Not the whole mask. Just the gasket. Use readily available FDA approved UV curing material. Were I not up to my donkey in alligators I would have already done this.
http://www.researchposters.com/Posters/C...5/H118.pdf
Introduction
Obstructive Sleep Apnea (OSA) is highly prevalent among
children with craniofacial anomalies and syndromes involving
the mid-face and mandible 1-7 . Traditional surgical
interventions to treat OSA are often unsuccessful in these
children, who then often require continuous positive airway
pressure (CPAP) 8-10 . However, mask fit issues and high leaks
are common in children with dysmorphic features and can
create significant barriers to effective CPAP therapy 11-13 .
Creation of a customized mask using 3D printing technology
could potentially alleviate this obstacle.
Methods
A three-dimensional (3D) model of the patient’s face is
generated using 3D photography (3dMDface, 3dMD) (Fig.
1b) 14 . The facial model is then used to map a custom
mask:face interface along the desired facial contours. This
interface is then extruded into a CPAP mask insert, and
converted to a digital mold using patient-specific computer-
aided design (CAD) (Mimics Innovation Suite, Materialise,
Leuvian, Belgium) (Fig. 1c-d). The mold is then manufactured
on a 3D printer (Objet Connex, Stratasys Inc.) and silicone is
cured into the mold creating a unique mask insert (Fig. 1e-f).
Validated OSA questionnaires (the OSA-18 15 and PSQ sleep
disordered breathing subscale 16 ) were collected from the
parents at enrollment and after 1 month of use of the custom
mask. CPAP machine downloads were collected at
enrollment, after 1 month of use
Discussion
Abstract
Personalized CPAP masks can be successfully
created utilizing 3D photography, patient-
specific CAD, and 3D printing for children with
craniofacial syndromes and OSA suffering from
ineffective CPAP therapy. These custom masks
have demonstrated the ability to reduce
interface leak, increase compliance, and reduce
residual AHI on an initial patient with Treacher
Collins Syndrome. There were corresponding
improvements in validated pediatric OSA
metrics.
The high prevalence of obstructive sleep apnea (OSA) in children with craniofacial anomalies
has been well-described. Failure of continuous positive airway pressure (CPAP) therapy may
require potentially morbid surgery. Yet, achieving a functional mask-face interface using
conventional masks is difficult due to leak and discomfort resulting from atypical facies. The
objective was to develop a personalized CPAP mask using patient-specific computer-aided
design (CAD) and three-dimensional (3D) printing for children with OSA and craniofacial
anomalies which prevent effective CPAP therapy. University of Michigan Institutional Review
Board approval was granted prior to initiating the study. A 3D model of a personalized CPAP
mask based on the patient’s anatomy was designed using 3D photography (3dMD, Atlanta,
GA) and CAD software (Materialise, Leuven, Belgium). The model is converted into a mold
which is 3D printed (Stratasys, Rehovot, Israel) then filled with medical grade silicone to
create the final mask. Validated OSA questionnaires (the OSA-18 and PSQ sleep disordered
breathing subscale) and CPAP machine downloads were collected from the subject's family
at enrollment, after 1 month of consistent use of the mask, and at termination of use. Three
patients have been enrolled to date. Results obtained to date are promising. Median leak
improved by 74%, nightly compliance improved by 5.5%, and residual apnea-hypopnea index
improved by 24%. Personalized CPAP masks can be successfully created utilizing 3D
photography, patient-specific CAD, and 3D printing for children with craniofacial syndromes
and OSA suffering from ineffective CPAP therapy. Results indicate this design and
manufacturing process may improve CPAP therapy effectiveness in this patient population.
This technology could potentially increase
CPAP adherence among patients with
craniofacial anomalies who have issues with the
mask interface. Further trial recruitment is
necessary to ascertain whether the benefit is
seen with other facial dysmorphisms.
Ultimately,
this process may potentially be utilized for the
many CPAP users who experience poor mask fit
when using commercially available interfaces.
