Fig 1.
(a) Vaginal Inserter with digital colposcope inserted, imaging a mannequin cervix with white LED illumination. (b) Image of the device with dimensions with the mini USB camera inserted and interfacing with the smartphone for imaging. The image shows the camera in the inserter device imaging a mock cervix in real time.
Fig 2.
CAD designs of standard speculum (from GrabCAD) and vaginal inserter/expander prototypes.
Table 1.
Design specifications and constraints.
Fig 3.
a) Vaginal organ model b) Schematic of phantom with vaginal organ suspended in acrylic tank and filled with gel. Pgel is pressure from the gel, ID is inner diameter of the opening. c) Cervix image from phantom showing central os and side walls d) Circular cervix grid for calculating percent visual area e) Cervix overlaid with circular grid with PVA calculated.
Fig 4.
Original flat tip inserter and optimized curved tip probe inserter.
Images of the devices inserter into the vagina show how the curved tip of the optimized inserter enables manipulation of the cervix.
Fig 5.
Finite element analysis and factor of safety (FOS) plots for the standard speculum and the inserter/expander prototypes.
Green arrows indicate fixed surfaces and other colored arrows indicate applied pressure. All the prototypes designed have minimum FOS greater than 4 with the minimum factor of safety for the devices as follows: a) speculum = 8.07, b) billed expander = 11.67, c) silicone expander = 346, d) flat tip inserter = 3095 and e) the curved tip inserter = 90.9.
Fig 6.
a) Results from experimental determination of percent visual area showing images of the mock cervix (with centered os) in the vaginal phantom with the graves speculum, silicone expander, flat tip inserter and the billed expander. Images are captured at different vaginal pressures 0.1, 5, 10 and 15 cm H2O. b) Grouped bar plot of mean percent visual area of the cervix for the different devices under the different pressures. Error bars are standard deviations.
Table 2.
Mean percent visual area (PVA) enabled by speculum and different inserter designs under a range of supine position vaginal pressures and normal (axially) positioned uteri.
Fig 7.
Results from comparing the ability of the speculum, flat tip and curved tip probe inserters to manipulate the cervix.
a) Images of the cervix at after manipulation with the standard speculum, flat tip and curved tip inserters for normal, sideverted, anteverted and retroverted positions. b) Top: Measured mean offset of the os from the center for each device under different uterus tilts. Bottom: Mean PVA for each device under different uterus tilts. Error bars are standard deviations.
Table 3.
Mean percent visual area (PVA) enabled by speculum, flat tip and curved tip inserter designs under 500 cm H2O pressure and various uterine positions (normal, anteverted, retroverted and sideverted).
Table 4.
Mean percent offset of os from central position after manipulation with the speculum, flat tip and curved tip inserter designs under 500 cm H2O pressure and uterine tilts (anteverted, retroverted, sideverted).
Table 5.
Participants’ (n = 15) demographics for clinical study.
Fig 8.
a) A sideverted cervix manipulated and imaged using the flat probe inserter, showing off centered cervix with os to the side. b) Same sideverted cervix manipulated and imaged using the curved tip probe inserter, showing a more centered cervix with os closer to the center. c) Graph comparing percent visual area for the flat and curved tip inserters. d) Graph comparing percent offset of the cervical Os from the center for the flat and curved tip inserters. Error bars are standard deviations.
Fig 9.
Pre-insertion questionnaire responses regarding attitudes towards cervical examinations from volunteers for self-testing (n = 15) showing responses to questions.
Fig 10.
Post-insertion questionnaire responses from volunteer (n = 13) after self-testing, comparing the inserter to a speculum and self-examination to physician examination.
Volunteers with no prior history of speculum examinations were excluded from answering these questions.