WO2007017447A2 - Dispositif de tracheotomie - Google Patents

Dispositif de tracheotomie Download PDF

Info

Publication number
WO2007017447A2
WO2007017447A2 PCT/EP2006/064984 EP2006064984W WO2007017447A2 WO 2007017447 A2 WO2007017447 A2 WO 2007017447A2 EP 2006064984 W EP2006064984 W EP 2006064984W WO 2007017447 A2 WO2007017447 A2 WO 2007017447A2
Authority
WO
WIPO (PCT)
Prior art keywords
endotracheal tube
cuff
ring
positioning
inflating
Prior art date
Application number
PCT/EP2006/064984
Other languages
English (en)
Other versions
WO2007017447A3 (fr
Inventor
Mario Dauri
Stefania Improta
Original Assignee
H.S. Hospital Service S.P.A.
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 H.S. Hospital Service S.P.A. filed Critical H.S. Hospital Service S.P.A.
Publication of WO2007017447A2 publication Critical patent/WO2007017447A2/fr
Publication of WO2007017447A3 publication Critical patent/WO2007017447A3/fr

Links

Classifications

    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0472—Devices for performing a tracheostomy
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0402—Special features for tracheal tubes not otherwise provided for
    • A61M16/0409—Special features for tracheal tubes not otherwise provided for with mean for closing the oesophagus
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0434—Cuffs
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • 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
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/082—Mounting brackets, arm supports for equipment

