Good News for Children Suffering From Cleft Lip and Palate, Worldwide

PD Dr. Andreas Mueller and his team made a first giant leap towards allowing worldwide pre-surgical cleft lip and palate treatment by access to an orthopaedic plate, possible through to digitalisation, automation and decentralised 3D printing. This collaborative project of University of Basel (DBE/University Hospital Basel) and ETH Zurich is funded by Botnar Research Center for Child Health.

Cleft operations and continuous research in the quest of its further improvement has a long history in Basel and is a topic close to the heart of the facial and cranial anomalies group of PD. Dr. Andreas Mueller. He is also a chief surgeon at the University Hospital of Basel with experience in cleft surgeries for more than 20 years. Dr. Barbara Solenthaler and her team from the Department of Computer Science at the Federal Institute of Technology in Zurich are specialised in computer graphics and bring the state of the art technology into the preoperative cleft treatment regime. Teaming up these seemingly different disciplines with the funding from the Botnar Research Center for Child Health (BRCCH) build the basis of that success story.

The team vision right at the beginning of that cooperation in March 2020 was to reduce the treatment burden for cleft patients straight after birth with the mission to be able to give worldwide access to this treatment to every child born with a cleft at the project end in September 2025.

There are different types of clefts, a splitting of the lip and the palate or just of the lip or the palate in differing severities. The treatment we developed here is benefitting the patients with a cleft in the palate, which accounts for roughly one in 700 babies born. These babies have a continuity of the oral space to the nasal cavity, as the developmental step of its closure in week 12 did not happen. The babies habit of pushing the tongue into the cleft, keeps the cleft wide and the tissue is dislocated, both negative factors for cleft closure, which is performed around 8 months after birth. There are additional conundrums for these cleft babies. How to drink and to gain weight, if the food partially runs out of the nose, or mistakenly runs into the breathing tube? How about the ease of feeding and the “new mothers” trying to fit in with their babies?

A laboursome process

A proven widespread treatment is to give a palatal plate to babies with a palatal cleft, straight after birth, now covering up the cleft and carried by the baby constantly. The plate prohibits the tongue access to the cleft. Due to the soft bone structure, the first months after birth, the shape of the palate and therefore its tissue is malleable. The inaccessibility of the tongue alone is enough to narrow the cleft and to bring the tissue in its optimal position, now allowing an easier cleft closure once the baby is 8 months. A further benefit of the palatal plate is the improved aesthetics of feeding and as a side effect the improved feeding also allows normal weight gain.

Until now the production of that palatal plate is a laboursome process, which is not risk free for the patient and requires highly skilled personnel only available at good resourced medical centres. The process required an impression from the cleft area, which has to be performed by a physician to minimize the risk of material entering the breathing tube. From this impression a model is produced, to which afterwards the palatal plate is laboursome fitted by again highly specialized personnel. Therefore, until now this pre-surgical plate treatment is only an option for a few cleft patients.

Working with available technology

A breakthrough for an easier palatal plate production comes through the availability of new technologies like scanners and 3D printing and the use of newly developed digital solutions from the group around Dr. Barbara Solenthaler, ETHZ. Starting from around two years ago the manual impression of the palate was replaced by a digital impression by newly available scanner technology, a procedure which abolishes the risk of suffocating and which can be performed by a more widely available medical staff. Furthermore, highly skilled researchers from the ETHZ are able with algorithms and artificial intelligence to predict straight away from the digital input data a digital individual plate for each cleft-baby. These digital plates can then be printed in the hospital or anywhere else on a 3D printer and are then available for the patient.

One big advantage of digital data is its worldwide instant access and instant sharing, after initial overcoming of regulation requirements dealing with these sensitive medical data, here. As a consequence, there is an independence of the location of data collection and data usage. Therefore, digital palate impression taking can benefit any cleft-baby anywhere in the world, where there is access to a scanner. The digital plate design can be performed online with a method using algorithms developed by the ETHZ and the palatal plate can be 3D-printed in close proximity to the patient.

We were totally overwhelmed when Dr. Nalabothu put our digital pipeline to test at two cleft centres in India, at the Saveetha Medical College and Hospital and at Bhagwan Mahaveer Jain Hospital in Bangalore. For the first time outside of Switzerland, we could prove our digital workflow: from data collection by scanning, to the automatic plate design and its subsequent 3D printing. The plate was given to the baby, the plate stopped the tongue entering into the cleft and passively allowed the narrowing of the cleft, allowing a less burdensome cleft closure. We also received positive feedback from the parents, who valued the plate highly also in terms of feeding.

We are pleased with our achievement: “First step in allowing worldwide pre-surgical cleft lip and palate treatment by access to an orthopaedic plate, possible through to digitalisation, automation and decentralised 3D printing.”

Even so we have achieved a main goal of our endeavour, we continue our journey by pushing forward in order to bring our great invention to cleft-babies, which at the moment do not have the privilege of access to a treatment centre with a scanner, as these scanners remain for the foreseeable future a big investment.

We furthermore continue our observations “on the ground” in other cleft-centres in middle and low income countries to understand how best and most efficiently to introduce our digital workflow there. We have learned that the needs and local settings may vary from country to county or even from centre to centre. Therefore, we incorporate these learnings by creating various options to choose from in our digital workflow, aiming to accommodate all Cleft Care Centres and in turn supporting all cleft patients.

If you share our mission and would like to support us, we would be very pleased to continue also in your name.

Donation opportunity

  • Reference:                 FO148000, research group account FCA Mueller;
  • Bank Name:               UBS AG, Aeschenplatz 6, 4052 Basel
  • BLZ:                            233
  • SWIFT:                       UBSWCHZH80A
  • Konto                          0233-622614.03E
  • IBAN                           CH83 0023 3233 6226 1403 E

We thank you very much.

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