Blood processing system

• US 6,695,803 B1
• Filed: 10/15/1999
• Issued: 02/24/2004
• Est. Priority Date: 10/16/1998
• Status: Expired due to Fees

• Current Assignee: Terumo Medical Corporation (Terumo Corporation)
• Original Assignee: Mission Medical, Inc. (Terumo Corporation)
• Inventors: Robinson, Thomas C., Hickman, Frank, Sahines, Thomas P., Fernandez, Robert K., DʼElia, Richard R.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Deak, Leslie R
• Application Number:
  US09/419,216
• Time in Patent Office: 1,593 Days
• Field of Search: 210/252, 210/257.2, 210/258, 210/645-647, 604/4.01, 604/5.01, 604/6.01, 604/30, 604/34
• US Class Current: 604/4.01
• CPC Class Codes: A61M 1/02 Blood transfusion apparatus blood infusion by syringes A61M5/14
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/024 Means for controlling the quantity of transfused blood, e.g. by weighing the container and automatic stopping of the transfusion after reaching a determined amount
• CPC Class Codes: A61M 1/025 Means for agitating or shaking blood containers A61M1/0245 takes precedence; shaking in general B01F31/00
• 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 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3489 by biological cells, e.g. bioreactor
• CPC Class Codes: A61M 1/3496 Plasmapheresis; Leucopheresis; Lymphopheresis A61M1/3472 takes precedence
• 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 1/3603 in the same direction
• 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 1/36223 the cassette being adapted for heating or cooling the blood
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362264 the filter being a blood filter
• 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 1/3633 Blood component filters, e.g. leukocyte filters
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3606 : cooled
• CPC Class Codes: A61M 2205/3673 : thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2230/207 : hematocrit

Abstract

A blood processing system (2), includes a housing (4), to which a user control panel is mounted, having an access opening (47) therein. A cassette assembly (22), mounted to the housing for movement between a use position covering the access opening and a cassette-replacement position, includes a cassette holder and cassette (26) removably mounted to the holder. The cassette includes in part by tubing aligned with a through-hole (45) in the cassette. A door (34) is mounted to the housing for movement between a latched position, capturing the cassette between the panel and the door, and a released position. Independently-driven roller assemblies (46, 54, 72) pass part-way through the access opening to capture first tubing portions (44A, 52A, 68A) between the roller tracks (100, 102, 104) and the roller assemblies for peristaltic pumping of fluid. A number of movable pinch elements (48, 80, 90, 96) are extendable through the front panel to selectively pinch the tubing against the door and thus seal the tubing.

Claims

1. A blood processing system comprising:

a housing having a panel with an outer surface and an access opening therethrough;

user-accessible controls operably coupled to the housing;

a cassette removably mounted to the housing, the cassette having a cassette body with inner and outer surfaces and a hole portion formed therein, the cassette removably mounted to the housing with the inner surface adjacent to the access opening, said cassette comprising flow channels, said flow channels defined at least in part by tubing, said tubing comprising first and second tubing portions aligned with the hole portion;

a roller pump drive assembly within the housing comprising a plurality of independently-driven roller assemblies mounted for rotation about their roller assembly axes, each said roller assembly comprising a plurality of circumferentially-positioned rollers, said roller assemblies located to be aligned with said access opening and aligned with respective ones of said first tubing portions;

a fastening assembly mounted to the housing for movement between a latched position, at which the cassette is captured between the outer surface of the panel and the fastening assembly, and a released position, at which the cassette is not thus captured;

one of the cassette and the fastening assembly having roller tracks positioned at the hole portion to engage said first tubing portions when the fastening assembly is in the latched position whereby rotation of said roller assemblies causes said rollers to engage said first tubing portions to pump any fluid in said first tubing portions;

a plurality of movable pinch elements within the housing adjacent to said access opening, said pinch elements aligned with said second tubing portions, said pinch elements movable between retracted and extended positions, said pinch elements extending through said access opening and into tube-collapsing engagement with said second tubing portions when in the extended positions;

one of the cassette and the fastening assembly having pinch surfaces positioned to engage said second tubing portions in alignment with said pinch elements so said pinch elements seal said second tubing portions when said fastening assembly is in the latched positions and the pinch plungers are in the extended position; and

a controller operably coupled to the user-accessible controls, the roller pump drive assembly, the cassette and the pinch elements.

2. The system according to claim 1 wherein said fastening assembly has said roller tracks and said pinch surfaces.

3. The system according to claim 1 wherein:

said roller assembly axes define a common axis;

first and second of said roller assemblies are positioned along said common axis;

said roller pump drive assembly comprises coaxial, nested drive tubes; and

each said roller assembly is driven by a separate one of said drive tubes.

