Noninvasive ventilator support using bi-level positive airway pressure/continuous positive airway pressure (BiPAP/CPAP) is commonly utilized for chronic medical conditions like sleep apnea and neuromuscular disorders like amyotrophic lateral sclerosis (ALS) that lead to weakness of respiratory muscles. Generic masks come in standard sizes and are often perceived by patients as being uncomfortable, ill-fitting, and leaky. A significant number of patients are unable to tolerate the masks and eventually stop using their devices. The goal of this project is to develop custom-fit masks to increase comfort, decrease air leakage, and thereby improve patient compliance. A single-patient case study of a patient with variant ALS was performed to evaluate the custom-fit masks. His high nose bridge and overbite of lower jaw caused poor fit with generic masks, and he was noncompliant with his machine. Using desktop Stereolithography three-dimensional (3D) printing and magnetic resonance imaging (MRI) data, a generic mask was extended with a rigid interface such that it was complementary to the patient's unique facial contours. Patient or clinicians interactively select a desired mask shape using a newly developed computer program. Subsequently, a compliant silicone layer was applied to the rigid interface. Ten different custom-fit mask designs were made using computer-aided design software. Patient evaluated the comfort, extent of leakage, and satisfaction of each mask via a questionnaire. All custom-fit masks were rated higher than the standard mask except for two. Our results suggest that modifying generic masks with a 3D-printed custom-fit interface is a promising strategy to improve compliance with BiPAP/CPAP machines.

References

References
1.
van Es
,
M. A.
,
Hardiman
,
O.
, and
Chio
,
A.
,
2017
,
Amyotrophic Lateral Sclerosis
,
Lancet
,
London
.
2.
Bourke
,
S. C.
,
Bullock
,
R. E.
, and
Williams
,
T. L.
,
2003
, “
Noninvasive Ventilation in ALS: Indications and Effect on Quality of Life
,”
Neurology
,
61
(
2
), pp.
171
177
.
3.
Carratu
,
P.
,
Spicuzza
,
L.
, and
Cassano
,
A.
,
2009
, “
Early Treatment With Noninvasive Positive Pressure Ventilation Prolongs Survival in Amyotrophic Lateral Sclerosis Patients With Nocturnal Respiratory Insufficiency
,”
Orphanet J. Rare Dis.
,
4
, p.
10-1172-4-10
.
4.
Kleopa
,
K. A.
,
Sherman
,
M.
, and
Neal
,
B.
,
1999
, “
BiPAP Improves Survival and Rate of Pulmonary Function Decline in Patients With ALS
,”
J. Neurol. Sci.
,
164
(
1
), pp.
82
88
.
5.
Eisen
,
A.
,
2009
, “
Amyotrophic Lateral Sclerosis: A 40-Year Personal Perspective
,”
J. Clin. Neurosci.
,
16
(
4
), pp.
505
512
.
6.
Lechtzin
,
N.
,
Scott
,
Y.
, and
Busse
,
A. M.
,
2007
, “
Early Use of Non-Invasive Ventilation Prolongs Survival in Subjects With ALS
,”
Amyotrophic Lateral Scler.
,
8
(
3
), pp.
185
188
.
7.
American Sleep Association
,
2017
, “
Sleep and Sleep Disorder Statistics
,” American Sleep Association, Lititz, PA.
8.
Garvey
,
J. F.
,
Pengo
,
M. F.
, and
Drakatos
,
P.
,
2015
, “
Epidemiological Aspects of Obstructive Sleep Apnea
,”
J. Thorac. Dis.
,
7
(
5
), pp.
920
929
.
9.
Peppard
,
P. E.
,
Young
,
T.
, and
Barnet
,
J. H.
,
2013
, “
Increased Prevalence of Sleep-Disordered Breathing in Adults
,”
Am. J. Epidemiol.
,
177
(
9
), pp.
1006
1014
.
10.
Heinzer
,
R.
,
Vat
,
S.
, and
Marques-Vidal
,
P.
,
2015
, “
Prevalence of Sleep-Disordered Breathing in the General Population: The HypnoLaus Study
,”
Lancet Respir. Med.
,
3
(
4
), pp.
310
318
.
11.
Aboussouan
,
L. S.
,
Khan
,
S. U.
, and
Banerjee
,
M.
,
2001
, “
Objective Measures of the Efficacy of Noninvasive Positive-Pressure Ventilation in Amyotrophic Lateral Sclerosis
,”
Muscle Nerve
,
24
(
3
), pp.
403
409
.
12.
Hsu
,
D. Y.
,
Cheng
,
Y. L.
, and
Bien
,
M. Y.
,
2015
, “
Development of a Method for Manufacturing Customized Nasal Mask Cushion for CPAP Therapy
,”
Australas. Phys. Eng. Sci. Med.
,
38
(
4
), pp.
657
664
.
13.
Cheng
,
Y. L.
, and
Chu
,
J. C.
,
2013
, “
Application of Rapid Tooling to Manufacture Customized Nasal Mask Cushion for Continuous Positive Airway Pressure (CPAP) Devices
,”
Rapid Prototyping J.
,
19
(
1
), pp.
4
10
.
14.
Han
,
D. H.
,
Rhi
,
J.
, and
Lee
,
J.
,
2004
, “
Development of Prototypes of Half-Mask Facepieces for Koreans Using the 3D Digitizing Design Method: A Pilot Study
,”
Ann. Occup. Hyg.
,
48
(
8
), pp.
707
714
.
You do not currently have access to this content.