Apparatus for indicating uterine activity in labor

• US RE31,158 E
• Filed: 11/14/1979
• Issued: 02/22/1983
• Est. Priority Date: 06/23/1976
• Status: Expired due to Term

• Current Assignee: British Technology Group Ltd. (Boston Scientific Corporation)
• Original Assignee: National Research Development Corporation
• Inventors: Carter, Michael C., Steer, Philip J.
• Primary Examiner(s): Wise, Edward J.
• Application Number:
  US06/094,160
• Time in Patent Office: 1,196 Days
• Field of Search: 364/415, 128/748, 128/778
• US Class Current: 600/591
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G06F 19/3468 Computer-assisted delivery of medication via infusion or injection infusion devices per se A61M5/14

Abstract

Apparatus for providing an indication of uterine activity in labor is described. Intrauterine pressure above the basal pressure existing between contractions is integrated over intervals of between ten and thirty minutes to give the required indication. An algorithm is disclosed for calculating dosage of a labor inducing substance, the algorithm containing safeguards to prevent hyperstimulation.

Claims

1. Apparatus for indicating uterine activity in labor including:

means adapted to be coupled to a uterine pressure transducer for providing a first signal representative of intrauterine pressure,

means for providing a second signal .[.which is equal to.]. .Iadd.representative of .Iaddend.the first signal except .[.when a.]. .Iadd.during each .Iaddend.contraction .[.occurs.]. when .[.it takes up a value equal to that of.]. the .Iadd.value the .Iaddend.first signal .Iadd.would have had .Iaddend.in the absence of .[.the.]. .Iadd.that .Iaddend.contraction .Iadd.is represented.Iaddend.,

.[.means for subtracting the second signal from the first 65 signal, to provide a third signal,.]. .Iadd.means for deriving a third signal from the first and second signals, the third signal being representative of the additional uterine pressure, which occurs during contractions, above the uterine pressure existing in the absence of contractions.Iaddend., and

means for integrating the third signal over intervals of at least ten but not more than thirty minutes to provide an activity signal indicative of uterine activity in labor.

2. Apparatus according to claim 1 wherein the first and second signals are analog signals.

3. Apparatus according to claim 1 wherein the means for providing the second signal includes means for holding, during each contraction, a signal equal to the first signal at the beginning of the contraction, the signal held forming the second signal during contractions.

4. Apparatus according to claim 1 wherein the means for providing the second signal include

detection means for detecting first and second changes in the first signal likely to be indicative of the onset and completion, respectively, of a contraction, and

a sample-and-hold circuit for sampling the first signal except between the detection of said first and subsequent second changes by the detection means when the last value sampled is held, the ouput of the sample and hold circuit providing the said second signal.

5. Apparatus according to claim 4 wherein the detection means includes a differentiation circuit with output coupled to a first input of a first comparator by way of a full-wave rectifier circuit, and

gating means for applying a signal to a second input of the first comparator which is of opposite polarity to output signals of the full-wave rectifier circuit when the rate of change of the first signal falls to zero during a contraction,

the first comparator providing signals maintaining the sample-and-hold circuit in its hold state whenever the signal applied to the first comparator is of the same polarity as and greater than that applied to its second input and when the applied signals are of opposite polarities.

6. Apparatus according to claim 5 wherein the gating means includes a second comparator connected to receive the said first signal as one input and a reference signal representative of an intrauterine pressure usually only attained near the beginning of a contraction as another input, the output of the second comparator forming the second input for the first comparator.

7. Apparatus according to claim 5 wherein the gating means includes

a further differentiation circuit,

a half-wave rectifier circuit with input coupled to the output of the further differentiation circuit,

an addition circuit for adding a reference signal to the output of the further full-wave rectifier circuit, the reference signal being representative of an intrauterine pressure usually only attained near the beginning of a contraction, and

an inverter for inverting the output signal of the addition circuit and applying the inverted signal to the second input of the first comparator.

8. Apparatus according to claim 1 wherein the third signal is integrated over approximately 15 minutes.

9. Apparatus for automatically calculating the dosage of a labour stimulating substance including

activity-indicating means, adapted to be coupled to a uterine pressure transducer, for providing an activity signal representative of the integral of the additional intrauterine pressure which occurs during contractions above the pressure existing between contractions, the said integral being taken over at least 10 but not more than 30 minutes,

.[.first comparison means for comparing the most recently obtained value of an activity signal with the value of a recently obtained previous activity signal,.]. and

dose calculating means for determining the dosage of a labour stimulating substance in dependence upon values of the activity signal .[.and for stabilising or reducing the dosage, at least when the value of the activity signal is above a predetermined minimum and below a predetermined maximum, if the first comparison means indicates that the said most recently obtained value of the activity signal is equal to or less than the said recently-obtained previous value of the activity signal,.].

the dosage being so calculated, in operation, that when employed in stimulating labour, labour progresses without substantial interruption and without the activity signal exceeding a dangerous value.

