{"title":"Development And Mechanical Testing Of Implant For Cranial Reconstruction After Burr Hole Trepanation","authors":"Julia Bodnarova, Adam Kratochvil, Matej Daniel","doi":"10.1115/1.4063344","DOIUrl":"https://doi.org/10.1115/1.4063344","url":null,"abstract":"\u0000 Burr hole trepanation is a surgical procedure in which one or more small holes, or trephines, are made in the skull to allow for the drainage of fluids or to relieve pressure within the skull. Burr hole trepanation is generally considered a safe and effective treatment for conditions such as brain abscesses and subdural hematomas. However, the bone defects must be closed after the surgery with a suitable implant. Current designs are mostly based on bone plates with limited lifetime, revision access, and low aesthetic. Within this study, a new type of cranial implant is proposed made using additive manufacturing (AM) techniques. The implant is anchored in the burr hole and does not penetrate the skull space or prominate the skull. Four different types of implants have been proposed on the basis of an analytical model and verified using finite element analysis (FEA). New push-in mechanical tests are introduced using artificial bone to determine the strength of the locking mechanisms and ensure the safety of implants. The burr-hole implant with an overlap on the bone surface after implantation was proven to be the safest solution. The design of the new cranial implant can significantly improve the aesthetic outcome after surgery and minimize invasiveness in reoperations.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43064307","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":"A Novel Quasilinear Viscoelastic Model of the Bending of a Steerable Catheter","authors":"Jajun Ryu, Jung-Hwa Ahn, Hwa-Young Kim","doi":"10.1115/1.4063215","DOIUrl":"https://doi.org/10.1115/1.4063215","url":null,"abstract":"\u0000 The present study proposes a novel model that establishes the relationship between the bending moment and the curvature of a steerable catheter. The catheters exhibit a nonlinear viscoelastic tendency, so the moment-curvature relationship is modeled as a bending of a quasilinear viscoelastic (QLV) cantilever beam. Stress relaxation tests with multiple magnitudes are performed on a catheter, and the parameter tuning is carried out with the test results to find out the coefficients of the model. The form of the instantaneous moment response, which is an important term within the QLV equation, is selected as a logarithmic form by analyzing the test results. This differentiates the accuracy of the model from using the commonly used exponential form. The performance of the logarithmic QLV model is compared to the conventional models by checking the curvature range each model can cover with a certain accuracy. The covering range for elastic, linear viscoelastic, and exponential QLV models are 22.1%, 64.4%, and 55.5%, respectively, whereas the covering range of the logarithmic QLV model is 100%.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47514965","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}
Kathryn R Marusich, N. Harel, Matthew D. Johnson, Paul Rothweiler, A. Erdman
{"title":"Trajectory Planning Software for Deep Brain Stimulation Driven by Patient Specific Data","authors":"Kathryn R Marusich, N. Harel, Matthew D. Johnson, Paul Rothweiler, A. Erdman","doi":"10.1115/1.4063142","DOIUrl":"https://doi.org/10.1115/1.4063142","url":null,"abstract":"\u0000 Deep brain stimulation (DBS) is a treatment for several neurological disorders including Parkinson's Disease, Essential tremor, and Epilepsy. The neurosurgical procedure involves implanting a lead of electrodes to a deep brain target and thereafter electrically stimulating that target to suppress symptoms. To reduce the probability of intracranial bleeding during implantation, neurosurgeons carefully plan out a patient-specific lead trajectory that avoids passing the lead through regions with major blood vessels. This process can be tedious, and there is a need to provide neurosurgeons with a more efficient and quantitative means to identify major blood vessels on a patient specific basis. Here, we developed a modular graphical user interface (GUI) containing anatomically segmented digital reconstructions of patient vasculature, cortex, and deep brain target anatomy from preoperative high-field (3T and 7T) MRI. The system prompts users to identify the deep brain target, and then algorithmically calculates a log-scale blood vessel density along the length of potential lead trajectories that pivot around the deep brain target. Heatmaps highlighting regions with low blood vessel density were calculated for cortical and subcortical vasculature models. The modeling framework enabled users to further interact with the models by panning, rotating, zooming, showing, or hiding the various anatomical reconstructions and heatmaps. Providing surgeons with quantitative, patient specific vasculature data has potential to further reduce the likelihood of hemorrhage events during microelectrode mapping and DBS lead implantation.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42334249","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}
L. Pasaguayo, Z. Al Masry, Sergio Lescano, N. Zerhouni
