WO2020099706A1 - Abdominal immobilisation device for medical diagnosis and treatment - Google Patents

Abdominal immobilisation device for medical diagnosis and treatment Download PDF

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Publication number
WO2020099706A1
WO2020099706A1 PCT/ES2019/070772 ES2019070772W WO2020099706A1 WO 2020099706 A1 WO2020099706 A1 WO 2020099706A1 ES 2019070772 W ES2019070772 W ES 2019070772W WO 2020099706 A1 WO2020099706 A1 WO 2020099706A1
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Prior art keywords
abdominal
diagnosis
belt
medical treatments
immobilizer device
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PCT/ES2019/070772
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Spanish (es)
French (fr)
Inventor
Carolina DE LA PINTA ALONSO
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Fundación Para La Investigación Biomédica Del Hospital Ramón Y Cajal
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Publication of WO2020099706A1 publication Critical patent/WO2020099706A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/04—Positioning of patients; Tiltable beds or the like

Definitions

  • the present invention refers to an immobilizer or compressor device for diagnosis and medical treatments, such as: radiotherapy, magnetic resonance imaging, CT, etc.
  • the invention is especially applicable as an abdominal immobilizer, for body stereotaxic radiotherapy treatments.
  • an object of the invention is to provide an immobilizing device or abdominal compressor for diagnosis and medical treatments, which is simple, low cost, versatile, allowing immobilization to be carried out quickly and with greater control of the tumor area. to treat.
  • Liver metastases derived from colon tumors or other tumors
  • pancreatic adenocarcinoma or hepatocarcinoma all of them inoperable, can benefit from curative treatments with radiotherapy by means of high intensity and precision techniques such as stereotaxic body radiotherapy, known in English as: “Stereotactic Body RadioTherapy” or (SBRT).
  • SBRT stereotaxic Body RadioTherapy
  • the abdominal organs are subjected to internal movement due to breathing and bowel movement.
  • This is how the SBRT emerged, defined as a high-precision irradiation technique, which allows very high doses of the tumor to be administered, focused on it, with a highly cytotoxic ablative biological effect (massive destruction of tumor cells) in a limited number of sessions. , and minimum doses on the surrounding healthy tissues.
  • conventional radiotherapy treatments are administered in sessions of 1.8 to 2 Gy up to doses of 60 or 70 Gy (30-35 treatment sessions)
  • the doses administered in SBRT exceed 5 Gy per session with a maximum of 8 sessions, which is a higher radiobiological equivalent (higher radiation dose to the tumor).
  • the movement to which the abdominal organs are subjected can be limited with the use of adapted body immobilizers.
  • the consequences of not controlling this movement are worse control of tumor disease and the appearance of side effects, for example, by irradiating large volumes of healthy liver, radio-induced liver failure can occur, which in turn can lead to death of the liver. individual.
  • the same occurs in the rest of the organs of the abdominal region, and duodenal ulcers, gastric ulcers or perforations of hollow viscera (intestine or stomach) can occur.
  • the invention consists of an immobilization device preferably applicable for abdominal SBRT, which is based on the dampening technique described above for abdominal immobilization of patients.
  • an abdominal immobilizer device for diagnosis and medical treatments, preferably radiotherapy, comprising a flexible material belt that has a central zone and two lateral bands that start from the central zone up to the two ends of the belt.
  • the central area has an adequate area to cover most of a patient's abdomen, in order to be able to apply pressure to any area of the abdomen.
  • the side bands are of adequate length to fix the device to a clinical table through the side bars of the table, or alternatively through a tool designed for that purpose that will be described later.
  • the device incorporates a plastic material plate that provides rigidity to this central zone of the belt, which can have a certain degree of flexibility or be completely rigid, and which is embedded in the central zone of the belt.
  • the central zone is defined by the rigid plate.
  • the device also has one or more pads of various sizes and shapes, which serve as a pressure element in a specific area of the abdomen.
  • the pad is fixable by its flat base to one of the faces of the central area, and since the area of the flat base is less than the area of the rigid plate, the pad can be fixed in various positions of the abdomen, depending on of the abdominal organ to be treated (pancreas, liver, adrenal glands, kidneys and lymph nodes) and the patient's physiognomy. In this way, the device is very versatile, since it can be personalized to each patient, choosing the position of the pad to press on the desired area.
  • the pad is attached to the belt by sailboat ⁇ (or any variety thereof), since the sailboat, being made of a plastic and textile material, does not interfere with radiation.
  • It also has a sailboat (or a variety thereof) to fix part of the side bands on the other side of the central area and / or part of the bands themselves lateral when they fold over themselves.
  • a sailboat or a variety thereof
  • brackets or straps are used, to fix part of the side bands on the other side of the central area and / or part of the side bands themselves when they fold over themselves.
  • - Versatility can be used in any abdominal organ: pancreas, liver, adrenal glands, kidneys and lymph nodes, achieving personalized movement control.
  • the immobilization time does not interfere with the treatment of other patients, in many occasions only one table is available on which the immobilizer is fixed and is the one used for all patients. Since the device can be easily attached or removed from the table, it is no longer necessary to coordinate patients in simulation and in the treatment machine at the same time.
  • Figure 1 A shows in drawing 1 A) a perspective view from the upper face of the belt of the device object of the invention; in drawing 1 B) shows another perspective view from the underside of the device; and drawing 1 C) shows a cross-sectional view along the belt of the device.
  • Figure 2. shows in drawings 2A) and 2B) respective perspective views respectively from the upper and lower face of a variant of the pad of triangular shape; in the drawings 2C) and 2D) respective perspective views respectively from the upper and lower face of another variant of the circular shaped pad.
