Emma Schinstock, Michael A. Bielecki, D. Kudlik, M. Eggen, P. Iaizzo
Isolated heart failure models are valuable to researchers for multiple uses, including device design. Currently, models often use artificial materials and/or simulated pulsatile pre-clinical models or alternatively, employ animal models which often present obstacles to gaining access to the heart. The Visible Heart® apparatus allows researchers to benefit from a live tissue model while increasing access to the heart and adding the abilities to directly visualize the anatomic effects of a therapy or device. This work presents the development of a model to mimic dilated cardiomyopathy in humans by utilizing rapid pacing in swine and subsequently reanimating the heart on the Visible Heart® apparatus. This heart failure model allowed for functional assessments, multimodal imaging, and the administrations of various therapeutic approaches.
{"title":"Development of a Dilated Cardiomyopathy Heart Failure Model Employing High-Rate Pacing via an Implantable Leadless Pacemaker: Utilized for in Situ and Ex Vivo Investigations","authors":"Emma Schinstock, Michael A. Bielecki, D. Kudlik, M. Eggen, P. Iaizzo","doi":"10.1115/dmd2022-1064","DOIUrl":"https://doi.org/10.1115/dmd2022-1064","url":null,"abstract":"\u0000 Isolated heart failure models are valuable to researchers for multiple uses, including device design. Currently, models often use artificial materials and/or simulated pulsatile pre-clinical models or alternatively, employ animal models which often present obstacles to gaining access to the heart. The Visible Heart® apparatus allows researchers to benefit from a live tissue model while increasing access to the heart and adding the abilities to directly visualize the anatomic effects of a therapy or device. This work presents the development of a model to mimic dilated cardiomyopathy in humans by utilizing rapid pacing in swine and subsequently reanimating the heart on the Visible Heart® apparatus. This heart failure model allowed for functional assessments, multimodal imaging, and the administrations of various therapeutic approaches.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"66 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115819424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A. DeVos, D. Ramirez, Celia Gonzalez, A. Shaffer, P. Iaizzo
Computational models and three-dimensional prints were developed to aid in the pre-procedural planning of a LVAD exchange surgery. Clinical imaging was used to model and segment the anatomy and implanted device for computational implantation and 3D printing. The physicians visualized the pre-procedural anatomy in a 3D space to better understand the device-tissue-interface of the current implant and assess the optimal location for surgical entry. The models also contributed to the education of the surgical team by providing hands-on tools to understand the planned steps involved in the procedure.
{"title":"Ilization of Computational Modeling and 3D Printing for Pre-Procedural Planning of an LVAD Exchange Surgery","authors":"A. DeVos, D. Ramirez, Celia Gonzalez, A. Shaffer, P. Iaizzo","doi":"10.1115/dmd2022-1068","DOIUrl":"https://doi.org/10.1115/dmd2022-1068","url":null,"abstract":"\u0000 Computational models and three-dimensional prints were developed to aid in the pre-procedural planning of a LVAD exchange surgery. Clinical imaging was used to model and segment the anatomy and implanted device for computational implantation and 3D printing. The physicians visualized the pre-procedural anatomy in a 3D space to better understand the device-tissue-interface of the current implant and assess the optimal location for surgical entry. The models also contributed to the education of the surgical team by providing hands-on tools to understand the planned steps involved in the procedure.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126098531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Meatotomy is a surgical procedure performed primarily on infants and adolescents to widen the urethral opening (meatus). The current standard surgical meatotomy requires several steps and multiple instruments. The procedure is oftentimes performed with local anesthesia in the office setting. We present a novel, all-inclusive device that utilizes a centrally-located blade on the upper jaw flanked on all sides by parallel grooves acting as a crimping platform. The simultaneous action of these two important steps aims to improve patient cooperation by minimizing the tools and steps required for this procedure. Qualitative data is used to compare the novel device to current surgical tools. In addition, modeling material and chicken skin are used to illustrate the workflow of the metal 3D-printed prototype. Ultimately, we plan to fabricate a device with the potential to become the preferred instrument for meatotomy procedures.
