WO2020019090A1 - Simplified device for mounting a percutaneous endoscopic gastrotomy (peg) tube, which is installed outside the abdominal wall of a patient and which facilitates the connection thereof with an enteral feeding tube - Google Patents

Simplified device for mounting a percutaneous endoscopic gastrotomy (peg) tube, which is installed outside the abdominal wall of a patient and which facilitates the connection thereof with an enteral feeding tube Download PDF

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Publication number
WO2020019090A1
WO2020019090A1 PCT/CL2019/050049 CL2019050049W WO2020019090A1 WO 2020019090 A1 WO2020019090 A1 WO 2020019090A1 CL 2019050049 W CL2019050049 W CL 2019050049W WO 2020019090 A1 WO2020019090 A1 WO 2020019090A1
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WO
WIPO (PCT)
Prior art keywords
probe
mounting
wall
cap
radial
Prior art date
Application number
PCT/CL2019/050049
Other languages
Spanish (es)
French (fr)
Inventor
Mariela Isabel CAMPOS STEMPFLE
Valentina Constanza MARQUEZ VILLABLANCA
Fernanda Sofía ROMAGNOLI TORRES
Iván Alberto CARO PINTO
Juan Carlos PATILLO SILVA
Jose Fernando Enrique VULETIN SOLIS
Alejandro Luis ZAVALA BUSQUETS
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Pontificia Universidad Catolica De Chile
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Application filed by Pontificia Universidad Catolica De Chile filed Critical Pontificia Universidad Catolica De Chile
Publication of WO2020019090A1 publication Critical patent/WO2020019090A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites

Definitions

  • the invention that is the subject of the present invention patent application relates to a simplified device for mounting a percutaneous endoscopic gastrostomy (PEG) probe, which is installed outside the abdominal wall of a patient and facilitates its connection with an enteral feeding tube.
  • PEG percutaneous endoscopic gastrostomy
  • Gastrostomy is a surgical intervention that creates a direct route of temporary or permanent feeding between the stomach and the skin of a patient's abdominal wall. Specifically, it involves opening a hole in the anterior wall of the abdomen to insert a feeding tube into the stomach.
  • Gastrostomies are usually performed by the endoscopic placement of a feeding tube in which a cable passes to the stomach through the abdominal wall and the cable is recovered with an endoscope inserted orally.
  • the known probes have at their distal end an internal retention device, with which the flexible tube of probe rests on the inner wall of the stomach;
  • the flexible tube of the probe is sized to extend beyond the abdominal wall.
  • the flexible tube presents a connection piece, in order to connect the transfer system to provide the nutritive solution.
  • a retention dome at the distal end of the catheter retains the tube inside the patient's stomach, being, among others, inflatable or serum-refillable balloons, which are supported by the inner wall of the stomach;
  • Other types of probe retainers are of the foldable type that, once arranged inside the abdominal cavity, are deployed or expanded, generating a support surface against the abdominal wall.
  • the probe Normally, through the outer area of the patient's abdomen, the probe has external retention or retention means that seek to stabilize the probe in the abdominal wall, preventing axial displacements, since these displacements not only entail the possibility of contracting infections, but which also produce unexpected and unwanted leaks for the patient.
  • a clamp is provided in the adapter.
  • the known adapter has a mounting piece to fix the probe in front of a slip out.
  • the mounting piece has a central hole to introduce the probe, in which it is blocked.
  • the assembly piece is composed of two halves that can be disassembled, joined together articulately. However, both halves of the mounting piece fit together and around the proximal end of the probe when it has already been fixed to a tube or stoma, so that it produces an adjustment or assurance that prevents the probe from coming out.
  • the described device comprises a complex construction of several pieces, it does not solve the problem of the contact of the device with the patient's skin, because the contact surface is a rigid plane that remains on the skin, favoring the irritation and lack of comfort being a rigid plane.
  • the present invention relates to a simplified device for mounting a percutaneous endoscopic gastrostomy (PEG) probe outside the abdominal wall of a patient and which facilitates its connection with an enteral feeding tube.
  • PEG percutaneous endoscopic gastrostomy
  • One of the main objectives of the present invention is to provide a device for the assembly of a PEG probe that is simplified, of few pieces, but at the same time solving the problem of clamping the probe before proceeding to cut it to a desired length in the assembly process and preventing it from being returned to the interior of the patient before finishing the assembly of the external fastening means.
  • Another objective of the present invention is to provide a simplified device for mounting a PEG probe that, in addition to allowing its fastening for the desired length of cut, also provides adequate means of connection between the cut probe and the feeding tube, understood as adequate, means that facilitate said coupling and prevent fluid reflux from occurring when feeding tube is introduced into the mounting device.
  • Yet another objective of the present invention is to provide a simplified device for mounting a PEG probe that allows effective contact of the device with the patient's skin, but with the smallest possible contact surface to avoid irritation.
  • the present device comprises means for securing by external radial compression of the probe before being cut, and means for retention by radial expansion of the proximal end resulting from the cut probe, consisting of a threaded inner surface cap.
  • the compression clamping means comprise a clamp that surrounds the probe outside and, in turn, comprises radially impacted teeth, on an inner surface, which, when impacted on the outer surface of the probe, stabilize it in a position determined to prevent its axial displacement into the abdominal cavity once it has been cut to the desired length.
  • the tube portion of the probe that is projected outward from the patient is surrounded by this clamp that is also placed flush with the surface of the skin, ensuring that the remaining probe length is just enough to avoid axial displacements that favor the outflow of fluids and consequent infections.
  • This clamp comprises two semi-cylindrical pieces that can be coupled to each other, facing each other by their vertical edges, so that once they fit together, they form a cylindrical body that surrounds the probe.
  • Each of said two semi-cylindrical pieces comprises an outer wall with a given diameter and a height not exceeding 5 mm, thus providing a low profile adapter that does not protrude much from the surface of the user's skin.
  • This outer wall of the semi-cylindrical pieces is provided with outer thread, arranged in such a way that once the two semi-cylindrical pieces are coupled, the thread is formed as a single functional unit that is capable of receiving the thread disposed in said cap that forms the retention means by radial expansion of the proximal end of the cut probe.
  • Said semi-cylindrical pieces also comprise an upper straight end, a lower end with an external radial shoulder and an inner wall of a determined diameter that coincides with the outer diameter of the PEG probe, since it is said inner wall that surrounds said probe;
  • This inner wall comprises said radial impaction teeth, which consist of at least one pointed radial projection, which can be triangular in shape, where said tip is the one that hits the outer wall of the probe and immobilizes it.
  • the impact teeth in the form of projections can be located one at each upper and lower end of the inner wall of each semi-cylindrical piece, as well as, they can be constituted as a plurality of projections located throughout the entire interior wall.
  • said impaction teeth comprise at least one groove arranged at the top of the inner wall, where this groove can have a pointed distal edge, as a cutting edge that presses and compresses radially to said wall. outside of the PEG probe.
  • said striations can be oriented diagonally or inclined on the inner walls of each of the semi-cylindrical pieces that conform to the fastening means of the device described herein.
  • the two semi-cylindrical pieces comprise, integrally, external radial flaps projected from the external radial projection located in the lower area of the outer walls of the clamp, which comprise an upper face and an opposite lower face that is in contact with the external abdominal wall of the patient.
  • said flaps have an elongated shape with a rounded end to prevent them from being buried in the patient's skin and their flared shape allows the skin contact surface to be as small as possible to avoid irritation.
  • the clamp that forms the radial fastening means also comprises a band-shaped extension with a pressurized lid at its distal end, where this band projects from the external radial shoulder, where this cover serves to close an opening arranged in the upper face of the cap that will be described in detail below.
  • the aforementioned means of retaining the device is a cap that engages outside the clamp body of the clamping means and provides anti-reflux and spill-free connector means between the proximal end of the probe and a feeding tube enteral
  • the cap comprises a cylindrical body having an outer wall, an upper wall, an opposite lower wall and a central axial perforation that defines an inner wall and where said axial perforation in turn defines an upper opening and a lower opening.
  • Said upper opening is arranged to attach in it a conventional enteral feeding tube connector, of the type that has a conical projection tube with a lateral projection that acts as a key and that would be introduced into said upper opening to connect with the PEG probe. and provide the nutrient fluid for patient feeding.
  • the inner wall of the cap related to axial perforation, comprises an intermediate annular collar with a central perforation and from said collar downwards, the cap comprises a lower cavity connected to the lower opening; from said The upward collar has an intermediate cavity and an upper cavity adjacent to the upper opening is attached.
  • the lower cavity has an inner wall of a determined diameter that coincides with the outer diameter of the clamp body, this cavity has a lower portion of height coinciding with the outer wall of the clamp body and is provided with an inner thread which splices with the outer thread of said clamp; on this portion with the thread presents a smaller upper portion that houses the protruding clearance of the cut probe.