  • Figure 3. Shows an enlarged and perspective detail of the central area of the device with one of the pads fixed, and with an opening on the right side of the figure to show the rigid plate.
  • Figure 6. Shows a view of the device in the position of use attached to the side bars of a hospital table, where the position of the abdomen of a patient has been represented by a dashed line.
  • Figure 1 shows a preferred embodiment of an abdominal immobilizer device for radiotherapy treatments according to the invention, which comprises a belt (1) of flexible material having a central area (1c) and two lateral bands (1 a, 1 b) that they start from the central zone (1c) to the two ends of the belt.
  • the central zone (1c) is wider than the lateral bands (1 a, 1b).
  • the central zone (1c) incorporates a plate (2) of plastic material, of a certain thickness to give rigidity to the central zone, which is preferably rectangular and is immersed in the belt (1) and is therefore hidden in it .
  • the extension of the central zone (1c) is defined by the rigid plate (2), and is dimensioned so that in its use it can cover most of the abdomen of a patient.
  • the belt (1) can be made of a plastic or textile material, which is washable, for example by superimposing two layers of said material by placing the plate between the two layers, and then sewing or gluing the two layers together, so that the plate is immersed in the belt.
  • the side bands (1a, 1 b) have a suitable extension to go through the side bars (7) (or the tool (4)) of a clinical table, as shown in Figures 5 and 6, and fold over themselves for the proper fixation and immobilization of a patient.
  • the device also incorporates one or more pads (3) of various sizes and shapes, to better adapt to the abdominal area to be immobilized.
  • the pad has a flat base (9) to be fixed in different positions of the central area (1c) of the belt (1), according to the abdominal organ to be treated, achieving a personalized use for each patient and greater efficiency in immobilization.
  • Figure 2 shows several examples of pads, for example the pad of the drawings (3A, 3B) has two flat bases, substantially parallel to each other, and of triangular configuration, while the pad of the drawings (2C, 2D) is a semi-sphere with a flat base (9) circular.
  • the device of the invention also has a tool (4) that allows the fixation of the belt (1) to clinical tables that do not have side bars.
  • This tool (4) is shown in figure 4, and is made up of a flat central plate (5) that can be fixed to the rigid platform of a clinical table by conventional means, for example by screwing.
  • the tool (4) has lateral handles (6,6 ' ) with a “U” shape emerging orthogonally respectively from the ends of the central plate (5), through which the lateral bands (1 a, 1b) of the belt are passed for immobilization of a patient, as shown in Figure 5B.
  • the belt (1) has on one of its edges, a graduated scale (10) in a unit of length.
  • the other side of the belt (1) (drawing 1 B), has on the central area (1c) and on an internal part of the lateral bands (1a, 1b) a first part of the sailboat (8), while the rest of the lateral bands (1a, 1 b) up to the ends have the second part of the sailboat (8 ' ) complementary to the first (8) to join both parts by pressure, when the lateral bands fold on themselves towards the center of the belt passing through the bars (7) of a table or by the handles (6,6 ' ) of the tool (4), thus being able to adjust the belt to properly immobilize a patient's desired abdominal area.
  • the rigid plate (2) constitutes a suitable support for the pad (3,3 ' ), which enhances the pressure that it can exert on the abdominal area.

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Abstract

The present invention relates to an abdominal immobilisation device for medical diagnosis and treatment, comprising: a belt of flexible material having a central area and two lateral straps. The belt further comprises a plate of plastic material enveloped in the central area and which defines said central area, and at least one cushion featuring a flat base whose area is lesser than the area of the rigid plate; likewise an attachment means to attach the cushion by its flat base to one of the sides of the central area, and an attachment means to attach part of the lateral straps on the other side of the central area and/or part of said lateral straps. The invention provides a simple immobilisation device at a reduced cost, highly versatile, that enables the immobilisation to be carried out rapidly and with greater control.

Description

DISPOSITIVO INMOVILIZADOR ABDOMINAL PARA DIAGNOSTICO Y  ABDOMINAL IMMOBILIZING DEVICE FOR DIAGNOSIS AND
TRATAMIENTOS MEDICOS  MEDICAL TREATMENTS
D E S C R I P C I O N D E S C R I P C I O N
Objeto de la invención Object of the invention
La presente invención se refiere a un dispositivo inmovilizador o compresor para diagnóstico y tratamientos médicos, como por ejemplo: radioterapia, resonancia magnética, TAC., etc. La invención es especialmente aplicable como inmovilizador abdominal, para tratamientos de radioterapia estereotáxica corporal. The present invention refers to an immobilizer or compressor device for diagnosis and medical treatments, such as: radiotherapy, magnetic resonance imaging, CT, etc. The invention is especially applicable as an abdominal immobilizer, for body stereotaxic radiotherapy treatments.
Más concretamente, un objeto de la invención es el de proporcionar dispositivo inmovilizador o compresor abdominal para diagnóstico y tratamientos médicos, que sea sencillo, de bajo coste, versátil, que permita realizar la inmovilización de una forma rápida y con mayor control de la zona tumoral a tratar. More specifically, an object of the invention is to provide an immobilizing device or abdominal compressor for diagnosis and medical treatments, which is simple, low cost, versatile, allowing immobilization to be carried out quickly and with greater control of the tumor area. to treat.
