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
  • A61M16/0468—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters with valves at the proximal end limiting exhalation, e.g. during speaking or coughing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/20—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith
  • A61F2/203—Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith comprising an air passage from trachea to oesophagus or to pharynx; Artificial epiglottis

Definitions

• the present invention relates, as a new industrial product, to a phonatory valve intended for persons who have undergone a total or partial laryngectomy and who are equipped with a phonatory prosthesis. It consists of a valve and a filter, is in the form of a one-piece adhesive dressing and is disposable.
• US Patent 3,952,335 relates to a voice valve which comprises a flexible diaphragm capable of occupying three positions, the first position corresponding to normal breathing of the patient, the two- xth position corresponding to the closing of said valve, caused by the pressing of said membrane on a fixed seat, the third position corresponding to an opening of the valve, by displacement of the membrane outside the valve, said displacement being caused by overpressure or increased pressure in the trachea, caused in particular by a cough.
• a major drawback of such a phonatory valve lies in the fact that the flexible membrane is weakened at the level of the lateral connection with the valve body.
• EP-B ⁇ -0 078 685 discloses a phonatory valve, the flexible membrane of which is mounted on a transverse bar disposed in the valve body, so as to comprise two lips, one on each side of said transverse bar.
• the membrane for this purpose, is provided with an orifice in which engages a teton.
• a disadvantage of this phonatory valve is that the membrane is only maintained in its center which, in the event of strong pressure generated by a strong cough, could move it completely outside, the pa ⁇ holds before having to disassemble quickly the valve for re ⁇ placing the membrane in its normal operating position.
• the present invention relates to a phonatory valve of the type comprising a valve body, a valve with two lips capable of moving between an open position and a closed position, and means for adhering said valve around the stoma, and it is characterized in that the valve is a one-piece assembly in which the valve is permanently fixed to the support member, in that it further comprises a grid for filtering the air entering the stoma, said grid being arranged outside said body and on the side of the valve, and in that the adhesion means consist of an annular base, the contact face of which is coated with a repositionable adhesive.
• Figure 1 is a schematic sectional view of a patient's head comprising a prosthesis and a phonatory valve.
• Figure 2 is a sectional view of the phonatory valve according to a first embodiment of the invention.
• Figure 3 is a plan view of the base of the voice valve shown in Figure 2.
• Figure 4 is a sectional view of a voice valve according to a second embodiment of the invention.
• the phonatory valve 1 shown in the figures is intended to be placed on the neck 2 of a patient, at the location of the tracheosto e 3.
• the phonatory valve 1 which is in the form of a monobloc assembly comprises a body valve 4, of generally frustoconical or cylindrical shape, the front end 5 of which has two passages 6 and 7 separated by a support member 8 which extends transversely along a diameter be of said body.
• the rear end 9 of the body 4 is surrounded by a flexible annular base 10 whose contact face 11 is coated with a repositionable adhesive and protected before use by a peelable protective film 12.
• the peelable film 12 can be folded back on itself as shown in FIG. 2.
• a part 12a adheres to the base 10 and covers only the adhesive part which allows access to the interior of the body 4, the another part 12b extending beyond the peripheral edge 10a of the base 10 so as to constitute a gripping zone for the patient when the latter wishes to detach the film 12 from the base 10.
• a flexible valve 13, of form circular for example is permanently fixed along a diameter to the support member 8, for example by gluing, so as to comprise two flexible lips 14 capable of moving between an open position which corresponds to normal breathing of the patient and a closed position, shown in dotted lines in the figure, which is caused by the effect of a sudden increase in the pressure of the exhaled air when the patient wants to speak.
• Another safety grid 19 is mounted in the body 4, near the lower part 9.
• the grid 19 constitutes a retaining member for the valve 13, if, inadvertently, the latter is detached from the support member 8 .
• the means for fixing the phonatory valve 1 to the patient include a base 20 which is preferably in the form of a flexible dressing provided at its center with an orifice 21.
• the flange 22 has a curved part 23 which adapts to the curved junction part 4a between the base 10 and body 4, so as to allow easy and correct positioning of the valve on said base 20.
