News Column

"Erythrocyte Mechanical Fragility Test" in Patent Application Approval Process

February 6, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventors Tarasev, Michael (Pinckney, MI); Alfano, Kenneth (Canton, MI); Chakraborty, Sumita (Ann Arbor, MI), filed on September 18, 2013, was made available online on January 23, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application is assigned to Blaze Medical Devices, LLC.

The following quote was obtained by the news editors from the background information supplied by the inventors: "This section contains general background material, which is not necessarily prior art.

"Red blood cell (RBC, erythrocyte) membrane fragility can be measured in various ways, principally either osmotically or mechanically. In general, it involves subjecting (wholly or partially) a sample of cells to a stress/force and measuring how much hemolysis occurs as a result of the applied stress/force. In the case of mechanical fragility (MF), cell membranes are exposed to some kind of mechanical disturbance such as a shear stress--which may vary in intensity, duration, or other parameters--while the proportion of cells lysing is tracked. This enables cells' overall susceptibility to hemolysis to be characterized and presented (comprehensively or selectively) in various ways. Such susceptibility to lysis of cells can be referred to in other ways (e.g. stress-resistance or lack thereof, stability under stress, stress-susceptibility, hemolytic propensity under stress, etc.) or even indirectly (e.g. stress-caused hemolysis, stress-induced hemolysis, stress hemolysis, etc). Fragility indices or profiles (single-parameter or multi-parameter) for erythrocytes may be desirable for research purposes or for clinical purposes. Applications may include blood product quality testing, diagnostics, clinical research, or basic research."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "This section briefly and non-exhaustively summarizes the subject matter of this disclosure.

"Devices and methods for measuring red blood cell (RBC) fragility can be useful for characterizing blood product or patient blood, in a wide variety of possible applications. Fragility measurements involve some means for applying known sources/amounts of a stress, as well as some means for determining the extent of hemolysis resulting from particular extent(s) of the stress. There are different ways this extent-of-hemolysis can be measured (in conjunction with various means of applying the stress), including various types of spectral analysis as well as cell-counting.

"This disclosure and others of its patent family pertain to RBC mechanical fragility testing, including by utilizing an integrated system to automatably combine the stressing and detection steps, and a (preferably single-use) disposable component for holding blood samples, with said component capable of serving in effect as both a stressing chamber and a detection chamber--albeit optionally in different portions of said component. In some embodiments, no fluidic transfer is needed within the disposable component between stressing and detection of portions of a sample. Employing a disposable/consumable cartridge or chip or other such piece for housing each sample to be tested can enable convenient testing of discrete samples with minimal cleaning or risk of contamination--among other benefits. Such single-use components can be configured to subdivide a given sample into multiple (discrete/separate/step-wise or continuous-flow based) subsamples to facilitate concurrent or otherwise disparate stressing for a single- or multi-dimensional profile, and/or be configured to receive multiple samples from multiple respective sources to facilitate multiplex testing.

"This disclosure also addresses utilizing sonication, to subject RBC to high-energy mechanical stress, as part of a particular approach to measuring RBC mechanical fragility. 'Low-energy' mechanical fragility, such as that utilizing a typical bead mill, tends to more directly reflect erythrocyte membrane properties (e.g. related to its integrity), whereas 'high-energy' mechanical fragility, such as that utilizing a sonicator, tends to more directly reflect hemoglobin viscosity and cell size/volume. (Note that both general kinds of fragility assays could be useful for different purposes, and potentially could be used in conjunction.)

"The scope of the invention is defined by the claims, which are incorporated into this section by reference. A more complete understanding of the present disclosure (including other filings that are incorporated herein by reference) and associated embodiments will be afforded to those skilled in the art, as well as the realization of additional advantages thereof, in consideration of the overall disclosure including drawings where applicable. s. Reference will be made to the appended sheets of drawings that will first be described briefly.

BRIEF DESCRIPTION OF THE DRAWINGS

"This section briefly describes the accompanying drawings for this disclosure. All drawings are for selectively and non-exhaustively illustrative and explanatory purposes only.

"FIG. 1 shows a single-sample disposable cartridge for testing RBC fragility via sonication, the cartridge being in effect both a stressing chamber and an optical cuvette.

"FIG. 2 shows a single disposable sample cartridge being inserted into an ultrasonic RBC fragility test system wherein a sonication head is ready to be moved into place.

"FIG. 3 shows beneath the device shroud of an ultrasonic RBC fragility test system, wherein a sonication mechanism, cooling and alignment fixture, light emitter and optical detector, and control board are visible.

"FIG. 4 shows a complete ultrasonic RBC fragility test system, with supporting computer (for control and analysis). Note that this particular version holds only one cartridge at a time, and each cartridge holds only one sample (although multiple such systems could be run by the same computer concurrently)

"FIG. 5 shows a 'multi-lane' ultrasonic RBC fragility testing system, which holds multiple single-sample cartridges for testing.

"FIG. 6 shows a multi-sample disposable cartridge for testing RBC fragility via sonication, each section of the cartridge being in effect both a stressing chamber and an optical cuvette for its respective sample.

"FIG. 7 shows a single-sample disposable cartridge for testing RBC fragility via sonication, wherein the sample gets split into multiple sub-samples, each section of the cartridge being in effect both a stressing chamber and an optical cuvette for its respective sub-sample.

"FIG. 8 shows a single-sample, multi-sub-sample disposable cartridge placed within a casing containing components for cooling, sonication, and optical detection.

"FIG. 9 shows a tower stacking multiple single-sample, multi-sub-sample disposable cartridges as 'drawers,' each such drawer containing components for cooling, sonication, and optical detection of its respective sample, so as to integrate ultrasonic RBC fragility testing of multiple samples and their respective subsamples.

"FIG. 10 shows a single-sample disposable cartridge to contain sample content during concentric-cylinder based testing of RBC mechanical fragility, the cartridge comprising both a stressing chamber and an optical cuvette.

"FIG. 11 shows a core view of a base unit of a concentric-cylinder based system for testing of RBC mechanical fragility that utilizes a disposable cartridge to contain sample content during testing, the base unit comprising both a stressing portion and an optical portion, and with a door closed over the optical portion.

"FIG. 12 shows a see-through view of a concentric-cylinder based RBC mechanical fragility test system from the front, which incorporates a disposable cartridge to contain sample content during testing.

"FIG. 13 shows a see-through view of a concentric-cylinder based RBC mechanical fragility test system from the top, which incorporates a disposable cartridge to contain sample content during testing.

"FIG. 14 shows a close-up front view of the optical portion of a concentric-cylinder based mechanical fragility test system for red blood cells."

URL and more information on this patent application, see: Tarasev, Michael; Alfano, Kenneth; Chakraborty, Sumita. Erythrocyte Mechanical Fragility Test. Filed September 18, 2013 and posted January 23, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2429&p=49&f=G&l=50&d=PG01&S1=20140116.PD.&OS=PD/20140116&RS=PD/20140116

Keywords for this news article include: Hemolysis, Immunology, Blood Cells, Erythrocytes, Erythroid Cells, Blaze Medical Devices LLC.

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Source: Politics & Government Week


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