Definitions

  • the following invention relates to a device for tracheotomies, in particular for low-invasive or percutaneous tracheotomies.
  • Low-invasive or mini-invasive tracheotomies have gained increasing interest in recent years and increasing space in intensive therapies, being today the most used techniques in the management of respiratory airways in patients who require medium to long- term ventilation, i.e. for periods that are longer than, for example, two weeks.
  • Percutaneous tracheotomy involves making an incision of limited dimensions in the front wall of the trachea, dilating the incision by means of suitable dilating devices until it is possible to insert a cannula therein for ventilating the patient .
  • Making the incision and introducing the cannula have to occur under continuous bronchoscopic control in order to permit a more correct performance of the operations and reduce the risk of possible complications, such as, for example, lesions to the mucous of the trachea.
  • percutaneous tracheotomy is currently performed after inserting into the trachea of the patient an endotracheal tube through which a fibre-optic bronchoscope is inserted; the tube is extracted as much as possible to enable the incision of the trachea below the distal end of the endotracheal tube, and the bronchoscopic view of the tip of the introducer needle at the entry into the tracheal lumen and the subsequent technical steps .
  • the endotracheal tube used is normally provided with a standard inflatable sealing cuff for ensuring the seal during ventilation of the patient at positive pressure.
  • the limit to this method lies in the long distance between the proximal part of the cuff and the tip of the tube, which makes viewing difficult or impossible in patients with short necks and any way does not enable the rear wall of the trachea to be protected.
  • An object of the present invention is to provide a device that enables, during performance of a tracheotomy, appropriate ventilation of the patient, protection of the rear wall of the trachea, insertion of a fibre-optic bronchoscope and complete viewing of the front wall of the trachea, transillumination from the tracheal lumen, said device having reduced dimensions and being simple and quick to use.
  • a device for tracheotomy comprising:
  • This appendage which is introduced into the trachea by a standard laryngoscope technique, enables total exposure of the front wall of the trachea to be able to conduct transillumination and view with facility the entry of the needle into the tracheal lumen and simultaneously constitutes a protection against possible lesions to the rear wall of the trachea that can be caused by the instrument used to carry out the incision of the trachea, for example a needle instrument, or by other elements present in the various tracheotomy kits .
  • said inflatable sealing cuff has an asymmetrical shape, said asymmetrical shape being selected in such a way that the cuff, after inflating, adapts to the shape of the laryngeal aditus of a patient.
  • the asymmetrical shape of the cuff means that when it is inflated after the introduction of the endotracheal tube, immediately in front of the laryngeal aditus, it is in a supraglottal position enabling the necessary seal for ventilation, not occupying space inside the trachea, but ensuring the occlusion of the oesophagus.
  • FIG. 1 is a schematic view from above of a device according to the invention
  • Figure 2 is a schematic side view of the device in Figure 1;
  • Figures 3 and 4 show an enlarged detail of the device in Figures 1 and 2, to illustrate the sealing cuff respectively before and after inflating;
  • Figure 5 is a greatly enlarged detail of Figure 3, that illustrates the connection between the inflating tube obtained inside the wall of the endotracheal tube and the sealing cuff;
  • Figure 6 illustrates the tracking device;
  • Figure 7 illustrates the endotracheal tube with the tracking device in position.
  • a device for tracheotomy comprises an endotracheal tube 1 made, for example, of relatively stiff material, in which, at a certain distance from the proximal end thereof, an asymmetrical inflatable sealing cuff C is provided, the function of which is to ensure the seal of the tube in front of the laryngeal aditus AL ( Figure 7), i.e. above the glottis G, and to occlude the oesophagus ES after the distal end of the tube 1 has been introduced into the trachea of the patient.
  • an endotracheal tube 1 made, for example, of relatively stiff material, in which, at a certain distance from the proximal end thereof, an asymmetrical inflatable sealing cuff C is provided, the function of which is to ensure the seal of the tube in front of the laryngeal aditus AL ( Figure 7), i.e. above the glottis G, and to occlude the oesophagus ES after
  • the portion of tube after the cuff C consists of a short tubular length 2a followed by an appendage 2b having the shape of a portion of cylindrical wall, for example with an angular extent of approximately 180°, intended to be introduced into the trachea.
  • the appendage 2b is preferably made from a softer and more flexible material than the material from which the endotracheal tube 1 is made, i.e. in order to limit the risks of lesions to the trachea of the patient during insertion into the trachea.
  • the radius of curvature of the appendage 2b is substantially the same as the radius of the tubular portion 2a.
  • the cuff C is associated with an inflating line that comprises a conduit D obtained in the side wall 6 of the tube 1 ( Figures 3-5) that ends at 7 at the lower fitting 10 of the inflatable sealing cuff C, and with an external inflating line E, as in the normal endotracheal tubes.
  • the external inflating line E consists of a flexible inflating line 5 provided, in the proximal portion, with a monitoring ball 11 for controlling the pressure inside the inflatable sealing cuff C and with a standard fitting S for connecting to any inflating device (syringe or other) .
  • This cuff C consists of a sleeve of elastic material, applied coaxially above the side wall 6 of the tube 1 and fixed thereto at the two ends 9 and 10 thereof so as to ensure the air seal.
