Automatic blood collection system

Abstract

A whole blood collection system includes an automated pump/control unit and an accompanying disposable blood set. When combined and connected to a source of anticoagulant, these elements allow automatic priming of the blood set with anticoagulant and automatic collection of anticoagulated blood product according to three different collection modes. The unit's pump and the blood set are specially designed to cooperate during the collection process to assure that the collected product has a precise blood to anticoagulant ratio. During the collection procedure, the pump/control unit automatically collects data relating to the procedure. Additional data specifically identifying components of the blood set, such as the blood collection bag, along with identification data on the donor's registration form may be scanned into the pump/controller unit by a scanner associated with the unit; this facilitates positive sample identification and tracking. At the end of the procedure, a printer in the pump/controller unit automatically prints out this information so that a detailed record is immediately available about the collected blood product, the procedure for collecting it and the source of the product, i.e., the donor.

What is claimed is: 
     
       1. Blood collection apparatus comprising
 a phlebotomy needle;   a blood collection bag having an inlet;   a first tube having one end in fluid communication with the needle and a second end connected to said inlet;   a second tube composed of in-line first and second segments, and having one end in fluid communication with said needle and an other end adapted for connection to an anticoagulant source;   a tubing tray, said tray having an opening therethrough and a window in line with said opening;   means for securing said first tube to the tray so that a segment thereof is maintained opposite said opening, and   means for securing said second tube to the tray so that in-line first and second segments thereof are maintained opposite said opening and said window, respectively, said first segment being spaced from said segment of the first tube.   
     
     
       2. The apparatus defined in  claim 1  wherein said tray and said openings and window are generally rectangular in shape. 
     
     
       3. The apparatus defined in  claim 1  and further including connection means at the other end of the second tube for connecting said other end to an anticoagulant bag. 
     
     
       4. The apparatus defined in  claim 3  and further including an antibacterial filter connected in the second tube between said segment of the second tube and said connection means. 
     
     
       5. The apparatus defined in  claim 3  and further including means for coupling a pressure sensor to the first tube at a location therealong between said segment of the first tube and said needle. 
     
     
       6. The apparatus defined in  claim 5  wherein the coupling means include a length of tubing containing an antibacterial filter. 
     
     
       7. The apparatus defined in  claim 1  wherein said apparatus also includes
 at least one satellite collection bag, and 
 tubing connecting the interiors of said at least one satellite bag and said blood collection bag. 
 
     
     
       8. The apparatus defined in  claim 1  and further including
 fluid conduit means for connecting said needle to said one ends of said first and second tubes, and 
 a blood sample pouch in fluid communication with said conduit means. 
 
     
     
       9. The apparatus defined in  claim 8  and further including a first clamp for interrupting fluid flow from said needle to said pouch, and
 a second clamp for interrupting fluid flow from said needle to said first and second tubes. 
 
     
     
       10. The apparatus defined in  claim 8  and further including scannable codes affixed to said blood collection bag and/or said sample pouch and/or sample tubes associated with the apparatus for being correlated with a scannable code affixed to a donor registration form to track the contents of said bag and/or pouch and/or tubes. 
     
     
       11. The apparatus defined in  claim 1  and further including scannable codes affixed to said blood collection bag and/or a said sample pouch and/or sample tubes associated with the apparatus for being correlated with a scannable code affixed to a donor registration form to track the contents of said bag and/or pouch and/or tubes. 
     
     
       12. The apparatus defined in  claim 1  and further including an adhesive label affixed to said blood collection bag, said label having a scannable identifier code thereon, said label also containing a plurality of peel-away stickers, each sticker bearing a scannable code corresponding to said identifier code. 
     
     
       13. A blood collection system comprising:
 a blood collection machine,   a computer connected in communication with the blood collection machine,   an operator interface with operator input controls in communication with the computer, including a data input device in communication with the computer and configured to read and input information into the computer,   a display in communication with the computer and configured to display information about a blood collection procedure to an operator,   a disposable tubing set connectable to the blood collection machine defining at least a portion of a blood collection pathway and having identification information that is readable by the data input device,   wherein the computer is configured to control the operation of the blood collection machine and collect procedure information during a blood collection procedure and the computer is further configured to receive commands from the operator interface and to receive donor information.   
     
     
       14. The blood collection system as defined in claim 13 wherein the data input device comprises a bar code scanner configured to read donor information into the computer. 
     
     
       15. The blood collection system as defined in claim 14 wherein the scanner is a portable hand held device. 
     
     
       16. The blood collection system as defined in claim 15 wherein the barcode scanner is configured to read donor information for a procedure and communicate the information to the computer. 
     
