Clinical Utility of a 3D-Printed Patient-Specific Surgical Guide for Partial Nephrectomy.

Partial nephrectomy (PN) is a common surgery for small renal masses. The goal is to remove the mass completely while preserving renal function. A precise incision is, therefore, important. However, no specific method for surgical incision in PN exists, although there are several guides for bony structures using three-dimensional (3D) printing methods. Therefore, we tested the 3D printing method to create a surgical guide for PN. We describe the workflow to make the guide, which comprises computed tomography data acquisition and segmentation, incision line creation, surgical guide design, and its use during surgery. The guide was designed with a mesh structure that could be fixed to the renal parenchyma, indicating the projected incision line. During the operation, the 3D-printed surgical guide accurately indicated the incision line, without distortion. An intraoperative sonography was performed to locate the renal mass, which confirmed that the guide was well placed. The mass was completely removed, and the surgical margin was negative. No inflammation or immune reaction occurred during and 1 month after the operation. This surgical guide proved useful during PN for indicating the incision line and was easy to handle, without complications. We, therefore, recommend this tool for PN with improved surgical outcome.

The Feasibility of Computer Simulations and 3-Dimensional-Printed Resection Guides for Skin Cancer Resection.

The surgical resection margin in skin cancer is traditionally determined by the lesion's surface boundary without 3-dimensional information. Computed tomography (CT) can offer additional information, such as tumor invasion and the exact cancer extent. This study aimed to demonstrate the clinical application of and to evaluate the safety and accuracy of resection guides for skin cancer treatment. This prospective randomized comparison of skin cancer resection with (guide group; n=34) or without (control group; n=28) resection guide use was conducted between February 2020 and November 2021. Patients with squamous cell carcinoma or basal cell carcinoma were included. In the guide group, based on CT images, the surgical margin was defined, and a 3-dimensional-printed resection guide was fabricated. The intraoperative frozen biopsy results and distance from tumor boundary to resection margin were measured. The margin involvement rates were 8.8% and 17.9% in the guide and control groups, respectively. The margin involvement rate was nonsignificantly higher in the control group as compared with the guide group ( P =0.393). The margin distances of squamous cell carcinoma were 2.3±0.8 and 3.4±1.6 mm ( P =0.01) and those of basal cell carcinoma were 2.8±1.0 and 4.7±3.2 mm in the guide and control groups, respectively ( P =0.015). Margin distance was significantly lower in the guide group than the control group. The resection guide demonstrated similar safety to traditional surgical excision but enabled the minimal removal of normal tissue by precisely estimating the tumor border on CT scans.

Evaluation of the accuracy of an augmented reality-based tumor-targeting guide for breast-conserving surgery.

BACKGROUND AND OBJECTIVES: Although magnetic resonance imaging (MRI) is commonly used for breast tumor detection, significant challenges remain in determining and presenting the three-dimensional (3D) morphology of tumors to guide breast-conserving surgery. To address this challenge, we have developed the augmented reality-breast surgery guide (AR-BSG) and compared its performance with that of a traditional 3D-printed breast surgical guide (3DP-BSG). METHODS: Based on the MRI results of a breast cancer patient, a breast phantom made of skin, body, and tumor was fabricated through 3D printing and silicone-casting. AR-BSG and 3DP-BSG were executed using surgical plans based on the breast phantom's computed tomography scan images. Three operators independently inserted a catheter into the phantom using each guide. Their targeting accuracy was then evaluated using Bland-Altman analysis with limits of agreement (LoA). Differences between the users of each guide were evaluated using the intraclass correlation coefficient (ICC). RESULTS: The entry and end point errors associated with AR-BSG were -0.34±0.68 mm (LoA: -1.71-1.01 mm) and 0.81±1.88 mm (LoA: -4.60-3.00 mm), respectively, whereas 3DP-BSG was associated with entry and end point errors of -0.28±0.70 mm (LoA: -1.69-1.11 mm) and -0.62±1.24 mm (LoA: -3.00-1.80 mm), respectively. The AR-BSG's entry and end point ICC values were 0.99 and 0.97, respectively, whereas 3DP-BSG was associated with entry and end point ICC values of 0.99 and 0.99, respectively. CONCLUSIONS: AR-BSG can consistently and accurately localize tumor margins for surgeons without inferior guiding accuracy AR-BSG can consistently and accurately localize tumor margins for surgeons without inferior guiding accuracy compared to 3DP-BSG. Additionally, when compared with 3DP-BSG, AR-BSG can offer better spatial perception and visualization, lower costs, and a shorter setup time.

Educational simulator for mastoidectomy considering mechanical properties using 3D printing and its usability evaluation.

