Table 3.

Reviewed Studies Detailing Other Three-Dimensional-Printed Medical Devices

Field of application	Device description[Ref.]	3D-printing technology Printer (producer) Material	Patients Medical condition	Device use and clinical outcome
Abdominal surgery	Patient-specific hollow, curving pipe stent to plug enteroatmospheric fistula.106	FDM N/A TPU	♂, 33 yrs Enteroatmospheric fistula with intermittent high fever and cachexia.	Successful implantation of stent into the bowel with no obstruction around the fistulous-tract orifice, decrease in enteric fistula effluent amount, and increased stool frequency and capacity. Enteral nutrition restored by nasal feeding 4 days after surgery, without abnormal or subjective discomfort throughout the process. No sign of pyrexia or obvious infection, improved general condition at the 7-day follow-up.
Dental surgery	Patient-specific donor tooth replica to guide the preparation of artificial tooth sockets before donor tooth extraction for autotransplantation.103	SLM LayerWise (Layer-Wise NV, 3D Systems) Titanium alloy grade 23	2♀, 1♂, 11–13 yrs Agenesis of mandibular premolars, patients indicated for orthodontic extraction therapy of maxillary premolars.	Successful autotransplantation of 5 premolars, with immediate good fit (single fitting attempts), and decreased extraalveolar (15–45 s) and procedural times (20–30 min).
Gastro-enterology	Tailored endoscope caps for mucosal resection, submucosal dissection, Trucut biopsy, and peroral endoscopic myotomy.105	MJ Objet260 Connex (Stratasys) Silicone	14♀, 21♂, 33–78 yrs (mean 56) Gastric epithelial neoplasia, esophageal subepithelial tumor, and esophageal achalasia.	Increased ease and shorter duration of endoscopic procedure, with successful outcomes and without complications.
Immobilization
Wrist	Personalized hand–wrist–arm cast.110	FDM F370 (Stratasys) Stratasys ABS M30	Five pediatric patients Wrist fracture.	Patient-specific cast for wrist immobilization produced and applied by clinicians in day hospital, using a system for 3D scanning and semi-automatic 3D-modeling; manual generation of ventilation holes by an expert CAD modeler.
Leg	Customized external fixator in treating long bone fractures (Q-Fixator).112	SLA SPS600B (Shaanxi Hengtong Intelligent Machine) Photosensitive resin	3♂, 25–36 yrs Traumatic tibial shaft fracture.	Minimally invasive, accurate, experience-independent reduction and appropriate fixation without exposure to X-rays. Successful fracture healing without fixation pin loosening, pin site infection, or other complications at the 1-year follow-up. Fixator removal after 20–25 weeks.
	Patient-specific fracture external fixator.111	SLA SPS600B (Shaanxi Hengtong Intelligent Machine) Photosensitive resin	3 patients Tibial fracture	Successful repositioning of fragments, based on prior computer simulation of fracture reduction, without intraoperative exposure to X-rays. Fracture healing success monitoring during 20–25 weeks of external fixator use.
Infectology	Nasal swab.123	SLS N/A PA2200	Overall, 50 hospital staff, 2 patients with COVID-19	Sample collection with 3D-printed and conventional swab (Copan ESwab) in each patient. No significant differences in discomfort (median 5 points on a 10-point scale) were found between swabs. Overall, 67% participants preferred the 3D-printed swab, and 19% the conventional swab. According to health care providers, the swabs are easy to use, moderately easy to snap at the breakpoint, and provide a good balance between flexibility and rigidity.
Neurosurgery
Skull	Single-use, nonmetallic self-retaining skin and soft tissue retractor for insertion of ventricular catheter for treatment of hydrocephalus. Adaptable shunt retainer.104	N/A N/A UV-curable liquid resin	♂, 85 yrs Normotensive hydrocephalus	Successful ventricular shunt placement after unsuccessful attempts with standard stainless-steel retractor that caused intraoperative loss of signal of electromagnetic neuronavigation system due to interference with local magnetic field.
Orthopedics
Spine	Patient-specific self-docking tubular retractors for the minimally invasive transforaminal approach in revision lumbosacral surgery.37	SLS Eosint (EOS) PA-12 Manufactured by Anatomics	♀, 72 yrs Sciatica, complex L5–S1 pseudoarthrosis, 2 months after L2–S1 fixation surgery for symptomatic degenerative scoliosis.	Successful revision lumbosacral surgery, resolution of symptoms without implant dysfunction at the 6-month follow-up.
Oncology
Radiotherapy	Patient-specific bolus for desired dose distribution in photon/modulated electron radiotherapy.17	FDM MakerBot Z18 (MakerBot) PLA	♂, 74 yrs Recurrent squamous cell carcinoma of nasal septum, basal cell carcinoma of posterior pinna, and upper face mycosis fungoides.	Highly conformal bolus for radiotherapy, relative sparing of all the organs at risk distal to the target volume, while maintaining similar target volume coverage.