  • An expanding cone extends from the central bore of the collar downwards, this cone being the one that generates the means of retention by radial expansion of the proximal end resulting from the cut probe, since said end of the probe is protruding from the upper wall of the body of the clamp and once it is fitted around the probe retaining it with the impact teeth, when introducing the cap and screw it out of the clamp, said expander cone penetrates the lumen of the protruding end of the probe and due to its conical shape, as it penetrates, it expands radially to said probe and secures it against the cylindrical inner wall of the clamp body through the impaction teeth.
  • the intermediate cavity is arranged, just above the collar, where in said cavity a unidirectional anti-reflux valve of the diaphragm type is housed, which allows the passage of the tube of the feeding tube adapter to be adjusted to the perforation of the collar and to the upper entrance of the expander cone, so that the nutrient fluid passes from the feeding tube to the probe without a reflux of the fluid towards the upper area of the cap and outwards through the opening higher.
  • This anti-reflux valve is a silicone disc with a central cut, preferably it is a silicone disc approximately 4mm thick at its center has a cut that covers approximately 80% of the diameter.
  • the silicone disk By attaching the conventional enteral feeding tube connector to the cap, it expands vertically to the silicone disk that acts as an anti-reflux valve, which in addition to giving stability to the connection, when removing the connector, the silicone disk returns to its original state avoiding the outflow of gastric fluids.
  • This upper opening of the cap has a suitable diameter to receive the tube of the conventional enteral feeding tube connector, which is normally of the tube type with a lateral projection that acts as a key, where said cap, thanks to the fact that it comprises a radial lateral groove in the upper opening, you can receive the connector, enter the upper cavity of the cap and when it is rotated, it is hunted inside without being able to leave until it turns again and the lateral projection is aligned with the lateral groove where it can pass up; therefore, the upper cavity has a diameter that is equivalent to the diameter of the upper opening plus the length of the radial lateral groove.
  • the clamp can be made of medical grade polypropylene, medical grade polycarbonate or medical grade vinyl polychloride.
  • the cap can be made of medical grade polypropylene, medical grade polycarbonate and medical grade vinyl polychloride.
  • Figure 1 shows an isometric view of the device for mounting a PEG probe in application around a cut probe and with an inner cavity retainer.
  • Figure 2 shows a top plan view of the lower clamp body of the device for mounting a PEG probe, in the displaced state.
  • Figure 3 shows a side elevation view of the lower clamp body of the device for mounting a PEG probe, in the displaced state.
  • Figure 4 shows a side elevation view of the lower clamp body of the device for mounting a PEG probe, in coupled state.
  • Figure 5 shows a top plan view of the lower clamp body of the device for mounting a PEG probe, in coupled state.
  • Figure 6 shows a sectional isometric view of the cap of the device for mounting a PEG probe.
  • Figure 7 shows a side sectional view of the cap of the device for mounting a PEG probe.
  • Figure 8 shows an isometric view of the device in connection with a conventional power tube adapter.
  • Figure 9 shows an isometric view in vertical section of the device in an armed state and installed around the PEG probe.
  • the present invention relates to a simplified device (1) for the assembly of a percutaneous endoscopic gastrostomy (PEG) probe, which is installed outside the abdominal wall of a patient and allows its connection with an enteral feeding tube.
  • PEG percutaneous endoscopic gastrostomy
  • the device (1) comprises means for holding (10) of the probe (A) before being cut, holding it by external radial compression, and also includes, retention means by radial expansion of the proximal end (a) resulting from the cut probe (A), where the retention means is a cap (20) that engages the clamping means (10) and provides anti-reflux connector means between the proximal end (a) of the probe (A) and an enteral feeding tube (not shown).
  • the clamping means (10) comprise a clamp (11) formed by two semi-cylindrical pieces (111) interconnectable;
  • the semi-cylindrical parts (111) comprise an outer wall (112) provided with outer thread (13), an inner wall (113) comprising impaction teeth (12) formed by a pointed radial projection that stabilize the probe in a certain position to avoid its axial displacement towards the interior of the abdominal cavity once it has been cut to the desired length.
  • the semi-cylindrical pieces (111) show an upper straight end (114) and a lower end (115) with an external radial projection (116), from which they project, from integrally, outer radial flaps (117) comprising an upper face (118) and an opposite lower face (119) that is in contact with the patient's external abdominal wall.
  • the clamp (11) comprises a band-shaped extension (14) having a snap closure cover (15) at its distal end, where this band (14 ) is projected from the external radial projection (116), this cover (15) being the closure element of an upper opening present in the cap (20) and which will be explained later.
  • the cap (20) comprises a cylindrical body having an outer wall (21), an upper wall (23), a lower wall (24) opposite and a central axial perforation (25) defining an inner wall (22), wherein said axial perforation (25) defines an upper opening (251) and a lower opening (252).
  • the inner wall (22) of the cap (20) comprises an intermediate annular collar (221) with a central perforation (222); from said collar downwards the cap (20) comprises a lower cavity (223) connected to the lower opening (252), and from said collar upwards it presents an intermediate cavity (224), followed by an upper cavity (225 ) adjacent to the upper opening (251).
  • the lower cavity (223) has an inner wall (226) with a lower portion (227) provided with an inner thread (16) and also has a lower upper portion (228).
  • the upper opening (251) of the cap (20) comprises a radial lateral groove (253); while the upper cavity (225) has a diameter equivalent to the diameter of the upper opening (251) plus the length of the radial lateral groove (253).
  • the diameter of the outer wall (112) of the clamp (11) is coincident with the inner diameter of the lower portion (227) of the cap (20).
  • the outer thread (13) of the clamp (11) is coupled with the inner thread (16) of the cap (20).
  • the PEG probe (A) is installed in the internal abdominal cavity (D) of the patient, held in the inner wall (d) by a mechanism of the type expanded (B); the tube of the probe (A) is protruding outside and on the skin (E) of the patient's abdomen, in said tube the fastening means (10) is placed formed by the two semi-cylindrical pieces (111) that fit between them flush with the skin (E), making the underside (119) of the flaps (117) in direct contact and flush with skin
  • the protruding portion of the probe is cut leaving an outstanding portion of approximately 2mm, the proximal end (a) of the probe (A) being formed; the cap (20) is then inserted by turning it and coupling its inner thread (16) with the outer thread (13) of the clamp (11), during this fixation the lower end of the expander cone (17) is it is introduced into the lumen of the proximal end (a) of the cut probe (A), causing it to expand and adjust radially to the clamp (11) where the radial impaction teeth (12) are secured; once the cap (20) is attached to the clamp (11), a key connector (F) can be fitted to the upper opening (251) of the cap (20) to generate the adaptation of the feed tube (not shown) with the PEG probe

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Abstract

The invention relates to a simplified device (1) for mounting a percutaneous endoscopic gastrostomy tube outside the abdominal wall of a patient and which allows the connection thereof with an enteral feeding tube, which comprises means (10) for attachment by external radial compression of the tube (A) before being cut, and means for retaining by radial expansion the resulting proximal end (a) of the cut tube (A), wherein the retaining means is a cap (20) that is coupled to the attachment means (10) and provides anti-reflux connector means between the proximal end (a) of the tube (A) and an enteral feeding tube.

Description

DISPOSITIVO SIMPLIFICADO PARA EL MONTAJE DE UNA SONDA DE GASTROSTOMÍA ENDOSCÓPICA PERCUTÁNEA (PEG), QUE SE INSTALA POR FUERA DE LA PARED ABDOMINAL DE UN PACIENTE Y QUE FACILITA SU CONEXIÓN CON UN TUBO DE ALIMENTACIÓN ENTERAL  SIMPLIFIED DEVICE FOR THE ASSEMBLY OF A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROBE (PEG), WHICH IS INSTALLED OUTSIDE THE ABDOMINAL WALL OF A PATIENT AND FACILITATES ITS CONNECTION WITH AN ENTERAL FEEDING TUBE
MEMORIA DESCRIPTIVA DESCRIPTIVE MEMORY
La invención que es motivo de la presente solicitud de Patente de Invención se refiere a un dispositivo simplificado para el montaje de una sonda de gastrostomía endoscópica percutánea (PEG), que se instala por fuera de la pared abdominal de un paciente y que facilita su conexión con un tubo de alimentación enteral. The invention that is the subject of the present invention patent application relates to a simplified device for mounting a percutaneous endoscopic gastrostomy (PEG) probe, which is installed outside the abdominal wall of a patient and facilitates its connection with an enteral feeding tube.
DESCRIPCIÓN DEL ARTE PREVIO DESCRIPTION OF THE PRIOR ART
La gastrostomía es una intervención quirúrgica que crea una vía directa de alimentación temporal o permanente entre el estómago y la piel de la pared abdominal de un paciente. Específicamente consiste en la apertura de un orificio en la pared anterior del abdomen para introducir una sonda de alimentación en el estómago.  Gastrostomy is a surgical intervention that creates a direct route of temporary or permanent feeding between the stomach and the skin of a patient's abdominal wall. Specifically, it involves opening a hole in the anterior wall of the abdomen to insert a feeding tube into the stomach.