4. The system according to claim 1 further comprising:

a bag-type reservoir fluidly coupled to the flow channels; and

a mechanical bag manipulator operably coupled to the bag to change the shape of the bag thereby mixing any contents within the bag.

5. The system according to claim 1 wherein said cassette is removably mounted to pins extending from the panel of the housing.

6. The system according to claim 1 wherein:

said cassette comprises a blood component separator mounted to the cassette body;

the cassette comprises a blood filter mounted to the cassette body; and

the roller tracks are arcuate roller tracks.

7. The system according to claim 1 further comprising a flow detector carried by the housing adjacent to the access opening in the panel and operably coupled to the controller;

and wherein;

the tubing comprises a third portion and the fastening assembly comprises a bias surface positioned to bias the third portion into operative engagement with the flow detector when the fastening assembly is in the latched position;

said access opening comprises separate access openings for the roller assemblies and for the pinch elements;

said roller assemblies extend part way through the access opening;

said pinch elements are arranged in a staggered, two-dimensional array.

8. The system according to claim 7 wherein the flow channels comprise a first recirculation path segment fluidly coupled to the main path between the first port and the separator and a second recirculation path segment fluidly coupled to the main path between the second port and the separator, and further comprising a blood recirculation receptacle associated with the housing and having first and second recirculation ports fluidly coupled to the first and second recirculation path segments, respectively, thereby creating a closed loop recirculation path.

9. The system according to claim 8 wherein:

the flow channels comprise a supplemental fluid segment fluidly coupled to the main path; and

at least a portion of the supplemental fluid segment comprises supplemental fluid tubing; and

further comprising;

a supplemental fluid source fluidly coupled to the supplemental fluid segment; and

wherein

a third of said roller assemblies engages said supplemental fluid tubing so that actuation of said third roller assembly drives a supplemental fluid from said supplemental fluid source to said main flow path.

10. The system according to claim 9 wherein said supplemental fluid segment is fluidly coupled to the main flow path by said closed loop recirculation path.

11. The system according to claim 9 wherein:

said supplemental fluid source is a saline source;

the cassette comprises at least one of a bacterial filter and a viral filter along said supplemental fluid segment; and

said cassette comprises an air bubble detector, operably coupled to the controller, along said supplemental fluid segment.

12. The system according to claim 1 wherein:

the flow channels define a main flow path having first and second ports;

the system further comprises;

a source of blood fluidly coupled to the first port;

a collection receptacle fluidly coupled to the second port;

the cassette comprises;

a blood component separator, comprising an entrance port, an exit port and a discharge port, said entrance and exit ports of said separator situated along the main flow path between the source of blood and the collection reservoir;

the system further comprises;

a discharge receptacle fluidly coupled to the discharge port;

said separator is adapted to separate blood entering the entrance port into a retained fraction which is directed through the exit port, along the main flow path and to the collection reservoir, and a discharged fraction which is directed through the discharge port to the discharge receptacle; and

the cassette comprises;

pressure access ports along said main flow path between the source of blood and the blood component separator permitting measurement of pressures at said pressure access ports.

13. The system according to claim 12 wherein:

the pressure access ports comprise first and second pressure access ports;

the cassette comprises a pressure drop device along the main flow path between the first and second pressure access ports, said pressure drop device configured to provide a chosen pressure drop under a chosen flow condition;

the pressure drop device comprises a laminar flow tube;

said pressure access ports each comprise a fluid-sealing diaphragm to permit non-invasive fluid pressure measurements along said main flow path;

the cassette comprises an air bubble detector, operably coupled to the controller, along the main flow path adjacent to the first port;

a first of said roller assemblies engages said tubing along said main flow path between said first port and said separator; and

a second of said roller assemblies engages said tubing between said separator and said discharge port.

14. The system according to claim 12 wherein:

the flow channels comprise a supplemental fluid segment fluidly coupled to the main path; and

at least a portion of the supplemental fluid segment comprises supplemental fluid tubing;

and further comprising;

a supplemental fluid source fluidly coupled to the supplemental fluid segment;

and wherein a third of said roller assemblies engages said supplemental fluid tubing so that actuation of said third roller assembly drives a supplemental fluid from said supplemental fluid source to said main flow path.

15. The system according to claim 12 further comprising:

a pressure sensor operably coupling the pressure access ports with the controller; and

wherein;

the pressure sensor is within the housing.

