COVER STORY

“It’s – it’s amazing to have this movement, just gets me more excited about now, about the future” – says Iraq war veteran Sergeant Juan Arredondo. One of the first recipients of the bionic hand with movements controlled by the brain (i-LIMB), he compares the innovation to the bionics in the films ‘Star Wars’ and ‘Terminator’, what with its ability to deal with moving and stationary objects with comparable ease. These ‘smart’ prosthetics have become a divine intervention for numerous victims of amputation, and plastics has enabled these devices in becoming a feasible option for the common man. Sundeep Nadkarni discovers that for giving a new lease of life to people who have lost hope without a limb, the word is not only ‘prosthetics’ but also ‘plastics’. Read on…

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n an excerpt from his book Wings of Fire, the ace scientist and past President of India Dr APJ Abdul Kalam, quotes the following incident as one of the four milestones of his illustrious career. In his own words, “One day an orthopaedic surgeon from the Nizam Institute of Medical Sciences visited my laboratory. He lifted the material and found it so light that he took me to his hospital and showed me his patients. There were these little girls and boys with heavy metallic calipers weighing over 3 kg each, dragging their feet around. He asked me to remove the pain of his patients. In three weeks, we made these floor reaction orthosis 300 gm calipers and took them to the orthopaedic centre. The children did not believe their eyes. From dragging around a 3 kg load on their legs, they could now move around! Their parents had tears in their eyes. That was my fourth bliss!”

Miguel Linares
director - Medical Engineering and Design, Linares Medical Devices

Blending plastics with ceramics or metals at the molecular level allows the best properties of both substances to be retained. Novel plastics have been developed resulting in materials with lightweight and elasticity, combined with strength and durability.
ceramic, and plastic-mineral alloy compounds to improve upon the materials currently used for medical applications. “Our proprietary materials are being blended to optimise their functional lifespan, with an emphasis on durability. The high fidelity imitation of nature is a perfect example of the superiority of plastics over metals for orthopaedic applications,” Linares adds. The company specialises in the development of polymers for the prosthetic & orthopaedic market, and presently has over 50 patents emphasising the use of plastics in these applications. Plastics and polymers are widely used in the fabrication of prosthetics or artificial limbs and orthotic supports. The technique of moulding a lightweight, load-bearing artificial limb comprises the steps providing a number of carbon-fibre sheets. The prosthetic limb socket can be designed by taking a negative cast and then moulding a positive cast of a patient’s residual limb, known as stump. Thermoplastics are moulded over the positive cast to form a socket, which is worn over the stump. Another method of fabricating a socket is the lamination process in which a blend of resins, accelerators and catalysts have wide applications. “The socket fabrication is a significant aspect because the entire fitment of the artificial limb depends on how the socket has been fabricated. For giving the artificial limb a cosmetic appearance, it is necessary to provide it with a covering of polyurethane foam that is shaped to give a natural appearance similar to a real limb. Polyethylene foam is also widely used as it is suitable for skin contact, does not absorb perspiration, does not support the growth of microorganisms, is tough with a soft-feel, odourless and has increased resilience. The combination of being lightweight and having excellent shock dissipation makes it a good padding material for body protection between the rigid plastics and the skin. These are easyto-fabricate, economical and improve the performance of the prosthetic &

Plastics redefine prosthetics
This dream of not needing to carry the burden of 3 kg metal prosthetics was realised with the use of plastics. Polymeric applications have redefined flexibilities in prosthetic movements. Material manufacturers are on an innovation spree, due to the supreme heights reached by the prosthetics industry in enabling unimaginable limb replacements. “A number of companies and research laboratories have successfully employed degradable & nondegradable structure-controlled, dendritic macromolecules to function as a scaffold to support in-growth of human tissue culture cells like osteocytes, chondrocytes, or hepatocytes. This holds promise for the eventual development of artificial human organs without the need for harvesting cadaver or living donor organs,” mentions Miguel Linares, director - Medical Engineering and Design, Linares Medical Devices. The company is developing a large number of plastic-metal, plastic-