10. Apparatus according to claim .[.9.]. .Iadd.23 .Iaddend.including second comparison means for comparing a recent value of the activity signal with a first reference signal representing an upper limit for the values of the activity signal which it is dangerous to exceed, the dose calculating means being coupled to the second comparison means and constructed to stabilize or reduce the calculated dosage when the upper limit is exceeded.

11. Apparatus according to claim 10 wherein the first reference signal is equivalent to an activity signal value of about 1500 kPas.

12. Apparatus according to claim 10 including third comparison means for comparing a recent value of the activity signal with a second reference signal representing a lower limit for the values of activity signals corresponding to a possibility of labour ceasing, the dose calculating means being coupled to the third comparison menas and constructed to increase the dosage if the lower limit is not exceeded.

13. Apparatus according to claim 12 wherein the second reference signal is equivalent to an activity signal value of about 500 KPas.

14. Apparatus according to claim 10 wherein the activity indicating means includes

means adapted to be coupled to a uterine pressure transducer for providing a first signal representative of intrauterine pressure,

means for providing a second signal which is equal to the first signal except when a contraction occurs when it takes up a value equal to that of the first signal in the absence of the contraction,

means for substracting the second signal from the first signal, to provide a third signal, and

means for integrating the third signal over intervals of at least 10 but not more than thirty minutes to provide the activity signals.

15. Apparatus according to claim 10 wherein the dose calculating means includes a read-only memory or a programmable read-only memory programmed according to an algorithm for determining the dosage which takes account of the values of recent activity signals.

16. Apparatus according to claim 15 wherein at, at least one point in the said algorithm, the dosage determined is stabilized or reduced if a later activity signal is equal to, or less than, an earlier activity signal.

17. Apparatus according to claim 16 wherein the said algorithm is such that at, at least one point therein, the dosage determined is stabilized or reduced if the value of a recent activity signal exceeds an upper limit for integral signals which it is dangerous to exceed.

18. Apparatus according to claim 17 wherein the said algorithm is such that at, at least one point therein, the dosage determined is increased if the value of a recent activity signal is below a lower limit for integral signals indicating that labour may cease.

19. Apparatus according to claim 10 wherein the dose-calculating means is coupled to dispensing means for controlling the rate of infusion of a labour stimulating substance into a patient. .[.20. Apparatus for deriving a corrected signal from a signal with a varying datum, including means for receiving a first signal having a varying datum,

means for providing a second signal which is equal to the first signal except when the first signal deviates from the datum when it takes up a value equal to that of the first signal in the absence of deviation, including detection means for detecting first and second changes in the first signal likely to be indicative of the onset and completion, respectively, of deviation from the datum, and a sample-and-hold circuit for sampling the first signal except between the detection of said first and subsequent second changes by the detection means when the last value sampled is held, the output of the sample and hold circuit providing the said second signal, said detection means further including a differentiation circuit with output coupled to a first input of a first comparator by way of a full-wave rectifier circuit, and gating means for applying a signal to a second input of the first comparator which is of opposite polarity to output signals of the full-wave rectifier circuit when the rate of change of the first signal falls to zero during deviation from the datum, the first comparator providing signals maintaining the sample-and-hold circuit in its hold state whenever the signal applied to the first comparator is of the same polarity as the greater than that applied to its second input and when the applied signals are of opposite polarities, and

means for providing a third corrected signal by subtracting the second signal from the first signal..]. .[.21. Apparatus according to claim 20 wherein the gating means includes a second comparator connected to receive the said first signal as one input and a reference signal representative of a value of the first signal usually only attained near the beginning of a deviation from the datum as another input, the output of the second comparator forming the second input for the first comparator..]. .[.22. Apparatus according to claim 20 wherein the gating means includes

a further differentiation circuit,

a half-wave rectifier circuit with input coupled to the output of the further differentiation circuit,

an addition circuit for adding a reference signal to the output of the further full-wave rectifier circuit, the reference signal being representative of a value of the first signal usually only attained near the beginning of a deviation from the datum, and

an inverter for inverting the output signal of the addition circuit and applying the inverted signal to the second input of the first comparator..]. .Iadd. 23. An apparatus as in claim 9 further including first comparison means for comparing the most recently obtained value of an activity signal with the value of a recently obtained previous activity signal and wherein said dose calculating means stabilises or reduces the dosage, at least

when the value of the activity signal is above a predetermined minimum and below a predetermined maximum, if the first comparison means indicates that the most recently obtained value of the activity signal is equal to or less than the said recently-obtained previous value of the activity signal. .Iaddend.