The Cleft Palate Repair Simulator (Nicholas) is a low-cost trainer for infant cleft palate repair, built as a 3D-printed skeletal base that carries a disposable silicone soft-tissue cartridge.[1] The Supplementary Appendix provides an illustrated trainee instruction manual.[2] Trainees use it to practise the vomerine mucosal flap and intra-velar veloplasty, and the source notes it also accommodates the Furlow opposing Z-palatoplasty.
Field
Details
Features and Basic Operation
The silicone soft-tissue cartridge is disposable, swapped out between repairs. One fidelity limit is stated by the source itself: at the cleft margin the guide tells trainees that "in a real cleft you will see the colour difference between the oral and nasal mucosa", so the simulator does not reproduce that colour cue. The base's mandibular component can be adjusted to restrict oral access and grade difficulty. The source says the base can be made locally from an open-access STL file, but it publishes no address for that file (see Step 3). Procedural training is provided in Appendix 2, “Cleft Palate Training Simulator — Step-by-Step Guide,” in the paper’s Supplementary Appendix.[2]
Current Development Status
Built and evaluated in an educational pilot study with surgical trainees; not clinically validated.
Estimated Build Time and Cost
£64.30 (£38 for the skeletal base including lower jaw and upper head, plus £26.30 for the replaceable cartridge).
depends on local 3D-printing and silicone-casting throughput.
Specialized Tools and Equipment
To make the base: a 3D printer that prints VeroWhite, plus plastic molding of the printed base. To make the cartridge: 3D surface scanning, mold-making, and silicone casting. In use: standard surgical instruments and sutures (operator-supplied). The source's step-by-step guide names a beaver blade as helpful for the initial incision along the cleft margin. Its photographs also show a scalpel, fine forceps and scissors in use; the guide does not name the instrument used to lift the mucoperiosteal flap.
Version
Version 1
Development Team Contact Information
Nicholas R, Heinze Z, Papavasiliou T, Fiadeiro R, Atherton D, Timoney N, Echlin K — Evelina London Children's Hospital, Oxford University Hospitals, Brunel University London, and Birmingham Children's Hospital. Corresponding author: R. Nicholas (rebeccanicholas@ymail.com).
Mucoperiosteum of the hard palate — the layer raised in the vomerine mucoperiosteal flap. Cast in silicone; the source varies shore hardness to mimic each tissue but does not give specific values.
Muscle layer of the soft palate, released and repositioned in intra-velar veloplasty. The source labels this layer "muscle" and does not name the individual muscles. Cast in silicone.
Bone of the alveolar arch, part of the reusable skeletal base. The source 3D-prints the base in VeroWhite before molding it in hard plastic. The source's orientation diagram labels it Bone: Alveolar Arch.
Bone of the hard palate, part of the reusable skeletal base. The source 3D-prints the base in VeroWhite before molding it in hard plastic. The source's orientation diagram labels it Bone: Palatal Shelf. The mucoperiosteum is lifted off this bone for about 3 mm.
Midline nasal-septal bone, part of the reusable skeletal base. The source 3D-prints the base in VeroWhite before molding it in hard plastic. The source's orientation diagram labels it Vomer. The vomer flap is incised down to this bone and sutured under the oral mucosa.
Lining of the nasal cavity above the palate, labelled Nasal Lining on the source's orientation diagram. Distinct from the soft-palate nasal mucosa row above.
Uvula at the posterior free edge of the soft palate, labelled Uvula on the source's orientation diagram. In a cleft palate it is bifid.
Structural Parts
Part Name
Qty
Material
Cost
Notes
Skeletal base (lower jaw and upper head)
1 set
Hard plastic (molded)
£38
Reusable cranio-facial skeletal base. The source generated it by fine-cut CT of a preserved pathology specimen, 3D-printed it in VeroWhite, then molded it in hard plastic. Its mandibular component adjusts to restrict oral access and grade difficulty. The disposable cartridge seats into it.
Build Instructions
No download address is given for the print or mould files. The paper describes an open-access STL file for the base but gives no download address (see Step 3). No files for the layer moulds are named. Until files are found, Steps 2 and 3 cannot be followed without the base file, and Steps 7 and 8 cannot be followed without the layer moulds from Step 6.
Step 1: Take a fine-cut CT scan of a formaldehyde-preserved pathology specimen. The source used a preserved specimen because living-infant CT scans were too widely spaced to give the needed skeletal detail, owing to radiation-exposure limits.
Step 2: 3D-print the skeletal base in VeroWhite from the CT geometry.
Step 3: Mold the skeletal base in hard plastic from the 3D print. The paper describes an open-access STL file but gives no download address. Contact the corresponding author of Nicholas et al. (2022) about access to the design files.
Step 4: Wax-model each soft-tissue layer (hard-palate mucoperiosteum, soft-palate oral mucosa, soft-palate nasal mucosa, and muscle) onto the skeletal base.
Step 5: 3D surface-scan each waxed layer to capture its geometry.
Step 6: Generate a mold for each layer from its scan.
Step 7: Cast each layer in silicone, varying the shore hardness to mimic each tissue.
Step 8: Build up the cast layers in sequence to form the disposable soft-tissue cartridge.
Step 9: Seat the cartridge into the base, which carries the adjustable mandibular component used to grade oral access.