Es un método seguro que se considera de elección en situaciones de nutrición enteral prolongada y se usa principalmente para permitir la alimentación directa a pacientes que no pueden aceptar alimentos por vía oral; por ejemplo, a menudo se requiere gastrostomía para pacientes que tienen disfagia (dificultad para tragar los alimentos) debida a un problema mecánico o neurológico y que se suponga que puedan tener una adecuada esperanza de vida. Las gastrostomías generalmente se realizan mediante la colocación endoscópica de un tubo de alimentación en el que un cable pasa al estómago a través de la pared abdominal y el cable se recupera con un endoscopio introducido por vía oral. It is a safe method that is considered of choice in situations of prolonged enteral nutrition and is mainly used to allow direct feeding to patients who cannot accept food by mouth; For example, gastrostomy is often required for patients who have dysphagia (difficulty swallowing food) due to a mechanical or neurological problem and who are supposed to have adequate life expectancy. Gastrostomies are usually performed by the endoscopic placement of a feeding tube in which a cable passes to the stomach through the abdominal wall and the cable is recovered with an endoscope inserted orally.
Las sondas conocidas presentan en su extremo distal un dispositivo de retención interno, con el que el tubo flexible de sonda se apoya en la pared interior del estómago; el tubo flexible de la sonda está dimensionado para que se extienda más allá de la pared abdominal. En su extremo proximal presenta el tubo flexible una pieza de conexión, para poder conectar el sistema de trasvase para aportar la solución nutritiva. The known probes have at their distal end an internal retention device, with which the flexible tube of probe rests on the inner wall of the stomach; The flexible tube of the probe is sized to extend beyond the abdominal wall. At its proximal end, the flexible tube presents a connection piece, in order to connect the transfer system to provide the nutritive solution.
Un domo de retención en el extremo distal de la sonda retiene el tubo dentro del estómago del paciente, encontrándose, entre otros, retensores del tipo balones inflables o rellenables con suero, que se sostienen por la pared interior del estómago; otro tipo de retensores de sonda son del tipo plegables que una vez dispuestos dentro de la cavidad abdominal, se despliegan o expanden generando una superficie de soporte contra la pared abdominal.  A retention dome at the distal end of the catheter retains the tube inside the patient's stomach, being, among others, inflatable or serum-refillable balloons, which are supported by the inner wall of the stomach; Other types of probe retainers are of the foldable type that, once arranged inside the abdominal cavity, are deployed or expanded, generating a support surface against the abdominal wall.
Normalmente, por la zona exterior del abdomen del paciente, la sonda lleva medios de sujeción o retención exterior que buscan estabilizar la sonda en la pared abdominal, evitando que se produzcan desplazamientos axiales, pues estos desplazamientos no solo conllevan la posibilidad de contraer infecciones, sino que también producen filtraciones inesperadas e indeseadas para el paciente. Normally, through the outer area of the patient's abdomen, the probe has external retention or retention means that seek to stabilize the probe in the abdominal wall, preventing axial displacements, since these displacements not only entail the possibility of contracting infections, but which also produce unexpected and unwanted leaks for the patient.
La sujeción básica de este tipo de sondas se produce con un disco exterior que se posa sobre la piel del paciente, pero esta solución es poco efectiva por cuanto las sondas vienen con medidas preestablecidas de la distancia entre el retensor interior y el disco de sujeción exterior, limitando las posibilidades de acople a diferentes tipos de pacientes; especialmente el problema se acrecienta porque la distancia entre las piezas de sujeción debe ajustarse al espesor de las paredes abdominales, incluyendo tejido adiposo y muscular, pero estas capas se ven habitualmente reducidas por el mismo efecto de un sistema de alimentación que no es natural, de modo que es habitual ver que el ajuste inicial entre el retensor interior y el disco externo es insuficiente al poco tiempo, apareciendo claras filtraciones y a veces hasta el desprendimiento completo de la sonda. The basic clamping of this type of probes is produced with an outer disc that rests on the patient's skin, but this solution is not very effective because the probes come with pre-established measures of the distance between the inner retainer and the outer clamping disc , limiting the possibilities of coupling to different types of patients; especially the problem increases because the distance between the clamping pieces must be adjusted to the thickness of the abdominal walls, including adipose and muscular tissue, but these layers are usually reduced by the same effect of an unnatural feeding system, so it is usual to see that the initial adjustment between the inner retainer and the outer disk is insufficient soon, clear leaks appear and sometimes until complete detachment of the probe.
En el campo de aplicación es posible encontrar soluciones para este tipo de problemas, los que consisten básicamente en aparatos que permiten ajustar el largo del tubo, superando el arte anterior que proveía solo de una sonda con el disco de sujeción a una distancia fija, tal como el que se describe en la patente norteamericana US4,863,438, donde se ve un dispositivo de bajo perfil para gastrostomía que comprende un medio de sujeción interior y un botón de conexión exterior para introducir un tubo de alimentación enteral, pero tal como se mencionó anteriormente, el largo de la sonda definido entre el retensor interior y el botón exterior es un largo fijo, que no podría adaptarse a diferentes pacientes con diferente espesor de pared abdominal, como tampoco se podría adaptar al mismo paciente que va sufriendo adelgazamiento de sus paredes con el correr del tiempo, por lo que la filtración de fluidos sería inminente. In the field of application it is possible to find solutions for these types of problems, which basically consist of devices that allow the length of the tube to be adjusted, exceeding the prior art that provided only a probe with the clamping disc at a fixed distance, such such as that described in US Pat. No. 4,863,438, where a low profile device for gastrostomy is seen comprising an inner fastening means and an outer connection button for introducing an enteral feeding tube, but as mentioned above , the length of the probe defined between the inner retainer and the outer button is a fixed length, which could not be adapted to different patients with different abdominal wall thickness, nor could it be adapted to the same patient that is suffering from thinning of its walls with the passage of time, so the filtration of fluids would be imminent.
Para superar el problema anterior, se buscaron soluciones que permitían más de una posición de fijación, con pasos determinados entre un largo y otro, tal como se ve descrito en la solicitud de patente norteamericana US2016/0302999; sin embargo, al traer prefijados los tramos de longitud de la sonda, igualmente limita el uso en posiciones intermedias y dificultaría el uso de la misma sonda para ir ajustándola al requerimiento del paciente. No obstante, ha resultado un inconveniente, en pacientes activos y móviles, el que el tubo flexible de sonda sobresalga en medida relativamente grande de la pared abdominal. Este y otros dispositivos han demostrado ser productos útiles en que cuanto son de perfil bajo, es decir, esencialmente al ras con la piel evitando así los problemas asociados con los tubos de alimentación de longitud extendida, y también porque incluyen válvulas de una vía que evitan el reflujo de contenido gástrico (reflujo). Sin embargo, a pesar de la utilidad de dichos productos, es probable que la longitud del dispositivo varíe de paciente a paciente; por lo tanto, los hospitales deben mantener un inventario de diferentes tamaños ya que los dispositivos disponibles no son ajustables en tamaño. To overcome the above problem, solutions were sought that allowed more than one fixation position, with determined steps between one length and another, as described in US patent application US2016 / 0302999; however, by bringing the lengths of the probe prefixed, it also limits the use in intermediate positions and would make it difficult to use the same probe to adjust it to the patient's requirement. However, it has been a drawback, in active and mobile patients, that the probe tube protrudes relatively large from the abdominal wall. This and other devices have proven to be useful products in that how much they are low profile, that is, essentially flush with the skin thus avoiding the problems associated with extended length feeding tubes, and also because they include one-way valves that prevent the reflux of gastric contents (reflux). However, despite the usefulness of such products, the length of the device is likely to vary from patient to patient; therefore, hospitals must maintain an inventory of different sizes since the available devices are not adjustable in size.
Otro de los problemas habituales en el uso de sondas para gastrostomía, se ven reflejados en el proceso de montaje, donde cualquiera sea el medio de retención interior, se manifiesta una falla en los medios de sujeción externa, pues para el montaje del adaptador o disco de retención se fija el tubo flexible de la sonda por ejemplo con unas tenazas o pinzas quirúrgicas por encima de la pared abdominal y se acorta hasta la longitud necesaria. A continuación se conecta un adaptador, normalmente en forma cilindrica que se inserta dentro del extremo cortado de la sonda Another of the usual problems in the use of probes for gastrostomy, are reflected in the assembly process, where whatever the means of internal retention, a failure in the external fastening means is manifested, because for the assembly of the adapter or disk The flexible tube of the probe is fixed, for example, with surgical pliers or tweezers above the abdominal wall and shortened to the necessary length. An adapter is then connected, usually in a cylindrical shape that is inserted into the cut end of the probe
que sobresale de la pared abdominal, soltándose la fijación con las tenazas. Para fijar el tubo flexible de sonda, está prevista en el adaptador una pieza de sujeción. protruding from the abdominal wall, releasing the fixation with the tongs. To fix the probe hose, a clamp is provided in the adapter.
