Etse-Oghena Y. Campbell, Christopher G. Rylander, L. Thaxton, M. Y. Williams-Brown
The immediate post-partum period offers a convenient time to have an intrauterine device placed because of the co-location of a non-pregnant woman and her clinician; however, this practice is associated with increased expulsion rates of up to 30%, compared with a 3% expulsion rate for interval insertions. This paper presents a device and method to improve intrauterine device delivery and retention in the immediate postpartum period. This initial feasibility study illustrates that it is possible to temporarily tether a commercially available intrauterine device within the uterus of an immediately postpartum baboon. The results indicate this device and method are technically feasible, but further studies will be needed to evaluate safety and efficacy in reducing expulsion rates.
{"title":"Novel Method and Device for Delivery and Retention of Intrauterine Devices in the Immediate Postpartum Period: Pilot Baboon Feasibility Study","authors":"Etse-Oghena Y. Campbell, Christopher G. Rylander, L. Thaxton, M. Y. Williams-Brown","doi":"10.1115/dmd2020-9049","DOIUrl":"https://doi.org/10.1115/dmd2020-9049","url":null,"abstract":"\u0000 The immediate post-partum period offers a convenient time to have an intrauterine device placed because of the co-location of a non-pregnant woman and her clinician; however, this practice is associated with increased expulsion rates of up to 30%, compared with a 3% expulsion rate for interval insertions. This paper presents a device and method to improve intrauterine device delivery and retention in the immediate postpartum period. This initial feasibility study illustrates that it is possible to temporarily tether a commercially available intrauterine device within the uterus of an immediately postpartum baboon. The results indicate this device and method are technically feasible, but further studies will be needed to evaluate safety and efficacy in reducing expulsion rates.","PeriodicalId":93509,"journal":{"name":"2020 Design of Medical Devices Conference (DMD 2020). Design of Medical Devices Conferences (2020 : Minneapolis, Minn.)","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85999893","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}
N. Ueta, S. Sato, Masakazu Sato, Nakao Yoshio, Joshua P. Magnuson, R. Ishizuka
Miniaturization of electronics modules is always required for various medical applications including wearable technology, such as hearing aids, and implantable devices. Many types of high-density packaging technologies, such as package-on-package, bare-die stack, flex folded package and Through Si Via (TSV) technologies, have been proposed and used to fulfill the request. Among them, embedded die technology is one of the promising technologies to realize miniaturization and high-density packaging. We have developed WABE™ (wafer and board level device embedded) technology for embedding dies into multilayer flexible printed circuit (FPC) boards. The WABE package is comprised of thin dies (85 μm thickness), multi-layer polyimide, adhesive films and conductive paste. The dies are sandwiched by polyimide films with Cu circuits (FPCs). The conductive paste provides electrical connections between the layers as well as the layer and embedded die. First, each FPC layer is fabricated individually, and via holes are filled with conductive paste, and the dies are mounted on certain layers. Then, all layers undergo a one-step co-lamination process, and they are pressed to cure the adhesive material and conductive paste at the same time. This WABE technology has enabled multiple dies to be embedded by the one-step lamination process. Even if multiple dies are embedded, the footprint of a package can be reduced drastically by embedding multiple dies vertically in stacks. This paper describes the details of the results of fabricating a test vehicle with six embedded dies (three-dies in two stacks side-by-side). The fabricated test vehicle had 14 copper layers with less than 0.9 mm thickness. This paper also reports the results of various reliability testing on the package. These results were obtained by electrical measurements of daisy chain patterns formed between some of the layers. The fabricated test vehicle showed high reliability based on the results of a moisture and heat test and heat-shock test. These results show that the WABE technology to embed multiple dies vertically in polyimide film is one of the most promising packaging technologies to significantly miniaturize electronic circuits such as medical electronics.
