Luís Expedito Sabage, Mariana Pasqualin Wojcikiewicz, Thiago Meister, João Pedro Vieira Neto Murta, Gustavo Túlio Manfredini, Jair Marcelo Saad Ortega, Josmar Sabage, Carlos Augusto Moreira-Neto, Alessandra Mazzo
{"title":"Development and biomechanical validation of a 3D-printed Schepens scleral depressor.","authors":"Luís Expedito Sabage, Mariana Pasqualin Wojcikiewicz, Thiago Meister, João Pedro Vieira Neto Murta, Gustavo Túlio Manfredini, Jair Marcelo Saad Ortega, Josmar Sabage, Carlos Augusto Moreira-Neto, Alessandra Mazzo","doi":"10.1177/09544119261441042","DOIUrl":"https://doi.org/10.1177/09544119261441042","url":null,"abstract":"<p><p>This study aimed to develop a low-cost 3D-printed scleral depressor and evaluate its mechanical performance, safety margins, and ocular biomechanical effects. A Schepens-style depressor was developed and printed in PLA. Examiners performed two different tests: (1) the maximum simulated scleral depression force, using both the 3D-printed and conventional steel depressors, and (2) a breakage test performed only on the 3D-printed device, determining its mechanical failure threshold for probabilistic safety analysis. Peak forces were applied to the porcine belly and recorded by a precision balance with slow-motion video analysis. A third test, which was conducted exclusively with the 3D-printed depressor, was performed using one ex vivo porcine eye model to correlate the applied force with the induced intraocular pressure (IOP) elevation. The pressure-volume behavior was modeled via the Friedenwald rigidity coefficient. One unit of the depressor prototype consumed 3.06 g of PLA, with an estimated cost and print time of U$ 0.06 and 22 min, respectively. The simulated indentations produced forces of 21.21 ± 6.23 N (3D-printed depressor) and 25.02 ± 4.64 N (steel depressor), with no significant difference between devices. The 3D-printed instrument breakage point was 63.27 ± 10.72 N, with a 2.98 factor of safety (FS) and 3.39 reliability index (β). In the porcine model, scleral depression produced a 15.63 ± 8.13 mmHg increase in IOP, requiring 0.191 ± 0.09 N (FS = 331.2 and β = 5.88). The 3D-printed depressor demonstrates effective mechanical robustness, wide safety margins, and functional equivalence to steel instruments, supporting the use of customizable, low-cost 3D-printed depressors in training and clinical settings.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"9544119261441042"},"PeriodicalIF":1.5,"publicationDate":"2026-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147654849","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Harry Barratt, Harry Templeman, Karthik Nair, Gavin Day, Anthony Herbert
{"title":"Impacts of mixing techniques and vacuum levels on the structural and mechanical properties of PMMA bone cement: A comparative study.","authors":"Harry Barratt, Harry Templeman, Karthik Nair, Gavin Day, Anthony Herbert","doi":"10.1177/09544119261436611","DOIUrl":"https://doi.org/10.1177/09544119261436611","url":null,"abstract":"<p><p>The mechanical integrity of polymethyl methacrylate (PMMA) bone cement is crucial for the long-term fixation of orthopaedic implants, yet it is often compromised by porosity introduced during mixing. This study investigates the influence of mixing technique and vacuum level on the structural and mechanical properties of PMMA bone cement. Three clinically relevant mixing approaches, open bowl, vacuum bowl and vacuum cartridge were evaluated at vacuum levels ranging from 0 to 650 mm Hg. Cylindrical PMMA specimens were produced and their porosity assessed using high-resolution micro-computed tomography (µCT), with corresponding mechanical properties determined through compressive testing in accordance with ISO 5833:2002. µCT analysis revealed significant reductions in porosity at higher vacuum levels, particularly with the vacuum cartridge system. A strong and significant negative correlation was observed between compressive strength and porosity (<i>R</i><sup>2</sup> = 0.864), while specimen mass showed no predictive value for mechanical performance. Although vacuum mixing reduced porosity, no consistent changes in Young's modulus were detected across the mixing groups. These findings emphasise the importance of porosity control in bone cement preparation and highlight the limitations of current ISO standards. The study advocates for improved testing protocols that more accurately reflect clinical conditions to enhance the predictive value of in vitro assessments of PMMA cement performance.