• the base 20 is coated on the entire underside 24 with a suitable adhesive, non-irritating for the patient, around the stoma, with the exception of zones 25 which are non-adhesive to constitute gripping zones for the patient when the latter wishes to replace the base 20 or for medical personnel when access to the stoma must be cleared.
• the valve body 4 is preferably thermoformed, made of synthetic material (PEBAX or HYTREL type), while the valve 13 is made of flexible synthetic material, such as rubber, silicone, HYTREL, PEBAX, flexible PVC.
• the angle at the top, formed by the lips 14 in the open position, is between 40 and 120 ° and preferably between 45 and 90 °. It goes without saying that the flexibility of the valve and the angle at the top of the lips can be adapted as a function of the respiratory power of the patient.
• the filter or protective grid 18 is made of lint-free, woven or non-woven material, the connection to the valve body being able to be carried out by any suitable means such as gluing, welding or interlocking.
• the safety grid 19 is of the wide mesh type, made of synthetic material, the connection on the internal wall of the body being preferably made by bonding or welding, so as to avoid any possibility of separation and any risk of swallowing.
• the valve is not stuck directly on the skin, but on the base 20 formed of a dressing of hydrocolloid type.
• This base consists of a film of synthetic material such as polyethylene or polyurethane, of substantially circular or oval shape, and of an adhesive of the hydrocol ⁇ lo ⁇ de type. Before use, the base is protected on its adhesive side by a peelable film.
• the use of the valve according to the invention first requires the establishment of the base 20 on the stoma, taking care to make the orifice 21 of the base 20 coincide with the stoma.
• the antiallergenic type hydrocolloid adhesive allows the patient to keep this base in place for several days or about a week.
• the patient places the disposable valve 1 on the base, this operation being facilitated by the rim 22 of the base which cooperates with the curved junction 4a of the body 4 to obtain optimum centering of the valve on the stoma.
• valve 1 When valve 1 is in the correct position tion, the patient pulls on the parts 12b of the peelable film 12 to allow the bonding of the valve 1 on the base 20.
• the valve in place thus allows normal breathing of filtered air and allows speech by a forced expiration which causes the closing the valve 13 on its seat 15.
• the valve 13 returns to itself in the open position for breathing.
• the patient wishes to change the valve 1, he separates the latter by detaching it from the base 20, which is very easy due to the adhesive of the repositionable type on the contact face of the base 10. Due to the fact as the valve 1 is in one piece and of the disposable type, the patient can change the valve several times a week, without any difficulty since the valve 1 is put on and removed as easily as a bandage.
• the valve body 4 is provided with orifices 26 which are preferably distributed over the entire periphery.
• a second very flexible membrane 27, of a shape substantially similar to that of the valve body 4, is arranged outside and around the latter, in the manner of a sleeve whose lower edge 28 is integral with the body of valve and the upper part 29 of which is free to move away from said body, when a high pressure is generated in the valve.
• the valve 13 In the case of a cough, for example, the valve 13 is applied abruptly to its seat due to the relatively high pressure which is generated. But at the same time or almost, said pressure acts on the outer mem ⁇ brane 27, at the parts opposite the orifices 26. Under the action of this pressure, the outer membrane 27 moves away from the valve body 4 and the air escapes to the atmosphere without requiring intervention tion of the patient. In addition, it should be noted that the presence of such an outer membrane prevents the air exhaled by the patient from passing through the grid 18, thereby reducing the risk of pollution of said grid.

Landscapes

• Health & Medical Sciences (AREA)
• Pulmonology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• Transplantation (AREA)
• Vascular Medicine (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Cardiology (AREA)
• Otolaryngology (AREA)
• Emergency Medicine (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Prostheses (AREA)
• Orthopedics, Nursing, And Contraception (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=9444376

Family Applications (1)

Country Status (5)

Families Citing this family (9)

Family Cites Families (5)

• 1993
  • 1993-02-24 FR FR9302102A patent/FR2701834B1/fr not_active Expired - Fee Related
• 1994
  • 1994-02-09 EP EP94906256A patent/EP0686051A1/de not_active Withdrawn
  • 1994-02-09 CA CA 2156714 patent/CA2156714A1/fr not_active Abandoned
  • 1994-02-09 WO PCT/FR1994/000146 patent/WO1994019045A1/fr not_active Application Discontinuation
  • 1994-02-23 MX MX9401363A patent/MX9401363A/es not_active Application Discontinuation

Non-Patent Citations (1)

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