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
• • 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
  • 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
  • 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
  • A61M16/0436—Special fillings therefor
  • A61M16/0438—Liquid-filled
• • 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
  • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
  • A61M2205/0266—Shape memory materials

Definitions

• the present invention relates to a dilatative percutaneous tracheotomy device.
• tracheotomy i.e. the creation of a stoma directly connecting the dermis of the neck to the trachea
• tracheotomy is recommended in Intensive Care to reduce damage caused by prolonged tracheal intubation in the treatment of various pathologies, in which the patient is unable to breathe unaided or to eliminate bronchial secretions .
• tracheotomy was a surgical operation performed by an otorhinolaryngologist, either in Intensive Care or, at times, preferably in the operating theatre.
• Patent EP-Bl-O 784 989 proposes forming a tracheal stoma using a single increasing-gauge dilator guided by a metal wire positioned beforehand inside the trachea.
• 784 989 (Cook Inc.) comprises first pricking the trachea with a needle; making a small cut at the hole; threading a metal guide wire inside the needle; and withdrawing the needle, leaving only the metal guide wire in place.
• a dilator is immediately fitted over the guide wire, and has a small-diameter first tubular portion with a first balloon, into which a pressurized fluid is fed to dilate the hole made by the needle .
• the first balloon is then deflated, and a second tubular portion of the dilator, larger in diameter than the first portion, is then inserted inside the hole formed in the wall of the trachea.
• the second portion is practically equal in diameter to the hole through the epidermis and trachea.
• the first portion is then withdrawn from the second portion, and a second balloon, at the end of the second portion inside the trachea, is inflated to lock the second portion of the device inside the trachea.
• a second balloon at the end of the second portion inside the trachea
• the technique in EP-Bl-O 784 989 nevertheless has various limitations. That is, being rigid, the dilator used exposes the patient to the risk of rupturing the tracheal rings, which may result in serious bleeding and/or the creation of a foreign body which, if not detected and removed, may result in a pulmonary abscess.
• Another drawback lies in positioning of the dilator requiring force perpendicular to the trachea, thus possibly damaging the rear wall of the trachea and resulting in pneumothorax and subcutaneous emphysema.
• the tracheotomy device comprises a straightforward cannula, which is induced to pass from a contracted state to an expanded state to dilate a hole formed in a patient's trachea.
• Figure 1 shows a first step, in which a syringe needle is inserted into the patient's trachea
• Figure 2 shows a second step, in which the body of T/EP2005/050660
• Figure 3 shows a third step, in which a guide wire is threaded through the needle
• Figure 4 shows a fourth step, in which the needle is being removed from the guide wire, which remains partly inside the trachea;
• Figure 5 shows a fifth step, in which the needle has been completely removed, leaving the guide wire in position
• Figure 6A shows a sixth step, in which a hooded tracheostomic cannula is fitted over the guide wire;
• Figure 6B shows an enlarged detail of the hooded tracheostomic cannula in Figure 6A;
• Figure 7 shows a seventh step, in which a tubular portion of the cannula in Figures 6A, 6B is dilated;
• Figure 8 shows an eighth step,vin which a balloon- like retaining member at the distal end of the Figure 6A, 6B cannula is inflated;
• Figure 9 shows a ninth step, in which parts of the Figure 6A, 6B cannula are withdrawn;
• Figure 10 shows a tenth step, in which a fastening member is fitted to the tubular portion in Figure 7 projecting from the patient's dermis;
• Figure 11 shows an eleventh step, in which a tube of a respirator or bronchial secretion aspirator is connected to the fastening member in Figure 10.
• Figure 1 shows the first step in the use of a device T/EP2005/050660
• a surgical operator inserts a needle 1 through the wall W of the trachea T of a patient (shown only partly) , between two tracheal rings .
• a through hole H is thus formed in tracheal wall W to connect the outside atmosphere to the inside of trachea T .
• a syringe body 2 is attached in known manner to needle 1, and the surgical operator ensures needle 1 is positioned correctly by withdrawing the plunger of syringe body 2 to determine withdrawal of air.
• Wire 3 must be inserted rearwards towards the end of the bronchial tree, making sure guide wire 3 slides freely, thus showing it is positioned correctly.
