invasiva, por ejemplo mediante un imán. En una realización, el dispositivo comprende unos medios emisores de luz, implementados por ejemplo mediante uno o varios leds, para iluminar la cavidad estomacal, y una o varias cámaras alojadas en el encapsulado y configuradas para capturar imágenes de la cavidad estomacal. El dispositivo puede transmitir dichas imágenes al exterior de manera inalámbrica, para la revisión por parte de un especialista. La transmisión de las imágenes se puede realizar bien a través de un módulo inalámbrico instalado en las propias cámaras o empleando los medios de comunicación inalámbrica del dispositivo. The device may comprise a ferromagnetic element to allow the device to move from the outside of the stomach cavity in a non-invasive manner, for example by means of a magnet. In one embodiment, the device comprises light emitting means, implemented for example by one or more LEDs, to illuminate the stomach cavity, and one or several cameras housed in the encapsulation and configured to capture images of the stomach cavity. The device can transmit these images abroad wirelessly, for review by a specialist. The transmission of the images can be done either through a wireless module installed in the cameras themselves or using the device's wireless media.

El encapsulado puede comprender una pluralidad de aperturas para alojar elementos electrónicos o electromecánicos del dispositivo. Así, el dispositivo puede comprender uno o varios sensores (sensor de acidez, sensor de presión, etc.) alojados en las aperturas para la medición de una o varias variables de interés en el interior de la cavidad estomacal, como por ejemplo el grado de acidez del estómago. Así mismo, el dispositivo puede comprender un dispensador de medicamentos configurado para depositar de manera controlada medicamentos en el interior de la cavidad estomacal a través de una de las aperturas del encapsulado. The encapsulation may comprise a plurality of openings to house electronic or electromechanical elements of the device. Thus, the device can comprise one or more sensors (acidity sensor, pressure sensor, etc.) housed in the openings for the measurement of one or several variables of interest inside the stomach cavity, such as the degree of heartburn Likewise, the device may comprise a medication dispenser configured to deposit drugs in a controlled manner inside the stomach cavity through one of the openings of the encapsulation.

La unidad de control puede estar configurada para aumentar gradualmente el volumen del elemento expandióle de acuerdo a un programa establecido de pérdida de peso. La unidad de control puede estar configurada, una vez terminado el programa de pérdida de peso, a disminuir gradualmente el volumen del elemento expandióle. The control unit may be configured to gradually increase the volume of the expanded element according to an established weight loss program. The control unit may be configured, once the weight loss program is over, to gradually decrease the volume of the expanded element.

El objetivo principal de la presente invención es proveer un dispositivo que permita un control sobre el volumen disponible de la cavidad estomacal, acción efectuada de manera remota por comandos inalámbricos y no invasivos, permitiéndole al paciente un tratamiento menos agresivo a lo largo de la duración de este. The main objective of the present invention is to provide a device that allows control over the available volume of the stomach cavity, an action performed remotely by wireless and non-invasive commands, allowing the patient a less aggressive treatment over the duration of this.

Otro objetivo opcional de la presente invención es realizar mediciones, a través de diferentes sensores alojados en el dispositivo, de distintas variables (e.g. acidez, presión, temperatura, presencia de sustancias de interés como la glucosa o la concentración de un medicamento, entre otras) dentro de la cavidad estomacal para aportar información de especial interés a los especialistas sobre algunos de los eventos que se presenten en el interior del estómago y conocer el estado del paciente. Another optional objective of the present invention is to make measurements, through different sensors housed in the device, of different variables (eg acidity, pressure, temperature, presence of substances of interest such as glucose or the concentration of a medicine, among others) within the stomach cavity to provide information of special interest to specialists about some of the events that occur inside the stomach and know the patient's condition.

Adicionalmente, el dispositivo puede incorporar la funcionalidad adicional de dispensación controlada de medicamentos cuando el paciente lo requiera, ya sea al estar programado temporalmente o cuando alguna de las variables medidas salga de un rango establecido. Additionally, the device can incorporate the additional functionality of controlled dispensing of medications when the patient requires it, either when programmed temporarily or when any of the measured variables leave a set range.

