Device Prototype for Vaginal Delivery of Extremely Preterm Fetuses in the Breech Presentation.
Journal
Journal of medical devices
ISSN: 1932-6181
Titre abrégé: J Med Device
Pays: United States
ID NLM: 101299321
Informations de publication
Date de publication:
01 Jun 2021
01 Jun 2021
Historique:
received:
12
02
2020
revised:
22
10
2020
entrez:
22
2
2021
pubmed:
23
2
2021
medline:
23
2
2021
Statut:
ppublish
Résumé
Vaginal delivery is typically avoided in the extremely preterm breech population due to the concern of entrapment by the cervix of the aftercoming head. A mechanical device concept is presented to enable vaginal delivery by preventing retraction of the cervix against the fetus during delivery. The two-part device was designed to dilate the cervix, prevent prolapse of small fetal parts and maintain sufficient dilation during delivery. The two-part device was designed and manufactured with the following modules: an inflatable saline-filled cervical balloon for dilation and a cervical retractor composed of semirigid beams to stabilize the cervix and maintain adequate dilation. The device was tested using a cervical phantom designed to simulate the compressive force the cervix exerts. The cervical balloon reached a maximum dilation of 8.5 cm, after which there was leakage of saline from the balloon. While this dilation was less than the target goal of 10 cm, the leaking was attributed to prototype manufacturing defects, which could be resolved with further development. The cervical retractor was able to withstand between 1-3 kPa. Although estimates of cervical pressure values can be upward of 30 kPa, there are no in vivo measurements to formally identify the pressure values for patients in preterm labor. This device serves as a viable proof-of-concept for utilizing an inflatable balloon device to prevent cervical retraction in the setting of extremely preterm vaginal breech delivery. Further manufacturing improvements and design changes could improve the device for continued development and testing.
Identifiants
pubmed: 33613807
doi: 10.1115/1.4049086
pii: MED-20-1010
pmc: PMC7871996
doi:
Types de publication
Journal Article
Langues
eng
Pagination
021002Informations de copyright
Copyright © 2021 by ASME.
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