Youngjae Chun

Thin-film nitinol (NiTi): A feasibility study for a novel aortic stent graft material

OBJECTIVE Although technological improvements continue to advance the designs of aortic stent grafts, miniaturization of the required delivery systems would allow their application to be available to a wider range of patients and potentially decrease the access difficulties that are encountered. We performed this feasibility study to determine if thin-film NiTi (Nitinol) could be used as a covering for stent grafts ranging from 16 mm to 40 mm in diameter. Specifically, we wished to determine the profile reduction attainable and improve the flexibility of our design. METHODS Using a novel hot-sputter deposition technique, we created sheets of thin-film NiTi (TFN) with a tensile strength of >500 Megapascal (MPa) and thickness of 5-10 microns. TFN was used to cover stents, which were then deployed in vitro. Patterned thin film was fabricated via a lift-off technique; grafts were constructed with stents ranging from 16-40 mm and deployed in a pulsatile flow system from the smallest diameter polymer tubing into which the stent and TFN would fit. The bending/stiffness ratio vs similar sized expanded polytetrafluoroethylene (ePTFE)-covered stents was also determined. RESULTS TFN was created in both non-patterned and patterned forms, with a tensile strength of >100 MPa for the latter. We created devices that were successfully deployed via delivery systems half the size of fabric-covered stent grafts (ie, the 16 mm stent graft that originally was delivered via a 16French (F) system was reduced to 8F, and the 40 mm stent graft delivered via a 24F system was reduced to 12F). No migration of the devices was observed with deployment in both straight and curved tubing, which was sized so that the stent grafts were oversized by 20%. Both forms of the thin-film were noted to be more flexible than the same sized ePTFE stent graft, and the patterned graft had an additional 15-30% flexibility vs the non-patterned film. CONCLUSION These in vitro results demonstrate the feasibility of TFN for covering stent grafts designed for placement in the aorta. The delivery profile can be significantly reduced across a wide range of sizes, while the material remained more flexible than ePTFE.

Super Hydrophilic Thin Film Nitinol Demonstrates Reduced Platelet Adhesion Compared with Commercially Available Endograft Materials

BACKGROUND Thin film nitinol (TFN) is a novel material with which to cover stents for the treatment of a wide range of vascular disease processes. This study aimed to show that TFN, if treated to produce a super hydrophilic surface, significantly reduces platelet adhesion, potentially rendering covered stents more resistant to thrombosis compared to commercially available materials. MATERIALS AND METHODS TFN was fabricated using a sputter deposition process to produce a 5-μ thin film of uniform thickness. TFN then underwent a surface treatment process to create a super hydrophilic layer. Platelet adhesion studies compared surface treated TFN (S-TFN) to untreated TFN, polytetrafluoroethylene, Dacron, and bulk nitinol. In vivo swine studies examined the placement of an S-TFN covered stent in a 3.5 mm diameter external iliac artery. Angiography confirmed placement, and repeat angiography was performed at 2 wk followed by post mortem histopathology. RESULTS S-TFN significantly reduced platelet adhesion without any evidence of aggregation compared with all materials studied (P < 0.05). Furthermore, in vivo swine studies demonstrated complete patency of the S-TFN covered stent at 2 wk. Post mortem histopathology showed rapid endothelialization of the S-TFN without excessive neointimal hyperplasia. CONCLUSIONS These results demonstrate that S-TFN significantly reduces platelet adhesion and aggregation compared with commercially available endograft materials. Furthermore, the hydrophilic surface may confer thromboresistance in vivo, suggesting that S-TFN is a possible superior material for covering stents.

Sustainable manufacturing and the role of the International Journal of Production Research

This paper reviews the broad range of literature related to sustainable manufacturing published in the International Journal of Production Research (IJPR) over the past 50 years. It establishes research frontiers and contributions in the topic of sustainable manufacturing and the related impact to environmental sustainability. With the growing concern of the environmental impact of factors such as pollution and waste, the research areas of sustainable manufacturing and efficient resource utilisation have become significantly more important over the last decade. Whereas early papers focused on safety, workplace, design, and process improvements, research today focuses on ergonomics, intelligence, global manufacturing, environmental challenges, design for sustainability, product life cycle management, and green supply chain management. The paper also briefly surveys existing approaches and identifies commonly used analytical tools and methodologies.

In vitro hemocompatibility of thin film nitinol in stenotic flow conditions.

