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Use of ceramic for specialist medical applications
Address of the article:http://www.morgantechnicalceramics.com/articles/medical_apps.htm

By Keith Ferguson, Market Development Manager, Dr Steven Hughes, Materials Technologist, Morgan Advanced Ceramics, and Tony Beswick, General Manager, Morgan Electro Ceramics



Introduction

Resistance to wear and its inherent stability, and electrical properties make ceramic an ideal material for a wide range of medial applications from implants to surgical tools. For example, developments in ceramic materials and product design are offering surgeons and patients new options for joint replacement surgery. Following the approval by the FDA of ceramic-on-ceramic joints in the US last year, their use is increasing. New developments in ceramic production promise to bring the proven bio-compatibility and long term durability benefits of the material to an increasingly wide range of medical applications. Now, driven by the industry's need for ever smaller yet more complex components, materials scientists are extending its benefits to new medical applications by the use of innovative processing techniques including injection moulding, engineered coatings and ceramic-metal assemblies. The results include hand tools, valves, and implantable devices. This article discusses recent advances in ceramic materials science and production and the benefits it offers for medical applications. It looks at some of the latest developments in ceramics processing and manufacturing and gives examples of the ways in which this work is helping move the boundaries for capability and cost-efficiency in the manufacture of medical devices.


Artificial joint components

Most artificial joints in use today incorporate a metal or ceramic head against an ultra-high molecular weight polyethylene (UHMWPE) cup. The use of ceramic components in joint replacement surgery was initiated in the 1970s with the introduction of first generation alumina products, when ceramic's superior resistance to wear in comparison to more traditional metal and polyethylene materials became apparent. Advances in material quality and processing techniques and a better understanding of ceramic design led to the introduction of second generation alumina components in the 1980s that offered even better performance than early systems. Low system wear rate leads to long life-times, typically 20 years plus for ceramic, and in particular less polyethylene particulate debris generation which is a known cause of osteolysis and a major source of revision operations that are both costly and add trauma to patients. For example, a study on the performance of Morgan Technical Ceramics' HIP Vitox® ceramic on ceramic hip joints performance which reported recently quoted a wear rate of just 0.032mm3/million cycles*. Ceramic systems also alleviate recent concerns that have been raised over metal ion release from the use of metal implants in the body and their possible side effects. More recently, 'ceramic-on-ceramic' systems have been developed to eliminate the problems associated with polyethylene and metal altogether. Such systems have by far the lowest wear rate of all available bearing couple technologies available today. These systems have grown in popularity in Europe over the past five years or so and a milestone was reached last year (2003) when the Federal Drugs Agency (FDA) gave their clearance for use in the USA. Because of the better wear properties of ceramic-on-ceramic, such systems are ideally suited for the younger and more active patients. The international golfer Jack Nicklaus famously has a replacement ceramic hip.

Injection moulding

Building on the known benefits of ceramic as a material for bio-implants, manufacturers are now starting to use injection moulding techniques to produce much smaller, more complex parts for implant, most notably hearing-assist devices, bone screws and implantable heart pumps. At the same time, surgical procedures have become more intricate, creating a need for smaller, more precise instrumentation. This is borne out by the increase in minimally invasive surgery (MIS) in areas including hernia, ulcer repairs and even complete hip replacement. One recent survey by University of Arkansas School for Medical Sciences and Arkansas Children's Hospital, Little Rock, USA reported that 82 percent of paediatric surgeons now perform MIS procedures. Less invasive procedures mean patients recover more quickly, which is good for the patient and more cost-effective for the hospital. Injection moulding of ceramic allows production of small, high-precision instruments. These strong and complex shapes - the hinge joints on powered hand tools for example - allow smaller designs. Traditional machining of ceramics would be more time consuming and expensive, and may not allow all the same features as ceramic injection molding. Internal testing at Morgan Technical Ceramics on injection molding versus 'green' machining showed more consistent strength on the injection molded parts.

Ultrasound

The piezoelectrical properties of PZT ceramic (Lead Zirconate Titanate) are used to generate ultrasound. Ultrasound is an important diagnostic technique which is used to scan unborn babies and it can also be used to monitor foetal heart rates, measure flow and distance and perform surgical operations. Piezoelectric sensors measure mechanical quantities such as force, acceleration or pressure by producing an electrical output when they experience a change in load. Alternatively when a pulsed electrical field is applied to the material it expands and contracts and in doing so sends out an acoustic pulse. When this occurs at a high frequency the ceramic vibrates, transmitting an ultrasonic signal. The signal then rebounds off tissue and is received by another piezoelectric ceramic which converts the ultrasonic pulses back into an electrical signal to generate the image. In this way it is used as internal and external ultrasonic sensors. The transmitter/receiver combination can be made from one piece of piezoceramic or from two separate pieces of piezoceramic. An example where the sensor is used in pairs is when the transmitter and receiver are aligned opposite each other to monitor fluid flow through a tube. As fluid passes between the sensors the presence of fluid or air can be measured depending on the strength of the acoustic signal at the receiver. Piezoelectric components for sensors can be made with a wide range of electrode configurations such as wrap around and multiple electrodes to assist with sensor design and manufacturing.

Surgical Instruments

The ceramic is used as a high power transmitter of high frequency waves to assist with surgical cutting and is used in applications such as cataract removal. Piezoceramic components are sandwiched between a horn and rear mass, for example in an ultrasonic scalpel the intense vibration allows the surgeon to cut with less force to achieve less tissue damage as well as coagulating at the same time as cutting. To support creating smaller, less intrusive tools, Morgan Technical Ceramics has the capability to manufacture the PZT ceramic in many shapes (discs, plates, etc) and sizes to a thickness of 0.1mm, and a wide range of material compositions.

Future advances

Other advances in medical technologies are the result of combining existing technologies in innovative ways. In the US Morgan Technical Ceramics is investigating ceramic-metal joining solutions for medical applications using braze alloy systems. In another project the company is using diamond like carbon (DLC) coating technology for medical applications to offer extremely hard, low friction wear surfaces. Diamond-like coating (DLC), first developed for automotive and commercial applications, is finding use in medical / life science applications such as coating valves, wear plates and fluid delivery devices to make them inert, biocompatible, very hard (up to 3300 kg/mm2) and lubricious (coefficient of friction = 0.1) so they can handle extreme pressures while still allowing the instrument to function for analysis of small samples.

Conclusion

Morgan Technical Ceramics has nearly 20 years clinical history of development of ceramic joints using HIP Vitox® alumina and Zyranox® zirconia materials, and has amassed considerable specialist technical knowledge on the subject during this period. The company's flexible manufacturing process is well suited to this development; it is currently involved in a number of next generation orthopaedic development projects. Over the last 20 years, ceramic materials have been refined and there is now a range of ceramic and engineered solutions optimised for medical applications including surgical tooling, ultrasound and implants. Now, manufacturers of ceramic materials are concentrating their efforts on development of manufacturing processes to address specific medical needs. As a result of this research and development by industry leaders such as Morgan Technical Ceramics, medical device manufacturers, doctors and their patients are all benefiting from the ability to precision engineer very high reliability components in commercial quantities.



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