Medical textile implants: hybrid fibrous constructions towards improved performances.

OBJECTIVES: One main challenge for textile implants is to limit the foreign body reaction (FBR) and in particular the fibrosis development once the device is implanted. Fibrotic tissue in-growth depends on the fiber size, the pore size, and the organization of the fibrous construction. Basically, non-woven fibrous assemblies present a more favorable interface to biological tissues than do woven structures. However, they are mechanically less strong. In order to combine both strength and appropriate topography properties, the design of a hybrid fibrous construct was considered and discussed in this work. METHODS: Two polyethylene terephthalate (PET) weaves (satin and plain) were assembled with a non-woven PET mat, using an ultrasound welding process. RESULTS: The physical and mechanical properties of the construction as well as its ability to interact with the biological environment were then evaluated. In particular, the wettability of the obtained substrate as well as its ability to interact with mesenchymal stem cells (MSC) at 24 h (adhesion) and 72 h (proliferation) in vitro were studied. CONCLUSIONS: The results show that the non-woven layer helps limiting cell proliferation in the plain weave construction and promotes conversely proliferation in the satin construction.

Surface treatment of PET multifilament textile for biomedical applications: roughness modification and fibroblast viability assessment.

OBJECTIVES: The aim of this study was to investigate the potential of tuning the topography of textile surfaces for biomedical applications towards modified cell-substrate interactions. METHODS: For that purpose, a supercritical Nitrogen N2 jet was used to spray glass particles on multi-filament polyethylene terephthalate (PET) yarns and on woven fabrics. The influence of the jet projection parameters such as the jet pressure (P) and the standoff distance (SoD) on the roughness was investigated. RESULTS: The impact of the particles created local filament ruptures on the treated surfaces towards hairiness increase. The results show that the treatment increases the roughness by up to 17 % at P 300 bars and SoD 300 mm while the strength of the material is slightly decreased. The biological study brings out that proliferation can be slightly limited on a more hairy surface, and is increased when the surface is more flat. After 10 days of fibroblast culture, the cells covered the entire surface of the fabrics and had mainly grown unidirectionally, forming cell clusters oriented along the longitudinal axis of the textile yarns. Clusters were generated at yarn crossings. CONCLUSIONS: This approach revealed that the particle projection technology can help tuning the cell proliferation on a textile surface.

Fiber heart valve prosthesis: Early in vitro fatigue results.

Transcatheter aortic valve replacement has become today a largely considered alternative technique to surgical valve replacement in patients with high risk for open chest surgery. Biological valve tissue used in the transcatheter devices has shown success over 5 years now, but the procedure remains expensive. Moreover, different studies point out potential degradations that the tissue can undergo when folded to lower diameter and released in calcified environment with irregular geometry, which may jeopardize the durability of the device. The use of synthetic materials, like textile in particular, to replace biological valve leaflets would help reducing the procedure costs, and limit the degradations when the valve is crimped. Textile polyester material has been extensively used in the vascular surgery and is characterized by outstanding folding and strength properties combined with proven biocompatibility. However, the friction effects that occur between filaments and between yarns within a fabric under flexure loading could be critical for the resistance of the material on the long term. The purpose of this study was to assess the early fatigue performances of textile valve prototypes under accelerated cyclic loading up to 200 Mio cycles. Durability tests show that the fibrous material undergoes rearrangements between fibrous elements within the textile construction and the mechanical properties are modified on the long term. But testing is not complete with 200 Mio cycles. The material should be tested up to a higher number of cycles in future work to test the effective long-term durability. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 104B: 986-992, 2016.

Mechanical degradation of biological heart valve tissue induced by low diameter crimping: an early assessment.

Transcatheter aortic valve implantation (TAVI) has become today an increasingly attractive procedure to relieve patients from aortic valve disease. However, the procedure requires crimping biological tissue within a metallic stent for low diameter catheter insertion purpose. This step induces specific stress in the leaflets especially when the crimping diameter is small. One concern about crimping is the potential degradations undergone by the biological tissue, which may limit the durability of the valve once implanted. The purpose of the present work is to study the effect of low diameter crimping on the mechanical performances of pericardium valve prototypes. The prototypes were compressed to a diameter of 1mm within braided stents for 20 min. SEM observations performed on crimped material show that crimped leaflets undergo degradations characterized by apparent surface defects. Moreover mechanical extension tests were performed on pericardium strips before and after crimping. The strips (15 mm long, 5mm wide) were taken from both crimped and native leaflets considering 2 different valve diameters, 19 and 21 mm. In order to prevent the premature drying of the pericardium tissue during the procedure, the biological tissue was kept in contact with a formaldehyde solution. Results show that the ultimate strength value decreases nearly by up to 50%. The modifications observed in the material may jeopardize the long term durability of the device. However, further tests are necessary with a larger amount of samples to confirm these early results.

Transcatheter fiber heart valve: Effect of crimping on material performances.

Transcatheter aortic valve implantation (TAVI) has become a popular alternative technique to surgical valve replacement. However, the biological valve tissue used in these devices appears to be fragile material in the long term particularly due being folded for low diameter catheter insertion purposes and when released in a calcified environment with irregular geometry. Textile polyester material is characterized by outstanding folding and strength properties combined with proven biocompatibility. It could therefore be considered as a replacement for biological valve leaflets in the TAVI procedure. The folding process associated with crimping, however, may degrade the filaments involved in the fibrous assembly and limit the durability of the device. The purpose of the present work is to study the effect of different crimping conditions on the mechanical performances of textile valve prototypes made from various fabric constructions. Results show that crimping generates some creases in the fabrics, which surface topography varies with fabric construction and crimping configuration. The mechanical properties of the crimped materials are globally slightly reduced. To determine how critical the modifications due to crimping are for prosthesis durability, more detailed long term in vitro and in vivo trials with crimped textile prototypes are needed in addition to this preliminary work.

Textile heart valve: first in-vivo experiment in the aortic position.

Non-invasive aortic valve implantation has become an alternative technique to surgical valve replacement in patients at high risk for open-chest surgery. With over 100,000 procedures already performed clinically, the technology is expected to involve less-critical patients in future. Whereas, biological valve tissue is a fragile material when folded for low-diameter catheter insertion purposes, textile polyester is a less-fragile material and may offer an alternative material to replace valve leaflets. One issue related to textile is the porosity of the material, which may induce exaggerated tissue ingrowth. Today, data relating to interactions between living tissues and fabrics used as valve materials are available only in the mitral position. Hence, the study aim was to observe the interaction pattern when the valve is implanted in the aortic position, and to assess the influence of sinus whirls on this pattern.

Compliance properties of collagen-coated polyethylene terephthalate vascular prostheses.

BACKGROUND: Compliance mismatch between native artery and a prosthetic graft used for infrainguinal bypass is said to be a factor for graft failure. The aim of this study was to develop a technique for measuring the compliance of collagen-coated polyethylene terephthalate (PET) vascular prostheses and to analyze the influence of several key properties on the elastic behavior of the grafts. METHODS: Compliance testing was performed on 3 prostheses with and without internal compliant membrane (ICM). The principle of this test was to study the dimensional changes of prostheses submitted to internal pressure from 30 to 240 mm Hg at intervals of predetermined values. RESULTS: We demonstrated that the ICM created links with the inner surface of the crimps and considerably modified the graft behavior when submitted to internal pressure. The results showed that compliance properties were dependent on the wall thickness and the crimping geometry of textile vascular prostheses. Mechanical analysis predicts the circumferential tensile behavior of these arterial grafts and validates tests for measuring compliance.