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COVER STORY

Dr V J S Vohra
co-founder and director, Nevedac Prosthetic Centre

Manufacturers of basic resins produce different polymers to meet the needs of prosthetic patients. Manufacturing basic resins requires the plastic to be heated to a molten state twice, once to make the resin and a second time to blend in the additives that affect its final characteristics.
orthotic devices,” states Dr V J S Vohra, co-founder and director, Nevedac Prosthetic Centre. Dr Vohra is also the honorary prosthetic advisor to Governments of Punjab, Haryana, Chandigarh, and Himachal Pradesh. been recently launched to replace metal screws and pins in orthopaedic & trauma applications in order to avoid the traditional requirement for explantation. A device based on the development of a monobloc polymer material is under development. Acting like a shock absorber, this material has a flexible central part and rigid, upper & lower outer parts. The product – a prosthesis for inter-vertebral discs – is manufactured from biocompatible polymers and has greater compression and torsional-tensile strength. Currently, using the results of a similar technology, intra-ocular lenses are also being produced,” states D L Pandya, CEO, Medical Plastics Data Service. Material selection is driven by performance potential and ease of processing. With a broad range of medical-grade resins available, there are greater possibilities for medical OEMs to choose from. OEMs must apply the right material to a device design to enhance human interaction while reducing the development cycle and minimising scrap or production interruptions.

Biocompatible and mechanical properties
Plastics score more than any conventional materials in terms of performance, economics and compatibility. The favourable characteristics of plastics in healthcare include flexibility, ductility, toughness and lightweightedness. These materials are inert, non-toxic and biocompatible, and hence can come in contact with blood, tissue, etc. Transparency of the materials is vital to monitor flow through the tube visually as well as electronically. Flexibility in design, forming & jointing, ease-of-sterilisation, and low costs are other features that work in favour of polymers in prosthetic devices. “A range of screws and pins made from re-absorbable polymers has

“Test data helps confirm the attributes necessary to deliver the appropriate level of design flexibility, strength, clarity, and chemical resistance, which are key attributes for devices with maximum integrity. Comparing data makes material selection simpler. Material properties are also matched to application performance, secondary operations, and regulatory guidelines. In the case of a product redesign that leads to material conversion, companies should seek out materials compatible with their existing sterilisation and validation processes to contain costs and expedite processing,” feels Mark J Costa, executive vice president - Polymers Business Group, Eastman Chemical Company.

Down to the bone
One of the chief advantages associated with the use of plasticbased orthopaedic prosthetics and implantable hardware is the possibility to precisely match the strength, hardness, and elasticity of plastics with that of the bone. This is dramatically different from the case where metal is in direct contact with the bone. The ability of plastics to mimic the native bone is important for the long-term health of the native bone that is in direct contact with the prosthesis or implanted hardware. “Normal bone is a living tissue, which is capable of remodelling and rebuilding itself continuously in response to the conditions it

Courtesy: DuPont

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is experiencing. Just like muscles become stronger when subjected to weightlifting, bones, too, become denser, larger, and stronger in response to the stress of increased loads. The opposite occurs when bones are not stressed, ie, they become less dense, thinner, and weaker when not experiencing loads. The same effect occurs in the long thighbone following a hip replacement. There is a loss of 10-45 per cent of bone mass in the bone surrounding the implant during the first few years after total hip replacement. This is because the titanium implant cemented in the centre of the femur is much harder and stronger than the surrounding bone. As the titanium rod is hard and strong, the surrounding bone no longer has to work hard to support the patient’s weight, and thus is unloaded. The removal of stress from the bone by an implant is known as stress shielding, and leads to bone thinning & weakness, and eventually the bone surrounding the titanium implant breaks down,” says Linares.