Antecedentes de la invención Background of the Invention
El tratamiento más eficaz contra el cáncer es la cirugía, pero en muchas ocasiones, bien por antecedentes del paciente o por inoperabilidad del tumor no se puede llevar a cabo. Las metástasis hepáticas (derivadas de tumores de colon o de otros tumores), el adenocarcinoma de páncreas o el hepatocarcinoma, inoperables todos ellos, pueden beneficiarse de tratamientos curativos con radioterapia mediante técnicas de alta intensidad y precisión como es la radioterapia estereotáxica corporal, conocido en inglés como:“Stereotactic Body RadioTherapy” o (SBRT). The most effective treatment against cancer is surgery, but in many cases, either due to the patient's history or due to the inoperability of the tumor, it cannot be carried out. Liver metastases (derived from colon tumors or other tumors), pancreatic adenocarcinoma or hepatocarcinoma, all of them inoperable, can benefit from curative treatments with radiotherapy by means of high intensity and precision techniques such as stereotaxic body radiotherapy, known in English as: “Stereotactic Body RadioTherapy” or (SBRT).
Desde finales de los años 90, el reto de la oncología radioterápica ha sido lograr la misma precisión y control tumoral en la zona toraco-abdominal, tal y como se consiguió en los años 50 en el cráneo con la radioterapia estereotáxica craneal. Since the late 1990s, the challenge of radiotherapy oncology has been to achieve the same precision and tumor control in the thoraco-abdominal area, as was achieved in the 1950s in the skull with cranial stereotaxic radiotherapy.
Los órganos abdominales están sometidos a un movimiento interno debido a la respiración y al movimiento intestinal. Así surge la SBRT, definida como una técnica de irradiación de alta precisión, que permite administrar, en un número limitado de sesiones, dosis muy altas al tumor, focalizadas en él, con efecto biológico ablativo altamente citotóxico (destrucción masiva de las células tumorales), y dosis mínimas sobre los tejidos sanos circundantes. Mientras que los tratamientos de radioterapia convencional se administran en sesiones de 1 ,8 a 2 Gy hasta dosis de 60 o 70 Gy (30- 35 sesiones de tratamiento), las dosis administradas en SBRT superan los 5 Gy por sesión con un máximo de 8 sesiones, lo que supone un equivalente radiobiológico mayor (mayor dosis de radiación en el tumor). The abdominal organs are subjected to internal movement due to breathing and bowel movement. This is how the SBRT emerged, defined as a high-precision irradiation technique, which allows very high doses of the tumor to be administered, focused on it, with a highly cytotoxic ablative biological effect (massive destruction of tumor cells) in a limited number of sessions. , and minimum doses on the surrounding healthy tissues. While conventional radiotherapy treatments are administered in sessions of 1.8 to 2 Gy up to doses of 60 or 70 Gy (30-35 treatment sessions), the doses administered in SBRT exceed 5 Gy per session with a maximum of 8 sessions, which is a higher radiobiological equivalent (higher radiation dose to the tumor).
El movimiento al que están sometidos los órganos abdominales puede limitarse con el uso de inmovilizadores corporales adaptados. Las consecuencias de no controlar este movimiento son un peor control de la enfermedad tumoral y la aparición de efectos secundarios, por ejemplo, al irradiar volúmenes importantes de hígado sano puede producirse un fallo hepático radio-inducido, que a su vez puede conllevar la muerte del individuo. Lo mismo ocurre en el resto de órganos de la región abdominal, pudiéndose producir úlceras duodenales, úlceras gástricas o perforaciones de visceras huecas (intestino o estómago). The movement to which the abdominal organs are subjected can be limited with the use of adapted body immobilizers. The consequences of not controlling this movement are worse control of tumor disease and the appearance of side effects, for example, by irradiating large volumes of healthy liver, radio-induced liver failure can occur, which in turn can lead to death of the liver. individual. The same occurs in the rest of the organs of the abdominal region, and duodenal ulcers, gastric ulcers or perforations of hollow viscera (intestine or stomach) can occur.
Desde hace unos años, la técnica de SBRT se realiza con éxito en tumores de pulmón, para ello se han desarrollado diferentes inmovilizadores corporales en este campo y son muchos los centros que hacen estos tratamientos. Sin embargo, la SBRT abdominal ha estado más limitada aunque se está empezando a implementar, como ocurre en nuestro centro. Dentro de no mucho tiempo, se comenzarán a renovar los aceleradores lineales de los centros públicos, permitiendo que en estos centros comiencen a llevarse a cabo estos tratamientos, precisando de un sistema de inmovilización óptimo. Lo mismo ocurre fuera del país, donde la técnica está algo más desarrollada. For a few years, the SBRT technique has been successfully performed on lung tumors, for which different body immobilizers have been developed in this field and many centers carry out these treatments. However, abdominal SBRT has been more limited, although it is beginning to be implemented, as is the case in our center. In a short time, the linear accelerators of public centers will begin to be renewed, allowing these centers to begin to carry out these treatments, requiring an optimal immobilization system. The same occurs outside the country, where the technique is somewhat more developed.
Para poder administrar la SBRT abdominal son necesarios inmovilizadores para esta región del cuerpo que disminuyan sobre todo el movimiento causado por la respiración. En el mercado existen varios dispositivos disponibles, como por ejemplo el descrito en la solicitud de patente norteamericana US 2012/0186588 A1 , pero son dispositivos complejos de utilizar y muy molestos para el paciente, por lo que ninguno de ellos es satisfactorio. In order to administer the abdominal SBRT, immobilizers are required for this region of the body, which reduces especially the movement caused by breathing. There are several devices available on the market, such as the one described in US patent application US 2012/0186588 A1, but they are complex devices to use and very bothersome for the patient, so none of them are satisfactory.
