Surgery – Instruments – Internal pressure applicator
Reexamination Certificate
1998-11-12
2001-01-30
Buiz, Michael (Department: 3731)
Surgery
Instruments
Internal pressure applicator
Reexamination Certificate
active
06179855
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a device for protecting physiological pathways subjected to explorations performed with diagnostic and/or operating instruments.
In medical work it is currently often necessary to explore and inspect organs of the human body by introducing particular instruments which use optical fibers in body passages.
This is the case in particular of urethroscopies, during which damage is usually caused to the tissues that compose the urethral canal through which the instruments pass in order to reach the bladder.
This is particularly evident when these passages are repeated at short intervals, for example to change the instrument, as usually occurs when replacing the diagnostic instrument with the operating instrument.
For example, it can also become necessary to insert a permanent catheter of the type known as the Foley catheter, which, despite being made of polyurethane, silicone, latex or other equivalent material and despite being inserted in the urethra with the aid of lubricants and of a thin rigid sound, can cause further damage to a tissue which has already suffered alterations and/or lacerations.
This damage is due to the particular concertina-like configuration of the tissue of the urethra, which does not form a true open canal but rather a canal which can be considered as such only once it is fully open and dilated by a foreign object.
Furthermore, in this case the tissue is more or less consistent and offers a variable resistance to the passage of the instrument, which is followed by the movement of the concertina-like mucous membrane.
The simple dilation of the canal actually produces very little or no damage.
On the contrary, the insertion of a foreign object having a considerable diameter causes important damage; for example, a diameter of 8 mm for an adult and 6 mm for children is sufficient.
Furthermore, if this insertion is repeated at closely spaced intervals, the damage can become more severe, although not permanent, and usually heals within 4-10 days, during which pain persists and is subsequently replaced by discomfort.
As a first step, the possibility of using a protective device substantially constituted by a tube of netting, capable of dilating when an instrument having a larger diameter than the tube passes, was considered.
However, such device unfortunately causes traumas in the tissue of the urethra when the netting, after elongating, returns to its original dimensions, entraining parts of the previously dilated tissue in the meshes that close.
Furthermore, since the meshes of the tube of netting are very thin in order to avoid increasing excessively the diameter of the passage canal, said meshes can become a sharp blade.
It should also be added that the netting tube does not allow the passage of a Foley catheter due to the presence therein of the Y-shaped union for inflating the balloon for retaining it.
Another drawback observed in the described netting tube occurs during elongation, when as the diameter increases the length of the tube decreases, but this variation is not acceptable.
A protective device obtained by mutually joining two half-tubes at two sides which can be semirigid or partially flexible was then considered.
However, this produces two parts which have different lengths according to the diameter to which they expand during the insertion of the instrument; moreover, it has been observed that the total diameter, constituted by the diameter of the instrument plus the diameter of the tube, increases considerably.
Even with this type of protective device, it is not possible to insert a Foley catheter for the same reasons mentioned for the netting tube.
SUMMARY OF THE INVENTION
The aim of the present invention is to provide a device for protecting the tissues of physiological pathways during explorations performed with diagnostic and/or operating instruments which solves all of the above mentioned drawbacks.
A consequent primary object of the present invention is to provide a protective device which can avoid direct contact between diagnostic or surgical instruments and the tissue of the pathway into which they must be inserted, thus avoiding as much as possible any damage thereto.
Another important object of the present invention is to provide a protective device which can be used easily.
Another important object is to provide a protective device which can be adapted to the various diameters of instruments.
Another object of the present invention is to provide a protective device whose insertion in the pathway to be protected causes no trauma to the tissue of said pathway.
Another object of the present invention is to provide a protective device for the tissues of a pathway of the human body which can be produced at a very low cost.
Another object of the present invention is to provide a protective device which allows to insert Foley catheters if it is inserted in the urethral canal.
This aim, these objects and others which will become apparent hereinafter are achieved by a device for protecting the tissues of a pathway of the human body during explorations performed with diagnostic and/or operating instruments, comprising a sheet made of plastics which is rolled up so as to form a tuboid which, when inserted in said pathway, increases its diameter by elongation and/or unrolling as a consequence of the insertion of one of said instruments therein.
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patent: 5865826 (1999-02-01), Paul
patent: 5948191 (1999-09-01), Solovay
patent: 0 770 365 (1997-05-01), None
Bidoia S.a.s. di Gianfranco Bidoia E C.
Buiz Michael
Ho (Jackie) Tan-Uyen T
Josif Albert
Modiano Guido
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