Digital electronic fetal heart rate and uterine contraction monitoring system

• US 9,693,690 B2
• Filed: 03/16/2016
• Issued: 07/04/2017
• Est. Priority Date: 03/19/2015
• Status: Active Grant

• Current Assignee: Stewart Bruce Ater
• Original Assignee: Stewart Bruce Ater
• Inventors: Ater, Stewart Bruce
• Primary Examiner(s): Fernandez, Katherine
• Assistant Examiner(s): Sakamoto, Colin T
• Application Number:
  US15/071,979
• Publication Number:
  US 20160270658A1
• Time in Patent Office: 475 Days
• CPC Class Codes: A61B 5/0011 Foetal or obstetric data
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/033 Uterine pressure
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• 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: A61B 8/02 Measuring pulse or heart rate
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A digital electronic fetal heart rate and uterine contraction monitoring system with an electronic fetal monitor, a contraction monitoring sensor and a fetal heart rate sensor. A controller configured to receive fetal heart rate data and uterine contraction pressure, identify a contraction start time and end time, and calculate each rest interval in seconds between contractions. The system compares rest intervals to a safe preset limit for rest intervals, calculates a median rest interval and an average rest interval for each fifteen-minute period of labor, and presents a contraction and rest interval graph to a display. The system can activate an alarm on an electronic fetal monitor display or a third party display and can pause a pump that is delivering a drug to increase uterine contractions when a significant criteria of excessive uterine activity is detected outside preset limits to assure adequate blood flow to the fetal brain.

Claims

1. A digital electronic fetal heart rate and uterine contraction monitoring system comprising:

a an electronic fetal monitor with an electronic fetal monitor processor, an electronic fetal monitor data storage, and an electronic fetal monitor display connected to the electronic fetal monitor processor, wherein the electronic fetal monitor processor is in further communication with a network;

b a contraction monitoring sensor for sensing uterine contraction pressure over time from a mother, wherein the contraction monitoring sensor is adapted to be secured to the mother and in communication with the electronic fetal monitor;

c a fetal heart rate sensor for sensing fetal heart rate over time from a fetus, wherein the fetal heart rate sensor is in communication with the electronic fetal monitor;

d a maternal heart rate sensor for sensing maternal heart rate over time from the mother, wherein the maternal heart rate sensor is in communication with the electronic fetal monitor; and

e a controller comprising a controller processor and a controller data storage in communication with the electronic fetal monitor, the controller data storage having stored therein computer instructions that, when executed by the controller processor, causes the controller processor to;

i receive the sensed fetal heart rate from the fetal heart rate sensor, record and store the sensed fetal heart rate as fetal heart rate versus time data at a user selected sampling rate, and display the fetal heart rate versus time data as a fetal heart rate tracing;

ii receive the sensed maternal heart rate from the maternal heart rate sensor, record and store the sensed maternal heart rate as maternal heart rate versus time data at a user selected sampling rate, and display the maternal heart rate versus time data as a maternal heart rate tracing;

iii receive the sensed uterine contraction pressure from the contraction monitoring sensor, and record and store the sensed uterine contraction pressure as contraction pressure versus time data at a user selected sampling rate;

iv utilize the contraction pressure versus time data to detect, calculate and store a contraction onset time for each contraction, a contraction offset time for each contraction, an average contraction onset pressure, and an average contraction offset pressure utilizing at least one of;

a neural network model for contraction onset and contraction offset, a duration percentage max model for contraction onset and contraction offset, a contraction slope model for contraction onset and contraction offset, and a user adjustable minimum pressure model that evaluates only a portion of each contraction above a user adjustable minimum pressure for each contraction;

v detect and store an active pressure of each detected contraction of the contraction pressure versus time data by subtracting an average uterine resting tone pressure from a contraction peak pressure;

vi compute, store, and display each measure of each resting interval duration in seconds utilizing a stored contraction onset time for a respective contraction and a stored contraction offset time for an immediately previous contraction, both graphically and numerically;

vii calculate and display a graph of an average rest interval duration for at least one fifteen-minute period of labor and a minimum normal rest interval for the same fifteen-minute period of labor;

viii present a rest interval spectrum graph to depict a quantity of rest intervals occurring in a plurality of risk categories from low risk to high risk during the at least one fifteen-minute period of labor;

ix transmit data and the graph depicting the average rest interval duration and the rest interval spectrum graph to a client device via the network; and

x control a pump infusing a labor inducing drug to the mother to pause or decrease infusion of the labor inducing drug automatically when the controller processor detects resting intervals below a preset limit for the average rest interval duration, and wherein the digital electronic fetal heart rate and uterine contraction monitoring system protects a fetal brain automatically and without human intervention by pausing the pump or decreasing a pump flow for the pump that delivers the labor inducing drug to the mother that increases contractions.

2. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the plurality of risk categories are discrete ranges of rest intervals comprising:

very safe rest intervals for time intervals greater than 90 seconds, safe rest intervals for time intervals from 60 seconds to 90 seconds, potentially inadequate rest intervals for time intervals from 40 seconds to 60 seconds, unsafe rest intervals for time intervals from 20 seconds to 40 seconds if repetitive, and potentially dangerous rest intervals for time intervals from 1 second to 20 seconds if repetitive.

3. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 2, wherein different risk categories of the plurality of risk categories are graphically differentiable in the rest interval spectrum graph by using different colors or different brightnesses.

4. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the preset limit for the average rest interval duration is changeable using at least one risk factor associated with the mother and/or the fetus, the risk factors consisting of:

a the mother'"'"'s weight;

b a presence of maternal diabetes;

c an advanced fetal gestational age;

d a macrosomic estimated fetal weight;

e a cephalopelvic disproportion;

f whether the mother is a primigravida;

g the mother'"'"'s medical history; and

h a measured abnormal labor curve with protraction, arrest or both protraction and arrest of cervical dilatation, fetal head descent or both cervical dilatation and fetal head descent.

5. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to:

a present a graph of a quantity of resting intervals with quantity of pushing episodes per fifteen-minute period of labor;

b activate at least one alarm when at least one risk factor is detected outside of at least one safety limit, including the average rest interval duration, a median rest interval duration, resting time percent, the number of resting intervals per fifteen-minute period of labor, and an average uterine resting tone pressure for at least one fifteen-minute period of labor; and

c control the pump infusing the labor inducing drug to the mother to pause or decrease the labor inducing chemicals automatically when the controller processor detects when the at least one risk factor is outside of the at least one safety limit.

6. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to detect, store and display, associated with fetal heart rate tracing, at least one of:

an early fetal heart rate deceleration, a variable fetal heart rate deceleration, a late fetal heart rate deceleration and a prolonged fetal heart rate deceleration by simultaneous analysis of the fetal heart rate tracing and uterine contraction pressure versus time in a tocograph tracing of uterine contraction patterns.

7. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the contraction monitoring sensor is at least one of:

a a tocodynamometer adapted to be secured to the mother; and

b an intrauterine pressure catheter adapted to be secured to the mother and connected to a pressure transducer to measure strength and duration of a contraction for the mother.

8. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the fetal heart rate sensor is at least one of:

a an ultrasound sensor adapted to be attached to the mother for monitoring a fetal heart rate; and

b a fetal scalp electrode adapted to be attached to a fetal scalp for monitoring the fetal heart rate.

9. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to form and display a pie chart and continuously update the pie chart for dangerous rest intervals and non-dangerous rest intervals by duration and depict a plurality of rest interval durations simultaneously.

10. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 3, wherein the different colors are different shades of primary and secondary colors to indicate very safe rest intervals, safe rest intervals, potentially inadequate rest intervals, inadequate rest intervals and potentially unsafe rest intervals for the fetus when these are repetitive.

11. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to display, graphically, contraction active pressure for each contraction, computed as maximum contraction pressure in mm Hg minus the average uterine resting tone pressure before and after each contraction.

12. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to provide pairs of markers on graphs of resting intervals depicting a plurality of contraction durations and a plurality of rest interval durations over time for the mother which indicate the average contraction onset pressure and the average contraction offset pressure.

13. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to insert annotations automatically above detected deceleration waveforms on the fetal heart rate tracing.

14. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the comprises computer instructions, when executed by the controller processor, further cause the controller processor to display measurements of each contraction duration in seconds with measurements of each contraction pressure on a mm Hg pressure scale.

15. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 6, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to:

a display contraction duration annotations including numeric duration of each contraction measured in seconds displayed with width corresponding to measured contraction duration detected by the digital electronic fetal heart rate and uterine contraction monitoring system and displayed below each contraction on the tocograph;

b display deceleration annotations or symbols to denote early, variable, late or prolonged fetal heart rate decelerations, detected by the digital electronic fetal heart rate and uterine contraction monitoring system, above detected deceleration waveforms on the fetal heart rate tracing; and

c display, below each contraction on the tocography, a contraction duration annotation and an active pressure annotation that visually identify both a numeric duration of each contraction measured in seconds and a quantitative pressure measurement of active pressure of each contraction measured in mm Hg.

16. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller to:

a detect risk trends describing a risk/problem event

b upon detection of the risk trends, trigger detection of risks or technical problems of the digital electronic fetal heart rate and uterine contraction monitoring system; and

c administer at least one alarm comprising;

i at least one of;

an audio alarm, a visual alarm, and a message alarm, and

ii a graph depicting the risk trends to medical providers describing the risk/problem event.

17. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to present at least one of:

a a user selected safety limit for a quantity of resting intervals per fifteen-minute period of labor;

b a user selected minimum normal resting time percent per fifteen-minute period of labor;

c a user selected minimum average rest interval duration per fifteen-minute period of labor;

d a user selected minimum median rest interval duration per fifteen-minute period of labor; and

e a user selected maximum average uterine resting tone pressure per fifteen-minute period of labor.

18. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 6, wherein the computer instructions are further configured to cause the controller processor to calculate a summated active pressure utilizing area under a tocograph tracing of uterine contraction patterns between each contraction onset pressure and each contraction offset pressure during each fifteen-minute period of labor.

19. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 5, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to calculate and display a resting time percent of all rest intervals during the at least one fifteen-minute period of labor and computer instructions configured to instruct the controller processor to calculate and display a median rest interval duration and an average rest interval duration of all rest intervals during the at least one fifteen-minute period of labor.

20. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 1, wherein the computer instructions, when executed by the controller processor, further cause the controller processor calculate a pressure equivalent by calculating:

a a user defined contraction onset slope in degrees to create a contraction onset marker;

b a user defined contraction offset slope in degrees to create a contraction offset marker; and

c indicating the pressure equivalent between the contraction onset marker and the contraction offset marker.

21. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 18, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to detect the summated active pressure during portions of uterine contractions when risks of increased pressure are elevated by using a user adjustable fraction of the active pressure to calculate the summated active pressure by measuring the area under the curve for each contraction during each fifteen-minute period of labor.

22. The digital electronic fetal heart rate and uterine contraction monitoring system of claim 5, wherein the computer instructions, when executed by the controller processor, further cause the controller processor to display the at least one alarm on at least one of:

the electronic fetal monitor display and a third party client device display.