Control systems and methods for blood or fluid handling medical devices

• US 10,463,774 B2
• Filed: 05/27/2015
• Issued: 11/05/2019
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Ballantyne, Todd A., Cook, Jon H., Colburn, Benjamin E., Harner, Andrew E., Christous, Corey, Whalen, Shane
• Primary Examiner(s): Kim, John
• Application Number:
  US14/723,237
• Publication Number:
  US 20160058933A1
• Time in Patent Office: 1,623 Days
• CPC Class Codes: A61M 1/154 with sensing 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 1/16 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 1/1692 Detection of blood traces in dialysate
• 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 1/3413 Diafiltration
• 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 1/36225 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 1/362265 : Details of valves
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 2202/0498 : Urea
• 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 2205/3313 : 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 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• 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 60/515 : Regulation using real-time patient data
• CPC Class Codes: A61M 60/538 : Regulation using real-time blood pump operational parameter data, e.g. motor current
• 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: G05B 15/02 : electric
• CPC Class Codes: G06F 21/00 : Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
• CPC Class Codes: G06F 21/50 : Monitoring users, programs or devices to maintain the integrity of platforms, e.g. of processors, firmware or operating systems
• CPC Class Codes: G06F 21/51 : at application loading time, e.g. accepting, rejecting, starting or inhibiting executable software based on integrity or source reliability
• CPC Class Codes: G06F 21/55 : Detecting local intrusion or implementing counter-measures
• CPC Class Codes: G06F 21/56 : Computer malware detection or handling, e.g. anti-virus arrangements
• CPC Class Codes: G06F 21/565 : by checking file integrity
• CPC Class Codes: G06F 21/568 : eliminating virus, restoring damaged files
• CPC Class Codes: G06F 21/57 : Certifying or maintaining trusted computer platforms, e.g. secure boots or power-downs, version controls, system software checks, secure updates or assessing vulnerabilities
• CPC Class Codes: G06F 21/575 : Secure boot
• CPC Class Codes: G06F 21/62 : Protecting access to data via a platform, e.g. using keys or access control rules
• CPC Class Codes: G06F 21/6218 : to a system of files or objects, e.g. local or distributed file system or database
• CPC Class Codes: G06F 21/6227 : where protection concerns the structure of data, e.g. records, types, queries
• CPC Class Codes: G06F 21/6245 : Protecting personal data, e.g. for financial or medical purposes
• CPC Class Codes: G06F 2206/1008 : Graphical user interface [GUI]
• CPC Class Codes: G06F 2221/2143 : Clearing memory, e.g. to prevent the data from being stolen
• 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 40/40 : for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• 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: G16H 40/67 : for remote operation

Abstract

A processor of a medical device configured to communicate with a remote server can be programmed to protect the medical device from exposure to unauthorized or malicious software. A system or method to implement this form of protection can include, for example, at least one processor on the medical device, a control software module that controls the operation of the medical device and is executable on the processor, a data management module that manages data flow to and from the control software module from sources external to the medical device, and an agent module that has access to a limited number of designated memory locations in the medical device. In addition, a hemodialysis apparatus can be configured to operate in conjunction with an apparatus for providing purified water from a source such as a municipal water supply or a well. A system for controlling delivery of purified water to the hemodialysis apparatus can comprise a therapy controller of the hemodialysis apparatus configured to communicate with a controller of a water purification device, and a user interface controller of the hemodialysis apparatus configured to communicate with the therapy controller, and to send data to and receive data from a user interface.

Claims

1. A system for controlling delivery of purified water to a hemodialysis apparatus comprising:

a therapy controller of the hemodialysis apparatus configured to communicate with a controller of a water purification device; and

a user interface controller of the hemodialysis apparatus configured to communicate with the therapy controller, and configured to send data to and receive data from a user interface;

the therapy controller configured to receive information of an error condition from the water purification device controller during a hemodialysis therapy, wherein the therapy controller is configured to suspend or terminate the hemodialysis therapy if the information of the error condition indicates that purified water production within pre-determined specifications is insufficient to support continuing the hemodialysis therapy, and to continue the hemodialysis therapy if the information of the error condition indicates that purified water production within the pre-determined specifications is sufficient to allow completion of the hemodialysis therapy;

wherein said information represents an error condition regarding;

an amount of purified water stored in the water purification device;

a temperature of stored purified water in the water purification device;

a conductivity or resistivity of purified water in the water purification device;

whether the water purification device is ready to provide purified water;

whether one or more components of the water purification device is due for service or replacement;

or

whether the water purification device has issued one or more error flags, and

wherein a major error flag issued by the water purification device causes the therapy controller to calculate whether a store of dialysate solution produced from purified water received from the water purification device is sufficient to allow the hemodialysis apparatus to rinse a blood tubing circuit of the hemodialysis apparatus with dialysate; and

the therapy controller commands a rinseback operation if the store of dialysate solution is sufficient, or the therapy controller commands a discontinuation of therapy if the store of dialysate solution is insufficient; and

the therapy controller commands the user interface controller to issue a notification to the user interface.