	Patient-specific bolus for desired dose distribution in photon/modulated electron radiotherapy.17	FDM LulzBot TAZ 5 (Aleph Objects) NinjaFlex TPU	1♂, 1♀, 67–68 yrs Recurrent squamous cell carcinoma of nasal septum, basal cell carcinoma of posterior pinna, and upper face mycosis fungoides.	Highly conformal bolus for radiotherapy, relative sparing of all the organs at risk distal to the target volume, while maintaining similar target volume coverage.
	Patient-specific bolus cap for delivering a uniform dose in total scalp irradiation.107	MJ PolyJet J750 (Stratasys) Agilus-60	♂, 78 yrs Squamous cell carcinoma of the scalp.	High conformality of bolus to patient scalp, 5.3% difference between measured and planned doses. The one-piece bolus was faster and easier to setup, with higher reproducibility of daily treatment compared with existing methods.
	Patient-specific bolus for chest wall radiotherapy.108	FDM LulzBot TAZ 5 (Aleph Objects) PLA	16♀, 38–83 yrs (median 61) Breast cancer, postmastectomy.	Minimum 4 treatments with bolus. Better fit to the chest wall compared with standard sheet bolus. No difference in agreement with the treatment planning system. Reduced setup time, considerable time for fabrication, and quality assurance.
	Patient-specific radiotherapy bolus.109	FDM Maker-Gear M2 (MakerGear) PLA/PHA	4♀, 6♂, 55–84 yrs (mean 68) Basal cell carcinoma, plasmacytoma of nose, nasal cavity, lacrimal gland, ear, scalp, knee, and tibia.	Successful use of boluses without issues with fit or comfort. In 9 of 12 cases, bolus bulk density within 3% of reference value, density uniformity as good as or better compared with traditional sheet bolus material.
Brachytherapy	Patient-specific applicator for desired dose distribution in surface high-dose rate brachytherapy.17	FDM LulzBot TAZ 5 (Aleph Objects) NinjaFlex TPU	♂, 75 yrs Rapidly growing squamous cell carcinoma of nose and face.	Highly conformal applicator for surface brachytherapy with adequate coverage. Relatively high dose to the left eye, owing to its proximity to the tumor.
Ophtalmology	Smart storage glide for preservation, transport, and easy insertion of lenticules into the recipient eye in Descemet stripping automated endothelial keratoplasty.122	MJ Projet 3510 HD plus (3DZ) N/A	Overall, 14 patients Fuchs' dystrophy, pseudophakic bullous keratopathy, posterior polymorphous dystrophy, and previous keratoplasty failure.	Successful corneal transplantation, without difference in visual outcomes, postoperative endothelial cell loss, and complication rates compared with conventional procedures. Reduced surgical time and required surgical tools, eliminated complications related to tissue preparation and loading onto delivery tools.
Orthodontics	Patient-specific orthodontic palatal stimulation plate for hypotonic musculature stimulation, and improved tongue position/tonus in infants.121	DLP Solflex 170 (VOCO) Methacrylate-based photosensitive resin	One patient, 13 months Hypotonic perioral musculature and macroglossia due to Trisomy 21.	Better fit, stayed in a place longer without adhesive cream compared with a conventionally produced plate.
Orthotics
Hand	Patient-specific fingerboard for poststroke limb rehabilitation and prevention/treatment of finger spasm.115	FDM N/A PLA	5♀, 8♂, 68.3 ± 4.9 yrs ∼2 months poststroke	Wearing of fingerboard for 2 h after rehabilitation exercises 3 times/day. Three patients discontinued use at the 3-week follow-up, and 2 patients at the 3-month follow-up. No skin allergy or hand swelling, improved grip strength, hand function and range of motion by varying degrees, decreased muscular tension by varying degrees, and no fingerboard failure at the 3-month follow-up.
	EMG-controlled hand orthosis to enhance tenodesis grip.117	FDM Moment2 (Moment) PLA	1♀, 9♂, 31–65 yrs Chronic spinal cord injury (C4–C7) with stable impairment of hand function.	Evaluation of strength and stability of grasp, palmar grasp torque, lateral pinch force, and eccentric load that the grasp could sustain, and functional independence in daily living. Significant improvement in the eating category of functional independence, no significant improvement grooming, bathing, clothing, or using small or relatively flat objects. Rating of orthosis dimensions 3.2/5.0, weight 3.8/5.0, adjustments 3.4/5.0, safety 4.1/5.0, durability 3.8/5.0, simplicity of use 3.9/5.0, comfort 3.8/5.0, effectiveness 4.5/5.0. 1 participant with spinal cord injury for 28 yrs, and flexor contracture of fingers and wrist performed worse using the orthosis.
