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surgical tools
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Image
Published: 01 June 2012
Fig. 7 River patterns evident in a martensitic stainless steel surgical tool brittle fracture (arrow indicates crack growth direction)
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Image
Published: 01 June 2012
Image
Published: 01 June 2012
Series: ASM Handbook
Volume: 11A
Publisher: ASM International
Published: 30 August 2021
DOI: 10.31399/asm.hb.v11A.a0006811
EISBN: 978-1-62708-329-4
... 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...
Abstract
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.
Book Chapter
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005673
EISBN: 978-1-62708-198-6
... Abstract Stainless steels are used for medical implants and surgical tools due to the excellent combination of properties, such as cost, strength, corrosion resistance, and ease of cleaning. This article describes the classifications of stainless steels, such as austenitic stainless steels...
Abstract
Stainless steels are used for medical implants and surgical tools due to the excellent combination of properties, such as cost, strength, corrosion resistance, and ease of cleaning. This article describes the classifications of stainless steels, such as austenitic stainless steels, martensitic stainless steels, ferritic stainless steels, precipitation-hardening stainless steels, and duplex stainless steels. It contains a table that lists common medical device applications for stainless steels. The article discusses the physical metallurgy and physical and mechanical properties of stainless steels. Medical device considerations for stainless steels, such as fatigue strength, corrosion resistance, and passivation techniques, are reviewed. The article explains the process features of implant-grade stainless steels, including type 316L, type 316LVM, nitrogen-strengthened, ASTM F1314, ASTM F1586, ASTM F2229, and ASTM F2581 stainless steels.
Image
in Failure Analysis of Medical Devices
> Analysis and Prevention of Component and Equipment Failures
Published: 30 August 2021
Fig. 14 Scanning electron microscopy micrograph showing brittle cleavage fracture morphology on a high-hardness surgical tool
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Published: 30 September 2015
Fig. 14 Raised logos (as well as numbers and other surface features) are commonly incorporated on MIM parts, such as this titanium surgical tool. Courtesy of Epson-Atmix
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in Failure Analysis of Medical Devices
> Analysis and Prevention of Component and Equipment Failures
Published: 30 August 2021
Fig. 15 Scanning electron microscopy micrographs showing (a) ductile overload fracture morphology on a surgical tool and (b) higher-magnification view of the area highlighted with a red box in (a)
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Image
in Failure Analysis of Medical Devices
> Analysis and Prevention of Component and Equipment Failures
Published: 30 August 2021
Fig. 16 Scanning electron microscopy micrograph showing an intergranular fracture surface on an embrittled surgical tool. Corrosion pitting on adjacent surfaces (white arrows) was the source for monoatomic hydrogen that resulted in embrittlement.
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Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006888
EISBN: 978-1-62708-392-8
... F1801-20) compared to devices that are intended for short-term use/contact (e.g., surgical tools) (ASTM International F1089-18) ( Ref 5 – 7 ). Types of Stainless Steels Stainless steels are generally classified as austenitic, ferritic, martensitic, duplex, or precipitation hardened ( Ref 5...
Abstract
Metallic alloys that are typically used for medical purposes include stainless steels, Ti-6Al-4V, and Co-Cr-Mo. This article discusses the relative merits of each of these alloys. The utilization of stainless steels in the biomedical industry, especially in relation to the additive manufacturing (AM) process, is the main focus of this article. The characteristics of various stainless steels are described subsequently, and the categories that are of relevance to the biomedical industry are identified. The types of stainless steels covered are austenitic, ferritic, martensitic, duplex, and precipitation-hardened stainless steels. The article discusses the potential benefits of AM for biomedical devices. It describes the types of AM processes for stainless steels, namely binder jet, directed-energy deposition, and laser powder-bed fusion. The article reviews the AM of austenitic, martensitic, and PH stainless steels for biomedical applications. In addition, the challenges and obstacles to the clinical use of AM parts are covered.
