Surgery – Diagnostic testing – Measuring electrical impedance or conductance of body portion
Reexamination Certificate
2002-06-14
2004-09-14
Marmor, Charles (Department: 3736)
Surgery
Diagnostic testing
Measuring electrical impedance or conductance of body portion
C600S564000, C606S167000
Reexamination Certificate
active
06792305
ABSTRACT:
The invention relates to a device for collecting a soft biological sample and to a method of using said device.
BACKGROUND OF THE INVENTION
Biological assays using reagents with a mutual affinity have been known for decades. They involve a biological sample suspected of containing an analyte and one or more reagents with an affinity or ability to react with the analyte in the sample.
The test sample is most frequently a patient's or individual's body fluid such as a sample of whole blood, plasma, serum, urine, cerebrospinal fluid, etc. A sample of biological fluid can be collected simply by using any appropriate device such as a pipette, a syringe, an automatic sample collector, etc. In some cases it may need to be filtered beforehand in order to remove all kinds of unwanted debris or microorganisms. In general terms the methods of sampling body fluids which are performed on a day-to-day basis are satisfactory: they are generally reproducible, giving quantitative results, and the devices available on the market are reliable and relatively inexpensive.
The sample can also consist of a biological solid, such as an organ or tissue fragment, which is not distributed in a systematically homogeneous manner in the sampling device. In this case the method of collecting the sample is much more complex and the devices often have to be adapted to each particular case according to the greater or lesser fluidity or viscosity of these body solids.
A very large number of common analyses and screenings are currently performed on fluid samples. This is not the case of the tests currently performed in the diagnosis of transmissible spongiform encephalopathies (TSE), which are degenerative neurological diseases such as scrapie in sheep, “mad cow disease”, also called bovine spongiform encephalopathy (hereafter “BSE”), in cattle, Creutzfeldt-Jakob disease (CJD) and kuru in humans, and related transmissible spongiform encephalopathies.
In the case of BSE, there is not yet a common in vitro diagnostic test which can be performed on a sample of body fluid, but only a test which can be performed on brain samples collected after the animal has been slaughtered. The postmortem examination reveals vacuolations in the cells of the bovine brain tissue and deposits of a specific marker of this disease, namely PrPres (abnormal form of a protein called “prion protein”). Diagnosis currently requires a sample to be collected from the brain matter, especially from the animal's brain stem and more particularly from the sensory and motor nuclei of the vagus nerve, which constitute the zone of preferential accumulation of PrPres, the diagnostic marker of BSE.
The sample collected is then subjected to various treatments for extraction of the PrPres, the specific marker of the disease, which is then analyzed by immunoassay.
The recent incidence of BSE in Great Britain (since 1985), and subsequently in Europe, is the cause of a very considerable public health problem in view of the possibility of transmission of the disease to humans, and its eradication has consequently become of very great economic importance.
In view of its plastic properties and its viscosity, bovine brain matter is not easy to sample in a simple, rapid, reproducible, quantifiable and safe manner. Now, for a mass screening of bovine carcasses, it is essential that the tests—and hence the sampling—are effected in the simplest manner usable in an abattoir, as quickly as possible after slaughter and as reproducibly, quantifiably and safely as possible, i.e. with the best possible sensitivity and without external contamination.
Conventionally, when a sample of brain matter is collected for analysis for the presence of PrPres, it is necessary to use an elaborate protocol which involves cutting off the head, possibly opening the brainpan, seizing a piece of brain matter, for example with a spoon, curette or any appropriate instrument of this kind, and manually cutting off, with a scalpel, at least one portion of said matter until the necessary weight is obtained, which must then be checked with a balance. The scalpel blade has to be changed for each sampling so as to avoid any contamination between samples. This protocol therefore proves rather inconvenient in practice and rather inappropriate for mass screening.
Finally, the sampling operation must be as inexpensive as possible (in terms of equipment and labor) for the final consumer, for obvious reasons.
There is therefore an urgent need for a device for collecting a soft biological sample, particularly brain matter, which is simple, can be used for example in an abattoir or in an analytical laboratory, is quick to use, is economic, has a reproducible performance and is quantifiable, effective and safe from any external contamination. There is also an urgent need for a method of carrying out this type of sampling. The object of the present invention was to meet these needs.
In general, such a need still exists in all situations where it is necessary to collect a soft biological sample, and not only in the area of spongiform disease in cattle or scrapie in sheep.
BRIEF SUMMARY OF THE INVENTION
The inventors have now found that it is possible to collect a reproducible volume of a soft biological sample using a device equipped with a slicing end, making it possible to effect a clean section of the soft matter constituting a sample. In particular, the inventors have discovered that it is possible to collect a constant mass of soft matter using a hollow cylindrical device equipped at one end with a slicing section carrying one or more cutting wires, positioned diametrically and perpendicularly to the axis of said hollow cylindrical body, when said cylindrical device is rotated to a sufficient extent about itself.
“Soft biological sample” is to be understood as meaning a sample of a biological material whose consistency is such that it can be cut effortlessly with a tool such as a scalpel. As indicated previously, an example of such a biological material is brain matter.
“Brain matter” is to be understood as meaning any portion of the mass constituting the central nervous system, and particularly, but not exclusively, the anatomical part conventionally called the “brain stem”, especially that which is centered on the sensory and motor nuclei of the vagus nerve, whether said matter be in the natural state or whether it has been treated, e.g. obtained in the form of a pasty ground material.
The invention therefore relates to a device for collecting a soft biological sample, especially of brain matter, comprising a hollow cylindrical body with two openings, one at each end, wherein a piston with a rod is inserted via a first end and said piston-and-rod assembly can be displaced back and forth inside said hollow cylindrical body, characterized in that the opening in the second end of the hollow cylindrical body has a slicing edge and in that said second end carries at least one cutting wire arranged across this opening.
The edge of the second end of the hollow cylindrical body slices sufficiently well to penetrate the soft biological sample by cutting it. The sharpness of the edge may be chosen according to the nature of the sample.
The hollow cylindrical body is advantageously transparent and the piston is advantageously opaque and colored. The hollow cylindrical body and the piston have to be chosen so as to allow and assure substantial leaktightness between them.
The device advantageously has means of identifying a volume corresponding to a variation in the position of the piston in the body. These means comprise e.g. one or more visible marks located in one or more different positions on the hollow cylindrical body and delimiting one or more given cylindrical volumes. Preferably, but not exclusively, the number of visible marks according to the invention is at least two.
The “visible marks” according to the invention, also called identification means, can consist e.g. of conventional graduations, such as those shown in
FIG. 1
, or of a variety of geometric symbols such as squares, circles,
Comoy Emmanuel
Deslys Jean-Philippe
Rastorgoueff Michel
Bio-Rad Pasteur
Marmor Charles
Merchant & Gould P.C.
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