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Keywords of this article:  injection molding 
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The medical industry is growingtremendously in recent years. Part of the growth can be attributed to acontinuously aging population worldwide, which generates greater demand formedical care. On the other hand, advancement in technology has led to morecost-effective solutions, of which plastics play an important role due to theirunmatched versatility – they can be lightweight, chemical and impact resistant,and even biocompatible, etc, making possible previously unachievable designs.


The Pixie pen revolutionizes the technology for treating warts at home.
The Pixie pen revolutionizes the technology for treating warts at home.

The medical plastics market is projected to grow from US$13.85 billion in 2016 to US$21.06 billion by 2022, at a compound annual growth rate (CAGR) of 7.3%, according to the research company Marketsandmarkets.

In matured economies where the cost of living is high, there is the demand for low-cost, easy-to-use medical devices. The design freedom and ease of processing offered by plastics allows device manufacturers to manage costs while also meeting high product requirements.

Revolutionary dispensing pen for fungal nail infection

A disposable liquefied-gas dispensing pen for removing warts is coming to market, of which the major parts are made of different kind of plastics.

The Pixie pen, invented by Oystershell Laboratories in collaboration with Quadrant CMS, doses small amounts of nitrous oxide onto the skin from a pressurized container for topical treatment of fungal nail infections.

Of the 14 assembled components, Quadrant CMS injection molded six of them using five different engineering plastics, including acetal, polycarbonate (PC), polyamide (PA), polymethyl methacrylate (PMMA) and styrene acrylonitrile (SAN).

Current products for freezing warts at home are all based on the same old technology – canisters with a dangerous mixture of liquefied propane gas and dimethylether. The Pixie pen, which can be used for up to eight treatments, is easy and safe to use and more importantly, it is a price attractive option in comparison, thanks to the ability of key components to withstand high pressures, remain gas tight, and handle an ultra-low application temperature (-80°C) as the nitrous oxide expands from liquid to gas and freezes the targeted wart.

These are a few of the great benefits that will revolutionize the current market,” commented Bart Rossel, CSO at Oystershell.

Biological and clinical studies indicate that the Pixie pen is superior to various other available methods for the treatment of warts.

This is attributed to the tip of the application, which is made of polyurethane (PU) foam. The gas flows through this foam and takes the cryogenic energy so it freezes. The user places the tip onto the wart, transferring the cold to the wart. The soft foam ensures that contact with the wart is ideal because when it heats up it makes excellent surface contact.

The Pixie pen is CE marked and approved for use in the European Union as a medical device Class IIa. All processes at Oystershell and Quadrant have been accredited through external audit under standards equivalent to ISO13485.

Cheap video laryngoscope allows for widespread usage

With a focus on addressing affordability, AIMPLAS, the Plastics Technology Center in Spain, has taken part in the development of a low-cost video laryngoscope, which consists of a clip-on plastic part and a video connection to devices, such as mobile phones or tablets.

Each year, four million general anesthesia are performed in Spain, with many assistances requiring the performance of an orotracheal intubation. This method involves passing a plastic tube between the vocal cords in order to ensure oxygenation and ventilation in patients.
With the use of plastics, a conventional laryngoscope can be turned into a high performance video laryngoscope.
In order to undertake this technique a conventional laryngoscope is used to perform a direct laryngoscopy that allows seeing the vocal cords of the patient and thus leading the tube to the right place.

This maneuver may fail with varying frequency. According to the physical characteristics of the patient, it may develop complications if the vocal cords are not seen, which result in a margin of error higher than 20% in some cases. It is an unforeseen event that is only shown at the moment of the intubation and whose solution is the use of a kit of specific devices to manage the airway.

Video laryngoscope, though proved to be effective in avoiding such maneuver, is expensive and that limits its use.

Doctor Lucas Rovira, an anesthesiologist currently working at the Manises Hospital, has created and led the project CLEVERSCOPE to develop equipment that would allow the widespread usage of video laryngoscope due to lower costs.

In the first stage of conceptual development of the product, additive manufacturing technology was used to evaluate the behavior of the supporting part. A prototype has since been manufactured, with three parts that, when placed in a conventional laryngoscope in a smartphone or tablet with camera, turns it into a high performance video laryngoscope.