Existen diferentes técnicas de control del movimiento mediante inmovilización o marcadores en el tumor. Uno de estos sistemas es el“dampening” que se basa en la compresión controlada del abdomen del paciente para restringir el desplazamiento del diafragma durante el ciclo respiratorio, de esta forma también se limita el desplazamiento de las lesiones localizadas en pulmón o en abdomen superior. La compresión se realiza con dispositivos de tipo cinturón o tipo arco que están diseñados para que la compresión sea constante a lo largo del tratamiento. Este es uno de los métodos más empleados para disminuir el movimiento del tumor asociado a la respiración en SBRT sobretodo en pacientes con grandes desplazamientos. There are different techniques to control movement by immobilization or markers on the tumor. One of these systems is "dampening" which is based on controlled compression of the patient's abdomen to restrict the movement of the diaphragm during the respiratory cycle, thus also limiting the movement of lesions located in the lung or upper abdomen. The Compression is performed with belt-type or arch-type devices that are designed so that compression is constant throughout the treatment. This is one of the most used methods to decrease the movement of the tumor associated with respiration in SBRT, especially in patients with large displacements.
Es conocido que para una correcta aplicación de las técnicas de SBRT, es de vital importancia conseguir una posición estable y reproducible de los pacientes, y que la posición del paciente sea: con los brazos detrás de la cabeza y con un soporte de rodillas, It is known that for a correct application of the SBRT techniques, it is vitally important to achieve a stable and reproducible position of the patients, and that the position of the patient is: with the arms behind the head and with a knee support,
una posición segura para el paciente y para el tratamiento.  a safe position for the patient and for treatment.
A pesar de estas recomendaciones, las características exactas del movimiento varían en función de la localización tumoral y el inmovilizador óptimo aún no ha sido desarrollado. Despite these recommendations, the exact characteristics of the movement vary depending on the tumor location and the optimal immobilizer has not yet been developed.
Así, los principales inconvenientes de los dispositivos actuales, son: Thus, the main drawbacks of current devices are:
• Alteran el haz de irradiación por contener metal, esto dificulta la planificación, ya que al entrar el haz de irradiación por la zona del metal los cálculos de dosis se alteran y no se conocen con precisión, algo que con esta técnica de irradiación es muy importante por las dosis tan elevadas que se administran.• They alter the irradiation beam because it contains metal, this makes planning difficult, since when the irradiation beam enters the metal area, the dose calculations are altered and are not precisely known, something that with this irradiation technique is very important for the high doses that are administered.
• Incompatibilidad con la resonancia magnética, algunos por tamaño y otros por contener metal, lo que impide el uso de las imágenes de resonancia adquiridas con compresión abdominal, para la delimitación de volúmenes. • Incompatibility with magnetic resonance imaging, some due to size and others due to containing metal, which prevents the use of resonance images acquired with abdominal compression to delimit volumes.
• Otros dispositivos precisan de un entrenamiento del paciente y una función pulmonar conservada para llevarlos a cabo.  • Other devices require patient training and preserved lung function to perform them.
• Son incómodos para el paciente, provocando dolor, ansiedad o importante inquietud, lo que se traduce en respiraciones agitadas y forzadas y por tanto empeora la calidad del tratamiento.  • They are uncomfortable for the patient, causing pain, anxiety or major restlessness, which translates into heavy and forced breathing and therefore worsens the quality of treatment.
• Se tarda mucho tiempo en su correcta colocación.  • It takes a long time for its correct placement.
• Algunos sistemas son de un solo uso.  • Some systems are for single use only.
Por lo tanto, para extender y facilitar la implementación de la SBRT abdominal se hace necesario contar con un dispositivo adaptable, que facilite la tarea del técnico de radioterapia y mejore el confort del paciente mientras recibe el tratamiento. Descripción de la invención Therefore, to extend and facilitate the implementation of the abdominal SBRT, it is necessary to have an adaptable device, which facilitates the task of the radiotherapy technician and improves the patient's comfort while receiving the treatment. Description of the Invention
La invención consiste en un dispositivo de inmovilización preferentemente aplicable para SBRT abdominal, que se basa en la técnica del“dampening” descrita anteriormente para la inmovilización abdominal de pacientes. The invention consists of an immobilization device preferably applicable for abdominal SBRT, which is based on the dampening technique described above for abdominal immobilization of patients.
De este modo, un aspecto de la invención se refiere a un dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, preferentemente radioterapia, que comprende un cinto de material flexible que tiene una zona central y dos bandas laterales que parten de la zona central hasta los dos extremos del cinto. La zona central tiene un área adecuada para cubrir la mayor parte del abdomen de un paciente, con objeto de poder ejercer presión en cualquier zona del abdomen. Thus, one aspect of the invention relates to an abdominal immobilizer device for diagnosis and medical treatments, preferably radiotherapy, comprising a flexible material belt that has a central zone and two lateral bands that start from the central zone up to the two ends of the belt. The central area has an adequate area to cover most of a patient's abdomen, in order to be able to apply pressure to any area of the abdomen.
Las bandas laterales tienen una longitud adecuada para fijar el dispositivo a una mesa clínica a través de las barras laterales de la mesa, o alternativamente a través de un útil diseñado para esa finalidad que se describirá más adelante. The side bands are of adequate length to fix the device to a clinical table through the side bars of the table, or alternatively through a tool designed for that purpose that will be described later.
El dispositivo incorpora una placa de material plástico que aporta rigidez a esta zona central del cinto, que puede tener cierto grado de flexibilidad o ser completamente rígida, y que está inmersa en la zona central del cinto. La zona central está definida por la placa rígida. The device incorporates a plastic material plate that provides rigidity to this central zone of the belt, which can have a certain degree of flexibility or be completely rigid, and which is embedded in the central zone of the belt. The central zone is defined by the rigid plate.
