A Thin Film Nitinol Heart Valve

2005 ◽  
Vol 127 (6) ◽  
pp. 915-918 ◽  
Author(s):  
Lenka L. Stepan ◽  
Daniel S. Levi ◽  
Gregory P. Carman
Keyword(s):  
Thin Film ◽  
Heart Valve ◽  
Heart Valves ◽  
Thrombus Formation ◽  
Prosthetic Heart Valve ◽  
Flow Loop ◽  
Niti Wire ◽  
Tissue Samples

In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A “butterfly” valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Bio-corrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material’s in vivo biocompatibility, thin film nitinol was implanted in pigs using stents covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on thin film nitinol samples after immersion in Hank’s solution for one month. Finally, organ and tissue samples explanted from four pigs at 2, 3, 4, and 6 weeks after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation. Although long term testing is still necessary, thin film NiTi may be very well suited for use in artificial heart valves.

A Thin Film Nitinol Heart Valve

Aerospace ◽  
2004 ◽  
Author(s):  
Lenka Stepan ◽  
Daniel Levi ◽  
Gregory Carman
Keyword(s):  
Thin Film ◽  
Heart Valve ◽  
Heart Valves ◽  
Thrombus Formation ◽  
Prosthetic Heart Valve ◽  
Flow Loop ◽  
Niti Wire ◽  
Tissue Samples

In order to create a less thrombogenic heart valve with improved longevity, a prosthetic heart valve was developed using thin film nitinol (NiTi). A “butterfly” thin film NiTi valve was constructed using a single, elliptical piece of thin film NiTi and a scaffold made from Teflon tubing and NiTi wire. Flow tests and pressure readings across the valve were performed in vitro in a pulsatile flow loop. Biocorrosion experiments were conducted on untreated and passivated thin film nitinol. To determine the material’s in vivo biocompatibility, thin film nitinol was implanted in a pig using a stent covered with thin film NiTi. Flow rates and pressure tracings across the valve were comparable to those through a commercially available 19 mm Perimount Edwards tissue valve. No signs of corrosion were present on samples of thin film nitinol after immersion in Hank’s solution for 1 month. Finally, organs and tissue samples explanted from the pig 17 days after thin film NiTi implantation appeared without disease, and the thin film nitinol itself was without thrombus formation or endothelialization. Although long term testing will be needed, thin film NiTi may be very well suited for use in artificial heart valves.

Modeling of Tissue Fatigue Damage in Bio-Prosthetic Heart Valve

2011 ◽  
Author(s):  
Caitlin Martin ◽  
Wei Sun
Keyword(s):  
Fatigue Damage ◽  
Heart Valve ◽  
Anticoagulant Therapy ◽  
Heart Valves ◽  
Prosthetic Heart Valve ◽  
Bovine Pericardium ◽  
Prosthetic Heart Valves ◽  
Mechanical Valves ◽  
In Vivo Degradation

Bio-prosthetic heart valves (BHVs) with leaflets made of glutaraldehyde-treated bovine pericardium (GLBP), have been used extensively to replace diseased heart valves. BHVs display superior hemodynamics to mechanical valves and eliminate the need for anticoagulant therapy; however, they exhibit poor durability resulting from in vivo degradation and fatigue damage of the leaflets.

scholarly journals Polyisobutylene-Based Thermoplastic Elastomers for Manufacturing Polymeric Heart Valve Leaflets: In Vitro and In Vivo Results

2019 ◽  
Vol 9 (22) ◽  
pp. 4773 ◽  
Author(s):  
Evgeny Ovcharenko ◽  
Maria Rezvova ◽  
Pavel Nikishau ◽  
Sergei Kostjuk ◽  
Tatiana Glushkova ◽  
...  
Keyword(s):  
Mechanical Properties ◽  
Heart Valve ◽  
Heart Valves ◽  
Reference Sample ◽  
Sample Surface ◽  
Thermoplastic Elastomers ◽  
Water Contact ◽  
Promising Alternative