     
       17. The blood collection system as defined in claim 16 wherein the donor information includes a donor identifier. 
     
     
       18. The blood collection system as defined in claim 16 wherein the system further comprises a database in communication with the computer and the donor information is stored in the database for later retrieval and analysis. 
     
     
       19. The blood collection system as defined in claim 13 wherein the blood collection system is configured to perform a blood component collection. 
     
     
       20. The blood collection system as defined in claim 13 wherein the blood collection system is configured to perform apheresis. 
     
     
       21. The blood collection system as defined in claim 13 wherein the operator interface further comprises a control panel with a plurality of operator input controls. 
     
     
       22. The blood collection system as defined in claim 13 wherein the operator interface is configured to receive input from the operator to select a mode of operation in which the blood collection system will operate. 
     
     
       23. The blood collection system as defined in claim 13 wherein parameters of system operation controlled by the computer include pump motor speed and volume collected. 
     
     
       24. The blood collection system as defined in claim 13 further comprising: a sensor positioned in a fluid pathway to monitor the performance of a collection procedure and being in communication with the computer, the sensor configured to communicate status information about the procedure to the computer, the computer configured to automatically make adjustments to the system operation based on that information to change collection performance. 
     
     
       25. The blood collection system as defined in claim 13 further wherein the collection system is configured to signal the computer when the disposable tubing set is completely loaded onto the machine. 
     
     
       26. The blood collection system as defined in claim 25 wherein the computer is configured to operate the blood collection system to prime a tubing set loaded onto the machine and indicate to the operator through the display when the system is ready to begin a procedure. 
     
     
       27. The blood collection system as defined in claim 13 wherein the computer is configured to start the blood collection system and accelerate the blood collection system until a steady state operating condition is achieved. 
     
     
       28. The blood collection system as defined in claim 13 wherein the system further comprises a database in communication with the computer and procedure information for each procedure is stored in the database. 
     
     
       29. The blood collection system as defined in claim 28 wherein the procedure information includes, time and date of the procedure, procedure time, any procedural problems encountered and blood volume collected. 
     
     
       30. The blood collection system as defined in claim 13 wherein the system further comprises a printer in communication with the computer and configured to print out donor information and procedure information for a given procedure. 
     
     
       31. The blood collection system as defined in claim 13 wherein the blood collection machine is configured for surgical wound drainage. 
     
     
       32. The blood collection system as defined in claim 13 wherein the computer is programmed to define at least a portion of a blood collection procedure. 
     
     
       33. The blood collection system as defined in claim 32 wherein the computer is programmed to define a plurality of blood collection modes. 
     
     
       34. A blood collection system comprising:
 a blood collection machine,   a computer connected in communication with the blood collection system and in communication with a database and being programmed to define at least a portion of a blood collection procedure,   an operator interface with operator input controls in communication with the computer,   a data input device barcode scanner is configured to read donor information for a procedure and communicate the information to the computer,   a disposable tubing set with identification information that is readable by the data input device connected to the computer to input the information into the computer,   a printer in communication with the computer,   a display in communication with the computer and configured to display information about a blood collection procedure to an operator,   wherein the computer is configured to control the operation of the blood collection machine and collect procedure information during a blood collection procedure and the computer is further configured to receive commands from the operator interface and to receive donor information.   
     
     
       35. A blood collection system comprising:
 a blood collection machine,   a disposable tubing set,   means for electronically controlling the operation of the system and for collecting and storing information regarding a blood collection procedure performed including information obtained from the machine,   means for interfacing with an operator in communication with the means for controlling the system,   means for displaying information about a blood collection procedure to an operator in communication with the means for controlling the system,   means for reading information electronically in communication with the means for controlling the system.   
     
     
       36. A method of collecting blood comprising:
 providing a blood collection system in communication with a computer that communicates with a database,   providing an operator interface, a visual display and a barcode reader each in communication with the computer,   reading donor information into the computer for a given procedure,   installing a tubing set on the blood collection system and connecting the tubing set to a donor,   providing commands to the computer though the interface to operate the system to perform blood collection procedure with information relating to performance of the procedure being communicated to the computer.   
     
     
       37. The method defined in claim 36 wherein the method of providing commands to the computer further includes selecting the type of blood collection procedure to be performed. 
     
     
       38. The method of claim 36 further comprising: forwarding the donor information and procedure information from the computer to the database for later retrieval and analysis. 
     
     
       39. A system for managing at least one procedure in a blood collection facility and remotely monitoring the status of the blood collection procedure performed upon a donor and facilitated by an operator, the system comprising:
 a blood component collection machine for collecting a blood component from a blood donor;   a tubing set having an identifier, the tubing set being operatively connectable to the blood donor and the blood component collection machine;   a system computer being operatively responsive to the blood component collection instrument, the system computer configured to define a blood component collection process and being capable of monitoring a status of the tubing set identifier;   an operator interface being operatively connected to the system server, the operator interface comprising a reader for entering information to be transmitted to the system computer, the operator interface configured to transmit the tubing set identifier to the system computer; and   a display unit being operatively connected to the system computer, the system computer configured to monitor the tubing set status.   
     