El dispositivo además dispone de una o varias almohadillas de varios tamaños y formas, las cuales sirven como elemento de presión en una zona concreta del abdomen. La almohadilla es fijable por su base plana a una de las caras de la zona central, y puesto que el área de la base plana es menor que el área de la placa rígida, la almohadilla se puede fijar en diversas posiciones del abdomen, en función del órgano abdominal que se desea tratar (páncreas, hígado, glándulas suprarrenales, riñones y ganglios linfáticos) y la fisionomía del paciente. De este modo, el dispositivo es muy versátil, ya que se puede personalizar a cada paciente, eligiendo la posición de la almohadilla para presionar sobre la zona deseada. The device also has one or more pads of various sizes and shapes, which serve as a pressure element in a specific area of the abdomen. The pad is fixable by its flat base to one of the faces of the central area, and since the area of the flat base is less than the area of the rigid plate, the pad can be fixed in various positions of the abdomen, depending on of the abdominal organ to be treated (pancreas, liver, adrenal glands, kidneys and lymph nodes) and the patient's physiognomy. In this way, the device is very versatile, since it can be personalized to each patient, choosing the position of the pad to press on the desired area.
Preferentemente la almohadilla se fija al cinto mediante velero © (o cualquier variedad del mismo), ya que el velero al estar realizado con un material plástico y textil, no interfiere con la radiación. Preferably the pad is attached to the belt by sailboat © (or any variety thereof), since the sailboat, being made of a plastic and textile material, does not interfere with radiation.
Igualmente dispone de velero (o una variedad del mismo) para fijar parte de las bandas laterales en la otra cara de la zona central y/o parte de las propias bandas laterales cuando éstas se pliegan sobre sí mismas. Alternativamente, en lugar o en combinación con el velero, se utilizan unos corchetes o unas cinchas, para fijar parte de las bandas laterales en la otra cara de la zona central y/o parte de las propias bandas laterales cuando éstas se pliegan sobre sí mismas. It also has a sailboat (or a variety thereof) to fix part of the side bands on the other side of the central area and / or part of the bands themselves lateral when they fold over themselves. Alternatively, instead or in combination with the sailboat, brackets or straps are used, to fix part of the side bands on the other side of the central area and / or part of the side bands themselves when they fold over themselves. .
Algunas de las ventajas del dispositivo objeto de la invención, son las siguientes: Some of the advantages of the device object of the invention are the following:
- Versatilidad, se puede utilizar en cualquier órgano abdominal: páncreas, hígado, glándulas suprarrenales, riñones y ganglios linfáticos, logrando un control del movimiento personalizado. - Versatility, can be used in any abdominal organ: pancreas, liver, adrenal glands, kidneys and lymph nodes, achieving personalized movement control.
- Adaptabilidad a diferentes fisionomías de paciente (edad, peso, altura) y posibilidad de disponer de varias tallas para ello. - Adaptability to different physiognomies of the patient (age, weight, height) and the possibility of having various sizes for it.
- No va fijado a la mesa del tratamiento, lo que facilita su utilización en cualquier equipo de radioterapia, e incluso en otros equipos como TAC o resonancia por muy pequeña que sea. - It is not fixed to the treatment table, which facilitates its use in any radiotherapy equipment, and even in other equipment such as CT or resonance, however small it may be.
- No interfiere el tiempo de inmovilización con el tratamiento de otros pacientes, en muchas ocasiones solo se dispone de una mesa sobre la que va fijado el inmovilizador y es la que se utiliza para todos los pacientes. Puesto que el dispositivo se acoplar o retirar fácilmente de la mesa, ya no es necesario coordinar los pacientes en simulación y en la máquina de tratamiento a la vez. - The immobilization time does not interfere with the treatment of other patients, in many occasions only one table is available on which the immobilizer is fixed and is the one used for all patients. Since the device can be easily attached or removed from the table, it is no longer necessary to coordinate patients in simulation and in the treatment machine at the same time.
- Portátil y pequeño tamaño. - Portable and small size.
- Reutilizable y lavable, no es desechable por lo que no se encarece el coste del tratamiento. - Reusable and washable, it is not disposable so the cost of treatment is not expensive.
- Eficaz, ya que permite la administración de dosis altas de radiación con intención ablativa o curativa sobre los tumores malignos de páncreas, hígado, riñones, suprarrenales o ganglios, limitando los efectos secundarios sobre otros órganos sanos. - Effective, since it allows the administration of high doses of radiation with ablative or curative intention on malignant tumors of the pancreas, liver, kidneys, adrenals or nodes, limiting the secondary effects on other healthy organs.
- Compatible la resonancia magnética lo que permitirá su utilización para la delimitación de imágenes más precisa durante la fase de preparación del tratamiento de radioterapia. - De bajo coste por la sencillez de su diseño y los materiales de fabricación. - Magnetic resonance is compatible, which will allow its use for the most precise delimitation of images during the preparation phase of radiotherapy treatment. - Low cost due to the simplicity of its design and the manufacturing materials.
- Se trata de un dispositivo seguro para el paciente, que además aumenta su calidad de vida disminuyendo la ansiedad por la inmovilización con otros sistemas más voluminosos. - It is a safe device for the patient, which also increases their quality of life, reducing anxiety due to immobilization with other more voluminous systems.