Complex temporal bone anatomy complicates operations; thus, surgeons must engage in practice to mitigate risks, improving patient safety and outcomes. However, existing training methods often involve prohibitive costs and ethical problems. Therefore, we developed an educational mastoidectomy simulator, considering mechanical properties using 3D printing. The mastoidectomy simulator was modeled on computed tomography images of a patient undergoing a mastoidectomy. Infill was modeled for each anatomical part to provide a realistic drilling sensation. Bone and other anatomies appear in assorted colors to enhance the simulator's educational utility. The mechanical properties of the simulator were evaluated by measuring the screw insertion torque for infill specimens and cadaveric temporal bones and investigating its usability with a five-point Likert-scale questionnaire completed by five otolaryngologists. The maximum insertion torque values of the sigmoid sinus, tegmen, and semicircular canal were 1.08 ± 0.62, 0.44 ± 0.42, and 1.54 ± 0.43 N mm, displaying similar-strength infill specimens of 40%, 30%, and 50%. Otolaryngologists evaluated the quality and usability at 4.25 ± 0.81 and 4.53 ± 0.62. The mastoidectomy simulator could provide realistic bone drilling feedback for educational mastoidectomy training while reinforcing skills and comprehension of anatomical structures.

Patient-specific, deliverable, and self-expandable surgical guide development and evaluation using 4D printing for laparoscopic partial nephrectomy.

Accurate lesion diagnosis through computed tomography (CT) and advances in laparoscopic or robotic surgeries have increased partial nephrectomy survival rates. However, accurately marking the kidney resection area through the laparoscope is a prevalent challenge. Therefore, we fabricated and evaluated a 4D-printed kidney surgical guide (4DP-KSG) for laparoscopic partial nephrectomies based on CT images. The kidney phantom and 4DP-KSG were designed based on CT images from a renal cell carcinoma patient. 4DP-KSG were fabricated using shape-memory polymers. 4DP-KSG was compressed to a 10 mm thickness and restored to simulate laparoscopic port passage. The Bland-Altman evaluation assessed 4DP-KSG shape and marking accuracies before compression and after restoration with three operators. The kidney phantom's shape accuracy was 0.436 ± 0.333 mm, and the 4DP-KSG's shape accuracy was 0.818 ± 0.564 mm before compression and 0.389 ± 0.243 mm after restoration, with no significant differences. The 4DP-KSG marking accuracy was 0.952 ± 0.682 mm before compression and 0.793 ± 0.677 mm after restoration, with no statistical differences between operators (p = 0.899 and 0.992). In conclusion, our 4DP-KSG can be used for laparoscopic partial nephrectomies, providing precise and quantitative kidney tumor marking between operators before compression and after restoration.

Comparing the biomechanical properties of conventional suture and all-suture anchors using patient-specific and realistic osteoporotic and non-osteoporotic phantom using 3D printing.

Conventional suture anchors (CAs) and all-suture anchors (ASAs) are used for rotator cuff repair. Pull-out strength (POS) is an important factor that affects surgical outcomes. While the fixation mechanism differs between the anchor types and relies on the quality, few studies have compared biomechanical properties of anchors based on bone quality. This study aimed to compare the biomechanical properties of anchors using osteoporotic bone (OB) and non-osteoporotic bone (NOB) simulators. Humerus simulators were fabricated using fused deposition modeling of 3D printing and acrylonitrile butadiene styrene adjusting the thickness of cortical bone and density of cancellous bone based on CT images. Cyclic loading from 10 to 50 N, 10 to 100 N, and 10 to 150 N for 10 cycles was clinically determined at each anchor because the supraspinatus generates a force of 67-125 N in daily activities of normal control. After cyclic loading, the anchor was extruded at a load of 5 mm/min. Displacement, POS, and stiffness were measured. In OB simulators, CAs revealed bigger gap displacement than ASAs with cyclic loading of 10-150 N. ASA showed higher values for POS and stiffness. In NOB simulators, ASAs revealed bigger gap displacement than CAs with cyclic loading of 10-150 N. ASA showed higher values for POS and CA showed higher values for stiffness. POS of anchors depends on anchors 'displacement and bone stiffness. In conclusion, ASA demonstrated better biomechanical performance than CA in terms of stability under cyclic loading and stiffness with similar POS in OB.

Utilizing patient-specific 3D printed kidney surgical guide with realistic phantom for partial nephrectomy.

