Apparatus and method for blood separation

• US 5,964,724 A
• Filed: 01/31/1997
• Issued: 10/12/1999
• Est. Priority Date: 01/31/1996
• Status: Expired due to Fees

• Current Assignee: Arteriocyte Medical Systems, Inc (Isto Biologics, Inc.)
• Original Assignee: Medtronic Electromedics, Inc.
• Inventors: Le, Son, Cheek, Daniel, Rivera, John, Kaminski, Roger P., Matt, Richard
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): O YONG, KI
• Application Number:
  US08/791,179
• Time in Patent Office: 984 Days
• Field of Search: 604/4-6, 210/739, 210/745, 210/787, 364/413, 434/262
• US Class Current: 604/5.04
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• 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 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6081 Colour codes
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 21/302 Active control mechanisms with external energy, e.g. with solenoid valve
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues apparatus for dental treatment A61C17/065
• CPC Class Codes: B04B 13/00 Control arrangements specially designed for centrifuges; Programme control of centrifuges control arrangements for feed, charge, or discharge B04B11/00

Abstract

The present invention is a blood separation system that is fully mechanized to collect blood from a patient, separate waste portions of the blood, wash the blood, and redirect the usable portions to a device for reinjecting the usable portions into the patient. The present invention prevents accidental activation of an improper operation that could cause harm to a patient or a shut down of the system by requiring confirmation of each step by an operator. The invention provides screen displays with detailed setup instructions, eliminating the need for secondary documentation that might not be allowed in a surgical environment. The invention also instructs the operator at the appropriate times to do certain manual steps such as opening and closing clamps. Since the opening and closing of clamps is a highly critical operation, confirmation of these steps is also required. A method and suitable apparatus is also disclosed for sequestration of platelet rich plasma whereby a blood sample is spun at a high speed sufficient to separate solid cells from the blood sample and spun at a lower speed for a predetermined time to allow platelets to elute from the solid cells.

Claims

1. A blood separation system comprising:

a blood separator for separating blood into blood components,

a plurality of collectors coupled to said blood separator for receiving said blood components,

a controller for said blood separator,

an output device coupled to said controller for displaying text messages, said output device displaying a plurality of instructions that guide an operator to perform predetermined operations, and

an input device coupled to said controller for allowing an operator to input commands to said controller,

said controller requiring confirmation of each command by said operator prior to executing each command.

2. A blood separation system as set forth in claim 1 wherein said output device displays detailed instructions for setup including setup of a sterile, disposable kit that includes all elements that physically contact said blood components.

3. A blood separation system as set forth in claim 1 further comprising:

a blood separator control coupled to said controller for controlling the operation of said blood separator,

a pump connected to said blood separator for pumping said blood and said blood components to and from said blood separator,

a pump control coupled to said controller for controlling said pump,

a plurality of clamps connected to said pump and to said collectors and to a source of blood for controlling the flow of said blood and said blood components to and from said pump,

a clamp control coupled to said controller for controlling said clamp.

4. A blood separation system as set forth in claim 3 wherein said controller is a programmable central processing unit,

said blood separator is a centrifuge,

said blood separator control includes a centrifuge motor that rotates said centrifuge, a centrifuge motor controller and a centrifuge brake controller that control the speed of rotation of said centrifuge motor, a centrifuge hall sensor and a centrifuge encoder that independently monitor the speed of rotation of said centrifuge motor, a centrifuge cover sensor that senses whether a centrifuge cover is closed, and a centrifuge cover lock that locks a centrifuge latch whenever said centrifuge rotates above a predetermined speed,

said pump control includes a pump motor that drives said pump, a pump relay that supplies power to said pump motor, a pump motor controller that controls the speed and direction of said pump motor, a pump hall sensor and a pump encoder that independently monitor the speed and direction of rotation of said pump motor, a pump lid sensor that senses whether a pump cover is closed, an air bubble sensor that senses whether fluid or air is flowing through said pump header, and a level sensor which signals when said centrifuge is full, and

said clamp control includes a clamp motor which opens and closes said clamps, a clamp motor controller that controls said clamp motor, and a clamp position sensor that determines the position of said clamps.

5. A blood separation system as set forth in claim 1 further comprising:

a 4-way connector,

a first tube connected between a source of blood and said connector for transporting said blood from said source to said connector,

a first clamp located on an intermediate portion of said first tube for occluding flow through said first tube,

a source of saline for washing said blood,

a second tube connected between said source of saline and said connector for transporting said saline from said source to said connector,

a second clamp located on an intermediate portion of said second tube for occluding flow through said second tube,

a third tube connected between said connector and one of said collectors for transporting reusable blood components from said connector to said collector,

a third clamp located on an intermediate portion of said third tube for occluding flow through said third tube,

a fourth tube connected between said connector and said blood separator for transporting fluids between said connector and said blood separator, said blood separator being a centrifuge,

a peristaltic pump located along an intermediate portion of said fourth tube for pumping fluids through said fourth tube,

a fifth tube coupled to said blood separator for transporting waste blood components from said centrifuge, and

a waste bag for collecting said waste blood components,

said controller operating said pump and said clamps to control transport of fluids through said tubes, and said centrifuge.