各种医疗应用总是需要电子模块的小型化，包括可穿戴技术，如助听器和植入式设备。许多类型的高密度封装技术，如封装上封装、裸芯片堆叠、柔性折叠封装和通过Si Via (TSV)技术，已经被提出并用于满足这一要求。其中，嵌入式芯片技术是实现微型化和高密度封装的重要技术之一。我们开发了WABE™(晶圆和板级设备嵌入式)技术，用于将模具嵌入多层柔性印刷电路(FPC)板中。WABE封装由薄模具(厚度85 μm)、多层聚酰亚胺、胶膜和导电浆料组成。这些模具被带有Cu电路的聚酰亚胺薄膜(fpc)夹在中间。导电浆料提供层之间以及层与嵌入式模具之间的电连接。首先，每个FPC层单独制造，并通过孔填充导电浆料，并将模具安装在某些层上。然后，所有层都经过一步共层工艺，并同时压制粘合材料和导电浆料。这种WABE技术可以通过一步层压工艺嵌入多个模具。即使嵌入多个晶片，通过垂直堆叠嵌入多个晶片，也可以大大减少封装的占地面积。本文详细介绍了用6个嵌入式模具(3个模具并排放置在两堆)制造试验车的结果。制造的试验车辆有14层厚度小于0.9 mm的铜层。本文还报道了该封装的各种可靠性测试结果。这些结果是通过在一些层之间形成的菊花链图案的电测量得到的。根据湿热试验和热冲击试验的结果，制造的试验车具有较高的可靠性。这些结果表明，在聚酰亚胺薄膜中垂直嵌入多个芯片的WABE技术是实现医疗电子等电子电路小型化的最有前途的封装技术之一。
{"title":"Flexible Circuit Board Package Embedded With Multi-Stack Dies","authors":"N. Ueta, S. Sato, Masakazu Sato, Nakao Yoshio, Joshua P. Magnuson, R. Ishizuka","doi":"10.1115/dmd2020-9032","DOIUrl":"https://doi.org/10.1115/dmd2020-9032","url":null,"abstract":"\u0000 Miniaturization of electronics modules is always required for various medical applications including wearable technology, such as hearing aids, and implantable devices. Many types of high-density packaging technologies, such as package-on-package, bare-die stack, flex folded package and Through Si Via (TSV) technologies, have been proposed and used to fulfill the request. Among them, embedded die technology is one of the promising technologies to realize miniaturization and high-density packaging. We have developed WABE™ (wafer and board level device embedded) technology for embedding dies into multilayer flexible printed circuit (FPC) boards. The WABE package is comprised of thin dies (85 μm thickness), multi-layer polyimide, adhesive films and conductive paste. The dies are sandwiched by polyimide films with Cu circuits (FPCs). The conductive paste provides electrical connections between the layers as well as the layer and embedded die. First, each FPC layer is fabricated individually, and via holes are filled with conductive paste, and the dies are mounted on certain layers. Then, all layers undergo a one-step co-lamination process, and they are pressed to cure the adhesive material and conductive paste at the same time. This WABE technology has enabled multiple dies to be embedded by the one-step lamination process. Even if multiple dies are embedded, the footprint of a package can be reduced drastically by embedding multiple dies vertically in stacks. This paper describes the details of the results of fabricating a test vehicle with six embedded dies (three-dies in two stacks side-by-side). The fabricated test vehicle had 14 copper layers with less than 0.9 mm thickness. This paper also reports the results of various reliability testing on the package. These results were obtained by electrical measurements of daisy chain patterns formed between some of the layers. The fabricated test vehicle showed high reliability based on the results of a moisture and heat test and heat-shock test. These results show that the WABE technology to embed multiple dies vertically in polyimide film is one of the most promising packaging technologies to significantly miniaturize electronic circuits such as medical electronics.","PeriodicalId":93509,"journal":{"name":"2020 Design of Medical Devices Conference (DMD 2020). Design of Medical Devices Conferences (2020 : Minneapolis, Minn.)","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89598688","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}
This paper outlines the design of a reconfigurable, partially disposable, tendon-driven robotic arm for providing assistance in laparoscopic surgery. The rationale for its development and design objectives are provided, followed by a description of its mechanical design. Kinematic simulations to assess workspace are presented, and a first-stage assessment of the functionality of a prototype using a custom test bench is also included.
