Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Reexamination Certificate
1999-12-15
2002-04-16
Snay, Jeffrey (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
C422S051000, C422S105000, C600S584000, C604S318000, C604S409000
Reexamination Certificate
active
06372182
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention herein relates to the collection and analysis of body fluid samples, especially blood samples, from humans or animals. More particularly it is related to devices used for such collection and analysis.
2. Description of the Prior Art
The health care industry relies on the donation of blood and plasma by many thousands of people each year. For each blood donor, a health care professional performs a venipuncture and drains a pint (or half-liter) of blood through a length of transfer tubing and into a flexible plastic bag. Plasma typically is collected into a bottle, with red blood cells being returned to the donor. The resulting filled bag or bottle is known as a “unit’ of blood or plasma,
After collection, each unit of blood or plasma must be tested for several infectious organisms, including the human immunodeficiency virus (HIV) and several types of hepatitis. Other tests may be performed as well. To perform these tests, a sample must be removed from each unit of collected blood or plasma. Each sample is then labeled, to identify the unit from which it was drawn, and sent to a laboratory for analysis.
Many techniques and devices are available to make these analyses. The particular ones used may vary with the substances of concern to the blood bank operator, the researcher, or whichever other party intends to use the product. Blood analyzers may range from small “per drop” analysis devices to large laboratory equipment capable of rapidly analyzing a large number of samples.
If the laboratory tests performed detect the presence of an infectious disease or other contaminant in the sample, the unit from which the sample was drawn must be identified and discarded. Personnel at the blood storage facility are responsible for matching the tested samples with their original units and correctly selecting the tainted units for disposal.
Clearly, this procedure requires considerable care and attention from everyone in the system—those who draw and label the samples, those Who issue the test results, and especially those who match the test results to the original units.
Unfortunately, although the system functions smoothly most of the time in the United States, on occasion a tainted unit of blood still finds its way into the blood pool and, eventually, into a patient who leaves the hospital with an incurable disease that he did not have when he entered the hospital. It should be mentioned that many Third World countries have too few resources to perform any screening tests at all on blood or plasma before delivering it to the end user. Consequently, although even the small degree of error encountered in the American system is unacceptable, the amount of risk incurred in other areas of the world may be staggering.
The same process—with the same risks—applies to veterinary blood supplies as well. The result of this potential for infected or contaminated blood products to be unknowingly administered to previously uninfected recipients has created a significant—and justified—level of anxiety among members of the public and among health care professionals responsible for ordering and administering these products.
Similar problems arise in the collection and analysis of other body fluids, such as urine, lymph, bile, pleural fluid, ascites fluid, stomach and intestinal fluids, colostrom, milk, and the like. While the principal emphasis in the medical field has been upon blood and blood plasma collection, because of the vast quantities collected, provision of secure collection and analysis means for other body fluids is also important and of significant interest.
Secure collection must also be followed by protection of the sample against subsequent contamination, either by handling or by the analysis testing itself. Even such acts as exposure of the sample to ambient air can introduce contaminants into the sample.
Further, whether with blood or other body fluids, it is important to have a long term record available of the properties of each sample obtained. Usually this is done for the most part by the keeping of written sample analysis records. However, written records can be misplaced or destroyed, or, most importantly, can be recognized or suspected of being incorrect. It would therefore be advantageous to have an analysis and collection/containment device which would maintain a drawn body fluid sample and its analyses in essentially permanent physical form, so that the sample and its analyses can be visually checked at a later date if written records are absent or of doubtful accuracy.
There have been devices described as useful for analysis of blood and related bodily fluids and which incorporate a test device in some manner with a collection bag or vial. See, for instance, U.S. Pat. Nos. 4,820,297; 4,846,005; 4,900,321 and 5,595,187. Such devices have not proved successful or workable for many types of blood or fluid analysis, however, since they lack features such as maintenance of permanent unaltered samples of the blood or other fluid, they do not provide for controls to confirm that the device is operating properly, or they permit contact of the sample with the ambient atmosphere or other source of contaminants.
SUMMARY OF THE INVENTION
We have now developed a single, integrated device in which a body fluid (e.g., blood) can be both collected and analyzed easily without risk of contamination. The transfer of the body fluid between the collection portion and analysis portion of the device is through a unique structure designed to permit movement of small quantities of body fluid under controlled conditions, to minimize any waste of the body fluid and to ensure that no contamination reaches the main fluid volume. The device also is permanently associated with the collection container and retains a significant quantity of the blood or other fluid in a contamination- or reaction-free condition, so that tests can be repeated at subsequent periods with consistent and reliable results. Further, control means are incorporated into the device to provide assurance the when in operation the device contains a sufficient quantity of the fluid for accurate analysis, and that the testing reagents in the device are operating accurately.
A wide variety of different body fluid components which may be indicative of various diseases, dysfunctions and abnormalities of the patient or the body fluid itself can be analyzed. In some embodiments the device is entirely hand manipulated such that the device can be used in any location, even where no external sources of power or other mechanical or electrical aids are available. In other embodiments the operation of the device can be with mechanical or electrical pumping components. The device is thus ideal for use in the field for emergency and preliminary analysis of a patient's condition, thus allowing field medical personnel to deal with such conditions as appropriate long before the patient can be transferred to more extensive medical facilities, as well as in regular blood banks and research laboratories where analysis can be substantially automated.
The device is also useful for veterinary purposes. By appropriate selection of the testing and analysis sensors to be used, body fluid drawn from animals can be rapidly analyzed, such that, for instance, a diseased animal in a herd can be quickly identified and isolated from the other animals to prevent the spread of infection within the herd. The ability to use the device in the field is of significant advantage in veterinary use, since in many cases the animals are in remote locations far from veterinary medical facilities, or it is difficult or impractical to transport the animals to such facilities.
Of particular significance with the present device is that its structure and operation ensure that the main portion of the body fluid unit drawn from the patient or donor remains isolated within the collection container during transfer of the test sample and cannot be contaminated by external contaminants, by backflow of the test sample, by t
Mauro Stephen F.
Reynolds Robert A.
Aalto Scientific LTD
Brown Martin Haller & McClain
Snay Jeffrey
LandOfFree
Integrated body fluid collection and analysis device with... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Integrated body fluid collection and analysis device with..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Integrated body fluid collection and analysis device with... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2841504