Integrated rupture disk assemblies for medical OEM equipment - Today's Medical Developments

2022-04-26 02:47:04 By : Ms. Catherine Fan

Custom engineered miniature rupture disk assemblies are ideal for many medical device original equipment manufacturer applications involving gases and liquids.

Medical devices and equipment depend on highly reliable integrated, application specific, rupture disk solutions for critical life safety, diagnostic, and analytical applications. Rupture disks serve as an effective passive safety mechanism to protect against overpressure, such as in compressed specialty gases in laboratory and analytical instrumentation, magnetic resonance imaging, laser surgery, cryogenic, and other applications.

The disk, which is a one-time-use membrane made of various metals including exotic alloys, is designed to activate within milliseconds when a pre-determined differential pressure is achieved. Such disks also protect against over-pressure conditions in the sanitary chamber of autoclaves, which rely on pressurized heat or steam to sterilize medical instruments and research labware.

Medical equipment reliability is essential, and this demands high integrity from the pressure relief technology used to protect low- and high-pressure original equipment manufacturer (OEM) systems. As a result, medical OEMs are increasingly turning to integrated rupture disk assemblies where all components are combined by the manufacturer, as opposed to standalone components that leave much to chance. These assemblies are tailored to the application, miniaturized, and use a range of standard and exotic materials, as required. This approach ensures the rupture disk device performs as expected, enhancing equipment safety, reliability, and longevity while simplifying installation and replacement.

OEMs like BS&B utilize threading and several other connection types to attach the rupture disk assembly to the application.

Separate components versus integrated assemblies Traditionally, medical device rupture disks began as individual components combined with the manufacturer's separate holder device at the point of use, and installation actions of the user contribute significantly to the function of the rupture disk device. Installed improperly, the rupture disk may not burst at the expected set pressure. There’s a delicate balance between the rupture disk membrane, its supporting holder, and the flanged, threaded, or other fastening arrangement used to locate the safety device on the protected equipment.

For this reason, for medical applications an integrated rupture disk assembly is often a better choice than separable parts. Available ready-to-use and with no assembly required, integrated units are certified as a device to perform at the desired set pressure. The one-piece design allows for easier installation and quick removal if the rupture disk is activated.

The assembly includes the rupture disk and housing and is custom engineered to work with the user's desired interface to the pressurized equipment. The devices are typically threaded or flanged, and can be configured for industry specific connections such as CF/KF/Biotech/VCR couplings. Based on the application conditions and leak tightness requirements, the manufacturer combines the rupture disk and holder by welding, bolting, tube stub, adhesive bonding, or crimping.

There are additional advantages to this approach. Integrated assemblies prevent personnel from using unsafe or jury-rigged solutions to replace an activated rupture disk to save a few dollars or rush equipment back online. The physical characteristics of increasingly miniaturized rupture disks as small as 1/8" can also make it challenging for personnel to pick up the disk and place it into a separate holder.

“Medical device OEMs are driven to deliver the best performance while respecting cost of ownership for their customers,” says Geof Brazier, managing director of BS&B Safety Systems Custom Engineered Products Division. “The use of an integral assembly maximizes the longevity, proper function and trouble-free service of the pressure relief technology.”

The integrated assembly is ideal for numerous hydraulic, pneumatic, and other low-, medium-, and high-pressure applications including pumps, piston & bladder accumulators, engines, pressure vessels, and piping.

With the availability of integrated, miniaturized rupture disk solutions tailored to the application in a variety of standard and exotic materials, OEMs like BS&B can significantly enhance equipment safety, compliance, and reliability even in extreme work conditions.

Integrated assemblies – Rupture disk design According to Brazier, the most important considerations in rupture disk device design for medical applications are having the right operating pressure and temperature information along with the expected service life – the number of cycles the device is expected to endure during its lifetime. Since pressure and cycling varies depending on the application, each requires a specific engineering solution.

“Coming up with a good, high reliability, cost-effective, and application specific solution for a medical device OEM involves selecting the right disk technology, the correct interface (weld, screw threads, compression fittings, single machined part) and the right options as dictated by the codes and standards,” Brazier says.

Because user material selection can also determine the longevity of rupture disks, the devices can be manufactured from metals and alloys such as stainless steel, nickel, Monel, Inconel, and Hastelloy.

According to Brazier, for medical applications it can be important for rupture disks to have a miniaturized reverse buckling capability in both standard and exotic materials.