{"title":"Meatome: A Novel Clamp for Single Step Urethral Meatal Stenosis Surgery","authors":"T. Hartmann, Sang-Eun Song, H. Swana","doi":"10.1115/dmd2022-1004","DOIUrl":"https://doi.org/10.1115/dmd2022-1004","url":null,"abstract":"\u0000 Meatotomy is a surgical procedure performed primarily on infants and adolescents to widen the urethral opening (meatus). The current standard surgical meatotomy requires several steps and multiple instruments. The procedure is oftentimes performed with local anesthesia in the office setting.\u0000 We present a novel, all-inclusive device that utilizes a centrally-located blade on the upper jaw flanked on all sides by parallel grooves acting as a crimping platform. The simultaneous action of these two important steps aims to improve patient cooperation by minimizing the tools and steps required for this procedure. Qualitative data is used to compare the novel device to current surgical tools. In addition, modeling material and chicken skin are used to illustrate the workflow of the metal 3D-printed prototype. Ultimately, we plan to fabricate a device with the potential to become the preferred instrument for meatotomy procedures.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"61 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122584348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Etse-Oghena Y. Campbell, Fang-Chi Hsu, Christopher G. Rylander
Convection-enhanced delivery (CED) is an emerging method for treating highly aggressive and infiltrative forms of brain cancer, like glioblastomas. However, drawbacks of utilizing CED include limited availability of tools capable of bypassing the blood-brain barrier and blood-brain tumor barrier to deliver therapeutics to saturate the tumor and adjacent tumor periphery where highly infiltrative glioma cells may be located. The consequence is that tumor recurrence at or near the original tumor site is inevitable. The Convection-Enhanced Thermo-Therapy Catheter System (CETCS) is a remote-operable device comprising of an arborizing catheter and therapeutic delivery control system designed to maximize the distribution of therapeutics in target tissue volumes. In this study, we evaluate the performance of the CETCS in agarose gel brain tissue phantoms while monitoring the volume of infusate delivered, the dispersal volume of the infusate, and the mean distribution ratio of infusate. We report high infusion flow rates increase infusate dispersal volume but can result in backflow up the microneedles tracts; constant microneedle retraction maximizes infusate dispersal volume; and finally, low infusion flow rates resulted in better control of infusion cloud shape and minimized occurrence of backflow along microneedles.
{"title":"Evaluating The Dispersal Volume of a Six-Port Arborizing Catheter in Agarose as a Function of Infusion Flow Rate and Catheter Retraction Speed","authors":"Etse-Oghena Y. Campbell, Fang-Chi Hsu, Christopher G. Rylander","doi":"10.1115/dmd2022-1057","DOIUrl":"https://doi.org/10.1115/dmd2022-1057","url":null,"abstract":"\u0000 Convection-enhanced delivery (CED) is an emerging method for treating highly aggressive and infiltrative forms of brain cancer, like glioblastomas. However, drawbacks of utilizing CED include limited availability of tools capable of bypassing the blood-brain barrier and blood-brain tumor barrier to deliver therapeutics to saturate the tumor and adjacent tumor periphery where highly infiltrative glioma cells may be located. The consequence is that tumor recurrence at or near the original tumor site is inevitable.\u0000 The Convection-Enhanced Thermo-Therapy Catheter System (CETCS) is a remote-operable device comprising of an arborizing catheter and therapeutic delivery control system designed to maximize the distribution of therapeutics in target tissue volumes. In this study, we evaluate the performance of the CETCS in agarose gel brain tissue phantoms while monitoring the volume of infusate delivered, the dispersal volume of the infusate, and the mean distribution ratio of infusate. We report high infusion flow rates increase infusate dispersal volume but can result in backflow up the microneedles tracts; constant microneedle retraction maximizes infusate dispersal volume; and finally, low infusion flow rates resulted in better control of infusion cloud shape and minimized occurrence of backflow along microneedles.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"150 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122927767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nathan D. Davies, Yusra Farhat Ullah, Timothy M. Kowalewski
Surgeons are human: their best possible performance is limited by their neurophysiology. What if an inoperable patient’s condition demands surgical treatment that exceeds such human performance limits? Can precision surgical robots help surgeons surpass such fundamental human neurophysiological limits? This article employs the Steering law to proposes a quantitative framework and benchmark tasks to evaluate the feasibility of a handheld surgical tool for meeting the quantified speed and accuracy requirements of a clinical need in non-contact interactions that exceed human limitations. Example use cases of such interactions in common surgical scenarios are presented. Preliminary results from a straight-line tracking task with and without computer assistance demonstrate the proposed framework in the context of falling short of a clinical speed/accuracy need. The framework is then used to articulate specifications for additional technology candidates to successfully exceed the speed and accuracy characteristics of the modality used.
