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500 sets of a medical device

In Morpheus' arms

"The design of medical appliances is a very delicate matter and has to be verified several times with doctors and patients. Single-piece prototypes come in very handy then. We need the support of experts like Materialise to accomplish our projects in a successful way."

Adrian Zacher - Managing Director of ZSA Ltd

Maybe you can't help laughing when somebody is complaining of his snoring problem but the social consequences of snoring alone make snoring no laughing matter. Snoring can cause great distress for the snorers' bed partners, leading up to 80% of couples sleeping in different rooms. Indeed, not a great recipe for a good relationship.
Snoring is often a symptom of Obstructive Sleep Apnea, a sleep disorder that is potentially life-threatening. Apnea sufferers are often diagnosed as depressed, when really they are simply exhausted and cannot function properly. Sleep apnea raises your blood pressure, reduces the flow of oxygen to your brain and can, at worst, lead to stroke, heart attack and death. In other words, this is not something you can ignore.

 

 

Snoring is a disease and diseases should be treated.

Mouthpiece devices -- also known as dental appliances, or mandibular advancement splints -- have been effective for many snorers, including those suffering from mild or moderate obstructive sleep apnea.
Such devices are sometimes called "boil and bite"; they are made of soft plastic which you soften by placing in hot water; you then bite into the mouthpiece, moulding it to your jaw.

 

"You are no doubt familiar with 'Boil and Bite' devices and you know about custom adjustable devices which cost a fortune. There is now a third way... the new DontSnore® device inexpensively answers the questions about intra oral tolerance (where a 'Boil and Bite' is useful - first two weeks BIG drop out) and then goes on and allows adjustment of the jaw position to determine if there is an effective position."

Adrian Zacher, Managing Director of ZSA Ltd

ZSA Ltd was formed in September 2003 by Adrian Zacher. Mr. Zacher ran a small specialist dental laboratory (Zacher Sleep Appliances) producing dental appliances for snorers and apnoeaics on medical referral.
ZSA Ltd. was formed with a view to expand the science of dental sleep medicine in the UK, by bringing the best devices, equipment and experts from around the world to explain their application.

 

In January 2003, Mr. Zacher decided to develop a new type of mouthpiece device as a remedy for sleep apnea. Materialise assisted him throughout the whole project, from the first concept models to the pre-series in the final production material.

"The design of medical appliances is a very delicate matter and has to be verified several times with doctors and patients, leading eventually to multiple adjustments to the initial design. Single-piece prototypes come in very handy then. That is one of the reasons why we need experts like Materialise to accomplish our projects in a successful way."

Mr. Zacher realised the difficult side of his project

In a first stage, selective laser sintering was chosen as the appropriate technology due to its ability to produce fully functional models. The polyamide material allows the manufacturing of strong, durable parts that can be used for extensive functional testing.
The very first 3D model was thus printed on one of the SLS machines on the Materialise shopfloor. After thorough evaluation, the initial design was revised and a new, adapted STL-file was sent to the SLS machine.

In total, five prototypes were made in SLS, with phases of evaluation and revision in between the five builds.

 

 

"We used the prototypes to refine the design, perfect the form and test its medical possibilities. The SLS parts came up to my expectations; they allowed us to discuss the DontSnore® device in great detail and finally optimize it

Mr. Zacher

First selective laser sintering models - ready to be tested

When the device had been approved by everyone - Mr. Zacher himself, surgeons, dentists, patients,… - the aluminium tools were prepared in our tooling plant in the UK. A series of 500 sets was moulded in the real production material.

 

Two different tools were used to mould all components

Two different tools were used to mould all components

By the beginning of July 2003 all sets of the new DontSnore® device were moulded and ready to be used as a diagnostic tool.

 

"At present, our DontSnore® appliance is being field-tested in the world of dental and medical science", indicates Mr. Zacher. "With Materialise's help we were able to develop a successful device which is adjustable to the patient's mouth and will be a revolutionary remedy for sleep apnea. Once the regular procedures have been followed and the medical world is convinced of its capability, we can apply our knowledge to manufacture the 'real thing'."

Materialise wishes to thank Mr. Zacher for involving us in this interesting project and sharing his experiences.

Sources:
www.zsa.co.uk  
www.putanendtosnoring.com

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