6. A blood separation system as set forth in claim 1 further comprising a blood separator control coupled to said controller for controlling the operation of said blood separator.

7. A blood separation system as set forth in claim 6 wherein said blood separator is a centrifuge, and

said blood separator control includes a centrifuge motor that rotates said centrifuge, a centrifuge motor controller and a centrifuge brake controller that control the speed of rotation of said centrifuge motor, a centrifuge hall sensor and a centrifuge encoder that independently monitor the speed of rotation of said centrifuge motor, a centrifuge cover sensor that senses whether a centrifuge cover is closed, and a centrifuge cover lock that locks a centrifuge latch whenever said centrifuge rotates above a predetermined speed.

8. A blood separation system as set forth in claim 1 further comprising:

a pump connected to said blood separator for pumping said blood and said blood components to and from said blood separator, and

a pump control coupled to said controller for controlling said pump.

9. A blood separation system as set forth in claim 8 wherein said pump control includes a pump motor that drives said pump, a pump relay that supplies power to said pump motor, a pump motor controller that controls the speed and direction of said pump motor, a pump hall sensor and a pump encoder that independently monitor the speed and direction of rotation of said pump motor, a pump lid sensor that senses whether a pump cover is closed, an air bubble sensor that senses whether fluid or air is flowing through said pump header, and a level sensor which signals when said centrifuge is full.

10. A blood separation system as set forth in claim 1 further comprising:

a plurality of clamps connected to said pump and to said collectors and to a source of blood for controlling the flow of said blood and said blood components to and from said pump, and

a clamp control coupled to said controller for controlling said clamp.

11. A blood separation system as set forth in claim 10 wherein said clamp control includes a clamp motor which opens and closes said clamps, a clamp motor controller that controls said clamp motor, and a clamp position sensor that determines the position of said clamps.

12. A blood separation system as set forth in claim 1 wherein said controller is a programmable central processing unit.

13. A blood separation system for sequestration of platelet rich plasma comprising:

a centrifugal blood separator,

a waste bag coupled to said blood separator for collecting waste blood components with a first clamp that occludes flow between said waste bag and said blood separator,

at least one collection bag coupled to said blood separator for collection of said platelet rich plasma with a second clamp that occludes flow between said collection bag and said blood separator

a controller for said blood separator,

an output device coupled to said controller for displaying text messages, said output device displaying instructions that instruct an operator to open and close said clamps, and

an input device coupled to said controller for allowing an operator to input commands to said controller,

said controller requiring confirmation of each instruction by said operator prior to executing each instruction.

14. An autotransfusion system comprising:

a first device for supplying blood from a patient,

a blood separator coupled to said first device for separating waste products from usable blood components,

a second device coupled to said blood separator for collecting said usable blood components for reinjection into said patient,

a control system coupled to said blood separator for controlling said first device, said second device and said blood separator so that each step that an operator command said control system to perform must be confirmed to prevent accidental commands from being performed by said control system.

15. A blood separation system comprising:

a blood separator for separating blood into blood components,

a plurality of collectors coupled to said blood separator for receiving said blood components,

a controller for said blood separator,

an output device coupled to said controller for displaying text messages, said output device displaying a plurality of instructions that guide an operator to perform predetermined operations, and

an input device coupled to said controller for allowing an operator to input commands to said controller,

said controller requiring confirmation by the operator that each instruction was performed prior to continuing through said plurality of instructions.

16. A blood separation system as set forth in claim 15 wherein said output device displays detailed instructions for setup including setup of a sterile, disposable kit that includes all elements that physically contact said blood components.

17. A blood separation system as set forth in claim 15 further comprising:

a blood separator control coupled to said controller for controlling the operation of said blood separator,

a pump connected to said blood separator for pumping said blood and said blood components to and from said blood separator,

a pump control coupled to said controller for controlling said pump,

a plurality of clamps connected to said pump and to said collectors and to a source of blood for controlling the flow of said blood and said blood components to and from said pump,

a clamp control coupled to said controller for controlling said clamp.