El dispositivo puede además utilizarse para implementar un método de pérdida de peso asociado a un sistema realimentado, mediante un control programado que va aumentando gradualmente el volumen que ocupa dentro del estómago hasta llegar a un valor deseado, adaptándose entonces a la respuesta del paciente hasta que al finalizar el tratamiento comienza a disminuir su impacto (mediante la reducción de volumen) también de manera controlada y sin supervisión externa. The device can also be used to implement a method of weight loss associated with a feedback system, through a programmed control that gradually increases the volume it occupies inside the stomach until reaching a desired value, then adapting to the patient's response until At the end of the treatment, its impact begins to decrease (by reducing the volume) also in a controlled manner and without external supervision.

Breve descripción de los dibujos Brief description of the drawings

A continuación se pasa a describir de manera muy breve una serie de dibujos que ayudan a comprender mejor la invención y que se relacionan expresamente con una realización de dicha invención que se presenta como un ejemplo no limitativo de ésta.  A series of drawings that help to better understand the invention and that expressly relate to an embodiment of said invention which is presented as a non-limiting example thereof is described very briefly below.

La Figura 1 muestra una vista frontal del dispositivo. Figure 1 shows a front view of the device.

La Figura 2 muestra una vista en planta inferior del dispositivo. Figure 2 shows a bottom plan view of the device.

La Figura 3 muestra una vista lateral derecha del dispositivo. Figure 3 shows a right side view of the device.

La Figura 4 muestra una vista lateral izquierda del dispositivo. Figure 4 shows a left side view of the device.

Descripción detallada de la invención Detailed description of the invention

La presente invención se refiere a un dispositivo para tratamiento de la obesidad, que se implanta dentro de la cavidad estomacal.  The present invention relates to a device for the treatment of obesity, which is implanted within the stomach cavity.

La Figura 1 muestra una vista de elevación frontal del dispositivo 1 para tratamiento de la obesidad, el cual comprende un elemento expandible 2, que cambia de volumen dentro del estómago por acción de un actuador 7 que comprende un elemento electromecánico que permite modificar el volumen según sea programado para realizar su acción terapéutica. Dependiendo de la cantidad de volumen que este elemento expandible 2 ocupe dentro de la cavidad estomacal, aumenta o disminuye la capacidad del estómago de alojar alimento y por ende contribuye a la pérdida de peso. Figure 1 shows a front elevation view of the device 1 for treatment of obesity, which comprises an expandable element 2, which changes volume within the stomach by the action of an actuator 7 comprising an electromechanical element that allows the volume to be modified according to be programmed to perform its therapeutic action. Depending on the amount of volume that this expandable element 2 occupies within the stomach cavity, it increases or decreases the stomach's ability to house food and therefore contributes to weight loss.

El dispositivo 1 comprende también un encapsulado 3 en donde se albergan los componentes electrónicos y electromecánicos del dispositivo. Para ello el encapsulado dispone de unas aperturas (4a, 4b, 4c) que pueden ser utilizadas para ubicar los distintos tipos de elementos electrónicos, mecánicos o electromecánicos. En una realización, el extremo del elemento expandióle 2 se fija al encapsulado 3, de forma que la base superior del encapsulado 3 y la pared periférica del elemento expandióle 2 generan un volumen 12, controlable por el propio dispositivo. El elemento expandióle 2 está fabricado en una realización preferida por un material flexible y blando, por ejemplo silicona, que permite el control de dicho volumen 12 por medio del cambio de la presión de un fluido, por ejemplo aire, en su interior. En una realización alternativa el elemento expandióle 2 puede estar fabricado en un material rígido con lo cual el cambio de volumen no depende de la presión en su interior sino del desplazamiento de sus paredes periféricas por medio de la acción del actuador 7. The device 1 also comprises an encapsulation 3 where the electronic and electromechanical components of the device are housed. For this the encapsulation It has openings (4a, 4b, 4c) that can be used to locate the different types of electronic, mechanical or electromechanical elements. In one embodiment, the end of the expanded element 2 is fixed to the encapsulation 3, so that the upper base of the encapsulation 3 and the peripheral wall of the expanded element 2 generate a volume 12, controllable by the device itself. The expanded element 2 is manufactured in a preferred embodiment by a flexible and soft material, for example silicone, which allows the control of said volume 12 by changing the pressure of a fluid, for example air, inside. In an alternative embodiment, the expanding element 2 may be made of a rigid material, whereby the change in volume does not depend on the pressure inside it, but on the displacement of its peripheral walls by means of the action of the actuator 7.

