Blood pumping and processing system

• US 5,423,738 A
• Filed: 09/07/1993
• Issued: 06/13/1995
• Est. Priority Date: 03/13/1992
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Felix, Augustus, Robinson, Thomas C., Nevers, Craig, Sahines, Thomas P., Cross, Klaus J., Kitrilakis, Sotiris, Appleby, Timothy
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/117,921
• Time in Patent Office: 644 Days
• Field of Search: 604/4-6, 604/27, 604/28, 604/30, 604/31, 604/48, 604/49, 604/51, 604/52, 604/56, 604/118-120
• US Class Current: 604/6.01
• 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 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3606 Arrangements for blood-volume reduction of extra-corporeal circuits
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• 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 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/71 Suction drainage systems containers therefor A61M1/60, A61M1/64; negative pressure wound therapy systems A61M1/90
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 1/784 : by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
• CPC Class Codes: A61M 1/79 : Filters for solid matter specially adapted for dental use A61C17/065
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 5/40 : using low-level float-valve to cut off media flow from reservoir position detection of a floating member A61M5/1685
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/258 : Piston pumps
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/435 : with diastole or systole switching by valve means located between the blood pump and the hydraulic or pneumatic energy source
• CPC Class Codes: A61M 60/531 : using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/538 : Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 : of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/585 : User interfaces
• CPC Class Codes: A61M 60/849 : Disposable parts
• CPC Class Codes: A61M 60/851 : Valves
• CPC Class Codes: A61M 60/892 : Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 : Passive valves, i.e. valves actuated by the blood

Abstract

A blood processing system is described in which blood pressure readings obtained before and after passage of blood aspirated from an operative site through a membrane separator is used by a programmed controller to determine the hematocrit level of the blood and to add saline solution to adjust the hematocrit level to a desired level. The blood processing system contains a distributor cap to distribute wash solution to the inside of a filter to wash out additional blood cellular material within the filter. A precollector may be used remotely from the site of the blood processing system and later joined with the system to withdraw blood contained in the precollector for processing by the blood processing system.

Claims

1. A blood processing system for use in processing blood of various hematocrit levels aspirated from a surgical site comprising:

a separator for receiving the aspirated blood and for separating a mixture of blood cells and platelets from blood fluids;

means for conveying the blood being processed through the blood processing system; and

,

means for controlling the hematocrit level of the reinfused blood cells and platelets which comprises;

means for measuring a first pressure of blood entering the separator;

means for measuring a second pressure of blood existing the separator;

means for measuring the difference between the first and second pressures; and

means, responsive to the measured pressure differential, for adjusting the hematocrit of the mixture of blood cells and platelets.

2. The blood processing system of claim 1 wherein the means for adjusting the hematocrit of the mixture is a means for infusing wash fluid into the mixture.

3. The blood processing system of claim 2 wherein the means for measuring pressure comprises pressure transducers.

4. The blood processing system of claim 1 wherein the means for measuring and adjusting are controlled by a programmed microprocessor.

5. A blood filtration unit having a container for receiving blood aspirated from an operative site, an inlet opening into the container for conveying the aspirated blood into the container, a filter within the container for filtering blood received from the operative site, the filter being in communication with the inlet opening such that blood aspirated from the operative site first enters the inlet opening and subsequently the filter, the container further having a storage portion to store filtered blood, wherein the improvement comprises:

the inlet opening being a distributor cap having a central aperture for conveying blood from the operative site into the container, the distributor having disposed around the central aperture a plurality of distributing apertures, the distributing apertures having a means for connection to a source of wash solution, the distributing openings being adapted to convey wash solution entering through the means for connection into the filter to wet the filter prior to the entry of aspirated blood and to dislodge cellular blood materials from the filter and into the storage portion of the container.

6. The blood filtration unit of claim 5 wherein the plurality of distributing apertures surrounds the central aperture to uniformly wet the filter and dislodge blood materials from the filter.

7. A system for blood storage and processing purposes comprising:

a disposable housing for processing blood received in the housing;

a reservoir contained within the disposable housing for receiving blood from outside the housing and having an opening therein for communication with a source of blood;

a precollector having a housing, the housing having an inlet which may be connected to a means for suctioning blood and other fluids from an operative site;

the inlet communicating with a filter to filter blood introduced through the inlet, wherein blood passes through the filter and into the precollector housing for storage purposes or for purposes of transfer into the reservoir;

a support housing associated with the disposable housing, the support supporting the precollector;

an inlet on the precollector for receiving a vacuum line to withdraw filtered blood contained in the precollector;

a blood transfer line contained partially within the precollector to provide a conduit for withdrawal of the filtered blood and partially outside the precollector to communicate with the opening in the reservoir to allow the withdrawal of blood from the precollector into the reservoir and disposable housing.

8. The system of claim 7, wherein the filtered blood is moved from the precollector to the reservoir through the action of a vacuum source connected to the inlet on the precollector.

9. The system of claim 8 further comprising a float valve connected to the inlet to prevent the ingress of blood into the vacuum line from the precollector.