Because of its low profile and biologically inert behavior, thin film nitinol (TFN) is ideally suited for use in construction of endovascular devices. We have developed a surface treatment for TFN designed to minimize platelet adhesion by creating a superhydrophilic surface. The hemocompatibility of expanded polytetrafluorethylene (ePTFE), untreated thin film nitinol (UTFN), and a surface treated superhydrophilic thin film nitinol (STFN) was compared using an in vitro circulation model with whole blood under flow conditions simulating a moderate arterial stenosis. Scanning electron microscopy analysis showed increased thrombus on ePTFE as compared to UTFN or STFN. Total blood product deposition was 6.3 ± 0.8 mg/cm(2) for ePTFE, 4.5 ± 2.3 mg/cm(2) for UTFN, and 2.9 ± 0.4 mg/cm(2) for STFN (n = 12, p < 0.01). ELISA assay for fibrin showed 326 ± 42 μg/cm(2) for ePTFE, 45.6 ± 7.4 μg/cm(2) for UTFN, and 194 ± 25 μg/cm(2) for STFN (n = 12, p < 0.01). Platelet deposition measured by fluorescent intensity was 79,000 20,000 AU/mm(2) for ePTFE, 810 ± 190 AU/mm(2) for UTFN, and 1600 ± 25 AU/mm(2) for STFN (n = 10, p < 0.01). Mass spectrometry demonstrated a larger number of proteins on ePTFE as compared to either thin film. UTFN and STFN appear to attract significantly less thrombus than ePTFE. Given TFNs low profile and our previously demonstrated ability to place TFN covered stents in vivo, it is an excellent candidate for use in next-generation endovascular stents grafts.

An overview of thin film nitinol endovascular devices

Thin film nitinol has unique mechanical properties (e.g., superelasticity), excellent biocompatibility, and ultra-smooth surface, as well as shape memory behavior. All these features along with its low-profile physical dimension (i.e., a few micrometers thick) make this material an ideal candidate in developing low-profile medical devices (e.g., endovascular devices). Thin film nitinol-based devices can be collapsed and inserted in remarkably smaller diameter catheters for a wide range of catheter-based procedures; therefore, it can be easily delivered through highly tortuous or narrow vascular system. A high-quality thin film nitinol can be fabricated by vacuum sputter deposition technique. Micromachining techniques were used to create micro patterns on the thin film nitinol to provide fenestrations for nutrition and oxygen transport and to increase the devices flexibility for the devices used as thin film nitinol covered stent. In addition, a new surface treatment method has been developed for improving the hemocompatibility of thin film nitinol when it is used as a graft material in endovascular devices. Both in vitro and in vivo test data demonstrated a superior hemocompatibility of the thin film nitinol when compared with commercially available endovascular graft materials such as ePTFE or Dacron polyester. Promising features like these have motivated the development of thin film nitinol as a novel biomaterial for creating endovascular devices such as stent grafts, neurovascular flow diverters, and heart valves. This review focuses on thin film nitinol fabrication processes, mechanical and biological properties of the material, as well as current and potential thin film nitinol medical applications.

Soft, conformal bioelectronics for a wireless human-wheelchair interface

There are more than 3 million people in the world whose mobility relies on wheelchairs. Recent advancement on engineering technology enables more intuitive, easy-to-use rehabilitation systems. A human-machine interface that uses non-invasive, electrophysiological signals can allow a systematic interaction between human and devices; for example, eye movement-based wheelchair control. However, the existing machine-interface platforms are obtrusive, uncomfortable, and often cause skin irritations as they require a metal electrode affixed to the skin with a gel and acrylic pad. Here, we introduce a bioelectronic system that makes dry, conformal contact to the skin. The mechanically comfortable sensor records high-fidelity electrooculograms, comparable to the conventional gel electrode. Quantitative signal analysis and infrared thermographs show the advantages of the soft biosensor for an ergonomic human-machine interface. A classification algorithm with an optimized set of features shows the accuracy of 94% with five eye movements. A Bluetooth-enabled system incorporating the soft bioelectronics demonstrates a precise, hands-free control of a robotic wheelchair via electrooculograms.

