Blood treatment systems and methods

• US 9,517,295 B2
• Filed: 05/24/2012
• Issued: 12/13/2016
• 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., van der Merwe, Dirk A., Ballantyne, Todd A., Grant, Kevin L., Rosse, Jonathan P., Flynn, Catharine N., Yee, Brian K.
• Primary Examiner(s): Kim, John
• Application Number:
  US13/480,454
• Publication Number:
  US 20130020237A1
• Time in Patent Office: 1,664 Days
• Field of Search: 210 85- 87, 210/90, 210 961- 97, 210103-104, 210134-135, 210/141, 210/143, 210/321.71, 604/4.01, 604/5.01, 604/6.09, 604/6.11, 604/30, 326/9, 326/14, 326/37, 326/39
• US Class Current: 1/1
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• 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 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• 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 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• 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 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• 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 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1666 : by dissolving solids
• CPC Class Codes: A61M 1/1668 : Details of containers
• CPC Class Codes: A61M 1/1692 : Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/267 : used for pumping
• CPC Class Codes: A61M 1/301 : Details
• 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 1/341 : by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 : Diafiltration
• CPC Class Codes: A61M 1/3603 : in the same direction
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• 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 1/36224 : with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 : with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 : Constructional details of cassettes, e.g. specific details on material or shape
• 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 1/362264 : 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 1/3638 : with a vapour trap
• 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 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• 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 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 : the displacement member being flexible, e.g. membranes, diaphragms or bladders
• 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 60/837 : Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• 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
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Dialysis systems are disclosed comprising new fluid flow circuits. Systems may include blood and dialysate flow paths, where the dialysate flow path includes balancing, mixing, and/or directing circuits. Dialysis systems may include a safety system utilizing a field programmable gate array (FPGA) that monitors at least conductivity and temperature of dialysate in the flow circuit upstream of a dialyzer and enters a fail-safe state if the measured conductivity is outside of a range of values. The FPGA may be verified to be operating properly by exposing sensors in fluid paths to temperatures or conductivities that are outside pre-determined permissible ranges of values, and confirming that the FPGA safety system enters a fail-safe state in response to the temperatures or conductivities. The FPGA may be configured to monitor an amount of ultrafiltration fluid withdrawn from a patient during dialysis treatment and to enter a fail-safe state if a maximum amount is exceeded.

Claims

1. A dialysis unit including:

a dialysate flow circuit including a dialyzer and an ultra-filtration pump; and

a field programmable gate array that monitors an amount of ultrafiltration fluid withdrawn from a patient during a dialysis treatment by the dialysis unit by setting a given register to a first value and increasing the value of the register by a first incremental value for every pump stroke of the ultra-filtration pump and decreasing the value of the register by a second incremental value for each pre-determined increment of time, wherein the field programmable gate array enters a fail-safe state if the value of the register exceeds a pre-determined maximum value.

2. The dialysis unit of claim 1, wherein said field programmable gate array is configured to monitor a pre-treatment ultrafiltration volume, and wherein said dialysis unit further comprises an automatic computer processing unit that is configured to assign a nominal ultrafiltration pump rate to the field programmable gate array, operate the ultra-filtration pump at a pre-determined rate above the nominal ultrafiltration pump rate, and verify that the field programmable gate array enters the fail-safe state prior to the start of the dialysis treatment.

3. The dialysis unit of claim 1, wherein the pre-determined maximum value is fixed or programmable.

4. The dialysis unit of claim 1, wherein the field programmable gate array is configured to also enter the fail-safe state if the value of the register decreases to zero from the first value.

5. A dialysis unit including:

a dialysate flow circuit including a dialyzer; and

an automatic computer processing unit that verifies before a start of a treatment that a safety system mediated by a field programmable gate array (FPGA) is operating properly by exposing sensors in fluid paths in the dialysis unit to temperatures or conductivities that are outside pre-determined permissible ranges of values, and confirming that the FPGA safety system enters a fail-safe state in response to the temperatures or conductivities outside the predetermined permissible ranges of values, wherein the computer processing unit resets the FPGA after verifying that the safety system is operating properly by writing to one or more registers in the FPGA within a pre-determined interval of time.

6. The dialysis unit of claim 5, wherein the automatic computer processing unit is configured to perform said verification before a patient is connected to the dialysis unit, and wherein the automatic computer processing unit is configured to set a status indicating that the patient is connected to the dialysis unit while performing the step of exposing sensors in fluid paths in the dialysis unit to temperatures or conductivities that are outside pre-determined permissible ranges of values.

7. The dialysis unit of claim 5, wherein the automatic computer processing unit is configured to command the pumping of dialysate heated to a temperature of about 42 degrees Celsius while performing the step of exposing sensors in fluid paths in the dialysis unit to temperatures or conductivities that are outside pre-determined permissible ranges of values.