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WO2020169872A1 - Otic applicator device - Google Patents

Otic applicator device Download PDF

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Publication number
WO2020169872A1
WO2020169872A1 PCT/ES2020/070131 ES2020070131W WO2020169872A1 WO 2020169872 A1 WO2020169872 A1 WO 2020169872A1 ES 2020070131 W ES2020070131 W ES 2020070131W WO 2020169872 A1 WO2020169872 A1 WO 2020169872A1
Authority
WO
WIPO (PCT)
Prior art keywords
membrane
window
filament
applicator device
oval
Prior art date
Application number
PCT/ES2020/070131
Other languages
Spanish (es)
French (fr)
Inventor
Carlos MAGRIÑÁ VECIANA
Original Assignee
Nomen Calvet, Juan Eusebio
ROVIRA VILARÓ, Xavier
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 Nomen Calvet, Juan Eusebio, ROVIRA VILARÓ, Xavier filed Critical Nomen Calvet, Juan Eusebio
Publication of WO2020169872A1 publication Critical patent/WO2020169872A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/227—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for ears, i.e. otoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body

Definitions

  • the present invention relates to a device for the precise application with visual control and controlled retention of fluids or gels containing substrates, therapeutic substances, stem cells or growth factors on the membrane of the round window or of the oval window and for the application controlled energy over these fluids or gels for the mobilization of carriers, drug carriers, activated by energy sources, to improve the passage through the membrane of the oval window or the round window and to position and release the therapeutic product, the stem cells or growth factors in the desired area of the inner ear or in the area of the cochlea suitable to access the central nervous system, in order to carry out therapeutic and regenerative treatments of the inner ear, its nervous system and the central nervous system .
  • the membrane of the round window has a level of permeability to certain fluids or gels that allows the passage of these from the middle ear to the inner ear and, where appropriate, to the central nervous system.
  • the oval window also has a similar permeability to the same permeable substances as the round window and allows access to the part of the Inner ear that is closest to the sensors that are part of the vestibular system. Access to these round and oval windows is made through a puncture or incision in the tympanic membrane. It is known that from the cochlea of the inner ear the central nervous system can be accessed through the cerebrospinal fluid. Endoscopic devices are known.
  • an Injection-type applicator device can currently be used that by means of a puncture passes through the tympanic membrane until it reaches the membrane of the round window or the oval window. This procedure does not allow a visual control of the contribution made and part of the fluid may drain uncontrollably through the Eustachian tube.
  • the wick passes through the opening made in the tympanic membrane, occluding it and making vision impossible to correctly direct said wick to the round or oval window.
  • fluids are poured from the outer ear into the middle ear in order to reach the membrane of the round window or the oval window.
  • These devices in the form of a closed conduit tube or wick pose several problems: lack of visual control in the attempt to apply the fluid on the membrane of the round window or of the oval window; and of an infectious type due to lack of ventilation, in the case of the wick, as it is a space in which the cultivation of pathogens is facilitated, including bacteria from the external ear that find an entry medium in the wick and culture within the middle and inner ear.
  • the present invention seeks to solve one or more of the drawbacks and challenges set forth above by means of an applicator device as defined in the claims.
  • the applicator device is configured to direct, visually control, and retain fluids and gels containing therapeutic substances, substrate, stem cells, or growth factors from the outer ear toward the membrane of the round window or oval window.
  • the device is configured to provide energy in a controlled way to activate carriers, drug carriers, in order to position and release therapeutic substances, stem cells or growth factors in a precise area of the inner ear and especially the cochlea to access the central nervous system in a controlled way.
  • the applicator device comprises an otic endoscope that allows a clear view of the middle ear from the outer ear; It comprises a guide for supplying fluids or gels or energy with an outlet that is positioned on the membrane of the round window or the oval window and whose function is to apply the precise dose of fluid or gel in a controlled manner on the membrane.
  • round window or oval window It comprises at least one energy supply guide with the function of activating carriers, drug carriers, containing therapeutic substances, stem cells or growth factors in a controlled and precise manner; a feeding mouth that is fixed to the tympanic membrane and through which the otic endoscope, the guide for supplying fluids or gels and the guide for supplying energy are introduced; and at least one filament connected to the feeding mouth and positioned in contact with or close to the membrane of the round window or the oval window of the ear and whose function is to guide, channel and retain in a controlled manner on the membrane 6 of the round window or oval window the fluids or gels delivered from the fluid or gel delivery guide.
  • the therapeutic substance, stem cells or growth factors can be delivered on the membrane of the round window or of the oval window with carriers, drug carriers.
  • the energy source required by the carrier, drug carrier can be provided in a precise, controlled and adequate intensity in order to activate the carrier with the corresponding energy to activate the movement to through the membrane of the oval window or the round window or to release the substances contained within the carrier, drug carrier.
  • the desired area of the inner ear or the cochlea to deliver the precise doses in the desired place in order to carry out precisely and controlled therapeutic and regenerative treatments of the inner ear, its nervous system and the central nervous system.
  • Carriers, drug carriers may have markers so that, through the endoscope, the rate of fluid absorption can be accurately monitored or gel with carriers, drug carriers, which takes place through the membrane of the round window or the oval window.
  • The, at least one, filament can be composed of different materials and can have different coatings with the appropriate polarity according to the polarity needs that are required to achieve more or less adhesion forces with the fluid or gel to be applied and controlled in a controlled manner.
  • the at least one filament may have a final fat to facilitate bearing on the membrane of the round window or oval window and improve controlled retention of fluids or gels.
  • the at least one filament may be connected to a fine capillary structure that covers, at least in part, the membrane of the round window or of the oval window to facilitate controlled retention of the fluids or gels.
  • the at least one filament can be elongated or spiral, it can have different angles in relation to the plane of the tympanic membrane and it can have a cylindrical, irregular or flattened section to form slats, to increase the adhesion surface and facilitate canalization and retention of fluids or gels on the round window or oval window membrane.
  • the otic endoscope introduced through the feeding mouth allows perfect visualization of the middle ear; allows to clearly identify the position of the membrane of the round window or of the oval window, which may differ between patients; allows the outlet mouth of the fluid or gel application guide to be precisely positioned close to the membrane of the round window or oval window once the guide outlet is perfectly positioned near the desired application point; It allows to introduce and apply on the membrane of the round window or of the oval window the precise dose of fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors; allows visual control of the process of applying a fluid or gel and the result of this application; and allows to visualize the position of the energy supply guide and visually control the energy supply on the fluid or gel containing drug carriers.
  • the at least one filament between the feeding mouth and the membrane of the round window or of the oval window allows: to guide or channel the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors in an orderly manner in the final section until reaching the membrane of the round window or of the oval window, when the exit of the guide is kept close to the membrane of the round window or of the oval window; and, by adhesion, it allows the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors to be retained on the membrane of the round window or the oval window in a controlled manner.
  • the endoscope and its guide are removed so that the at least one filament retains the fluid or gel in the desired position and a hygienic path free of obstructions from the mouth is maintained until the next application. feeding.
  • the at least one filament facilitates the application of therapeutic fluids with some precision by applying a drip in the feeding mouth.
  • FIG. 1 shows a diagram of an applicator device consisting of an endoscope with a guide for supplying fluids or gels and a feeding mouth attached to the tympanic membrane through which the endoscope and its guide for supplying fluids or gels are inserted and with at least one filament that reaches the membrane of the round window or the oval window.
  • FIG. 2 shows a diagram of an applicator device composed of an endoscope with a guide for the delivery of fluids or gels, with a guide for the delivery of energy to activate carriers, drug carriers, and a feeding mouth attached to the tympanic membrane by the one where the endoscope is inserted, its guide for the supply of fluids or gels and its guide for the supply of energy and with at least one filament that reaches the membrane of the round window or oval window.
  • FIG. 3 shows a diagram of the portion of the feeding mouth of an applicator device with at least one filament in contact with a wick that covers, at least in part, the membrane of the round window or of the oval window.
  • FIG. 4 shows a diagram of the portion of the feeding mouth of an applicator device with at least one filament with a fat that facilitates contact with the membrane of the round window or the oval window.
  • FIG. 5 shows a schematic of the feeding mouth portion of an applicator device with at least one filament forming an angle other than 90 ° between the filament and the plane of the tympanic membrane.
  • FIG. 6 shows a diagram of the portion of the feeding mouth of an applicator device with the at least one spiral-shaped filament.
  • FIG. 7 shows a diagram of the portion of the feeding mouth of the applicator device with at least one filament in the shape of a slat to increase the adhesion surface and facilitate the channeling of fluids or gels and the retention of fluids or gels on the membrane of the round window or oval window.
