IP Library Granted Patent US 12693287
Granted Patent B2
US 12693287 · App. 17/558,721 · Granted Jul 28, 2026

Disposable hemolysis sensor

Inventors: Brian Joseph Bosy (Hull, MA); Josef Kerimo (Concord, MA)
Assignee: Instrumentation Laboratory Company
G01N33/4915G01N15/1404G01N33/491G01N2015/142
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Quick Facts
Patent No.
US 12693287
App. No.
17/558,721
Granted
Jul 28, 2026
Kind
B2
Abstract

An apparatus for measuring hemolysis in a cartridge based automated blood analyzer is described. The apparatus allows hemolysis testing to be performed on a sample which is presented as a whole blood sample for other testing by the cartridge based automated blood analyzer. A disposable module is configured for optically analyzing one or more plasma analytes in a flow cell while red blood cells are acoustically separated from plasma in the flow cell.

Claims (32)

1 . A sensor module comprising:

a flow cell for holding a blood sample, the flow cell comprising a lumen and at least one wall surrounding the lumen;

an apparatus that is configured to be installed in, and removed from, an instrument configured to perform one or more analyses on a blood sample, wherein the flow cell is secured in a fixed position within the apparatus, the apparatus comprising an inlet port and an outlet port that are configured so that the sensor module can be installed in-line with a structure holding blood contained within the instrument to provide the blood sample from the instrument to the flow cell; and

from the instrument, respectively, the acoustic transducer being responsive to an electrical signal to generate an acoustic transducer secured between parts of the apparatus to be proximate to the flow cell such that the acoustic transducer is installed in and removed from the instrument when the apparatus and the flow cell are installed in and removed acoustic force that causes separation of blood cells from plasma in the blood sample such that plasma is localized in the lumen of the flow cell and blood cells are localized next to the plasma localized in the lumen between the at least one wall of the flow cell and the plasma localized in the lumen;

wherein, when the sensor module is installed in-line with the structure of the instrument, the flow cell is aligned to an optical path to an optical device configured to capture information at least from the plasma localized in the lumen of the flow cell, the one or more analyses being based on the information.

2 . The sensor module of claim 1 , further comprising:

a light source to provide light to at least the plasma localized in the lumen in the flow cell.

3 . The sensor module of claim 2 , wherein the light source comprises light emitting diodes (LEDs).

4 . The sensor module of claim 3 , wherein the LEDs produce at least two different colors of light.

5 . The sensor module of claim 4 , wherein the at least two different colors of light comprise yellow light and red light.

6 . The sensor module of claim 2 , wherein the sensor module is configured to produce alignment among the flow cell, the light source, and the optical device.

7 . The sensor module of claim 2 , wherein the blood sample flows through, or is contained in, the flow cell when the apparatus is installed in the instrument.

8 . A system comprising the sensor module of claim 1 , wherein the system comprises:

processor circuitry to analyze the information to characterize one or more analytes in the plasma, the processing circuitry being external to the apparatus.

9 . The sensor module of claim 1 , wherein the flow cell is alignable to an optical path of light from a light source configured to illuminate at least the plasma localized in the lumen in the flow cell.

10 . The sensor module of claim 9 , wherein the light source is part of the sensor module and wherein the sensor module further comprises:

a light pipe between the light source and the flow cell, the light pipe for homogenizing the light provided by the light source.

11 . The sensor module of claim 9 , wherein the light source comprises light emitting diodes (LEDs); and

wherein the LEDs produce at least two different colors of light.

12 . The sensor module of claim 11 , wherein the at least two different colors of light comprise yellow light and red light.

13 . The sensor module of claim 12 , wherein the blood sample flows through, or is contained in, the flow cell following installation of the apparatus in the instrument.

14 . The sensor module of claim 9 , wherein the sensor module is configured to produce alignment among the flow cell, the light source, and the optical device.

15 . A system comprising:

the sensor module of claim 1 ; and

a light source to provide light to at least the plasma localized in the lumen to enable the optical device to capture the information.

16 . The system of claim 15 , wherein the separation of blood cells from the plasma is such that the plasma is localized in a center of the lumen.

17 . The system of claim 15 , wherein the light source comprises light emitting diodes (LEDs) that produce at least two different colors of light; and

wherein the system comprises a light pipe between the light source and the flow cell, the light pipe for homogenizing the light provided by the light source.

18 . The system of claim 15 , further comprising:

processor circuitry to analyze the information to characterize one or more analytes in the plasma;

wherein the acoustic transducer is internal to the apparatus and the processing circuitry is external to the apparatus.

19 . The sensor module of claim 1 , wherein the optical device comprises a camera.