• a hooded tracheostomic cannula 4 which may be formed using typical vascular stent technology, is inserted into trachea T (see Figures 6A, 6B onwards) .
• the structure of cannula 4 may also be defined by a metal coil (not shown) .
• cannula 4 comprises a tubular inner member 5 having a sagittal end 5a, in turn having a shoulder 5b on which rests a shape-memory cylinder 6 (see below) .
• Tubular inner member 5 is hollow, and has a cavity 5c which slides freely on guide wire 3.
• Shape-memory cylinder 6 in turn comprises an elastic metal mesh 6a immersed in a matrix 6b of easily deformable plastic material. More specifically, a first end 6c of cylinder 6 rests on shoulder 5b.
• Shape-memory cylinder 6 is maintained in the compressed configuration shown in Figure 6B by a sheath 7 also made of a convenient plastic material of a certain elasticity.
• member 8 is shown deflated, and, in use (see below), can be fed with gas (e.g. air) by means of a small tube 9 incorporated in cylinder 6 (see below) .
• gas e.g. air
• the stent or metal coil tracheostomic cannula may also be fitted inside with a liquid- or air-inflatable balloon, which may or may not be used to improve tracheal tissue dilatation.
• the balloon may be inflated after removal of sheath 7, is the same length as cylinder 6, promotes expansion of the tracheostomic cannula, and is deflated and removed after use.
• Sheath 7 may be removed by sliding ife upwards as shown in Figure 7, or may be a "peel-away" type, i.e. with two weak opposite longitudinal slits, by which the end of the sheath is first torn, and, when pull is exerted, the sheath splits into two, allowing cylinder 6
• Figure 10 shows the situation in which sheath 7 has been removed completely in the direction of arrow F to free cylinder 6, which at this point functions as a tube to which a fitting 9b is attached to fix to wall W a second end 6d of cylinder 6, which projects outwards of trachea T.
• the operator may attach a fitting 9c of a respirator or bronchial secretion aspirator (shown only partly) to end 6d of cylinder 6.
• Cannula 4, inflatable member 8, and tube 9 form part of device 10 according to the present invention.
• One variation (not shown) of the device according to the present invention employs a preformed or non- preformed high-pressure cannula system.
• a cylinder of non-extensible, collapsible material is used.
• the cylinder comprises two walls about 1.2 mm apart, a gap-filling system, and a distal retaining hood, and is inserted, in the fully retracted position, inside a sheath which may be of the peel-away type already described.
• tissue symmetrically and assumes an expanded configuration typical of a tracheostomic cannula.
• the cylinder may be expanded using pressurized fluid, setting gel, or bicomponent materials which set when mixed together.
• pressurized fluid setting gel, or bicomponent materials which set when mixed together.
• the latter two substances produce a long-lasting tracheostomic cannula, with obvious benefits to the patient.
• - insertion of the device according to the invention is fast and easy, can be performed by one operator, and can be mastered more or less immediately, especially by anyone already experienced in dilatative tracheotomy;
• a gaping tracheal stoma present between dilatation and insertion of the cannula; this is extremely important, in that, while the stoma is wide open, oxygenation of the patient cannot be • ensured, and numerous cases of desaturation are recorded, especially when insertion of the cannula proves difficult and further dilatation is required; moreover, a gaping stoma exposes the operator and bystanders to splattering by blood and/or bronchial secretion; the trachea and peritracheal tissue being gradually dilated radially, the tissue is in no way lacerated, but simply compressed and shifted aside by the cannula passing from the contracted to the memory, i.e. expanded, position; by virtue of this mechanism, the technique according to the present invention minimizes the risk of bleeding, and eliminates any risk of damage to the tracheal rings;
• the device according to the invention eliminates any risk of damage to the rear wall of the trachea, thus preventing subcutaneous emphysema or pneumothorax; - extubation and reintubation of the patient are not necessary, both these operations being performed with the cannula already in position;

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• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Emergency Medicine (AREA)
• Engineering & Computer Science (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Media Introduction/Drainage Providing Device (AREA)

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• 2005
  • 2005-02-15 WO PCT/EP2005/050660 patent/WO2006087032A1/en active Application Filing
  • 2005-02-15 EP EP05708017A patent/EP1853339A1/de not_active Withdrawn

Non-Patent Citations (1)

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