Blood treatment systems and methods

• US 10,682,450 B2
• Filed: 03/24/2017
• Issued: 06/16/2020
• 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:
  US15/469,065
• Publication Number:
  US 20170319765A1
• Time in Patent Office: 1,180 Days
• 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 hemodialysis system that includes a dialysate mixing circuit, the system comprising:

a first port fluidly connected to a first pump in the dialysate mixing circuit, the first port configured to connect to a bicarbonate charge line, the bicarbonate charge line arranged to convey fluid from the first pump to an inlet of a bicarbonate source;

a second port fluidly connected to a second pump in the dialysate mixing circuit, the second port configured to connect to a bicarbonate return line, the bicarbonate return line arranged to convey a bicarbonate solution from an outlet of the bicarbonate source to the second pump;

a third port fluidly connected to a third pump in the dialysate mixing circuit, the third port configured to connect to an acid flow line, the acid flow line arranged to convey an acid solution from an acid source to the third pump;

a bypass connector comprising three fluid prongs configured to connect with the first, the second, and the third ports, wherein channels in each of the three fluid prongs of the bypass connector terminate within a common chamber within the bypass connector so that the bicarbonate charge line, the bicarbonate return line and the acid flow line are fluidly connected to each other upon connection of the bypass connector to the first, the second, and the third ports; and

a controller of the hemodialysis system configured to cause the application of negative pressure on the bicarbonate charge line, the bicarbonate return line, or the acid flow line to confirm the first port, the second port or the third port is not open to atmosphere.

2. The hemodialysis system of claim 1, wherein upon confirmation that the first, second and third ports are not open to the atmosphere, the controller is configured to conclude that the first port is connected to the bicarbonate charge line, that the second port is connected to the bicarbonate return line, and that the third port is connected to the acid flow line, and to operate the dialysate mixing circuit.

3. The hemodialysis system of claim 1, wherein the controller is configured to monitor an amount of negative pressure applied and to determine that one or more of the first, second and third ports is open to the atmosphere based on a detection of pressure decay.

4. The hemodialysis system of claim 1, wherein the first, second and third ports are enclosable by one or more doors, so that the one or more doors must be open for tubing to be connected between the bicarbonate source or the acid source and the dialysate mixing circuit of the hemodialysis system.

5. The hemodialysis system of claim 4, wherein the controller is configured to monitor whether the one or more doors are open to confirm that chemical tubing can be connected between the bicarbonate source or the acid source and the dialysate mixing circuit.

6. The hemodialysis system of claim 1, wherein the controller is configured to cause application of a negative pressure to the bicarbonate charge line, the bicarbonate return line, or the acid flow line to detect a leak between any of the first, the second, and the third ports and the bypass connector.

7. The hemodialysis system of claim 6, wherein the controller is configured to detect a leak between the bypass connector and the first, the second, and the third ports by monitoring for a pressure decay after the application of the negative pressure.

8. In a hemodialysis system, an assembly for interconnecting fluid lines that are configured to connect to an inlet and an outlet of a bicarbonate source and a fluid line configured to connect to an acid source, the assembly comprising:

a first port fluidly connected to a first pump in a dialysate mixing circuit of the hemodialysis system, the first port configured to connect to a bicarbonate charge line, the bicarbonate charge line arranged to convey fluid from the first pump to an inlet of a bicarbonate source;

a second port fluidly connected to a second pump in the dialysate mixing circuit, the second port configured to connect to a bicarbonate return line, the bicarbonate return line arranged to convey a bicarbonate solution from an outlet of the bicarbonate source to the second pump;

a third port fluidly connected to a third pump in the dialysate mixing circuit, the third port connected to an acid flow line, the acid flow line arranged to convey an acid solution from an acid source to the third pump; and

a controller of the hemodialysis system configured to cause application of negative pressure on the bicarbonate charge line, the bicarbonate return line, or the acid flow line to confirm the first port, the second port or the third port is not open to atmosphere; and

a bypass connector comprising three fluid prongs configured to connect with the first, the second, and the third ports;

wherein channels in each of the three fluid prongs of the bypass connector terminate within a common chamber within the bypass connector, so that the bicarbonate charge line and the first pump, the bicarbonate return line and the second pump, and the acid flow line and the third pump are fluidly connected to each other upon connection of the bypass connector to the first, the second, and the third ports.

9. The hemodialysis system of claim 8, wherein the controller is configured to control the hemodialysis system to circulate a fluid for disinfection through the bicarbonate charge line, the bicarbonate return line, and the acid flow line when the bypass connector is connected to the first, the second, and the third ports.

10. The hemodialysis system of claim 8, wherein the three fluid prongs are configured to make a sealing engagement with the first, the second, and the third ports, respectively, allowing the controller to cause the first, the second, or the third pumps to apply a negative pressure to the bicarbonate charge line, the bicarbonate return line, or the acid flow line to detect a leak between any of the first, the second, and the third ports and the bypass connector.