Monitoring compliance using venous refill detection

• US 10,314,531 B2
• Filed: 03/08/2017
• Issued: 06/11/2019
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Kpr U.S., LLC (Cardinal Health, Inc.)
• Original Assignee: Kpr U.S., LLC (Cardinal Health, Inc.)
• Inventors: Watson, Kristin L., Vess, Mark A.
• Primary Examiner(s): Towa, Rene T
• Application Number:
  US15/452,971
• Publication Number:
  US 20170196502A1
• Time in Patent Office: 825 Days
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/6802 Sensor mounted on worn items
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61H 2201/0184 by raising an alarm
• CPC Class Codes: A61H 2201/164 Feet or leg, e.g. pedal
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5069 Angle sensors
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2205/10 Leg
• CPC Class Codes: A61H 2209/00 Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
• CPC Class Codes: A61H 9/0078 with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

Monitoring patient compliance with a compression therapy regimen. Venous Refill Time (VRT) is monitored via a pressure sensor in a bladder of a compression system. A controller of the compression system correlates the monitored VRT to a predetermined threshold to determine whether the patient is using the compression system.

Claims

1. A control unit for monitoring patient compliance with a compression therapy regimen delivered to a body part by inflatable bladders of a compression garment in fluid communication with the control unit, the control unit comprising:

at least one pressure sensor for detecting pressure in at least one of the inflatable bladders and generating signals corresponding to the measured pressure;

a pump for pressurizing fluid;

an outlet port in fluid communication with the pump, said outlet port being configured to connect fluid tubing thereto for selectively delivering pressurized fluid to at least one of the inflatable bladders;

a memory for storing data;

one or more processors receiving and responsive to the signals generated by the at least one pressure sensor, the one or more processors being in communication with the memory; and

computer-executable instructions embodied on a computer readable storage medium, the computer-executable instructions including instructions for causing the one or more processors to;

determine a characteristic of blood flow in the body part as a function of the received signals; and

increment a patient compliance timer when the determined blood flow characteristic meets a predetermined standard.

2. The control unit as set forth in claim 1 wherein the instructions for causing the one or more processors to determine a characteristic of blood flow includes instructions to evaluate a pressure profile from the signals generated by the at least one pressure sensor.

3. The control unit as set forth in claim 2 wherein the instructions to evaluate a pressure profile comprise instructions to calculate vascular refill time.

4. The control unit as set forth in claim 3 wherein the instructions to increment a patient compliance timer comprise instructions to increment the patient compliance timer when vascular refill time exceeds a predetermined threshold.

5. The control unit as set forth in claim 1 wherein computer-executable instructions further comprise instructions to cause the one or more processors to activate the pump to pressurize at least one of the inflatable bladders to a first pressure and then to a second pressure less than the first pressure, wherein determining a characteristic of blood flow is a function of signals received from the at least one pressure sensor when the inflatable bladder is at the second pressure.

6. The control unit as set forth in claim 5 wherein the instructions to activate the pump include instructions to depressurize the at least one inflatable bladder from the first pressure to the second pressure.

7. A method of monitoring patient compliance with a compression therapy regimen, said method comprising:

receiving signals from a pressure sensor coupled to a compression garment, wherein the garment is sized and shaped to be wrapped around substantially a limb of a wearer and comprises one or more selectively inflatable bladders for applying compression to the limb upon inflation, the received signals indicating a pressure in the one or more selectively inflatable bladders, the signals being indicative of a characteristic of blood flow in the limb when the compression garment is wrapped substantially around the limb of the wearer;

determining the blood flow characteristic as a function of the received signals;

comparing the blood flow characteristic to a predetermined standard of blood flow characteristics; and

correlating the blood flow characteristic to patient compliance as a function of said comparing.

8. The method as set forth in claim 7 wherein determining a characteristic of blood flow comprises creating a pressure profile from the signals generated by the pressure sensor.

9. The method as set forth in claim 8 wherein correlating the blood flow characteristic to patient compliance comprises comparing the pressure profile to an expected pressure profile.

10. The method as set forth in claim 9 wherein correlating the blood flow characteristic to patient compliance comprises calculating vascular refill time.

11. The method as set forth in claim 10 further comprising incrementing a patient compliance timer when vascular refill time exceeds a predetermined threshold.

12. The method as set forth in claim 7 further comprising controlling pressure in at least one of the inflatable bladders to a first pressure and then to a second pressure less than the first pressure, wherein determining a characteristic of blood flow is a function of signals received from the pressure sensor when the inflatable bladder is at the second pressure.

13. The method as set forth in claim 12 wherein controlling pressure in at least one of the inflatable bladders includes depressurizing the at least one inflatable bladder from the first pressure to the second pressure.