D L Pandya
CEO, Medical Plastics Data Service

Polymers, when combined with ‘nanomaterials’ offer a range of polymer compounds, composites & semi-finished parts with amazing functional properties, including electrical & thermal conductivity, mechanical properties and opto-electronic properties.
the Linares Medical Devices team has developed an entirely new class of materials. These materials are blends, or alloys, of FDA-approved plastics & metals, or FDA-approved plastics and ceramics. Individually, all these materials have been approved and successfully implanted in humans for many years, and hence its biocompatibility issues have been addressed. What is new and completely revolutionary, is the Linares Medical Devices proprietary method of combining these substances in a way that greatly enhances their biomechanical usefulness,” feels Linares. According to him, blending plastics with ceramics or metals at the molecular level allows the best properties of both substances to be retained, while the undesirable properties are minimised. “Linares has developed novel plastics resulting in materials with lightweight and elasticity, combined with strength and durability normally found in metals and ceramics. One major advantage inherent to the use of plastic-based hardware for orthopaedic surgery applications is that it is ‘radiolucent.’ It does not interfere with radiological imaging technologies like CT, X-rays, or MRIs, which is extremely important to better follow-up and evaluate the patients after surgery,” he adds.

Replacing nature
By matching the strength and hardness of the implant with that of the natural bone, the loads should be evenly distributed between the implant and host-bone. Plasticbased orthopaedic hardware has an advantage – the host-bone and the implant can be adjusted so it matches that of the bone. Linares Medical Devices has developed a method of transitioning so that the articulating surface can be made softer and more elastic to mimic cartilage, while the bone segment can be made with the same hardness as the natural bone. This helps in creating a longer lasting and better performing product and improving patient’s satisfaction. “Currently, there are only a select few plastics that have been approved by the FDA for permanent human implantation. Because of the limited choices for FDA-approved plastics,

Brawn with brains
Since decades now, scientists have been working towards developing a technique for interpreting brain activity to motor output. In other words, this

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Courtesy: SABIC Innovative Plastics

COVER STORY

Mark J Costa
EVP - Polymers Business Group, Eastman Chemical Company

Material properties are also matched to application performance,secondary operations, and regulatory guidelines. Companies should seek out materials compatible with their existing sterilisation & validation processes to contain costs and expedite processing.
enables in deciphering the electric patterns of the brain and converting them into coherent thoughts. The majority of motor functions in our body are driven by electrical currents originating in the brain motor cortex and conducted through the spinal cord and peripheral nerves to the muscles, where the electrical impulse is converted into motion by the contraction & retraction of specific muscles. “For example, when the arm is bent at the elbow joint, the bicep muscles contract and the triceps relax. This seemingly simple movement is the result of the cumulative activity of numerous brain cells in the area of the cortex in charge of arm movement. The neurons, following a cognitive decision to bend the arm, generate an electric impulse through the peripheral nerves, causing the correct muscles to contract or relax. Microprocessor technology with a computer interface allows the prosthetist and the patient to fine-tune the adjustments to achieve maximum performance of the artificial arm. The i-LIMB Hand, a recent development, is controlled by a unique, highly intuitive control system that uses a traditional two-input myoelectric (muscle signal) to open and close the hand’s life-like fingers. The modular construction of i-LIMB means that each individually powered finger can be quickly removed by simply removing one screw. This means that a prosthetist can easily swap out fingers that require servicing and patients can return to their everyday lives after a short clinic visit,” states Dr Vohra. Essentially until now, people using the prosthetics have controlled one motor at a time and had to think carefully about what motor they

wanted to control and how to move it instead of just thinking about moving it and being able to do it. However, a new technique called targeted muscle reinnervation, involves taking the nerves that remain after an arm is amputated and connecting them to another muscle in the body, often in the chest. Electrodes are placed over the chest muscles, acting as antennae. When the person wants to move the arm, the brain sends signals that first contract the chest muscles, which send an electrical signal to the prosthetic arm, instructing it to move. This process requires no more conscious effort than it would for a person who has a natural arm. The Touch Bionics i-LIMB was developed using leading-edge mechanical engineering techniques and is manufactured using highstrength plastics. The result was a next-generation prosthetic device that is lightweight, robust and highly appealing to both patients and healthcare professionals. “Myoelectric controls utilise the electrical signal generated by the muscles in the remaining portion of the patient’s limb. This signal is picked up by electrodes that sit on the surface of the skin. Existing users of basic myoelectric prosthetic hands are able to quickly adapt to the system and can master the new functionality of the device within minutes. For new patients, i-LIMB Hand offers a prosthetic solution that has never before been available,” claims Dr Vohra.

