Custom 3D Printed Medical Devices for Reconstructive Craniomaxillofacial Surgery

3D imaging and printing is bringing the future of revolutionized healthcare very near. With more advancement in the technology in the related fields for instance artificial intelligence, powerful computations, image acquisition and processing times will be impressively minimized. Furthermore, medical imaging data will probably be cloud-hosted freeing up local computer storage which is substantial for 3D renders. Along with 2D imagery, 3D models offer a more comprehensive depiction of the patient’s state and are additional tool that neurosurgeons can implement to analyze and plan medical management for problematic neurological ailments.

3D printing is changing the dynamics of Craniomaxillofacial surgeries and also turning the impossible into endless possibilities. Craniomaxillofacial reconstructive surgery is however a tough but evolving area. Initially it focuses to bring back primary functions and then to safeguard the craniofacial anatomical structures like synchronization with the earlier features and of course restoring symmetrical features. Three-dimensional (3D) printed Bio-models have been extensively adopted in medical fields by offering tangible feedback and a higher gratitude to visuo-spatial relationship between various and unique anatomical structures. Craniomaxillofacial reconstructive surgery was one of the prime areas to implement 3D printing technology in their practice. Bio-modeling has been utilized in congenital disorders, craniofacial reconstruction of traumatic injuries, iatrogenic injuries, tumor removal, orthognathic surgery, and implantology. 3D printing has shown itself as an excellent method, it allows simulation and planning for pre-operation, establishes tools for intraoperative management, minimize operative time, and considerably augment the bio-functional and the visual results of the surgery.

3D Imaging for Neurosurgical assistance

Process of Development of 3D Bio-Models

Development of 3D Bio-models is what which has become the core of revolution in successful surgical operations becomes. The robust process of manufacturing of 3D bio-models, normally referred as reverse engineering, comprises of the stated four fundamental progressive steps:

Step 1: Generation of super quality volumetric 3D image data of the anatomical entity by any of the two techniques either the CT or the MRI, both techniques help for modeling the anatomical object. CT slice thickness which is less than 1-mm is normally required and recommended.

Step 2: 3D image processing is used to grasp the area of interest from the neighboring tissues, which may need two software types:

First software is “3D modeling” software. It interprets the digital imaging and encodings in medicine (DICOM) files from CT/MRI scans into a Computer Aided Design (CAD) file; emphasizing the areas of surgical interest.

Second software is a “3D slicing” software that process the CAD file and splits it into thin data slices which is appropriate for 3D printing.

Step 3: The 3D Model preparation and building is done by either of the two methods:

Subtractive Manufacturing: Machining a block of material to the desired 3D CAD model.

Additive Manufacturing: This method is mostly used. It comes with material addition layer by layer or we can say it is the fusion of the layers into the desired model.

Step 4: Quality assurance (QA) of the 3D model is important. This step checks the dimensional accuracy and if the model is not with desired quality it is reprocessed or a new model is produced.

It is vital that biomedical models produced by 3D printing technology are put under rigorous QA at all steps of the manufacturing process.

Jaw Surgery & Facial Models

A model of a man’s mouth was imitated with the help 3D printing and employed as a prototype to form a wax model, which was then hardened and ultimately adjusted with teeth.

One case is about the Indian man’s upper jaw removal. The removal was done because of cancer. Due to removal of his parts, both his nose and mouth left unprotected and exposed to the environment. Situation worsen for the forty-one year old person, when due to six-week radiotherapy, he induced radiation fibrosis and consequently got lockjaw, ruthlessly influencing his capability to open his mouth.

Specialists utilized a CT scan to form a 3D reconstruction of the person’s face. A 3D replica of the affected person’s mouth was then printed and utilized as a reference to form a wax model, which was then hardened and tailored with teeth fitment. With the prosthesis adjusted to fit comfortably in position, the person’s swallowing, chewing, speaking and remaining facial movements are reported to be significantly improved.

Neurosurgery & Cranial Tumor

The inception of 3D printing, HD imaging or 3D imaging has got the premier quality in imaging modalities to the area of neurosurgery. Marginally intrusive brain surgery has now become the hallmark of care in field of neurosurgery because of the implementation of endoscopic aperture methods together with high-quality 3D imaging systems which are intra-operative along-with the 3D printing devices. All these advancements have improved the quality and safety in the area of neurosurgery.

Personalized, patient-unique surgical implants are presently available and are renovating the landscape in cranioplasty and the human-machine interaction in the same way as surgical education. A 3D model from 3D printing now serves as a specimen, which can train present-day and prospective surgeons to deal with intricate skull base diseases together with malignant brain tumors and invasive benign.

In the beginning of 3D printing for medical implementation in the year 2014, there was an incredible event related to a person who saved the eyesight of his wife by 3D printing meningioma, her brain tumor, which was complicated and tangled her optic nerves. The 3D model persuaded Pamela Shavaun Scott’s physicians to employ a minimally invasive keyhole approach in the eyebrow to eliminate the tumor and protect the woman’s eyesight.

TS Quality can help in 3D Imaging, Reverse Engineering & 3D Printing Solutions

Cranial and maxillofacial structures are not only complicated but also singularly unique among individuals. The implementation of these 3D biomedical models in both maxillofacial and cranial reconstructive surgery is said to be very beneficial in the design and development of singular prosthesis and dimensioning of bone grafts. It is also used for production of frameworks for bone regeneration along with other traits of medical research and education.

TS Quality & Engineering has a pool of competent engineers, and consultants who can help companies with the challenges they are facing in the areas of 3D Imaging, Reverse Engineering, & 3D Printing Solutions. Please give us a call and let us know your needs. 

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.

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