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| Q: Has your device received 510(k) clearance from the FDA? |
| A: Yes. The cranial molding orthosis designed and manufactured by Infinite Technologies (formerly Infinite Technologies and Eastern Cranial Affiliates) has received 510(k) clearance from the FDA . Our clearance number is K020448 and we have recently named our device the KidCap™ for Helmet Therapy. |
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| Q: What is your cranial mapping analysis in your plagiocephaly assessment? |
 A: The 2-Dimensional Cranial Mapping Analysis is an innovative assessment tool designed by the practitioners at Infinite Technologies. This system utilizes geometric principles to assess specific regions of the skull for asymmetry. Using this hand measurement system, asymmetry can be identified and quantified within 2mm.
The measurements from the 2-Dimensional Cranial Mapping Analysis are combined with the 3-dimensional image to create the most accurate and effective KidCap for each patient. Each KidCap is customized to meet the patient's specific and unique goals for correction; a main reason it is in the forefront of cranial molding technologies.  |
| Q: Aren't all plagiocephaly cranial helmets and band devices essentially the same? |
| A: No they are not. Learn about the difference among helmet therapies and devices. |
| However, the basic principles of correction are consistent for all devices: |
- Cranial prominences intimately contact the orthotic device (F1R1, F2R2)
- The areas of correction are suspended within the correctional voids (F3, F4)
- During growth, the bossed regions are held in equilibrium, while the depressed regions expand into the orthosis
- Correction depends on rate of head growth
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| The key to correction is providing an adequate counterforce to direct the growth of the expanding cranium. Therefore, a device must be strong enough to resist the expanding cranium at all times to provide an efficient correction. |
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| Q: What type of scanning device do you use to measure the infant or child's head? |
| A: Infinite Technologies uses one of the most advanced technologies in body capture and imaging, the Omega Scanner by Ohio Willow Wood. The Omega is an FDA approved handheld scanner, which captures a 3-dimensional model of the patient, which can be analyzed and modified on the computer. |
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| Q: What physical properties are unique to the KidCap Helmet? |
A: There are four unique physical properties on the KidCap Helmet:
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KidCap Front Image
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KidCap side Image
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KidCap Back Image
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- Transparent Polyester Shell (A) Safer for the child since the skin can be checked constantly. The material used by Infinite Technologies possesses the highest rigidity and structural integrity according to the latest engineering tests.
- Polymer Hinge (B) Device opens for simple application and cleaning.
- Dual Floating Guide & Stop (C) The KidCap is the only cranial molding orthosis to have a component to precisely and safely preset the "dynamic pressure" exerted on your child's skull.
The Stop is a unique component that will prevent the device from ever exerting too much pressure, or perhaps more importantly, prevents from over-tightening. These parts also prevent the KidCap from distorting to provide the most efficient mode of correction and optimal results.
- Hypoallergenic Padding (D) Padding is skin-friendly and placed only along the edges of the KidCap because less padding means healthier skin and better view of the head. 2-Stage Velcro Strap (E) Simple to adjust and guarantee complete closure of the device.
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The Flexural Modulus is a measure of a material’s stiffness when flexed. The flexural test (D790) measures the force required to bend a material under a 3-point loading condition. The KidCap possesses the highest modulus of 310,000 psi, the highest density (1.27 g/cm 3), and rates higher than The Band styles on the Rockwell R Scale Hardness Test (D 785).
The orthosis must also resist gravity’s pull of the child’s head and orthosis onto the surface of contact (i.e. bed, car seat, stroller). This could mimic the deformational effect of the cranium. Heat is absorbed through conduction into the material of the orthosis. A child will perspire in any orthosis worn and experience slightly higher than normal temperatures at sites of direct contact. Perspiration may also adversely interact with polymers that possess the ability to uptake water molecules into the chains potentially altering the structure of the plastic. Band style helmets are designed from Copolymer which is a polypropylene - polyethylene blend, usually of a 9:1 ratio possessing strength and resistance of both materials. Polyethylene foam (Volara) is a biocompatible foam irradiated with electrons during manufacturing. Polyethylene foam liners encompass the underside of the orthosis contacting the infant’s skull when the orthosis is donned.
The Vicat Softening Temperature (D1525) reflects the point of softening when a material is used in an elevated temperature application. Again, the material of the KidCap holds the highest rating, indicating the greatest resistance to body heat exposure. |
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