Partial nephrectomy has been demonstrated to preserve renal function compared with radical nephrectomy. Computed tomography (CT) is used to reveal localized renal cell carcinoma (RCC). However, marking RCC directly and quantitatively on a patient's kidney during an operation is difficult. We fabricated and evaluated a 3D-printed kidney surgical guide (3DP-KSG) with a realistic kidney phantom. The kidney phantoms including parenchyma and three different RCC locations and 3DP-KSG were designed and fabricated based on a patient's CT image. 3DP-KSG was used to insert 16-gauge intravenous catheters into the kidney phantoms, which was scanned by CT. The catheter insertion points and angle were evaluated. The measurement errors of insertion points were 1.597 ± 0.741 mm, and cosine similarity of trajectories was 0.990 ± 0.010. The measurement errors for X-axis, Y-axis, and Z-axis in the insertion point were 0.611 ± 0.855 mm, 0.028 ± 1.001 mm, and - 0.510 ± 0.923 mm. The 3DP-KSG targeted the RCC accurately, quantitatively, and immediately on the surface of the kidney, and no significant difference was shown between the operators. Partial nephrectomy will accurately remove the RCC using 3DP-KSG in the operating room.

An interactive and realistic phantom for cricothyroidotomy simulation of a patient with obesity through a reusable design using 3D-printing and Arduino.

BACKGROUND AND OBJECTIVES: Proper airway management during emergencies can prevent serious complications. However, cricothyroidotomy is challenging in patients with obesity. Since this technique is not performed frequently but at a critical time, the opportunity for trainees is rare. Simulators for these procedures are also lacking. Therefore, we proposed a realistic and interactive cricothyroidotomy simulator. METHODS: All anatomical structures were modeled based on computed tomography images of a patient with obesity. To mimic the feeling of incision during cricothyroidotomy, the incision site was modeled to distinguish between the skin and fat. To reinforce the educational purpose, capacitive touch sensors were attached to the artery, vein, and thyroid to generate audio feedback. The tensile strength of the silicone-cast skin was measured to verify the similarity of the mechanical properties between humans and our model. The fabrication and assembly accuracies of the phantom between the Standard Tessellation Language and the fabricated model were evaluated. Audio feedback through sensing the anatomy parts and utilization was evaluated. RESULTS: The body, skull, clavicle, artery, vein, and thyroid were fabricated using fused deposition modeling (FDM) with polylactic acid. A skin mold was fabricated using FDM with thermoplastic polyurethane. A fat mold was fabricated using stereolithography apparatus (SLA) with a clear resin. The airway and tongue were fabricated using SLA with an elastic resin. The tensile strength of the skin using silicone with and without polyester mesh was 2.63 ± 0.68 and 2.46 ± 0.21 MPa. The measurement errors for fabricating and assembling parts of the phantom between the STL and the fabricated models were -0.08 ± 0.19 mm and 0.13 ± 0.64 mm. The measurement errors internal anatomy embodied surfaces in fat part were 0.41 ± 0.89 mm. Audio feedback was generated 100% in all the areas tested. The realism, understanding of clinical skills, and intention to retrain were 7.1, 8.8, and 8.3 average points. CONCLUSIONS: Our simulator can provide a realistic simulation experience for trainees through a realistic feeling of incision and audio feedback, which can be used for actual clinical education.

Accuracy evaluation of a 3D printing surgical guide for breast-conserving surgery using a realistic breast phantom.

To prevent recurrence after breast-conserving surgery (BCS), it is imperative to secure a clear resection margin, and magnetic resonance imaging (MRI) is useful for predicting this. Although MRI is highly accurate in predicting the extent of a tumor, it is difficult to quantitatively mark the tumor area directly on the patient's breast skin using MRI. Therefore, we developed a 3D-printed breast surgical guide (3DP-BSG). The 3DP-BGS is positioned on the breast using the guideline pointing to the opposite nipple and clavicle notch, centering on the nipple of the breast with the tumor. Then, the tumor was visualized by injecting blue-dye into the breast along the guide's columns using a syringe. For the quantitative evaluation of 3DP-BSG, the experiment must be done in the simulated environment. However, since it is difficult to construct the environment in the clinical field, we have fabricated a realistic breast phantom using an MRI. For modeling the 3DP-BSG, the phantom was scanned using computed tomography (CT), and. Based on these images, the 3DP-BSG was modeled to mark a 5-mm safety margin on a patient's breast skin by inserting a 16-gauge intravenous catheter. Then, the breast phantom was scanned by CT for quantitative evaluation. The insertion point measurement error (mean ± standard deviation) was 2.513 ± 0.914 mm, and the cosine similarity of the trajectories was 0.997 ± 0.005. This 3DP-BSG exhibits high accuracy in tumor targeting and is expected to facilitate precise BCS by providing a quantitative measure of the tumor area to surgeons.

