Model-based infusion site monitor

• US 9,514,279 B2
• Filed: 05/05/2010
• Issued: 12/06/2016
• 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 D., Stock, Brian, Strait, Melissa, Dudley, Harry, Rosenthal, Stephen
• Primary Examiner(s): Bouchelle, Laura
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US13/319,081
• Publication Number:
  US 20120123229A1
• Time in Patent Office: 2,407 Days
• Field of Search: 604 65- 67, 604/503, 604/508, 604/518, 604/890.1, 604/891.1
• US Class Current: 1/1
• 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 medication delivery monitoring device comprising:

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

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

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;

a processor that creates a model of a state of the infusion site region based on the plurality of measured fluid state parameters and the input information, wherein the state of the infusion site region comprises a fluid volume and protein mass for (i) plasma within a blood vessel at the infusion site region, (ii) tissue at the infusion site region, and (iii) tissue surrounding the infusion site region; and

an output device that provides a communication, based on the model, regarding the state of the infusion site region.

2. The device of claim 1, wherein the communication regarding the state of the infusion site region comprises an alert, alarm and/or graphical/numerical indication of the state when the model and the plurality of fluid state parameters of the fluid delivery channel to the infusion site region indicate an infiltration.

3. The device of claim 1, wherein the plurality of fluid state parameters comprises a pressure and a resistance of the fluid delivery channel.

4. The device of claim 1, wherein the plurality of fluid state parameters comprises a capacitance and impedance of the fluid delivery channel.

5. The device of claim 1, wherein the processor generates a model of a state of an infusion site region based on a pressure of the fluid delivery channel, a resistance of the fluid delivery channel, and at least one of medication information and VAD information.

6. The device of claim 5, wherein the model is further based on a capacitance and impedance of the fluid delivery channel.

7. The device of claim 5, further comprising a memory configured to store a history of the measured plurality of fluid state parameters, wherein the model is further based on the history of the measured fluid state parameters.

8. The device of claim 1, wherein the input information further comprises at least one of medication information and VAD information.

9. The device of claim 8, wherein the medication 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.

10. The device of claim 8, wherein the VAD information comprises at least one of a type of the VAD, a dimension of the VAD, and a location of the VAD.

11. The device of claim 1, wherein the processor further records a least one of instantaneous liquid state parameters, filtered fluid state parameters, and long term trends of fluid state parameters.

12. The device of claim 3, wherein the pressure is measured at an outlet of the fluid delivery channel.

13. The device of claim 3, wherein the resistance is measured based on small scale modulations, introduced by the processor, in an average infusion rate of the medication.

14. The device of claim 13, 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.

15. The device of claim 1, wherein the output device comprises a display configured to display the communication.

16. The device of claim 1, wherein the state of the infusion site region comprises a plurality of expected fluid state parameters, and wherein the communication comprises an alert if the plurality of measured fluid state parameters are not within a pre-determined range of the plurality of expected fluid state parameters.

17. A method for monitoring medication delivery comprising:

receiving input information, wherein the input information includes patient information;

infusing, using a vascular access device (VAD), a medication to an infusion site region of a patient;

measuring a plurality of fluid state parameters of a fluid delivery channel through which the medication is delivered by the VAD to an infusion site region of a patient;

modeling, with a processor, a state of the infusion site region based on the plurality of measured fluid state parameters and the input information, wherein the state of the infusion site region comprises a fluid volume and protein mass for (i) plasma within a blood vessel at the infusion site region, (ii) tissue at the infusion site region, and (iii) tissue surrounding the infusion site region; and

providing a communication, based on the model, regarding the state of the infusion site region.

18. The method of claim 17, wherein the communication regarding the state of the infusion site region comprises an alert, alarm and/or graphical/numerical indication of the state when the model and the plurality of fluid state parameters of the fluid delivery channel to the infusion site region indicate an infiltration.

19. The method of claim 17, wherein the plurality of fluid state parameters comprises a pressure and a resistance of the fluid delivery channel.

20. The method of claim 17, wherein the plurality of fluid state parameters comprises a capacitance and impedance of the fluid delivery channel.

21. The method of claim 17, wherein the processor models a state of an infusion site region based on a pressure of the fluid delivery channel, resistance of the fluid delivery channel, and at least one of patient information, medication information, and VAD information.

22. The method of claim 21, wherein the model is further based on a capacitance and impedance of the fluid delivery channel.

23. The method of claim 21, further comprising a memory configured to store a history of the measured plurality of fluid state parameters, wherein the model is further based on the history of the measured fluid state parameters.

24. The method of claim 17, wherein the input information further comprises at least one of medication information and VAD information, wherein the patient information comprises at least one of a weight of the patient, a height of the patient, a body surface area of the patient, an age of the patient, and a gender of the patient, wherein the medication 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, and wherein the VAD information comprises at least one of a type of the VAD, a dimension of the VAD and a location of the VAD.

25. The method of claim 19, wherein the resistance is measured based on small scale modulations, introduced by the processor, in an average infusion rate of the medication.

26. The method of claim 17, wherein the state of the infusion site region comprises a plurality of expected fluid state parameters, and wherein the communication comprises an alert if the plurality of measured fluid state parameters are not within a pre-determined range of the plurality of expected fluid state parameters.

27. A computer-readable medium comprising computer-readable instructions for causing a processor to execute a method as recited in any of claims 17-26.

28. A medication delivery monitoring device comprising:

a user interface configured to receive input information;

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

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;

a processor that creates a model of a state of the infusion site region based on the plurality of measured fluid state parameters and one or more of a weight of the patient, a height of the patient, a body surface area of the patient, an age of the patient, and a gender of the patient, wherein the state of the infusion site region comprises a fluid volume and protein mass for (i) plasma within a blood vessel at the infusion site region, (ii) tissue at the infusion site region, and (iii) tissue surrounding the infusion site region; and

an output device that provides a communication, based on the model, regarding the state of the infusion site region.