Cost-effective solution for oxygenator

Membrane oxygenators, popularly known as artificial lungs, can be used to replace lung function during open heart surgery by oxygenating blood outside the human body.
Wego New Life Medical Devices selected=
Transparent medical grade polycarbonate (PC) is proved to be a cost-friendly solution for oxygenators, according to Wego New Life Medical Devices Co. Ltd, a medical device manufacturer in China.

Wego is committed to setting an industry benchmark,” said Liu Chengwu, Production Director of Wego. “We’ve established a close partnership with Covestro in the design and production of oxygenators since 2008 and reached a proper balance between benefits and costs.”

The glass-like clarity of Covestro’s Makrolon 2458 polycarbonate makes for an entirely transparent shell that enables clear observation of the proper functioning of the oxygenating process. It also exhibits high impact strength and reduces the risk of accidental damage during the course of a surgery.

Its biocompatibility has been tested according to ISO10993-1, ensuring high safety for the human body.

Thanks to its outstanding balance of properties, medical-grade Makrolon polycarbonate from Covestro makes oxygenators safe and durable,” said Liu.

Reusable part for CPAP therapy

CPAP therapy – for continuous positive airway pressure – maintains open airways for pre-term and low-birth weight newborns who breathe spontaneously but often inadequately.

Based in Vietnam, MTTS Company Ltd. has been focusing on delivering cost-effective solutions for newborns in need of intensive medical care since its establishment in 2004. Its new Dolphin Bubble CPAP machine ensures high quality respiratory care with exceptional value through the use of durable plastic parts.

In designing our Dolphin CPAP system, we aimed to innovate a complete, non-invasive solution that was also more cost-efficient due to its integrated design and replacement of consumable components with reusable parts,” said Gregory Dajer, Director of MTTS.
Solvay’s Udel P-1700 PSU forms the two semi-transparent components, shown here on the right side of MTTS’s machine. From left: the humidifier housing and the system’s positive end-expiratory pressure chamber.
Offering a sterilizable alternative to disposable polymer parts, Solvay’s Udel P-1700 polysulfone (PSU) forms two injection molded components of MTTS’ machine: the humidifier housing and the system’s positive end-expiratory pressure (PEEP) chamber.

Dolphin Bubble CPAP machines maintain pressure in the breathing circuit by immersing the distal end of the expiratory tubing in water. As the gas flows through the system, it “bubbles” out and prevents buildup of excess pressure. Its integrated design encompasses gas mixing, humidification, PEEP chamber, air compressor and pulse-oximeter in one compact unit.

The PEEP chamber primarily improves oxygenation by increasing functional residual capacity and helps to improve lung compliance and decrease the work of breathing.

Udel P-1700 PSU is a medical-grade, biocompatible polymer that maintains high-strength and toughness after repeated exposure to up to 100 autoclave sterilization cycles.

The material is highly resistant to harsh chemical disinfectants commonly used in the healthcare industry, such as sodium hypochlorite bleach and 2.4% glutaraldehyde solution. It offers higher heat resistance and better hydrolytic stability than polycarbonate and exhibits low creep under sustained loads at elevated temperatures.

MTTS received the CE mark in Europe for its system last year.

MTTS’s integrated Dolphin CPAP system fulfills an important mission with an innovative simple solution and Solvay was gratified to play a role in its success,” said Jeff Hrivnak, Global Healthcare Business Manager for Solvay’s Specialty Polymers business unit.

Microfluidics on the rise

Equipment used in diagnostics and treatment must be automated and operate reliably so that these advantages can be applied and utilized. Samples need to be sent for analysis in precisely defined quantities and then processed and tested. Microfluidic systems play an important role in all of these processes.

The microfluidics market is growing exponentially in recent years and COMPAMED 2017, one of the world’s largest medical industry trade shows held from November 13-16 in Düsseldorf, Germany, has also dedicated its focus on microfluidics.

Henne van Heeren, from the micro and nanotechnology (MNT) industry marketing firm enablingMNT, said, “Currently, 750 companies worldwide are active in the field of microfluidics. Around 45 new startups are added to this each year.”

COC is a commonly used material in microfluidics articles.The number of patents with the phrase “microfluidic” in their title or abstract has gone from zero in 1998 to over 1,300 per year, developing at breakneck speed.

In terms of materials, cyclic olefin copolymer (COC) is one of the favorites in the industrial world. It has all the necessary attributes for diagnostic products such as microfluidics and microplates, according to Topas Advanced Polymers.