El montaje de adaptadores para sondas del tipo antes descrito se ve dificultado por cuanto la pinza es relativamente grande y difícil de manejar, lo que dificulta el montaje. El documento norteamericano US5,549,657 describe un adaptador que permite un acortamiento del tubo flexible de sonda en una sonda ya colocada, sin que sea necesario sustituir la sonda cuando el tubo flexible de la sonda está aún intacto. The mounting of adapters for probes of the type described above is difficult because the clamp is relatively large and difficult to handle, which makes assembly difficult. US document US5,549,657 describes an adapter that allows a shortening of the probe hose in an already placed probe, without the need to replace the probe when the probe hose is still intact.
El adaptador conocido dispone de una pieza de montaje para fijar la sonda frente a un resbalamiento hacia fuera. La pieza de montaje presenta un agujero central para introducir la sonda, en el que queda bloqueada. La pieza de montaje está compuesta por dos mitades que pueden desensamblarse, unidas entre sí articuladamente. Sin embargo, ambas mitades de la pieza de montaje se ajustan entre sí y en torno al extremo proximal de la sonda cuando ésta ya ha sido fijada a un tubo o estoma, de modo que produce un ajuste o aseguramiento que impide que la sonda se salga desde el estoma de la pieza de montaje, actuando efectivamente como abrazadera entorno al estoma; lo anterior, no permite que la sonda sea cortada antes de que se le introduzca el tubo o estoma del adaptador, sino que primero debe cortarse la sonda, introducir el adapatador y finalmente asegurar con la abrazadera, por lo que al no permitir que sea cortada antes, impide que la sonda sea cortada a un largo deseado ajustado a la pared abdominal externa del paciente y del mismo modo, no permite sostener la sonda una vez cortada para impedir que se vaya hacia adentro mientras se instala el adaptador y la abrazadera. The known adapter has a mounting piece to fix the probe in front of a slip out. The mounting piece has a central hole to introduce the probe, in which it is blocked. The assembly piece is composed of two halves that can be disassembled, joined together articulately. However, both halves of the mounting piece fit together and around the proximal end of the probe when it has already been fixed to a tube or stoma, so that it produces an adjustment or assurance that prevents the probe from coming out. from the stoma of the assembly piece, effectively acting as a clamp around the stoma; This does not allow the probe to be cut before the tube or stoma of the adapter is inserted, but the probe must first be cut, insert the adapter and finally secure with the clamp, so by not allowing it to be cut before, it prevents the probe from being cut to a desired length adjusted to the external abdominal wall of the patient and, in the same way, does not allow the probe to be held once cut to prevent it from going inward while installing the adapter and the clamp.
Adicionalmente, el dispositivo descrito comprende una construcción compleja de varias piezas, no resuelve bien el problema del contacto del aparato con la piel del paciente, por cuanto la superficie de contacto es un plano rígido que queda sobre la piel, favoreciendo la irritación y falta de comodidad al ser un plano rígido. Additionally, the described device comprises a complex construction of several pieces, it does not solve the problem of the contact of the device with the patient's skin, because the contact surface is a rigid plane that remains on the skin, favoring the irritation and lack of comfort being a rigid plane.
Por lo anterior, se deduce la necesidad de un dispositivo simplificado de montaje, que tenga pocas piezas, que facilite el acortamiento de la sonda a una longitud deseada sin que ésta se vaya hacia adentro del paciente, ni que deba manipularse mucho el extremo cortado para instalarle el adaptador que permite conectar la sonda con el tubo de alimentación, como también, que aborde el problema del contacto con la piel del paciente, procurando que sea un producto flexible y con poca superficie de contacto que disminuya irritaciones y finalmente, que aborde también el problema del reflujo de fluidos que se produce en los adaptadores donde se genera la conexión entre la sonda y el tubo de alimentación enteral. DESCRIPCIÓN DE LA INVENCIÓN Therefore, the need for a simplified mounting device, which has few parts, that facilitates the shortening of the probe to a desired length without it going into the patient, nor that the cut end should be manipulated much to be manipulated is deduced. install the adapter that allows the probe to be connected to the feeding tube, as well as to address the problem of contact with the patient's skin, ensuring that it is a flexible product with a small contact surface that reduces irritation and finally, that also addresses the problem of fluid reflux that occurs in adapters where the connection between the probe and the enteral feeding tube is generated. DESCRIPTION OF THE INVENTION
La presente invención se refiere a un dispositivo simplificado para el montaje de una sonda de gastrostomía endoscópica percutánea (PEG) por fuera de la pared abdominal de un paciente y que facilita su conexión con un tubo de alimentación enteral.  The present invention relates to a simplified device for mounting a percutaneous endoscopic gastrostomy (PEG) probe outside the abdominal wall of a patient and which facilitates its connection with an enteral feeding tube.
Uno de los principales objetivos de la presente invención es proveer un dispositivo para el montaje de una sonda PEG que sea simplificado, de pocas piezas, pero que a la vez resuelva el problema de la sujeción de la sonda antes de proceder al corte de ella a una longitud deseada en el proceso de montaje y que impida que ésta se devuelva hacia el interior del paciente antes de terminar el montaje de los medios de sujeción externa. One of the main objectives of the present invention is to provide a device for the assembly of a PEG probe that is simplified, of few pieces, but at the same time solving the problem of clamping the probe before proceeding to cut it to a desired length in the assembly process and preventing it from being returned to the interior of the patient before finishing the assembly of the external fastening means.
Otro de los objetivos de la presente invención es proveer un dispositivo simplificado para el montaje de una sonda PEG que además de permitir su sujeción para el corte al largo deseado, también provea de medios adecuados de conexión entre la sonda cortada y el tubo de alimentación, entendiendo como adecuados, medios que faciliten dicho acople e impidan se produzca reflujo de fluidos al introducir dicho tubo de alimentación en el dispositivo de montaje. Another objective of the present invention is to provide a simplified device for mounting a PEG probe that, in addition to allowing its fastening for the desired length of cut, also provides adequate means of connection between the cut probe and the feeding tube, understood as adequate, means that facilitate said coupling and prevent fluid reflux from occurring when feeding tube is introduced into the mounting device.
Aún otro de los objetivos de la presente invención es proveer un dispositivo simplificado para el montaje de una sonda PEG que permita un contacto efectivo del dispositivo con la piel del paciente, pero con la menor superficie de contacto posible para evitar irritaciones. Yet another objective of the present invention is to provide a simplified device for mounting a PEG probe that allows effective contact of the device with the patient's skin, but with the smallest possible contact surface to avoid irritation.
Por lo tanto, el presente dispositivo comprende medios de sujeción por compresión radial exterior de la sonda antes de ser cortada, y medios de retención por expansión radial del extremo proximal resultante de la sonda cortada, consistentes en un capuchón de superficie interior roscada. Donde los medios de sujeción por compresión comprenden una abrazadera que rodea por fuera a la sonda y que a su vez, comprende unos dientes de impactación radial, en una superficie interior, que al impactarse en la superficie exterior de la sonda la estabilizan en una posición determinada para evitar su desplazamiento axial hacia el interior de la cavidad abdominal una vez que ha sido cortada a la longitud deseada. Therefore, the present device comprises means for securing by external radial compression of the probe before being cut, and means for retention by radial expansion of the proximal end resulting from the cut probe, consisting of a threaded inner surface cap. Where the compression clamping means comprise a clamp that surrounds the probe outside and, in turn, comprises radially impacted teeth, on an inner surface, which, when impacted on the outer surface of the probe, stabilize it in a position determined to prevent its axial displacement into the abdominal cavity once it has been cut to the desired length.
Así, una vez que la sonda ha sido instalada y retenida en el interior de la cavidad abdominal, la porción de tubo de la sonda que queda proyectada hacia afuera del paciente es rodeada por esta abrazadera que además se coloca a ras con la superficie de la piel, asegurando que la longitud sobrante de sonda sea la justa para evitar desplazamientos axiales que favorezcan la salida de fluidos y consecuentes infecciones. Thus, once the probe has been installed and retained inside the abdominal cavity, the tube portion of the probe that is projected outward from the patient is surrounded by this clamp that is also placed flush with the surface of the skin, ensuring that the remaining probe length is just enough to avoid axial displacements that favor the outflow of fluids and consequent infections.
