Can mechanical heart valves perform similarly to tissue valves? An in vitro study.

Current surgical aortic valve (AV) replacement options include bioprosthetic and mechanical heart valves (MHVs), each with inherent limitations. Bioprosthetic valves offer superior hemodynamics but suffer from durability issues, typically initiating deterioration within 7-8 years. MHVs, while durable, necessitate lifelong anticoagulation therapy, presenting risks such as severe bleeding and thromboembolic events. The need for anticoagulants is caused by non-physiological flow through the hinge area during the closed phase and large spikes of regional backflow velocity (RBV) during the closing phase that produces high shear events. This study introduces the iValve, a novel MHV designed to combine the hemodynamic benefits of bioprosthetic valves with the durability of MHVs without requiring anticoagulation. The iValve features eye-like leaflets, a saddle-shaped housing, and an optimized hinge design to enhance blood flow and minimize thrombotic risk. Fabricated using 6061-T6 aluminum and polyether ether ketone (PEEK), twelve iValve iterations were evaluated for their opening and closing dynamics. The reported top-performing prototypes demonstrated competitive performance against industry standards. The proposed iValve prototype exhibited a mean RBV of -4.34 m/s with no spikes in RBV, performing similarly to bioprosthetic valves and significantly outperforming existing MHVs. The iValve's optimized design showed a 7-10% reduction in closing time and a substantial decrease in RBV spikes, potentially reducing the need for anticoagulation therapy. This study highlights the iValve's potential to revolutionize prosthetic heart valve technology by offering a durable, hemodynamically superior solution that mitigates the drawbacks of current MHVs.

Valve interstitial cells under impact load, a mechanobiology study.

Understanding the relationship between mechanobiology and the biosynthetic activities of the valve interstitial cells (VICs) in health and disease under severe dynamic loading conditions is of particular interest. The purpose of this study is to further understand the mechanobiology of heart valve leaflet tissue and the VICs under impact forces. Two novel computational and experimental platforms were developed to study the effect of impact load on the VICs to monitor for apoptosis. The first objective was to design and develop an apparatus to experimentally study viability (apoptosis) of the porcine heart valve leaflet tissue VICs in the aortic position under controlled impact forces. Apoptosis was assessed based on terminal transferase dUTP nick end-labelling (TUNEL) assay. The second objective was to develop a computational platform to estimate the stress and strain fields in the vicinity of VICs when the tissue experiences impact forces. A nonlinear finite element (FE) model with an anisotropic, hyperelastic and heterogeneous material model for the matrix and cells was developed. Preliminary results confirm that interstitial cells are successfully resistant to impact loads up to 30 times more than normal physiological conditions. Additionally, the structure and composition of heart valve leaflet tissue provides a mechanical shield for VICs protecting them from excessive mechanical forces such as impact loads. Although, the entire tissue may experience excessive stresses, which may lead to structural damage, the stresses around and near VICs remain consistency low. Results of this study may be used for heart valve leaflet tissue-engineering, as well as further understanding the mechanobiology of the VICs in health and disease.

Computational study and validation of a novel passive hand tremor attenuator.

Tremors are a prevalent movement disorder due to a nervous system condition that leads to involuntary muscle movements observed in patients. This paper converts the tremorous anatomical human arm model to a single degree of freedom (SDOF) forced vibration problem. The mathematical modelling with Euler-Lagrange's equation is performed for the SDOF human arm model with two different potential vibration absorbers. A computational study is conducted on MATLAB Simulink by MathWorks Inc. (Natick, MA) to compare two absorbers, and the results are verified on the multibody dynamics simulation solution software, MSC Adams by Hexagon AB. It is concluded that the T beam-shaped vibration absorber represented a higher amplitude reduction, up to 80%, compared to the inertial mass absorber, which had an amplitude reduction of 65% over the range of frequencies. Experiments conducted with the T beam absorber prototype also support the computational findings. Future research focuses on designing an ergonomic wearable device with a proposed T-beam absorber that can passively attenuate the tremor at various frequencies.

A review of the experimental methods and results of testing the mechanical properties of Tunica Albuginea.

The present work provides a comprehensive review of the literature on the mechanical properties and existing human tunica albuginea tissue testing methods. Assessments were completed on papers reporting experimental values of Young's modulus, tensile strength, puncture strength, stiffness, toughness, and strain at the ultimate tensile strength (UTS). A high degree of variability in the reported experimental values was found; Young's modulus ranged from 5 MPa to 118 MPa, and tensile strength went from 1.1 MPa to 6.1 MPa. A comparison of the variability of the reported experimental values for puncture strength, stiffness, toughness, and strain at the UTS could not be completed due to a lack of experimental results. This review discusses the pathophysiology and surgical treatment of erectile dysfunction and Peyronie's disease, variability in the existing reported mechanical properties, the impact of the variability of mechanical properties on in silico models and explores the absence of a standardised testing method as a possible reason for the variable in results. Finally, this work attempts to provide suggestions for standardising future mechanical testing of the tunica albuginea through minimising and reporting freeze/thaw cycling, noting the proximal/distal region of the cadaver tunica sample, reporting the orientation (o'clock position) of the cadaver tunica sample, and testing the cadaver tunica samples in bi-axial tension. Ultimately, standardising the testing methodologies of the tunica albuginea will provide higher confidence in reported mechanical property values.

