Single-use body fluid analysis device

Surgery – Diagnostic testing – Liquid collection

Patent

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A61B 500

Patent

active

058107452

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

The present invention relates to the analysis of a body fluid taken directly from an elongate intra-corporeal cavity. By way of a nonlimiting example, the present invention will be introduced, defined and explained with reference to the recovery of the cervical mucus in the vaginal cavity of women for detection of the period of fertility.
In order to determine the periods of fertility in women, it is known, and it has been proposed, to detect and monitor the presence and/or concentration of certain biochemical or biological constituents of said mucus, such as a peroxidase or a compound having a peroxidase activity, or such as a mucopolysaccharide or a glycoprotein, by using reagents or colored reagent systems, for example, in the former case, an oxidation-reduction compound, of which at least the oxidized form is colored, for example guaiacol, and in the latter case safranin.
The solutions which have been proposed for the use of such reagents or reactive systems have generally been rudimentary and have in practice been difficult for women to put into use, namely: recovering the mucus, such as a swab, then bringing said element into contact, outside the vaginal cavity, with the reagent in liquid form; coated with a layer of reagent, and withdrawing said tampon after a certain time, and treating the layer of reagent with a color-developing agent.
These methods are known, for example, from the documents FR-A-2,216,975, EP-A-0,363,196 and EP-A-0,555,109.
The disadvantages of these methods result from the need to treat the extract of cervical mucus recovered extemporaneously, in order to reveal the possible presence or concentration of certain of its biochemical constituents.
Furthermore, in order to culture microorganisms directly, in particular pathogens, which may be present in an elongate intracorporeal cavity, a disposable device according to the embodiment in FIG. 3 of the document US-C-4,257,427 has been proposed, said device comprising: flexible foam; this element has, at its two ends, a relatively narrow neck and a base; it is inherently sufficiently stiff or rigid along its length for it to be pushed via its base and introduced into the intracorporeal cavity; microorganisms, said means being mounted at least in part in the interior of the conduit element, extending from a zone for sampling of the body fluid, outside the neck, to an axial collection point for said fluid, situated inside the conduit element, toward its base; this means consists of a wick of braided filaments, the outer unravelled end of which serves for taking the samples, and the inner end of which concentrates the body fluid which has been collected; an intermediate tube ensures sealing between the wick and the neck of the conduit element in such a way that the interior of the latter is substantially isolated from the intracorporeal cavity in which said element has been introduced;
This device is introduced by the user into the intracorporeal cavity, in which it remains for a period of time sufficient to permit the recovery of the body fluid, and the culturing of the microorganisms sought. The user then removes the device from the intracorporeal cavity and observes the development, or lack of development, of the culture of the microorganism sought, through the wall of the conduit element.


SUMMARY OF THE INVENTION

The subject of the present invention is a disposable device permitting extemporaneous analysis of a body fluid, with results which can be identified directly by the user, and without any intervention by the latter, other than that of introducing and removing said device into and from the intracorporeal cavity.
In accordance with the present invention, the starting point is a disposable device such as is described in the document US-C-4,257,427, which device is then modified specifically in the following manner: peripheral ring, supported in the aperture of the neck of the conduit element, protruding radially and to the outside of said neck, and forming a passage for communication between the in

REFERENCES:
patent: 3850160 (1974-11-01), Denson
patent: 4227537 (1980-10-01), Suciu et al.
patent: 4257427 (1981-03-01), Bucalo
patent: 4614715 (1986-09-01), Tsibris et al.

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