The ‘nano’ effect in prosthetics
The use of both synthetic as well as natural materials in medical and pharmaceutical applications has been successful due to the availability of a wide variety of user-specific materials at affordable prices. However, the integration of nanotechnology into this application has resulted in possibilities beyond the conventional. “Polymers – the wonder material of the century – when combined with ‘nano-materials’ offer a range

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of nanotechnology-based polymer compounds, composites and semifinished parts with amazing functional properties including electrical conductivity, thermal conductivity, mechanical properties and optoelectronic properties for various unique application opportunities in the medical device sector. The electrically conducting compounds made from carbon nanotubes or fibres have tiny nano-structures about 80,000 times smaller in diameter than a human hair. These materials – ‘smart Nano’ conductors in a polymer matrix – can be intelligently used as smart-sensors or commonly known as electrodes for bio-potential detection. Most common applications are for brain wave detection, cardio measurements, and muscle movement detection in a human body,” states Pandya.

rigidity, strength and resistance to fatigue allow polypropylene to be typically used in lower extremity prosthetic applications like above-knee sockets and below-knee sockets. The typical shrinkage of these devices is around 1.5-2 per cent. Copolymers have less rigidity and can be processed at slightly lower temperatures. These qualities allow copolymers to be spot modified more easily. Co-polymers are more commonly used in orthotics, but are now also gaining acceptance for above-knee and below-knee sockets,” explains Dr Vohra.

for several reasons. First, the stress relieving process occurs under the minimum forming temperature. In the O&P industry, the plastic is heated above this temperature, which allows the plastic to flow freely and relieve its internal stresses. Stress may be reintroduced into the plastic during the forming process. Second, it is not apparent that there are any chemical additives added to the plastic to change the molecular structure so as to relieve stress. It is possible that some of the commercial methods for stress relieving could be adapted to relieve stress in formed parts, which would allow for a more reliable finished part,” mentions Dr Vohra.

Realising dreams for a better tomorrow
Arms have become a particular focus in the prosthetics industry, as science has long had success with prosthetic legs. Recent developments on this front include more flexible and sensitive skin & arm designs, and wireless devices implanted in prosthetic arms to allow more natural movement. In recent experiments, researchers have also used sensors implanted in the brain to enable monkeys control a mechanical arm, and a paralysed man to move a cursor on a computer screen. Some of these methods, if perfected and approved by regulatory agencies, may eventually become more viable for amputees. Polymers are bound to drive these initiatives forward, particularly in making this sophisticated equipment economically feasible for the common man. While the reinnervation technique does not require regulatory approval because it is done using surgery and existing devices, it has limitations, which even its creators acknowledge - including the fact that it is not feasible for every patient and is expensive. However, there is a possibility of these negatives getting completely eradicated with the advent of advanced technologies in the world of medical plastics.

What prothetists seek?
Thermoplastics over the past several years have increased in popularity in both orthotic as well as prosthetic applications. Clarity, flexibility, rigidity, faster processing times, localised adjustment by the use of heat, inert material and surface quality are just a few of the benefits associated with thermoplastics. Thermoplastics, like any other type of technology, are subject to lack of understanding and failures do occur. This process quite often discourages the user and brands the material or process as an unacceptable method of fabrication. Through education and detailed study, thermoplastics & resins have become one of the most valuable technologies available to prosthetists and orthotists. “Handling the plastic sheets is critical for the success of the finished device. The manufacturers of basic resins produce different types of polymers to meet the needs of prosthetic and orthotic patients. Manufacturing the basic resin requires the plastic to be heated to a molten state twice, once to make the resin and a second time to blend in the additives that affect its final characteristics. The

Linear low-density polyethylene finds applications in all areas of traditional polyethylene usages. It has better tensile & puncture resistance, impact and tear properties making linear low-density polyethylene a good choice for aboveknee and below-knee socket liners, thereby improving prosthetic fitment to a great extent, which further increases the comfort level for the patients using the prosthetic and orthotic devices. “The stress relieving process occurs during the extrusion process, and there are several methods of accomplishing stress relieving. Stress relieving has no effect on the quality of the part produced in the orthotic & prosthetic (O&P) industry

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