Labor monitoring of pelvic floor

• US 10,080,520 B2
• Filed: 02/26/2016
• Issued: 09/25/2018
• Est. Priority Date: 02/27/2015
• Status: Active Grant

• Current Assignee: Stetrix, Inc.
• Original Assignee: Stetrix, Inc.
• Inventors: Blurton, David D.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US15/054,987
• Publication Number:
  US 20160249848A1
• Time in Patent Office: 942 Days
• CPC Class Codes: A61B 2562/0261 Strain gauges
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61B 5/4343 Pregnancy and labour monitoring, e.g. for labour onset detection
• CPC Class Codes: A61B 5/4356 Assessing uterine contractions A61B5/033 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation

Abstract

The present disclosure provides devices that noninvasively monitor the activity of pelvic floor muscles during labor, and in embodiments also provides perivaginal tissue support. electrode sensors are applied to perivaginal tissue and, in embodiments, a perivaginal support device during labor. The electrode signals are analyzed to estimate an efficacy of voluntary pushing and the efficacy is used, at least in part, to predict a success of vaginal birth. A pressure detection system may also be included with the perivaginal support device to detect pressure indicative of pressure on the perivaginal tissue of a patient, which may be modified to prevent tissue damage to the patient. The incidence of Cesarean childbirth may be reduced by managing the labor process in this manner. In one aspect, a tactile feedback device is positioned adjacent the perivaginal tissues.

Claims

1. A child birth labor apparatus, comprising:

an electrode configured for placement adjacent a pelvic floor of a patient in childbirth labor, the electrode configured to detect an electrical signal from a tissue of the pelvic floor and output the detected electrical signal;

a perivaginal support member comprising a tissue contact surface configured to contact tissue of a perivaginal region of the pelvic floor where the electrode is placed;

a computing system configured to receive the electrical signal from the electrode and a processor configured to analyze the electrical signal from the tissue of the pelvic floor to estimate an efficacy of voluntary pushing by the patient; and

a user interface coupled to the computing system and configured to present information relating to the estimated efficacy of voluntary pushing by the patient.

2. The child birth labor apparatus of claim 1, wherein the perivaginal support member further comprises:

a side contact portion coupled with the tissue contact surface and comprising a first surface disposed to face a first buttock in a gluteal cleft of the patient and a second surface disposed to face a second buttock in the gluteal cleft of the patient when the tissue contact surface is disposed adjacent an anal orifice of the patient.

3. The child birth labor apparatus of claim 2, wherein:

the tissue contact surface is configured to apply pressure to the contacted tissue of the perivaginal region, and

the side contact portion is configured to convey an applied load to the tissue contact surface.

4. The child birth labor apparatus of claim 1, wherein the perivaginal support member is placed behind the electrode and applies pressure to the electrode in order to maintain placement of the electrode.

5. The child birth labor apparatus of claim 4, wherein the perivaginal support member comprises a pressure sensor, the pressure sensor configured to detect pressure applied by tissue of the perivaginal region on the perivaginal support member.

6. The child birth labor apparatus of claim 1, wherein the perivaginal support member comprises the electrode, the electrode being integrated with the tissue contact surface.

7. The child birth labor apparatus of claim 6, wherein the electrode is placed adjacent to at least one of a transverse perineal muscle or a levator ani muscle.

8. The child birth labor apparatus of claim 1, wherein the computing system is configured to estimate the efficacy of the voluntary pushing by comparing a metric related to the electrical signal with a predetermined threshold.

9. The child birth labor apparatus of claim 1, wherein the electrode comprises a plurality of electrodes, comprising:

a first electrode from among the plurality of electrodes placed adjacent to a transverse perineal muscle, the first electrode configured to detect an electrical signal generated by an electrical potential at the transverse perineal muscle; and

a second electrode from among the plurality of electrodes placed adjacent to a levator ani muscle, the second electrode configured to detect an electrical signal generated by an electrical potential at the levator ani muscle.

10. The child birth labor apparatus of claim 1, wherein the electrode comprises a surface electrode.

11. A child birth labor apparatus, comprising:

an electrode configured for placement adjacent a pelvic floor of a mother in childbirth labor, the electrode configured to detect an electrical signal from a tissue of the pelvic floor and output the detected electrical signal;

a perivaginal support member comprising a tissue contact surface configured to contact tissue of the pelvic floor where the electrode is placed; and

a computing system configured to receive the electrical signal from the electrode and analyze the electrical signal to estimate an efficacy of voluntary pushing by the mother.

12. The child birth labor apparatus of claim 11, wherein the perivaginal support member further comprises a side contact portion comprising a first surface disposed to face a first buttock in a gluteal cleft of the mother and a second surface disposed to face a second buttock in the gluteal cleft of the mother when the tissue contact surface is disposed adjacent an anal orifice of the mother.

13. The child birth labor apparatus of claim 12, wherein:

the tissue contact surface is configured to apply pressure to the contacted tissue of the pelvic floor, and

the side contact portion is configured to convey an applied load to the tissue contact surface.

14. The child birth labor apparatus of claim 11, wherein the perivaginal support member is placed behind the electrode and applies pressure to the electrode in order to maintain placement of the electrode.

15. The child birth labor apparatus of claim 11, wherein the perivaginal support member comprises a pressure sensor, the pressure sensor configured to detect pressure applied by tissue of the pelvic floor on the perivaginal support member.

16. The child birth labor apparatus of claim 11, wherein the perivaginal support member further comprises a side contact portion, and the electrode is integrated with at least one of the tissue contact surface and the side contact portion.

17. The child birth labor apparatus of claim 11, wherein the electrode comprises a plurality of electrodes, comprising:

a first electrode from among the plurality of electrodes placed adjacent to a transverse perineal muscle, the first electrode configured to detect an electrical signal generated at the transverse perineal muscle; and

a second electrode from among the plurality of electrodes placed adjacent to a levator ani muscle, the second electrode configured to detect an electrical signal generated at the levator ani muscle.

18. A method, comprising:

placing a perivaginal support member over an electrode adjacent to a pelvic floor of a patient in childbirth labor;

applying, with the perivaginal support member, pressure on tissue of the pelvic floor where the electrode is placed;

receiving, at a computing system, an electrical signal generated from the electrode placed adjacent to the pelvic floor;

analyzing, by the computing system, the electrical signal to estimate an efficacy of voluntary pushing by the patient; and

presenting, from the computing system, information relating to the estimated efficacy of voluntary pushing by the patient.

19. The method of claim 18, further comprising:

deriving an intrauterine measurement of the patient based at least in part on the electrical signal from the electrode; and

predicting whether the childbirth labor will be successful based at least in part on the estimated efficacy of the voluntary pushing, wherein the prediction is used to determine whether a cesarean section is necessary.

20. The method of claim 18, wherein the perivaginal support member comprises a pressure sensor, the method further comprising:

detecting, by the pressure sensor, an amount of pressure applied by the tissue of the pelvic floor on the perivaginal support member, wherein the analyzing to estimate the efficacy of the voluntary pushing further comprises;

determining, based on the detected amount of pressure in cooperation with the analysis of the electrical signal, whether the voluntary pushing meets a threshold corresponding to successful pushing.