Superior polymers represent a promising alternative to mechanical and biological materials commonly used for manufacturing artificial heart valves. The study is aimed at assessing poly(styrene-block-isobutylene-block-styrene) (SIBS) properties and comparing them with polytetrafluoroethylene (Gore-texTM, a reference sample). Surface topography of both materials was evaluated with scanning electron microscopy and atomic force microscopy. The mechanical properties were measured under uniaxial tension. The water contact angle was estimated to evaluate hydrophilicity/hydrophobicity of the study samples. Materials’ hemocompatibility was evaluated using cell lines (Ea.hy 926), donor blood, and in vivo. SIBS possess a regular surface relief. It is hydrophobic and has lower strength as compared to Gore-texTM (3.51 MPa vs. 13.2/23.8 MPa). SIBS and Gore-texTM have similar hemocompatibility (hemolysis, adhesion, and platelet aggregation). The subcutaneous rat implantation reports that SIBS has a lower tendency towards calcification (0.39 mg/g) compared with Gore-texTM (1.29 mg/g). SIBS is a highly hemocompatible material with a promising potential for manufacturing heart valve leaflets, but its mechanical properties require further improvements. The possible options include the reinforcement with nanofillers and introductions of new chains in its structure.

Research Contribution of Prosthetic Valve Manufacturers Interfacing Academic-Industry Research Efforts

1999 ◽  
Author(s):  
Xiao Gong ◽  
Yi-Ren Woo ◽  
Ajit P. Yoganathan ◽  
Andreas Anayiotos
Keyword(s):  
Heart Valve ◽  
Heart Valves ◽  
Clinical Performance ◽  
Thrombus Formation ◽  
Academic Research ◽  
Prosthetic Heart Valve ◽  
Structural Safety ◽  
Prosthetic Heart Valves ◽  
Implantable Medical Device ◽  
Valve Design

Abstract Prosthetic heart valve is one of the most successful implantable medical devices. However, introducing better performing and longer lasting prosthetic mechanical heart valves (MHV) into clinical use has been slow because predicting the long term performance of a new valve design is difficult. Although significant progresses in many scientific fronts relevant to prosthetic heart valve development have been achieved, we still have an imperfect understanding of host responses to an implantable medical device and incomplete knowledge in associating hemodynamic characteristics of a valve design to clinical performance. Valve designers, frequently need to over design the valve components to ensure structural safety and thus, sacrifice the opportunity to optimize performance. Complications such as infection, thrombus formation, thromboembolic incidents, and hemorrhage associated to the use of prosthetic valves are still reported and valve designers are working hard to eliminate them. Further advancing scientific knowledge in designing and evaluating prosthetic heart valves is of great interest to many Valve designers and manufacturers. Interfacing Industry and Academic research efforts has been thwarted due to predominantly proprietary issues. Considering the benefits of a better performing MHV to the patients, this industry session will bring researchers from various MHV companies and academic institutions to discuss how to share the results of scientific studies more effectively. This will help accelerate new MHV development without compromising the confidentiality of key valve design information. The issue of standardized MHV testing will also be addressed.

CURRENT DEVELOPMENTS AND FUTURE CHALLENGES FOR THE CREATION OF AORTIC HEART VALVE

2008 ◽  
Vol 08 (01) ◽  
pp. 1-15 ◽  
Author(s):  
YOS S. MORSI ◽  
CYNTHIA S. WONG
Keyword(s):  
Heart Valve ◽  
Heart Valves ◽  
Mechanical Characteristics ◽  
Polyglycolic Acid ◽  
Cellular Interactions ◽  
Trimethylene Carbonate ◽  
The Creation ◽  
Tissue Engineered Heart Valves