  • Figure 1 shows an applicator device with the following characteristics:
  • An embodiment of this visual window, feeding mouth 15 and support comprises at least two washers, an outer washer
  • the mouth of feed 15 can also have a geometric or irregular section but the cylindrical section 2 has the smallest perimeter in relation to the surface of the section of the feeding mouth 15, which allows to reduce the injury caused by the incision in the tympanic membrane 1.
  • the otic endoscope 11, a guide for supplying fluids or Gels 12 and an energy supply guide 17 are then introduced through the feeding mouth 15 so that the otic endoscope 11 has visual control from a viewer 14 on a membrane 6 of the round window or of the oval window, which allows the physician precisely and control position a guide outlet 13 or the outlet of the energy supply guide 17 on the membrane 6 of the round or oval window, and deliver in a controlled way the therapeutic substance, the substrate, the stem cells or the growth factors on the membrane 6 of the round window or of the oval window or provide energy on the carriers, drug carriers for their activation.
  • the applications of sorption-enhancing substrates for stem cells and the applications of growth factors and stem cells require precision and control in the doses provided and precision in the place where these products are applied.
  • the applications of therapeutic substances to reach specific positions in the cochlea to access specific locations in the central nervous system require precision and control.
  • the applicator device allows to deliver in a precise and controlled manner and retain on the membrane 6 of the round window or of the oval window fluids or gels containing a sorption-enhancing substrate, containing therapeutic substances, containing stem cells or containing growth factors, being the membrane 6 of the round window or of the oval window access routes for direct entry of therapeutic substances, stem cells or growth factors into the Inner ear for therapeutic or regenerative treatments of the Inner ear and its nervous system.
  • the applicator device can be used for regenerative and therapeutic stem cell or growth factor treatments for the Inner ear, for your nervous system and also for Therapeutic and regenerative treatments of the central nervous system by supplying therapeutic substances, stem cells or growth factors through the membrane 6 of the oval window or the round window.
  • Carriers, drug carriers facilitate the process of crossing the membrane 6 of the oval window or the round window and allow the release of the therapeutic substance, stem cells or growth factors they carry at the desired time and place.
  • Carriers, drug carriers can be activated by supplying energy.
  • An energy supply guide 17 like the one shown in Figure 2, allows to provide the necessary energy with precision and visual control on the fluid or gel containing the carriers, drug carriers, that carry a therapeutic substance, stem cells or factors of increase.
  • This precision and control in the energy supply on the carriers allows to precisely mobilize and release the therapeutic substance, stem cells or growth factors to the desired area of the Inner ear, including the cochlea, with the aim of providing the precise dose in the right place to carry out precise therapeutic or regenerative treatments in the Inner ear, in its nervous system or in the central nervous system.
  • the purpose of the fluid or gel supply guide 12 is to provide the fluids or gels with precision and control to the desired point.
  • the function of the energy supply guide 17 is to provide energy with precision and control to the carriers, drug carriers.
  • the function of the at least one filament 5 is to hold the fluids or gels in a controlled manner on the membrane 6 of the round window or of the oval window.
  • The, at least one, filament 5 can also carry out the function of guiding the fluid or gel, by adhesion forces, from the feeding mouth 15 to the membrane 6 of the round window or the oval window, but with less precision than which is achieved with the combination of the endoscope 11 and its guide for the supply of fluids or gels 12.
  • the at least one filament 5 can help guide or channel the fluid or gel in the final section between the guide outlet 13 and the 6 membrane of round window or oval window.
  • the adhesion forces between the, at least one, filament 5 and the fluid or gel also allow channeling or guiding a fluid or gel from the feeding mouth 15 to the membrane 6 of the round window or of the oval window, supplying it from the ear. external, but with less control than with the combination of the otic endoscope 11, its guide for the delivery of fluids or gels 12 and the, at least one, filament 5.
  • the feeding mouth 15 has a section between 1.6 mm and 2.5 mm in internal diameter, sufficient to facilitate the introduction of the otic endoscope 11 and the guide for supplying fluids or gels or energy 12 and being the most small possible to facilitate the healing of the incision to be made in the tympanic membrane
  • the at least one filament 5 attached to the inside of the cylinder 2 or to one of the two washers 3, 4 so that the fluid or gel supplied from the guide outlet 13 drips or flows in the form of a thin film in an orderly manner through it, at least one filament 5 up to the membrane 6 of the round window or of the oval window and the at least one filament 5 retains the fluid or gel on the membrane 6 of the round or oval window.
  • the at least one filament 5 is made of a material flexible enough to maintain the necessary tension between the Interior part of the feeding mouth 15 and the surface of the membrane 6 of the round window or of the oval window and to avoid displacement and damage to the membrane 6 of the round window or oval window.
  • the material can be mechanically molded or thermo-moldable, so that it has flexibility at a temperature other than body temperature and that at body temperature it maintains the fixed position.
  • The, at least one, filament 5 can be composed of different materials and can have different coatings that will be selected according to the polarity and adhesion properties appropriate to the properties of the fluid or gel to be applied, to get the fluid or gel to enter and the surface of the at least one filament 5 produces the necessary adhesion forces to retain in a controlled way the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors on the membrane 6 of the window round or oval window.
  • different fluids or gels may require different finishes or composition materials for the at least one filament 5.
  • the at least one filament 5 allows channeling up to the membrane 6 of the round window or the oval window a therapeutic fluid or gel that is delivered from the outer ear through the feeding mouth 15.
  • The, at least one, filament 5 allows a hygienic ventilation between the inner ear and the outer ear reducing the risk of infection.
  • Figure 3 shows a diagram of the portion of the feeding mouth 15 of the applicator device with the end of the, at least one, filament 5 attached to a wick, 7 to keep a fluid or gel in contact with it for a controlled time.
  • the membrane 6 of the round window or of the oval window in order to achieve the filtering or absorption process of the therapeutic fluid or gel.
  • This wick 7 can preferably have a diameter of around 2mm, which is the reasonable size of an incision in the tympanic membrane 1. The placement of this fine wick 7 allows the controlled retention of substances that increase the permeability of the membrane 6 of the round window or oval window facilitating the subsequent controlled delivery and retention of stem cells or growth factors.
  • Figure 4 shows a diagram of the portion of the feeding mouth 15 of the applicator device in which the end of the, at least one, filament 5 presents a significant thickening 8 to have better orientation, support and adhesion area on the membrane 6 round window or oval window and facilitate retention of fluids or gels.
  • Figure 5 shows a diagram of the portion of the feeding mouth 15 of the applicator device with the at least one angled filament 9 positioned at an angle other than a right angle relative to the plane of the tympanic membrane 1. Since the membrane 6 of the round window or of the oval window of a patient may be in a position other than perpendicular to the plane of the tympanic membrane 1, applicator devices may be manufactured with materials that allow mechanical molding or thermoformed with, at least, an angled filament 9 to form different angles that facilitate the most appropriate placement of the device to the characteristics of each patient.
  • Figure 6 shows a diagram of the portion of the feeding mouth 15 of the applicator device with at least one angled filament 9 with a spiral shape to facilitate the retention of fluids or gels on the membrane 6 of the round window. or the oval window.
  • the at least one filament 5, 9 can have a circular, irregular or elongated section or forming a cylinder section 2 as in Figure 7, which shows a diagram of the portion of the feeding mouth 15 of the applicator device with the at least one filament 16 with a slat shape in order to increase the adhesion surface and facilitate the channeling of fluids or gels and the retention of fluids or gels on the membrane 6 of the round window or of the oval window.

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Abstract

The invention relates to an otic applicator device that directs, applies and retains, with precision and visual control, fluids and gels containing therapeutic substances, substrates, stem cells or growth factors on a membrane (6) of an oval or round window, for therapeutic and regenerative treatments of the inner ear and its nervous system and for therapeutic and regenerative treatments of the central nervous system, wherein the applicator device comprises an otic endoscope (11), a fluid-supply guide (12), an energy-supply guide (17) for activating carriers, a viewing window, a supply opening (15) and a support on the eardrum membrane (1) provided by at least one outer washer (3) and one inner washer (4), and at least one filament (5) for the guiding and controlled retention of a fluid or gel.

