Custom-made 3D printed masks for children using non-invasive ventilation: a comparison of 3D scanning technologies and specifications for future clinical service use, guided by patient and professional experience.

Non-invasive ventilation (NIV) is assisted mechanical ventilation delivered via a facemask for people with chronic conditions that affect breathing. Mass-produced masks are available for both the adult and paediatric markets but masks that fit well are difficult to find for children who are small or have asymmetrical facial features. A good fit between the mask and the patient's face to minimise unintentional air leakage is essential to deliver the treatment effectively. We present an innovative use of 3D assessment and manufacturing technologies to deliver novel custom-made facemasks for children for whom a well-fitting standard mask is not available. This paper aims to describe the processes undertaken to investigate and compare currently available technologies for 3D scanning children and to explore the design of a system for creating custom-made paediatric NIV masks within the NHS. The paper therefore considers not only the quality and accuracy of the data, but also other factors such as the time and ease of process. Searches for all currently available scanning technologies were made. Photogrammetry image stitch using a smartphone and a digital camera, and two structured light scanners were selected and compared in the laboratory, in discussion with user groups, and in adult volunteers. Using the processes described, it became apparent that the optimal 3D scanning system for this purpose was the handheld structured light scanner. This option offered both superior accuracy and convenience and was more cost effective.

Custom-made 3D printed masks for children using non-invasive ventilation: a feasibility study of production method and testing of outcomes in adult volunteers.

Non-invasive ventilation (NIV) is assisted mechanical ventilation delivered via a facemask for people with chronic conditions that affect breathing. NIV is most commonly delivered via an interface (mask) covering the nose (nasal mask) or the nose and mouth (oronasal mask). The number of children in the UK requiring NIV is currently estimated to be around 5000. Mass-produced masks are available for both the adult and paediatric markets but masks that fit well are difficult to find for children who are small or have asymmetrical facial features. A good conforming fit between the mask and the patient's face to minimise unintentional air leakage is essential to deliver the treatment effectively; most ventilators will trigger an alarm requiring action if such leakage is detected. We present an innovative use of 3D scanning and manufacturing technologies to deliver novel mask-face interfaces to optimise mask fit to the needs of individual patients. Ahead of planned user trials with paediatric patients, the project team trialled the feasibility of the process of creating and printing bespoke masks from 3D scan data and carried out testing of the masks in adult volunteers to select the strongest design concept for the paediatric trial. The evaluation of the process of designing a bespoke mask from scan data, arranging for its manufacture and carrying out user testing has been invaluable in gaining knowledge and discovering the pitfalls and timing bottlenecks in the processes. This allowed the team to iteratively refine the techniques and methods involved, informing user trials later on in the project. It has also provided indicative cost estimates for 3D printed mask prototype components which are useful in project decision making and trial planning. The value of the process extends to considerations for future implementation of the process within a clinical pathway.

A comfort assessment of existing cervical orthoses.

PURPOSE: Identify location and intensity of discomfort experienced by healthy participants wearing cervical orthoses. METHOD: Convenience sample of 34 healthy participants wore Stro II, Philadelphia, Headmaster, and AspenVista® cervical orthoses for four-hour periods. Participants reported discomfort level (scale 0-6) and location. RESULTS: Participants reported mean discomfort for all orthoses over the four-hour test between 'a little discomfort' and 'very uncomfortable' (mean discomfort score = 1.64, SD = 1.50). Seven participants prematurely stopped tests due to pain and six reported maximum discomfort scores. Significant linear increase in discomfort with duration of wear was found for all orthoses. Significantly less discomfort was reported with Stro II than Headmaster and Philadelphia. Age correlated with greater perceived discomfort. Orthoses differed in the location discomfort was experienced. CONCLUSION: Existing cervical orthoses cause discomfort influenced by design and duration of wear with orthoses' design the more significant factor. This work informed the design of a new orthosis and future orthoses developments. Practitioner Summary: The purpose of this study was to gain greater knowledge about the discomfort caused by wearing of existing neck orthoses in order to inform the design and development of a new neck orthosis. This study gathers empirical data from a surrogate population and concludes that orthosis design is more influential than the duration of wear.

Evaluating a novel cervical orthosis, the Sheffield Support Snood, in patients with amyotrophic lateral sclerosis/motor neuron disease with neck weakness.

Current practice and guidelines recommend the use of neck orthoses for people with amyotrophic lateral sclerosis (ALS) to compensate for neck weakness and to provide surrogate neck control. However, available options are frequently described by patients as restrictive and unsuitable and there was a need for a new device that addressed the needs of people with ALS. This project utilized a co-design process to develop a new neck orthosis that was more flexible yet supportive. Following development of a prototype device, a mixed methods cohort study was undertaken with patients and carers, in order to evaluate the new orthosis. Twenty-six patients were recruited to the study, with 20 of these completing all phases of data collection. Participants described the impact of neck weakness on their life and limitations of existing supports. Evaluation of the new orthosis identified key beneficial features: notably, increased support while providing a greater range of movement, flexibility of use, and improved appearance and comfort. In conclusion, the results of this evaluation highlight the value of this alternative option for people with ALS, and potentially other patient groups who require a neck orthosis.

Assessment of the Sheffield Support Snood, an innovative cervical orthosis designed for people affected by neck muscle weakness.

BACKGROUND: This study aimed at quantifying the biomechanical features of the Sheffield Support Snood, a cervical orthosis specifically designed for patients with neck muscle weakness. The orthosis is designed to be adaptable to a patient's level of functional limitation using adjustable removable supports, which contribute support and restrict movement only in desired anatomical planes. METHODS: The snood was evaluated along with two commercially available orthoses, the Vista and Headmaster, in a series of flexion, extension, axial-rotation and lateral flexion movements. Characterization was performed with twelve healthy participants with and without the orthoses. Two inertial-magneto sensors, placed on the forehead and sternum, were used to quantify the neck's range of motion. FINDINGS: In its less supportive configuration, the snood was effective in limiting movements to the desired planes, preserving free movement in other planes. The Headmaster was only effective in limiting flexion. The range of motion achieved with the snood in its rigid configuration was equivalent (P>0.05, effect size<0.4) to that achieved with the Vista, both in trials performed reaching the maximum amplitude (range of motion reduction: 25%-34% vs 24%-47%) and at maximum speed (range of motion reduction: 24%-29% vs 25%-43%). INTERPRETATION: The Sheffield Support Snood is effectively adaptable to different tasks and, in its most supportive configuration, offers a support comparable to the Vista, but providing a less bulky structure. The chosen method is suitable for the assessment of range of motions while wearing neck orthoses and is easily translatable in a clinical context.

Head-Up; An interdisciplinary, participatory and co-design process informing the development of a novel head and neck support for people living with progressive neck muscle weakness.

This paper presents the Head-Up project, that aims to provide innovative head support to help improve posture, relieve pain and aid communication for people living with progressive neck muscle weakness. The initial focus is motor neurone disease. The case study illustrates collaborative, interdisciplinary research and new product development underpinned by participatory design. The study was initiated by a 2-day stakeholder workshop followed by early proof-of-concept modelling and patient need evidence building. The work subsequently led to a successful NIHR i4i application funding a 24-month iterative design process, patenting, CE marking and clinical evaluation. The evaluation has informed amendments to the proposed design refered to here as the Sheffield Support Snood (SSS). The outcome positively demonstrates use and performance improvements over current neck orthoses and the process of multidisciplinary and user engagement has created a sense of ownership by MND participants, who have since acted as advocates for the product.