“Where economics is the driver, reverse buckling disks are typically made from materials such as nickel, aluminum, and stainless steel. Where aggressive conditions are required, more exotic materials like Monel, Inconel, Hastelloy, Titanium and even Tantalum can be used,” he says.

In almost all cases, “reverse buckling” rupture disks are used because they outperform the alternatives with respect to service life.

In a reverse buckling design, the dome of the rupture disk is inverted toward the pressure source. Burst pressure is accurately controlled by a combination of material properties and the shape of the domed structure. By loading the reverse buckling disk in compression, it can resist operating pressures up to 95% of minimum burst pressure even under pressure cycling or pulsating conditions. The result is greater longevity, accuracy, and reliability over time.

“The process industry has relied on reverse buckling disks for decades. Now the technology is available to medical device OEMs in miniature form as small as 1/8" burst diameter from BS&B. Until recently, obtaining disks of that size and performance was impossible,” Brazier says.

However, miniaturization of reverse buckling technology presents its own unique challenges. To resolve this issue, BS&B created novel structures that control the reversal of the rupture disk to always activate in a predictable manner. In this type of design, a line of weakness is also typically placed into the rupture disk structure to define a specific opening flow area when the reverse-type disk activates and also prevents fragmentation of the disk petal.

“Reverse buckling and therefore having the material in compression does a few things. Number one, the cyclability is much greater. Second, it allows you to obtain a lower burst pressure from thicker materials, which contributes to enhanced accuracy as well as durability,” Brazier says.

Small nominal size rupture disks are sensitive to the detailed characteristics of the orifice through which they burst. This requires strict control of normal variations in the disk holder.

“With small size pressure relief devices, the influence of every feature of both the rupture disk and its holder is amplified,” Brazier explains. “With the correct design of the holder and the correct rupture disk selection, the customer’s expectations will be achieved and exceeded.”

Due to cost, weight, and other considerations, Brazier says that BS&B has increasingly received more requests for housings that are made out of plastics and composites.

Because customers are often accustomed to certain types of fittings to integrate into a piping scheme, different connections can be used on the housing. Threading is popular, but BS&B is increasingly using several other connection types to attach the rupture disk assembly to the medical application. Once the integral assembly leaves the factory, the goal is that the set pressure cannot be altered.

“If you rely on someone to put a loose disk in a system and then capture it by threading over the top of it, unless they follow the installation instructions and apply the correct torque value, there’s still potential for a leak or the disk may not activate at the designed burst pressure,” Brazier explains. “When welded into an assembly, the rupture disk is intrinsically leak tight and the set-burst pressure fixed.”

While medical device OEMs have long relied on rupture disks in their gas-utilizing, hydraulic and pneumatic equipment, compact design suited to high-cycling environments have been particularly challenging. Fortunately, with the availability of integrated, miniaturized rupture disk solutions tailored to the application in a variety of standard and exotic materials, OEMs can significantly enhance equipment safety, compliance, and reliability even in extreme work conditions.

Join me for lunch 2/24 @12PM ET while I chat with grinding experts from Norton | Saint Gobain and Strausak.

Today there's a need in the market for high performing tools that provide a better value proposition to the end-user. During the first session, Norton | Saint Gobain experts, Philip Varghese and Alfredo Barragan, will discuss grinding product tiers and their key technology differences that help significantly lower cost per part when grinding cutting tools. Relevant end-user case studies involved in flute grinding, OD and clearance grinding of round tools (end mills, drills), as well as periphery and form grinding of inserts (carbide, PCBN) will be presented. Attendees will also get a sneak peek at the next generation products for round tool grinding and insert grinding that are being actively pursued and tested in the cutting tool market by Norton | Saint-Gobain Abrasives.

The second session will highlight the Strausak model ONE, the new flexible 5-axis CNC tool grinding machine for the orthopedic industry. The machine allows particularly long flute length which is common with surgical drills and reamers. This scalable model has been designed so that any options can be upgraded and retrofitted at any time during the life of the machine to help the user to stay competitive in a dynamic and unpredictable environment. Kris Zellmann, Strausak's National Sales Manager for the U.S. will lead the presentation. Strausak is a member of the Swiss Rollomatic Group of Companies specializing in the design and manufacturing of high precision CNC machines for production grinding and resharpening of cutting tools as well as orthopedic instruments and implants.

