Model-based infusion site monitor

• US 10,328,199 B2
• Filed: 12/05/2016
• Issued: 06/25/2019
• Est. Priority Date: 05/05/2009
• Status: Active Grant

• Current Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Original Assignee: Carefusion 303 Incorporated (Becton, Dickinson & Co)
• Inventors: Butterfield, Robert Dwaine, Stock, Brian, Strait, Melissa, Dudley, Harry, Rosenthal, Stephen
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US15/369,650
• Publication Number:
  US 20170080145A1
• Time in Patent Office: 932 Days
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• 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 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16836 by sensing tissue properties at the infusion site, e.g. for detecting infiltration detecting tissue temperature for diagnostic purposes A61M39/0247
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/16859 Evaluation of pressure response, e.g. to an applied pulse
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass
• 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

A medication delivery monitoring device is disclosed. The device includes a user interface configured to receive input information, and a sensor configured to measure a plurality of fluid state parameters of a fluid delivery channel through which the medication is delivered by a vascular access device (VAD) to an infusion site region of the patient. The device also includes a processor configured to determine a state of the infusion site region based on the plurality of measured fluid state parameters and the input information, and an output device configured to provide a communication regarding the state of the infusion site region. Methods and computer-readable mediums for monitoring medication delivery are also disclosed.

Claims

1. A device, comprising:

a vascular access device (VAD) configured to deliver a medication to an infusion site region of a patient;

a user interface configured to receive input information;

a sensor that measures a plurality of fluid state parameters of a fluid delivery channel through which the medication is delivered by the VAD to the infusion site region of a patient; and

a processor that (i) creates a model of a state of the infusion site region, comprising fluid state parameters of an interstitial tissue at the infusion site region, based on the fluid state parameters and the input information, wherein the model comprises a determination of a hydrostatic pressure component of a fluid flow and an osmotic gradient component of the fluid flow, the osmotic gradient component being indicative of a difference in a protein concentration across a membrane of the fluid delivery channel, and (ii) provides a communication to an output device if the fluid state parameters at the infusion site region are not within expected infusion site region parameters.

2. The device of claim 1, wherein the model of a state of the infusion site region comprises an uninfiltrated and infiltrated states.

3. The device of claim 1, wherein the input information comprises any of patient information, VAD information, and medication information.

4. The device of claim 1, wherein the input information comprises at least one of a chemical nature of the medication, a concentration of the medication, a rate of infusion of the medication, and a nature of at least one diluent or additive associated with the medication.

5. The device of claim 1, wherein the input information comprises at least one of a type of the VAD, a dimension of the VAD, and a location of the VAD.

6. The device of claim 1, wherein the fluid state parameters comprises any of pressure, resistance, capacitance, and impedance of the fluid delivery channel.

7. The device of claim 1, wherein a fluid state parameter comprises a resistance that is measured based on small scale modulations, introduced by the processor, in an average infusion rate of the medication.

8. The device of claim 1, wherein the processor introduces multiple small scale modulations in the fluid delivery channel, and wherein the small scale modulations are associated with resulting pressure variations in the fluid delivery channel to further measure capacitance and impedance at an input to the fluid delivery channel.

9. The device of claim 1, wherein the sensor is an outlet pressure sensor.

10. The device of claim 1, wherein the processor records any of instantaneous liquid state parameters, filtered fluid state parameters, and long term trends of fluid state parameters.

11. The device of claim 1, wherein the model is any of a discrete compartment model and a continuum model.

12. The device of claim 1, wherein the state of the infusion site region comprises any of an amount of fluid added to an interstitial space, an amount of protein transported, and expected pressure values.

13. The device of claim 1, wherein the state of the infusion site region comprises protein mass in the interstitial tissue at the infusion site region.

14. The device of claim 1, wherein the output device is a display configured to illustrate any of a measured and an expected fluid state parameters throughout a time the medication is infused into the patient.

15. The device of claim 1, comprising a memory configured to store a history of the fluid state parameters, wherein the model is further based on the history of the fluid state parameters.

16. A device, comprising:

a vascular access device (VAD) configured to deliver a medication to an infusion site region of a patient;

a user interface configured to receive input information, wherein the input information includes patient information;

a sensor that measures a plurality of fluid state parameters of a fluid delivery channel through which the medication is delivered by the VAD to the infusion site region of a patient, wherein the fluid state parameters comprise pressure and resistance;

an output device; and

a processor that (i) creates a model of a state of the infusion site region, comprising fluid state parameters of an interstitial tissue at the infusion site region, based on the fluid state parameters and the input information, wherein the model comprises a determination of a hydrostatic pressure component of a fluid flow and an osmotic gradient component of the fluid flow, the osmotic gradient component being indicative of a difference in a protein concentration across a membrane of the fluid delivery channel, and (ii) provides a communication to the output device if the fluid state parameters at the infusion site region are not within the model of a state of the infusion site region.

17. The device of claim 16, wherein the input information further comprises any of VAD information and medication information.

18. The device of claim 16, wherein the fluid state parameters further comprise any of capacitance and impedance of the fluid delivery channel.

19. The device of claim 16, wherein the sensor is a pressure sensor at an outlet of the fluid delivery channel.

20. The device of claim 16, wherein the state of the infusion site region comprises protein mass in the interstitial tissue at the infusion site region.

21. The device of claim 16, comprising a memory configured to store a history of the fluid state parameters, wherein the model is further based on the history of the fluid state parameters.