18. A blood separation system as set forth in claim 17 wherein said controller is a programmable central processing unit,

said blood separator is a centrifuge,

said blood separator control includes a centrifuge motor that rotates said centrifuge, a centrifuge motor controller and a centrifuge brake controller that control the speed of rotation of said centrifuge motor, a centrifuge hall sensor and a centrifuge encoder that independently monitor the speed of rotation of said centrifuge motor, a centrifuge cover sensor that senses whether a centrifuge cover is closed, and a centrifuge cover lock that locks a centrifuge latch whenever said centrifuge rotates above a predetermined speed,

said pump control includes a pump motor that drives said pump, a pump relay that supplies power to said pump motor, a pump motor controller that controls the speed and direction of said pump motor, a pump hall sensor and a pump encoder that independently monitor the speed and direction of rotation of said pump motor, a pump lid sensor that senses whether a pump cover is closed, an air bubble sensor that senses whether fluid or air is flowing through said pump header, and a level sensor which signals when said centrifuge is full.

said clamp control includes a clamp motor which opens and closes said clamps, a clamp motor controller that controls said clamp motor, and a clamp position sensor that determines the position of said clamps.

19. A blood separation system as set forth in claim 15 further comprising:

a 4-way connector,

a first tube connected between a source of blood and said connector for transporting said blood from said source to said connector,

a first clamp located on an intermediate portion of said first tube for occluding flow through said first tube,

a source of saline for washing said blood,

a second tube connected between said source of saline and said connector for transporting said saline from said source to said connector,

a second clamp located on an intermediate portion of said second tube for occluding flow through said second tube,

a third tube connected between said connector and one of said collectors for transporting reusable blood components from said connector to said collector,

a third clamp located on an intermediate portion of said third tube for occluding flow through said third tube,

a fourth tube connected between said connector and said blood separator for transporting fluids between said connector and said blood separator, said blood separator being a centrifuge,

a peristaltic pump located along an intermediate portion of said fourth tube for pumping fluids through said fourth tube,

a fifth tube coupled to said blood separator for transporting waste blood components from said centrifuge, and

a waste bag for collecting said waste blood components,

said controller operating said pump and said clamps to control transport of fluids through said tubes, and said centrifuge.

20. A blood separation system as set forth in claim 15 further comprising a blood separator control coupled to said controller for controlling the operation of said blood separator.

21. A blood separation system as set forth in claim 20 wherein said blood separator is a centrifuge, and

said blood separator control includes a centrifuge motor that rotates said centrifuge, a centrifuge motor controller and a centrifuge brake controller that control the speed of rotation of said centrifuge motor, a centrifuge hall sensor and a centrifuge encoder that independently monitor the speed of rotation of said centrifuge motor, a centrifuge cover sensor that senses whether a centrifuge cover is closed, and a centrifuge cover lock that locks a centrifuge latch whenever said centrifuge rotates above a predetermined speed.

22. A blood separation system as set forth in claim 15 further comprising:

a pump connected to said blood separator for pumping said blood and said blood components to and from said blood separator, and

a pump control coupled to said controller for controlling said pump.

23. A blood separation system as set forth in claim 22 wherein said pump control includes a pump motor that drives said pump, a pump relay that supplies power to said pump motor, a pump motor controller that controls the speed and direction of said pump motor, a pump hall sensor and a pump encoder that independently monitor the speed and direction of rotation of said pump motor, a pump lid sensor that senses whether a pump cover is closed, an air bubble sensor that senses whether fluid or air is flowing through said pump header, and a level sensor which signals when said centrifuge is full.

24. A blood separation system as set forth in claim 15 further comprising:

a plurality of clamps connected to said pump and to said collectors and to a source of blood for controlling the flow of said blood and said blood components to and from said pump, and

a clamp control coupled to said controller for controlling said clamp.

25. A blood separation system as set forth in claim 24 wherein said clamp control includes a clamp motor which opens and closes said clamps, a clamp motor controller that controls said clamp motor, and a clamp position sensor that determines the position of said clamps.

26. A blood separation system as set forth in claim 15 wherein said controller is a programmable central processing unit.

27. A blood separation system for sequestration of platelet rich plasma comprising:

a centrifugal blood separator,

a waste bag coupled to said blood separator for collecting waste blood components with a first clamp that occludes flow between said waste bag and said blood separator,

at least one collection bag coupled to said blood separator for collection of said platelet rich plasma with a second clamp that occludes flow between said collection bag and said blood separator

a controller for said blood separator,

an output device coupled to said controller for displaying text messages, said output device displaying instructions that instruct an operator to open and close said clamps,

an input device coupled to said controller for allowing an operator to input commands to said controller,

said controller requiring confirmation by the operator that each instruction was performed prior to continuing through said instructions.

28. An autotransfusion system comprising:

a first device for supplying blood from a patient,

a blood separator coupled to said first device for separating waste products from usable blood components,

a second device coupled to said blood separator for collecting said usable blood components for reinjection into said patient,

a control system coupled to said blood separator for controlling said first device, said second device and said blood separator,

an output device coupled to said control system for displaying text messages, said output device displaying a plurality of instructions that guide an operator to perform predetermined operations, and

an input device coupled to said control system for allowing an operator to input commands to said controller,

said control system requiring confirmation by the operator that each instruction was performed prior to continuing through said instructions.