- Rapidez, ya que hoy día con algunos de los dispositivos comercializados el tiempo que se tarda en realizar la inmovilización es muy alto, con este dispositivo reduciríamos este a una cuarta parte, disminuyendo la lista de espera en el TC de simulación y en la propia unidad de tratamiento, lo que nos permitiría aumentar el número de pacientes tratados. - Speed, since today with some of the commercialized devices the time it takes to perform the immobilization is very high, with this device we would reduce this to a quarter, reducing the waiting list in the simulation CT and in the own treatment unit, which would allow us to increase the number of patients treated.
- Aumento del control tumoral. - Increased tumor control.
Breve descripción de las figuras Brief description of the figures
Figura 1.- muestra en el dibujo 1 A) una vista en perspectiva desde la cara superior del cinto del dispositivo objeto de la invención; en el dibujo 1 B) muestra otra vista en perspectiva desde la cara inferior del dispositivo; y el dibujo 1 C) muestra una vista en sección transversal a lo largo del cinto del dispositivo. Figure 1.- shows in drawing 1 A) a perspective view from the upper face of the belt of the device object of the invention; in drawing 1 B) shows another perspective view from the underside of the device; and drawing 1 C) shows a cross-sectional view along the belt of the device.
Figura 2.- muestra en los dibujos 2A) y 2B) sendas vistas en perspectiva respectivamente desde la cara superior e inferior de una variante de la almohadilla de forma triangular; en los dibujos 2C) y 2D) sendas vistas en perspectiva respectivamente desde la cara superior e inferior de otra variante de la almohadilla de forma circular. Figure 2.- shows in drawings 2A) and 2B) respective perspective views respectively from the upper and lower face of a variant of the pad of triangular shape; in the drawings 2C) and 2D) respective perspective views respectively from the upper and lower face of another variant of the circular shaped pad.
Figura 3.- muestra un detalle ampliado y en perspectiva de la zona central del dispositivo con una de las almohadillas fijadas, y con una apertura en la parte derecha de la figura para mostrar la placa rígida. Figure 3.- Shows an enlarged and perspective detail of the central area of the device with one of the pads fixed, and with an opening on the right side of the figure to show the rigid plate.
Figura 4.- muestra una vista en perspectiva del útil de fijación a una mesa clínica. Figura 5.- muestra sendas vistas en perspectiva del dispositivo en uso con un paciente, en el dibujo 5A) fijado por sí mismo a través de las barras de una mesa hospitalaria, y en el dibujo 5B) fijado mediante el útil de la figura 4. Figure 4.- Shows a perspective view of the fixation tool to a clinical table. Figure 5.- Shows two perspective views of the device in use with a patient, in drawing 5A) fixed by itself through the bars of a hospital table, and in drawing 5B) fixed by means of the tool of figure 4 .
Figura 6.- muestra una vista del dispositivo en posición de uso fijado a las barras laterales de una mesa hospitalaria, donde la posición del abdomen de un paciente, se ha representado mediante línea discontinua. Figure 6.- Shows a view of the device in the position of use attached to the side bars of a hospital table, where the position of the abdomen of a patient has been represented by a dashed line.
Realización preferente de la invención PREFERRED EMBODIMENT OF THE INVENTION
La figura 1 muestra una realización preferente de un dispositivo inmovilizador abdominal para tratamientos de radioterapia según la invención, que comprende un cinto (1) de material flexible que tiene una zona central (1c) y dos bandas laterales (1 a, 1 b) que parten de la zona central (1c) hasta los dos extremos del cinto. Como se aprecia en la figura 1 , en esta realización preferente, la zona central (1c) es más ancha que las bandas laterales (1 a, 1b). Figure 1 shows a preferred embodiment of an abdominal immobilizer device for radiotherapy treatments according to the invention, which comprises a belt (1) of flexible material having a central area (1c) and two lateral bands (1 a, 1 b) that they start from the central zone (1c) to the two ends of the belt. As can be seen in figure 1, in this preferred embodiment, the central zone (1c) is wider than the lateral bands (1 a, 1b).
La zona central (1c) incorpora una placa (2) de material plástico, de cierto espesor para dar rigidez a la zona central, la cual es preferentemente rectangular y está inmersa en el cinto (1) y por lo tanto está oculta en el mismo. La extensión de la zona central (1c) está definida por la placa rígida (2), y está dimensionada para que en su utilización pueda cubrir la mayor parte del abdomen de un paciente. The central zone (1c) incorporates a plate (2) of plastic material, of a certain thickness to give rigidity to the central zone, which is preferably rectangular and is immersed in the belt (1) and is therefore hidden in it . The extension of the central zone (1c) is defined by the rigid plate (2), and is dimensioned so that in its use it can cover most of the abdomen of a patient.
El cinto (1) se puede fabricar con un material plástico o textil, que sea lavable, por ejemplo superponiendo dos capas de dicho material colocando la placa entre las dos capas, y posteriormente cosiendo o pegando entre sí las dos capas, de manera que la placa queda inmersa en el cinto. The belt (1) can be made of a plastic or textile material, which is washable, for example by superimposing two layers of said material by placing the plate between the two layers, and then sewing or gluing the two layers together, so that the plate is immersed in the belt.
Las bandas laterales (1a, 1 b) tienen una extensión adecuada para pasar por las barras laterales (7) (o el útil (4)) de una mesa clínica, tal y como se muestra en las figuras 5 y 6, y plegarse sobre sí mismas para la adecuada fijación e inmovilización de un paciente. The side bands (1a, 1 b) have a suitable extension to go through the side bars (7) (or the tool (4)) of a clinical table, as shown in Figures 5 and 6, and fold over themselves for the proper fixation and immobilization of a patient.