{"title":"Design of a Modular Cost-Effective Robot Arm for Increased Dexterity in Laparoscopic Surgery","authors":"J. Lowery, C. Nelson","doi":"10.1115/dmd2020-9010","DOIUrl":"https://doi.org/10.1115/dmd2020-9010","url":null,"abstract":"\u0000 This paper outlines the design of a reconfigurable, partially disposable, tendon-driven robotic arm for providing assistance in laparoscopic surgery. The rationale for its development and design objectives are provided, followed by a description of its mechanical design. Kinematic simulations to assess workspace are presented, and a first-stage assessment of the functionality of a prototype using a custom test bench is also included.","PeriodicalId":93509,"journal":{"name":"2020 Design of Medical Devices Conference (DMD 2020). Design of Medical Devices Conferences (2020 : Minneapolis, Minn.)","volume":"604 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77626128","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}
Samuel Frishman, Annabel M. Imbrie-Moore, M. Cutkosky, Ali Kight, I. Pirozzi, Michael J Paulsen, J. Woo
Mitral valve (MV) annular dynamics are critical to the long term efficacy of MV repair. Today’s annuloplasty rings, used to restore MV function, impose significant constraints on the motion profile of the MV annulus. We present a selectively compliant ring that provides sufficient stiffness to stabilize a diseased annulus while allowing physiological annular dynamics. Ring design is informed by a finite element analysis and experimentally evaluated with in-vitro stereophotogrammetry. We compare the ring dynamics to commercially available semi-rigid rings as well as values found in literature for healthy annuli. The results demonstrate that motion of the selectively compliant ring is significantly closer to that of a healthy annulus based on standard metrics that define MV annular movement. Specifically, the metrics for the new ring compare to those in literature as follows: change in orifice area 12.5 ± 3% vs.10 ± 2%; change in anterior-posterior diam. 5.4 ± 0.3% vs. 7 ± 1%; change in inter-commissural diam. 6.6 ± 1.3% vs. 5 ± 1%.
二尖瓣环动力学对二尖瓣修复的长期疗效至关重要。目前用于恢复中压功能的环成形术对中压环的运动轮廓有很大的限制。我们提出了一种选择性柔顺环，提供足够的刚度来稳定患病环空，同时允许生理环空动力学。环形设计是由有限元分析和实验评估与体外立体摄影测量。我们将环动力学与商业上可用的半刚性环以及健康环空文献中发现的值进行比较。结果表明，基于定义MV环空运动的标准指标，选择性柔顺环的运动明显接近健康环空的运动。具体而言，新环与文献中的指标进行了比较:孔口面积变化12.5±3% vs.10±2%;前后直径变化:5.4±0.3% vs. 7±1%;关节间直径变化:6.6±1.3% vs. 5±1%。
{"title":"Selectively Compliant Annuloplasty Ring to Enable Annular Dynamics in Mitral Valve Repair Evaluated by In-Vitro Stereovision","authors":"Samuel Frishman, Annabel M. Imbrie-Moore, M. Cutkosky, Ali Kight, I. Pirozzi, Michael J Paulsen, J. Woo","doi":"10.1115/dmd2020-9034","DOIUrl":"https://doi.org/10.1115/dmd2020-9034","url":null,"abstract":"\u0000 Mitral valve (MV) annular dynamics are critical to the long term efficacy of MV repair. Today’s annuloplasty rings, used to restore MV function, impose significant constraints on the motion profile of the MV annulus. We present a selectively compliant ring that provides sufficient stiffness to stabilize a diseased annulus while allowing physiological annular dynamics. Ring design is informed by a finite element analysis and experimentally evaluated with in-vitro stereophotogrammetry. We compare the ring dynamics to commercially available semi-rigid rings as well as values found in literature for healthy annuli. The results demonstrate that motion of the selectively compliant ring is significantly closer to that of a healthy annulus based on standard metrics that define MV annular movement. Specifically, the metrics for the new ring compare to those in literature as follows: change in orifice area 12.5 ± 3% vs.10 ± 2%; change in anterior-posterior diam. 5.4 ± 0.3% vs. 7 ± 1%; change in inter-commissural diam. 6.6 ± 1.3% vs. 5 ± 1%.","PeriodicalId":93509,"journal":{"name":"2020 Design of Medical Devices Conference (DMD 2020). Design of Medical Devices Conferences (2020 : Minneapolis, Minn.)","volume":"71 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85697974","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}