Description

DISPOSITIVO APLICADOR ÓTICO OPTICAL APPLICATOR DEVICE
OBJETO OBJECT
La presente invención se refiere a un dispositivo para la aplicación precisa con control visual y retención controlada de fluidos o geles conteniendo sustratos, sustancias terapéuticas, células madre o factores de crecimiento sobre la membrana de la ventana redonda o de la ventana oval y para la aplicación controlada de energía sobre estos fluidos o geles para la movilización de portadores, drug carriers, activadles por fuentes de energía, para mejorar el paso a través de la membrana de la ventana oval o de la ventana redonda y posicionar y liberar el producto terapéutico, las células madre o los factores de crecimiento en la zona del oído interno deseada o en la zona de cóclea adecuada para acceder al sistema nervioso central, con el fin de efectuar tratamientos terapéuticos y regenerativos del oído Interno, de su sistema nervioso y del sistema nervioso central. The present invention relates to a device for the precise application with visual control and controlled retention of fluids or gels containing substrates, therapeutic substances, stem cells or growth factors on the membrane of the round window or of the oval window and for the application controlled energy over these fluids or gels for the mobilization of carriers, drug carriers, activated by energy sources, to improve the passage through the membrane of the oval window or the round window and to position and release the therapeutic product, the stem cells or growth factors in the desired area of the inner ear or in the area of the cochlea suitable to access the central nervous system, in order to carry out therapeutic and regenerative treatments of the inner ear, its nervous system and the central nervous system .
ESTADO DE LA TÉCNICA STATE OF THE ART
Para poder Introducir fluidos o geles en el oído Interno disponemos de dos vías de acceso con una cierta permeabilidad a fluidos o geles: la membrana de la ventana redonda y la membrana de la ventana oval. In order to introduce fluids or gels into the inner ear, we have two access routes with a certain permeability to fluids or gels: the round window membrane and the oval window membrane.
Es conocido que la membrana de la ventana redonda tiene un nivel de permeabilidad a ciertos fluidos o geles que permite el paso de éstos desde el oído medio hasta el oído Interno y, en su caso, hasta el sistema nervioso central. It is known that the membrane of the round window has a level of permeability to certain fluids or gels that allows the passage of these from the middle ear to the inner ear and, where appropriate, to the central nervous system.
Es conocido que algunas sustancias terapéuticas tienen una mala capacidad para atravesar membranas orgánicas, como la membrana de la ventana redonda o de la ventana oval. Es conocido que los portadores, más comúnmente denominados bajo el término inglés drug carriers, mejoran el paso de sustancias terapéuticas, células madre o factores de crecimiento a través de las membranas orgánicas como es el caso de la membrana de la ventana redonda y de la ventana oval. Es conocido que los portadores, drug carriers, se pueden activar con el aporte de una energía específica para cada portador como la lumínica, calórica, magnética o química y es conocido que un portador puede liberar en el punto y momento deseado la sustancia terapéutica, la célula madre o el factor de crecimiento que acarrea, al ser activado por una fuente de energía. It is known that some therapeutic substances have a poor ability to pass through organic membranes, such as the membrane of the round window or the oval window. It is known that carriers, more commonly known under the English term drug carriers, improve the passage of therapeutic substances, stem cells or growth factors through organic membranes, as is the case of the membrane of the round window and the window oval. It is known that drug carriers can be activated with the contribution of a specific energy for each carrier such as light, caloric, magnetic or chemical and it is known that a carrier can release the substance at the desired point and time. therapy, the stem cell or the growth factor that it carries, when activated by an energy source.
La ventana oval también tiene una permeabilidad parecida a las mismas sustancias permeables a la ventana redonda y permite el acceso a la parte del oído Interno que se encuentra más cerca de los sensores que forman parte del sistema vestibular. El acceso a dichas ventanas redonda y oval se efectúa mediante una punción o una Incisión en la membrana timpánica. Es conocido que a partir de la cóclea del oído Interno se puede acceder al sistema nervioso central por medio del fluido cefalorraquídeo. Son conocidos los dispositivos endoscópicos. The oval window also has a similar permeability to the same permeable substances as the round window and allows access to the part of the Inner ear that is closest to the sensors that are part of the vestibular system. Access to these round and oval windows is made through a puncture or incision in the tympanic membrane. It is known that from the cochlea of the inner ear the central nervous system can be accessed through the cerebrospinal fluid. Endoscopic devices are known.
Actualmente, el acceso al oído medio desde el oído externo se puede realizar mediante una punción o una Incisión quirúrgica en la membrana timpánica. Esta Incisión suele tener un diámetro en torno a 2 mm para permitir su posterior cicatrización correcta. La ventana oval y la ventana redonda se encuentran apartadas de la membrana timpánica de modo que el correcto aporte de fluidos o geles hasta la membrana de la ventana oval o la ventana redonda sin control visual es difícil. Además, los fluidos o geles que se aportan sin el debido control dentro del oído medio y sin elementos de retención, se pueden drenar rápidamente por la trompa de Eustaquio. Currently, access to the middle ear from the outer ear can be done through a puncture or surgical incision in the tympanic membrane. This incision usually has a diameter of around 2 mm to allow its subsequent correct healing. The oval window and the round window are located away from the tympanic membrane so that the correct delivery of fluids or gels to the membrane of the oval window or the round window without visual control is difficult. In addition, fluids or gels that are delivered uncontrollably into the middle ear and without retention elements can quickly drain through the Eustachian tube.
Para tratamientos ocasionales, actualmente se puede utilizar un dispositivo aplicador tipo Inyección que mediante una punción atraviesa la membrana timpánica hasta llegar a la membrana de la ventana redonda o de la ventana oval. Este procedimiento no permite efectuar un control visual del aporte realizado y parte del fluido puede drenarse descontroladamente por la trompa de Eustaquio. For occasional treatments, an Injection-type applicator device can currently be used that by means of a puncture passes through the tympanic membrane until it reaches the membrane of the round window or the oval window. This procedure does not allow a visual control of the contribution made and part of the fluid may drain uncontrollably through the Eustachian tube.
Los Inconvenientes que presenta el procedimiento descrito en el punto anterior para el caso de tratamientos que requieren aplicaciones controladas del producto terapéutico o en tratamientos que requieren repetidas aplicaciones a lo largo de semanas o meses son, por una parte, que la aplicación de continuas Inyecciones podría provocar lesiones en la membrana timpánica, así como también en la membrana de la ventana redonda o de la ventana oval y, por otra parte, que dicho procedimiento no permite control visual durante la aplicación. Para tratamientos prolongados en el tiempo existen actualmente dispositivos aplicadores que incorporan un conducto cerrado o una mecha, generalmente denominada con el término inglés wick, que atraviesa la incisión en la membrana timpánica llegando a proximidad de la ventana redonda o de la ventana oval. La mecha atraviesa la apertura realizada en la membrana timpánica, ocluyéndola e imposibilitando la visión para dirigir correctamente dicha mecha hasta la ventana redonda u oval. Dentro de este conducto o mecha se vierten fluidos desde el oído externo que llegan al oído medio con el objetivo de alcanzar la membrana de la ventana redonda o de la ventana oval. Estos dispositivos con forma de tubo de conducto cerrado o de mecha plantean diversos problemas: de ausencia de control visual en el intento de aplicación del fluido sobre la membrana de la ventana redonda o de la ventana oval; y de tipo infeccioso por falta de ventilación, en el caso de la mecha, por tratarse de un espacio en el que se facilita el cultivo de agentes patógenos, entre ellos las bacterias provenientes del oído externo que encuentran en la mecha un medio de entrada y cultivo dentro del oído medio e Interno. The drawbacks of the procedure described in the previous point in the case of treatments that require controlled applications of the therapeutic product or in treatments that require repeated applications over weeks or months are, on the one hand, that the application of continuous injections could cause lesions on the tympanic membrane, as well as on the membrane of the round window or oval window and, on the other hand, that said procedure does not allow visual control during the application. For long-term treatments, there are currently applicator devices that incorporate a closed canal or a wick, generally known by the English term wick, which passes through the incision in the tympanic membrane, reaching the proximity of the round window or the oval window. The wick passes through the opening made in the tympanic membrane, occluding it and making vision impossible to correctly direct said wick to the round or oval window. Inside this canal or wick, fluids are poured from the outer ear into the middle ear in order to reach the membrane of the round window or the oval window. These devices in the form of a closed conduit tube or wick pose several problems: lack of visual control in the attempt to apply the fluid on the membrane of the round window or of the oval window; and of an infectious type due to lack of ventilation, in the case of the wick, as it is a space in which the cultivation of pathogens is facilitated, including bacteria from the external ear that find an entry medium in the wick and culture within the middle and inner ear.