El dispositivo también incorpora uno o varias almohadillas (3) de varios tamaños y formas, para adaptarse mejor a la zona abdominal a inmovilizar. Para ello, la almohadilla tiene una base plana (9) para fijarse en distintas posiciones del área central (1c) del cinto (1), según le órgano abdominal tratar, logrando un uso personalizado para cada paciente y mayor eficiencia en la inmovilización. The device also incorporates one or more pads (3) of various sizes and shapes, to better adapt to the abdominal area to be immobilized. For this, the pad has a flat base (9) to be fixed in different positions of the central area (1c) of the belt (1), according to the abdominal organ to be treated, achieving a personalized use for each patient and greater efficiency in immobilization.
La figura 2 muestra varios ejemplos de almohadillas, por ejemplo la almohadilla de los dibujos (3A,3B) tiene dos bases planas, substancialmente paralelas entre sí, y de configuración triangular, mientras que la almohadilla de los dibujos (2C,2D) es una semi-esfera con una base plana (9) circular. Figure 2 shows several examples of pads, for example the pad of the drawings (3A, 3B) has two flat bases, substantially parallel to each other, and of triangular configuration, while the pad of the drawings (2C, 2D) is a semi-sphere with a flat base (9) circular.
El dispositivo de la invención, además dispone de un útil (4) que permite la fijación del cinto (1) a mesas clínicas que no dispongan de barras laterales. Este útil (4) se ha representado en la figura 4, y se compone de una placa central plana (5) que puede fijarse a la plataforma rígida de una mesa clínica por medios convencionales, por ejemplo mediante atornillado. El útil (4) tiene asas laterales (6,6') con forma de“U” emergentes ortogonalmente respectivamente de los extremos de la placa central (5), por donde se hacen pasar las bandas laterales (1 a, 1b) del cinto para la inmovilización de un paciente, como se muestra en la figura 5B. The device of the invention also has a tool (4) that allows the fixation of the belt (1) to clinical tables that do not have side bars. This tool (4) is shown in figure 4, and is made up of a flat central plate (5) that can be fixed to the rigid platform of a clinical table by conventional means, for example by screwing. The tool (4) has lateral handles (6,6 ' ) with a “U” shape emerging orthogonally respectively from the ends of the central plate (5), through which the lateral bands (1 a, 1b) of the belt are passed for immobilization of a patient, as shown in Figure 5B.
En la zona central (1c) y por una de las caras del cinto (1) (dibujo 1 A) se dispone de una primera parte de velero (8), mientras que la cara plana (9) de las almohadillas (3,3') disponen de la segunda parte de velero (8') complementaria con la primera (8), para obtener la fijación de ambas partes por contacto entre ellas de forma ya conocida. La base plana (9) de la almohadilla es menor que el área de la placa rígida (2), por lo que la almohadilla (3,3') se puede fijar en distintas posiciones de la zona de central (1c), de forma preestablecida para cada paciente en función del órgano al que se vaya a someter a una sesión de radioterapia, tal y como muestra la figura 3. In the central area (1c) and on one of the sides of the belt (1) (drawing 1 A) there is a first part of the sailboat (8), while the flat face (9) of the pads (3.3 ' ) have the second part of the sailboat (8 ' ) complementary to the first (8), to obtain the fixing of both parts by contact between them in a known manner. The flat base (9) of the pad is less than the area of the rigid plate (2), so that the pad (3,3 ' ) can be fixed in different positions in the central area (1c), so pre-established for each patient depending on the organ to be subjected to a radiotherapy session, as shown in figure 3.
Para ayudar en el posicionamiento adecuado de la almohadilla (3,3'), el cinto (1) dispone en uno de sus bordes, de una escala graduada (10) en una unidad de longitud. To assist in the proper positioning of the pad (3,3 ' ), the belt (1) has on one of its edges, a graduated scale (10) in a unit of length.
La otra cara del cinto (1) (dibujo 1 B), dispone sobre la zona central (1c) y sobre una parte interna de las bandas laterales (1a, 1b) una primera parte de velero (8), mientras que el resto de las bandas laterales (1a, 1 b) hasta los extremos disponen de la segunda parte de velero (8') complementaria con la primera (8) para unir ambas partes por presión, cuando las bandas laterales se pliegan sobre sí mismas hacia el centro del cinto pasando por las barras (7) de una mesa o por las asas (6,6') del útil (4), pudiéndose ajustar de este modo el cinto para inmovilizar adecuadamente la zona abdominal deseada de un paciente. The other side of the belt (1) (drawing 1 B), has on the central area (1c) and on an internal part of the lateral bands (1a, 1b) a first part of the sailboat (8), while the rest of the lateral bands (1a, 1 b) up to the ends have the second part of the sailboat (8 ' ) complementary to the first (8) to join both parts by pressure, when the lateral bands fold on themselves towards the center of the belt passing through the bars (7) of a table or by the handles (6,6 ' ) of the tool (4), thus being able to adjust the belt to properly immobilize a patient's desired abdominal area.
En este proceso de inmovilización, la placa rígida (2) constituye un soporte adecuado para la almohadilla (3,3'), que potencia la presión que puede ejercer la misma sobre la zona abdominal. In this immobilization process, the rigid plate (2) constitutes a suitable support for the pad (3,3 ' ), which enhances the pressure that it can exert on the abdominal area.