Evaluation of skin cancer resection guide using hyper-realistic in-vitro phantom fabricated by 3D printing.

Skin cancer usually occurs in the facial area relatively exposed to sunlight. Medical imaging can confirm the invasiveness and metastasis of skin cancer, which is used to establish a surgical plan. However, there is no method of directly marking this information on the patient's skin in the operating room. We evaluated a skin cancer resection guide that marks resection areas including safety margins on the patient's skin based on medical images and in-vitro phantom fabricated via 3D printing. The in-vitro phantom, which includes the skull, skin, and five different cancer locations was designed and fabricated based on a CT image of a patient. Skin cancer resection guides were designed using a CT image of an in-vitro phantom, with a safety margin, and four injection points at each cancer. The guide was used to insert 16 cc intravenous catheters into each cancer of the phantom, which was rescanned by CT. The catheter insertion point and angle were evaluated. The accuracy of the insertion points was 2.09 ± 1.06 mm and cosine similarities was 0.980 ± 0.020. In conclusion, skin cancer resection guides were fabricated to mark surgical plans on the patient's skin in the operating room. They demonstrated reasonable accuracies in actual clinical settings.

Utilizing patient-specific 3D printed guides for graft reconstruction in thoracoabdominal aortic repair.

In thoracoabdominal aortic aneurysm repair, repairing the visceral and segmental arteries is challenging. Although there is a pre-hand-sewn and multi-branched graft based on the conventional image-based technique, it has shortcomings in precisely positioning and directing the visceral and segmental arteries. Here, we introduce two new reconstruction techniques using patient-specific 3D-printed graft reconstruction guides: (1) model-based technique that presents the projected aortic graft, visualizing the main aortic body and its major branches and (2) guide-based technique in which the branching vessels in the visualization model are replaced by marking points identifiable by tactile sense. We demonstrate the effectiveness by evaluating conventional and new techniques based on accuracy, marking time requirement, reproducibility, and results of survey to surgeons on the perceived efficiency and efficacy. The graft reconstruction guides cover the segmentation, design, fabrication, post-processing, and clinical application of open surgical repair of thoracoabdominal aneurysm, and proved to be efficient for accurately reconstructing customized grafts.

Mimicking the Mechanical Properties of Aortic Tissue with Pattern-Embedded 3D Printing for a Realistic Phantom.

3D printing technology has been extensively applied in the medical field, but the ability to replicate tissues that experience significant loads and undergo substantial deformation, such as the aorta, remains elusive. Therefore, this study proposed a method to imitate the mechanical characteristics of the aortic wall by 3D printing embedded patterns and combining two materials with different physical properties. First, we determined the mechanical properties of the selected base materials (Agilus and Dragonskin 30) and pattern materials (VeroCyan and TPU 95A) and performed tensile testing. Three patterns were designed and embedded in printed Agilus-VeroCyan and Dragonskin 30-TPU 95A specimens. Tensile tests were then performed on the printed specimens, and the stress-strain curves were evaluated. The samples with one of the two tested orthotropic patterns exceeded the tensile strength and strain properties of a human aorta. Specifically, a tensile strength of 2.15 ± 0.15 MPa and strain at breaking of 3.18 ± 0.05 mm/mm were measured in the study; the human aorta is considered to have tensile strength and strain at breaking of 2.0-3.0 MPa and 2.0-2.3 mm/mm, respectively. These findings indicate the potential for developing more representative aortic phantoms based on the approach in this study.

Patient-specific and hyper-realistic phantom for an intubation simulator with a replaceable difficult airway of a toddler using 3D printing.

Difficult tracheal intubation is the third most common respiratory-related adverse co-morbid episode and can lead to death or brain damage. Since difficult tracheal intubation is less frequent, trainees have fewer opportunities to perform difficult tracheal intubation; this leads to the need to practice with a hyper-realistic intubation simulator. However, conventional simulators are expensive, relatively stiffer than the human airway, and have a lack of diversity in terms of disease variations and anatomic reproducibility. Therefore, we proposed the development of a patient-specific and hyper-realistic difficult tracheal intubation simulator using three-dimensional printing technology and silicone moulding and to test the feasibility of patient-specific and hyper-realistic difficult intubation simulation using 3D phantom for the trainee. This difficult tracheal intubation phantom can provide a realistic simulation experience of managing various difficult tracheal intubation cases to trainees, which could minimise unexpected tissue damage before anaesthesia. To achieve a more realistic simulation, a patient-specific phantom was fabricated to mimic human tissue with realistic mouth opening and accurate difficult airway shape. This has great potential for the medical education and training field.