Para tratamientos prolongados en el tiempo también existen actualmente dispositivos cilindricos que se anclan en la membrana timpánica, tras realizar una incisión sobre la misma, y que permiten el vertido de sustancias en el oído externo con el fin de alcanzar el oído medio y finalmente permear a través de la membrana de la ventana redonda o de la ventana oval dentro del oído Interno. Dichos dispositivos presentan problemas de falta de visión y de falta de precisión en el objetivo de aportar las sustancias terapéuticas sobre la membrana de la ventana redonda o de la ventana oval. A esto se le añade que la sustancia o agente terapéutico instilado difícilmente puede llegar a la membrana de la ventana redonda o de la ventana oval en las dosis precisas deseadas y, a su vez, por la proximidad anatómica, que el agente terapéutico Instilado puede perderse a través de la trompa de Eustaquio. For long-term treatments, there are currently also cylindrical devices that are anchored in the tympanic membrane, after making an incision on it, and that allow the discharge of substances into the external ear in order to reach the middle ear and finally permeate the through the membrane of the round window or the oval window into the inner ear. Said devices present problems of lack of vision and lack of precision in the objective of delivering the therapeutic substances on the membrane of the round window or the oval window. To this is added that the instilled therapeutic agent or substance can hardly reach the membrane of the round window or of the oval window in the precise desired doses and, in turn, due to the anatomical proximity, that the instilled therapeutic agent can be lost. through the Eustachian tube.
Por tanto, los actuales dispositivos de aplicación de fluidos terapéuticos sobre la membrana de la ventana redonda o de la ventana oval presentan serios problemas consistentes en su falta de control visual y precisión en la aplicación, así como en la dificultad para controlar el tiempo de aplicación y para que dichos fármacos queden retenidos sobre la membrana de la ventana oval o de la ventana redonda y que así ejerzan el efecto terapéutico en las dosis y tiempos de aplicación deseados. Therefore, current devices for the application of therapeutic fluids on the membrane of the round window or of the oval window present serious problems consisting of their lack of visual control and precision in the application, as well as the difficulty to control the application time. and so that these drugs remain retained on the membrane of the oval window or round window and thus exert the therapeutic effect at the desired doses and application times.
Es conocido que la aplicación de determinadas sustancias terapéuticas sobre la membrana de la ventana redonda o de la ventana oval, como péptidos o ácido hialurónico, entre muchas otras, facilitan la permeabilidad de fármacos a través de la membrana de la ventana redonda o de la ventana oval. It is known that the application of certain therapeutic substances on the membrane of the round window or the oval window, such as peptides or hyaluronic acid, among many others, facilitate the permeability of drugs through the membrane of the round window or the window. oval.
Es conocido que las soluciones hidrosolubles o acuosas penetran mejor a través de la membrana de la ventana redonda o de la ventana oval que las soluciones liposolubles u oleosas. It is known that water-soluble or aqueous solutions penetrate better through the membrane of the round window or of the oval window than fat-soluble or oil solutions.
Es conocido que las sustancias con bajo peso molecular penetran a través de la membrana de la ventana redonda o de la ventana oval con más facilidad que las que tienen un peso molecular más elevado. It is known that substances with low molecular weight penetrate through the membrane of the round window or the oval window more easily than those with a higher molecular weight.
Es conocido que ciertos fármacos aportados a través de la membrana de la ventana redonda o de la ventana oval adquieren mayor concentración y efectividad terapéutica que si se aportan por vía sistémica, endovenosa o parenteral. It is known that certain drugs delivered through the membrane of the round window or the oval window acquire greater concentration and therapeutic effectiveness than if they are delivered systemically, intravenously or parenterally.
Es conocida la conveniencia de aplicar un sustrato potenciador de sorción sobre la membrana de la ventana redonda o de la ventana oval para que las células madre o factores de crecimiento puedan penetrar eficientemente en el oído interno a través de la membrana de la ventana redonda o de la ventana oval. It is known the convenience of applying a sorption-enhancing substrate on the membrane of the round window or of the oval window so that the stem cells or growth factors can efficiently penetrate into the inner ear through the membrane of the round or oval window. the oval window.
SUMARIO SUMMARY
La presente Invención busca resolver uno o más de los Inconvenientes y retos expuestos anteriormente mediante un dispositivo aplicador tal como se define en las reivindicaciones. The present invention seeks to solve one or more of the drawbacks and challenges set forth above by means of an applicator device as defined in the claims.
El dispositivo aplicador está configurado para dirigir, aplicar con control visual y retener fluidos y geles conteniendo sustancias terapéuticas, sustrato, células madre o factores de crecimiento desde el oído externo hacia la membrana de la ventana redonda o de la ventana oval. El dispositivo está configurado para aportar de manera controlada energía para activar portadores, drug carriers, con el objetivo de posicionar y liberar sustancias terapéuticas, células madre o factores de crecimiento en una zona precisa del oído interno y especialmente de la cóclea para acceder de modo controlado al sistema nervioso central. The applicator device is configured to direct, visually control, and retain fluids and gels containing therapeutic substances, substrate, stem cells, or growth factors from the outer ear toward the membrane of the round window or oval window. The device is configured to provide energy in a controlled way to activate carriers, drug carriers, in order to position and release therapeutic substances, stem cells or growth factors in a precise area of the inner ear and especially the cochlea to access the central nervous system in a controlled way.
El dispositivo aplicador comprende un endoscopio ótico que permite una clara visión del oído medio desde el oído externo; comprende una guía de aporte de fluidos o geles o de energía con una boca de salida que se posiciona sobre la membrana de la ventana redonda o de la ventana oval y cuya función es aplicar la dosis precisa de fluido o gel de manera controlada sobre la membrana de la ventana redonda o de la ventana oval; comprende al menos una guía de aporte de energía con la función de activar de manera controlada y precisa portadores, drug carriers, conteniendo sustancias terapéuticas, células madre o factores de crecimiento; una boca de alimentación que se fija a la membrana timpánica y por la que se Introducen el endoscopio ótico, la guía de aporte de fluidos o geles y la guía de aporte de energía; y al menos un filamento conectado a la boca de alimentación y posicionado en contacto con o a proximidad de la membrana de la ventana redonda o de la ventana oval del oído y cuya función es la de guiar, canalizar y retener controladamente sobre la membrana 6 de la ventana redonda o de la ventana oval los fluidos o geles aportados desde la guía de aporte de fluidos o geles. The applicator device comprises an otic endoscope that allows a clear view of the middle ear from the outer ear; It comprises a guide for supplying fluids or gels or energy with an outlet that is positioned on the membrane of the round window or the oval window and whose function is to apply the precise dose of fluid or gel in a controlled manner on the membrane. round window or oval window; It comprises at least one energy supply guide with the function of activating carriers, drug carriers, containing therapeutic substances, stem cells or growth factors in a controlled and precise manner; a feeding mouth that is fixed to the tympanic membrane and through which the otic endoscope, the guide for supplying fluids or gels and the guide for supplying energy are introduced; and at least one filament connected to the feeding mouth and positioned in contact with or close to the membrane of the round window or the oval window of the ear and whose function is to guide, channel and retain in a controlled manner on the membrane 6 of the round window or oval window the fluids or gels delivered from the fluid or gel delivery guide.
La sustancia terapéutica, las células madre o los factores de crecimiento se pueden aportar sobre la membrana de la ventana redonda o de la ventana oval con portadores, drug carriers. A través de una guía de aporte de energía se puede aportar de manera precisa, controlada y con la Intensidad adecuada la fuente de energía requerida por el portador, drug carrier, con el fin de activar al portador con la energía correspondiente para activar el movimiento a través de la membrana de la ventana oval o de la ventana redonda o de liberar las sustancias contenidas dentro del portador, drug carrier. en la zona deseada del oído interno o de la cóclea para aportar las dosis precisas en el lugar deseado con el objetivo de realizar de manera precisa y controlada tratamientos terapéuticos y regenerativos del oído Interno, de su sistema nervioso y del sistema nervioso central. The therapeutic substance, stem cells or growth factors can be delivered on the membrane of the round window or of the oval window with carriers, drug carriers. Through an energy supply guide, the energy source required by the carrier, drug carrier, can be provided in a precise, controlled and adequate intensity in order to activate the carrier with the corresponding energy to activate the movement to through the membrane of the oval window or the round window or to release the substances contained within the carrier, drug carrier. in the desired area of the inner ear or the cochlea to deliver the precise doses in the desired place in order to carry out precisely and controlled therapeutic and regenerative treatments of the inner ear, its nervous system and the central nervous system.
Los portadores, drug carriers, pueden tener marcadores de modo que, a través del endoscopio, se puede monitorizar con precisión el ritmo de la absorción de fluido o gel con portadores, drug carriers, que tiene lugar a través de la membrana de la ventana redonda o de la ventana oval. Carriers, drug carriers, may have markers so that, through the endoscope, the rate of fluid absorption can be accurately monitored or gel with carriers, drug carriers, which takes place through the membrane of the round window or the oval window.
