Blood component processing systems and methods using fluid-actuated pumping elements that are integrity tested prior to use

• US 7,004,727 B2
• Filed: 11/05/2004
• Issued: 02/28/2006
• Est. Priority Date: 10/24/2002
• Status: Expired due to Term

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Baxter International Inc.
• Inventors: Nayak, Abinash, Ingo, Carson, Bedard, Peter, Scheidt, Robert, Kline, Tiffany, Boniquit, Christopher
• Primary Examiner(s): FREAY, CHARLES GRANT
• Application Number:
  US10/983,014
• Publication Number:
  US 20050118030A1
• Time in Patent Office: 480 Days
• Field of Search: 417/46, 417/63, 417/395, 417/477.2, 417/479, 604/29, 604/30, 604/153
• US Class Current: 417/46
• CPC Class Codes: A61M 1/0218 with filters
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• 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 1/36225 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 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• 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 1/3652 using gas, e.g. air
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• 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 2205/128 with incorporated valves
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3393 by weighing the reservoir
• CPC Class Codes: A61M 2205/705 Testing of filters for leaks
• CPC Class Codes: A61M 2209/084 Supporting bases, stands for equipment
• CPC Class Codes: F04B 43/009 : leakage control; pump systems with two flexible members; between the actuating element and the pumped fluid
• CPC Class Codes: F04B 43/06 : Pumps having fluid drive

Abstract

Blood component processing systems and methods are coupled to a blood component processing device. The systems and methods include a fluid circuit that comprises at least one fluid pressure actuated pump station, at least one fluid flow path communicating with the pump station, and at least one valve in the fluid flow path. A control module is sized and configured to interact with the fluid circuit. The control module includes an actuator to selectively apply fluid pressure to the pump station in concert with operation of the valve to pump fluid through the fluid flow path in response to a control program. A controller coupled to the control module includes the control program and a fluid circuit integrity test function. The fluid circuit integrity test function commands the control module to selectively apply fluid pressure to the pump station in concert with operation of the valve to introduce a fluid within a region of the fluid circuit and to confine the fluid within the region while applying fluid pressure to the pump chamber. The fluid circuit integrity test function generates an integrity output in response to sensing leakage of fluid from the region.

Claims

1. A blood component processing system comprising a cassette including a body containing preformed, fluid pressure actuated pump stations, preformed fluid flow paths, and preformed, fluid pressure actuated valves in the fluid flow paths, and a flexible diaphragm overlying the body and flexing in response to fluid pressure to operate the pump stations and valves,

an actuator station including a holder to receive the cassette for use, a fluid pressure manifold assembly in the holder including an operative surface contacting the flexible diaphragm to selectively apply fluid pressure to flex the diaphragm in response to a control program, the actuator station including a door that opens to allow placement of the cassette into the holder and closes to seat the diaphragm against the operative surface, and

a controller coupled to the fluid pressure manifold including the control program and a cassette integrity test function that ascertains presence of the cassette in the holder when the door is closed and enables use of the control program only if presence of the cassette is ascertained.

2. A system according to claim 1 wherein the door includes a bladder that expands in response to fluid pressure and that, when expanded, seats the diaphragm against the operative surface when the door is closed, and

wherein the cassette integrity test function includes expanding the bladder when the door is closed and sensing pressure within the bladder for a prescribed time period until a prescribed minimum threshold pressure is sensed, thereby ascertaining presence of the cassette in the holder.