10. A blood processing system for use in processing aspirated blood in which blood fluids are separated comprising:

a disposable housing for processing blood received within the housing;

the disposable housing having a separator for receiving the aspirated blood and for separating a mixture of blood cells and platelets from blood fluids;

the disposable housing further having means for conveying blood to the separator for separating blood cells;

a reusable housing which cooperates with the disposable housing;

the reusable housing having means for controlling the means for conveying blood for separating blood cells from blood fluids wherein the reusable housing cooperates with the disposable housing through at least one connector which mates with a corresponding connector in the disposable housing.

11. The blood processing system of claim 10 in which the means for controlling the separating of blood cells is under the control of a programmed controller.

12. The blood processing system of claim 11 in which the programmed controller comprises a microprocessor controlled and associated control program.

13. A blood processing system for use in processing blood of various hematocrit levels aspirated from a surgical site comprising:

a separator for receiving the aspirated blood and for separating a mixture of blood cells and platelets from blood fluids;

a transducer for sensing a first pressure of blood entering the separator;

a transducer for sensing a second pressure of blood exiting the separator;

a microprocessor for determining the difference between the first and second pressures; and

a pump controlled by the microprocessor for introducing a variable amount of fluid into the mixture of separated blood cells and platelets, the pump delivering a variable amount of fluid in response to the pressure differential determined by the microprocessor so as to adjust the hematocrit of the mixture of blood cells and platelets.

14. The blood processing system recited in claim 13 further including a pump for pumping blood to be processed into the separator wherein the transducer for sensing the first pressure is in communication with the pump.

15. The blood processing system recited in claim 13 wherein the separator and the fluid pump are supported by a disposable housing and the microprocessor and the transducers for sensing the first and second pressures are supported by a reusable housing.

16. The blood processing system recited in claim 13 wherein the separator includes an outlet and the system further includes a pneumatically controlled diaphragm valve which is in communication with the outlet of the separator and the transducer for sensing the second pressure.

17. The blood processing system recited in claim 16 wherein the pneumatically controlled diaphragm valve includes first and second ports in communication with one side of the diaphragm and a third port on an other side of the diaphragm, wherein the first and second ports regulate fluid flow through the valve and the third port conducts positive or negative pressure relative to the diaphragm.

18. The blood processing system of claim 13 wherein the fluid pump includes a driving chamber and a pumping chamber and wherein a valve admits a variable volume of media into the driving chamber to cause a variable amount of fluid to be pumped from the pumping chamber.

19. The blood processing system recited in claim 18 wherein the valve includes multiple solenoid switches.

20. The blood processing system recited in claim 18 wherein the valve includes a pulse width modulated valve.

21. A blood processing system for use in processing aspirated blood in which blood fluids are separated comprising;

a disposable housing for processing blood received within the housing;

the disposable housing having a separator for receiving the aspirated blood and for separating a mixture of blood cells and platelets from blood fluids;

the disposable housing further including a pump for conveying blood to the separator for separating blood cells;

a reusable housing which cooperates with the disposable housing having at least one pneumatic connector which mates with a corresponding connector in the disposable housing and including a microprocessor for controlling the pneumatic pressure applied to the pump.

22. The blood processing system recited in claim 21 wherein the disposable housing includes a plurality of collinear pneumatic connectors.

23. The blood processing system recited in claim 22 wherein the reusable housing includes a plurality of mateable collinear pneumatic connectors.

24. The blood processing system recited in claim 21 wherein one of the disposable housing and the reusable housing includes a camming member and the other includes a cover moveable between a first position when the pneumatic connectors are sealed by the cover and a second position when the pneumatic connectors are unsealed, the cover including a receiving portion against which movement of the camming member will move the cover from the first position to the second position.

25. The blood processing system recited in claim 24 wherein the cover is resiliently biased into the first position.

26. A blood processing system, comprising:

first and second separators for separating blood cell and fluid components, each separator having an inlet for the blood to be processed and an outlet for the separated blood cells and an outlet for the separating fluid, a line in communication with the blood cell outlet of the first separator and the inlet of the second separator;

a blood pump for pumping the blood to be processed into the first separator;

a fluid pump for introducing a variable amount of fluid into the line;

a waste pump for pumping the separated fluid from the first and second separators;

a plurality of pneumatic diaphragm valves for controlling the flow of blood and fluid through the blood processing system;

a plurality of pneumatic connectors in communication with the plurality of pneumatic diaphragm valves; and

a disposable housing for supporting the first and second separators, blood pump, fluid pump, waste pump, plurality of pneumatic diaphragm valves and plurality of pneumatic connectors.

27. The blood processing system of claim 26 wherein at least one of the blood pump, fluid pump and waste pump are pneumatically driven and the disposable housing includes corresponding pneumatic connectors in communication therewith.

28. A method of processing blood, comprising:

introducing blood into a separator which separates the blood into cell components and blood fluids;

determining a pressure differential between the blood introduced into the separator and the blood exiting the separator;

introducing a predetermined variable amount of fluid into the separated blood cell components to adjust the hematocrit level to a desired amount in response to the determined pressure differential.