Ambulatory, ultrasonic transit time, real-time, cervical effacement and dilatation monitor with disposable probes

• US 5,438,996 A
• Filed: 10/12/1994
• Issued: 08/08/1995
• Est. Priority Date: 10/12/1994
• Status: Expired due to Fees

• Current Assignee: Tritton Technologies
• Original Assignee: Tritton Technologies
• Inventors: Kemper, W. Scott, Guberek, Michael P.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/322,613
• Time in Patent Office: 300 Days
• Field of Search: 128/660.01, 128/660.02, 128/660.06, 128/661.02, 128/662.03, 128/662.06, 128/675, 128/774, 128/775, 128/778
• US Class Current: 600/448
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/435 Assessing cervix alteration or dilation
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• 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

Preferred transducers in the substantial shapes of a three-dimensional bodies, normally spheres or cylinders, emit ultrasound omni-directionally. The transducers are secured to the wall of the cervix uteri of human female, preferably by a barb or corkscrew coil, so that a straight line ultrasonic acoustic path exists between them. An ultrasonic transit time sonomicrometer detecting a variable propagation delay between the transducers dependent upon the dilatation or effacement of the cervix uteri serves as a ultrasonic cervimeter. Cervical dimension, and changes in dimension, developed by the ultrasonic cervimeter directly in millimeters are (i) validated for reasonableness, (ii) monitored so as to generate several alarms upon the occurrence(s) of several predetermined conditions, (iii) displayed, and (iv) archived all in a battery-powered ambulatory instrument.

Claims

1. A probe for use with an ultrasonic transit time cervimeter, the probe comprising:

a transducer in the substantial shape of a three-dimensional, non-planar, body characterized in that ultrasound emissions from the transducer are along a multiplicity of axis in multiple different directions;

means for securing the transducer to the wall of the cervix uteri of human female; and

an electrical wire adapted for connecting between the transducer in its position secured to the wall of the cervix and an ultrasonic transit time cervimeter in a location exterior to human female'"'"'s body.

2. The probe according to claim 1

wherein the transducer is in the substantial shape of a cylinder characterized in that ultrasound emissions from the cylindrically-shaped transducer assembly are along a multiplicity of axis in multiple directions all substantially perpendicular to an imaginary central axis of the cylinder.

3. The probe according to claim 1

wherein the transducer is in the substantial shape of a sphere characterized in that ultrasound emissions from the spherically-shaped transducer assembly are along a multiplicity of axis in multiple directions all substantially radial to an imaginary centroid of the sphere.

4. The probe according to claim 1 wherein the securing means comprises:

a barbed hook engaging the wall of the cervix uteri of the human female when stuck therein.

5. The probe according to claim 1 wherein the securing means comprises:

a corkscrew coil engaging the wall of the cervix uteri of the human female when threaded therein.

6. An ultrasonic transit time cervimeter comprising:

an ultrasonic transmitter in the substantial shape of a three-dimensional, non-planar, body characterized in that ultrasound is emitted from the transmitter along a multiplicity of axis in multiple different directions;

an ultrasonic receiver in the substantial shape of a three-dimensional, non-planar, body characterized in that ultrasound is received along a multiplicity of axis from multiple different directions;

a means for securing the ultrasonic transmitter, and also the ultrasonic receiver, to the wall of the cervix uteri of human female at spaced apart positions so that a straight line ultrasonic acoustic path at least partially through the cervix exists between the ultrasonic transmitter and the ultrasonic receiver, the path being simultaneously along at least one ultrasound emission axis of the ultrasonic transmitter and at least one ultrasound reception axis of the ultrasonic receiver;

an ultrasonic transit time micrometer for detecting a delay in the propagation of ultrasound from the ultrasonic transmitter to the ultrasonic receiver as an indication of the dilatation of the cervix uteri; and

electrical wires adapted for connecting both the ultrasonic transmitter and the ultrasonic receiver in their positions secured to the wall of the cervix to the ultrasonic transit time micrometer.

7. The ultrasonic transit time cervimeter according to claim 6 wherein at least one of the ultrasonic transmitter and the ultrasonic receiver comprises:

an ultrasonic transducer in the substantial shape of a cylinder.

8. The ultrasonic transit time cervimeter according to claim 6 wherein at least one of the ultrasonic transmitter and the ultrasonic receiver comprises:

an ultrasonic transducer in the substantial shape of a sphere.

9. The ultrasonic transit time cervimeter according to claim 6 wherein the securing means comprises:

a barbed hook engaging the wall of the cervix uteri of the human female when stuck therein.

10. The ultrasonic transit time cervimeter according to claim 6 wherein the securing means comprises:

a corkscrew coil engaging the wall of the cervix uteri of the human female when threaded therein.

11. The ultrasonic transit time cervimeter according to claim 6 wherein the ultrasonic transit time micrometer comprises:

a first alarm circuit for causing an alarm upon such times as the detected ultrasound delay varies sufficiently regularly over time so as to, by indicating a corresponding temporally regular variation in the dilatation of the cervix uteri, mark the onset of labor.

12. The ultrasonic transit time cervimeter according to claim 11 wherein the ultrasonic transit time micrometer comprises:

another, second, alarm, circuit enabled only after actuation of the first alarm and upon such times as the detected ultrasound delay exhibits an insufficient variation over time so as to, by indicating a lack of temporal variation in the dilatation of the cervix uteri, mark the onset of problems with labor.