El, al menos un, filamento puede estar compuesto por distintos materiales y puede tener distintos recubrimientos con la polaridad adecuada según las necesidades de polaridad que se requieran para lograr más o menos fuerzas de adhesión con el fluido o gel a aplicar y a retener controladamente sobre la membrana de la ventana redonda o de la ventana oval. The, at least one, filament can be composed of different materials and can have different coatings with the appropriate polarity according to the polarity needs that are required to achieve more or less adhesion forces with the fluid or gel to be applied and controlled in a controlled manner. round window membrane or oval window membrane.
El, al menos un, filamento puede tener un engrasamiento final para facilitar el apoyo sobre la membrana de la ventana redonda o de la ventana oval y mejorar la retención controlada de los fluidos o geles. The at least one filament may have a final fat to facilitate bearing on the membrane of the round window or oval window and improve controlled retention of fluids or gels.
El, al menos un, filamento puede quedar conectado a una fina estructura capilar que cubra, al menos en parte, la membrana de la ventana redonda o de la ventana oval para facilitar la retención controlada de los fluidos o geles. The at least one filament may be connected to a fine capillary structure that covers, at least in part, the membrane of the round window or of the oval window to facilitate controlled retention of the fluids or gels.
El, al menos, un filamento puede ser alargado o en espiral, puede tener diferentes ángulos con relación al plano de la membrana timpánica y puede tener una sección cilindrica, Irregular o aplanada hasta formar lamas, para Incrementar la superficie de adhesión y facilitar la canalización y retención de fluidos o geles sobre la membrana de la ventana redonda o de la ventana oval. The at least one filament can be elongated or spiral, it can have different angles in relation to the plane of the tympanic membrane and it can have a cylindrical, irregular or flattened section to form slats, to increase the adhesion surface and facilitate canalization and retention of fluids or gels on the round window or oval window membrane.
El endoscopio ótico introducido a través de la boca de alimentación permite la perfecta visualización del oído medio; permite Identificar claramente la posición de la membrana de la ventana redonda o de la ventana oval, que puede diferir entre pacientes; permite colocar la boca de salida de la guía de aplicación de fluidos o geles con precisión cerca de la membrana de la ventana redonda o de la ventana oval una vez la salida de la guía está perfectamente posicionada cerca el punto de aplicación deseado; permite Introducir y aplicar sobre la membrana de la ventana redonda o de la ventana oval la dosis precisa de fluido o gel conteniendo la sustancia terapéutica, el sustrato, las células madre o los factores de crecimiento; permite el control visual del proceso de aplicación de un fluido o gel y del resultado de esta aplicación; y permite visualizar la posición de la guía de aporte de energía y controlar visualmente el aporte de energía sobre el fluido o gel conteniendo portadores, drug carriers. El, al menos, un filamento entre la boca de alimentación y la membrana de la ventana redonda o de la ventana oval permite: guiar o canalizar ordenadamente el fluido o gel conteniendo la sustancia terapéutica, el sustrato, las células madre o los factores de crecimiento en el tramo final hasta llegar a la membrana de la ventana redonda o de la ventana oval, cuando la salida de la guía se mantiene a proximidad de la membrana de la ventana redonda o de la ventana oval; y, por adhesión, permite retener controladamente sobre la membrana de la ventana redonda o la ventana oval el fluido o gel conteniendo la sustancia terapéutica, el sustrato, las células madre o los factores de crecimiento. The otic endoscope introduced through the feeding mouth allows perfect visualization of the middle ear; allows to clearly identify the position of the membrane of the round window or of the oval window, which may differ between patients; allows the outlet mouth of the fluid or gel application guide to be precisely positioned close to the membrane of the round window or oval window once the guide outlet is perfectly positioned near the desired application point; It allows to introduce and apply on the membrane of the round window or of the oval window the precise dose of fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors; allows visual control of the process of applying a fluid or gel and the result of this application; and allows to visualize the position of the energy supply guide and visually control the energy supply on the fluid or gel containing drug carriers. The at least one filament between the feeding mouth and the membrane of the round window or of the oval window allows: to guide or channel the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors in an orderly manner in the final section until reaching the membrane of the round window or of the oval window, when the exit of the guide is kept close to the membrane of the round window or of the oval window; and, by adhesion, it allows the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors to be retained on the membrane of the round window or the oval window in a controlled manner.
Una vez aplicado el fluido o gel se retira el endoscopio y su guía de modo que el, al menos, un filamento retiene el fluido o gel en la posición deseada y se mantiene hasta la siguiente aplicación, un higiénico trayecto libre de obstrucciones desde la boca de alimentación. Once the fluid or gel has been applied, the endoscope and its guide are removed so that the at least one filament retains the fluid or gel in the desired position and a hygienic path free of obstructions from the mouth is maintained until the next application. feeding.
En caso de necesidad de aplicación de un fluido o gel terapéutico con dosis un poco menos precisas entre aplicaciones endoscópicas, el, al menos, un filamento facilita la aplicación de fluidos terapéuticos con cierta precisión aplicando un goteo en la boca de alimentación. In case of need for the application of a therapeutic fluid or gel with slightly less precise doses between endoscopic applications, the at least one filament facilitates the application of therapeutic fluids with some precision by applying a drip in the feeding mouth.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
Una explicación más detallada de la Invención se da en la descripción que sigue y que se basa en las figuras adjuntas: A more detailed explanation of the Invention is given in the description that follows and is based on the attached figures:
□ La Figura 1 muestra un esquema de un dispositivo aplicador compuesto por un endoscopio con una guía de aporte de fluidos o geles y una boca de alimentación sujeta a la membrana timpánica por la que se Introduce el endoscopio y su guía de aporte de fluidos o geles y con al menos un filamento que llega hasta la membrana de la ventana redonda o de la ventana oval. □ Figure 1 shows a diagram of an applicator device consisting of an endoscope with a guide for supplying fluids or gels and a feeding mouth attached to the tympanic membrane through which the endoscope and its guide for supplying fluids or gels are inserted and with at least one filament that reaches the membrane of the round window or the oval window.
□ La Figura 2 muestra un esquema de un dispositivo aplicador compuesto por un endoscopio con una guía de aporte de fluidos o geles, con una guía de aporte de energía para activar portadores, drug carriers, y una boca de alimentación sujeta a la membrana timpánica por la que se introduce el endoscopio, su guía de aporte de fluidos o geles y su guía de aporte de energía y con al menos un filamento que llega hasta la membrana de la ventana redonda o de la ventana oval. □ Figure 2 shows a diagram of an applicator device composed of an endoscope with a guide for the delivery of fluids or gels, with a guide for the delivery of energy to activate carriers, drug carriers, and a feeding mouth attached to the tympanic membrane by the one where the endoscope is inserted, its guide for the supply of fluids or gels and its guide for the supply of energy and with at least one filament that reaches the membrane of the round window or oval window.
□ La Figura 3 muestra un esquema de la porción de la boca de alimentación de un dispositivo aplicador con al menos un filamento en contacto con una mecha que cubre, al menos en parte, la membrana de la ventana redonda o de la ventana oval. □ Figure 3 shows a diagram of the portion of the feeding mouth of an applicator device with at least one filament in contact with a wick that covers, at least in part, the membrane of the round window or of the oval window.
□ La Figura 4 muestra un esquema de la porción de la boca de alimentación de un dispositivo aplicador con al menos un filamento con un engrasamiento que facilita el contacto con la membrana de la ventana redonda o de la ventana oval. □ Figure 4 shows a diagram of the portion of the feeding mouth of an applicator device with at least one filament with a fat that facilitates contact with the membrane of the round window or the oval window.
□ La Figura 5 muestra un esquema de la porción de la boca de alimentación de un dispositivo aplicador con al menos un filamento formando un ángulo distinto a 90° entre el filamento y el plano de la membrana timpánica. □ Figure 5 shows a schematic of the feeding mouth portion of an applicator device with at least one filament forming an angle other than 90 ° between the filament and the plane of the tympanic membrane.
□ La Figura 6 muestra un esquema de la porción de la boca de alimentación de un dispositivo aplicador con el, al menos un, filamento con forma de espiral. □ Figure 6 shows a diagram of the portion of the feeding mouth of an applicator device with the at least one spiral-shaped filament.
□ la Figura 7, muestra un esquema de la porción de la boca de alimentación del dispositivo aplicador con al menos un filamento con forma de lama para aumentar la superficie de adhesión y facilitar la canalización de fluidos o geles y la retención de fluidos o geles sobre la membrana de la ventana redonda o de la ventana oval. □ Figure 7 shows a diagram of the portion of the feeding mouth of the applicator device with at least one filament in the shape of a slat to increase the adhesion surface and facilitate the channeling of fluids or gels and the retention of fluids or gels on the membrane of the round window or oval window.