  • the cuff C is furthermore asymmetrical so that, inflating, it takes on a shape substantially corresponding to the shape of the laryngeal aditus so as to ensure the seal during ventilation and to occlude the oesophagus of the patient by exerting a pressure that is as reduced as possible on the mucous of the patient, so as to minimise the risks of lesions from compression on the mucous .
  • the device After inflating the cuff C, the device connects to a system for ventilating the patient through a fitting 4 or a catheter mount.
  • This fitting comprises a first portion 4a, of cylindrical shape, intended to be connected to the above ventilation device, and a second portion 4b, this also with a cylindrical shape, intended to be inserted into the proximal end of the endotracheal tube 1.
  • the external diameter of the second portion 4b of the fitting 4 element is chosen in such a way that the coupling between said second portion 4b and the internal wall of the endotracheal tube 1 occurs with interference to ensure the seal when the ventilation device blows in air; in other words, the external diameter of the second portion 4b of the fitting 4 element is chosen slightly greater than the internal diameter of the endotracheal tube 1.
  • the endotracheal tube 1 can be provided with a standard catheter mount with sealing cap to be connected to the ventilation fitting and with a fixing device for fixing to the head of the patient to prevent movement of the endotracheal tube when it has been inserted into the patient .
  • the endotracheal tube 1 can be provided on the external side surface thereof with position indicators and be provided with a radio-opaque line along the entire length thereof or in some parts thereof, or with other means that is useful for correct viewing and evaluation of the positioning of the device through radiographic means .
  • the endotracheal tube 1 can be made, in a preferred embodiment, completely of soft and/or flexible material.
  • the device according to the invention furthermore comprises tracking means P intended to facilitate identification of the point of the throat of the patient in which to conduct the tracheotomy and keep in position the instrument with which initial perforation of the wall of the trachea is conducted, when conducting a tracheotomy.
  • the tracking means P comprises a telescopic rod 12, preferably metal, with fixing screw 13, that locks the telescopic movement of the rod 12, to prevent any variation in length when an appropriate length of the rod 12 has been fixed, on the basis of the physical features of the patient.
  • the telescopic rod 12 is fixable to the proximal end of the endotracheal tube 1, immediately below the fitting element 4 with the ventilation system, by means of a ring 14 that can be tightened with a screw mechanism 14a on the external wall of the endotracheal tube 1.
  • the telescopic rod 12 is connected to the ring 14 by means of an articulated connecting element 15 with locking screw 15a.
  • the articulated connecting element 15 enables said first end of the rod 12 to be positioned angularly with respect to the ring 14 and said first end to be locked in the chosen angular position by means of the locking screw 15a.
  • the telescopic rod 12 is connected to a second ring 16a by means of a further articulated connecting element 20 with locking screw 21.
  • This ring 16a can be tightened with a screw mechanism 16b on the wall of a positioning system 16, consisting of housing for a metal cannula 17 that acts as a guide for a surgical instrument intended for making an incision in the trachea of the patient .
  • the sliding of the further ring 16a is used to position the cannula 17 at the point of incision 18 of the trachea ( Figure 7) in which the tracheotomy has to be performed.
  • the articulated element 20 permits angular positioning of the cannula 17, so that it is in the optimal position and at the point of the throat of the patient where the incision has to be made for the tracheotomy.
  • the cannula 17 furthermore has a screw connection 19 for connecting a source of external lighting, for example a source of fibre-optic lighting.
  • the procedure for using the tracker P is as follows: once the tube 1 is positioned with the inflatable sealing cuff C inflated and in position and the distal end 2b of the endotracheal tube 1 inserted into the trachea of the patient, through the catheter mount a bronchoscope is inserted into the endotracheal tube 1.
  • the transillumination from the inside of the trachea achievable through the bronchoscope, enables the point to be identified (seeing the light from the exterior) where the incision has to be made.
  • the tracker P is fixed, adjusting the length of the telescopic rod 12, the angular position of the articulated connecting elements 15 and 20 and the position of the further ring 16 on the pin 16a.
  • the luminous intensity of the light source of the bronchoscope is lowered and the source of external illumination is inserted into the metal cannula 17, connecting it to the appropriate fitting 19. Transillumination from the exterior is then conducted. In fact with the bronchoscope, from the interior it will be possible to see the light and check, - thus from the interior of the trachea - whether the tracker P is positioned in the correct manner. It is thus possible to modify the position of the tracker P if necessary and possibly fix it with appropriate screws or other fixing systems so that the chosen position remains unvaried during performance of the tracheotomy.
  • the source of external lighting is removed and through the tracking cannula 17, the tracheotomy is performed using normal tracheotomy techniques.
  • the materials, the dimensions and the constructional details may be different from those indicated but be technically equivalent thereto, without thereby falling outside the scope of the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Otolaryngology (AREA)
  • Instruments For Viewing The Inside Of Hollow Bodies (AREA)
  • Catching Or Destruction (AREA)

