Senior Design I



Product Design Specifications (PDS)

REVISION 4 (Final): Revised 4/17/2006

BIOE 1160/1161: Senior Design

Calano, Kumar, McNeal, Odle

- Product:

o Modified neck brace for patients lacking neck extensor muscle strength

- Patient population:

o This brace will primarily benefit patients suffering from ALS, MS, or other neurodegenerative diseases. These patients do not have proper muscular neck support, and require a neck brace to maintain appropriate positioning for everyday interaction and activity.

- Product function:

o This brace is being designed to compensate for the ineffective designs of current neck braces. Because current designs are tailored for use on patients with a neck injury or trauma, they aim to completely immobilize the head. In ALS patients, progressive muscular degeneration often results neck extensor muscle weakness (“dropped head syndrome”). However, often these patients still retain the ability to laterally rotate their head. Thus, current neck braces are unable to provide the proper vertical support and functional lateral mobility for these patients.

- Product use environment:

o This neck brace device will be designed for everyday use. Parts of the device (particularly soft goods) will be washable or easily replaceable. The brace will comply with both US and European government safety standards.

▪ FDA Class I device (“cervical orthotic”)

o Device Labels

▪ This device should only be worn by those suffering from muscle weakness due to a neuromuscular degenerative disease, such as Amyotrophic Lateral Sclerosis (ALS).

▪ This device can be worn while the user is sleeping, but it is not recommended.

▪ Do not wear this device if more neck pain results; but before the device is taken off, the user should make sure that the fit is proper by consulting the instructions for use and their doctor.

▪ This device is not waterproof, so the user is advised not to wear it while bathing.

- Design constraints:

o Support for chin

▪ Maintains neutral position

▪ Prevents forward flexion greater than 20 degrees

▪ Non abrasive

▪ Moldable to patient’s anatomy

o Support for back of head

▪ Maintains neutral position

▪ Prevents extension greater than 20 degrees

▪ Non abrasive

▪ Washable or replaceable

o Adjustability

▪ Adjustable from 5 to 9 inches in girth

o Proper skin ventilation

▪ Minimize fully closed materials

▪ Leave anterior portion open

o Non collapsible materials

o Washable

▪ Materials can be hand washed, rinsed, and air dried

▪ If not washable, component should be replaceable

o Pivot to facilitate head rotation

▪ To be designed to allow lateral rotation within 50% of normal range of motion for the cervical spine

▪ Allowing ~30 degrees of lateral rotation to the left

▪ Allowing ~ 30 degrees of lateral rotation to the right

o Lightweight

▪ Less than 1lb

▪ Optimum weight: 8-10 oz.

o Maximum distribution area of force/pressure on neck/chest

- Optional design components:

o Extra adjustability that accounts for obesity and differences in girth

o Material compatible with facial hair

o Cosmetic appearance

▪ Neutral/blending colors: Pantone #406, 420, 428, 434, 4515, 4525, 4535

- Possible materials to be used:

o Frame: Stainless steel (prototype only), Aluminum wire, HD-polyethylene

o Track: WaterShed 11120 Resin (prototype only), plastic with a low coefficient of friction that is able to be injection molded/cast

o Chin cup: Close cell foam, open cell foam (memory foam)

o Back piece: Velcro straps, polypropylene plastic support

o Padding: Closed cell polyethylene foam, surgical tubing, open cell foam

- Product lifespan:

o Neck brace should be capable of being worn up to ~18 hours per day (during waking hours), however most patients will only utilize the brace for about 4-5 hours per day

o With everyday use, the neck brace frame should last approximately 5 years, while the soft goods should be replaced about every 6 months

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