Medical system, method and apparatus employing MEMS

• US 20050269251A1
• Filed: 08/05/2005
• Published: 12/08/2005
• Est. Priority Date: 07/07/2000
• Status: Abandoned Application

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Lo, Ying-Cheng, Min, Kyungyoon, West, Richard L., Weber, Mark C., Cork, William H., Ulmes, James J.
• Application Number:
  US11/198,805
• Publication Number:
  US 20050269251A1
• Time in Patent Office: Days
• US Class Current: 210/85
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 50/13 Trolleys, e.g. carts
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/3609 Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: B01D 61/22 : Controlling or regulating
• CPC Class Codes: G01N 2035/00237 : Handling microquantities of analyte, e.g. microvalves, capillary networks
• CPC Class Codes: G01N 33/491 : by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: G01N 33/5005 : involving human or animal cells immunoassay G01N33/56966; immunoassays of protozoa G01N33/56905; protozoa in screening assays C12Q1/025
• CPC Class Codes: G01N 33/5094 : for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 35/08 : using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
• CPC Class Codes: Y10T 436/117497 : with a continuously flowing sample or carrier stream

Abstract

A biological suspension processing system is disclosed that may include a suspension treatment device for treating one or more components of a biological suspension, a first fluid flow path for introducing a suspension into the treatment device and a second fluid flow path for withdrawing a constituent of the suspension from the device. At least one microelectromechanical (MEM) sensor communicates with one of the fluid flow paths for sensing a selected characteristic of the fluid therewith. The MEM sensor may be located elsewhere, such as on a container or bag and communicate with the interior for sensing a characteristic of the fluid contained therein. A wide variety of characteristics may be sensed, such as flow rate, pH, cell type, cell antigenicity, DNA, viral or bacterial presence, cholesterol, hematocrit, cell concentration, cell count, partial pressure, pathogen presence, or viscosity.

Claims

1. A biological suspension processing system comprising:

a suspension treatment device for treating one or more components of a biological suspension;

a first fluid flow path, wherein said first fluid flow path is adapted for continuing, direct communication with the vascular system of the human subject and the treatment device for introducing a suspension into the treatment device;

a second fluid flow path communicating with the treatment device for withdrawing a constituent of the suspension from the treatment device;

at least one microelectromechanical sensor communicating with one of said fluid flow paths for sensing a selected characteristic of the fluid within the flow path; and

a controller adapted to receive signals from said sensor and control the blood treatment device in response thereto.

2. The system of claim 1 in which a sensor senses one or more characteristics selected from the group consisting of flow rate, pH, cell type, cell antigenicity, cell concentration, cell count, viscosity, cholesterol, hematocrit, DNA, viral or bacterial presence, pathogen presence, and partial pressure of a selected gas.

3. The system of claim 1 in which a sensor communicates with the first fluid flow path and generates a signal responsive to one or more selected characteristics of the fluid in one of the flow paths.

5. The system of claim 1 in which the sensor is adapted to sense the selected characteristic a plurality of times at discrete intervals.

7. The system of claim 1 in which the sensor communicates with one of the fluid flow path and senses the approximate quantity or concentration of a selected cell.

8. The system of claim 1 further comprising a container communicating with the second fluid flow path for receiving the withdrawn constituent, the system being adapted to provide tracking information for associating with the container the particular characteristic sensed by at least one sensor.

9. The system of claim 8 in which the system comprises machine readable or human readable data storage media carried by the container, the data storage media storing information regarding the particular characteristic sensed by at least one sensor.

10. The system of claim 9 in which the data storage media comprises a bar code label on the container.

11. The system of claim 9 in which the data storage media comprises an electronic data storage device.

12. The system of claim 11 in which the electronic data storage device has a non-volatile semiconductor memory.

13. The system of claim 9 in which the data storage media comprises at least one icon carried by the container and representative of the sensed characteristic.

14. The system of claim 9 in which the suspension includes one or more blood components and the blood component withdrawn is a cellular component, and the container is for storing the cellular component withdrawn, and the data storage media includes data regarding the type, quality, purity, quantity or concentration of the cellular blood component in the container.

15. The system of claim 1 in which the at least one sensor includes a first sensor communicating with the first fluid flow path and a second sensor communicating with the second flow path and the treatment device comprises an apheresis device and the suspension comprises whole blood, the first sensor sensing platelets to determine a platelet count in the suspension introduced into the apheresis device and the second sensor sensing platelets to determine a platelet count in the second flow path, wherein the system includes a container communicating with the second flow path for storing blood platelets withdrawn, and the system further comprises machine readable or human readable data storage media carried by the container, the data storage media storing information regarding platelet count sensed by one or both of said sensors.

16. The system of claim 1 in which a sensor communicates with said second fluid flow path, and said system includes a container for storing the constituent withdrawn, the sensor generating a signal responsive to a characteristic of the constituent withdrawn, and the system includes a data recording device for receiving the signal and recording data regarding the sensed characteristic of the constituent withdrawn.

17. The system of claim 16 in which the data recording device comprises a printer for printing a report of the characteristic sensed.

18. The system of claim 17 in which the report is in machine readable graphic format.

19. The system of claim 16 wherein the container carries a machine readable electronic data storage device, and in which the data recording device is adapted to transfer data regarding the selected characteristic sensed by the sensor to the electronic data storage device.

20. The system of claim 19 in which the electronic storage device comprises a non-volatile semiconductor memory.

4. (canceled)

6. (canceled)

21-45. -45. (canceled)