{"title":"Surgical Microgrippers: A Survey And Analysis","authors":"L. Pasaguayo, Z. Al Masry, Sergio Lescano, N. Zerhouni","doi":"10.1115/1.4062950","DOIUrl":"https://doi.org/10.1115/1.4062950","url":null,"abstract":"\u0000 This review article provides an overview of some challenges that arise when developing new medical robotic microgrippers. The main challenges are due to miniaturization and are present in the manufacturing and assembly processes, the types of mechanisms, the biomaterials used, the actuation principles, and the compliance with some standards and regulations. The main medical fields where these microgrippers are used are in MIS and biomedical applications. Therefore, taking these two large groups into account, this review presents a microgrippers classification according to the type of mechanism used (traditional rigid-body mechanisms and complaint mechanisms). Moreover, parameters such as applications, functionalities, DOF, sizes, range of motion, biomaterial used, and proposed methods are highlighted. In total, the analysis of 21 microgrippers among commercial and developed by research institutes is presented.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46612500","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":"Design And Mechanical Testing Of A Novel Dual-Stiffness Ankle-Foot Orthosis","authors":"Luke Nigro, E. Arch","doi":"10.1115/1.4062864","DOIUrl":"https://doi.org/10.1115/1.4062864","url":null,"abstract":"\u0000 This study details the concept, design, and mechanical testing results of a novel dual-stiffness ankle-foot orthosis (DS-AFO). The DS-AFO utilizes two separate stiffness elements (rear struts) to yield an AFO with low stiffness properties about the ankle in the sagittal plane at small dorsiflexion angles, and higher stiffness at larger dorsiflexion angles. The motivation behind This DS-AFO follow from the existence of similar moment-angle (stiffness) properties of the healthy human ankle during walking, referred to as dual-stiffness natural ankle quasi-stiffness (DS-NAS). Crucial to the design of the DS-AFO is the ability to adjust both the stiffness and the dorsiflexion angle at which the net stiffness increases, referred to as the activation angle. Three different DS-AFO stiffness configurations were tested, each with three different activation angles, along with a standard single strut/stiffness AFO configuration. The DS-AFO was able to achieve distinct regions of low and high stiffness at every configuration. Additionally, altering the activation angle by ±1° generally did not result in different stiffness properties. This work is a step forward in AFOs with complex stiffness properties that can better approximate the mechanics of a healthy human ankle.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47567475","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}
Jack Mankowsky, Connor Quigley, Scott Clark, A. Habib
{"title":"Identifying Suitable Three-Dimensional Bio-Printed Scaffold Architectures to Incubate in a Perfusion Bioreactor: Simulation and Experimental Approaches","authors":"Jack Mankowsky, Connor Quigley, Scott Clark, A. Habib","doi":"10.1115/1.4062492","DOIUrl":"https://doi.org/10.1115/1.4062492","url":null,"abstract":"\u0000 Traditional cell culturing methods are limited in their ability to supply growth medium to cells within scaffolds. To address this, we developed a custom perfusion bioreactor that allows for dynamic medium supply to encapsulated or seeded cells. Our custom-designed bioreactor improves the in vivo stimuli and conditions, which may enhance cell viability and proliferation performance. Some of the efforts include using dual medium tanks to replace the medium without stopping perfusion and a newly designed perfusion chamber that can accommodate an array of cassettes allowing for a wide assortment of scaffold shapes and sizes. In this paper, we explored the response of fluid flow to certain types of scaffold pore geometries and porosities using simulation and experimental approaches. Various pore geometries were considered, such as uniform triangular, square, diamond, circular, and honeycomb having uniform and variable sizes. Finally, bone tissue architecture was mimicked and simulated to identify the impact of fluid flow. Based on the results, optimum pore geometry for scaffolds were determined. We explored real-time fluid flow response on scaffolds fabricated with 8% Alginate, 4% Alginate-4% Carboxymethyl Cellulose (CMC), and 2% Alginate-6% CMC incubated, allowing a constant fluid flow for various periods such as 1, 2, 4, and 8 h. The change of fabricated scaffolds was determined in terms of swelling rate, i.e., change of filament width and material diffusion, i.e., comparison of dry material weight before and after incubation. This comparative study can assist in application-based materials selection suitable for incubating in a perfusion bioreactor.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43930728","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}
M. Afsar, Md Ashiquzzaman, D. Martelli, Xiangrong Shen
{"title":"SW-SiStA2: A New-Generation Semi-Wearable Device for Sit-to-Stand Assistance","authors":"M. Afsar, Md Ashiquzzaman, D. Martelli, Xiangrong Shen","doi":"10.1115/1.4062337","DOIUrl":"https://doi.org/10.1115/1.4062337","url":null,"abstract":"\u0000 Mobility impairment is a major problem that affects the quality of life of numerous older adults. With impaired mobility, such individuals usually have significant difficulty in standing up from a seated position, and thus often suffer from the lack of physical activities in their daily life. To address this problem, the authors present a new assistive device, namely Semi-Wearable Sit-to-Stand Assist Generation-2 (SW-SiStA2), in this paper. Similar to the original (first generation) SW-SiStA, this novel semi-wearable device can be easily attached to the user to provide sit-to-stand assistance, and can also be easily detached after reaching the standing posture to facilitate the subsequent ambulation. The new SW-SiStA2 is powered with a remote-release gas spring, which serves the dual purpose of actuation and energy storage (i.e., storing the energy accumulated during compression and powering the sit-to-stand assistance through extension). The remote release feature enables a user to easily control the SW-SiStA2 assistance through the locking and unlocking of the gas spring. The SW-SiStA2 was experimentally tested with human participants. Under the device's assistance, the participants were able to stand up much more easily, with significant reduction (up to 28% compared with the unassisted condition) of the muscle efforts in the process.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41874930","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}
