# US 11,896,372 B2 · Device for reading, processing and transmitting test result data for pathogens or viruses in fluid test samples

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- Number: US 11,896,372 B2
- Document ID: US11896372B2
- Status: Granted
- Kind: B2
- Application number: 17/505,611
- Filed: 2021-10-19
- Published: 2022-11-24
- Granted: 2024-02-13
- Earliest claimed: 2021-05-18
- Applicants: Matthew Hummer; Gregory J. Hummer
- Inventors: Matthew Hummer; Gregory J. Hummer
- Web page: https://patentgrep.com/patent/US11896372B2

## CPC

- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- C12Q 1/6825: Nucleic acid detection involving sensors
- A61B 5/1468: using chemical or electrochemical methods, e.g. by polarographic means
- A61B 5/4881: {Determining interstitial fluid distribution or content within body tissue (measuring analytes in interstitial fluid in-vivo A61B5/1451)}
- B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces}
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 40/40: for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
- G16H 40/67: for remote operation
- G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems
- G16H 50/80: for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
- G16H 70/60: relating to pathologies
- H04Q 9/00: Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom
- B01L 3/502707: {characterised by the manufacture of the container or its components}
- B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
- B01L 2300/023: Sending and receiving of information, e.g. using Bluetooth®
- B01L 2300/0645: Electrodes
- B01L 2300/0816: Cards, e.g. flat sample carriers usually with flow in two horizontal directions
- B01L 2300/123: Flexible; Elastomeric
- B01L 2300/1822: using Peltier elements
- B01L 2300/1827: using resistive heater
- B01L 2400/0478: pistons
- B01L 2400/049: vacuum
- G08C 2201/93: Remote control using other portable devices, e.g. mobile phone, PDA, laptop
- H04Q 2209/43: using wireless personal area networks [WPAN], e.g. 802.15, 802.15.1, 802.15.4, Bluetooth® or Zigbee®
- H04Q 2209/88: Providing power supply at the sub-station
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- H04Q: SELECTING (switches, relays, selectors H01H; wireless communication networks H04W)
- G08C: TRANSMISSION SYSTEMS FOR MEASURED VALUES, CONTROL OR SIMILAR SIGNALS (fluid pressure transmitting systems F15B; mechanical means for transferring the output of a sensing member into a different variable G01D5/00; mechanical control systems G05G)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The embodiments disclose a test cartridge assembly system including a test cartridge assembly for loading of a test sample moving the fluid through the internal fluidic channels processing and presenting the sample to one or more electrochemical sensors for measuring analytes in the test sample, at least one fluidic channel formed directly in a rigid portion of an upper test cartridge assembly housing to form a fluidic path, a port coupled to the at least one fluidic channel for receiving a spring loaded vacuum source, a port coupled to the upper test cartridge assembly housing to communicate the vacuum through the upper cartridge housing into the fluidic path, and a functional layer coupled to the test cartridge assembly configured to provide electrical functionalities and interconnections to various fluidic components.

## Claims

### Claim 1

A test cartridge assembly system, comprising:
a test cartridge assembly for loading of a test sample moving a fluid through internal fluidic channels processing and presenting the test sample to one or more electrochemical sensors for measuring analytes in the test sample, wherein the one or more electrochemical sensors are printed on a conductive sensor;
a measuring device coupled to the test sample configured for measuring an electrical field and ionic strength of the test sample to determine calibration settings of the test cartridge assembly;
at least one fluidic channel formed directly in a rigid portion of an upper test cartridge assembly housing to form a fluidic path;
a first port coupled to the at least one fluidic channel for receiving a spring loaded vacuum source;
a second port coupled to the upper test cartridge assembly housing to communicate the spring loaded vacuum source through the upper test cartridge assembly housing into the fluidic path;
a functional layer coupled to the test cartridge assembly configured to provide electrical functionalities and interconnections to various fluidic components; and
at least one electrochemical sensing device coupled to the functional layer electrical functionalities configured to detect plural types of viruses and bacterial pathogens using impedimetric detection of analytical targets including infectious viruses, bacteria, and pathogens.

### Claim 2 (depends on 1)

The test cartridge assembly system of claim 1, further comprising the internal fluidic channels made from a conformal material including at least one from a group consisting of silicone and a thermoplastic elastomer.

### Claim 3 (depends on 1)

The test cartridge assembly system of claim 1, further comprising the internal fluidic channels is formed with a second injection molded shot in the upper test cartridge assembly housing to form the fluidic path.

### Claim 4 (depends on 1)

The test cartridge assembly system of claim 1, further comprising a lower cartridge housing formed from an injection molded plastic including at least one from a group consisting of polycarbonate and cyclic-olefin-copolymer to provide rigid structural support.

### Claim 5 (depends on 1)

The test cartridge assembly system of claim 1, further comprising the upper test cartridge assembly housing provides protection and support in conjunction with a lower cartridge housing providing operator access to apply test samples and operate the test cartridge.