13. The ultrasonic transit time cervimeter according to claim 6 wherein the ultrasonic transit time micrometer comprises:

an alarm upon circuit for causing an alarm upon, such times as the detected ultrasound delay is sufficiently great so as to indicate that the dilatation of the cervix uteri has exceeded a predetermined size.

14. An ultrasonic transit time cervical dilatation monitor comprising:

an ultrasonic transmitter;

an ultrasonic receiver;

a means for securing the ultrasonic transmitter, and also the ultrasonic receiver, to the wall of the cervix uteri of human female at spaced apart positions so that an ultrasonic acoustic path at least partially through the cervix exists between the ultrasonic transmitter and the ultrasonic receiver;

an ultrasonic transit time micrometer, connected to both the ultrasonic transmitter and the ultrasonic receiver in their positions secured to the wall of the cervix, for detecting a delay in the propagation of ultrasound from the ultrasonic transmitter to the ultrasonic receiver as an indication of the dilatation of the cervix uteri;

a monitor for monitoring dilatation of the cervix uteri and for causing an alarm if a predetermined condition of dilatation is detected.

15. The ultrasonic transit time cervical dilatation monitor according to claim 14 wherein the monitor of the indicated dilatation of the cervix uteri is causing the alarm upon the monitoring of regular temporal variations in the dilatation of the cervix, indicating the onset of labor.

16. The ultrasonic transit time cervical dilatation monitor according to claim 14 wherein the monitor of the indicated dilatation of the cervix uteri is causing the alarm upon a cessation of any temporal variations in the dilatation of the cervix, indicating an onset of problems once labor has commenced.

17. The ultrasonic transit time cervical dilatation monitor according to claim 14 wherein the monitor of the indicated dilatation of the cervix uteri is causing the alarm upon the dilatation of the cervix exceeding a predetermined distance.

18. An automated method of monitoring cervical dilatation comprising:

securing an ultrasonic transmitter and an ultrasonic receiver at spaced-apart positions upon the wall of the cervix uteri;

energizing the secured ultrasonic transmitter and ultrasonic receiver with and by an ultrasonic transit time micrometer;

detecting the ultrasound propagation transit time from the ultrasonic transmitter to the ultrasonic receiver with and by use of the ultrasonic transit time micrometer in order to provide an indication of the corresponding dilatation of the cervix uteri;

electronically monitoring the detected transit time, and the indicated dilatation of the cervix uteri corresponding to the detected transit time, in order so as to sound an alarm if a predetermined condition of dilatation is detected.

19. The automated method of monitoring cervical dilatation according to claim 18

wherein the electronically monitoring is of a detected transit time, and of a correspondingly indicated dilatation, that marks the onset of labor.

20. The automated method of monitoring cervical dilatation according to claim 18

wherein the electronically monitoring is of detected delay, and of a correspondingly indicated dilatation, that marks, once labor has commenced, the onset of problems with labor.

21. The automated method of monitoring cervical dilatation according to claim 18

wherein the electronically monitoring is of detected delay, and correspondingly indicated dilatation, so as mark that the dilatation of the cervix uteri has exceeded a predetermined distance.

22. The automated method of monitoring cervical dilatation according to claim 18

wherein the securing of the ultrasonic transmitter and the ultrasonic receiver is at spaced-apart positions between a first point upon an interior wall of the cervix uteri and a second point, the second point radially disposed radially outwardly from the first point along an extension of an imaginary vector between an imaginary central axis of the cervix uteri and the first point;

and

wherein the detecting is of the delay in the propagation transit time of ultrasound from the first point to the second point along an imaginary radius of the cervix uteri.

23. The automated method of monitoring cervical dilatation according to claim 18

wherein the securing of the ultrasonic transmitter and the ultrasonic receiver is at spaced-apart positions between two points located upon an imaginary arc segment of the wall of the cervix uteri;

and

wherein the detecting is of the delay in the propagation transit time of ultrasound between the two points along an imaginary arc segment of the cervix uteri.

24. A real-time ambulatory recording and displaying monitor of the cervix uteri comprising;

an ultrasonic transmitter;

an ultrasonic receiver;

a means for securing the ultrasonic transmitter, and also the ultrasonic receiver, to the wall of the cervix uteri of human female at spaced apart positions so that a straight line ultrasonic acoustic path at least partially within the cervix exists between the ultrasonic transmitter and the ultrasonic receiver; and

a case suitable for attachment to the body containing

an ultrasonic transit time micrometer electrically connected to both the ultrasonic transmitter and the ultrasonic receiver in their positions secured to the wall of the cervix, for detecting a delay in the propagation of ultrasound from the ultrasonic transmitter to the ultrasonic receiver as an indication of the dilatation of the cervix uteri,

a memory for storing the delays as are detected over time as an indication of the dilatation of the cervix uteri over time, and

a display for displaying at times each of the present dilatation of the cervix uteri, and also the dilatation of the cervix uteri over time.

25. The real-time ambulatory recording and displaying monitor of the cervix uteri according to claim 24 further for alarming, the monitor further comprising within case suitable for attachment to the body:

an alarm circuit for alarming if the indicated dilatation of the cervix uteri equals a predetermined condition.

26. The real-time ambulatory recording, displaying and alarming monitor of the cervix uteri according to claim 25

wherein the alarm circuit is further for alarming if the indicated history of the dilatation of the cervix uteri equals a predetermined condition.