Labor management methods for decreasing the incidence of cesarean childbirth

• US 8,597,306 B1
• Filed: 03/15/2013
• Issued: 12/03/2013
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Stetrix, Inc.
• Original Assignee: Plexus Biomedical, Inc.
• Inventors: Blurton, David D., Buchanan, Mark
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): BERNIER, KATELYN J
• Application Number:
  US13/833,017
• Time in Patent Office: 263 Days
• Field of Search: 606/119, 606/121, 606/130, 606/197, 600/588, 600/591, 128/830, 128/835, 128/898
• US Class Current: 606/119
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00017 Electrical control of surgical instruments
• CPC Class Codes: A61B 2017/00115 with audible or visual output with imaging means A61B90/37, A61B34/20
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0004 characterised by the type of physiological signal transmitted
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 5/4343 Pregnancy and labour monitoring, e.g. for labour onset detection
• 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 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6813 Specially adapted to be attached to a specific body part A61B5/6802 takes precedence
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6831 Straps, bands or harnesses
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6843 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/7455 characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61F 5/0093 : Rectal devices, e.g. for the treatment of haemorrhoids
• CPC Class Codes: A61F 6/08 : Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception , e.g. combined with devices protecting against contagion

Abstract

Provided herein are methods for decreasing the incidence of Cesarean childbirth by managing the labor process. In one aspect, a tactile feedback device is positioned adjacent the perianal tissues. A mother'"'"'s labor is monitored for the progression of the baby along the birth canal and adjustments are performed in response to the progression of labor to promote a vaginal childbirth. A perianal support device includes a perianal support member having a pressure surface configured for engagement with tissue adjacent an anal orifice and a pressure detecting system associated with the perianal support member to detect pressure indicative of pressure on the perianal tissue of a patient.

Claims

1. A method of managing child birth labor to reduce an incidence of Cesarean section child delivery by promoting vaginal child delivery, the method comprising:

applying a perianal support device to a perianal region of a patient undergoing child birth labor;

monitoring pressure in the perianal region with a feedback device associated with the perianal support device;

advancing the perianal support device against the perianal region until the monitored pressure meets or exceeds a first pressure threshold based on the feedback device; and

securing the perianal support device in a position where the monitored pressure meets or exceeds the first pressure threshold.

2. The method of managing child birth labor of claim 1, comprising utilizing the feedback device to sense pressure changes associated with child birth labor contractions;

and

alerting a user to the sensed pressure changes.

3. The method of managing child birth labor of claim 2, wherein alerting the user includes one of activating an audible alert, activating a visual alert, and activating a tactile change.

4. The method of managing child birth labor of claim 3, wherein activating the visual alert includes turning a light on, off, or changing its color.

5. The method of managing child birth labor of claim 3, wherein activating the visual alert includes changing a color or indicator associated with the perianal support device.

6. The method of managing child birth labor of claim 1, comprising alerting a user when the monitored pressure exceeds a second pressure threshold higher than the first pressure threshold.

7. The method of managing child birth labor of claim 1, further comprising monitoring progression of labor and adjusting pressure applied to the perianal region in response to changes in the progression of labor.

8. The method of managing child birth labor of claim 7, wherein monitoring includes detecting a descent of a fetus, and wherein adjusting includes further advancing the perianal support device to apply a second higher pressure to the perianal region when the descent of the fetus is delayed.

9. A method of managing child birth labor to reduce an incidence of Cesarean section child delivery by promoting vaginal child delivery, the method comprising:

providing a support member having a pressure surface configured to engage a perianal area of a mother undergoing child birth labor;

positioning the pressure surface proximate the perianal area of the mother undergoing child birth labor; and

detecting pressure on the perianal area of the mother in labor applied by the pressure surface against the perianal area of the mother undergoing child birth labor.

10. The method of managing child birth labor of claim 9, wherein detecting the pressure on the perianal area comprises detecting the pressure with a strain gauge disposed on a compression element forming a portion of the support member.

11. The method of managing child birth labor of claim 9, comprising displaying information relating to the detected pressure on a user interface.

12. The method of managing child birth labor of claim 11, comprising displaying perianal pressure detected during contractions of the mother undergoing child birth labor.

13. The method of managing child birth labor of claim 9, comprising alerting a healthcare provider or the mother when the detected pressure detects application of a therapeutic pressure level on the perianal tissue.

14. The method of managing child birth labor of claim 13, wherein alerting the healthcare provider or the mother comprises changing a color of a component associated with the support member.

15. The method of managing child birth labor of claim 13, wherein alerting the health care provider or mother comprises generating feature changes in a securing member when stretching is sufficient to apply a therapeutic pressure on the perianal tissue.

16. A method of managing child birth labor to reduce an incidence of Cesarean section child delivery by promoting vaginal child delivery, the method comprising:

providing a tactile feedback device configured for positioning within a gluteal cleft adjacent perianal tissue;

positioning the tactile feedback device in contact with at least a portion of the perianal tissue of a mother prior to delivery of a child;

adjusting tactile sensation generated by the tactile feedback device on the perianal tissue of the mother until a first sensation threshold is reached; and

monitoring progression of labor with the tactile feedback device in position.

17. The method of managing child birth labor of claim 16, wherein the first sensation threshold is indicated by a pressure detecting system associated with the tactile feedback device.

18. The method of managing child birth labor of claim 16, further comprising receiving input from the mother indicating when the first sensation threshold is reached.

19. The method of managing child birth labor of claim 16, further comprising receiving input from a healthcare provider indicating when the first sensation threshold is reached.

20. The method of managing child birth labor of claim 16, wherein adjusting tactile sensation comprises pulling a device adjustment element attached to the tactile feedback device to increase pressure on the perianal tissue of the mother.

21. The method of managing child birth labor of claim 17, wherein the first sensation threshold is a therapeutic pressure threshold, the method further comprising monitoring the pressure detecting system to confirm applied pressure is above the therapeutic pressure threshold.

22. The method of managing child birth labor of claim 17, comprising monitoring pressure applied on the perianal tissue during contractions of the mother and providing a corresponding contraction pressure indication to the mother or healthcare provider.

23. The method of managing child birth labor of claim 17, wherein the pressure detecting system displays information relating to a detected pressure on a user interface.

24. A method of managing child birth labor to reduce an incidence of Cesarean section child delivery by promoting vaginal child delivery, the method comprising:

applying a tactile feedback device to a mother in labor adjacent a perianal tissue in a first tactile position;

securing the tactile feedback device to the mother in labor to maintain the device in the first tactile position;

monitoring progression of labor; and

moving the tactile feedback device to a second tactile position in response to changes in the progression of labor.

25. The method of managing child birth labor of claim 24, wherein the moving includes advancing the tactile feedback device inward towards the anus of the mother to increase pressure on the perianal tissue.

26. The method of managing child birth labor of claim 24, wherein the applying step includes monitoring pressure applied to the perianal tissue as the tactile feedback device is being applied.

27. The method of managing child birth labor of claim 24, wherein monitoring includes receiving feedback from the tactile feedback device indicative of pressure applied to the perianal tissue during a child birth labor contraction by the mother.

28. The method of managing child birth labor of claim 24, wherein the moving includes moving the tactile feedback device to a second tactile position applying less pressure on the perianal tissue.

29. The method of managing child birth labor of claim 24, further including increasing a tactile sensation provided by the tactile feedback device in response to the monitoring indicating that a numbing medication has been administered to the mother.

30. The method of managing child birth labor of claim 24, further including alerting the mother or a healthcare provider when contractions generate a change in pressure on the perianal tissue.