Surgery – Respiratory method or device
Reexamination Certificate
1999-03-01
2001-02-13
Lewis, Aaron J. (Department: 3761)
Surgery
Respiratory method or device
C128S207170, C128S918000
Reexamination Certificate
active
06186139
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATION
This is the national stage of international application PCT/FR97/01170, filed on Jul. 1, 1997, which designated the USA.
BACKGROUND OF THE INVENTION
The invention concerns a filter to be placed over the surgical orifice at the base of the neck connecting the trachea of a tracheotemized person to the outside, the filter comprising a filter material bib with a cut-out neck and a border extended by at least an attachment strip adapted to form with the border a closed loop around the neck of the person by joining together of complementary joining means.
A surgical orifice at the base of the neck and connecting the trachea directly to the outside enabling the person to breathe in and out unaided is made during surgery to the upper respiratory tract, above the trachea, for example for sarcoma of the larynx.
Breathing in and out does not then benefit from the filtering, warming and saturation with water vapor functions effected by the passage of air breathed in via the nostrils, the nasal fossae and the pharynx.
DESCRIPTION OF RELATED PRIOR ART
To compensate for the elimination of these functions, “artificial noses” have been proposed in which the presence of a hygroscopic spongy mass in the breathed air path provides the three-fold function of filtering, warming and saturation with water vapor, the latter two functions condensing moisture in the air leaving the lungs on breathing out and evaporating moisture retained by the spongy mass on breathing in, together with corresponding heat exchanges. A “nose” of this kind is described in patent document FR-A-2 683 150, for example.
Because of the inherent weight of an artificial nose and because of the contact of the material of the nose with the tissues, some persons find wearing an artificial nose of the above kind somewhat uncomfortable. Also, the fitting of an artificial nose is undesirable during the post-operative period, before complete healing of the scars and stabilization of the surgical orifice.
Provided that certain precautions are taken with regard to the environment, temperature and relative humidity, it is possible to attenuate the drawbacks of direct entry into the trachea of air with uncontrolled temperature and relative humidity. However, the filter function is still necessary, not to say essential, unless the person is kept under clean room conditions. The necessary filtering involves preventing the entry of relatively large foreign bodies, such as parts of clothing.
In the early post-operative period the filtering function is assured by dressings arranged appropriately to enable air to pass through whilst protecting the exposed tissues. Such dressings are merely temporary, however. The devices taking the place of these dedicated dressings must be light in weight, easy to fit, effective as filters and in their role of protecting against entry of foreign bodies, and sufficiently sterile.
Filters in the form of bibs are available off the shelf, comprising a material formed of multiple thicknesses of filter fabric with a cut-out neck, the border of which is extended by two attachment straps that attach to each other to form a closed loop around the person's neck so that the bib hangs down onto the front of the person's torso, covering the surgical orifice leading to the trachea. The multiple thicknesses of fabric assure efficient filtering with a fabric that is loose enough to provide sufficient permeability to air. The diameter of the threads of the fabric cannot be made infinitely small and so the permeability of a fabric, depending on the surface area between the threads and the total surface area, requires passages of large unit surface area, with the result that it is necessary to stack several thicknesses of fabric to obtain sufficient blocking of fine particles. The fabric is washable.
Clearly the efficacy of the expected filtering result presupposes that the bib filter is changed frequently and washed regularly and carefully. Also, the cost of such filters is by no means negligible, given their construction, which entails a large number of manufacturing operations, and the stock required for regular changing. Also, regular changing and washing may be compromised inadvertently or because of negligence, leading to serious risks.
Document DE 3 525 658 describes a neck cover designed to protect access to the surgical opening of persons who have undergone surgery of the larynx and comprising a piece of loosely woven tissue (so that air can pass through it) hanging in front of the surgical opening with a shape corresponding to a V-shaped neck of an open-neck shirt or pullover and fixed to the neck of the person by a sewn strip, the ends of which are joined by “textile” closure pieces (i.e. of the “Velcro” type). The fabric is advantageously lined on the side towards the neck with thicknesses of tulle. The neck cover of the above document has, without prejudice to advantages and disadvantages compared to the bib described previously, the same disadvantages as that bib associated with reuse, namely the need for it to be maintained in a sterile condition and the risks of non-sterility resulting from failure to wash it or imperfect washing.
BRIEF SUMMARY OF THE INVENTION
To alleviate the above drawbacks, the invention proposes a filter adapted to cover a surgical orifice at the base of the neck connecting the trachea of a tracheotemized person to the outside, the filter comprising a filter material bib having a cut-out neck with a border extended by at least one attachment strip adapted to form, with said border, a closed loop around the neck of the person by joining together of complementary joining means, characterized in that the joining means, once joined, cannot be separated without rendering them unserviceable, with the result that the filter cannot be reused.
The inventors are aware that the hygiene required can be attained only if the filter, which is sterile when new, cannot be reused and must be discarded after a single use. This implies, firstly, that the unit cost should be low (materials and manufacturing process) so that the person is not tempted to reuse it, and, secondly and more importantly, that the filter is not able to be reused after a single use. The latter result is achieved by employing joining means that work only once, so that after the bib has been removed it is no longer possible to fix it around the person's neck again. Note that the two results referred to, namely low cost and difficult re-use, combine to dissuade the person from attempting to re-use the filter. Note also that single-use items such as paper handkerchiefs are in practice rendered unusable by the first use made of them whereas respiratory filters cannot indicate that their first use has made them inadequate in terms of protection.
The filter material is preferably a non-woven film which combines the advantages of low cost, easy manufacture by cutting out on a press, the ability to adjust its porosity with pores that are small by their very nature, and limited intrinsic cohesion, favoring the rendering of the joining means unserviceable after they are separated.
In a preferred arrangement, the bib has on a face designed to come into contact with the torso of the person an adhesive area in the form of an adhesive strip disposed substantially transversely to the bottom of the neck. This adhesive area is fixed to the neck of the subject, above the surgical orifice. It then assures that the filter material is kept spread across the front of the surgical orifice despite movements of the person and rubbing of their clothing. Also, the at least partial ablation of the larynx resulting from the tracheotomy produces a depression at the base of the neck around the surgical opening. Holding the filter material onto the neck above the surgical orifice prevents a space forming between the bib and the neck through which non-filtered air could pass.
Also, the bib preferably has, as far as possible from the neck, two adhesive areas adapted to hold the bottom part of the bib against the skin t
Bezicot Eric
Bezicot Robert
Voranger Daniele
Lewis Aaron J.
Young & Thompson
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