Claims

R E I V I N D I C A C I O N E S
1.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, caracterizado porque comprende: 1.- Abdominal immobilizer device for diagnosis and medical treatments, characterized in that it comprises:
un cinto de material flexible que tiene una zona central y dos bandas laterales que parten de la zona central hasta los dos extremos del cinto, y donde el cinto está dimensionado para que su zona central pueda cubrir la mayor parte del abdomen de un paciente,  a flexible material belt that has a central zone and two lateral bands that start from the central zone to the two ends of the belt, and where the belt is dimensioned so that its central zone can cover most of a patient's abdomen,
una placa de material plástico inmersa en la zona central y que define dicha zona central,  a plate of plastic material immersed in the central zone and defining said central zone,
al menos una almohadilla que tiene una base plana cuyo área es menor que el área de la placa rígida,  at least one pad having a flat base whose area is less than the area of the rigid plate,
un medio de fijación para fijar la almohadilla mediante su base plana a una de las caras de la zona central,  fixing means to fix the pad by means of its flat base to one of the faces of the central area,
un medio de fijación para fijar parte de las bandas laterales en la otra cara de la zona central y/o parte de las propias bandas laterales cuando éstas se pliegan sobre sí mismas.  fixing means for fixing part of the side bands on the other side of the central area and / or part of the side bands themselves when they fold over on themselves.
2.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos según la reivindicación 1 , caracterizado porque el medio de fijación entre la almohadilla y el cinto, es velero. 2.- Abdominal immobilizer device for diagnosis and medical treatments according to claim 1, characterized in that the means of fixation between the pad and the belt is a sailboat.
3.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos según la reivindicación 1 o 2, caracterizado porque el medio de fijación para fijar parte de las bandas laterales en la otra cara de la zona central y/o parte de las propias bandas laterales, es velero. 3.- Abdominal immobilizer device for diagnosis and medical treatments according to claim 1 or 2, characterized in that the fixing means to fix part of the lateral bands on the other side of the central zone and / or part of the lateral bands themselves, is sailboat.
4 Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos según la reivindicación 1 o 2, caracterizado porque el medio de fijación para fijar parte de las bandas laterales en la otra cara de la zona central y/o parte de las propias bandas laterales, son unos corchetes o unas cinchas. 4 Abdominal immobilizer device for diagnosis and medical treatments according to claim 1 or 2, characterized in that the fixing means for fixing part of the lateral bands on the other side of the central area and / or part of the lateral bands themselves, are brackets or some straps.
5.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según cualquiera de las reivindicaciones anteriores, caracterizado porque la placa de plástico es rectangular. 5.- Abdominal immobilizer device for diagnosis and medical treatments, according to any of the previous claims, characterized in that the plastic plate is rectangular.
6.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según cualquiera de las reivindicaciones anteriores, caracterizado porque la zona central es más ancha que las bandas laterales. 6. Abdominal immobilizer device for diagnosis and medical treatments, according to any of the previous claims, characterized in that the central area is wider than the lateral bands.
7.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según cualquiera de las reivindicaciones anteriores, caracterizado porque la almohadilla tiene configuración triangular vista en planta. 7.- Abdominal immobilizer device for diagnosis and medical treatments, according to any of the preceding claims, characterized in that the pad has a triangular plan view configuration.
8.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según cualquiera de las reivindicaciones 1 a 6, caracterizado porque la almohadilla tiene configuración circular vista en planta. 8. Abdominal immobilizer device for diagnosis and medical treatments, according to any of claims 1 to 6, characterized in that the pad has a circular configuration seen in plan.
9.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según cualquiera de las reivindicaciones anteriores, caracterizado porque además comprende un útil para la fijación del cinto a una plataforma rígida de una mesa sanitaria, y porque el útil comprende una placa central plana, y dos asas laterales con forma de“U” emergentes ortogonalmente respectivamente de los extremos de la placa central. 9.- Abdominal immobilizer device for diagnosis and medical treatments, according to any of the previous claims, characterized in that it also comprises a tool for fixing the belt to a rigid platform of a sanitary table, and because the tool comprises a flat central plate, and two lateral U-shaped handles emerging orthogonally respectively from the ends of the central plate.
10.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos de radioterapia, según cualquiera de las reivindicaciones anteriores, caracterizado porque en una cara del cinto dispone de una parte de velero en la zona central. 10.- Abdominal immobilizer device for diagnosis and radiotherapy treatments, according to any of the previous claims, characterized in that on one side of the belt it has a sailboat part in the central area.
11.- Dispositivo inmovilizador abdominal para diagnóstico y tratamientos médicos, según la reivindicación 9, caracterizado porque la otra cara del cinto dispone de una parte de velero en la zona central y en una parte interna de las bandas laterales, y porque dispone de otra parte de velero complementaria con la anterior, en el resto de las bandas laterales. 11.- Abdominal immobilizer device for diagnosis and medical treatments, according to claim 9, characterized in that the other side of the belt has a sailboat part in the central area and an internal part of the side bands, and because it has another part sailboat complementary to the previous one, in the rest of the lateral bands.
PCT/ES2019/070772 2018-11-12 2019-11-12 Abdominal immobilisation device for medical diagnosis and treatment WO2020099706A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202015101579U1 (en) * 2015-03-27 2015-07-14 Dornier Medtech Systems Gmbh System for reducing the respiratory movement of abdominal organs
CN105214216A (en) * 2015-11-17 2016-01-06 中国人民解放军第二军医大学 A kind of stereotactic radiotherapy assists the staylace of use
WO2017064182A1 (en) * 2015-10-16 2017-04-20 Pearl Technology Ag Fixation device for a part of the body

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE202015101579U1 (en) * 2015-03-27 2015-07-14 Dornier Medtech Systems Gmbh System for reducing the respiratory movement of abdominal organs
WO2017064182A1 (en) * 2015-10-16 2017-04-20 Pearl Technology Ag Fixation device for a part of the body
CN105214216A (en) * 2015-11-17 2016-01-06 中国人民解放军第二军医大学 A kind of stereotactic radiotherapy assists the staylace of use

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