Search Results for catheter wire

This article focuses on the analysis of materials and mechanical- (or biomechanical-) based medical device failures. It reviews the failure analysis practices, including evidence receipt, cleaning, nondestructive examination, destructive examination, exemplars analysis, and device redesign. The article examines the common failure modes, such as overload, fatigue, corrosion, hydrogen embrittlement, and fretting, of medical devices. The failure analysis of orthopedic implants, such as permanent prostheses and internal fixation devices, is described. The article reviews the failure mechanisms in some of the more common medical device materials, namely, stainless steels, titanium alloys, cobalt-base alloys, and nitinol. It presents case histories with examples for failure analysis.

This article tabulates materials that are known to have been used in orthopaedic and/or cardiovascular medical devices. The materials are grouped as metals, ceramics and glasses, and synthetic polymers in order. These tables were compiled from the Medical Materials Database which is a product of ASM International and Granta Design available by license online and as an in-house version. The material usage was gleaned from over 24,000 U.S. Food and Drug Administration (USFDA), Center for Devices and Radiological Health, Premarket notifications (510k), and USFDA Premarket Approvals, and other device records that are a part of this database. The database includes other material categories as well. The usage of materials in predicate devices is an efficient tool in the material selection process aiming for regulatory approval.

This article focuses on the fractography of Nitinol, a shape memory alloy of nickel and titanium, in superelastic biomedical applications, which primarily comprise drawn and/or laser-cut wire and tube components. Overload fracture, hydrogen embrittlement fracture, and fatigue fracture are discussed in detail.

This article provides an overview of the fundamentals of tribology. It describes the advantages, disadvantages, and applications of the pin-on-disk method, which is the most commonly used configuration for testing biomaterials and for the reproducible measurement of friction and wear. The article illustrates a practical tribocorrosion setup that allows a user to perform wear tests in corrosive environments under well-defined electrochemical conditions and at controlled temperature. It explains the effect of changes in electrical contact resistance on tribological mode. The article discusses various in vivo environmental conditions in tribological tests. Some typical examples of biomaterials testing are also provided.

The biocompatibility of a material relates to its immunological response, toxicity profile, and ability to integrate with surrounding tissue without undesirable local or systemic effects on a patient. This article underscores the transformation of the medical device design ecosystem engaged as an integral part of the device ecosystem. It discusses the applications of biomaterials, including orthopedic, cardiovascular, ophthalmic, and dental applications. The article describes four major categories of biomaterials such as metals, polymers, glass and ceramics, and composites. A discussion on natural materials, nanomaterials, and stem cells is also provided. The article concludes with examples of biomaterials applications, such as endovascular devices, knee implants, and neurostimulation.

This article provides a summary of the biocompatibility or biological response of metals, ceramics, and polymers used in medical implants, along with their clinical issues. The polymers include ultrahigh-molecular-weight polyethylene, nonresorbable polymer, and resorbable polymers.

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

Microjoining methods are commonly used to fabricate medical components and devices. This article describes key challenges involved during microjoining of medical device components. The primary mechanisms used in microjoining for medical device applications include microresistance spot welding (MRSW) and laser welding. The article illustrates the fundamental principles involved in MRSW and laser welding. The article presents examples of various microjoining methods used in medical device applications, including pacemaker and nitinol microscopic forceps.

This article focuses on the specific aspects of nitinol that are of interest to medical device designers. It describes the physical metallurgy, physical properties, and tensile properties of the nitinol. The article discusses the factors influencing superelastic shape memory effects, fatigue, and corrosion in medical device design. It reviews the biocompatibility of nitinol based on corrosion behavior. The article explains the general principles, potential pitfalls, and key properties for manufacturing, heat treatment, and processing of nitinol.

This article discusses the history of shape memory alloys (SMAs) along with their properties, capabilities, and crystallography, including phase transformations that occur during thermal treatment. It describes the thermomechanical behaviors of SMAs and explains how to characterize them using differential scanning calorimeter (DSC) techniques as well as other methods. The article examines the most common shape memory alloys, namely, nickel-titanium and copper-base SMAs, and provides information on their respective properties.

This article focuses on the use of noble and precious metals for biomedical applications. These include gold, platinum, palladium, ruthenium, rhodium, iridium, and osmium. The physical and mechanical properties of noble and precious metals are presented in tables. A brief discussion on the ancient history of noble and precious metal use in dentistry is provided. The article discusses the use of direct gold dental filling materials, direct silver dental filling materials, traditional amalgam alloys, high-copper amalgam alloys, and gallium alloys in biomedical applications. It also provides information on gold coatings and iridium oxide coatings for stents.

This article is a detailed account of the advantages, disadvantages, and applications of microdispensing processes used in electronics manufacturing industries. The discussion covers various approaches to control material flow, namely time pressure, auger, positive displacement, and progressive cavity pump dispensing. The concept of valving to control starting and stopping is also discussed. The applications include printing solders in microelectronic packaging, printing to pads, printing conductive patterns for antennas, printing active circuits, printing on flexible surfaces, and structural printing.

This article discusses some of the additive manufacturing (AM) based fabrication of alloys and their respective mechanical, electrochemical, and in vivo performance. Firstly, it briefly discusses the three AM techniques that are most commonly used in the fabrication of metallic biomedical-based devices: binder jetting, powder-bed fusion, and directed-energy deposition. The article then characterizes the electrochemical properties of additive-manufactured/processed cobalt-chromium alloys. This is followed by sections providing an evaluation of the biological response to CoCr alloys in terms of the material and 3D printing fabrication. Discussion on the biological response as a function of direct cellular activity on the surface of CoCr alloys in static conditions (in vitro), in dynamic physiological conditions (in vivo), and in computer-simulated conditions (in silico) are further discussed in detail. Finally, the article provides information on the qualification and certification of AM-processed medical devices.

Biomaterials are the man-made metallic, ceramic, and polymeric materials used for intracorporeal applications in the human body. This article primarily focuses on metallic materials. It provides information on basic metallurgy, biocompatibility, chemistry, and the orthopedic and dental applications of metallic biomaterials. A table compares the mechanical properties of some common implant materials with those of bone. The article also provides information on coatings, ceramics, polymers, composites, cements, and adhesives, especially where they interact with metallic materials.

This article characterizes the corrosion resistance of precious metals, namely, ruthenium, rhodium, palladium, silver, osmium, iridium, platinum, and gold. It provides a discussion on the general fabricability; atomic, structural, physical, and mechanical properties; oxidation and corrosion resistance; and corrosion applications of these precious metals. The article also tabulates the corrosion rates of these precious metals in corrosive environment, namely, acids, salts, and halogens.