DESCRIPCIÓN DESCRIPTION
La Figura 1 muestra un dispositivo aplicador con las características siguientes: Figure 1 shows an applicator device with the following characteristics:
- Una ventana visual, una boca de alimentación 15 y soporte o anclaje en una membrana timpánica 1. Una forma de realización de esta ventana visual, boca de alimentación 15 y soporte comprende al menos dos arandelas, una arandela exterior - A visual window, a feeding mouth 15 and support or anchoring in a tympanic membrane 1. An embodiment of this visual window, feeding mouth 15 and support comprises at least two washers, an outer washer
3 y una arandela Interior 4 unidas por un cilindro 2, de forma que una arandela Interior3 and an Inner washer 4 joined by a cylinder 2, so that an Inner washer
4 se sitúa sobre la cara Interna de la membrana timpánica 1 y la otra arandela exterior 3 se sitúa sobre la cara externa de la membrana timpánica 1, estando unidas por un cilindro 2 que atraviesa la Incisión realizada en la membrana timpánica 1. La boca de alimentación 15 puede tener también una sección geométrica o Irregular pero la sección cilindrica 2 tiene el menor perímetro con relación a la superficie de la sección de la boca de alimentación 15, lo cual permite reducir la lesión causada por la Incisión en la membrana timpánica 1. 4 is located on the inner face of the tympanic membrane 1 and the other outer washer 3 is placed on the outer face of the tympanic membrane 1, being joined by a cylinder 2 that passes through the incision made in the tympanic membrane 1. The mouth of feed 15 can also have a geometric or irregular section but the cylindrical section 2 has the smallest perimeter in relation to the surface of the section of the feeding mouth 15, which allows to reduce the injury caused by the incision in the tympanic membrane 1.
- Un endoscopio ótico 11, una guía de aporte de fluidos o geles 12 y una guía de aporte de energía 17 que se Introducen por la entrada del conducto auditivo externo, meato, 10. El endoscopio ótico 11, una guía de aporte de fluidos o geles 12 y una guía de aporte de energía 17 se Introducen seguidamente por la boca de alimentación 15 de forma que el endoscopio ótico 11 tiene control visual desde un visor 14 sobre una membrana 6 de la ventana redonda o de la ventana oval, que permite al médico posicionar con precisión y control una salida de guía 13 o la salida de la guía 17 de aporte de energía sobre la membrana 6 de la ventana redonda o de la oval, y aportar de modo controlado la sustancia terapéutica, el sustrato, las células madre o los factores de crecimiento sobre la membrana 6 de la ventana redonda o de la ventana oval o aportar la energía sobre los portadores, drug carriers para su activación. - An otic endoscope 11, a guide for supplying fluids or gels 12 and a guide for supplying energy 17 that are introduced through the entrance of the external auditory canal, meatus, 10. The otic endoscope 11, a guide for supplying fluids or Gels 12 and an energy supply guide 17 are then introduced through the feeding mouth 15 so that the otic endoscope 11 has visual control from a viewer 14 on a membrane 6 of the round window or of the oval window, which allows the physician precisely and control position a guide outlet 13 or the outlet of the energy supply guide 17 on the membrane 6 of the round or oval window, and deliver in a controlled way the therapeutic substance, the substrate, the stem cells or the growth factors on the membrane 6 of the round window or of the oval window or provide energy on the carriers, drug carriers for their activation.
- Las aplicaciones de sustratos potenciadores de sorción para células madre y las aplicaciones de factores de crecimiento y de células madre requieren precisión y control en las dosis aportadas y precisión en el lugar en el que se aplican estos productos. Las aplicaciones de sustancias terapéuticas para llegar a posiciones concretas de la cóclea para acceder hasta lugares específicos del sistema nervioso central, requieren precisión y control. El dispositivo aplicador permite aportar de manera precisa y controlada y retener sobre la membrana 6 de la ventana redonda o de la ventana oval fluidos o geles conteniendo un sustrato potenciador de sorción, conteniendo sustancias terapéuticas, conteniendo células madre o conteniendo factores de crecimiento, siendo la membrana 6 de la ventana redonda o de la ventana oval vías de acceso para la entrada directa sustancias terapéuticas, de células madre o de factores de crecimiento en el oído Interno para tratamientos terapéuticos o regenerativos del oído Interno y de su sistema nervioso. Una vez dentro del oído Interno, y concretamente, una vez dentro de la cóclea, las sustancias terapéuticas, las células madre y los factores de crecimiento pueden llegar al sistema nervioso central a través del fluido cefalorraquídeo. De forma que el dispositivo aplicador se puede usar para tratamientos terapéuticos y regenerativos con células madre o con factores de crecimiento para el oído Interno, para su sistema nervioso y también para tratamientos terapéuticos y regenerativos del sistema nervioso central mediante el aporte de sustancias terapéuticas, de células madre o de factores de crecimiento a través de la membrana 6 de la ventana oval o de la ventana redonda. - The applications of sorption-enhancing substrates for stem cells and the applications of growth factors and stem cells require precision and control in the doses provided and precision in the place where these products are applied. The applications of therapeutic substances to reach specific positions in the cochlea to access specific locations in the central nervous system, require precision and control. The applicator device allows to deliver in a precise and controlled manner and retain on the membrane 6 of the round window or of the oval window fluids or gels containing a sorption-enhancing substrate, containing therapeutic substances, containing stem cells or containing growth factors, being the membrane 6 of the round window or of the oval window access routes for direct entry of therapeutic substances, stem cells or growth factors into the Inner ear for therapeutic or regenerative treatments of the Inner ear and its nervous system. Once inside the inner ear, and specifically, once inside the cochlea, therapeutic substances, stem cells, and growth factors can reach the central nervous system through the cerebrospinal fluid. So the applicator device can be used for regenerative and therapeutic stem cell or growth factor treatments for the Inner ear, for your nervous system and also for Therapeutic and regenerative treatments of the central nervous system by supplying therapeutic substances, stem cells or growth factors through the membrane 6 of the oval window or the round window.
- Los portadores, drug carriers, facilitan el proceso de atravesar la membrana 6 de la ventana oval o de la ventana redonda y permiten liberar la sustancia terapéutica, las células madre o los factores de crecimiento que portan en el momento y lugar deseado. Los portadores, drug carriers, se pueden activar mediante el aporte de energía. Una guía de aporte de energía 17 como la que se muestra en la Figura 2, permite aportar con precisión y control visual la energía necesaria sobre el fluido o gel conteniendo los portadores, drug carrier, que portan una sustancia terapéutica, células madre o factores de crecimiento. Esta precisión y control en el aporte de energía sobre los portadores permite movilizar y liberar con precisión la sustancia terapéutica, las células madre o los factores de crecimiento hasta la zona deseada del oído Interno, Incluida la cóclea, con el objetivo de aportar la dosis precisa en el lugar adecuado para realizar tratamientos terapéuticos o regenerativos precisos en el oído Interno, en su sistema nervioso o en el sistema nervioso central. - Carriers, drug carriers, facilitate the process of crossing the membrane 6 of the oval window or the round window and allow the release of the therapeutic substance, stem cells or growth factors they carry at the desired time and place. Carriers, drug carriers, can be activated by supplying energy. An energy supply guide 17 like the one shown in Figure 2, allows to provide the necessary energy with precision and visual control on the fluid or gel containing the carriers, drug carriers, that carry a therapeutic substance, stem cells or factors of increase. This precision and control in the energy supply on the carriers allows to precisely mobilize and release the therapeutic substance, stem cells or growth factors to the desired area of the Inner ear, including the cochlea, with the aim of providing the precise dose in the right place to carry out precise therapeutic or regenerative treatments in the Inner ear, in its nervous system or in the central nervous system.
- La fundón de la guía de aporte de fluidos o geles 12 es la de aportar con precisión y control los fluidos o geles hasta el punto deseado. La función de la guía de aporte de energía 17 es la de aportar con precisión y control energía a los portadores, drug carriers. La función del, al menos un filamento 5 es la de retener controladamente los fluidos o geles sobre la membrana 6 de la ventana redonda o de la ventana oval. El, al menos un, filamento 5 también puede realizar la función de guiado del fluido o gel, por fuerzas de adhesión, desde la boca de alimentación 15 hasta la membrana 6 de la ventana redonda o de la ventana oval, pero con menos precisión que la que se consigue con la combinación del endoscopio 11 y su guía de aporte de fluidos o geles 12. El al menos un filamento 5 puede ayudar en el guiado o canalización del fluido o gel en el tramo final entre la salida de guía 13 y la membrana 6 de la ventana redonda o de la ventana oval. - The purpose of the fluid or gel supply guide 12 is to provide the fluids or gels with precision and control to the desired point. The function of the energy supply guide 17 is to provide energy with precision and control to the carriers, drug carriers. The function of the at least one filament 5 is to hold the fluids or gels in a controlled manner on the membrane 6 of the round window or of the oval window. The, at least one, filament 5 can also carry out the function of guiding the fluid or gel, by adhesion forces, from the feeding mouth 15 to the membrane 6 of the round window or the oval window, but with less precision than which is achieved with the combination of the endoscope 11 and its guide for the supply of fluids or gels 12. The at least one filament 5 can help guide or channel the fluid or gel in the final section between the guide outlet 13 and the 6 membrane of round window or oval window.