	Dynamic hand device for improving dexterity and hand force in patients after stroke.118	N/A UP Box (Go Hot Technologies) N/A	Orthosis group: 5♂, 60 ± 8 yrs Control group: 1♀, 4♂, 57 ± 8 yrs >6 months poststroke with upper limb hemiparalysis.	30-min onsite training (daily life tasks) 2 times/week, ≥30-min/day home training for the rest of the week for 4 weeks. Significant improvement in Box and Blocks Test, grasp force, lateral pinch force, and palmar pinch force after training; no significant differences compared with the control group. Larger motivation for training: improvement consistent at the 2-week follow-up; deterioration in control group.
Wrist	Wrist orthosis for spasticity in chronic hemiparetic stroke.116	N/A N/A Photosensitive resin	3D-printing group: 5♀, 15♂, 55.2 ± 14.5 yrs Control group: 4F, 16M, 60.3 ± 9.8 yrs Chronic poststroke hemiparesis with wrist flexor spasticity.	Overall, 6 weeks of wearing orthoses 4–8 h per day, for at least 30 min. Greater changes in reducing spasticity and swelling of the wrist, improving motor function and passive range of wrist extension compared with low-temperature thermoplastic plate orthosis. No differences in pain. No feeling of increased spasticity or skin allergy reactions throughout the wearing process.
Foot	Patient-specific therapeutic foot insole.114	N/A Bodyarch X1 EVA	3D-printing group: 15♀, 15♂; 31–58 yrs (mean 40) Control group: 15F, 15M; 33–60 yrs (mean 43) Bilateral plantar fasciitis.	Overall, 9 weeks of insole use. Higher peak pressure in hallux and first metatarsal area, lower in mid-heel and lateral heel area at week 0 compared with conventional prefabricated insole. Lower comfort scores at week 8 compared with control group.
	Patient-specific insole for midfoot load distribution.113	N/A Bodyarch X1 Printer EVA Manufactured by Bodyarch	Experimental group: 20♀, 20♂, 26–55 yrs (mean 39) Control group: 20♀, 20♂, 29–60 yrs (mean 42) Symptomatic bilateral flatfoot.	Midfoot peak pressure significantly higher, contact areas of third and fourth metatarsal areas significantly smaller, no significant difference in heel and toe pressure, force, and contact area; significant improvement in comfort at week 8, significantly higher comfort score compared with prefabricated insoles.
Plastic surgery	Patient-specific framework and contour guide for paramedian forehead flap heminasal reconstruction.101	MJ Object30 Prime (Stratasys) MED 610	Guide group: 7♀, 3♂, 29–78 yrs (mean 43.6) Control group: 1♀, 9♂, 33–78 yrs (mean 49.3) Basal cell carcinoma, squamous cell carcinoma, congenital melanocytic nevus, benign alar tumor, alar trauma, and congenital deformity.	Successful heminasal reconstruction with reduced operative time, no significant differences in alar height or base width between the native and reconstructed sides, and significant improvement in alar width and area symmetry compared with the conventional approach.
	Cartilaginous-framework template for auricle reconstruction with autogenous costal cartilage and tissue-expanding technique.102	FDM MakerBot Replicator 2 (MakerBot Industries) PLA	10♀, 30♂, 6–29 yrs Unilateral microtia.	Auricular reconstruction with superior accuracy and decreased surgical time compared with the conventional approach. No surgery-related complications.
Prosthetics	Patient-specific antibacterial finger prosthesis.119	FDM Ultimaker 2 extended (Ultimaker B.V.) PLACTIVE™ (PLA +1% Cu nanoparticles)	2♂, 65 and 40 yrs Traumatic nondominant index finger amputation at the proximal phalanx.	1-min Box and Block Test to assess unilateral gross dexterity; 2 weeks of prosthesis use for 12–15 h/week. Increase in manual gross dexterity, high patient satisfaction scores (dimensions 4.2–5.0, weight 4.7, adjustments 4.3, safety 5.0, durability 4.5, ease of use 4.5–5.0, comfort 5.0, effectiveness 4.5–4.6, device satisfaction 4.6–4.8). Effectiveness against bacteria: 98.95% MRSA, 99.99% S. aureus, and 95.03–99.99% E. coli.
	Nasal prosthesis.120	MJ (multi-material jetting) Objet Connex 500 (Objet Geometries) TangoPlus	One patient 2 yrs after rhinectomy due to cancer.	Only the indirectly-produced prosthesis was judged clinically viable and worth rating in terms of esthetic quality. Likert 5-point scale for evaluation of positional accuracy, shape, color, and quality of edge; 19 evaluators unaware of the manufacturing procedure. Significantly better esthetics compared with conventional prosthesis, especially edge quality.