Esta abrazadera comprende dos piezas semicilíndricas acoplables entre sí, de manera enfrentada por sus bordes verticales, de modo que una vez que se acoplan entre sí, conforman un cuerpo cilindrico que rodea a la sonda. Cada una de dichas dos piezas semicilíndricas comprende una pared exterior con un diámetro determinado y con una altura que no excede los 5 mm, proveyendo así de un adaptador de bajo perfil que no sobresale mucho de la superficie de la piel del usuario. This clamp comprises two semi-cylindrical pieces that can be coupled to each other, facing each other by their vertical edges, so that once they fit together, they form a cylindrical body that surrounds the probe. Each of said two semi-cylindrical pieces comprises an outer wall with a given diameter and a height not exceeding 5 mm, thus providing a low profile adapter that does not protrude much from the surface of the user's skin.
Esta pared exterior de las piezas semicilíndricas está provista de hilo de rosca exterior, dispuesto de tal manera que una vez que las dos piezas semicilíndircas se acoplan, el hilo de rosca se conforma como una sola unidad funcional que es capaz de recibir el hilo de rosca dispuesto en el mencionado capuchón que conforma a los medios de retención por expansión radial del extremo proximal de la sonda cortada. Dichas piezas semicilíndricas comprenden también un extremo recto superior, un extremo inferior con un resalte radial externo y una pared interior de diámetro determinado que coincide con el diámetro exterior de la sonda PEG, pues es dicha pared interior la que rodea a la mencionada sonda; esta pared interior comprende a dichos dientes de impactación radial, los que consisten en al menos un resalte radial en punta, que puede ser en forma triangular, donde dicha punta es la que se impacta en la pared exterior de la sonda y la inmoviliza. This outer wall of the semi-cylindrical pieces is provided with outer thread, arranged in such a way that once the two semi-cylindrical pieces are coupled, the thread is formed as a single functional unit that is capable of receiving the thread disposed in said cap that forms the retention means by radial expansion of the proximal end of the cut probe. Said semi-cylindrical pieces also comprise an upper straight end, a lower end with an external radial shoulder and an inner wall of a determined diameter that coincides with the outer diameter of the PEG probe, since it is said inner wall that surrounds said probe; This inner wall comprises said radial impaction teeth, which consist of at least one pointed radial projection, which can be triangular in shape, where said tip is the one that hits the outer wall of the probe and immobilizes it.
Alternativamente, los dientes de impactación en forma de resaltes pueden ubicarse uno en cada extremo superior e inferior de la pared interior de cada pieza semicilíndrica, como también, pueden constituirse como una pluralidad de resaltes ubicados en toda la pared interior. Alternatively, the impact teeth in the form of projections can be located one at each upper and lower end of the inner wall of each semi-cylindrical piece, as well as, they can be constituted as a plurality of projections located throughout the entire interior wall.
En otra modalidad de la invención, dichos dientes de impactación comprenden al menos una estría dispuesta a lo alto de la pared interior, donde esta estría puede tener una arista distal en punta, a modo de un filo que presiona y comprime radialmente a la mencionada pared exterior de la sonda PEG. In another embodiment of the invention, said impaction teeth comprise at least one groove arranged at the top of the inner wall, where this groove can have a pointed distal edge, as a cutting edge that presses and compresses radially to said wall. outside of the PEG probe.
En otra modalidad alternativa, dichas estrías pueden ir orientadas de manera diagonal o inclinada en las paredes interiores de cada una de las piezas semicilíndricas que conforman a los medios de sujeción del dispositivo aquí descrito. In another alternative embodiment, said striations can be oriented diagonally or inclined on the inner walls of each of the semi-cylindrical pieces that conform to the fastening means of the device described herein.
Las dos piezas semicilíndricas comprenden, de manera integral, unas solapas radiales exteriores proyectadas desde el resalte radial externo ubicado en la zona inferior de las paredes exteriores de la abrazadera, las que comprenden una cara superior y una cara inferior opuesta que queda en contacto con la pared abdominal externa del paciente. En una modalidad preferida, dichas solapas poseen forma alargada de extremo redondeado para evitar que se entierren en la piel del paciente y su forma alaragada permite que la superficie de contacto con la piel sea la menor posible para evitar irritaciones. The two semi-cylindrical pieces comprise, integrally, external radial flaps projected from the external radial projection located in the lower area of the outer walls of the clamp, which comprise an upper face and an opposite lower face that is in contact with the external abdominal wall of the patient. In a preferred embodiment, said flaps have an elongated shape with a rounded end to prevent them from being buried in the patient's skin and their flared shape allows the skin contact surface to be as small as possible to avoid irritation.
La abrazadera que conforma a los medios de sujeción radial comprenden también una extensión en forma de banda con una tapa a presión en su extremo distal, donde esta banda se proyecta desde el resalte radial externo, donde esta tapa sirve para cerrar una abertura dispuesta en la cara superior del capuchón que será descrito en detalle a continuación. The clamp that forms the radial fastening means also comprises a band-shaped extension with a pressurized lid at its distal end, where this band projects from the external radial shoulder, where this cover serves to close an opening arranged in the upper face of the cap that will be described in detail below.
El mencionado medio de retención del dispositivo, como ya se dijo, es un capuchón que se acopla por fuera del cuerpo de abrazadera del medio de sujeción y provee de medios conectores antirreflujo y sin derrames entre el extremo proximal de la sonda y un tubo de alimentación enteral. The aforementioned means of retaining the device, as already said, is a cap that engages outside the clamp body of the clamping means and provides anti-reflux and spill-free connector means between the proximal end of the probe and a feeding tube enteral
El capuchón comprende un cuerpo cilindrico que tiene una pared exterior, una pared superior, una pared inferior opuesta y una perforación axial central que define una pared interior y donde dicha perforación axial define a su vez, una abertura superior y una abertura inferior. The cap comprises a cylindrical body having an outer wall, an upper wall, an opposite lower wall and a central axial perforation that defines an inner wall and where said axial perforation in turn defines an upper opening and a lower opening.
Dicha abertura superior se dispone para anexar en ella un conector convencional de tubo de alimentación enteral, del tipo que posee un tubo de proyección cónica con un resalte lateral que actúa como llave y que se introduciría en la mencionada abertura superior para conectarse con la sonda PEG y proveer del fluido nutriente para alimentación del paciente. Said upper opening is arranged to attach in it a conventional enteral feeding tube connector, of the type that has a conical projection tube with a lateral projection that acts as a key and that would be introduced into said upper opening to connect with the PEG probe. and provide the nutrient fluid for patient feeding.
La pared interior del capuchón, relacionada con la perforación axial, comprende un collarín anular intermedio con una perforación central y a partir de dicho collarín hacia abajo, el capuchón comprende una cavidad inferior conectada a la abertura inferior; a partir de dicho collarín hacia arriba presenta una cavidad intermedia y se le anexa una cavidad superior colindante con la abertura superior. The inner wall of the cap, related to axial perforation, comprises an intermediate annular collar with a central perforation and from said collar downwards, the cap comprises a lower cavity connected to the lower opening; from said The upward collar has an intermediate cavity and an upper cavity adjacent to the upper opening is attached.
La cavidad inferior tiene una pared interior de diámetro determinado que coincide con el diámetro exterior del cuerpo de la abrazadera, esta cavidad cuenta con una porción inferior de altura coincidente con la pared exterior del cuerpo de la abrazadera y está provista de un hilo de rosca interior que empalma con el hilo de rosca exterior de dicha abrazadera; sobre esta porción con el hilo de rosca presenta una porción menor superior que aloja la holgura sobresaliente de la sonda cortada.  The lower cavity has an inner wall of a determined diameter that coincides with the outer diameter of the clamp body, this cavity has a lower portion of height coinciding with the outer wall of the clamp body and is provided with an inner thread which splices with the outer thread of said clamp; on this portion with the thread presents a smaller upper portion that houses the protruding clearance of the cut probe.
A partir de la perforación central del collarín hacia abajo se extiende un cono expansor, siendo este cono el que genera los medios de retención por expansión radial del extremo proximal resultante de la sonda cortada, pues dicho extremo de la sonda queda sobresaliendo desde la pared superior del cuerpo de la abrazadera y una vez que ésta está ajustada alrededor de la sonda reteniéndola con los dientes de impactación, al introducir el capuchón y atornillarlo por fuera de la abrazadera, dicho cono expansor penetra en el lumen del extremo sobresaliente de la sonda y debido a su forma cónica, a medida que penetra, va expandiendo radialmente a dicha sonda y la asegura contra la pared interior cilindrica del cuerpo de la abrazadera a través de los dientes de impactación. An expanding cone extends from the central bore of the collar downwards, this cone being the one that generates the means of retention by radial expansion of the proximal end resulting from the cut probe, since said end of the probe is protruding from the upper wall of the body of the clamp and once it is fitted around the probe retaining it with the impact teeth, when introducing the cap and screw it out of the clamp, said expander cone penetrates the lumen of the protruding end of the probe and due to its conical shape, as it penetrates, it expands radially to said probe and secures it against the cylindrical inner wall of the clamp body through the impaction teeth.