TOPAS COC delivers superior purity, chemical resistance and UV transparency compared to competitive thermoplastics like polystyrene (PS), PMMA, and polypropylene (PP), while being much easier to manufacture in volume via simple injection molding compared to alternatives like glass and silicones.

With the exceptional clarity (92%) and mold detail of TOPAS COC, well counts are maximized, flow channels can be incorporated, and analyses are optimized.
Trak Male Fertility System, in which COC grade TOPAS 8007S-04 is used in a disposable cartridge.
Due to its ultra-high purity, TOPAS COC has lower leachables and extractables than competing materials. The inert nature of the material prevents interference with reactions and analyses. Other important features include the best available UV transparency of any plastic, heat resistance suitable for PCR or sterilization, and low autofluorescence.

MiTeGen LLC, a US supplier of consumables for X-ray diffraction, crystallography, and protein crystallization for academic, pharmaceutical, industrial, and government research, selected TOPAS COS for its new In-Situ-1 crystallization plate due to the material’s moisture vapor resistance and x-ray transparency compared to competitive thermoplastics.

Another company Sandstone Diagnostics has launched a unique male fertility management system made of TOPAS COC. The Trak Male Fertility System is a microfluidic device which uses the COC grade TOPAS 8007S-04 in a disposable cartridge due to its low moisture vapor transmission rate (MVTR), decreased water absorption, and biocompatibility.

The sample is transferred into a cartridge using a dropper and the cartridge is pressed onto a centrifuge which spins to initiate the microfluidic process.

Ulrich Schaff, Co-Founder and Chief Technology Officer at Sandstone, explained that other material options such as polycarbonate, PS, and clear acrylonitrile butadiene styrene (ABS) were considered but lacked the adequate barrier properties. The main issue was that these materials absorbed fluid and transmitted vapor over time, according to Schaff.

Storage of materials that are moisture sensitive or trying to keep fluid in can be a real challenge,” he said. “We needed to store a small amount of fluid, less than 1/10ml, which pushed the limits for what you can store long-term. Most plastics aren’t suitable for storing fluids for an extended period, but the TOPAS material performed very well.”

Additionally, the TOPAS resin provided adequate durability compared with PS, along with better dimensional stability than PC, resulting in flat injection molded parts which were tough enough for the mechanical processes of the application.COC also delivered strong biocompatibility with the reagents that were used, resulting in no leaching.

 

The disposable cartridge also required high transparency and low autofluorescence for efficient sample analysis. Because COC is an amorphous material, a solid ultrasonic weld of the two sections of the cartridge was achieved, according to Schaff. Among the polymers tested, the TOPAS material offered the best control in welding.

COC did present one challenge in pad printing. The company overcame the ink’s non-adherence by using a low-powered corona treatment combined with ink formulated for polyolefins.

Digitalization advances drug packaging


The trend of digitalization constitutes another important drive towards technological advances in the fields of medical technology and healthcare. Combining digitalization with packaging potentially creates a smart solution for personalized drug delivery system.
S.M.R.T Bottle enabled by digitalization for personalized drug delivery.
A collaboration between Amcor Rigid Plastics and Confrérie Clinique resulted in the S.M.R.T Bottle, a pill dispensing system that delivers drug compliance, user-friendliness, child and senior citizen safety, and connection to any smartphone for easy tracking and monitoring.

S.M.R.T Bottle includes a clock-calendar function and unit dose tablet detector. It registers the time and date and number of doses taken from the bottles and stores the data. Using devices such as Near Field Communication (NFC) readers, the information contained in the memory can be read, displayed, and transmitted to any smartphone.

It combines the benefits of a blister pack and a bottle in one package, according to Greg Rosati, Amcor’s Marketing Director for Healthcare. “The pill dispenser is a major technological advancement that not only offers effective pill dispensing but also digital communication to ensure patient adherence,” he said.

Designed as two-piece assembly, it can be fitted onto any pill bottle and existing filling lines with no changes required to the sealing process.

Amcor injection molds the PP insert which is custom designed to match the tablet geometry. The dispenser’s electronic system, custom designed and built by Confrérie Clinique, counts pills going in or out of the bottle, tracks the temperature of the container, and ensures product integrity.

In addition to the track and trace features, the device is also easier for seniors to remove tablets from the container and is safer for children because it makes multiple pill removal very difficult and nearly impossible to remove the desiccant canister preventing accidental ingestion.

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