Las fuerzas de adhesión entre el, al menos un, filamento 5 y el fluido o gel también permiten canalizar o guiar un fluido o gel desde la boca de alimentación 15 hasta la membrana 6 de la ventana redonda o de la ventana oval aportándolo desde el oído externo, pero con menos control que con la combinación del endoscopio ótico 11, su guía de aporte de fluidos o geles 12 y el, al menos un, filamento 5. The adhesion forces between the, at least one, filament 5 and the fluid or gel also allow channeling or guiding a fluid or gel from the feeding mouth 15 to the membrane 6 of the round window or of the oval window, supplying it from the ear. external, but with less control than with the combination of the otic endoscope 11, its guide for the delivery of fluids or gels 12 and the, at least one, filament 5.
- La boca de alimentación 15 tiene una sección entre 1,6 mm y 2,5 mm de diámetro Interior, suficiente para facilitar la Introducción del endoscopio ótico 11 y de la guía de aporte de fluidos o geles o de energía 12 y siendo lo más pequeña posible para facilitar la cicatrización de la Incisión que se debe realizar en la membrana timpánica - The feeding mouth 15 has a section between 1.6 mm and 2.5 mm in internal diameter, sufficient to facilitate the introduction of the otic endoscope 11 and the guide for supplying fluids or gels or energy 12 and being the most small possible to facilitate the healing of the incision to be made in the tympanic membrane
1. one.
- El al menos un filamento 5 unido a la parte Interior del cilindro 2 o a una de las dos arandelas 3, 4 de forma que el fluido o gel aportado desde la salida de guía 13 gotea o fluye en forma de fina película ordenadamente por el, al menos un, filamento 5 hasta la membrana 6 de la ventana redonda o de la ventana oval y el, al menos un , filamento 5 retiene el fluido o gel sobre la membrana 6 de la ventana redonda o de la oval. - The at least one filament 5 attached to the inside of the cylinder 2 or to one of the two washers 3, 4 so that the fluid or gel supplied from the guide outlet 13 drips or flows in the form of a thin film in an orderly manner through it, at least one filament 5 up to the membrane 6 of the round window or of the oval window and the at least one filament 5 retains the fluid or gel on the membrane 6 of the round or oval window.
- El, al menos un, filamento 5 está realizado en un material lo suficientemente flexible para mantener la tensión necesaria entre la parte Interior de la boca de alimentación 15 y la superficie de la membrana 6 de la ventana redonda o de la ventana oval y para evitar desplazamientos y daños en la membrana 6 de la ventana redonda o de la ventana oval. El material puede ser moldeadle mecánicamente o termo-moldeable, de modo que tenga flexibilidad a una temperatura distinta de la corporal y que a temperatura corporal mantenga la posición fijada. - The at least one filament 5 is made of a material flexible enough to maintain the necessary tension between the Interior part of the feeding mouth 15 and the surface of the membrane 6 of the round window or of the oval window and to avoid displacement and damage to the membrane 6 of the round window or oval window. The material can be mechanically molded or thermo-moldable, so that it has flexibility at a temperature other than body temperature and that at body temperature it maintains the fixed position.
- El, al menos un, filamento 5 puede estar compuesto por distintos materiales y puede tener distintos recubrimientos que se seleccionarán según las propiedades de polaridad y de adhesión adecuadas a las propiedades del fluido o gel a aplicar, para conseguir que entre el fluido o gel y la superficie del, al menos un, filamento 5 se produzcan las fuerzas de adhesión necesarias para retener de modo controlado el fluido o gel conteniendo la sustancia terapéutica, el sustrato, las células madre o los factores de crecimiento sobre la membrana 6 de la ventana redonda o de la ventana oval. De modo que distintos fluidos o geles pueden necesitar distintos acabados o materiales de composición del, al menos un, filamento 5. - Para aplicaciones terapéuticas que no requieran la precisión necesaria con la sustancia terapéutica, el sustrato potenciador de sorción, las células madre o los factores de crecimiento, el, al menos un, filamento 5 permite canalizar hasta la membrana 6 de la ventana redonda o la ventana oval un fluido o gel terapéutico que se aporte desde el oído externo por la boca de alimentación 15. - The, at least one, filament 5 can be composed of different materials and can have different coatings that will be selected according to the polarity and adhesion properties appropriate to the properties of the fluid or gel to be applied, to get the fluid or gel to enter and the surface of the at least one filament 5 produces the necessary adhesion forces to retain in a controlled way the fluid or gel containing the therapeutic substance, the substrate, the stem cells or the growth factors on the membrane 6 of the window round or oval window. Thus, different fluids or gels may require different finishes or composition materials for the at least one filament 5. - For therapeutic applications that do not require the necessary precision with the therapeutic substance, the sorption-enhancing substrate, the stem cells or the growth factors, the at least one filament 5 allows channeling up to the membrane 6 of the round window or the oval window a therapeutic fluid or gel that is delivered from the outer ear through the feeding mouth 15.
- El, al menos un, filamento 5 permite una higiénica ventilación entre el oído Interno y el oído externo reduciendo los riesgos de Infecciones. - The, at least one, filament 5 allows a hygienic ventilation between the inner ear and the outer ear reducing the risk of infection.
La Figura 3 muestra un esquema de la porción de la boca de alimentación 15 del dispositivo aplicador con el extremo del, al menos un, filamento 5 unido a una mecha, wick, 7 para mantener durante un tiempo controlado un fluido o gel en contacto con la membrana 6 de la ventana redonda o de la ventana oval, con el objetivo de conseguir el proceso de filtrado o absorción del fluido o gel terapéutico. Esta mecha 7 puede, preferentemente, tener entorno a 2mm de diámetro que es el tamaño razonable de una Incisión en la membrana timpánica 1. La colocación de esta fina mecha 7 permite la retención controlada de sustancias que aumentan la permeabilidad de la membrana 6 de la ventana redonda o de la ventana oval facilitando el posterior aporte y retención controlados de las células madre o de los factores de crecimiento. Figure 3 shows a diagram of the portion of the feeding mouth 15 of the applicator device with the end of the, at least one, filament 5 attached to a wick, 7 to keep a fluid or gel in contact with it for a controlled time. the membrane 6 of the round window or of the oval window, in order to achieve the filtering or absorption process of the therapeutic fluid or gel. This wick 7 can preferably have a diameter of around 2mm, which is the reasonable size of an incision in the tympanic membrane 1. The placement of this fine wick 7 allows the controlled retention of substances that increase the permeability of the membrane 6 of the round window or oval window facilitating the subsequent controlled delivery and retention of stem cells or growth factors.
La Figura 4 muestra un esquema de la porción de la boca de alimentación 15 del dispositivo aplicador en el que el extremo del, al menos un, filamento 5 presenta un engrasamiento 8 significativo para tener mejor orientación, apoyo y área de adhesión sobre la membrana 6 de la ventana redonda o de la ventana oval y facilitar la retención de fluidos o geles. Figure 4 shows a diagram of the portion of the feeding mouth 15 of the applicator device in which the end of the, at least one, filament 5 presents a significant thickening 8 to have better orientation, support and adhesion area on the membrane 6 round window or oval window and facilitate retention of fluids or gels.
La Figura 5 muestra un esquema de la porción de la boca de alimentación 15 del dispositivo aplicador con el, al menos un, filamento en ángulo 9 colocado en un ángulo diferente a un ángulo recto con relación al plano de la membrana timpánica 1. Dado que la membrana 6 de la ventana redonda o de la ventana oval de un paciente puede estar en una posición distinta a la de la perpendicularidad con relación al plano de la membrana timpánica 1, se pueden manufacturar dispositivos aplicadores con materiales que permiten el moldeado mecánico o el termo-moldeado con, al menos, un filamento en ángulo 9 para formar distintos ángulos que faciliten la colocación más adecuada del dispositivo a las características de cada paciente. Figure 5 shows a diagram of the portion of the feeding mouth 15 of the applicator device with the at least one angled filament 9 positioned at an angle other than a right angle relative to the plane of the tympanic membrane 1. Since the membrane 6 of the round window or of the oval window of a patient may be in a position other than perpendicular to the plane of the tympanic membrane 1, applicator devices may be manufactured with materials that allow mechanical molding or thermoformed with, at least, an angled filament 9 to form different angles that facilitate the most appropriate placement of the device to the characteristics of each patient.
