A High-Value, Low-Cost Bubble Continuous Positive Airway Pressure System for Low-Resource Settings: Technical Assessment and Initial Case Reports

Acute respiratory infections are the leading cause of global child mortality. In the developing world, nasal oxygen therapy is often the only treatment option for babies who are suffering from respiratory distress. Without the added pressure of bubble Continuous Positive Airway Pressure (bCPAP) which helps maintain alveoli open, babies struggle to breathe and can suffer serious complications, and frequently death. A stand-alone bCPAP device can cost $6,000, too expensive for most developing world hospitals. Here, we describe the design and technical evaluation of a new, rugged bCPAP system that can be made in small volume for a cost-of-goods of approximately$350. Moreover, because of its simple designﾗconsumergrade pumps, medical tubing, and regulators—it requires only the simple replacement of a ,$1 diaphragm approximately every 2 years for maintenance. The low-cost bCPAP device delivers pressure and flow equivalent to those of a reference bCPAP system used in the developed world. We describe the initial clinical cases of a child with bronchiolitis and a neonate with respiratory distress who were treated successfully with the new bCPAP device

Design and preliminary analysis of a vaginal inserter for speculum-free cervical cancer screening.

OBJECTIVE:Cervical cancer screening usually requires use of a speculum to provide a clear view of the cervix. The speculum is one potential barrier to screening due to fear of pain, discomfort and embarrassment. The aim of this paper is to present and demonstrate the feasibility of a tampon-sized inserter and the POCkeT Colposcope, a miniature pen sized-colposcope, for comfortable, speculum-free and potentially self-colposcopy. STUDY DESIGN:We explored different designs using 3D computer-aided design (CAD) software and performed mechanical testing simulations on each. Designs were rapid prototyped and tested using a custom vaginal phantom across a range of vaginal pressures and uterine tilts to select an optimal design. Two final designs were tested with fifteen volunteers to assess cervix visualization, comfort and usability compared to the speculum and the optimal design, the curved-tip inserter, was selected for testing in volunteers. RESULTS:We present a vaginal inserter as an alternative to the standard speculum for use with the POCkeT Colposcope. The device has a slim tubular body with a funnel-like curved tip measuring approximately 2.5 cm in diameter. The inserter has a channel through which a 2 megapixel (MP) mini camera with LED illumination fits to enable image capture. Mechanical finite element testing simulations with an applied pressure of 15 cm H2O indicated a high factor of safety (90.9) for the inserter. Testing of the device with a custom vaginal phantom, across a range of supine vaginal pressures and uterine tilts (retroverted, anteverted and sideverted), demonstrated image capture with a visual area comparable to the speculum for a normal/axial positioned uteri and significantly better than the speculum for anteverted and sideverted uteri (p<0.00001). Volunteer studies with self-insertion and physician-assisted cervix image capture showed adequate cervix visualization for 83% of patients. In addition, questionnaire responses from volunteers indicated a 92.3% overall preference for the inserter over the speculum and all indicated that the inserter was more comfortable than the speculum. The inserter provides a platform for self-cervical cancer screening and also enables acetic acid/Lugol's iodine application and insertion of swabs for Pap smear sample collection. CONCLUSION:This study demonstrates the feasibility of an inserter and miniature-imaging device for comfortable cervical image capture of women with potential for synergistic HPV and Pap smear sample collection

El Diario de Pontevedra : periódico liberal: Ano XLII Número 12022 - 1925 xaneiro 13

<p>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.</p

Pre-insertion questionnaire responses regarding attitudes towards cervical examinations from volunteers for self-testing (n = 15) showing responses to questions.

<p>Pre-insertion questionnaire responses regarding attitudes towards cervical examinations from volunteers for self-testing (n = 15) showing responses to questions.</p

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.

<p>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.</p

Design specifications and constraints.

<p>Design specifications and constraints.</p

CAD designs of standard speculum (from GrabCAD) and vaginal inserter/expander prototypes.

<p>CAD designs of standard speculum (from GrabCAD) and vaginal inserter/expander prototypes.</p

Finite element analysis and factor of safety (FOS) plots for the standard speculum and the inserter/expander prototypes.

<p>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.</p