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Decontamination method and composition therefor

A decontamination and compound technology, applied in the fields of chemistry, disinfection, etc., can solve problems such as increasing the risk of adverse effects

Inactive Publication Date: 2002-01-23
UNITED THERAPEUTICS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oxidized adsorbed proteins can enter the patient and can react with biological systems in vitro, thus increasing the risk of adverse effects including contact phase activation caused by the interaction of blood and oxidized proteins on the dialysis membrane

Method used

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  • Decontamination method and composition therefor
  • Decontamination method and composition therefor
  • Decontamination method and composition therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] This example proves that the composition of the present invention has a synergistic effect on the disinfection of hemodialysis apparatus. The selected hemodialyzer labeled as F60 is made of polysulfone membrane and manufactured by Fresenius Medical Care (Bad Homburg, Germany). This dialyzer is used clinically for the first time.

[0069] In vitro test: In this test, the hemodialysis machine was contaminated with Pseudomonas aeruginosa PAl03 strain. Bacteria were first cultured on Tryptic Soy Agar (TSA) plates for 8 days (32°C). Collect spores by flooding the surface with sterile sodium bicarbonate buffer. The suspension was inoculated in sodium bicarbonate dialysate and incubated at 37°C with shaking. When colony forming units reached 10 9 / ml of the growth phase, rinse the selected dialyzer with the contaminated solution for 60 minutes in repeated cycles. Immediately after contamination, according to step 1 of the present invention, the dialyzer is rinsed and washe...

Embodiment 2

[0074] This example demonstrates that a dialyzer retreated with a composition according to the invention has no adsorbed oxidized protein compared to a conventional hemodialyzer. This results in better biocompatibility of the dialysis membrane with respect to circulating blood during hemodialysis without an activated contact phase.

[0075] Using a dialysis machine, a fresh dialyzer (made of polysulfone membrane produced by Fresenius Medical Care Bad Homburg, Germany) was perfused with human plasma for 4 hours. The dialyzer is treated according to the reprocessing step of the invention. The reprocessing step was repeated 50 times per dialyzer. Rinse the dialyzer with 2L saline to remove residual blood, then perfuse the dialysate compartment and the blood compartment with a cleaning agent containing 50mmol diethanolamine / HCl (pH=11.5) + 100mmol sodium chloride + 1% Triton X and leave at room temperature Incubate for 120 minutes. After incubation, the dialyzer was rinsed with...

Embodiment 3

[0079] This example demonstrates that the use of the composition of the present invention containing urea and low concentration of peracetic acid for retreatment of dialyzers effectively reduces the risk of bradykinin release in patients receiving ACE-inhibitors such as captopril. This property is related to the fact that the protein layer of the dialysis membrane of the dialyzer reprocessed according to the invention is not oxidatively negatively charged.

[0080]Clinical trial: The composition tested according to the invention was the composition A described in Example 1. Clinical trials were carried out as in Example 1, and the desorbed proteins were covalently conjugated to polystyrene microwells (CovaLink NH; Nunk) for testing. Coupling of proteins with N-hydroxysuccinimide (NHS esterified molecule). The final concentration of the protein was 10 μg / ml; 2) 100 μl of the protein solution was then added to the wells of the Covalink culture plate and capped on top. Then pla...

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Abstract

The present invention provides a new composition and method for reprocessing hemodialysers devices. The method involves the washing and filling the dialysate and blood compartment with an aqueous solution which includes urea and a low concentration of a germicidal sterilant.

Description

field of invention [0001] The present invention relates to methods and compositions for decontaminating instruments and equipment that have been in contact with biological material, especially blood and blood products. More specifically, the present invention relates to an improved method of reprocessing used dialyzers (this method may be performed manually and / or automatically). Background of the invention [0002] Extracorporeal hemodialysis is currently a method for removing uremic toxins in the body of patients with end-stage renal failure and prolonging their survival. The principle of hemodialysis involves the circulation of blood and dialysate through a dialyzer (called a "hemodialyzer") on either side of a dialysis membrane. This hemodialysis machine allows the metabolites that are elevated due to kidney failure to pass, while the permeation of proteins and cells in the blood is limited. Typically, this treatment is given three times a week for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/18
CPCA61L2/186
Inventor A·马希奥特W·克莱奥法斯
Owner UNITED THERAPEUTICS CORP