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"9544119261436611"},"PeriodicalIF":1.5,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147628321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Data-driven optimal design of foam-padded vests for female protection against air blast.","authors":"Feng Zhu, George Wang, Zhiqing Cheng","doi":"10.1177/09544119261432726","DOIUrl":"10.1177/09544119261432726","url":null,"abstract":"<p><p>Blast-induced thoracic injuries pose a significant threat to military personnel, particularly during training and combat operations involving high-explosive weapons. While conventional body armor is primarily designed for ballistic protection, it is often inadequate for mitigating internal injuries caused by air blast waves. This study presents a data-driven approach for the optimal design of foam-padded protective vests tailored for female users exposed to air blast loading. A finite element (FE) model of the VIVA+ 50th percentile female torso was integrated with a multilayer foam vest model and subjected to simulated blast pressures ranging from 140 kPa to 1.4 MPa. The densities of three foam layers (inner, middle, outer) and the explosive charge mass were varied parametrically, and a surrogate model was developed to map these inputs to a biomechanical injury metric- peak chest wall velocity. The surrogate, based on second-order nonlinear regression, was validated against simulation data (<i>R</i><sup>2</sup> = 0.98) and used in conjunction with a multi-objective genetic algorithm (NSGA-II) to identify optimal foam configurations. Results revealed that high-density inner and middle layers minimize local deformation, while the outer layer should have lower density to dissipate energy efficiently. Energy absorption analysis confirmed a shift in layer contributions with increasing blast intensity. Additionally, a simplified regression tree model (M5P) was developed to partition the design space and enhance interpretability without compromising accuracy. This study offers new insight into blast-specific armor design and demonstrates the value of surrogate-based optimization in protective equipment engineering.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"373-385"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147513898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Topological optimization and biomechanical analysis of porous fusion cage with TPMS structures.","authors":"Waseem Ur Rahman, Tianxiang Dong, Wei Jiang","doi":"10.1177/09544119261425378","DOIUrl":"10.1177/09544119261425378","url":null,"abstract":"<p><p>Porous fusion cages present a promising alternative to traditional solid fusion cages in anterior cervical decompression and fusion surgery (ACDF), offering improved bone in growth through interconnectivity and a reduced elastic modulus, which may reduce the risk of cage subsidence. This study employs an integrated topology optimization approach to design a novel porous fusion cage to minimize the risk associated with cage subsidence and stress shielding. Two innovative porous cervical fusion implants, RPF-G and RPF-D, were proposed through Boolean operations based on optimal topological structures and Triply Periodic Minimal Surfaces (TPMS). After optimizing fusion cages, finite element simulations of ACDF surgeries were performed at C5-C6 segment to evaluate their biomechanical performance. The results showed the range of motion (ROM) in the porous fusion cage model exceeded that of the solid fusion cage model, with maximum intradiscal pressure occurring at the C4-C5 segment in all models. Moreover, stress distribution across the cortical bone surface was more uniform in the porous fusion cages, with the RPF-G and RPF-D cage models exhibiting increased stress at the vertebra C6 cortical bone. Notably, the surface stress on porous cages surpasses solid fusion cages, particularly in flexion loading conditions. The RPF-G model demonstrates superior mechanical stability. In conclusion, the optimized porous fusion cage demonstrates promising mechanical performance and emerges as a potential candidate for fusion surgery. These preliminary investigations guide the design of the fusion cage, potentially offering novel solutions to address the issue of cage subsidence.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"347-359"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Wei Wei, Zhengqian Li, Nan Xiao, Zihan Gao, Dong Yang, Jianming Guo, Qian Zheng, Jiaqian Li