Series: ASM Handbook
Volume: 23
Publisher: ASM International
Published: 01 June 2012
DOI: 10.31399/asm.hb.v23.a0005657
EISBN: 978-1-62708-198-6
... analysis failure analysis fatigue fretting hydrogen embrittlement internal fixation devices medical devices nitinol nondestructive examination orthopedic implants overload permanent prostheses stainless steels titanium alloys MEDICAL DEVICES such as medical equipment, surgical tools...
Abstract
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.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006852
EISBN: 978-1-62708-392-8
..., and implants. The article includes sections on education that focus on the use of 3D-printed surgical simulators and other tools to teach medical students and residents. It briefly touches on the FDA regulations associated with the respective application of 3D printing in medicine. Lastly, the article briefly...
Abstract
This article provides highlights of the general process and workflow of creating a 3D-printed model from a medical image and discusses the applications of additively manufactured materials. It provides a brief background on Food and Drug Administration (FDA) classification and regulation of medical devices, with an emphasis on 3D-printed devices. Then, the article discusses two broad applications of 3D printing in craniofacial surgery: surgery and education. Next, it discusses, with respect to surgical applications, preoperative planning, use in the operating room, surgical guides, and implants. The article includes sections on education that focus on the use of 3D-printed surgical simulators and other tools to teach medical students and residents. It briefly touches on the FDA regulations associated with the respective application of 3D printing in medicine. Lastly, the article briefly discusses the state of medical billing and reimbursement for this service.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006902
EISBN: 978-1-62708-392-8
... Hospital Increasing technological advancements and AM accessibility have resulted in fast and cost-effective production of medical or surgical instruments from biocompatible materials. Three-dimensional printing enables fabrication of customized tools for single or multiple uses based...
Abstract
Additive manufacturing (AM), or three-dimensional (3D) printing, is a class of manufacturing processes that create the desired geometries of an object, or an assembly of objects, layer by layer or volumetrically. AM has been used extensively for manufacturing medical devices, due to its versatility to satisfy the specific needs of an intended medical field for the product/device. This article provides a comprehensive review of AM in medical devices by the medical specialty panels of the Food and Drug Administration (FDA) Code of Federal Regulations, Parts 862 to 892, including anesthesiology, ear and nose, general hospital, ophthalmic, plastic surgery, radiology, cardiovascular, orthopedic, dental, neurology, gynecology, obstetrics, physical medicine, urology, toxicology, and pathology. It is classified under these panels, and critical reviews and future outlooks are provided. The application of AM to fabricate medical devices in each panel is reviewed; lastly, a comparison is provided to reveal relevant gaps in each medical field.
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Published: 01 January 2005
Fig. 18 Rust stains on what should have been a clean surgical chisel prompted an investigation as to the cause. The history of use explains the condition. The instrument was first discarded by a surgeon due to a lack of cutting edge on the tool. Later, small blemishes on the surface alerted
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Book Chapter
Book: Fractography
Series: ASM Handbook
Volume: 12
Publisher: ASM International
Published: 01 January 1987
DOI: 10.31399/asm.hb.v12.a0000618
EISBN: 978-1-62708-181-8
... fracture, microcrack, and stair-step fracture surface of these alloys. cobalt alloys fatigue fracture fractograph surgical implants Fig. 881, 882 Fatigue fracture of a cast Vitallium (Co-30Cr-7Mo) surgical implant (side plate of Jewett nail) due to improper insertion. A tool used...
Abstract
This article is an atlas of fractographs that helps in understanding the causes and mechanisms of fracture of cobalt alloys (cast Vitallium and cast ASTM F75 alloys) and in identifying and interpreting the morphology of fracture surfaces. The fractographs illustrate the fatigue fracture, microcrack, and stair-step fracture surface of these alloys.
Book: Powder Metallurgy
Series: ASM Handbook
Volume: 7
Publisher: ASM International
Published: 30 September 2015
DOI: 10.31399/asm.hb.v07.a0006020
EISBN: 978-1-62708-175-7
... to more than 100 million per year are more suitable for MIM. Production at the low side of the range includes high-value components used in jet engines, biomedical implants, specialty firearm sights, military components, specialty surgical tools, and luxury items such as ceramic and platinum watches...
