USING PHYSIOLOGICAL DATA IN A MEDICAL DEVICE

• US 20130190674A1
• Filed: 01/17/2013
• Published: 07/25/2013
• 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
• Granted Patent: US 10,286,148 B2
• Time in Patent Office: Days
• US Class Current: 604/6.01
• 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 in a medical device comprising:

generating, by a processing circuit, a start procedure command configured to cause the medical device to begin a medical procedure on a subject;

receiving, at the processing circuit, physiological data from a measurement device, the physiological data being indicative of a physiological condition of the subject during the medical procedure;

analyzing, by the processing circuit, the physiological data; and

generating, by the processing circuit, a control command for the medical device based in part on the analyzed physiological data.

2. The method of claim 1, wherein the physiological data comprises at least one of a measured blood pressure, body temperature, respiratory rate, or pulse rate of the subject.

3. The method of claim 1, wherein the medical procedure comprises administering a medicament to the subject, pausing the medical procedure, or aborting the medical procedure.

4. The method of claim 3, wherein the control command is configured to cause the medical device to adjust an infusion rate of the medicament to the subject.

5. The method of claim 4, 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.

6. The method of claim 2, wherein the medical device comprises an apheresis machine, the medical procedure comprises an apheresis procedure, and the control command is configured to cause the apheresis machine to adjust a flow rate of blood through the apheresis machine.

7. The method of claim 1, further comprising:

storing, in a first memory partition, a control module configured to generate the control commands;

storing, in a second memory partition, operational data generated during the medical procedure; and

preventing, by the processing circuit, access to the first memory partition during the medical procedure.

8. The method of claim 7, further comprising:

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

preventing the installation data from accessing the first memory partition during the medical procedure; and

allowing the installation data to alter the control module when the medical device is in a service mode.

9. The method of claim 8, 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.

10. The method of claim 9, 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. A system for using physiological data in a medical device comprising a processing circuit operable to:

generate a start procedure command configured to cause the medical device to begin a medical procedure on a subject;

receive physiological data from a measurement device, the physiological data being indicative of a physiological condition of the subject during the medical procedure;

analyze the physiological data; and

generate a control command for the medical device based in part on the analyzed physiological data.

12. The system of claim 11, wherein the physiological data comprises at least one of a measured blood pressure, body temperature, respiratory rate, or pulse rate of the subject.

13. The system of claim 12, wherein the control command is configured to cause the medical device to administer a medicament comprising at least one of a bolus of saline, an anticoagulant, or a blood replacement fluid.

14. The system of claim 12, wherein the medical device comprises an apheresis machine, the medical procedure comprises an apheresis procedure, and the control command is configured to cause the apheresis machine to adjust a flow rate of blood through the apheresis machine.

15. The system of claim 11, wherein the processing circuit is further operable to:

store, in a first memory partition, a control module configured to generate the control commands;

store, in a second memory partition, operational data generated during the medical procedure; and

prevent access to the first memory partition during the medical procedure.

16. The system of claim 15, wherein the processing circuit is further operable to:

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

prevent the installation data from accessing the first memory partition during the medical procedure; and

allow the installation data to alter the control module when the medical device is in a service mode.

17. The system of claim 16, wherein the processing circuit is further operable 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.

18. The system of claim 11, wherein the medical device comprises at least one of:

a dialysis machine, an infusion pump, or a drug delivery machine.

19. An apheresis machine comprising:

a separation component configured to separate blood into blood components; and

a processing circuit configured to control the separation component, wherein the processing circuit is further configured to;

generate a start procedure command configured to cause the separation component to begin separating blood from a subject into blood components;

receive physiological data from a measurement device, the physiological data being indicative of a physiological condition of the subject during the apheresis procedure;

analyze the physiological data; and

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

20. The apheresis machine of claim 19, wherein the processing circuit is further configured to:

store, in a first memory partition, a control module configured to generate the control commands;

store, in a second memory partition, operational data generated during the apheresis procedure; and

prevent access to the first memory partition during the apheresis procedure.