# US 12,005,449 B2 · Method and retainer for hemostasis testing

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- Number: US 12,005,449 B2
- Document ID: US12005449B2
- Status: Granted
- Kind: B2
- Application number: 17/855,634
- Filed: 2022-06-30
- Published: 2022-11-03
- Granted: 2024-06-11
- Earliest claimed: 2013-03-15
- Applicants: Haemonetics Corporation
- Inventors: Peter Delmenico; Carlos G. Lopez-Espina; Gabriel Raviv
- Web page: https://patentgrep.com/patent/US12005449B2

## CPC

- B01L 3/50273: {characterised by the means or forces applied to move the fluids}
- B01L 3/502: {with fluid transport, e.g. in multi-compartment structures}
- B01L 3/502753: {characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation}
- G01N 11/16: by measuring damping effect upon oscillatory body
- G01N 29/032: by measuring attenuation of acoustic waves
- G01N 29/036: by measuring frequency or resonance of acoustic waves
- G01N 29/2418: {using optoacoustic interaction with the material, e.g. laser radiation, photoacoustics (photoacoustic cells G01N21/1702; measuring characteristics of vibrations by using radiation-sensitive means G01H9/00; acousto-optical conversion techniques for short-range imaging G01S15/8965; sound-producing devices using laser bundle G10K15/046)}
- G01N 33/4905: {Determining clotting time of blood (by chemical methods G01N33/86, C12Q1/56)}
- B01L 2300/0663: Whole sensors
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/0877: Flow chambers
- B01L 2300/165: Specific details about hydrophobic, oleophobic surfaces
- B01L 2400/0433: vibrational forces
- B01L 2400/0481: squeezing of channels or chambers
- B01L 2400/0487: fluid pressure, pneumatics
- B01L 2400/0638: membrane valves, flap valves
- G01N 2291/02466: Biological material, e.g. blood
- G01N 2291/0251: Solidification, icing, curing composites, polymerisation
- G01N 2291/02818: Density, viscosity
- G01N 2291/02827: Elastic parameters, strength or force
- G01N 2291/0427: Flexural waves, plate waves, e.g. Lamb waves, tuning fork, cantilever
- G01N 2800/224: Haemostasis or coagulation
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A sample testing cartridge is usable to perform a variety of tests on a visco-elastic sample, such hemostasis testing on a whole blood or blood component sample. The cartridge includes a sample processing portion that is in fluid communication with a sample retention structure. A suspension, such as a beam, arm, cantilever or similar structure supports or suspends the sample retention portion relative to the sample processing portion in a unitary structure. In this manner, the sample retention portion may be placed into dynamic excitation responsive to excitation of the cartridge and correspondingly dynamic, resonant excitation of the sample contained within the sample retention portion, while the sample processing portion remains fixed. Observation of the excited sample yields data indicative of hemostasis. The data may correspond to hemostasis parameters such as time to initial clot formation, rate of clot formation, maximum clot strength and degree of clot lysis.

## Claims

### Claim 1

A cartridge for hemostasis testing comprising:
a retainer for a viscous sample for resonant testing, the retainer having an annulus having a first end and a second end, a relief formed about a circumference of the second end; and the retainer further being formed as an integral portion of the cartridge; wherein the cartridge further comprises:
a sample preparation portion including a fluid processing structure having a first fluid passage disposed within a sample preparation portion;
a sample testing portion including the retainer, the sample testing portion being coupled by a cantilever to the sample preparation portion, and a second fluid passage disposed within the sample testing portion in fluid communication with the first fluid passage communicatively coupling the fluid processing portion with the retainer; and
a pump coupled to the at least one fluid passage to pump fluid from the sample preparation portion to the sample testing portion via the first fluid passage and the second fluid passage.

### Claim 2 (depends on 1)

The cartridge of claim 1, wherein the cartridge comprises a laminate.

### Claim 3 (depends on 1)

The cartridge of claim 1, wherein the fluid processing structure comprising operatively arranged a plurality of fluid passages, at least one valve, a bellows and a reservoir.

### Claim 4 (depends on 1)

The cartridge of claim 1, the fluid processing structure comprising a reagent.

### Claim 5 (depends on 1)

The cartridge of claim 1, the fluid processing structure comprising a reagent disposed within the first fluid passage.

### Claim 6 (depends on 1)

The cartridge of claim 1, the fluid processing structure comprising a valve comprising a hydrophobic surface disposed within one of the first and second fluid passages.

### Claim 7 (depends on 1)

The cartridge of claim 1, the fluid processing structure comprising a fluid passage and a valve comprising a flexible membrane disposed within one of the first and second fluid passages.