En la parte inferior del encapsulado 3 se encuentra un cargador inalámbrico o sistema de carga inalámbrica 5, un elemento que permite la carga inalámbrica de una fuente de almacenamiento de energía (e.g. una o varias baterías recargables) ubicada en el interior del dispositivo (no mostrada en la figura). En la parte superior del encapsulado 3 se encuentran uno o varios sensores 6 y el actuador 7, utilizados por una unidad de control del dispositivo (implementada por ejemplo mediante un microcontrolador) para regular el volumen efectivo del dispositivo. En una realización, el actuador 7 se implementa mediante unos medios neumáticos de control del volumen para inyectar o desalojar un fluido, por ejemplo aire, en el volumen 12, y los sensores 6 incluyen un sensor de presión para medir la presión del fluido alojado en el interior del volumen 12. In the lower part of the package 3 there is a wireless charger or wireless charging system 5, an element that allows wireless charging of an energy storage source (eg one or several rechargeable batteries) located inside the device (not shown in the figure). In the upper part of the package 3 there are one or several sensors 6 and the actuator 7, used by a device control unit (implemented for example by a microcontroller) to regulate the effective volume of the device. In one embodiment, the actuator 7 is implemented by pneumatic volume control means for injecting or dislodging a fluid, for example air, in volume 12, and the sensors 6 include a pressure sensor for measuring the pressure of the fluid housed in the inside of volume 12.

La Figura 2 representa una vista inferior del dispositivo 1 en donde se pueden ver unos puertos de acceso o aperturas adicionales (8a, 8b) y un elemento ferromagnético 9 (e.g. un imán) utilizado para el desplazamiento o reubicación del dispositivo 1 desde el exterior de manera no invasiva. Figure 2 represents a bottom view of the device 1 where you can see additional access ports or openings (8a, 8b) and a ferromagnetic element 9 (eg a magnet) used for the movement or relocation of the device 1 from the outside of non-invasive way.

Las Figuras 3 y 4 ilustran, respectivamente, una vista lateral derecha e izquierda del dispositivo 1 , en donde se aprecia un puerto o cavidad practicado a ambos lados del encapsulado 3 del dispositivo para ubicar en cada uno de ellos una cámara (10a, 10b) encargada de transmitir imágenes del interior del estómago en caso de que se necesite una revisión puntual de la cavidad estomacal. Alrededor de la cámara se ubican elementos o medios emisores de luz (1 1 a, 1 1 b) que permiten iluminar la cavidad estomacal cuando se vayan a realizar exámenes. En otra realización se utiliza una única cámara, en lugar de dos, para aumento de autonomía y reducción de tamaño, complejidad y coste. Si bien en la realización de las figuras se muestra un único elemento ferromagnético 9 ubicado en la base del dispositivo 1 , en otras posibles realizaciones se puede incorporar más elementos ferromagnéticos en el contorno del encapsulado 3, por ejemplo en sus laterales, para permitir más grados de libertad y mayor control de la rotación del dispositivo 1 , realizado externamente mediante uno o varios imanes. De esta forma, se puede tener un mayor control de la orientación del dispositivo 1 y de la rotación de las cámaras (10a, 10b). Figures 3 and 4 illustrate, respectively, a right and left side view of the device 1, where a port or cavity can be seen on both sides of the encapsulation 3 of the device for locating in each of them a camera (10a, 10b) responsible for transmitting images of the inside of the stomach in case a timely review of the stomach cavity is needed. Light emitting elements or means (1 1 a, 1 1 b) are placed around the chamber that allow the stomach cavity to be illuminated when examinations are to be performed. In another embodiment, a single camera is used, instead of two, to increase autonomy and reduce size, complexity and cost. Although in the embodiment of the figures a single ferromagnetic element 9 is shown located at the base of the device 1, in other possible embodiments more ferromagnetic elements can be incorporated in the contour of the package 3, for example on its sides, to allow more degrees of freedom and greater control of the rotation of the device 1, performed externally by means of one or more magnets. In this way, you can have greater control of the orientation of the device 1 and the rotation of the cameras (10a, 10b).

