Using physiological data in a medical device

• US 10,286,148 B2
• Filed: 01/17/2013
• Issued: 05/14/2019
• Est. Priority Date: 01/23/2012
• Status: Active Grant

• Current Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fenwal Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Case, Brian C., Prendergast, Jonathan, Foster, Joseph M., Moskal, Witold
• Primary Examiner(s): Nguyen, Tran N
• Application Number:
  US13/743,922
• Publication Number:
  US 20130190674A1
• Time in Patent Office: 2,308 Days
• CPC Class Codes: A61M 1/30 Single needle dialysis ; Reciprocating systems, alternately withdrawing blood from and returning it to the patient, e.g. single-lumen-needle dialysis or single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• 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 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Systems and methods for using physiological data in a medical device are disclosed. The physiological data may be measured by a vital sign reader and received by a processing circuit associated with the medical device. The processing circuit may automatically adjust the operation of the medical device during a medical procedure based on the physiological data. In some implementations, the processing circuit may mirror a memory partition to a redundant storage device, allowing for uninterrupted execution of the medical procedure in the event of a memory failure condition.

Claims

1. A method for using physiological data to control an apheresis machine, the apheresis machine comprising a processing circuit including a processor and a memory, the processor configured to execute instructions stored in the memory, the memory including a first memory partition including a control module for generating commands for controlling the apheresis machine and a first procedure data module storing a medical procedure routine, and a second memory partition including a second procedure data module, the method comprising:

generating a start procedure command at the control module based on the medical procedure routine;

causing the apheresis machine to begin a medical procedure on a subject based on the start procedure command generated at the control module, wherein the medical procedure is an apheresis procedure;

in response to causing the medical device to begin the medical procedure and receiving a data change request, determining whether the medical procedure routine is executing and whether the data change request is received from the medical procedure routine;

in response to determining that the medical procedure routine is executing and the data change request is received from the medical procedure routine, changing data stored in the first memory partition while the medical procedure routine is executing;

storing, in the second procedure data module, physiological data received from a measurement device, the physiological data being indicative of a physiological condition of the subject during the medical procedure, the physiological data including at least one of a measured blood pressure, body temperature, respiratory rate, or pulse rate of the subject;

analyzing, by the control module, the physiological data;

generating, by the control module, a control command for the apheresis machine based in part on the analyzed physiological data, wherein the control command causes the apheresis machine to adjust a flow rate of blood through the apheresis machine;

modifying operation of the medical procedure by the apheresis machine based on the control command by adjusting the flow rate of blood through the apheresis machine.

3. The method of claim 1, further comprising:

storing, in an installation data module of the second memory partition, installation data configured to alter the control module;

in response to causing the medical device to begin the medical procedure, preventing the installation data from accessing the first memory partition during the medical procedure; and

in response to causing the medical device to end the medical procedure and causing the medical device to enter a service mode, allowing the installation data to alter the control module.

4. The method of claim 3, further comprising:

mirroring the first memory partition to a redundant memory by storing a copy of the control module in the redundant memory, wherein the first memory partition is stored on a first data storage device and the redundant memory comprises a second data storage device; and

mirroring the second memory partition to the redundant memory, wherein the second memory partition is stored on the first data storage device.

5. The method of claim 4, further comprising:

using the installation data to alter the control module and the mirrored control module;

designating the mirrored first memory partition as a primary partition; and

using the mirrored control module in the primary partition to perform a second medical procedure.

11. The method of claim 1, wherein:

the physiological data includes at least two data measurements indicative of the physiological condition of the subject;

analyzing the physiological data further includes parsing the physiological data to select only one data measurement; and

the control command is configured to reduce a difference between a subsequent data measurement and the setpoint.

2. A system for using physiological data comprising:

an apheresis machine configured to perform a medical procedure on a subject, wherein the medical procedure comprises administering a medicament to the subject at an infusion rate, pausing the medical procedure, or aborting the medical procedure; and

a medical device controller including;

a processor and a memory, the processor configured to execute instructions stored in the memory, the memory including a first memory partition and a second memory partition;

the first memory partition including a control module configured to generate a start procedure command configured to cause the apheresis machine to begin the medical procedure on a subject, and a first procedure data module; and

the second memory partition including a second procedure data module configured to receive physiological data from a measurement device, the physiological data being indicative of a physiological condition of the subject during the medical procedure, and store the physiological data in the second procedure data module;

wherein the control module is further configured to;

analyze the physiological data stored in the second procedure data module;

generate a control command for the apheresis machine based in part on the analyzed physiological data, wherein the control command causes the apheresis machine to adjust the infusion rate of the medicament to the subject in response to receiving the control command;

cause the apheresis machine to modify operation of the medical procedure based on the control command; and

determine whether the apheresis machine is performing the medical procedure, in response to determining that the medical device is performing the medical procedure, apply a first read/write permission to prevent data from being written to the first memory partition, and in response to determining that the medical device is not performing the medical procedure, apply a second read/write permission to allow data to be written to the first memory partition.

6. The system of claim 2, wherein the medical procedure comprises an apheresis procedure and the medicament comprises at least one of:

an anticoagulant, blood replacement fluid, or bolus of saline.

7. The system of claim 2, wherein the physiological data comprises at least one of a measured blood pressure, body temperature, respiratory rate, or pulse rate of the subject.

8. The system of claim 7, wherein the control command causes the an apheresis machine to administer a medicament comprising at least one of a bolus of saline, an anticoagulant, or a blood replacement fluid.

9. The system of claim 2, wherein the control module is further configured to:

store, in an installation data module of the second memory partition, installation data configured to alter the control module;

in response to causing the apheresis machine to begin the medical procedure, prevent the installation data from accessing the first memory partition during the medical procedure; and

in response to causing the apheresis machine to end the medical procedure and causing the apheresis machine to enter a service mode, allow the installation data to alter the control module when the apheresis machine is in the service mode.

10. The system of claim 9, wherein the control module is further configured to:

mirror the first memory partition to a redundant memory by storing a copy of the control module in the redundant memory, wherein the first memory partition is stored on a first data storage device and the redundant memory comprises a second data storage device; and

mirror the second memory partition to the redundant memory, wherein the second memory partition is stored on the first data storage device.

12. The system of claim 2, wherein:

the physiological data includes at least two data measurements indicative of the physiological condition of the subject;

the control module is further configured to parse the physiological data to select only one data measurement; and

the control command is configured to reduce a difference between a subsequent data measurement and the setpoint.

13. A system for using physiological data comprising:

an apheresis machine configured to perform an apheresis procedure on a subject; and

a medical device controller including;

a processor and a memory, the processor configured to execute instructions stored in the memory, the memory including a first memory partition and a second memory partition;

the first memory partition including a control module configured to generate a start procedure command configured to cause the apheresis machine to begin the apheresis procedure on the subject, and a first procedure data module storing a medical procedure routine; and

the second memory partition including a second procedure data module configured to receive physiological data from a measurement device, the physiological data being indicative of a physiological condition of the subject during the apheresis procedure, and store the physiological data in the second procedure data module;

wherein the control module is further configured to;

analyze the physiological data stored in the second procedure data module;

generate a control command for the apheresis machine based in part on the analyzed physiological data;

cause the apheresis machine to modify operation of the apheresis procedure based on the control command; and

require a security credential to access the first memory partition during execution of the medical procedure routine.