Abstract
This article commences with a discussion on the qualitative and quantitative criteria for metal injection molding (MIM), including production quantities, shape complexity, material performance, and cost. It discusses geometric factors, such as surface finish, component size, and mass range, which help to identify a component for MIM. The article describes certain part features, including holes, undercuts, and flat faces. It concludes with a discussion on the common materials used in MIM; tensile properties of 17-4 PH stainless steel MIM, cast and wrought products; and attributes of the MIM process.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006859
EISBN: 978-1-62708-392-8
... profile tablets, multireservoir drug-delivery systems 62 Anatomical models SLS Three-dimensional visualization of organs, surgical training, surgical planning 63 Prostheses and orthoses SLS Lower-limb prosthetic sockets, ankle-foot orthoses, foot orthoses 64 Surgical tools and guides...
Abstract
Powder-bed fusion (PBF) is a group of additive manufacturing (AM) processes that includes selective laser sintering, selective laser melting, and electron beam melting. This article explains the processes and parameters of PBF systems that are used for biomedical applications. It also presents the desirable properties of biomedical devices and the advantages of using PBF systems for biomedical applications.
Book: Powder Metallurgy
Series: ASM Handbook
Volume: 7
Publisher: ASM International
Published: 30 September 2015
DOI: 10.31399/asm.hb.v07.a0006055
EISBN: 978-1-62708-175-7
... for different end-use markets such as electronics and telecommunications, medical, automotive, power hand tools, industries, and firearms. automotive applications electronics and telecommunications firearms medical applications metal injection molding power hand tools METAL INJECTION MOLDING...
Abstract
Metal injection molding (MIM) is a metalworking technology that has its origins as a commercial technology only dating back to the early 1970s. This article explores why the MIM is the preferred solution for many fabricated components. It illustrates the MIM components required for different end-use markets such as electronics and telecommunications, medical, automotive, power hand tools, industries, and firearms.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006896
EISBN: 978-1-62708-392-8
... to fourth finger (left), and model of the resultant hand posttreatment (right). Used with permission of Mayo Foundation for Medical Education and Research, all rights reserved The models were fabricated to be used as teaching aids and educational tools, illustrating surgical techniques as well...
Abstract
Bridging the gap between education and medical practice, centralized hospital-based 3D printing, or what is termed point-of-care (POC) manufacturing, has been rapidly growing in the United States as well as internationally. This article provides insights into the considerations and the current workflow of creating 3D-printed anatomical models at the POC. Case studies are introduced to show the complex range of anatomical models that can be produced while also exploring how patient care benefits. It describes the advanced form of communication in medicine. The advantages as well as pitfalls of using the patient-specific 3D-printed models at the POC are addressed, demonstrating the fundamental knowledge needed to create 3D-printed anatomical models through POC manufacturing.
Series: ASM Handbook
Volume: 23A
Publisher: ASM International
Published: 12 September 2022
DOI: 10.31399/asm.hb.v23A.a0006906
EISBN: 978-1-62708-392-8
... and patient-matched tooling for a specific surgical intervention. However, customization has also allowed for expansion into adjacent areas, such as actual implants made for a specific patient ( Ref 2 – 49 ) and/or scaffolding to enable the possibility of tissue engineering ( Ref 31 , 50 ). Figures 1 to 4...
Abstract
Additive manufacturing (AM), or three-dimensional printing, has ushered in an era of mass customization in the many different industries in which it is used. The use of the personalized surgical instrument (PSI) is no exception. Initially, PSIs were not a result of the use of AM; rather, what occurred is an improvement in their methods of manufacturing. This article discusses the fundamentals, benefits, manufacturing, and other application examples beyond orthopedics of PSIs. In addition, an outlook of AM in biomedical applications is also covered.
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