Container or bag mixing apparatuses and/or methods

Abstract

A mixing system, apparatus and / or method. Pathogen reduction of and / or mixing storage solutions into blood or blood components are useful purposes for these. Squeezing or clapping devices may be used to activate the mixing process, as may rotational devices or laterally movable, rotational and / or orbital devices. Constriction elements may also be used to create useful vortex mixing actions. Photoradiation may be provided while the components continue to be mixed together for pathogen reduction of blood or blood components.

Description

PRIORITY CLAIM [0001] This application is a Divisional of U.S. regular application Ser. No. 10 / 425,281, filed Apr. 28, 2003 claiming priority from U.S. Provisional application 60 / 375,734, filed Apr. 26, 2002.FIELD OF THE INVENTION [0002] This invention is generally related to apparatuses and / or methods for mixing the contents of various containers or bags while the contents are being irradiated. Of particular note is the use of these apparatuses and methods in a pathogen reduction procedure. BACKGROUND [0003] Contamination of human blood and blood components with pathogens such as human immunovirus (HIV), hepatitis and / or bacteria create a serious risk for patients who receive blood or blood components via blood transfusions. [0004] To help combat the problem of pathogenic contamination in blood and / or blood components, one method of reducing pathogens in blood and biologically useful fluids may be to use radiation to substantially destroy any pathogens contained in the fluid. Radia...

AI Technical Summary

Benefits of technology

[0018] The present invention relates to methods, systems and apparatuses for mixing various fluid (or other substance) elements. More particularly, the present invention applies desirably to the preparation including mixing of a blood or blood component product in a pathogen reduction procedure. In one embodiment, the apparatus comprises a support structure for hanging a flexible polymeric container or bag therein or thereon and a moveable “clapper” structure which alternately squeezes the bag and releases the bag to mix the contents thereof. A clamp-like structure may also be provided to create one or more constrictions in the bag to provide mixing vortices within the bag to enhance the exposure of the bag contents to or adjacent the internal surface of the bag and thus also to any photoradiation impinging thereon. Photoinactivation is thus enhanced particularly for relatively opaque fluids (such as RBCs). A photosensitizer may be added to the blood or blood component to be pathogen inactivated and then thoroughly mixed therein. Then, also or alternatively the mixing effect could be sustained during illumination of the product therein.

[0019] Another embodiment involves a rotating structure in which a flexible bag may be disposed such that when rotated, the contents of the bag are continually rotated up and alternately pulled down by gravity. Rotating embodiments may also have light illumination and / or clamp-like structures constricting portions of the bag to create vortices which enhance mixing.

Problems solved by technology

Contamination of human blood and blood components with pathogens such as human immunovirus (HIV), hepatitis and / or bacteria create a serious risk for patients who receive blood or blood components via blood transfusions.

Radiation damages the nucleic acids of the pathogens by creating intrastrand nicks and inducing nucleotide photodimerization, both of which disrupt nucleic acid replication.

Unfortunately, the energy of short wavelength UV light may also damage the blood and blood components that are the desired end-products of the irradiation process.

Thus, an inherent problem in the application of UV-irradiation techniques is controlling the irradiation of the fluid so as to ensure sufficient radiation exposure to reduce undesirable pathogens within a fluid while at the same time minimizing or eliminating damage to the biologically useful fluids.

One problem with the use of light alone or light in combination with a photosensitizer to reduce pathogens in blood or blood products, is that during the pathogen reduction process, a portion of the fluid to be pathogen reduced may become trapped within dead spaces or opaque portions of the bag or container.

Fluid trapped in these dead spaces or opaque portions may not be reached by light and may therefore still contain pathogens which will re-infect the fluid which was previously pathogen reduced.

Another problem in pathogen reducing fluid using light results from the laminar nature of fluid flow in a container.

In the absence of vigorous agitation, the blood located along the walls of the container would have an extremely long residence time.

Thus, the blood or blood component nearest the walls (closest to the irradiation source) runs the risk of being overexposed to radiation which may significantly damage the blood or blood components, while the fluid in the middle of the container runs the risk of being under irradiated, thus any pathogens contained in this region would receive little or no radiation, and would be likely to re-contaminate the fluid with still viable pathogens.

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