Wrinkle-induced tear in the mitral valve leaflet tissue: a computational model.

In this study, we offer a numerical platform to detect the locations of high-stress zones in the prosthetic heart valve, in the mitral position, during the closing phase due to existing wrinkles. The intended prosthetic valves in this study have the same shape as the native mitral valve but made of synthetic biomaterials. We assume the most high-risk locations for ruptures to either initiate or propagate are at the base of existing wrinkles. We developed a finite element model for the human mitral valve. A mesh model was effectively created to account for the uneven stress distribution and high-stress concentration zones in the valve tissue structure. The constitutive material model used in this study is anisotropic and hyperelastic such that the membrane elements are used for the leaflets and spar elements are utilised for the mitral valve cords for which it was assumed flexural stiffness is insignificant for both sets of elements. We developed a novel and effective computational model for the simulation of wrinkles in the valve leaflet during the closing phase. The proposed numerical model provided a quick but precise assessment for the detection of locations of rips and tears on the leaflet tissue during the closing phase. The proposed model is an essential step for the design of material and geometry of leaflets of prosthetic heart valves made of polymers or tissue materials in the mitral position.

New synthetic mitral valve model for human prolapsed mitral valve reconstructive surgery for training.

The training process of young surgeons is highly desirable in order for them to gain an understanding of the quality of care and patient safety required during cardiac surgeries, however, it may take a few years of practice in order for them to properly develop these skills. Artificial life-like platforms and models are extremely recommended for teaching hands-on and real-world practice in both junior and even experienced medical professionals and surgeons. Suitable and accessible training tools are of significant importance for simulating a particular surgery in order to provide practice opportunities for a specific surgical procedure. In this study, we focussed on the simulation of the human mitral valve prolapse reconstructive surgery. An innovative, artificial, biomimetic model was designed and fabricated made of Cryogel biomaterial developed in our lab that is suitable for the precise practice on the mitral valve prolapse model. The proposed model is mainly made up of polyvinyl alcohol (PVA) cryogel, which is designed to resemble the geometric and mechanical properties of a diseased (prolapse) mitral valve. We simulated the constructive prolapsed mitral valve surgery entirely on a synthetic platform. The platform was made available to four certified cardiac surgeon and there were unanimously very positive with no considerable differences in the procedural assessments between them. The proposed model has a similar appearance and texture to that of a diseased mitral valve and holds consistent mechanical properties to those of the real tissue. The offered technology may be used for other cardiothoracic reconstructive surgeries with high precision and consistency.

Transcatheter Mitral Valve Replacement: State of the Art.

The emergence of transcatheter aortic valve replacement (TAVR) has segued the development of transcatheter mitral valve (MV) repair devices. Transcatheter mitral valve repair has become a well-established alternative for patients with severe primary and secondary mitral regurgitation (MR) and with a perceived surgical risk. Transcatheter mitral valve replacement (TMVR) could become a more complete form of reduction of severe MR compared to MV repair devices, albeit with significant engineering challenges and all the risks associated with a bioprosthetic heart valve. The development of TMVR devices has become prominent while companies race to become the first commercially available system. Careful consideration of design challenges should be conducted by the developmental companies to ensure successful devices. Preclinical and clinical trials have shown promising results, showcasing the feasibility of total valve replacement utilizing transcatheter procedure techniques. Further development, testing, and trials need to be conducted before TMVR can become a sensible MR treatment. This review describes design challenges and considerations along with the state of the art, involving designs in both clinical and preclinical stages.

Proposed percutaneous aortic valve prosthesis made of cryogel.

Transcatheter heart valves are promising for high-risk patients. Generally, their leaflets are made of pericardium stented in a Nitinol basket. Despite their relative success, they are associated with significant complications such as valve migration, implantation risks, stroke, coronary obstruction, myocardial infraction, acute kidney injury (which all are due to the release of detached solid calcific pieces in to the blood stream) and expected issues existing with tissue valves such as leaflet calcification. This study is an attempt to fabricate the first ever polymeric percutaneous valves made of cryogel following the geometry and mechanical properties of porcine aortic valve to address some of the above-mentioned shortcomings. A novel, one-piece, tricuspid percutaneous valve, consisting of leaflets made entirely from the hydrogel, polyvinyl alcohol cryogel reinforced by bacterial cellulose natural nanocomposite, attached to a Nitinol basket was developed and demonstrated. Following the natural geometry of the valve, a novel approach was applied based on the revolution about an axis of a hyperboloid shape. The geometry was modified based on avoiding sharp warpage of leaflets and removal of the central opening orifice area of the valve when valve is fully closed using the finite element analysis. The modified geometry was replaced by a cloud of (control) points and was essentially converted to Bezier surfaces for further adjustment. A cavity mold was then designed and fabricated to form the valve. The fabricated valve was sewn into the Nitinol basket which is covered by Dacron cloth. The models presented in this study merit further development and revisions for both aortic and mitral positions.