Blood treatment systems and methods

• US 9,603,985 B2
• Filed: 06/24/2014
• Issued: 03/28/2017
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Wilt, Michael J., Ballantyne, Todd A., Demers, Jason A.
• Primary Examiner(s): Kim, John
• Application Number:
  US14/313,809
• Publication Number:
  US 20140309611A1
• Time in Patent Office: 1,008 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/15 with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/1561 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 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/1566 Means for adding solutions or substances to the treating fluid
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/1635 with volume chamber balancing devices between used and fresh dialysis fluid
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3427 back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3441 : Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3462 : Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3465 : using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3622 : with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/362223 : the interface being evacuated interfaces to enhance contact
• 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 1/362263 : Details of incorporated filters
• 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 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3652 : using gas, e.g. air
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: G06F 11/30 : Monitoring
• CPC Class Codes: G06F 11/3089 : Monitoring arrangements determined by the means or processing involved in sensing the monitored data, e.g. interfaces, connectors, sensors, probes, agents software debugging using additional hardware using a specific debug interface G06F11/3656; performance evaluation by tracing or monitoring G06F11/3466
• CPC Class Codes: G06F 9/00 : Arrangements for program control, e.g. control units program control for peripheral devices G06F13/10
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 137/87893 : With fluid actuator

Abstract

Dialysis systems comprising actuators that cooperate to perform dialysis functions and sensors that cooperate to monitor dialysis functions are disclosed. According to one aspect, such a hemodialysis system comprises a user interface model layer, a therapy layer, below the user interface model layer, and a machine layer below the therapy layer. The user interface model layer is configured to manage the state of a graphical user interface and receive inputs from a graphical user interface. The therapy layer is configured to run state machines that generate therapy commands based at least in part on the inputs from the graphical user interface. The machine layer is configured to provide commands for the actuators based on the therapy commands.

Claims

1. A system for delivering a liquid or air to an extracorporeal blood circuit in a hemodialysis apparatus comprising:

(1) A pump cassette having a top plate and an opposing bottom plate, the bottom plate having pneumatic ports for connection to a source of pneumatic pressure, the pump cassette comprising;

(a) a reciprocating membrane-based blood pump in which a pumping chamber of the blood pump is separated from a control chamber of the blood pump by a blood pump membrane operated by pneumatic pressure applied to the blood pump control chamber via at least one of said pneumatic ports, the blood pump fluidly connecting an inlet to an outlet of the pump cassette through a blood flow-path between the top plate and bottom plate of the pump cassette;

(b) a metering pump having a pumping chamber in valved fluid communication with;

a liquid flow-path between the top plate and bottom plate of the pump cassette, the liquid flow-path fluidly connected to the blood flow-path;

a hollow spike on the top plate of the pump cassette, the hollow spike configured to fluidly connect a liquid-containing container to the metering pump through a passageway in the top plate; and

an air vent on the top plate of the pump cassette, the air vent configured to fluidly connect to the metering pump through a passageway in the top plate; and

(c) a first metering pump valve interposed between the metering pump and the hollow spike, a second metering pump valve interposed between the metering pump and the air vent, and a third metering pump valve interposed between the metering pump and the blood flow-path; and

(2) a controller configured to control each of said valves and said metering pump to draw a volume of a liquid from the container via the hollow spike and to deliver the liquid to the blood flow-path via the liquid flow-path, or to draw a volume of air via the air vent and to deliver the volume of air to the container via the hollow spike or to the blood flow-path via the liquid flow-path.

2. The system of claim 1, wherein the controller is configured to control each of said valves and said metering pump, such that a volume of the liquid pumped from the container to the blood flow path is replaced by an approximately equal volume of air pumped from the air vent into the container.

3. The system of claim 1, wherein the metering pump comprises a reciprocating membrane-based pump in which a pumping chamber of the metering pump is separated from a control chamber of the metering pump by a metering pump membrane, the control chamber of the metering pump being fluidly connected to one of said pneumatic ports, and the metering pump having a pre-determined stroke volume.

4. The system of claim 3, further comprising a pressure sensor in fluid communication with the control chamber of the metering pump, the pressure sensor arranged to provide pressure information associated with the metering pump control chamber to the controller, and wherein the controller is configured to control the valves to establish fluid communication between the pumping chamber of the metering pump and the container to determine a pressure associated with the container.

5. The system of claim 4, wherein the controller is configured to control the valves and the metering pump to pump air into the attached container if the pressure associated with the container is less than a pre-determined value, and to pump an amount of the liquid from the container to the blood flow-path if the pressure associated with the container is greater than a pre-determined value.

6. The system of claim 4, wherein the controller is configured to compute a first volume of the pumping chamber of the metering pump by measuring a pressure in the metering pump control chamber at the end of a fill stroke of the metering pump, and to compute a second volume of the pumping chamber of the metering pump at the end of a delivery stroke of the metering pump, and to compute a measured stroke volume of the metering pump from a difference between the first and second volumes.

7. The system of claim 6, wherein the controller is configured to notify a user if a difference between the measured stroke volume and the pre-determined stroke volume of the metering pump exceeds a pre-determined value.

8. The system of claim 4, wherein the controller is configured to compute a first volume of the pumping chamber of the metering pump by measuring a first pressure in the metering pump control chamber when all said valves are closed, to compute a second volume of the pumping chamber of the metering pump by measuring a second pressure in the metering pump control chamber at the end of a fill stroke of the metering pump when the first valve is open to the container, to compute a third volume of the pumping chamber of the metering pump by measuring a third pressure in the metering pump control chamber at the end of a delivery stroke of the metering pump when the first valve is open to the container, and to compute a measured stroke volume of the metering pump from a difference between the first and second volumes, or between the first and third volumes.

9. The system of claim 8, wherein the controller is configured to control the valves and the metering pump to pump air into the container from the air vent if the measured stroke volume from the difference between the first and second volumes is less than the pre-determined stroke volume of the metering pump.

10. The system of claim 8, wherein the controller is configured to control the valves and the metering pump to pump a volume of liquid from the container to the blood flow-path of the pump cassette if the measured stroke volume from the difference between the first and third volumes is less than the pre-determined stroke volume of the metering pump.

11. The system of claim 1, wherein the controller is configured to control the valves and the metering pump to pump air from the air vent into the blood flow-path of the cassette to mix with a cleaning liquid in the extracorporeal blood circuit during cleaning of the extracorporeal blood circuit.

12. The system of claim 1, wherein the extracorporeal blood circuit comprises an arterial line connected to the inlet, a dialyzer connected to the outlet, and a venous line connected to the dialyzer, and wherein the controller is configured during a fluid draining operation to control the valves and the metering pump to pump air from the air vent into the blood flow-path of the pump cassette to remove fluid from the extracorporeal blood circuit via the arterial and venous lines.

13. The system of claim 1, wherein the extracorporeal blood circuit comprises an arterial line connected to the inlet, a dialyzer connected to the outlet, a venous line connected to the dialyzer, a blood pump inlet valve, and a blood pump outlet valve, and wherein the controller is configured to control the metering pump, the blood pump, and the metering pump and blood pump valves, to pump a first volume of the liquid from the container to the pumping chamber of the blood pump, to pump a second volume of dialysate from the dialyzer to the blood pump, and to pump a combination of the first volume and second volume from the blood pump into the arterial line.

14. The system of claim 13, wherein the controller is further configured to control said pumps and valves to pump a third volume of dialysate from the dialyzer to the blood pump, and to pump the third volume of dialysate into the arterial line.