La Figura 6 muestra un esquema de la porción de la boca de alimentación 15 del dispositivo aplicador con el, al menos, un filamento en ángulo 9 con una forma de espiral para facilitar la retención de fluidos o geles sobre la membrana 6 de la ventana redonda o de la ventana oval. Figure 6 shows a diagram of the portion of the feeding mouth 15 of the applicator device with at least one angled filament 9 with a spiral shape to facilitate the retention of fluids or gels on the membrane 6 of the round window. or the oval window.
El, al menos, un filamento 5, 9 puede tener una sección circular, irregular o alargada o formando una sección de cilindro 2 como en la Figura 7, que muestra un esquema de la porción de la boca de alimentación 15 del dispositivo aplicador con el, al menos, un filamento 16 con una forma de lama con el fin de aumentar la superficie de adhesión y facilitar la canalización de fluidos o geles y la retención de fluidos o geles sobre la membrana 6 de la ventana redonda o de la ventana oval. The at least one filament 5, 9 can have a circular, irregular or elongated section or forming a cylinder section 2 as in Figure 7, which shows a diagram of the portion of the feeding mouth 15 of the applicator device with the at least one filament 16 with a slat shape in order to increase the adhesion surface and facilitate the channeling of fluids or gels and the retention of fluids or gels on the membrane 6 of the round window or of the oval window.
LISTA DE REFERENCIAS NUMÉRICAS LIST OF NUMERICAL REFERENCES
1 membrana timpánica 1 tympanic membrane
2 cilindro 2 cylinder
3 arandela exterior 3 outer washer
4 arandela interior 4 inner washer
5 filamento 5 filament
6 membrana de la ventana 6 window membrane
7 mecha, wick, 7 wick, wick,
8 engrasamiento 8 greasing
9 filamento en ángulo 9 angled filament
10 entrada del conducto auditivo externo, meato 10 entrance of external auditory canal, meatus
11 endoscopio ótico 11 otic endoscope
12 guía de aporte de fluidos o geles 12 fluid or gel delivery guide
13 salida de guía 13 guide output
14 visor 14 visor
15 boca de alimentación 15 feeding mouth
16 filamento en lama 16 filament in slat
17 guía de aporte de energía 17 energy input guide

Claims

REIVINDICACIONES
1- Un dispositivo ótico de aplicación adaptado para dirigir, aplicar y retener con precisión y control visual fluidos o geles conteniendo sustancias terapéuticas, sustratos, células madre o factores de crecimiento sobre una membrana (6) de una ventana redonda o de una ventana oval para tratamientos terapéuticos y regenerativos del oído interno y de su sistema nervioso y para tratamientos terapéuticos y regenerativos del sistema nervioso central, caracterizado por que el dispositivo de aplicación comprende un endoscopio ótico (11) y una guía (12) de aporte de fluidos o geles adaptada para ser intraducibie por la entrada del conducto auditivo externo, meato, (10), que comprende además una ventana visual, una boca de alimentación (15) y un soporte o anclaje en la membrana timpánica (1) mediante al menos una arandela exterior (3) y al menos una arandela interior (4), por el interior de cuyo cilindro (2) se introduce dentro del oído medio el endoscopio ótico (11) y la guía de aporte de fluido o gel (12) hasta la proximidad objetivo de la membrana (6) de la ventana redonda o de la ventana oval, y comprende además al menos un filamento (5)de guía y retención controlada de un fluido o gel, sujeto al cilindro (2) de la boca de alimentación (15) o a las arandelas exterior (3) e interior (4) de soporte y que llega hasta la membrana (6) de la ventana redonda o de la ventana oval. 1- An otic application device adapted to direct, apply and retain with precision and visual control fluids or gels containing therapeutic substances, substrates, stem cells or growth factors on a membrane (6) of a round window or an oval window to therapeutic and regenerative treatments of the inner ear and its nervous system and for therapeutic and regenerative treatments of the central nervous system, characterized in that the application device comprises an otic endoscope (11) and an adapted fluid or gel supply guide (12) to be untranslatable through the entrance of the external auditory canal, meatus, (10), which also comprises a visual window, a feeding mouth (15) and a support or anchorage in the tympanic membrane (1) by means of at least one outer washer ( 3) and at least one inner washer (4), through the interior of which cylinder (2) the otic endoscope (11) and the fluid supply guide are inserted into the middle ear. do or gel (12) up to the objective proximity of the membrane (6) of the round window or of the oval window, and further comprises at least one filament (5) for guiding and controlled retention of a fluid or gel, attached to the cylinder (2) from the feed mouth (15) or to the outer (3) and inner (4) support washers and that reaches the membrane (6) of the round window or the oval window.
2- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que el dispositivo de aplicación comprende una guía (17) de aporte controlado y preciso de energía que activa portadores, drug carriers, contenidos en el fluido o gel retenido sobre la membrana (6) de la ventana redonda o de la ventana oval. 2- Applicator device according to claim 1, characterized in that the application device comprises a guide (17) with a controlled and precise supply of energy that activates carriers, drug carriers, contained in the fluid or gel retained on the membrane (6 ) of round window or oval window.
3- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que el, al menos un, filamento (5) tiene un engrasamiento (8) final de conexión y mayor retención de fluidos o geles sobre la membrana (6) de la ventana redonda o de la ventana oval. 3- Applicator device according to claim 1, characterized in that the, at least one, filament (5) has a final greasing (8) of connection and greater retention of fluids or gels on the membrane (6) of the round window or the oval window.
4- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que el, al menos un, filamento (5) está conectado a una fina mecha, wick, (7) que cubre, al menos en parte, la membrana (6) de la ventana redonda o de la ventana oval. 5- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que el dispositivo aplicador está fabricado en un material moldeadle mecánicamente o termo moldeadle y al menos un filamento en ángulo (9) que forma un ángulo distinto de 90° con relación al plano de la membrana timpánica (1). 4- Applicator device according to claim 1, characterized in that the at least one filament (5) is connected to a fine wick (7) that covers, at least in part, the membrane (6) of round window or oval window. 5- Applicator device according to claim 1, characterized in that the applicator device is made of a mechanically molded or thermo molded material and at least one angled filament (9) that forms an angle other than 90 ° in relation to the plane of the tympanic membrane (1).
6- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que al menos un filamento (5) tiene una forma en espiral. 6- Applicator device according to claim 1, characterized in that at least one filament (5) has a spiral shape.
7- Dispositivo aplicador de acuerdo con la reivindicación 1, caracterizado por que al menos un filamento (16) tiene una forma de lama. 7- Applicator device according to claim 1, characterized in that at least one filament (16) has a slat shape.
PCT/ES2020/070131 2019-02-22 2020-02-21 Otic applicator device WO2020169872A1 (en)

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ES201930290U ES1227773Y (en) 2019-02-22 2019-02-22 APPLICATOR DEVICE

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6045528A (en) * 1997-06-13 2000-04-04 Intraear, Inc. Inner ear fluid transfer and diagnostic system
US6152873A (en) * 1999-03-01 2000-11-28 Boehringer Ingelheim Pharmaceuticals, Inc. Otoscope for examination and treatment of the ear
WO2012156959A1 (en) * 2011-05-16 2012-11-22 Cork Institute Of Technology A fluid removal and delivery apparatus
WO2014117958A2 (en) * 2013-02-04 2014-08-07 Helen Of Troy Limited Otoscope
US20150366715A1 (en) * 2010-03-15 2015-12-24 Entra Tympanic, LLC. Device and method for delivering medicine into the tympanic cavity, with sliding assist

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6045528A (en) * 1997-06-13 2000-04-04 Intraear, Inc. Inner ear fluid transfer and diagnostic system
US6152873A (en) * 1999-03-01 2000-11-28 Boehringer Ingelheim Pharmaceuticals, Inc. Otoscope for examination and treatment of the ear
US20150366715A1 (en) * 2010-03-15 2015-12-24 Entra Tympanic, LLC. Device and method for delivering medicine into the tympanic cavity, with sliding assist
WO2012156959A1 (en) * 2011-05-16 2012-11-22 Cork Institute Of Technology A fluid removal and delivery apparatus
WO2014117958A2 (en) * 2013-02-04 2014-08-07 Helen Of Troy Limited Otoscope

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