Methods and apparatus for preventing vaginal lacerations during childbirth

• US 9,492,197 B2
• Filed: 10/13/2010
• Issued: 11/15/2016
• Est. Priority Date: 10/13/2009
• Status: Active Grant

• Current Assignee: Materna Medical, Inc.
• Original Assignee: Materna Medical, Inc.
• Inventors: Juravic, Mark, Stewart, Michael
• Primary Examiner(s): Ou, Jing
• Application Number:
  US13/499,548
• Publication Number:
  US 20130053863A1
• Time in Patent Office: 2,225 Days
• Field of Search: 606/119, 606/191, 606/193, 600184-210, 600/224, 600/588
• US Class Current: 1/1
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0206 with antagonistic arms as supports for retractor elements
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• 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 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 2017/345 for introduction into a natural body opening
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/22 Ergometry; Measuring muscular strength or the force of a muscular blow exercising apparatus A63B21/00 ; measuring of work or force in general G01L
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• 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 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A vaginal dilation device is provided that may include any of a number of features. One feature of the vaginal dilation device is that it is configured to dilate vaginal tissue during labor to prevent tissue damage. Another feature of the vaginal dilation device is that it can be manually controlled to dilate vaginal tissue, or can be automatically controlled to dilate vaginal tissue. In some embodiments, the vaginal dilation device is configured to measure a force applied by the device to tissue. In other embodiments, the vaginal dilation device is configured to apply a constant force to tissue. In other embodiments, the vaginal dilation device is configured to expand at a constant rate. Methods associated with use of the vaginal dilation device are also provided.

Claims

1. A vaginal dilation device, comprising:

a handle;

a plurality of arms coupled to the handle, each arm having a pad disposed thereon that is shaped and configured to conform to a vagina of a patient

an expansion mechanism coupled to the arms and configured to move the arms and the pads radially outwards at a controlled force; and

a bump-release disposed on a distal portion of the vaginal dilation device configured to quickly reduce an outer diameter of the vaginal dilation device if the bump-release is engaged by a fetus entering the vagina.

2. The vaginal dilation device of claim 1 further comprising a central rod coupled to the expansion mechanism, the handle, and the plurality of arms, wherein axial movement of the central rod moves the arms and the pads radially outwards from the central rod.

3. The vaginal dilation device of claim 2 wherein the pads are arranged in a substantially parallel configuration as the arms and pads move radially outwards.

4. The vaginal dilation device of claim 1 wherein a distance between opposing pads in an expanded configuration is approximately 8-10 cm.

5. The vaginal dilation device of claim 1 further comprising a quick-release lever configured to quickly reduce the outer diameter of the vaginal dilation device.

6. The vaginal dilation device of claim 1 further comprising a force sensor coupled to the pads and configured to measure a force applied by the pads against the vagina.