Sensor clip assembly for an optical monitoring system

• US 9,801,993 B2
• Filed: 11/17/2011
• Issued: 10/31/2017
• Est. Priority Date: 11/17/2010
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Barrett, Louis L., Peterson, David W., Stowell, Matthew A., Law, Perry N.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Fardanesh, Marjan
• Application Number:
  US13/299,303
• Publication Number:
  US 20120154789A1
• Time in Patent Office: 2,175 Days
• Field of Search: 600300-344
• CPC Class Codes: A61B 2560/0406 specially shaped apparatus housings
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2230/207 hematocrit
• CPC Class Codes: F16B 2/22 of resilient material, e.g. rubbery material F16B2/205 takes precedence

Abstract

Systems and sensor clip assemblies for optically monitoring blood flowing through a blood chamber are provided. A sensor clip assembly includes emitters and photodetectors positioned on opposing arms, a signal conditioning circuit for conditioning raw analog signals generated by the photodetectors while the sensor clip assembly is fastened to a blood chamber, and an analog-to-digital converter for converting the conditioned analog signals to raw digital data. The sensor clip assembly may output the raw digital data to an external device and receive synchronized control signals from the external device, or the sensor clip assembly may include a microcontroller for performing calculations on the raw digital data and providing synchronized control signals internally. Parameters of blood flowing through the blood chamber such as hematocrit, oxygen saturation, and change in blood volume may be calculated from the raw digital data derived from the raw analog signals generated by the photodetectors.

Claims

1. A sensor clip assembly for optically monitoring extracorporeal blood flowing through a blood chamber, the sensor clip assembly comprising:

a housing;

a first photodetector, configured to, in a first time interval, generate a first current corresponding to a first detected signal based on light of a first wavelength from a first emitter of the sensor clip assembly that has passed through extracorporeal blood in the blood chamber;

a second photodetector, configured to, in a second time interval, generate a second current corresponding to a second detected signal based on light of a second wavelength from a second emitter of the sensor clip assembly that has passed through extracorporeal blood in the blood chamber;

a signal processing unit within the housing, comprising a processor and a signal conditioning circuit, the signal conditioning circuit being configured to convert the first current to a first voltage and apply a first gain to the first voltage, and configured to convert the second current to a second voltage and apply a second gain to the second voltage; and

an analog-to-digital converter, configured to convert the first voltage with the first gain applied to a first digital signal and to convert the second voltage with the second gain applied to a second digital signal, wherein the first digital signal corresponds to a hemoglobin level of the extracorporeal blood and the second digital signal corresponds to a water concentration level of the extracorporeal blood;

wherein the processor is configured to synchronize operation of the signal conditioning circuit with operation of the first emitter and the second emitter of the sensor clip assembly such that the first gain is only applied to the first voltage while the first emitter is on and the second gain is only applied to the second voltage while the second emitter is on, and to calculate a hematocrit value based on a ratio between the first and second digital signals;

wherein the sensor clip assembly further comprises;

an output port configured to facilitate transmission of the calculated hematocrit value to an external computing device;

wherein the signal processing unit is further configured to, in response to determining an insufficient number of bits on the analog-to-digital converter being activated, adjust a resolution level for signals received by the analog-to-digital converter by increasing the first gain and/or the second gain.

2. The sensor clip assembly of claim 1, wherein the signal conditioning circuit further comprises:

at least one transimpedance amplifier corresponding to each photodetector for converting current to voltage; and

at least one digitally-controllable trimpot corresponding to each photodetector for applying a gain.

3. The sensor clip assembly of claim 1, wherein the sensor clip assembly further comprises:

at least one shroud for blocking ambient light from being received at the first photodetector and/or the second photodetector.

4. The sensor clip assembly of claim 1, wherein the first and second photodetectors comprise a silicon photodetector and an Indium-Gallium-Arsenide photodetector.

5. The sensor clip assembly of claim 1, wherein the output port corresponds to a USB (Universal Serial Bus) connection.

6. The sensor clip assembly of claim 1, wherein the output port is further configured to facilitate transmission of commands from the external computing device to the signal processing unit.

7. The sensor clip assembly of claim 6, wherein the signal processing unit is further configured to verify accuracy of the sensor clip assembly based on a verification filter uniquely associated with the sensor clip assembly upon receiving a corresponding command from the external computing device.

8. The sensor clip assembly of claim 7, wherein the signal processing unit is further configured to recalibrate the sensor clip assembly upon confirming user input of a correct verification filter identification code.