### Claim 6 (depends on 1)

The test cartridge assembly system of claim 1, further comprising a sample collection system for collecting a test sample.

### Claim 7 (depends on 1)

The test cartridge assembly system of claim 1, further comprising a test sample collection system consisting of a test sample collection device and a test sample extraction device.

### Claim 8 (depends on 1)

The test cartridge assembly system of claim 1, further comprising a vacuum adapter coupled to the spring loaded vacuum source fitted with a reduced-size orifice to increase flow impedance between the spring loaded vacuum source and the fluidic path.

### Claim 9

A test cartridge assembly system, comprising:
a test cartridge assembly for loading of a test sample moving a fluid through internal fluidic channels processing and presenting the test sample to one or more electrochemical sensors for measuring analytes in the test sample, wherein the one or more electrochemical sensors are printed on a conductive sensor;
a measuring device coupled to the test sample configured for measuring an electrical field, ionic strength, and saline detector of the test sample to determine calibration settings of the test cartridge assembly;
wherein the electrical field, ionic strength, and salt concentration of the test sample affect sensing performance speed;
at least one fluidic channel formed directly in a rigid portion of an upper test cartridge assembly housing to form a fluidic path;
a first port coupled to the at least one fluidic channel for receiving a spring loaded vacuum source;
a second port coupled to the upper test cartridge assembly housing to communicate the spring loaded vacuum source through the upper test cartridge assembly housing into the fluidic path;
a functional layer coupled to the test cartridge assembly configured to provide electrical functionalities and interconnections to various fluidic components; and
at least one electrochemical sensing device coupled to the functional layer electrical functionalities configured to detect plural types of viruses and bacterial pathogens using impedimetric detection of analytical targets including infectious viruses, bacteria, and pathogens.

### Claim 10 (depends on 9)

The test cartridge assembly system of claim 9, further comprising the internal fluidic channels made from a conformal material including at least one from a group consisting of silicone and a thermoplastic elastomer.

### Claim 11 (depends on 9)

The test cartridge assembly system of claim 9, further comprising the internal fluidic channels is formed with a second injection molded shot in the upper test cartridge assembly housing to form the fluidic path.

### Claim 12 (depends on 9)

The test cartridge assembly system of claim 9, wherein the electrical field is created by a flow of current in the one or more electrochemical sensors.

### Claim 13 (depends on 9)

The test cartridge assembly system of claim 9, further comprising the upper test cartridge assembly housing providing protection and support in conjunction with a lower cartridge housing providing operator access to apply test samples and operate the test cartridge assembly.

### Claim 14 (depends on 9)

The test cartridge assembly system of claim 9, further comprising a sample collection system for collecting a test sample.

### Claim 15

A test cartridge assembly system, comprising:
a test cartridge assembly for loading of a test sample moving a fluid through internal fluidic channels processing and presenting the test sample to one or more electrochemical sensors for measuring analytes in the test sample, wherein the one or more electrochemical sensors are printed on a conductive sensor;
a measuring device coupled to the test sample configured for measuring an electrical field, ionic strength, and salt concentration of the test sample to determine calibration settings of the test cartridge assembly;
wherein the electrical field is created by a flow of current in the one or more electrochemical sensors;
wherein the electrical field, ionic strength, and salt concentration of the test sample affect sensing performance speed;
at least one fluidic channel formed directly in a rigid portion of an upper test cartridge assembly housing to form a fluidic path;
a first port coupled to the at least one fluidic channel for receiving a spring loaded vacuum source;
a second port coupled to the upper test cartridge assembly housing to communicate the spring loaded vacuum source through the upper test cartridge assembly housing into the fluidic path;
a functional layer coupled to the test cartridge assembly configured to provide electrical functionalities and interconnections to various fluidic components; and
at least one electrochemical sensing device coupled to the functional layer electrical functionalities configured to detect plural types of viruses and bacterial pathogens using impedimetric detection of analytical targets including infectious viruses, bacteria, and pathogens.

### Claim 16 (depends on 15)

The test cartridge assembly system of claim 15, further comprising a vacuum adapter coupled to the spring loaded vacuum source fitted with a reduced-size orifice to increase flow impedance between the spring loaded vacuum source and the fluidic path.

### Claim 17 (depends on 15)

The test cartridge assembly system of claim 15, wherein the conductive sensor includes a carbon sensor.

### Claim 18 (depends on 15)

The test cartridge assembly system of claim 15, further comprising the upper test cartridge assembly housing providing protection and support in conjunction with a lower cartridge housing providing operator access to apply test samples and operate the test cartridge assembly.

### Claim 19 (depends on 15)

The test cartridge assembly system of claim 15, further comprising a lower cartridge housing formed from an injection molded plastic including at least one from a group consisting of polycarbonate and cyclic-olefin-copolymer to provide rigid structural support.

### Claim 20 (depends on 15)

The test cartridge assembly system of claim 15, further comprising the internal fluidic channels made from a conformal material including at least one from a group consisting of silicone and a thermoplastic elastomer.