{"title":"A Framework for Objective Evaluation of Handheld Robotic Surgical Tools Against Patient Needs","authors":"Nathan D. Davies, Yusra Farhat Ullah, Timothy M. Kowalewski","doi":"10.1115/dmd2022-1039","DOIUrl":"https://doi.org/10.1115/dmd2022-1039","url":null,"abstract":"\u0000 Surgeons are human: their best possible performance is limited by their neurophysiology. What if an inoperable patient’s condition demands surgical treatment that exceeds such human performance limits? Can precision surgical robots help surgeons surpass such fundamental human neurophysiological limits? This article employs the Steering law to proposes a quantitative framework and benchmark tasks to evaluate the feasibility of a handheld surgical tool for meeting the quantified speed and accuracy requirements of a clinical need in non-contact interactions that exceed human limitations. Example use cases of such interactions in common surgical scenarios are presented. Preliminary results from a straight-line tracking task with and without computer assistance demonstrate the proposed framework in the context of falling short of a clinical speed/accuracy need. The framework is then used to articulate specifications for additional technology candidates to successfully exceed the speed and accuracy characteristics of the modality used.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"20 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126679027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In previous work, a proof-of-concept articulated instrument for minimally invasive laparoscopic surgery (MILS) was proposed to overcome limitations of existing instruments. In this paper, experimental validation is pursued to satisfy constraints on biocompatibility, cost, stiffness, and durability. It was found that the instrument exhibits minimal bending deflection of approximately 3mm under the maximum load experienced during MILS, has favorable workspace volume of 679cm3, and has adequate joint durability of over 700 bending cycles. Overall, this paper demonstrates that the instrument is able to meet many of the criteria required of minimally invasive laparoscopic surgery devices and addresses many of the shortcomings of traditionally used instruments.
{"title":"Experimental Validation and Design Refinement of a Disposable, Articulated Surgical Instrument","authors":"Monica Bomze, C. Nelson","doi":"10.1115/dmd2022-1011","DOIUrl":"https://doi.org/10.1115/dmd2022-1011","url":null,"abstract":"\u0000 In previous work, a proof-of-concept articulated instrument for minimally invasive laparoscopic surgery (MILS) was proposed to overcome limitations of existing instruments. In this paper, experimental validation is pursued to satisfy constraints on biocompatibility, cost, stiffness, and durability. It was found that the instrument exhibits minimal bending deflection of approximately 3mm under the maximum load experienced during MILS, has favorable workspace volume of 679cm3, and has adequate joint durability of over 700 bending cycles. Overall, this paper demonstrates that the instrument is able to meet many of the criteria required of minimally invasive laparoscopic surgery devices and addresses many of the shortcomings of traditionally used instruments.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"284 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124181478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Convection-enhanced delivery (CED) through an arborizing microneedle catheter system is an experimental drug delivery technique used to treat glioblastoma by providing a higher drug volume dispersed (Vd) of therapeutics directly to larger regions of brain tissue. A convection-enhanced thermo-chemotherapy catheter system (CETCS) can simultaneously deliver fluid and thermal energy to the infected area. The CETCS developed in our Medical Device Design lab comprises a bundle of 6 microneedles made from fiber optic capillary tubing, passed through a rigid cannula and individually arborized (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon a potential predicate device. The high-pressure burst and leakage test showed that the CETCS can withstand an internal pressure of 100 psi with no leakage or failure in any connections and attachments, resulting in a substantial equivalency to the predicate devices. The constant pressure flow rate test showed a flow rate average of 0.64 ml/h under 0.7 psi and 1.69 ml/h under 2.1 psi of constant pressure using distilled water column, resulting in substantial equivalency to the predicate devices.
