System and method for the infusing of tocolytic drugs in response to the onset of premature labor detected by ultrasonic monitoring of the dilatation and/or effacement of the cervix os

• US 5,829,438 A
• Filed: 08/07/1995
• Issued: 11/03/1998
• Est. Priority Date: 10/12/1994
• Status: Expired due to Fees

• Current Assignee: Regents of the University of California (University of California)
• Original Assignee: David L. Gibbs, Kemper W. Scott, Michael A. Harrison, Michael P. Guberek
• Inventors: Harrison, Michael, Kemper, W. Scott, Gibbs, David L., Guberek, Michael P.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/514,234
• Time in Patent Office: 1,184 Days
• Field of Search: 128/661.07, 128/660.06, 128/660.02, 128/662.03, 128/661.02, 128/675, 128/774, 128/775, 128/778, 424/608, 514/509, 514/565, 514/608
• US Class Current: 600/588
• 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

The onset of spontaneous abortion or premature labor of a pregnant human female is continuously monitored, potentially for periods of several months and longer, by a real-time transit-time ultrasonic monitor of the dilatation and/or effacement of the cervix os, preferably by a computerized ambulatory monitor. The preferred computerized monitor sounds an alarm upon the detection of variably present conditions, normally the compound conditions of five or more 10% cyclical variations in the dilatation or effacement of the cervix os within a period of one hour, coupled with a greater than 1 centimeter increase over baseline of either dilatation or effacement, which compound conditions normally indicate the early onset of labor. The monitor connects to an infusion pump, likewise preferably ambulatory, for directing and controlling the infusion of one or more tocolytic, labor-preventing, drugs if labor continues. In this manner patient activity and patient chemistry can be early detected, early alarmed and early beneficially altered even before it is possible to receive the diagnosis or treatment of a physician of other health care provider.

Claims

1. A system for the postponement of labor/spontaneous abortion in a pregnant human female patient, the system comprising:

a ultrasonic cervimeter monitor of the dilatation and/or effacement of the cervix os of a pregnant human female patient; and

an infusion pump responsive to certain conditions indicative of labor sensed by the monitor to infuse a tocolytic drug into the pregnant human female patient.

2. The system according to claim 1 wherein the ultrasonic cervimeter monitor comprises:

an ultrasonic transit-time cervimeter.

3. The system according to claim 1 wherein the monitor comprises:

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;

an ultrasonic transit-time cervimeter; and

an electrical wire 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.

4. The system according to claim 1 wherein the infusion pump comprises:

an electrical infusion pump; and

a battery for powering the electrical infusion pump.

5. The system according to claim 4 wherein the reservoir is of a beta-sympathomimetic tocolytic drug from the group consisting of Terbutaline and Ritodrine.

6. A system for the postponement of labor/spontaneous abortion in a pregnant human female patient, the system 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;

electrical wires 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; and

an infusion pump responsive to certain conditions indicative of labor sensed by the ultrasonic transit time micrometer to infuse a tocolytic drug into the pregnant human female patient.

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 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.

10. The ultrasonic transit time cervimeter according to claim 9 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.

11. 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.

12. 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 of the indicated dilatation of the cervix uteri for causing an alarm if a predetermined condition of dilatation is detected; and

an infusion pump responsive to certain conditions indicative of labor sensed by the monitor to infuse a tocolytic drug into the pregnant human female patient.

13. The ultrasonic transit time cervical dilatation monitor according to claim 12 wherein the monitor of the indicated dilatation of the cervix uteri is causing the alarm upon the monitoring of regular temporal cycles in the dilatation of the cervix, indicating the onset of labor.

14. The ultrasonic transit time cervical dilatation monitor according to claim 12 wherein the monitor of the indicated dilatation of the cervix uteri is causing the alarm upon a cessation of any temporal cycles in the dilatation of the cervix, indicating an onset of problems once labor has commenced.

15. The ultrasonic transit time cervical dilatation monitor according to claim 12 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.

16. An automated method of infusing a tocolytic drug into a pregnant human female patient in response to monitoring of 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; and

infusing a tocolytic drug into the pregnant human female patient in response to certain conditions indicative of labor detected by the electronic monitoring.

17. The automated method of infusing a tocolytic drug into a pregnant human female patient in response to monitoring of cervical dilatation according to claim 16

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

18. The automated method of infusing a tocolytic drug into a pregnant human female patient in response to monitoring of cervical dilatation according to claim 16

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.

19. The automated method of infusing a tocolytic drug into a pregnant human female patient in response to monitoring of cervical dilatation according to claim 16

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.

20. The automated method of infusing a tocolytic drug into a pregnant human female patient in response to monitoring of cervical dilatation according to claim 16

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.

21. A real-time system for the infusing of a tocolytic drug into a pregnant human female patient in response to monitoring of cervical dilatation of the cervix uteri, the system 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; and

an infusion pump responsive to certain conditions indicative of labor sensed by the ultrasonic transit time micrometer to infuse a tocolytic drug into the pregnant human female patient.

22. The system according to claim 21 further comprising:

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

23. The system according to claim 21 wherein the alarm circuit is further for alarming if the indicated history of the dilatation of the cervix uteri equals a predetermined condition.