Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using disinfecting or sterilizing substance
Reexamination Certificate
1994-03-14
2001-05-22
Alexander, Lyle A. (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Using disinfecting or sterilizing substance
C422S029000, C435S002000
Reexamination Certificate
active
06235239
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The subject invention relates to a composition for the disinfection of biological fluids and uses thereof. The invention also relates to methods of using the composition.
2. Background Information
A major concern among laboratory personnel is the handling of potentially infected blood and other samples for the purpose of laboratory testing. Patient samples can be potentially hazardous to the persons handling or performing the laboratory tests since the samples are capable of transmitting infectious or disease-causing agents.
Since all patient samples must be considered potentially dangerous, the cost of protective measures continues to rise while the efficacy of these measures remains to be determined. (American Hospital Association, “AIDS/HIV Infection: Recommendations for health care practices and public policy,”
AHA Report
(1988)).
Furthermore, another concern involves protecting those individuals receiving blood transfusions, as these individuals are particularly at risk of contracting blood-transmitted diseases. Current trends in the practice of transfusion medicine are focused on enhancing the sterility of donor blood, especially from the standpoint of blood-borne viruses (BBV). The application of high efficiency leukocyte-removal filters to remove cell-associated BBV from blood has been somewhat successful in both laboratory and clinical trials (Rawal et al.,
Transfusion
29:460-62 (1989); Rawal et al.,
Blood
76:2159-61 (1990); Gilbert et al.,
Lancet
1:1228-31 (1989); de Graan-Hentzen et al.,
Transfusion
29:757-60 (1990)). However, these filters are unable to remove cell-free virions from blood or plasma. Thus, leukocyte-depleted blood from infected donors may retain the potential of transmitting hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) to transfusion recipients.
Chemicals that are stable at room temperature, is compatible with blood samples and other biological fluids, and can kill microorganisms and viruses effectively in a relatively short period of time and methods of using same, can be of great importance and value in the prevention against various deadly diseases including AIDS, Hepatitis and several others that can be transmitted via blood and biological fluids.
Extensive studies have demonstrated the effectiveness of various chemical agents on the activity and growth of viral, bacterial and other organisms including human immunodeficiency virus, herpes virus, and gonorrhea. These agents include surfactants, purines or pyrimidines with ribose moiety, plant alkaloids, and antimutant agents.
In particular, Nonoxynol-9 and other nonionic surfactants have been employed as virucidal agents, but their use in blood samples and biological fluids is not acceptable due to their red cell lysing properties, or hemolytic effect, and their ability to alter proteins, enzymes and several other parameters that need to be tested in the blood samples. In particular, it is well known in the medical art that while chemical surfactants like Brij-35, Nonidet-P 40 and Nonoxynol-9 are capable of inactivating viruses by acting on the cell surface, proteins, and lipid layers, these chemicals can also damage the red cell surface if allowed to react for a prolonged period of time.
The applicant has considered the following patents and submits that the present invention is neither disclosed nor suggested therein: U.S. Pat. No. 4,012,494, U.S. Pat. No. 3,912,450, U.S. Pat. No. 3,867,517, U.S. Pat. No. 2,889,243, U.S. Pat. No. 2,380,166, U.S. Pat. No. 4,314,997, U.S. Pat. No. 4,164,565, U.S. Pat. No. 4,613,501, U.S. Pat. No. 4,806,463, U.S. Pat. No. 4,675,159, U.S. Pat. No. 4,978,688, U.S. Pat. No. 4,412,985, U.S. Pat. No. 4,924,624, U.S. Pat. No. 4,923,815, U.S. Pat. No. 4,833,165, U.S. Pat. No. 4,855,064, U.S. Pat. No. 4,471,054, U.S. Pat. No. 4,481,189, U.S. Pat. No. 4,841,023, and U.S. Pat. No. 4,764,369.
All U.S. patents and publications referred to herein are hereby incorporated by reference.
SUMMARY OF THE INVENTION
The subject invention relates to a novel composition which may be added to biological fluid samples, for example, blood samples, in order to efficiently kill and thereby inactivate the viruses and/or bacteria present therein. In this manner, the sample may be safely handled by laboratory personnel during routine laboratory tests, or in the case of blood products, utilized for transfusion purposes. One of several advantages of the composition is that it does not alter the customary test results which must be performed on the biological sample. Additionally, it may be added to any type of container means, for example, a test tube, blood collection tube, petri dish, blood bag or bottle filter paper.
The composition of this invention which is to be used for the disinfection of a lab sample consists essentially of the novel combination of: an anionic surfactant, at least one non-anionic surfactant, and a stabilizer which is used for the fixation of the biological sample. The preferred anionic surfactant is Brij-35 and the preferred non-anionic surfactant is Nonoxynol-9 or Nonidet-P 40. The preferred stabilizer is glutaraldehyde.
The invention further relates to a method of disinfecting a biological sample which is to be subjected to testing consisting essentially of the steps of: a) adding the above composition to a container means; b) adding the biological sample to the composition; and c) inducing intimate contact between the composition and the sample for a required time of several minutes in order to effect disinfection of the biological sample.
The present invention also relates to a composition for use in the disinfection of a blood or blood component sample contained in a blood bag, wherein the composition destroys all bacteria and viruses present in the sample yet maintains the structural integrity of the cells present in the sample such that the sample can be used for a transfusion. The composition consists essentially of, in combination: an anionic surfactant, at least one non-anionic surfactant, a stabilizer, two salts, and two phosphates. The preferred anionic surfactant is Brij-35. The preferred non-anionic surfactant is Nonoxynol-9 or Nonidet-P 40, and the preferred stabilizer is sucrose. The preferred salts are sodium and potassium chloride, and the preferred phosphates are sodium and potassium phosphate.
The present invention also includes a method of disinfecting a blood sample or blood component sample contained in a blood bag, consisting essentially of the combination of steps of: a) introducing the disinfectant composition into a blood bag containing blood or a component thereof; b) mixing the composition with the blood or blood component sample at regular intervals in order to induce intimate contact between the sample and the composition and thereby kill the viruses and bacteria present in the sample; c) separating the cellular components from the supernatant wherein the supernatant contains non-cellular components; and d) subjecting residual material to an extraction technique for a sufficient number of times effective for the removal of the remaining disinfectant composition components which were not separated out in step (c).
As noted above, the anionic surfactant and non-anionic surfactant of the present invention lyse red blood cells (i.e., cause a hemolytic effect) when used independently. However, when the anionic surfactant, non-anionic surfactant and stabilizer of the present invention are used in combination, unexpected results are observed. In particular, not only is the biological sample of interest disinfected, but in the case of a blood or blood component sample, the cells maintain their structural integrity and can be used for transfusion purposes. Moreover, the composition does not alter the results of lab tests to which the biological sample may be subjected. Thus, the composition of the present invention has remarkable properties which are due to the inventive combination of the three active elements.
REFERENCES:
patent: 4833165 (1989-05-01), Louder
Alexander Lyle A.
Medicine and Applied Sciences, Inc.
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