{"title":"Cross-modal fusion of external magnetic sensing and simulated 2D imaging for 3D guidewire pose estimation.","authors":"Wei Wei, Zhengqian Li, Nan Xiao, Zihan Gao, Dong Yang, Jianming Guo, Qian Zheng, Jiaqian Li","doi":"10.1177/09544119261426514","DOIUrl":"10.1177/09544119261426514","url":null,"abstract":"<p><p>During percutaneous coronary intervention, conventional 2D X-ray imaging lacks depth information, making it difficult for clinicians to determine the 3D position of the guidewire. While some recent approaches incorporate micro-sensors to assist with pose estimation, many rely on implanted electromagnetic sensors, which can introduce additional clinical risks. In the paper, we present a non-invasive alternative by using an external 3-axis electronic magnetometer array. We further propose a <b>L</b>ocal-<b>G</b>lobal <b>Mag</b>neto-Visual <b>Net</b>work framework (LG-MagNet) that fuses magnetic field information with image data to enable precise 3D pose estimation of the guidewire. Specifically, we first perform a shared encoder for cross-modal feature fusion. Then we employ convolutional operations that integrate local and global features. Finally, we utilize a lightweight prediction head for end-to-end depth regression. We constructed experimental equipment and collected a clinical simulation datasets. Results show a root mean square error (RMSE) of (0.797 ± 0.095 mm) for depth prediction along the Z-axis and an overall RMSE of (1.216 ± 0.072) mm for 3D guidewire shape reconstruction. Quantitative analysis indicates that fusing external magnetometer data with 2D imaging improves pose estimation stability, particularly in regions with curvature.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"386-399"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147593996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hamza Al Kouzbary, Mouaz Al Kouzbary, Jingjing Liu, Taha Khamis, Nooranida Arifin, Hamam Mokayed, Noor Azuan Abu Osman
{"title":"Utilization of a nonlinear autoregressive neural network with exogenous inputs for foot trajectory generation for upslope terrain.","authors":"Hamza Al Kouzbary, Mouaz Al Kouzbary, Jingjing Liu, Taha Khamis, Nooranida Arifin, Hamam Mokayed, Noor Azuan Abu Osman","doi":"10.1177/09544119261427508","DOIUrl":"10.1177/09544119261427508","url":null,"abstract":"<p><p>The rhythm in which robotic prostheses have evolved over the past two decades indicates that they have a promising potential to replace passive prostheses in the foreseeable future. Powered lower limb prostheses, unlike the passive ones, can provide net positive work during the late stance, thus reducing the metabolic cost. Moreover, robotic prostheses can provide different characteristics in compliance with the walking terrains. The conventional three-level controllers of robotic lower limb prostheses are known for their intermittent and nondynamic properties, which limit prosthesis functioning to certain predefined tasks and require intense calibration for the controller's parameters for each user. In this study, we report the capability of a nonlinear autoregressive recurrent neural network with exogenous inputs of generating the foot patterns for upslope terrain, that is, 10° incline, which is unknown for the neural network (not included in the training dataset). A new set of evaluation data from six able-bodied subjects (average age 31 and average weight 70.2 kg) was used to assess the network performance. The results show that the NARX was able to estimate foot trajectory for the new terrain without any further training, with an average RMSE of 2.953° for all six subjects.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"427-436"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147434946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bio-fabrication and 3D printing of keratin-enriched sodium alginate-gelatin scaffolds for the application of skin scar regeneration.","authors":"Rajkumar Velu, Anand Sankar Manipuzha, Bobby Tyagi, Harman Sandhu, Nidhi Bannait, Aysha Farzana, Rahul Gorka, Anand Kumar Subramaniyan, Lakshmipriya Ravindran","doi":"10.1177/09544119261427641","DOIUrl":"10.1177/09544119261427641","url":null,"abstract":"<p><p>The advancement of 3D printing technology offers transformative potential in developing functional skin substitutes for scar prevention and tissue regeneration. This research investigates optimized bio-ink formulations comprising sodium alginate, gelatin, and