Después de su implantación en el estómago, el dispositivo 1 puede cambiar el volumen que ocupa de manera remota sin tener que intervenir al paciente. El dispositivo 1 se comunica de manera inalámbrica, utilizando un módulo de comunicaciones inalámbrico (por ejemplo, utilizando Bluetooth de baja energía), con un dispositivo externo al paciente con el cual se puede efectuar un intercambio de datos entre las dos partes. De esta forma, la unidad de control (no mostrada en las figuras) alojada o soportada en el encapsulado 3 puede recibir comandos remotos para el control del volumen del elemento expandible 2. La unidad de control procede a regular el volumen 12 del elemento expandible 2, en función de la información contenido en dicho comando y de la información procedente de los sensores 6 por medio del actuador 7. After implantation in the stomach, the device 1 can change the volume it occupies remotely without having to intervene the patient. The device 1 communicates wirelessly, using a wireless communications module (for example, using Bluetooth low energy), with a device external to the patient with which an exchange of data between the two parties can be made. In this way, the control unit (not shown in the figures) housed or supported in the package 3 can receive remote commands for the control of the volume of the expandable element 2. The control unit proceeds to regulate the volume 12 of the expandable element 2 , depending on the information contained in said command and the information coming from the sensors 6 by means of the actuator 7.

La unidad de control está constantemente leyendo variables de interés dentro del estómago capturadas por los diferentes sensores del dispositivo 1 , las cuales pueden ser almacenadas en una memoria interna de la unidad de control o enviadas a la unidad externa para un posterior análisis. La unidad de control se puede implementar por ejemplo mediante un microcontrolador. The control unit is constantly reading variables of interest within the stomach captured by the different sensors of device 1, which can be stored in an internal memory of the control unit or sent to the external unit for further analysis. The control unit can be implemented, for example, by a microcontroller.

El actuador 7 del dispositivo 1 comprende un elemento electromecánico que, mediante el control del volumen del elemento expandible 2, permite cambiar su forma para ocupar más o menos espacio dentro de la cavidad estomacal. The actuator 7 of the device 1 comprises an electromechanical element that, by controlling the volume of the expandable element 2, allows it to change its shape to occupy more or less space within the stomach cavity.

El sistema de carga inalámbrica 5 permite recibir la energía necesaria, transferida desde un sistema externo, para recargar una fuente de almacenamiento de energía (e.g. una )interna del dispositivo. El dispositivo 1 tiene en la periferia de su encapsulado 3 distintos puertos de acceso o aperturas (4a, 4b, 4c, 8a, 8b) en donde se pueden ubicar elementos electrónicos o electromecánicos adicionales, tales como actuadores o sensores, entre otros. The wireless charging system 5 allows to receive the necessary energy, transferred from an external system, to recharge an internal energy storage source (e.g. one) of the device. The device 1 has on the periphery of its package 3 different access ports or openings (4a, 4b, 4c, 8a, 8b) where additional electronic or electromechanical elements, such as actuators or sensors, among others, can be located.