Jingzhen Guo, L. Mao, Chengli Song, Yiling Shi, Yongji Tian
{"title":"Design and Experiment Research of a Novel Retrievable Peripheral Vascular Stent","authors":"Jingzhen Guo, L. Mao, Chengli Song, Yiling Shi, Yongji Tian","doi":"10.1115/1.4062338","DOIUrl":"https://doi.org/10.1115/1.4062338","url":null,"abstract":"\u0000 Restenosis after stent implantation is a major limitation of revascularization technique. Retrieving the stent safely and smoothly after the vascular remodeling is completed shows important clinical significance. In this paper, a novel retrievable peripheral vascular stent and its modified retrieval platform were developed and the finite element analysis (FEA) model was established to study the retrieval process of the stent. Meanwhile, the safety and feasibility of the retrievable stent were assessed through in vivo experiments. The maximum strain of the stent is 6.87% during the whole retrieval process, which is less than the ultimate elastic strain of nitinol alloy. The simulation results indicate that the stent is not damaged or stuck during the whole retrieval process. Finally, the stents were implanted into Bama miniature pigs to assess the retrieval process, and the results suggest that the stents can be retrieved successfully within a short period of time after implantation, and minor local mechanical injury can be found in the intimal layer of the blood vessel due to the expansion and contraction of the stent. Studies presented in this work illustrate the feasibility of a novel retrievable peripheral vascular stent, providing an additional avenue to avoid in-stent restenosis.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49464630","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}
Samson Galvin, R. Yanalitis, Eric Leon, J. Winder, R. Haluck, P. von Lockette, J. Moore
{"title":"Design of the Novel Single Incision, Free Motion Laparoscopic Surgical System","authors":"Samson Galvin, R. Yanalitis, Eric Leon, J. Winder, R. Haluck, P. von Lockette, J. Moore","doi":"10.1115/1.4062178","DOIUrl":"https://doi.org/10.1115/1.4062178","url":null,"abstract":"\u0000 Laparoscopic surgery is a common minimally invasive surgery that uses specialized tools to access the abdominal cavity and pelvic regions via small incisions called ports. Compared to open surgery, laparoscopy's small incision size better protects a patient's health and reduces recovery time. However, restricted rotation of the tools around chosen port locations can limit a surgeon's mobility while operating. To address this, the Novel Single Incision, Free Motion (SIFM) Laparoscopic Surgical System was created, and its design was explored through three experiments. Experiment 1 analyzed different permanent magnetic configurations to optimize the magnetic force between a tool on the inside of the abdominal wall and an external tool. The chosen configuration was a single pole external magnet, coupled to an axially magnetized internal magnet. Experiment 2 analyzed the experimental and theoretical forces applied by the internal tool. The tool was able to provide sufficient cutting forces at 26.1 mm of separation between the tools. Experiment 3 measured the precision of the tool's end effector which was controlled by a stepper motor powered cable system. The tool's end effector rotates no more than 1 degree about the y axis and no more than 2 degrees about the x axis. The SIFM system combines the health benefits of minimally invasive laparoscopic surgery, with the free motion and ease of open surgery.","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45680464","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":"Development of an Endotracheal Tube Cap for Oxygen Delivery During Intubation","authors":"K. Hart, C. Salvino, Todd Pashak, B. Veatch","doi":"10.1115/1.4062151","DOIUrl":"https://doi.org/10.1115/1.4062151","url":null,"abstract":"\u0000 Endotracheal Intubation is a medical procedure whereupon a physician or trained personnel inserts a breathing tube into a patient's mouth, through their vocal cords, and into their trachea. Intubation can be lifesaving when a patient cannot breathe on their own. Intubations are performed routinely, with approximately 15 million performed annually just in the Operating Room (OR) with an additional 650,000 intubations in the wider hospital environment. Intubation is a complex, dynamic, and at times difficult procedure with major consequences if delayed and/or if the procedure fails. Complications for intubations outside of the operating room are reported as high as 27%, with the most common being hypoxia, or low oxygen levels. We have developed a simple, sterile attachment that directs oxygen down endotracheal tubes during intubation. In animal studies the device has been shown to significantly reduce hypoxia; thereby increasing the time a medical provider has to safely perform the procedure. While further development is warranted, as well as additional testing both in vitro and in vivo, the cap assembly appears to provide a viable solution to a persistent and dangerous problem in medicine","PeriodicalId":49305,"journal":{"name":"Journal of Medical Devices-Transactions of the Asme","volume":" ","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44793670","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}