keratin protein, evaluating their structural, mechanical, and biological properties through comprehensive characterization techniques. Scanning Electron Microscopy (SEM) revealed the structural morphology of raw materials and printed constructs, with sodium alginate exhibiting irregular shapes (100-200 µm diameter), gelatin displaying elongated particles (900-1000 µm diameter), and keratin featuring fibrous structures (300-500 µm diameter), all contributing to scaffold integration. Fourier Transform Infrared (FTIR) spectroscopy confirmed the retention of functional groups and formation of new molecular bonds during crosslinking. Rheological analysis highlighted an 81.8% increase in maximum shear stress, from 550 Pa in sodium alginate to 1000 Pa in sodium alginate-gelatin composites, demonstrating enhanced mechanical robustness and optimal shear-thinning behavior critical for printing. Tensile testing analysis revealed composition-dependent mechanical reinforcement, with the incorporation of 20% keratin leading to a maximum tensile strength improvement of approximately 64% relative to the alginate-gelatin matrix. Swelling and degradation studies indicated controlled hydration and improved structural stability of keratin-reinforced scaffolds over 48 h. In vitro biocompatibility was validated through brine shrimp toxicity tests, with keratin-enriched bio-inks achieving a 98% survival rate in seawater, a 5.55% improvement over sodium alginate-gelatin-only solutions. These findings underscore the synergistic role of gelatin in reducing toxicity and keratin in enhancing cellular attachment and tissue regenerative capabilities. This study concludes that the sodium alginate-gelatin-keratin bio-ink formulation offers superior platform for skin tissue engineering, combining enhanced printability, structural integrity, and biocompatibility.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"323-346"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147491474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anantha Narayanan Ramakrishnan, Immanuel Ries, Christopher Ludtka, Thomas Mendel, Friederike Klauke, Christoph Muhl, Stefan Schwan
{"title":"Inclusion of pelvic ligamentous boundary conditions using 3D continuum volume bodies in finite element modeling of the pelvis.","authors":"Anantha Narayanan Ramakrishnan, Immanuel Ries, Christopher Ludtka, Thomas Mendel, Friederike Klauke, Christoph Muhl, Stefan Schwan","doi":"10.1177/09544119261426439","DOIUrl":"https://doi.org/10.1177/09544119261426439","url":null,"abstract":"<p><p>Numerical techniques in the context of osteoporosis and osteoporotic pelvic fracture could potentially contribute toward the development of patient-specific diagnosis. In most finite element simulations of the pelvis the associated ligaments are often neglected due to the modeling complexities involved. This study aims to develop a 3D volume-based continuum approach for these ligaments. The pelvic ligaments were generated based on segmentation of magnetic resonance imaging data from specific patients. Closed volume models were generated based on segmentation and assembled with the 3D models of the corresponding pelvic bones, which themselves were generated from computed tomography data. The resulting pelvic assembly with the ligamentous boundary conditions was numerically simulated under two specific loading conditions: the double-leg stance and double-leg stance with an additional lateral bending moment. The stress state under the force of simulated upper body weight showed a maximum deformation of 0.16 mm at the center of the sacral promontory; this shifted toward the periphery of the sacral promontory and closer to the sacroiliac joint with the addition of the bending moment as well as the contact space between the sacrum and the ilium. The results demonstrated that some of the critical deformation zones are seen in the ligaments and also near their contact regions with the pelvic bones. The approach used for modeling these ligaments, when limited to using 1D springs or force-based boundary conditions, cannot fully factor-in these critical stress concentration zones. As such, this study highlights the necessity of incorporating accompanying ligaments into pelvic bone numerical models.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":"240 4","pages":"360-372"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147779400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohd Faizal Ali Akhbar, Shahrizan Jamaludin, Suriani Mat Jusoh, Fatin Alias, Mohd Azlan Musa, Rodianah Alias