Abstract

L'invention porte sur un dispositif de trachéotomie comprenant: un tube endotrachéal (1) présentant au voisinage de son extrémité distale (2a) un manchon gonflable d'obturation (C); un moyen de gonflage (D; E) du manchon (C) associé au tube (1) lequel est pourvu à son extrémité distale (2a) d'un appendice (2b) consistant en une paroi cylindrique.
PCT/EP2006/064984 2005-08-05 2006-08-02 Dispositif de tracheotomie WO2007017447A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000210A ITMO20050210A1 (it) 2005-08-05 2005-08-05 Dispositivo per tracheotomia
ITMO2005A000210 2005-08-05

Publications (2)

Publication Number Publication Date
WO2007017447A2 true WO2007017447A2 (fr) 2007-02-15
WO2007017447A3 WO2007017447A3 (fr) 2007-04-12

Family

ID=37075163

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/064984 WO2007017447A2 (fr) 2005-08-05 2006-08-02 Dispositif de tracheotomie

Country Status (2)

Country Link
IT (1) ITMO20050210A1 (fr)
WO (1) WO2007017447A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011032965A1 (fr) * 2009-09-18 2011-03-24 Atos Medical Ab Dispositif de protection du pharynx
US8313687B2 (en) 2007-09-20 2012-11-20 Kimberly-Clark Worldwide, Inc. Method of making an improved balloon cuff tracheostomy tube
US8607795B2 (en) 2007-09-20 2013-12-17 Kimberly-Clark Worldwide, Inc. Balloon cuff tracheostomy tube
WO2016028239A1 (fr) * 2014-08-20 2016-02-25 Yaşar Mehmet Akif Tube pour intubation utilisé dans des interventions de trachéostomie
WO2016102312A1 (fr) * 2014-12-23 2016-06-30 Deas S.R.L. Tube ventilatoire pour des procédures telles que trachéotomie
IT201700035827A1 (it) * 2017-03-31 2018-10-01 Alessandro Terrani Dispositivo per posizionare in modo ottimale un ago per tracheostomia rispetto ad un tubo endotracheale, ed apparecchiatura comprendente detto dispositivo connesso ad un tubo endotracheale

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0712638A1 (fr) * 1994-05-31 1996-05-22 Mallinckrodt Medical, Inc. Tubage pour la cavite pharyngienne
WO2000020062A2 (fr) * 1998-10-06 2000-04-13 Archibald Ian Jeremy Brain Dispositif respiratoire a masque larynge
EP1103280A1 (fr) * 1999-11-26 2001-05-30 Smiths Industries Public Limited Company Tubes médico-chirurgicaux avec manchons

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0712638A1 (fr) * 1994-05-31 1996-05-22 Mallinckrodt Medical, Inc. Tubage pour la cavite pharyngienne
WO2000020062A2 (fr) * 1998-10-06 2000-04-13 Archibald Ian Jeremy Brain Dispositif respiratoire a masque larynge
EP1103280A1 (fr) * 1999-11-26 2001-05-30 Smiths Industries Public Limited Company Tubes médico-chirurgicaux avec manchons

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8313687B2 (en) 2007-09-20 2012-11-20 Kimberly-Clark Worldwide, Inc. Method of making an improved balloon cuff tracheostomy tube
US8607795B2 (en) 2007-09-20 2013-12-17 Kimberly-Clark Worldwide, Inc. Balloon cuff tracheostomy tube
WO2011032965A1 (fr) * 2009-09-18 2011-03-24 Atos Medical Ab Dispositif de protection du pharynx
WO2016028239A1 (fr) * 2014-08-20 2016-02-25 Yaşar Mehmet Akif Tube pour intubation utilisé dans des interventions de trachéostomie
WO2016102312A1 (fr) * 2014-12-23 2016-06-30 Deas S.R.L. Tube ventilatoire pour des procédures telles que trachéotomie
IT201700035827A1 (it) * 2017-03-31 2018-10-01 Alessandro Terrani Dispositivo per posizionare in modo ottimale un ago per tracheostomia rispetto ad un tubo endotracheale, ed apparecchiatura comprendente detto dispositivo connesso ad un tubo endotracheale

Also Published As

Publication number Publication date
ITMO20050210A1 (it) 2007-02-06
WO2007017447A3 (fr) 2007-04-12

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