16. The system according to claim 12 wherein:

the source of blood is a needle cannula insertable into a vein of a donor;

the blood component separator comprises a plasma separator; and

the collection receptacle has an entrance port fluidly coupled to the second port and an exit port, said exit port fluidly coupled to the main flow path at a return position by a return line, whereby the main flow path between the return position and the second port and the flow path from the second port, through the collection receptacle and the return line comprise a recirculation loop.

17. The system according to claim 16 further comprising:

a storage receptacle, capable of containing a supply of red blood cell storage solution, fluidly coupled to the main flow path at a storage solution position between the first port and the blood pump; and

wherein;

the blood pump roller assembly is a reversable pump to selectively pump storage solution to the collection receptacle and to selectively pump blood and storage solution from the collection receptacle to the storage receptacle;

said first tubing sections comprise a recirculation pump tubing section and a blood pump tubing section engaged by recirculation pump and blood pump roller assemblies, respectably;

said recirculation pump tubing section is located along said main flow path between said return position and the second port; and

said blood pump tubing section is located along the main flow path between the first port and the return position.

18. The system according to claim 12 wherein said source of blood comprises a source of thawed blood to be subjected to component separation at said blood component separator.

19. The system according to claim 12 wherein the flow channels comprise a recirculation segment fluidly coupling the main flow path at a recirculation position between the separator and the second port to a third port, said source of blood fluidly coupled to the third port.

20. The system according to claim 12 wherein the flow channels comprise a recirculation relief segment fluidly coupling the recirculation segment and the waste port, said cassette comprising a pressure relief valve along said recirculation relief segment which permits flow along the recirculation relief segment from the recirculation segment to the waste port only when a pressure drop across the pressure relief valve is at least a chosen value.

21. The system according to claim 12 wherein:

the flow channels comprise a supplemental fluid segment fluidly coupled to the main path; and

at least a portion of the supplemental fluid segment comprises supplemental fluid tubing; and

further comprising;

a supplemental fluid source fluidly coupled to the supplemental fluid segment; and

wherein

a third of said roller assemblies engages said supplemental fluid tubing so that actuation of said third roller assembly drives a supplemental fluid from said supplemental fluid source to said main flow path.

22. The system according to claim 21 wherein:

said flow channels comprise a supplemental fluid relief segment fluidly coupling the supplemental fluid segment to the recirculation segment, said cassette comprising a second pressure relief valve along said supplemental fluid relief segment which permits flow along the supplemental fluid relief segment from the supplemental fluid segment to the recirculation segment only when a pressure drop across the second pressure relief valve is at least a chosen value;

said supplemental fluid source is a saline source;

the cassette comprises a bacterial filter along said supplemental fluid segment; and

said cassette comprises an air bubble detector, operably coupled to the controller, along said supplemental fluid segment.

23. An integrated blood processing system comprising a housing, a door mounted thereto and a disposable cassette, wherein:

the housing has a front side having operator-available controls exposed thereon and a signal processor enclosed in an interior thereof, the controls being connected in signal transferring relation to the signal processor, a plurality of roller pump roller assemblies mounted about a single axis located within the housing interior in close lateral relation to one another, the roller assemblies having circumferences which extend through a first opening defined in the housing front side, the first opening being of a size and shape sufficient to allow free passage of the roller assemblies circumferences, motivating means within the housing for independently motivating each of the roller assemblies to rotate about the single axis, the motivating means being in signal transmitting relation to the signal processor, a plurality of parallel plungers mounted to a corresponding plurality of independently controllable plunger motivating valves, the valves being mounted within the housing interior, the plungers each having a contact end which can be extended by the respective valve through a second opening defined in the housing front side, the second opening being of a size and shape sufficient to allow free passage of the plungers, the plungers being spaced laterally from one another, the plungers being in signal transmitting relation to the signal processor;

the door being selectively positioned to expose or close both the first and second openings, the door, when closed, defining a plurality of plunger contact end backing portions and a plurality of roller backing portions recessed into the door, the roller backing portions being arcuate in shape and being separated by ridges from one another, the door, when closed, being latched against the housing front side;

the cassette having a body which is mountable between the door and the housing and resilient tubing mounted to the body, the body and the tubing mounted thereto being positioned between the door and the housing when the door is open and being firmly held in place between the door and the housing when the door is thereafter closed with the tubing then having a plurality of pumping portions thereof in contact with the circumferences of the respective rollers and in contact with the corresponding roller backing portions of the door and having a plurality of pinch portions in contact with respective of the plunger contact ends and in contact with respective of the plunger contact end backing portions whereby selective pumping is enabled at each pumping portion and whereby selective closure is provided at each pinch portion.