System for management and prevention of venous pooling

• US 10,470,667 B2
• Filed: 11/09/2012
• Issued: 11/12/2019
• Est. Priority Date: 11/11/2011
• Status: Active Grant

• Current Assignee: University Of Ireland, Galway, University of Limerick
• Original Assignee: University Of Ireland, Galway
• Inventors: Corley, Gavin, O'Laighin, Gearoid, Breen, Paul, Broderick, Barry, Grace, Pierce A., O'Keeffe, Derek
• Primary Examiner(s): Jenness, Nathan J
• Application Number:
  US14/357,181
• Publication Number:
  US 20140303460A1
• Time in Patent Office: 2,559 Days
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/1071 measuring angles, e.g. using goniometers A61B5/1123 takes precedence
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6828 Leg
• CPC Class Codes: A61B 5/6829 Foot or ankle
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36135 using physiological parameters

Abstract

A monitoring system comprises sensors adapted to be worn by a user, and, a processor linked with the sensor. The processor receives sensor data and processes this data to determine user posture data including data indicative of vertical distance between level of the user'"'"'s heart and ankle. Based on the posture data together with a value for degree of user chronic venous insufficiency and/or blood density, generate an estimate of user static venous pressure while the user is static, without calf muscle pump activity. The processor also processes the sensor data to determine if there is calf muscle pump activity, and generates an estimate of user active venous pressure according to the static venous pressure estimate, rate of calf muscle activity, and a value for degree of user chronic venous insufficiency. The processor may generate the venous pressure estimate in real time, and may control an NMES device accordingly.

Claims

1. A monitoring system comprising:

a plurality of sensors adapted to be worn by a user and to provide sensor data;

the plurality of sensors selected from accelerometers measuring limb segment tilt and rapid changes to acceleration caused by impact forces during impact of user'"'"'s heel during stepping and walking, ultrasound range detectors measuring knee angle and time rate of change of knee angle, piezoelectric sensors measuring change in height and time rate of change of the change in height, gyroscopes measuring limb angular velocity and time rate of change of the limb angular velocity, magnetometers measuring body segment tilt and time rate of change of the body segment tilt, foot switches measuring heel input events during stepping and walking and time rate of change of the heel input events, or smart textiles incorporating electrical sensing elements detecting step counts, postural transitions, walking, lying, sitting, or standing up and/or measuring step counts;

an output device; and

a processor linked with the plurality of sensors to receive and process sensor data, and said processor is configured to;

estimate user step rate in real-time as being indicative of rate of calf muscle activity in real-time;

use said step rate to determine if the person is static, or active, or in a transition between static and active;

operate as a finite state machine to define states including;

a user static state, representing time spent in a fixed posture in which sensed user vertical height as measured by the plurality of sensors does not change, said fixed postures including lying, sitting and standing postures as measured by the plurality of sensors,

a user activity state as measured by the plurality of sensors, representing time spent taking steps, a refill state for a transition phase of pressure increasing due to increase in user height or cessation of activity as measured by the plurality of sensors, during which a user'"'"'s veins fill,

a transition down state for venous pressure decreasing due to drop in vertical height arising from a posture change or start of user motive activity as measured by the plurality of sensors, during which the start of pumping action of the calf muscle begins lowering venous pressure to a depressed value during a plateau phase, and

a user motive activity check state as measured by the plurality of sensors for checking for user activity;

generate an inactivity interrupt to trigger exit from the activity state;

generate an activity interrupt to trigger transition to the activity check state;

store a refill time for a patient by either (a) receiving said refill time as an input setting, or (b) selecting said refill time from pre-set values for degree of chronic venous insufficiency CVI, or (c) determining said refill time using indirect measurement of venous haemodynamics using air-plethysmography, and to use said stored refill time in the finite state machine to estimate a transition time of the venous pressure increasing due to an increase in user height or a cessation of user motive activity as measured by the plurality of sensors, during which a user'"'"'s veins fill;

identify lower leg activity primary phases as measured by the plurality of sensors including an emptying phase, and a plateau phase in which the veins do not empty any further and active venous pressure is maintained at a depressed level, and to determine a value for mean slope of active venous pressure change in the emptying phase by a rate of muscle activation and ankle range of motion as measured by the plurality of sensors, and to determine minimal pressure in the plateau phase by said degree of chronic venous insufficiency, a value for user calf circumference, and values for user ankle range of motion and head change as measured by the plurality of sensors;

generate in real time an estimate of static venous pressure of a user while the user is static, without calf muscle pump activity as measured by the plurality of sensors, by calculating a vertical distance Δ

h between a level of the user'"'"'s heart and ankle, by;

determining a first joint angle made by a thigh of the user with a first reference axis as measured by the plurality of sensors, determining a second joint angle made by of a lower leg of the user with a second reference axis, calculating Δ

h using a value for length of the thigh, a value for length of the shank of the leg, a value for distance from the hip to the level of the heart, and the first joint angle and the second joint angle using determined postural data, and completing said estimation of static venous pressure by an equation in which static pressure=ρ

gΔ

h, in which ρ

is blood density, g is acceleration due to gravity, and Δ

h is said vertical distance between the user'"'"'s heart and ankle; and

generate an estimate of user active venous pressure according to said static venous pressure estimate, and a reduction in venous pressure from said static venous pressure estimate, said reduction being determined by a rate of calf muscle activity, and a value for degree of user chronic venous insufficiency;

actuate said output device to provide real time user feedback including at least one of auditory, visual or tactile alerts, said feedback including one or more of;

an alert if a pre-determined postural or activity threshold has been exceeded,

an alert if a venous pressure level is exceeded,

an alert according to estimated venous pressure arising from posture status such as prolonged periods of inactivity,

feedback to assist with alleviating venous pooling or elevation of venous pressure for prevention and treatment of CVI, including promotion of activities including exercises which activate the lower leg muscles and hence reduce venous pressure, and limiting of postures which predispose a user to sustained elevated venous pressure,

real time feedback of average venous pressure levels over time intervals, and to

indicate an assessment of user adherence to prescribed activities including lower leg elevation and to goals for reduction of average venous pressure; and

communicate the venous pressure estimates and user feedback to one or more devices; and

a neuromuscular electrical stimulation device, said processor being configured to activate said neuromuscular electrical stimulation device according to said user feedback.