2. The system of claim 1, wherein a minor error flag issued by the water purification device causes the therapy controller to command the user interface controller to issue a notification to the user interface, and prevents the initiation of a future therapy until the minor error flag is reset or until a user input via the user interface confirms that a corrective action on the water purification device has occurred.

3. The system of claim 1, wherein information from the water purification device on whether it is ready to provide purified water comprises:

whether a water test is being performed by the water purification device, whether a test for contaminants in purified water meets pre-determined specifications, whether electrical conductivity of purified water meets pre-determined specifications, whether the water purification device is in an initial phase during which purified water is discarded, or whether a maintenance procedure must be performed before water purification can begin.

4. The system of claim 3, wherein the therapy controller is configured to command the user interface controller to issue a notification to the user interface, instructing a user to conduct a test of water generated by the water purification device, and wherein the therapy controller is configured to command the water purification device to produce purified water if the test meets a per-determined specification, or to produce purified water only after replacement of a filter of the water purification device.

5. The system of claim 1, wherein the therapy controller is configured to receive or calculate data on a remaining number of days or a remaining volume of water production before one or more filters in the water purification device is scheduled for replacement.

6. The system of claim 1, wherein the therapy controller is configured to receive or calculate data on a remaining number of hours before an ultraviolet lamp in the water purification device is scheduled for replacement.

7. The system of claim 1, wherein the therapy controller is configured to receive temperature information from the water purification device on the temperature of purified water produced by the water purification device, and to provide the temperature information to a control algorithm of a fluid heater of the hemodialysis apparatus.

8. The system of claim 1, wherein the therapy controller is configured to detect that the water purification device is fluidly connected to the hemodialysis apparatus.

9. A system for controlling delivery of purified water to a hemodialysis apparatus comprising:

a therapy controller of the hemodialysis apparatus configured to communicate with a controller of a water purification device;

a user interface controller of the hemodialysis apparatus configured to communicate with the therapy controller, and configured to send data to and receive data from a user interface;

the therapy controller configured to detect that the water purification device is fluidly connected to the hemodialysis apparatus, and to receive information of an error condition from the water purification device controller during a hemodialysis therapy, wherein the therapy controller is configured to suspend or terminate the hemodialysis therapy if the information of the error condition indicates that purified water production within pre-determined specifications is insufficient to support continuing the hemodialysis therapy, and to continue the hemodialysis therapy if the information of the error condition indicates that purified water production within the pre-determined specifications is sufficient to allow completion of the hemodialysis therapy

wherein said information represents an error condition regarding;

an amount of purified water stored in the water purification device;

a temperature of stored purified water in the water purification device;

a conductivity or resistivity of purified water in the water purification device;

whether the water purification device is ready to provide purified water;

whether one or more components of the water purification device is due for service or replacement;

or

whether the water purification device has issued one or more error flags, and

wherein a major error flag issued by the water purification device causes the therapy controller to calculate whether a store of dialysate solution produced from purified water received from the water purification device is sufficient to allow the hemodialysis apparatus to rinse a blood tubing circuit of the hemodialysis apparatus with dialysate; and

the therapy controller commands a rinseback operation if the store of dialysate solution is sufficient, or the therapy controller commands a discontinuation of therapy if the store of dialysate solution is insufficient; and

the therapy controller commands the user interface controller to issue a notification to the user interface.

10. The system of claim 9, wherein a minor error flag issued by the water purification device causes the therapy controller to command the user interface controller to issue a notification to the user interface, and prevents the initiation of a future therapy until the minor error flag is reset or until a user input via the user interface confirms that a corrective action on the water purification device has occurred.

11. The system of claim 9, wherein information from the water purification device on whether it is ready to provide purified water comprises:

whether a water test is being performed by the water purification device, whether a test for contaminants in purified water meets pre-determined specifications, whether electrical conductivity of purified water meets pre-determined specifications, whether the water purification device is in an initial phase during which purified water is discarded, or whether a maintenance procedure must be performed before water purification can begin.

12. The system of claim 11, wherein the therapy controller is configured to command the user interface controller to issue a notification to the user interface, instructing a user to conduct a test of water generated by the water purification device, and wherein the therapy controller is configured to command the water purification device to produce purified water if the test meets a per-determined specification, or to produce purified water only after replacement of a filter of the water purification device.

13. The system of claim 9, wherein the therapy controller is configured to receive or calculate data on a remaining number of days or a remaining volume of water production before one or more filters in the water purification device is scheduled for replacement.

14. The system of claim 9, wherein the therapy controller is configured to receive or calculate data on a remaining number of hours before an ultraviolet lamp in the water purification device is scheduled for replacement.

15. The system of claim 9, wherein the therapy controller is configured to receive temperature information from the water purification device on the temperature of purified water produced by the water purification device, and to provide the temperature information to a control algorithm of a fluid heater of the hemodialysis apparatus.