Labor management devices for decreasing the incidence of cesarean childbirth

• US 9,089,300 B2
• Filed: 10/31/2014
• Issued: 07/28/2015
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: Stetrix, Inc.
• Original Assignee: Stretrix Incorporated
• Inventors: Blurton, David D., Buchanan, Mark
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/529,235
• Publication Number:
  US 20150066048A1
• Time in Patent Office: 270 Days
• Field of Search: 600/534, 600/551, 600/587, 600/588, 600/591, 606/119, 606/121, 737/62
• US Class Current: 1/1
• 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

The present disclosure provides devices 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 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 child birth labor management apparatus, comprising:

a perianal support member comprising;

a perianal tissue engagement surface configured to apply pressure on tissue aligned with a patient'"'"'s midline within a sagittal plane adjacent an anal orifice of a mother in child birth labor;

a load transfer portion configured to convey an applied load to the perianal tissue engagement surface, the load transfer portion comprising;

a first surface disposed to face a first buttock in a gluteal cleft of the mother in child birth labor when the perianal tissue engagement surface is disposed adjacent the anal orifice; and

a second surface disposed to face a second buttock in the gluteal cleft of the mother in child birth labor when the perianal tissue engagement surface is disposed adjacent the anal orifice; and

a user interface associated with the perianal support member to present information relating to a pressure level applied by the perianal support member on the tissue adjacent the anal orifice of the patient as a result of the applied load.

2. The child birth labor management apparatus of claim 1, wherein the first and second surfaces are formed of one or more rigid compression elements extending away from a tactile feedback portion in a direction out of the gluteal cleft.

3. The child birth labor management apparatus of claim 1, wherein the user interface comprises a securing member attached to and extending from the perianal support member, the securing member being configured to convey information indicative of pressure applied on the tissue adjacent the anal orifice of the patient by the perianal support member.

4. The child birth labor management apparatus of claim 3, wherein the securing member comprises an element configured to change appearance when pressure changes.

5. The child birth labor management apparatus of claim 3, wherein the securing member is an elastic strap arranged to stretch and generate the applied load on the load transfer portion.

6. The child birth labor management apparatus of claim 1, wherein the user interface is a display screen that presents information to a user indicating pressure on the tissue adjacent the anal orifice of the patient.

7. The child birth labor management apparatus of claim 1, wherein the user interface comprises:

a load detecting element connected to the perianal support member for detecting a load indicative of pressure applied by the perianal support member on the tissue adjacent the anal orifice of the patient; and

a display element associated with the load detecting element to convey the detected load to the user.

8. The child birth labor management apparatus of claim 7, wherein the load detecting element is a pressure sensor and the display element is one of a light bulb and a display screen.

9. The child birth labor management apparatus of claim 7, wherein the load detecting element is a pressure responsive pad and the display element is a portion of the pad configured to change color when a pressure threshold is exceeded.

10. The child birth labor management apparatus of claim 9, wherein the perianal support member is at least partially transparent and the pressure responsive pad is visible through the perianal support member.

11. The child birth labor management apparatus of claim 7, wherein the load detecting element is a strain gauge and the display element comprises one of a light bulb and a display screen.

12. The child birth labor management apparatus of claim 7, wherein the display element is disposed remote from the load detecting element.

13. The child birth labor management apparatus of claim 12, wherein the load detecting element is configured to wirelessly communicate with the display element.

14. The child birth labor management apparatus of claim 7, further including a counter associated with the load detecting element, the counter configured to count pressure sequences above a first threshold indicative of effective pushes of the mother in child birth labor.

15. The child birth labor management apparatus of claim 14, wherein the counter is a mechanical device.

16. The child birth labor management apparatus of claim 1, wherein the user interface includes a light source arranged to change appearance in response to pressure changes sensed by the user interface.

17. The child birth labor management apparatus of claim 1, wherein the user interface comprises a pressure switch configured to complete an electrical circuit when the pressure level applied by the perianal support member on the tissue adjacent the anal orifice of the patient is above a threshold level.

18. A child birth labor management apparatus, comprising:

a perianal support member comprising;

a pressure surface configured to apply pressure on tissue aligned with a patient'"'"'s midline adjacent an anal orifice of a mother in child birth labor;

a load transfer portion configured to convey an applied load to the pressure surface for application of pressure on tissue aligned with the patient'"'"'s midline adjacent the anal orifice of the mother in child birth labor; and

a user interface means for presenting information relating to a pressure level applied by the perianal support member on the tissue adjacent the anal orifice of the patient as a result of the applied load.

19. The child birth labor management apparatus of claim 18, wherein the user interface means comprises a securing member attached to and extending from the perianal support member, the securing member being configured to convey information indicative of pressure applied on the tissue adjacent the anal orifice of the patient by the perianal support member.

20. The child birth labor management apparatus of claim 19, wherein the securing member comprises an element configured to change appearance when pressure changes.

21. The child birth labor management apparatus of claim 18, wherein the user interface means comprises:

a load detecting element connected to the perianal support member and arranged to detect a load indicative of pressure applied by the perianal support member on the tissue adjacent the anal orifice of the patient; and

a display element associated with the load detecting element to convey the detected load to the user.

22. The child birth labor management apparatus of claim 21, wherein the load detecting element is a pressure sensor and the display element is one of a light bulb, a display screen, a pressure responsive pad.

23. The child birth labor management apparatus of claim 21, wherein the load detecting element is a strain gauge and the display element comprises one of a light bulb, a display screen, a pressure responsive pad.

24. The child birth labor management apparatus of claim 21, wherein the display element is disposed remote from the load detecting element.

25. The child birth labor management apparatus of claim 21, further including a counter associated with the load detecting element, the counter configured to count pressure sequences above a first threshold indicative of effective pushes of the mother in child birth labor.

26. A child birth labor management apparatus, comprising:

a perianal support member comprising;

a perianal tissue engagement surface configured to apply pressure on tissue aligned with a patient'"'"'s midline within a sagittal plane adjacent an anal orifice of a mother in childbirth labor;

a load transfer portion configured to convey an applied load to the perianal tissue engagement surface for the application of pressure on tissue aligned with the patient'"'"'s midline adjacent the anal orifice of the mother in child birth labor;

a load detecting element connected to the perianal support member and arranged to detecting a load indicative of pressure applied by the perianal support member on the tissue adjacent the anal orifice of the patient; and

a display element associated with the load detecting element to convey the detected load or pressure to a user.

27. The child birth labor management apparatus of claim 26, wherein the load detecting element is one of a pressure sensor, a switch, and a strain gauge, and wherein the display element is one of a light bulb and a display screen.

28. The child birth labor management apparatus of claim 26, wherein the load detecting element is one of a pressure pad and a strap portion, and wherein the display element is one of color change and a strap element configured to change appearance under pressure.

29. The child birth labor management apparatus of claim 26, wherein the display element is disposed remote from the load detecting element.

30. The child birth labor management apparatus of claim 26, comprising a storage means to store and record obtained pressure information.