El elemento ferromagnético 9, implementado por ejemplo mediante un imán, permite la reubicación o el desplazamiento del dispositivo 1 dentro de la cavidad estomacal. Dicha reubicación se logra haciendo uso de un campo electromagnético externo, el cual desplaza el dispositivo 1 en la dirección deseada. El actuador 7 es un elemento electromecánico encargado de realizar el cambio en el volumen ocupado por el elemento expandible 2, modificando con ello el volumen disponible en la cavidad estomacal. El cambio de volumen se puede realizar de diferentes maneras, como por ejemplo de manera neumática o hidráulica. Debido a la ubicación del dispositivo 1 dentro del organismo, todos los materiales utilizados que puedan entrar en contacto con el paciente son biocompatibles y de grado implantable. The ferromagnetic element 9, implemented for example by means of a magnet, allows the relocation or movement of device 1 into the stomach cavity. Said relocation is achieved by using an external electromagnetic field, which moves the device 1 in the desired direction. The actuator 7 is an electromechanical element responsible for making the change in the volume occupied by the expandable element 2, thereby modifying the volume available in the stomach cavity. The volume change can be done in different ways, such as pneumatically or hydraulically. Due to the location of the device 1 within the organism, all the materials used that may come into contact with the patient are biocompatible and implantable grade.

