Simulation Based Design and Evaluation of a Transcatheter Mitral Heart Valve Frame

Young, Melissa; Erdemir, Ahmet; Stucke, Samantha; Klatte, Ryan; Davis, Brian L.; Navia, José L.

doi:10.1115/1.4007182

Cited by 5 publications

(2 citation statements)

References 29 publications

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“…This includes many of the leading TMVs currently in clinical trials, such as Intrepid (Medtronic, Dublin, Ireland), Tendyne (Abbott Laboratories, Chicago, IL) and Tiara (Neovasc, Richmond, Canada), as well as various earlier-stage stent concepts. 7,16 Effective stent design to achieve targeted levels of annular oversizing likely must account for the observed dynamics of this broader tissue region.…”

Section: Discussionmentioning

confidence: 99%

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part II: Radial Expansion Forces

et al. 2018

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Transcatheter mitral valve (TMV) replacement technology has great clinical potential for surgically inoperable patients suffering from mitral regurgitation. An important goal for robust TMV design is maximizing the likelihood of achieving a geometry post-implant that facilitates optimal performance. To support this goal, improved understanding of the annular forces that oppose TMV radial expansion is necessary. In Part II of this study, novel circular and D-shaped Radial Expansion Force Transducers (C-REFT and D-REFT) were developed and employed in porcine hearts (N=12), to detect the forces required to radially expand the mitral annulus to discrete oversizing levels. Forces on both the septal-lateral and inter-commissural axes (F SL and F IC ) scaled with device size. The D-REFT experienced lower F SL than the C-REFT (19.8±7.4 vs. 17.4±10.8N, p=0.002) and greater F IC (31.5±14.0 vs. 36.9±16.2N; p=0.002), and was more sensitive to degree of oversizing. Across all tests, F IC /F SL was 2.21±1.33, likely reflecting low resistance to radial expansion at the aorto-mitral curtain. In conclusion, the annular forces opposing TMV radial expansion are non-uniform, and depend on final TMV shape and size. Based on this two-part study, we propose that radial force applied at the commissural aspect of the annulus has the most potent effect on paravalvular sealing.

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Section: Discussionmentioning

confidence: 99%

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part II: Radial Expansion Forces

et al. 2018

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“…In recent years, transcatheter mitral valve implantation (TMVI) related to the development of such type bioprostheses is growing dramatically. More than 10-year TMVI development delaying from TAVI is due to complex mitral valve anatomy [2][3][4]. Currently, the main efforts are aimed to design bioprostheses and delivery systems for their implantation in a native mitral valve.…”

Section: Advanced Researchesmentioning

confidence: 99%

The Concept of a Device for the Redo Transcatheter Mitral Valve Implantation

Zhuravleva¹,

Nushtaev²,

Timchenko³

et al. 2017

Sovrem Tehnol Med

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The aim of the investigation is the development of the heart valve prosthesis and transcatheter delivery system for the replacement of a failed mitral biological prosthesis.Materials and Methods. Calculations and construction of three-dimensional models and drawings have been performed in the Computer-Aided Design environment CATIA V5 (Dassault Systèmes, France). The process of the product shaping has been simulated by the terminal element analysis in Abaqus Software (Dassault Systèmes, France). Prototypes of the stents have been made of nitinol tubes by Angioline Interventional Device company (Novosibirsk, Russia) using a laser cutting technique with outer diameter of 7.0 mm and wall thickness 0.5 mm (Vascotube GmbH, Germany). Bioprosthetic leaflets and the cover have been cut using a laser station Melas-Cardio (Institute of Laser Physics, Siberian Branch, Russian Academy of Sciences, Novosibirsk). The valve assemblage has been hand-made using surgical sutures 8/0.Results. The self-expanding biological prosthesis design is based on the anatomy of the left heart, considering the presence of previously implanted bioprosthesis in the mitral position. The nitinol stent of cellular structure consists of a cuff, the body and the outlet part. It is round-shaped that corresponds to the shape of a standard suture bioprostheses. One-third of the cuff adjacent to the mitralaortic contact area forms a 70-degree angle to the mitral annulus plane. In the outlet part there are three hook retainers of the previously implanted bioprosthetic leaflets. For prosthesis repositioning during implantation there are two-way (on the cuff and on hook retainers) retainers and complementary latches in the central catheter of the delivery system, they providing the connection of the valve with the delivery system in both transapical and transatrial access. The valve is provided with radiopaque markers to facilitate the positioning. Valve leaflets and the cover have been made of porcine pericardium treated with epoxy compound. The cover coats the inner surface of the stent cuff and a part of the body.Conclusion. We developed the prototype of a device for the redo transcatheter mitral valve implantation. Further preclinical testing is necessary to evaluate a safety of the medical device.

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Design considerations and quantitative assessment for the development of percutaneous mitral valve stent

Kumar

Cui

Phang

et al. 2014

Medical Engineering & Physics

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Simulation Based Design and Evaluation of a Transcatheter Mitral Heart Valve Frame

Cited by 5 publications

References 29 publications

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part II: Radial Expansion Forces

Novel In Vitro Test Systems and Insights for Transcatheter Mitral Valve Design, Part II: Radial Expansion Forces

The Concept of a Device for the Redo Transcatheter Mitral Valve Implantation

Design considerations and quantitative assessment for the development of percutaneous mitral valve stent

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