The concept of tissue-engineered heart valves offers an alternative to current heart valve replacements that is capable of addressing shortcomings such as life-long administration of anticoagulants, inadequate durability, and inability to grow. Since tissue engineering is a multifaceted area, studies conducted have focused on different aspects such as hemodynamics, cellular interactions and mechanisms, scaffold designs, and mechanical characteristics in the form of both in vitro and in vivo investigations. This review concentrates on the advancements of scaffold materials and manufacturing processes, and on cell–scaffold interactions. Aside from the commonly used materials, polyglycolic acid and polylactic acid, novel polymers such as hydrogels and trimethylene carbonate-based polymers are being developed to simulate the natural mechanical characteristics of heart valves. Electrospinning has been examined as a new manufacturing technique that has the potential to facilitate tissue formation via increased surface area. The type of cells utilized for seeding onto the scaffolds is another factor to take into consideration; currently, stem cells are of great interest because of their potential to differentiate into various types of cells. Although extensive studies have been conducted, the creation of a fully functional heart valve that is clinically applicable still requires further investigation due to the complexity and intricacies of the heart valve.

scholarly journals Recellularization of decellularized heart valves: Progress toward the tissue-engineered heart valve

2017 ◽  
Vol 8 ◽  
pp. 204173141772632 ◽  
Author(s):  
Mitchell C VeDepo ◽  
Michael S Detamore ◽  
Richard A Hopkins ◽  
Gabriel L Converse
Keyword(s):  
Heart Valve ◽  
Heart Valves ◽  
Mechanical Conditioning ◽  
New Era ◽  
Processing Strategies ◽  
Tissue Engineered Heart Valve ◽  
Tissue Engineered Heart Valves

The tissue-engineered heart valve portends a new era in the field of valve replacement. Decellularized heart valves are of great interest as a scaffold for the tissue-engineered heart valve due to their naturally bioactive composition, clinical relevance as a stand-alone implant, and partial recellularization in vivo. However, a significant challenge remains in realizing the tissue-engineered heart valve: assuring consistent recellularization of the entire valve leaflets by phenotypically appropriate cells. Many creative strategies have pursued complete biological valve recellularization; however, identifying the optimal recellularization method, including in situ or in vitro recellularization and chemical and/or mechanical conditioning, has proven difficult. Furthermore, while many studies have focused on individual parameters for increasing valve interstitial recellularization, a general understanding of the interacting dynamics is likely necessary to achieve success. Therefore, the purpose of this review is to explore and compare the various processing strategies used for the decellularization and subsequent recellularization of tissue-engineered heart valves.

Simulations of the Hinge Flow Fields of a Bileaflet Mechanical Heart Valve Under Physiologic Pulsatile Aortic Conditions

2008 ◽  
Author(s):  
Hélène A. Simon ◽  
Liang Ge ◽  
Iman Borazjani ◽  
Fotis Sotiropoulos ◽  
Ajit P. Yoganathan
Keyword(s):  
Heart Valve ◽  
Heart Valves ◽  
Mechanical Heart Valve ◽  
Prosthetic Heart Valve ◽  
Prosthetic Heart Valves ◽  
Valve Design ◽  
Bileaflet Mechanical Heart Valve ◽  
Hinge Flow ◽  
Blood Elements

Native heart valves with limited functionality are commonly replaced by prosthetic heart valves. Since the first heart valve replacement in 1960, more than three million valves have been implanted worldwide. The most widely implanted prosthetic heart valve design is currently the bileaflet mechanical heart valve (BMHV), with more than 130,000 implants every year worldwide. However, studies have shown that this valve design can still cause major complications, including hemolysis, platelet activation, and thromboembolic events. Clinical reports and recent in vitro experiments suggest that these thrombogenic complications are associated with the hemodynamic stresses imposed on blood elements by the complex non-physiologic flow induced by the valve, in particular in the hinge region.