As surrogates to human beings, rats are used occasionally to study the therapeutic impact of inhaled pulmonary drug particles in microscale. To speculate human responses from rat studies, scale-up factors are widely used to extrapolate particle lung deposition from rat to human. However, available scale-up methods are highly simplified and not accurate, because they directly use the human-to-rat ratios of body weights (RBW) or lung surface areas (RSA) as the scale-up factor. To find a precise scale-up strategy, an experimentally validated Computational Fluid-Particle Dynamics (CFPD) was employed to simulate the transport and deposition of microparticles in both human and rate respiratory systems, which encompasses the pulmonary routes from mouth/nose to airways up to Generation 17 (G17) for human and G23 for the rat. Microparticles with the same range of Stk/Fr were injected into both models with the airflow at resting conditions. Numerical results indicate that particles (with the size ranging from 1 to 13 μm for humans and 0.6 to 6 μm for rat) have similar deposition pattern (DP) and deposition fraction (DF) in both models, which are resulted from both inertial impaction and gravitational sedimentation effects. A novel correlation is proposed to predict DFs in both human and rat respiratory systems as a function of the ratio of Stokes number to Froude number (Stk/Fr). Using the correlation as the novel scale-up tool, inter-species extrapolations can be precisely done on predicting particle depositions in human respiratory systems based on the deposition data in rats obtained from animal studies.
{"title":"A Precise Scale-Up Method to Predict Particle Delivered Dose in a Human Respiratory System Using Rat Deposition Data: An In Silico Study","authors":"Hamideh Hayati, Yu Feng","doi":"10.1115/dmd2020-9060","DOIUrl":"https://doi.org/10.1115/dmd2020-9060","url":null,"abstract":"\u0000 As surrogates to human beings, rats are used occasionally to study the therapeutic impact of inhaled pulmonary drug particles in microscale. To speculate human responses from rat studies, scale-up factors are widely used to extrapolate particle lung deposition from rat to human. However, available scale-up methods are highly simplified and not accurate, because they directly use the human-to-rat ratios of body weights (RBW) or lung surface areas (RSA) as the scale-up factor. To find a precise scale-up strategy, an experimentally validated Computational Fluid-Particle Dynamics (CFPD) was employed to simulate the transport and deposition of microparticles in both human and rate respiratory systems, which encompasses the pulmonary routes from mouth/nose to airways up to Generation 17 (G17) for human and G23 for the rat. Microparticles with the same range of Stk/Fr were injected into both models with the airflow at resting conditions. Numerical results indicate that particles (with the size ranging from 1 to 13 μm for humans and 0.6 to 6 μm for rat) have similar deposition pattern (DP) and deposition fraction (DF) in both models, which are resulted from both inertial impaction and gravitational sedimentation effects. A novel correlation is proposed to predict DFs in both human and rat respiratory systems as a function of the ratio of Stokes number to Froude number (Stk/Fr). Using the correlation as the novel scale-up tool, inter-species extrapolations can be precisely done on predicting particle depositions in human respiratory systems based on the deposition data in rats obtained from animal studies.","PeriodicalId":93509,"journal":{"name":"2020 Design of Medical Devices Conference (DMD 2020). Design of Medical Devices Conferences (2020 : Minneapolis, Minn.)","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79792150","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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