A Review of PMMA Bone Cement and Intra-Cardiac Embolism

Percutaneous vertebroplasty procedure is of major importance, given the significantly increasing aging population and the higher number of orthopedic procedures related to vertebral compression fractures. Vertebroplasty is a complex technique involving the injection of polymethylmethacrylate (PMMA) into the compressed vertebral body for mechanical stabilization of the fracture. Our understanding and ability to modify these mechanisms through alterations in cement material is rapidly evolving. However, the rate of cardiac complications secondary to PMMA injection and subsequent cement leakage has increased with time. The following review considers the main effects of PMMA bone cement on the heart, and the extent of influence of the materials on cardiac embolism. Clinically, cement leakage results in life-threatening cardiac injury. The convolution of this outcome through an appropriate balance of complex material properties is highlighted via clinical case reports.

In vitro and in vivo testing of a novel, hyperelastic thin film nitinol flow diversion stent.

A flexible, low profile, flow diversion stent could replace endovascular coiling for the treatment of intracranial aneurysms. Micropatterned-thin film nitinol (TFN) is a novel biomaterial with high potential for use in next-generation endovascular devices. Recent advancements in micropatterning have allowed for fabrication of a hyperelastic thin film nitinol (HE-TFN). In this study, the authors describe in vitro and in vivo testing of novel HE-TFN based flow diverting stents. Two types of HE-TFN with expanded pores having long axes of 300 and 500 μm were used to fabricate devices. In vitro examination of the early thrombotic response in whole blood showed a possible mechanism for the devices function, whereby HE-TFN serves as a scaffold for blood product deposition. In vivo testing in swine demonstrated rapid occlusion of model wide-neck aneurysms. Average time to occlusion for the 300-μm device was 10.4 ± 5.5 min. (N = 5) and 68 ± 30 min for the 500-μm device (N = 5). All aneurysms treated with bare metal control stents remained patent after 240 min (N = 3). SEM of acutely harvested devices supported in vitro results, demonstrating that HE-TFN serves as a scaffold for blood product deposition, potentially enhancing its flow-diverting effect. Histopathology of devices after 42 days in vivo demonstrated a healthy neointima and endothelialization of the aneurysm neck region. HE-TFN flow-diverting stents warrant further investigation as a novel treatment for intracranial aneurysms.

Intra-aneurysmal flow reductions in a thin film nitinol flow diverter

A novel hyper-elastic thin film nitinol (HE-TFN) covered stent has been developed to promote aneurysm occlusion by diminishing flow in the aneurysm. Laboratory aneurysm models were used to assess the flow changes produced by stents covered with different patterns of HE-TFN placed across the aneurysm neck in the parent vessel. The flow diverters were constructed by covering Wingspan stents (Boston Scientific) with different HE-TFNs (i.e., of 82% and 77% porosity) and deployed in both in vitro wide-neck and fusiform glass aneurysm models. In wide-neck aneurysms, the 82% porous HE-TFN stent reduced mean flow velocity in the middle of the sac by 86 ± 1%, while the 77% porous stent reduced the velocity by 93 ± 5% (n = 3). Local wall shear rates were also significantly reduced by about 98% in this model after device placement. Tests conducted on the fusiform aneurysm revealed smaller intra-aneurysmal flow velocity reduction by 48 ± 3% for the 82% porous stent and by 59 ± 7% for the 77% porous stent. The wall shear was reduced by approximately 50% by HE-TFN stents in fusiform models. These results suggest that HE-TFN covered stents have the potential to promote thrombosis in both wide-neck and fusiform aneurysm sacs.

Microstructured Thin Film Nitinol for a Neurovascular Flow-Diverter

A cerebral aneurysm occurs as a result of a weakened blood vessel, which allows blood to flow into a sac or a ballooned section. Recent advancement shows that a new device, ‘flow-diverter’, can divert blood flow away from the aneurysm sac. People found that a flow-diverter based on thin film nitinol (TFN), works very effectively, however there are no studies proving the mechanical safety in irregular, curved blood vessels. Here, we study the mechanical behaviors and structural safety of a novel microstructured TFN membrane through the computational and experimental studies, which establish the fundamental aspects of stretching and bending mechanics of the structure. The result shows a hyper-elastic behavior of the TFN with a negligible strain change up to 180° in bending and over 500% in radial stretching, which is ideal in the use in neurovascular curved arteries. The simulation determines the optimal joint locations between the TFN and stent frame. In vitro experimental test qualitatively demonstrates the mechanical flexibility of the flow-diverter with multi-modal bending. In vivo micro X-ray and histopathology study demonstrate that the TFN can be conformally deployed in the curved blood vessel of a swine model without any significant complications or abnormalities.