Device for holding medical instrumentation sensors at and upon the cervix os of a human female, particularly for holding the ultrasonic transducers of an ultrasonic transit time, real-time, cervical effacement and dilatation monitor

• US 5,851,188 A
• Filed: 08/08/1995
• Issued: 12/22/1998
• Est. Priority Date: 10/12/1994
• Status: Expired due to Fees

• Current Assignee: Kelli M. Bullard, Kemper W. Scott, Michael A. Harrison, Michael P. Guberek
• Original Assignee: Kelli M. Bullard, Kemper W. Scott, Michael A. Harrison, Michael P. Guberek
• Inventors: Bullard, Kelli M., Harrison, Michael, Kemper, W. Scott, Guberek, Michael P.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/512,333
• Time in Patent Office: 1,232 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, 128/832, 128/841, 600/437, 600/438, 600/442, 600/448, 600/459, 600/462, 600/488, 600/587, 600/588, 600/591
• 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: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4427 Device being portable or laptop-like
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A flexible elastomeric annulus-shaped membrane having a shape-retentive memory and exerting a force so as to assume and to maintain a predetermined closed-loop geometric shape, normally a circle, fits circumferentially about the cervix os of a human female so as to hold and retain medical instrumentation probes, preferably two opposed wire-connected ultrasonic transducers of a real-time transit-time ultrasonic monitor of cervical dilatation and effacement. The annular membrane may optionally extend as a tube downwards in the vaginal canal, in the manner of a female diaphragm, as to shield the wires from the walls of the vagina. The membrane expands and contracts with such cyclical variation in the dilatation and effacement of the cervix os as occurs from the earliest onset of labor until imminent childbirth. The membrane holding the transducer probes of an ultrasonic cervimeter may be situated in place about the cervix os for prolonged periods ranging to several months, or may be placed only at the onset of full labor, for monitoring purposes.

Claims

1. A device for holding and retaining one or more medical instrumentation probes at and in contact with the cervix os of a human female, the device comprising:

a flexible ring means, having a shape retentive memory and exerting a force so as to assume and to maintain a predetermined closed-loop geometric shape, for, when inserted at the top of the vaginal canal and about the cervix os, holding, by its shape-retentive force, position inside and at the top of the vaginal canal and circumferentially around the cervix os; and

an annulus-shaped flexible elastic membrane connected at its outer circumference to the flexible ring means so as to enshroud the cervix Os while presenting a central aperture at the cervical opening through which aperture bodily fluids may be emitted and digital examination of the cervix os may transpire, the membrane being suitably strong so as to hold one or more medical instrumentation probes as are capable of being affixed anywhere upon its surface including at the rim of the central aperture.

2. The device according to claim 1 further comprising:

a tubular membrane, having two ends, connected at a one end opening to the flexible ring means and extending downwards in the vaginal canal from the cervix os sufficiently far so that no medical instrumentation probe affixed to the annulus-shaped membrane can come into contact with the wall of the vaginal canal.

3. The device according to claim 1 for use with two ultrasonic transducer probes of an ultrasonic transit time cervimeter, the annulus-shaped flexible elastic membrane comprising:

two regions at the rim of the central aperture each of which regions is suitable to engage and to hold an ultrasonic 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 so that, as engaged and as held, an ultrasonic acoustic path across the opening of the cervix os is presented and enabled between two ultrasonic transducers;

wherein measurement of a transit time of ultrasound between the two transducers is an indication of the dilatation of the cervix os.

4. 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 flexible elastomeric annulus-shaped membrane means fitting in position about the cervix os and holding 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 connecting both the ultrasonic transmitter and the ultrasonic receiver in their positions secured to the wall of the cervix by the flexible elastomeric annulus-shaped membrane means to the ultrasonic transit time micrometer.

5. The ultrasonic transit time cervimeter according to claim 4 wherein at least one of the ultrasonic transmitter and the ultrasonic receiver comprises:

an ultrasonic transducer in the substantial shape of a cylinder.

6. The ultrasonic transit time cervimeter according to claim 4 wherein at least one of the ultrasonic transmitter and the ultrasonic receiver comprises:

an ultrasonic transducer in the substantial shape of a sphere.

7. The ultrasonic transit time cervimeter according to claim 4 wherein the flexible elastomeric annulus-shaped membrane means comprises:

a flexible ring means, having a shape-retentive memory and exerting a force so as to assume and to maintain a predetermined closed-loop geometric shape, for, when inserted at the top of the vaginal canal and about the cervix os, holding, by its shape-retentive force, position inside and at the top of the vaginal canal and circumferentially around the cervix os; and

an annulus-shaped flexible elastic membrane connected at its outer circumference to the flexible ring means so as to enshroud the cervix os while presenting a central aperture at the cervical opening, the membrane being suitably strong so as to hold the ultrasonic transmitter and the ultrasonic receiver upon its surface at the rim of the central aperture.

8. A method of monitoring cervical dilatation comprising:

securing an ultrasonic transmitter and an ultrasonic receiver at spaced-apart positions upon a flexible elastomeric annulus-shaped membrane;

fitting the flexible elastomeric annulus-shaped membrane in position about the cervix os so as to hold 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;

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.

9. The method of monitoring cervical dilatation according to claim 8 further comprising:

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.

10. The method of monitoring cervical dilatation according to claim 8

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

11. The method of monitoring cervical dilatation according to claim 8

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.

12. The method of monitoring cervical dilatation according to claim 8

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.

13. The method of monitoring cervical dilatation according to claim 8

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.

14. The method of monitoring cervical dilatation according to claim 8

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.