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WO2020019090A1 - Dispositif simplifié pour le montage d'une sonde de gastrostomie endoscopique percutanée (peg), qui s'installe à l'extérieur de la paroi abdominale d'un patient et qui facilite son raccordement avec un tube d'alimentation entérale - Google Patents

Dispositif simplifié pour le montage d'une sonde de gastrostomie endoscopique percutanée (peg), qui s'installe à l'extérieur de la paroi abdominale d'un patient et qui facilite son raccordement avec un tube d'alimentation entérale Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
probe
mounting
wall
cap
radial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CL2019/050049
Other languages
English (en)
Spanish (es)
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
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pontificia Universidad Catolica de Chile
Original Assignee
Pontificia Universidad Catolica de Chile
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 Pontificia Universidad Catolica de Chile filed Critical Pontificia Universidad Catolica de Chile
Publication of WO2020019090A1 publication Critical patent/WO2020019090A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif (1) simplifié pour le montage d'une sonde de gastrostomie endoscopique percutanée à l'extérieur de la paroi abdominale d'un patient et qui permet son raccordement avec un tube d'alimentation entérale, lequel comprend des moyens de fixation (10) par compression radiale extérieure de la sonde (A) avant d'être coupé, et des moyens de retenue par expansion radiale de l'extrémité proximale (a) résultant de la sonde (A) coupée, le moyen de retenue étant un capuchon (20) qui s'accouple au moyen de fixation (10) et pourvu de moyens de raccordement antireflux entre l'extrémité proximale (a) de la sonde (A) et un tube d'alimentation entérale.
PCT/CL2019/050049 2018-07-24 2019-06-18 Dispositif simplifié pour le montage d'une sonde de gastrostomie endoscopique percutanée (peg), qui s'installe à l'extérieur de la paroi abdominale d'un patient et qui facilite son raccordement avec un tube d'alimentation entérale Ceased WO2020019090A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CL2018002000 2018-07-24
CL2000-2018 2018-07-24

Publications (1)

Publication Number Publication Date
WO2020019090A1 true WO2020019090A1 (fr) 2020-01-30

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Family Applications (1)

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PCT/CL2019/050049 Ceased WO2020019090A1 (fr) 2018-07-24 2019-06-18 Dispositif simplifié pour le montage d'une sonde de gastrostomie endoscopique percutanée (peg), qui s'installe à l'extérieur de la paroi abdominale d'un patient et qui facilite son raccordement avec un tube d'alimentation entérale

Country Status (1)

Country Link
WO (1) WO2020019090A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050110A1 (fr) * 1999-02-24 2000-08-31 Sherwood Services Ag Dispositif de fixation pour tube de gastrotomie court
US20030212385A1 (en) * 2002-05-09 2003-11-13 Brenner Laurence D. Low profile adaptor for use with a medical catheter
WO2003092780A2 (fr) * 2002-05-01 2003-11-13 Boston Scientific Limited Ensemble catheter medical et sa methode d'utilisation
EP2258334A2 (fr) * 2009-06-04 2010-12-08 Tyco Healthcare Group LP Appareil et procédé d'alimentation de gastrostomie
WO2014164277A1 (fr) * 2013-03-12 2014-10-09 University Of Florida Research Foundation, Inc. Dispositifs et procédés de maintien de sonde anti-fuite gastrique et/ou intestinale

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000050110A1 (fr) * 1999-02-24 2000-08-31 Sherwood Services Ag Dispositif de fixation pour tube de gastrotomie court
WO2003092780A2 (fr) * 2002-05-01 2003-11-13 Boston Scientific Limited Ensemble catheter medical et sa methode d'utilisation
US20030212385A1 (en) * 2002-05-09 2003-11-13 Brenner Laurence D. Low profile adaptor for use with a medical catheter
EP2258334A2 (fr) * 2009-06-04 2010-12-08 Tyco Healthcare Group LP Appareil et procédé d'alimentation de gastrostomie
WO2014164277A1 (fr) * 2013-03-12 2014-10-09 University Of Florida Research Foundation, Inc. Dispositifs et procédés de maintien de sonde anti-fuite gastrique et/ou intestinale

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