Sobre dicha cavidad inferior del capuchón, se dispone la cavidad intermedia, justo por sobre el collarín, donde en dicha cavidad se aloja una válvula antirreflujo unidireccional del tipo diafragma, la que permite el paso del tubo del adaptador del tubo de alimentación para que se ajuste a la perforación del collarín y a la entrada superior del cono expansor, de modo que el fluido nutriente pasa desde el tubo de alimentación hacia la sonda sin que se produzca un reflujo del fluido hacia la zona superior del capuchón y salga hacia el exterior por la abertura superior. Esta válvula antirreflujo es una disco de silicona con un corte central, preferentemente es un disco de silicona de aproximadamente 4mm de espesor que en su centro tiene un corte que abarca aproximadamente un 80% del diámetro. On said lower cavity of the cap, the intermediate cavity is arranged, just above the collar, where in said cavity a unidirectional anti-reflux valve of the diaphragm type is housed, which allows the passage of the tube of the feeding tube adapter to be adjusted to the perforation of the collar and to the upper entrance of the expander cone, so that the nutrient fluid passes from the feeding tube to the probe without a reflux of the fluid towards the upper area of the cap and outwards through the opening higher. This anti-reflux valve is a silicone disc with a central cut, preferably it is a silicone disc approximately 4mm thick at its center has a cut that covers approximately 80% of the diameter.
Al anexar el conector convencional de tubo de alimentación enteral en el capuchón, éste expande verticalmente al disco de silicona que actúa como válvula antirreflujo, el que además de dar estabilidad a la conexión, al momento de retirar el conector, el disco de silicona regresa a su estado original evitando la salida de fluidos gástricos. By attaching the conventional enteral feeding tube connector to the cap, it expands vertically to the silicone disk that acts as an anti-reflux valve, which in addition to giving stability to the connection, when removing the connector, the silicone disk returns to its original state avoiding the outflow of gastric fluids.
Esta abertura superior del capuchón posee un diámetro adecuado para recibir al tubo del conector convencional de tubo de alimentación enteral, el que normalmente es del tipo tubo con un resalte lateral que actúa como llave, donde dicho capuchón, gracias a que comprende una ranura lateral radial en la abertura superior, puede recibir al conector, entrar a la cavidad superior del capuchón y al ser girado, queda cazado en su interior sin poder salir sino hasta que se vuelva a girar y el resalte lateral quede alineado con la ranura lateral por donde puede pasar hacia arriba; por ello, la cavidad superior posee un diámetro que es equivalente al diámetro de la abertura superior más el largo de la ranura lateral radial. This upper opening of the cap has a suitable diameter to receive the tube of the conventional enteral feeding tube connector, which is normally of the tube type with a lateral projection that acts as a key, where said cap, thanks to the fact that it comprises a radial lateral groove in the upper opening, you can receive the connector, enter the upper cavity of the cap and when it is rotated, it is hunted inside without being able to leave until it turns again and the lateral projection is aligned with the lateral groove where it can pass up; therefore, the upper cavity has a diameter that is equivalent to the diameter of the upper opening plus the length of the radial lateral groove.
La abrazadera puede ser fabricada en polipropileno de grado médico, policarbonato de grado médico o policloruro de vinilo de grado médico. El capuchón puede ser fabricado en polipropileno de grado médico, policarbonato de grado médico y policloruro de vinilo de grado médico. The clamp can be made of medical grade polypropylene, medical grade polycarbonate or medical grade vinyl polychloride. The cap can be made of medical grade polypropylene, medical grade polycarbonate and medical grade vinyl polychloride.
DESCRIPCIÓN DE LAS FIGURAS DESCRIPTION OF THE FIGURES
Una descripción detallada de la invención se llevará a cabo en conjunto con las figuras que forman parte integral de esta presentación, donde: La figura 1 muestra una vista isométrica del dispositivo para el montaje de una sonda PEG en aplicación alrededor de una sonda cortada y con un retensor de la cavidad interior. A detailed description of the invention will be carried out in conjunction with the figures that are an integral part of this presentation, where: Figure 1 shows an isometric view of the device for mounting a PEG probe in application around a cut probe and with an inner cavity retainer.
La figura 2 muestra una vista en planta superior del cuerpo de abrazadera inferior del dispositivo para el montaje de una sonda PEG, en estado desplazado.  Figure 2 shows a top plan view of the lower clamp body of the device for mounting a PEG probe, in the displaced state.
La figura 3 muestra una vista en elevación lateral del cuerpo de abrazadera inferior del dispositivo para el montaje de una sonda PEG, en estado desplazado.  Figure 3 shows a side elevation view of the lower clamp body of the device for mounting a PEG probe, in the displaced state.
La figura 4 muestra una vista en elevación lateral del cuerpo de abrazadera inferior del dispositivo para el montaje de una sonda PEG, en estado acoplado.  Figure 4 shows a side elevation view of the lower clamp body of the device for mounting a PEG probe, in coupled state.
La figura 5 muestra una vista en planta superior del cuerpo de abrazadera inferior del dispositivo para el montaje de una sonda PEG, en estado acoplado.  Figure 5 shows a top plan view of the lower clamp body of the device for mounting a PEG probe, in coupled state.
La figura 6 muestra una vista isométrica seccionada del capuchón del dispositivo para el montaje de una sonda PEG.  Figure 6 shows a sectional isometric view of the cap of the device for mounting a PEG probe.
La figura 7 muestra una vista en corte lateral del capuchón del dispositivo para el montaje de una sonda PEG.  Figure 7 shows a side sectional view of the cap of the device for mounting a PEG probe.
La figura 8 muestra una vista isométrica del dispositivo en conexión con un adaptador convencional a tubo de alimentación.  Figure 8 shows an isometric view of the device in connection with a conventional power tube adapter.
La figura 9 muestra un vista isométrica en corte vertical del dispositivo en estado armado e instalado alrededor de la sonda PEG.  Figure 9 shows an isometric view in vertical section of the device in an armed state and installed around the PEG probe.
DESCRIPCIÓN DETALLADA DE LA MODALIDAD PREFERIDA DETAILED DESCRIPTION OF THE PREFERRED MODE
La presente invención se refiere a un dispositivo (1) simplificado para el montaje de una sonda de gastrostomía endoscópica percutánea (PEG), que se instala por fuera de la pared abdominal de un paciente y que permite su conexión con un tubo de alimentación enteral.  The present invention relates to a simplified device (1) for the assembly of a percutaneous endoscopic gastrostomy (PEG) probe, which is installed outside the abdominal wall of a patient and allows its connection with an enteral feeding tube.
Tal como se ve en la FIG.l, el dispositivo (1) comprende medios de sujeción (10) de la sonda (A) antes de ser cortada, sujetándola por compresión radial exterior, y comprende también, medios de retención por expansión radial del extremo proximal (a) resultante de la sonda (A) cortada, donde el medio de retención es un capuchón (20) que se acopla al medio de sujeción (10) y provee de medios conectores antirreflujo entre el extremo proximal (a) de la sonda (A) y un tubo de alimentación enteral (no ilustrado). As seen in FIG. 1, the device (1) comprises means for holding (10) of the probe (A) before being cut, holding it by external radial compression, and also includes, retention means by radial expansion of the proximal end (a) resulting from the cut probe (A), where the retention means is a cap (20) that engages the clamping means (10) and provides anti-reflux connector means between the proximal end (a) of the probe (A) and an enteral feeding tube (not shown).
Tal como se ve en la FIG.2 y FIG.3, los medios de sujeción (10) comprenden una abrazadera (11) formada por dos piezas semicilíndricas (111) acoplables entre sí; las piezas semicilíndricas (111) comprenden una pared exterior (112) provista de hilo de rosca exterior (13), un pared interior (113) que comprende a unos dientes de impactación (12) formados por un resalte radial en punta que estabilizan la sonda en una posición determinada para evitar su desplazamiento axial hacia el interior de la cavidad abdominal una vez que ha sido cortada a la longitud deseada. As seen in FIG. 2 and FIG. 3, the clamping means (10) comprise a clamp (11) formed by two semi-cylindrical pieces (111) interconnectable; The semi-cylindrical parts (111) comprise an outer wall (112) provided with outer thread (13), an inner wall (113) comprising impaction teeth (12) formed by a pointed radial projection that stabilize the probe in a certain position to avoid its axial displacement towards the interior of the abdominal cavity once it has been cut to the desired length.
