Medical system, method and apparatus employing MEMS

• US 7,217,356 B2
• Filed: 08/05/2005
• Issued: 05/15/2007
• Est. Priority Date: 07/07/2000
• Status: Expired due to Term

• 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.
• Primary Examiner(s): Cecil; Terry K.
• Application Number:
  US11/198,804
• Publication Number:
  US 20050269250A1
• Time in Patent Office: 648 Days
• Field of Search: 210/96.1, 210/143, 436/52, 436/63, 604/6.01, 604/6.07, 604/65
• US Class Current: 210/96.1
• 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 blood treatment device for treating one or more components of a biological suspension;

a human subject;

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

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

at least one microelectromechanical sensor communicating with one of said fluid flow paths for sensing either a biological or a chemical characteristic of the fluid within the flow path while said first fluid flow path is in continuing, direct communication with the vascular system of the human subject; 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 the sensor generates a signal responsive to one or more selected characteristics of the fluid in one of the fluid flow paths.

3. The system of claim 1 in which the second fluid flow path communicates with the human subject, the treatment device is adapted to add anticoagulant to the blood in the first fluid flow path, the selected characteristic includes the hematocrit of blood in the first fluid flow path, and the controller controls the addition of anticoagulant into the first fluid flow path.

4. The system of claim 1 in which the controller controls the treatment device in response to the signal to avoid one or more deleterious consequences to the human subject.

5. The system of claim 1 in which the controller controls the treatment device in response to the signal to withdraw a constituent of desired quality.

6. The system of claim 1 in which the controller controls the treatment device in response to the signal to withdraw a constituent of a desired quantity.

7. The system of claim 1 in which the controller controls the treatment device in response to the signal to withdraw a constituent that is depleted of an undesired component.

8. The system of claim 7 in which the undesired component is white cells.

9. The system of claim 1 in which the controller controls the treatment device in response to the signal to withdraw a desired constituent.

10. The system of claim 9 in which the desired constituent is platelets.

11. The system of claim 9 in which the desired constituent is red cells or plasma.

12. The system of claim 1 in which the sensor senses platelets and the controller controls the treatment device to withdraw a selected minimum quantity of platelets.

13. The system of claim 1 further comprising a fluid management module carried by the first fluid flow path between the vascular system of the human subject and the treatment device, said fluid management module adapted to receive blood from the vascular system of the human subject via the first fluid flow path and control the amount of blood introduced into the treatment device.

14. 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.

15. The system of claim 14 in which the system further 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.

16. The system of claim 15 in which the data storage media comprises a bar code label on the container.

17. The system of claim 15 in which the data storage media comprises an electronic data storage device.

18. The system of claim 15 in which the electronic data storage device has a non-volatile semiconductor memory.

19. The system of claim 15 in which the data storage media comprises at least one icon carried by the container and representative of the sensed characteristic.

20. The system of claim 15 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.