Claims

REIVINDICACIONES 1 . Dispositivo para tratamiento de la obesidad mediante su implantación en la cavidad estomacal de un paciente, caracterizado por que comprende: one . Device for the treatment of obesity through its implantation in the stomach cavity of a patient, characterized in that it comprises: un encapsulado (3) para soporte y alojamiento de los componentes del dispositivo an encapsulation (3) for support and housing of the device components (1 ); (one ); un elemento expandióle (2) sujeto al encapsulado (3) para definir un volumen (12); un sensor de volumen (6) configurado para medir el volumen (12) del elemento expandióle (2);  an expanded element (2) subject to encapsulation (3) to define a volume (12); a volume sensor (6) configured to measure the volume (12) of the expansion element (2); un actuador (7) configurado para regular el volumen (12) del elemento expandióle an actuator (7) configured to regulate the volume (12) of the expanded element (2); (two); medios de comunicación inalámbrica configurados para recibir de forma remota comandos para el control del volumen (12) del elemento expandióle (2);  wireless communication means configured to remotely receive commands for volume control (12) of the expanded element (2); una unidad de control configurada para recibir dichos comandos y proceder, en función de la información contenida en dicho comando y de la información procedente del sensor de presión (6), al control del volumen (12) del elemento expandióle (2) por medio del actuador (7);  a control unit configured to receive said commands and proceed, depending on the information contained in said command and the information from the pressure sensor (6), to control the volume (12) of the expansion element (2) by means of the actuator (7); una fuente de almacenamiento de energía;  a source of energy storage; un sistema de carga inalámbrica (5) que permite la carga inalámbrica de la fuente de almacenamiento de energía desde el exterior de la cavidad estomacal de manera no invasiva.  a wireless charging system (5) that allows wireless charging of the energy storage source from outside the stomach cavity in a non-invasive manner. 2. Dispositivo según la reivindicación 1 , que comprende un elemento ferromagnético (9) para permitir el desplazamiento del dispositivo (1 ) desde el exterior de la cavidad estomacal de manera no invasiva. 2. Device according to claim 1, comprising a ferromagnetic element (9) to allow the displacement of the device (1) from the outside of the stomach cavity in a non-invasive manner. 3. Dispositivo según cualquiera de las reivindicaciones anteriores, que comprende unos medios emisores de luz (1 1 a, 1 1 b) para iluminar la cavidad estomacal y al menos una cámara (10a, 10b) alojada en el encapsulado (3) y configurada para capturar imágenes de la cavidad estomacal, estando el dispositivo (1 ) configurado para transmitir dichas imágenes de manera inalámbrica. 3. Device according to any of the preceding claims, comprising light emitting means (1 1 a, 1 1 b) for illuminating the stomach cavity and at least one chamber (10a, 10b) housed in the package (3) and configured to capture images of the stomach cavity, the device (1) being configured to transmit said images wirelessly. 4. Dispositivo según cualquiera de las reivindicaciones anteriores, donde el encapsulado (3) comprende una pluralidad de aperturas (4a, 4b, 4c; 8a, 8b) para alojar elementos electrónicos o electromecánicos del dispositivo (1 ). Device according to any one of the preceding claims, wherein the encapsulation (3) comprises a plurality of openings (4a, 4b, 4c; 8a, 8b) for housing electronic or electromechanical elements of the device (1). 5. Dispositivo según la reivindicación 4, que comprende uno o varios sensores alojados en las aperturas para la medición de una o varias variables de interés en el interior de la cavidad estomacal. 5. Device according to claim 4, comprising one or several sensors housed in the openings for the measurement of one or more variables of interest inside the stomach cavity. 6. Dispositivo según la reivindicación 5, que comprende un sensor de acidez para medir el grado de acidez del estómago. 6. Device according to claim 5, comprising an acidity sensor for measuring the degree of acidity of the stomach. 7. Dispositivo según la reivindicación 4, que comprende un dispensador de medicamentos configurado para depositar de manera controlada medicamentos en el interior de la cavidad estomacal a través de una de las aperturas (4a, 4b, 4c; 8a, 8b) del encapsulado (3). 7. Device according to claim 4, comprising a medicament dispenser configured to deposit drugs in a controlled manner inside the stomach cavity through one of the openings (4a, 4b, 4c; 8a, 8b) of the package (3 ). 8. Dispositivo según cualquiera de las reivindicaciones anteriores, donde los elementos del dispositivo (1 ) en contacto con la cavidad estomacal están fabricados de un material biocompatible. 8. Device according to any of the preceding claims, wherein the elements of the device (1) in contact with the stomach cavity are made of a biocompatible material. 9. Dispositivo según cualquiera de las reivindicaciones anteriores, donde la unidad de control está configurada para aumentar gradualmente el volumen (12) del elemento expandible (2) de acuerdo a un programa establecido de pérdida de peso. 9. Device according to any of the preceding claims, wherein the control unit is configured to gradually increase the volume (12) of the expandable element (2) according to an established weight loss program. 10. Dispositivo según la reivindicación 9, donde la unidad de control está configurada, una vez terminado el programa de pérdida de peso, a disminuir gradualmente el volumen del elemento expandible (2). 10. Device according to claim 9, wherein the control unit is configured, once the weight loss program is finished, to gradually decrease the volume of the expandable element (2).
PCT/IB2018/051071 2018-02-21 2018-02-21 Device for treating obesity Ceased WO2019162720A1 (en)

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WO2010045477A2 (en) * 2008-10-16 2010-04-22 Obalon Therapeutics, Inc. Intragastric volume-occupying device and method for fabricating same
WO2011063307A1 (en) * 2009-11-20 2011-05-26 Innovelle, Llc Bariatric instrument or accessory with sensors
US20130226104A1 (en) * 2012-02-24 2013-08-29 Elwha LLC, a limited liability company of the State of Delaware Devices, systems, and methods to control stomach volume

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080243071A1 (en) * 2007-03-30 2008-10-02 Quijano Rodolfo C Intragastric balloon system and therapeutic processes and products
WO2010045477A2 (en) * 2008-10-16 2010-04-22 Obalon Therapeutics, Inc. Intragastric volume-occupying device and method for fabricating same
WO2011063307A1 (en) * 2009-11-20 2011-05-26 Innovelle, Llc Bariatric instrument or accessory with sensors
US20130226104A1 (en) * 2012-02-24 2013-08-29 Elwha LLC, a limited liability company of the State of Delaware Devices, systems, and methods to control stomach volume

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