Así como se ilustra en la FIG.3 y FIG.4 las piezas semicilíndricas (111) enseñan un extremo recto superior (114) y un extremo inferior (115) con un resalte radial externo (116), desde el que se proyectan, de manera integral, unas solapas (117) radiales exteriores que comprenden una cara superior (118) y una cara inferior (119) opuesta que queda en contacto con la pared abdominal externa del paciente. As illustrated in FIG. 3 and FIG. 4, the semi-cylindrical pieces (111) show an upper straight end (114) and a lower end (115) with an external radial projection (116), from which they project, from integrally, outer radial flaps (117) comprising an upper face (118) and an opposite lower face (119) that is in contact with the patient's external abdominal wall.
Tal como se ve en la FIG.4 y FIG.5, la abrazadera (11) comprende una extensión en forma de banda (14) que tiene una tapa (15) de cierre a presión en su extremo distal, donde esta banda (14) se proyecta desde el resalte radial externo (116), siendo esta tapa (15) el elemento de cierre de una abertura superior presente en el capuchón (20) y que se explicará más adelante. As seen in FIG. 4 and FIG. 5, the clamp (11) comprises a band-shaped extension (14) having a snap closure cover (15) at its distal end, where this band (14 ) is projected from the external radial projection (116), this cover (15) being the closure element of an upper opening present in the cap (20) and which will be explained later.
Como mejor se puede apreciar en la FIG.6, el capuchón (20) comprende un cuerpo cilindrico que tiene una pared exterior (21), una pared superior (23), una pared inferior (24) opuesta y una perforación axial (25) central que define una pared interior (22), donde dicha perforación axial (25) define una abertura superior (251) y una abertura inferior (252). As best seen in FIG. 6, the cap (20) comprises a cylindrical body having an outer wall (21), an upper wall (23), a lower wall (24) opposite and a central axial perforation (25) defining an inner wall (22), wherein said axial perforation (25) defines an upper opening (251) and a lower opening (252).
Tal como se ve en la FIG.7 la pared interior (22) del capuchón (20) comprende un collarín (221) anular intermedio con una perforación central (222); a partir de dicho collarín hacia abajo el capuchón (20) comprende una cavidad inferior (223) conectada a la abertura inferior (252), y a partir de dicho collarín hacia arriba presenta una cavidad intermedia (224), seguida por una cavidad superior (225) colindante con la abertura superior (251). La cavidad inferior (223) tiene una pared interior (226) con una porción inferior (227) provista de un hilo de rosca (16) interior y presenta además una porción menor superior (228). As seen in FIG. 7, the inner wall (22) of the cap (20) comprises an intermediate annular collar (221) with a central perforation (222); from said collar downwards the cap (20) comprises a lower cavity (223) connected to the lower opening (252), and from said collar upwards it presents an intermediate cavity (224), followed by an upper cavity (225 ) adjacent to the upper opening (251). The lower cavity (223) has an inner wall (226) with a lower portion (227) provided with an inner thread (16) and also has a lower upper portion (228).
A partir de la perforación central (222) del collarín (221) hacia abajo, se extiende un cono expansor (17). Mientras que la cavidad intermedia (224) dispuesta por sobre el collarín (221) aloja una válvula antirreflujo unidireccional del tipo diafragma (no ilustrada). From the central bore (222) of the collar (221) downwards, an expander cone (17) extends. While the intermediate cavity (224) disposed above the collar (221) houses a unidirectional diaphragm-type anti-reflux valve (not shown).
Nuevamente en referencia a la FIG.6, la abertura superior (251) del capuchón (20) comprende una ranura lateral radial (253); mientras que la cavidad superior (225) posee un diámetro equivalente al diámetro de la abertura superior (251) más el largo de la ranura lateral radial (253). El diámetro de la pared exterior (112) de la abrazadera (11) es coincidente con el diámetro interior de la porción inferior (227) del capuchón (20). A su vez, el hilo de rosca exterior (13) de la abrazadera (11) se acopla con el hilo de rosca (16) interior del capuchón (20). Again in reference to FIG. 6, the upper opening (251) of the cap (20) comprises a radial lateral groove (253); while the upper cavity (225) has a diameter equivalent to the diameter of the upper opening (251) plus the length of the radial lateral groove (253). The diameter of the outer wall (112) of the clamp (11) is coincident with the inner diameter of the lower portion (227) of the cap (20). In turn, the outer thread (13) of the clamp (11) is coupled with the inner thread (16) of the cap (20).
En referencia a la FIG.8 y FIG.9, es posible ver que en uso, la sonda PEG (A) es instalada en la cavidad abdominal (D) interna del paciente, sostenida en la pared interior (d) por un mecanismo del tipo expandióle (B); el tubo de la sonda (A) queda sobresaliendo por fuera y sobre la piel (E) del abdomen del paciente, en dicho tubo se coloca el medio de sujeción (10) formado por las dos piezas semicilíndricas (111) que se acoplan entre ellas a ras con la piel (E), haciendo que la cara inferior (119) de las solapas (117) queden en contacto directo y a ras de pielReferring to FIG. 8 and FIG. 9, it is possible to see that in use, the PEG probe (A) is installed in the internal abdominal cavity (D) of the patient, held in the inner wall (d) by a mechanism of the type expanded (B); the tube of the probe (A) is protruding outside and on the skin (E) of the patient's abdomen, in said tube the fastening means (10) is placed formed by the two semi-cylindrical pieces (111) that fit between them flush with the skin (E), making the underside (119) of the flaps (117) in direct contact and flush with skin
(E) del paciente; al unir ambas piezas semicilíndricas (111) se conforma la abrazadera que permite una compresión radial exterior de la sonda gracias a los dientes de impactación radial (12), los que quedan ajustados y presionando a dicha sonda (A), estabilizándola e impidiendo que ésta se devuelva y migre hacia adentro de la cavidad abdominal (D). (E) of the patient; by joining both semi-cylindrical pieces (111) the clamp is formed that allows an external radial compression of the probe thanks to the radial impaction teeth (12), which are adjusted and pressing said probe (A), stabilizing it and preventing it return and migrate into the abdominal cavity (D).
Una vez sujeta la sonda (A) en la abrazadera (11), la porción sobresaliente de la sonda es cortada dejando una porción sobresaliente de aproximadamente 2mm, conformándose el extremo proximal (a) de la sonda (A); a continuación se introduce el capuchón (20) girándolo y haciendo acoplar su hilo de rosca interior (16) con el hilo de rosca exterior (13) de la abrazadera (11), durante esta fijación el extremo inferior del cono expansor (17) se va introduciendo en el lumen del extremo proximal (a) de la sonda (A) cortada, provocando que éste se expanda y se ajuste de manera radial a la abrazadera (11) donde se asegura a los dientes de impactación radial (12); una vez acoplado el capuchón (20) en la abrazadera (11) se puede ajustar un conector tipo llave (F) a la abertura superior (251) del capuchón (20) para generar la adaptación del tubo de alimentación (no ilustrado) con la sonda PEG. Once the probe (A) is held in the clamp (11), the protruding portion of the probe is cut leaving an outstanding portion of approximately 2mm, the proximal end (a) of the probe (A) being formed; the cap (20) is then inserted by turning it and coupling its inner thread (16) with the outer thread (13) of the clamp (11), during this fixation the lower end of the expander cone (17) is it is introduced into the lumen of the proximal end (a) of the cut probe (A), causing it to expand and adjust radially to the clamp (11) where the radial impaction teeth (12) are secured; once the cap (20) is attached to the clamp (11), a key connector (F) can be fitted to the upper opening (251) of the cap (20) to generate the adaptation of the feed tube (not shown) with the PEG probe

Claims

REIVINDICACIONES
1. Dispositivo (1) simplificado para el montaje de una sonda de gastrostomía endoscópica percutánea, por fuera de la pared abdominal de un paciente, y que permite su conexión con un tubo de alimentación enteral, CARACTERIZADO porque comprende medios de sujeción (10) por compresión radial exterior de la sonda (A) antes de ser cortada, y medios de retención por expansión radial del extremo proximal (a) resultante de la sonda (A) cortada, donde el medio de retención es un capuchón (20) que se acopla al medio de sujeción (10) y provee de medios conectores antirreflujo entre el extremo proximal (a) de la sonda (A) y un tubo de alimentación enteral. 1. Simplified device (1) for the assembly of a percutaneous endoscopic gastrostomy tube, outside the abdominal wall of a patient, and which allows its connection with an enteral feeding tube, CHARACTERIZED because it comprises fastening means (10) by external radial compression of the probe (A) before being cut, and retention means by radial expansion of the proximal end (a) resulting from the cut probe (A), where the retention means is a cap (20) that engages to the clamping means (10) and provides anti-reflux connector means between the proximal end (a) of the probe (A) and an enteral feeding tube.
2. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 1,2. Device (1) for mounting a probe, according to claim 1,
CARACTERIZADO porque los medios de sujeción (10) comprenden una abrazadera (11) que rodea por fuera a la sonda (A) y que a su vez, comprende unos dientes de impactación radial (12) que estabilizan la sonda en una posición determinada para evitar su desplazamiento axial hacia el interior de la cavidad abdominal una vez que ha sido cortada a la longitud deseada. CHARACTERIZED because the clamping means (10) comprise a clamp (11) that surrounds the probe (A) on the outside and which, in turn, comprises radial impaction teeth (12) that stabilize the probe in a certain position to avoid its axial displacement into the abdominal cavity once it has been cut to the desired length.
3. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 2,3. Device (1) for mounting a probe, according to claim 2,
CARACTERIZADO porque la abrazadera (11) comprende dos piezas semicilíndricas (111) acoplables entre sí, y donde cada una comprende una pared exterior (112) provista de hilo de rosca exterior (13), un pared interior (113) que comprende a dichos dientes de impactación (12), un extremo recto superior (114) y un extremo inferior (115) con un resalte radial externo (116). CHARACTERIZED because the clamp (11) comprises two semi-cylindrical pieces (111) that can be coupled to each other, and where each comprises an outer wall (112) provided with outer thread (13), an inner wall (113) comprising said teeth of impact (12), a straight upper end (114) and a lower end (115) with an external radial shoulder (116).
1 one
4. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 3, CARACTERIZADO porque los dientes de impactación (12) comprenden al menos un resalte radial en punta. 4. Device (1) for mounting a probe, according to claim 3, CHARACTERIZED because the impact teeth (12) comprise at least one pointed radial projection.
5. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 3, CARACTERIZADO porque los dientes de impactación (12) comprenden al menos una estría dispuesta a lo alto de la pared interior (113). 5. Device (1) for mounting a probe, according to claim 3, CHARACTERIZED because the impaction teeth (12) comprise at least one groove arranged at the top of the inner wall (113).
6. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 2,6. Device (1) for mounting a probe, according to claim 2,
CARACTERIZADO porque las dos piezas semicilíndricas (111) comprenden, de manera integral, unas solapas (117) radiales exteriores proyectadas desde el resalte radial externo (116). CHARACTERIZED because the two semi-cylindrical pieces (111) comprise, integrally, outer radial flaps (117) projected from the external radial shoulder (116).
7. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 6,7. Device (1) for mounting a probe, according to claim 6,
CARACTERIZADO porque las solapas (117) comprenden una cara superior (118) y una cara inferior (119) opuesta que queda en contacto con la pared abdominal externa del paciente. CHARACTERIZED because the flaps (117) comprise an upper face (118) and an opposite lower face (119) that is in contact with the patient's external abdominal wall.
8. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 2,8. Device (1) for mounting a probe, according to claim 2,
CARACTERIZADO porque los medios de sujeción (10) radial comprenden una extensión en forma de banda (14) con una tapa (15) a presión en su extremo distal, donde esta banda (14) se proyecta desde el resalte radial externo (116). CHARACTERIZED because the radial clamping means (10) comprise a band-shaped extension (14) with a pressure cover (15) at its distal end, where this band (14) projects from the external radial shoulder (116).
9. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 1,9. Device (1) for mounting a probe, according to claim 1,
CARACTERIZADO porque el capuchón (20) del medio de retención del dispositivo (1) comprende un cuerpo cilindrico que tiene una pared exterior (21), una pared superior (23), CHARACTERIZED because the cap (20) of the device retention means (1) comprises a cylindrical body having an outer wall (21), an upper wall (23),
2 una pared inferior opuesta (24) y una perforación axial (25) central que define una pared interior (22), una abertura superior (251) y una abertura inferior (252). two an opposite lower wall (24) and a central axial perforation (25) defining an inner wall (22), an upper opening (251) and a lower opening (252).
10. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 9, CARACTERIZADO porque la pared interior (22) del capuchón comprende un collarín (221) anular intermedio con una perforación central (222) y a partir de dicho collarín hacia abajo, el capuchón (20) comprende una cavidad inferior (223) conectada a la abertura inferior (252) y a partir de dicho collarín hacia arriba presenta una cavidad intermedia (224) y una cavidad superior (225) colindante con la abertura superior (251). 10. Device (1) for mounting a probe, according to claim 9, CHARACTERIZED in that the inner wall (22) of the cap comprises an intermediate annular collar (221) with a central bore (222) and from said collar downwards, the cap (20) comprises a lower cavity (223) connected to the lower opening (252) and from said upward collar it has an intermediate cavity (224) and an upper cavity (225) adjoining the upper opening ( 251).
11. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 10,11. Device (1) for mounting a probe, according to claim 10,
CARACTERIZADO porque la cavidad inferior (223) tiene una pared interior (226) con una porción inferior (227) provista de un hilo de rosca (16) interior sobre la que hay una porción menor superior (228). CHARACTERIZED because the lower cavity (223) has an inner wall (226) with a lower portion (227) provided with an inner thread (16) on which there is a lower upper portion (228).
12. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 10,12. Device (1) for mounting a probe, according to claim 10,
CARACTERIZADO porque a partir de la perforación central (222) del collarín (221) hacia abajo se extiende un cono expansor (17). CHARACTERIZED because an expander cone (17) extends from the central bore (222) of the collar (221) downwards.
13. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 10,13. Device (1) for mounting a probe, according to claim 10,
CARACTERIZADO porque la cavidad intermedia (224) dispuesta por sobre el collarín (221) aloja una válvula antirreflujo unidireccional del tipo diafragma. CHARACTERIZED because the intermediate cavity (224) disposed above the collar (221) houses a unidirectional diaphragm type anti-reflux valve.
14. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 10,14. Device (1) for mounting a probe, according to claim 10,
CARACTERIZADO porque la abertura superior (251) del capuchón (20) comprende una ranura lateral radial (253). CHARACTERIZED because the upper opening (251) of the cap (20) comprises a radial lateral groove (253).
3 3
15. Dispositivo (1) para el montaje de una sonda, de acuerdo a la reivindicación 10, CARACTERIZADO porque la cavidad superior (225) del capuchón (20) posee un diámetro equivalente al diámetro de la abertura superior (251) más el largo de la ranura lateral radial (253). 15. Device (1) for mounting a probe, according to claim 10, CHARACTERIZED because the upper cavity (225) of the cap (20) has a diameter equivalent to the diameter of the upper opening (251) plus the length of the radial lateral groove (253).
16. Dispositivo (1) para el montaje de una sonda, de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque porque el diámetro de la pared exterior (112) de la abrazadera (11) es coincidente con el diámetro interior de la porción inferior (227) de la cavidad inferior (223) del capuchón (20) 16. Device (1) for mounting a probe, according to any of the preceding claims, CHARACTERIZED because because the diameter of the outer wall (112) of the clamp (11) is coincident with the inner diameter of the lower portion (227) of the lower cavity (223) of the cap (20)
17. Dispositivo (1) para el montaje de una sonda, de acuerdo a cualquiera de las reivindicaciones anteriores, CARACTERIZADO porque el hilo de rosca exterior (13) de la abrazadera (11) se acopla con el hilo de rosca (16) interior del capuchón (20). 17. Device (1) for mounting a probe, according to any of the preceding claims, CHARACTERIZED because the outer thread (13) of the clamp (11) is coupled with the internal thread (16) of the cap (20).
4 4
PCT/CL2019/050049 2018-07-24 2019-06-18 Simplified device for mounting a percutaneous endoscopic gastrotomy (peg) tube, which is installed outside the abdominal wall of a patient and which facilitates the connection thereof with an enteral feeding tube WO2020019090A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050110A1 (en) * 1999-02-24 2000-08-31 Sherwood Services Ag Securing device for a low profile gastrostomy tube
WO2003092780A2 (en) * 2002-05-01 2003-11-13 Boston Scientific Limited Medical catheter assembly and method of using the same
US20030212385A1 (en) * 2002-05-09 2003-11-13 Brenner Laurence D. Low profile adaptor for use with a medical catheter
EP2258334A2 (en) * 2009-06-04 2010-12-08 Tyco Healthcare Group LP Gastrostomy feeding apparatus and method
WO2014164277A1 (en) * 2013-03-12 2014-10-09 University Of Florida Research Foundation, Inc. Devices and methods for securing an anti-leak feeding tube for gastric and/or intestinal use

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050110A1 (en) * 1999-02-24 2000-08-31 Sherwood Services Ag Securing device for a low profile gastrostomy tube
WO2003092780A2 (en) * 2002-05-01 2003-11-13 Boston Scientific Limited Medical catheter assembly and method of using the same
US20030212385A1 (en) * 2002-05-09 2003-11-13 Brenner Laurence D. Low profile adaptor for use with a medical catheter
EP2258334A2 (en) * 2009-06-04 2010-12-08 Tyco Healthcare Group LP Gastrostomy feeding apparatus and method
WO2014164277A1 (en) * 2013-03-12 2014-10-09 University Of Florida Research Foundation, Inc. Devices and methods for securing an anti-leak feeding tube for gastric and/or intestinal use

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