9. A system for optically monitoring blood, the system comprising:

a blood chamber comprising a viewing window and a chamber body;

a sensor clip assembly, configured to be fastened to the blood chamber, the sensor clip comprising;

a housing;

a first photodetector, configured to, in a first time interval, generate a first current corresponding to a first detected signal based on light of a first wavelength from a first emitter of the sensor clip assembly that has passed through extracorporeal blood in the blood chamber;

a second photodetector, configured to, in a second time interval, generate a second current corresponding to a second detected signal based on light of a second wavelength from a second emitter of the sensor clip assembly that has passed through extracorporeal blood in the blood chamber;

a signal processing unit within the housing, comprising a processor and a signal conditioning circuit, the signal conditioning circuit being configured to convert the first current to a first voltage and apply a first gain to the first voltage, and configured to convert the second current to a second voltage and apply a second gain to the second voltage; and

an analog-to-digital converter, configured to convert the first voltage with the first gain applied to a first digital signal and to convert the second voltage with the second gain applied to a second digital signal, wherein the first digital signal corresponds to a hemoglobin level of the extracorporeal blood and the second digital signal corresponds to a water concentration level of the extracorporeal blood;

wherein the processor is configured to synchronize operation of the signal conditioning circuit with operation of the first emitter and the second emitter of the sensor clip assembly such that the first gain is only applied to the first voltage while the first emitter is on and the second gain is only applied to the second voltage while the second emitter is on, and to calculate a hematocrit value based on a ratio between the first and second digital signals;

wherein the sensor clip assembly further comprises;

an output port configured to facilitate transmission of the calculated hematocrit value to an external computing device; and

the external computing device, configured to display the results of the calculations performed by the microcontroller to a user;

wherein the signal processing unit is further configured to, in response to determining an insufficient number of bits on the analog-to-digital converter being activated, adjust a resolution level for signals received by the analog-to-digital converter by increasing the first gain and/or the second gain.

10. The system of claim 9, wherein the chamber body of the blood chamber is tinted blue so as to block ambient light from being received at the first photodetector and the second photodetector.

11. The system of claim 9, further comprising:

a verification filter uniquely associated with the sensor clip assembly for determining whether recalibration of the sensor clip assembly is needed.

12. The system of claim 11, wherein the output port is further configured to facilitate transmission of commands from the external computing device to the signal processing unit;

and

wherein the signal processing unit is further configured to verify accuracy of the sensor clip assembly based on the verification filter and to recalibrate the sensor clip assembly upon confirming user input of a correct verification filter identification code.

13. A method for optically monitoring extracorporeal blood using a sensor clip assembly attached to a blood chamber, the method comprising:

in a first time interval, turning on, by a processor of the sensor clip assembly, a first emitter of the sensor clip assembly corresponding to light of a first wavelength and generating a first detected signal at a first photodetector of the sensor clip assembly corresponding to detected light of the first wavelength that has passed through extracorporeal blood in the blood chamber;

converting, by a signal conditioning circuit, a first current corresponding to the first detected signal to a first voltage; and

applying, by the signal conditioning circuit, a first gain to the first voltage;

converting, by an analog-to-digital converter of the sensor clip assembly, the first voltage with the first gain applied to a first digital signal, wherein the first digital signal corresponds to a hemoglobin level of extracorporeal blood in a blood chamber to which the sensor clip assembly is fastened;

in a second time interval, turning on, by the processor, a second emitter of the sensor clip assembly corresponding to light of a second wavelength and generating a second detected signal at a second photodetector of the sensor clip assembly corresponding to detected light of the second wavelength that has passed through extracorporeal blood in the blood chamber;

converting, by the signal conditioning circuit, a second current corresponding to the second detected signal to a second voltage; and

applying, by the signal conditioning circuit, a second gain to the second voltage;

converting, by the analog-to-digital converter, the second voltage with the second gain applied to a second digital signal, wherein the second digital signal corresponds to a water concentration level of the extracorporeal blood in the blood chamber;

calculating, by the processor, a hematocrit value corresponding to the extracorporeal blood in the blood chamber based on a ratio between the first and second digital signals; and

transmitting the calculated hematocrit value to an external computing device;

wherein the method further comprises;

in response to determining an insufficient number of bits on the analog-to-digital converter being activated, adjusting a resolution level for signals received by the analog-to-digital converter by increasing the first gain and/or the second gain; and

wherein operation of the first emitter and the second emitter is synchronized with operation of the signal conditioning circuit with respect to the first time interval and the second time interval, respectively, such that the first gain is only applied to the first voltage while the first emitter is on and the second gain is only applied to the second voltage while the second emitter is on.

14. The method of claim 13, wherein one or more digitally-controllable trimpot(s) are used to adjust the resolution level for a future first voltage and/or a future second voltage.

15. The method of claim 13, further comprising:

verifying accuracy of the sensor clip assembly based on a verification filter uniquely associated with the sensor clip assembly upon receiving a corresponding command from the external computing device.

16. The method of claim 15, further comprising:

receiving a user input of a verification filter identification code; and

recalibrating the sensor clip assembly if the verification filter identification code input by the user corresponds to the verification filter uniquely associated with the sensor clip assembly.

17. The method of claim 13, further comprising:

outputting status information corresponding to the sensor clip assembly to the external computing device.

18. The method of claim 13, further comprising:

outputting a data stream including information pertaining to the calculated hematocrit, an oxygen saturation value, and a percent blood volume change.