An engineer-physician team working at Shriners Hospital for Children in Springfield, Mass has combined digital manufacturing technologies in a new procedure for treating babies born with severe cleft lip and palate.

One of the first babies to be treated, a few months after surgery.

The engineer, Beth Roscoe, and the physician, Dr. Philip Stoddard, are using Geomagic software to bring smiles to children’s faces. Using 3D scanning technologies, Roscoe and Stoddard have developed a new treatment for severe cleft lip and palate that reduces the cleft width before surgery without inhibiting upper-jaw growth.

Searching for a better way
Two existing treatments, Naso-Alveolar Molding (NAM) and DentoMaxillary Appliance (DMA), are less than ideal treatments for this condition. Stoddard thought that computers might be the key to better pre-surgical treatment for wide cleft lip and palate, but he didn’t know about the technology to make it happen. That’s when he met Roscoe, then a resident in prosthetics, but previously a software engineer who developed CAD systems.

Could Roscoe develop a proposal for using CAD/CAM for pre-surgical treatment of cleft lip and palate? She proposed scanning a plaster model of a patient’s cleft palate to obtain 3D shape data, modeling a corrected cleft, interpolating between the model of the patient at the beginning and end of the treatment to reduce cleft width while accommodating growth, and then producing the series of treatment appliances with a rapid manufacturing system.

“The serial appliance approach was a way to circumvent the need to modify a single appliance every week,” says Roscoe. “Each appliance in the series would represent the manual modification used in the other methods. I knew it wasn’t an A-to-B linear path of treatment. The appliances needed to morph to accommodate changes in size, shape and even configuration.”

The first and last appliances in a series modeled by Beth Roscoe using Geomagic software.

The right tool at the right time
With the procedure outlined, the main question was the software that would be used for 3D modeling. Roscoe thought she might have to use the scan data as a reference and create the CAD model from scratch.

She gave the proposal to Stoddard, who shared it with Peter Fuss, an electrical engineer on the Geomagic board of directors. He arranged for Roscoe to obtain Geomagic Studio software. “(This) was the perfect solution to our very specific need – to be able to create and easily manipulate detailed 3D models from point clouds,” says Roscoe. “It enables us to produce highly accurate appliances that provide a custom-fit for each baby, and a means of specifying each patient’s unique 3D prescription.”

This baby received the new cleft lip and palate
treatment, during his initial visit to Shriners Hospital.

The final piece of the puzzle, how to manufacture the series of individual appliances, involves Bob Morehardt, owner of RMB Tool (formerly Mor-Tech), the first rapid prototyping service bureau in the Northeast United States to use selective laser sintering (SLS) systems. They decided to use RMB Tool’s SLS systems from 3D Systems to create the dozen or more appliances needed to serially mold a patient’s gums into a more normal position, while allowing the palate to grow naturally.

Here this baby is shown wearing one of the
appliances in the series.

After outlining the treatment methodology and determining the technology tools, it was time to put the new regimen to the test. This required permission from the Institutional Review Board (IRB). As approved, the procedure includes three basic steps:

Establish the initial palate shape by scanning a mold of the child’s lip and palate. Initially a CMM system was used for this; now Roscoe uses a ShapeGrabber 3D laser scanner for data capture.

Within Geomagic, define the desired final palate shape (allowing for growth), create the intermediate steps, and convert each palate shape into a digital model of the appliance at the different intermediate steps.

Manufacture the series of appliances needed for treatment using Morehardt’s SLS systems.

Treatment typically begins within the first month of the baby’s life and lasts 10 to 15 weeks, after which lip repair surgery is performed by the plastic surgeon. Two patients have completed the process. Treatment was well tolerated in both cases and the physical transformations are stunning.

Geomagic, Inc.
www.geomagic.com

MPF