2. The monitoring system as claimed in claim 1, wherein the plurality of sensors are adapted to measure the acceleration and/or tilt of a limb segment in one or more axes.

3. The monitoring system as claimed in claim 1, wherein the system includes a pressure transducer adapted to detect status of a dressing, and wherein the processor is adapted to use an input from said pressure transducer as a conditional input for said estimation of venous pressure.

4. The monitoring system as claimed in claim 1, wherein the processor is configured to determine or select neuromuscular electrical stimulation device parameters according to at least one of:

a venous pressure estimate, average venous pressure over time intervals, a venous pressure-time integral, physical activity levels, leg elevation levels, and neuromuscular electrical stimulation device usage statistics.

5. The monitoring system as claimed in claim 1, wherein the processor is configured to generate or select neuromuscular electrical stimulation device stimulation parameters including at least one of:

stimulation amplitude;

pulse width, pulse frequency;

stimulation envelope ramp-up, ramp-down, on and off times;

number of channels and stimulation schedule.

6. The monitoring system as claimed in claim 1, wherein the processor is configured to execute a state machine algorithm in which:

if in the static state and an activity interrupt indicating a stepping motion is detected the processor logs a venous pressure profile for the static state and moves from the static state to the activity check state,

if in the static state and no activity interrupt or no change in vertical height is detected as measured by the plurality of sensors, the processor remains in the static state and the processor updates a time associated with the current posture,

if in the static state and there is no activity interrupt but a decrease in vertical height is detected as measured by the plurality of sensors, the processor logs a venous pressure profile for the static state and moves from the static state to the transition down state, and

if in the static state and there is no activity interrupt but an increase in vertical height is detected as measured by the plurality of sensors, the processor logs a pressure profile for the static state and moves to the refill state.

7. The monitoring system as claimed in claim 1, wherein the processor is configured to execute a state machine algorithm in which:

if in the activity state and the number of steps detected in the activity state is less than a predetermined number of steps, and the vertical height Hv has not changed from the previous state then the processor logs a venous pressure profile for the activity state and moves to the static state,

if in the activity check state and the number of steps detected in the activity check state is less than a predetermined number of steps, and the vertical height Hv is less than the vertical height from the previous state then the processor logs a pressure profile for the activity check state and moves to the transition down state,

if in the activity check state and the number of steps detected in the activity check state is less than a predetermined number of steps, and the vertical height Hv is greater than the vertical height from the previous state, then the processor logs the pressure profile for the activity check state and moves to the refill state,

if in the activity check state and the number of steps detected in the activity check state is greater than a predetermined number of steps, then the processor logs the pressure profile for the activity check state and moves to the activity state,

if no inactivity interrupt is detected, the processor stays in the activity state,

if in the activity state and an inactivity interrupt is detected and the vertical height Hv is decreasing the processor logs the pressure profile for the activity state and moves to the transition down state,

if in the activity state and an inactivity interrupt is detected and a calculated venous pressure Pr at the end of the activity state is less than an estimated venous pressure corresponding to the current vertical height under static conditions then the processor logs the pressure profile for the activity state and moves to the refill state, and

if no activity interrupt is detected, and the vertical height Hv continues to decrease the processor stays in the transition down state.

8. The monitoring system as claimed in claim 1, wherein the processor is configured to execute a state machine algorithm in which:

if in the transition down state and no activity interrupt is detected and the vertical height Hv is increasing, the processor logs a pressure profile for the transition down state and moves to the refill state,

if in the transition down state and no activity interrupt is detected and the vertical height Hv is not changing, log a pressure profile for the transition down state and move to the static state,

if in the transition down state and an activity interrupt is detected the processor logs the pressure profile for the transition down state and moves to the activity check state,

if in the refill state and no activity interrupt is detected, and the vertical height Hv is decreasing the processor logs a pressure profile for the refill state and moves to the transition down state,

if in the refill state and no activity interrupt is detected and the vertical height Hv is increasing or current estimated venous pressure Pr is not equal to an estimated stable venous pressure EPr for the current vertical height Hv, the processor stays in the refill state,

if in the refill state and no activity interrupt is detected and the vertical height Hv is not changing, the processor logs the pressure profile for the refill state and moves to the static state, and

if in the refill state and an activity interrupt is detected the processor logs the pressure profile for the refill state and moves to the activity check state.

9. The monitoring system as claimed in claim 1, wherein the processor is configured to process interval time data to determine if a postural change occurred during an interval, and to estimate an average pressure during said interval using estimates of static venous pressures, the duration of the interval, and the venous refill rate, and in which the processor is configured to identify lower leg activity primary phases including an emptying phase, and a plateau phase in which the veins do not empty any further and active venous pressure is maintained at a depressed level, and the processor is configured to determine a value for mean slope of the active venous pressure change in the emptying phase by the rate of muscle activation and ankle range of motion, and to determine minimal pressure in the plateau phase by the degree of chronic venous insufficiency, calf circumference, ankle range of motion and head height change.

10. The monitoring system as claimed in claim 1, wherein the processor determines the reduction in venous pressure due to walking based on the degree of user chronic venous insufficiency, number of steps taken and the estimated walking speed of the individual as measured by the at least one sensor and normative values.