Enhanced Response to Chemotactic Activation of Polymorphonuclear Leukocytes from Patients with Heart Valve Replacement

1997 ◽  
Vol 77 (01) ◽  
pp. 071-074 ◽  
Author(s):  
Norma Maugeri ◽  
Ana C Kempfer ◽  
Virgilio Evangelista ◽  
Chiara Cerletti ◽  
Giovanni de Gaetano ◽  
...  
Keyword(s):  
Valve Replacement ◽  
Heart Valve ◽  
Thrombus Formation ◽  
Oral Anticoagulant Therapy ◽  
Thrombotic Event ◽  
Mechanical Heart Valve ◽  
Cathepsin G ◽  
Heart Valve Replacement

SummaryArtificial surfaces activate blood components. Since anticoagulant and antiplatelet therapy fail to abolish thromboembolic complications in patients with mechanical heart valve replacement (MHVR), other mechanisms might contribute to switch on a thrombotic event. We therefore investigated the reactivity to chemotactic activation of PMN from patients with MHVR. PMN responses were analyzed in 3 groups: 130 patients with MHVR and oral anticoagulant therapy, with or without aspirin, 57 patients on a comparable antithrombotic regimen, but without MHVR and 50 healthy subjects. In vitro studies showed that the release of cathepsin G and elastase from fMLP-stimulated PMN was significantly higher in the MHVR group, the leukocyte content of α1-antitrypsin (an inhibitor of both enzymes) being similar in all three groups. CD1 lb expression after stimulation with fMLP was also significantly higher on PMN from MHVR patients than from control patients or healthy volunteers, while PMN CD 11b basal expression was similar in all three groups. This increased PMN response in vitro in the absence of an obvious activation in vivo, may reflect a modified reactivity of circulating PMN passing through the artificial valves. Increased reactivity to local stimuli might allow PMN to participate in thrombus formation, despite conventional antithrombotic therapy.

The Design, Fabrication and Evaluation of a Trileaflet Prosthetic Heart Valve

1980 ◽  
Vol 102 (1) ◽  
pp. 34-41 ◽  
Author(s):  
G. E. Chetta ◽  
J. R. Lloyd
Keyword(s):  
Heart Valve ◽  
Performance Index ◽  
Test Section ◽  
Heart Valves ◽  
Prosthetic Heart Valve ◽  
Prosthetic Heart Valves ◽  
In Vitro Evaluation ◽  
Design Considerations ◽  
Evaluation Techniques

Although prosthetic heart valves have been in existence for many years, the need for new improved designs and in-vitro evaluation techniques are apparent. This paper presents details on the design considerations, fabrication techniques and heart valve evaluation equipment. A valve performance index is discussed in light of various valve and mock circulatory test section designs. The need for national and indeed international valve evaluation techniques is made apparent.

On the Hemolytic and Thrombogenic Potential of Occluder Prosthetic Heart Valves From In-Vitro Measurements

1981 ◽  
Vol 103 (2) ◽  
pp. 83-90 ◽  
Author(s):  
R. S. Figliola ◽  
T. J. Mueller
Keyword(s):  
Heart Valves ◽  
Thrombus Formation ◽  
Test Chamber ◽  
Separated Flow ◽  
Prosthetic Heart Valves ◽  
Shear Stresses ◽  
Flow Loop ◽  
Mean Velocity ◽  
Test Loop

An experimental investigation was conducted to determine the magnitude of shear stresses and areas of stasis of several types of prosthetic occluder heart valves. These experiments were performed in a steady-flow test loop using an axisymmetric aortic-shaped test chamber and an aqueous-glycerine solution. The flow loop produced a low-turbulence intensity and uniform mean velocity profile upstream of the test chamber. Tests were perfomed on a Kay-Shiley disk, a Bjork-Shiley tilting disk and Starr-Edwards Models 1260 and 2320 ball prostheses at Reynolds numbers between 2000 and 6200. Momentum transfer and turbulence data were obtained both around and distal to the valve occluders using laser Doppler and hot-film anemometry. The region directly surrounding the valve occluders contained the largest stresses measured. Aortic wall shear measurements revealed magnitudes potentially damaging to the vessel lining. Regions of slowly moving separated flow found to exist in these occluder valve flow fields correlated with clinical findings of thrombus formation.

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