{"title":"Thermal performance of modified surgical drill margins during bone drilling: An experimental, numerical, and optimization case study.","authors":"Mohd Faizal Ali Akhbar, Shahrizan Jamaludin, Suriani Mat Jusoh, Fatin Alias, Mohd Azlan Musa, Rodianah Alias","doi":"10.1177/09544119261426440","DOIUrl":"10.1177/09544119261426440","url":null,"abstract":"<p><p>Excessive heat generation during bone drilling causes thermal osteonecrosis, posing a significant risk in orthopedic and dental procedures. While various aspects of drill design have been studied, the specific influence of margin geometry remains underexplored in the context of thermal engineering. This study integrates drilling simulation, experimental validation, and statistical optimization to evaluate the thermal impact of drill margin width (<i>M</i><sub><i>w</i></sub>) and height (<i>M</i><sub><i>h</i></sub>) during cortical bone drilling. A validated thermo-mechanical model was developed using commercial software DEFORM-3D. The simulation results were validated with experimental bone drilling with small temperature prediction errors (2.4% and 8.0%). Key thermal metrics (maximum temperature (<i>T</i><sub>max</sub>), osteonecrosis diameter (OD), and osteonecrosis depth (OH)) were optimized using a central composite design (CCD) of response surface methodology (RSM) and desirability-based multi-objective optimization. Results revealed that <i>M</i><sub><i>w</i></sub> had the most significant second-order influence on <i>T</i><sub>max</sub> (47.2%), while <i>M</i><sub><i>h</i></sub> dominated OD (41.1%) and OH (47.8%). The optimal drill margins (<i>M</i><sub><i>h</i></sub> = 0.05 mm and <i>M</i><sub><i>w</i></sub> = 0.22 mm), which achieved a desirability score of 0.985, could reduce <i>T</i><sub>max</sub> by up to 44.8°C, which is below the osteonecrosis threshold. This work highlights drill margins as a critical yet previously underutilized design variable, offering an alternative pathway for the thermally optimized development of surgical tools and next-generation robotic-assisted drilling systems.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"411-426"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147370087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zakiyyah Auchoybur, Aiden O'Loughlin, Sharath Sriram, Gary Rosengarten
{"title":"Analysis of nitinol coils expanded using an angioplasty balloon catheter.","authors":"Zakiyyah Auchoybur, Aiden O'Loughlin, Sharath Sriram, Gary Rosengarten","doi":"10.1177/09544119261424552","DOIUrl":"10.1177/09544119261424552","url":null,"abstract":"<p><p>The rupture of vulnerable plaques is associated with life-threatening cardiovascular events such as heart attacks and strokes. While promising medicine therapies could regress the plaque burden and prevent their rupture, no drug delivery device is currently available to deliver medicine directly, efficiently, and effectively into the arterial wall. In this study, a novel device is proposed and analysed. It comprises of a hollow nitinol coil element coupled to a catheter balloon. Finite element analyses were used to determine key geometric constraints of the coil element, including the wire diameter and number of revolution of coils. A catheter balloon inflation model was developed and validated against inflation experiments using corresponding balloons. Different coil geometries were affixed to the balloon model and inflated. It was observed that the balloon sustained an increasing deformation as the wire diameter and number of revolutions increased. Foreshortening of the coil, similar to stent expansion, was also observed. The device will need to be designed to accommodate for the foreshortening of the coil. It was concluded that any number of coil revolution between 0.5 and 3 could be used with a wire diameter of 0.18 mm or smaller. If the wire diameter is larger than 0.18 mm, then only a half revolution coil could be used without obstructing the balloon inflation. From a clinical perspective, smaller wires are more advantageous as they allow for easier navigation to the target lesion due to their smaller diameter and increased flexibility.</p>","PeriodicalId":20666,"journal":{"name":"Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine","volume":" ","pages":"400-410"},"PeriodicalIF":1.5,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147434861","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}