Surgery – Diagnostic testing – Measuring or detecting nonradioactive constituent of body...
Patent
1997-03-11
1998-10-20
Lacyk, John P.
Surgery
Diagnostic testing
Measuring or detecting nonradioactive constituent of body...
600573, A61B 1000
Patent
active
058239545
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a disposable device for analysis or detection of a component, or of a biological or biochemical state, of a body fluid present in an elongate intracorporeal cavity. By way of a non-limiting example, the present invention will be introduced, defined and explained with reference to the detection of the fertile period in women by means of the cervical mucus taken from the vaginal cavity.
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 device into contact with a 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.
Such solutions are proposed by the documents FR-A-2,216,975, FR-A-2,399,231, EP-A-0,363,196 and EP-A-0,555,109.
The disadvantages of these methods result from the requirement of subsequently treating the extract of recovered cervical mucus with separate solutions for development of a color reaction, in order to reveal the possible presence or concentration of certain of its biochemical constituents.
Furthermore, the different solutions which have been known hitherto were not suitable for recovery of cervical mucus in all women, and this is because of the variations in the fluidity of the mucus and the amount of mucus secreted. Indeed, the aforementioned solutions are only of practical use in cases where the mucus is present in a relatively large amount or is very fluid.
In accordance with the document U.S. Pat. No. 4,257,427, a disposable device has been proposed for detection of a microorganism present in an intracorporeal cavity. This device comprises a hollow, elongate sampling element, made of transparent plastic, adapted to be fitted and held by simple constriction of the intracorporeal cavity, by way of a flexible sleeve made of foam. This same element is thus inherently stiff or rigid along its length for it to be pushed via one end and introduced via the other end into the intracorporeal cavity. Means for removing a sample of the body fluid present in the intracorporeal cavity consist of a wick, arranged in a sealed manner in the neck of the sampling element, having an unravelled outer end, and an inner end gathering the body fluid which has been collected. A medium for culturing the microorganism is arranged inside the sampling element.
The user introduces this device into the intracorporeal cavity, leaves it in place there for a time sufficient to culture the microorganism in situ, then removes said device in order to observe the development, or nondevelopment, of a culture through the wall of the sampling element.
A device of this kind does not permit immediate or virtually immediate analysis or detection of a component or of a biological or biochemical state.
The subject of the present invention is a disposable device for extemporaneous and direct detection of a component, or of a biological or biochemical state, of a body fluid, such as the cervical mucus, in an elongate intracorporeal cavity, such as the vaginal cavity.
More particularly, the subject of the present invention is a device of this kind which permits the detection of the fertile period in women, on the basis of cervical mucus, when said mucus is secreted in small amounts or is relatively viscous, and which at the same time remains particularl
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Lacyk John P.
Winakur Eric F.
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