{"title":"Burst, Leakage, and Constant Pressure Infusion Testing of a Convection Enhanced Drug Delivery System for Glioblastoma Treatment","authors":"Iman Salafian, Christopher G. Rylander","doi":"10.1115/dmd2022-1060","DOIUrl":"https://doi.org/10.1115/dmd2022-1060","url":null,"abstract":"\u0000 Convection-enhanced delivery (CED) through an arborizing microneedle catheter system is an experimental drug delivery technique used to treat glioblastoma by providing a higher drug volume dispersed (Vd) of therapeutics directly to larger regions of brain tissue. A convection-enhanced thermo-chemotherapy catheter system (CETCS) can simultaneously deliver fluid and thermal energy to the infected area. The CETCS developed in our Medical Device Design lab comprises a bundle of 6 microneedles made from fiber optic capillary tubing, passed through a rigid cannula and individually arborized (branch-out). We are preparing CETCS for regulatory pathway application to advance it further toward clinical and human trials. In this paper, we performed three performance tests: infusion pressure, leakage, and constant pressure flow rate tests required by the FDA to file a traditional 510(K) based upon a potential predicate device. The high-pressure burst and leakage test showed that the CETCS can withstand an internal pressure of 100 psi with no leakage or failure in any connections and attachments, resulting in a substantial equivalency to the predicate devices. The constant pressure flow rate test showed a flow rate average of 0.64 ml/h under 0.7 psi and 1.69 ml/h under 2.1 psi of constant pressure using distilled water column, resulting in substantial equivalency to the predicate devices.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123528044","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mahshid Mansouri, Girish Krishnan, E. Hsiao-Wecksler
Inspired by natural waves such as water waves that can carry objects, this study presents design guidelines for moving a human body using traveling waves created on the surface of a bed. Particularly, through kinematic analysis and simulation of a traveling wave, the study explores various parameters, such as the wave’s frequency, wavelength, amplitude, number of wave-generating actuators and their movement pattern under the body. The study also investigates how these parameters affect human transportation speed and movement smoothness. The study results suggest that transportation speed is linearly proportional to the wave frequency. Additionally, to increase movement smoothness, the wave amplitude should be reduced while the number of actuators should be maximized. However, there is a tradeoff between the number of actuators that can be used and the complexity of the system’s design and control.
{"title":"Design Guidelines for Moving a Human Body on a Bed Using Traveling Waves","authors":"Mahshid Mansouri, Girish Krishnan, E. Hsiao-Wecksler","doi":"10.1115/dmd2022-1071","DOIUrl":"https://doi.org/10.1115/dmd2022-1071","url":null,"abstract":"\u0000 Inspired by natural waves such as water waves that can carry objects, this study presents design guidelines for moving a human body using traveling waves created on the surface of a bed. Particularly, through kinematic analysis and simulation of a traveling wave, the study explores various parameters, such as the wave’s frequency, wavelength, amplitude, number of wave-generating actuators and their movement pattern under the body. The study also investigates how these parameters affect human transportation speed and movement smoothness. The study results suggest that transportation speed is linearly proportional to the wave frequency. Additionally, to increase movement smoothness, the wave amplitude should be reduced while the number of actuators should be maximized. However, there is a tradeoff between the number of actuators that can be used and the complexity of the system’s design and control.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"113 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121202937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Piper C. Cannon, Miriam R. Smetak, R. Webster, R. Labadie
Many otologic surgeries, including cochlear implantation and mastoidectomy, require a post-auricular incision for exposure. The auricle must be retracted forward in order to enable an unobstructed view of the surgical field and improve procedural outcomes. Typical methods of securing the ear include tape, a small stitch, or an assistant’s finger, depending on surgeon preference. In this paper, we propose a novel design for a tool that retracts the auricle safely, effectively, and consistently with the appropriate tension for closure of a post-auricular incision. The tool attaches to the helix with a compression fit, and then anchors between the triangular fossa and the helical crus. The tool’s efficacy is demonstrated through a test fit and comparison to standard methods. This anchoring tool enables the surgeon to retract the pinna easily and effectively.
{"title":"A Novel Tool for Auricle Retraction During Closure of Post-Auricular Incisions","authors":"Piper C. Cannon, Miriam R. Smetak, R. Webster, R. Labadie","doi":"10.1115/dmd2022-1048","DOIUrl":"https://doi.org/10.1115/dmd2022-1048","url":null,"abstract":"\u0000 Many otologic surgeries, including cochlear implantation and mastoidectomy, require a post-auricular incision for exposure. The auricle must be retracted forward in order to enable an unobstructed view of the surgical field and improve procedural outcomes. Typical methods of securing the ear include tape, a small stitch, or an assistant’s finger, depending on surgeon preference. In this paper, we propose a novel design for a tool that retracts the auricle safely, effectively, and consistently with the appropriate tension for closure of a post-auricular incision. The tool attaches to the helix with a compression fit, and then anchors between the triangular fossa and the helical crus. The tool’s efficacy is demonstrated through a test fit and comparison to standard methods. This anchoring tool enables the surgeon to retract the pinna easily and effectively.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"21 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114303277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The front matter for this proceedings is available by clicking on the PDF icon.
通过点击PDF图标可获得本次会议的主题。
{"title":"DMD2022 Front Matter","authors":"","doi":"10.1115/dmd2022-fm1","DOIUrl":"https://doi.org/10.1115/dmd2022-fm1","url":null,"abstract":"\u0000 The front matter for this proceedings is available by clicking on the PDF icon.","PeriodicalId":236105,"journal":{"name":"2022 Design of Medical Devices Conference","volume":"83 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125631807","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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