     
       40. A system for collecting blood and interfacing with an operator administering one or more procedures in a blood component collection facility for collecting at least one blood component from a donor, the blood component collection facility comprising a blood component collection machine capable of being adapted to the donor, the system comprising:
 a blood component collection system configured to perform a procedure for removing a blood component from a blood component donor, the procedure including data associated with the removing the blood component from the blood component donor;   a system computer operatively connected to the blood component collection system, the system computer configured to define at least a portion of the blood component collection process;   an operator interface operatively connected to the system computer, the operator interface comprising a reader for entering one of a plurality of identifiers, each identifier associated with the blood component collection facility;   a transmitter operatively connected to the operator interface, the transmitter configured to transmit information associated with the blood component collection facility to the system computer; and   a donor identifier assigned to the donor wherein the operator interface is configured to transmit the donor identifier to the system server, the donor identifier is being associated with the data associated with the removing the blood component from the blood component donor.   
     
     
       41. A system for managing a database of blood component collection procedures, the system comprising:
 a blood component collection system for collecting a blood component from a blood component donor;   a system computer being operatively connected to the blood component collection system, the system computer defining at least a portion of a blood component collection process, wherein the system computer is in data communication with a system database having stored blood component collection procedures; and   an interface being operatively connected to the system computer.   
     
     
       42. A system for managing a procedure in a blood component collection facility, the system comprising:
 a blood component donor identifier corresponding to a blood component donor; a blood component collection system for collecting a blood component from the blood component donor;   a system computer being operatively connected to the blood component collection system, the system computer defining at least one step of a blood component collection process; and   an interface having a reader and being operatively connected to the system computer for receiving the blood component donor identifier and transmitting the donor identifier to the system computer.   
     
     
       43. A system for monitoring and tracking at least a portion of a blood component collection procedure in a blood component collection facility, the system comprising:
 a blood component collection machine for collecting a blood component from a donor, the donor having a donor identifier;   a tubing set having a tubing set identifier, the tubing set for collecting the blood component from the donor;   a system computer being operatively connected to the blood component collection machine, the system computer configured to monitor monitoring operation of the blood component collection instrument and receive information about the operation of the blood component collection instrument;   a non-transitory memory operably connected to the system computer, the memory for storing the information received by the system computer; and   an interface operably connected to the system computer, the interface further having a display for monitoring at least one portion of the blood component collection procedure.   
     
     
       44. A method of configuring a blood component collection machine comprising the steps of:
 collecting a biological characteristic of a donor;   calculating a nomogram by utilizing the biological characteristic of the donor;   transmitting the nomogram to a blood component collection instrument;   selecting a blood component collection application in response to the nomogram, the blood component collection application defining at least a portion of a blood component collection process; and   loading the selected blood component collection application wherein the blood component collection instrument is configured for the blood component collection process involving the donor.   
     
     
       45. A blood processing information management system comprising:
 a database;   a data input device connected in data communication relationship with the database;   a computer connected in data communication relationship with at least one of the database and the data input device; and   a communication conduit connected in data communication relationship with at least one of the database, the data input device and the computer; and   at least one blood processing machine;   whereby the communication conduit is connected in data communication relationship with the at least one blood processing machine to provide for data communication to and from the at least one blood processing machine;   whereby the communication conduit is configured to communicate data to the at least one blood processing machine, the data being preparation data generated by the computer, the at least one blood processing machine configured to use the preparation data in preparation of the at least one machine for a blood processing procedure; and   whereby the communication conduit is configured to communicate data from the at least one blood processing machine, whereby the data is procedure data, which represents information about a blood processing procedure run on the at least one blood processing machine.   
     
     
       46. A processing information management system comprising:
 a database;   a barcode data input device connected in data communication relationship with the database and configured to input barcode data;   a computer connected in data communication relationship with at least one of the central database and the data input device;   a communication conduit connected in data communication relationship with at least one of the central database, the data input device and the computer;   and at least one blood processing machine;   whereby the communication conduit is connected in data communication relationship with the at least one blood processing machine to provide for data communication to and from the at least one blood processing machine; whereby the communication conduit is configured to communicate data including barcode data and run data; whereby the communication conduit is configured to communicate barcode data to the at least one blood processing machine, and whereby the communication subsystem is configured to communicate barcode and run data from the at least one extracorporeal blood processing machine, whereby the run data represents information about an blood processing procedure run on the at least one blood processing machine.