Make sure to register today.

August to December 2021 was the first five-month stretch of orders exceeding $500 million.

Orders of manufacturing technology surpassed $5.9 billion in 2021, marking the best year ever, according to the latest U.S. Manufacturing Technology Orders (USMTO) report published by AMT – The Association For Manufacturing Technology. December 2021 orders were just shy of the $600 million mark, a 6.5% decrease from November 2021 and a 33% increase over December 2020. August to December 2021 was the first five-month stretch of orders exceeding $500 million, which helped to end the year 55% above the 2020 annual total of $3.8 billion.

“After five straight months of historically high orders, it is difficult to describe 2021 as anything other than exceptional,” says Douglas K. Woods, president of AMT. “Since 1998 one-quarter of all months exceeding $500 million are now in 2021.”

“Throughout 2021, industries and products that were not typically industry drivers saw renewed activity,” Woods says. Residential housing starts reached levels not seen since prior to the 2008 financial crisis, and increased consumer demand for durable goods required additional capacity throughout the manufacturing industry. Grinding machines, which are required to manufacture drill bits and other tools needed in construction and manufacturing, saw outsized demand through 2021.

“In addition to demand from changing consumer behavior, reshoring and supply-chain diversification drove demand for manufacturing technology orders in December,” Woods says. “Products that were typically manufactured overseas were often subjected to shipping delays, crowded ports, or factory-wide shutdowns to prevent the spread of COVID-19.” In addition to mold and die manufacturers, increased orders from metal valve manufacturers as well as hardware, spring, and wire manufacturers can be attributed to the need to overcome supply-chain hurdles and domestic capacity constraints. 

December 2021 saw particularly large demand from engine, turbine, and power transmission manufacturers. This demand stemmed from renewed interest in smaller generators, possibly in response to the power disruptions experienced throughout the year, as well as larger natural gas generators to add general capacity to the grid. 

“While forecasts still call for optimism in 2022, we do expect to see some pullback in the first few months of the year,” Woods says. “Expanded backlogs, shortages of key components, and unfilled positions will hamper our strong growth rates of late 2021 but will smooth as the year progresses. Economists and industry analysts are anticipating a modest, single-digit increase in orders for 2022, barring any major geopolitical turmoil.”

MIRAI robot control system enables hand-eye-coordinated actions for automation of tasks that improve productivity in industrial environments.

Micropsi Industries announced $30 million in funding. The company provides ready-to-use AI systems for controlling industrial robots to enable the automation of manufacturing processes that couldn't be automated.

Using cameras and sensors to react in real-time to dynamic conditions in a workspace, Micropsi -powered robots can be trained by humans to perform hand-eye-coordinated actions in industrial environments. MIRAI is deployed in assembly, material handling, and quality control applications in many industries. Companies like Siemens Energy; ZF Group, and BSH, use MIRAI in their production halls.

New investors Metaplanet, VSquared, and Ahren Innovation Capital co-led the funding round. Existing investors Project A Ventures and M Ventures also participated.

MIRAI’s “Different Approach” Does What Others Only Promise

"Our technology makes it easy to transfer dynamic motion know-how from humans to robots,” says Ronnie Vuine, CEO and co-founder of Micropsi. “We have not optimized the textbook approach for specific applications but took a radically different approach inspired by how humans coordinate motions. MIRAI is a proven and independent technology that’s working 24/7 in the factories of our customers. That is what convinced our investors: Here is a company that can already verifiably do what many current startups only promise to develop.”

Industrial robots can compensate for labor shortages and secure supply chains. The manufacturing skills gap in the U.S could result in 2.1 million unfilled jobs by 2030. Before factories can put robots into service, a lot of preparatory work is necessary, with specialists developing software code line by line to trigger the individual movements of the machines. This is complex, expensive, and makes robots inflexible, as variance in positions or materials throw the robots off.

Micropsi’s MIRAI changes this. Using artificial intelligence (AI), workers train the machines through demonstration. A human guides the robot arm through the work task, which learns and carries out the movements autonomously. In doing so, it can handle variance and changes in the environment and the robot’s target at execution time. This expands the commercial potential of industrial robots, allowing them to handle complexity and keeps them flexible even as conditions change.

MIRAI augments industrial robots. Once configured with MIRAI, a robot arm perceives its workspace through cameras and adjust its movements as it performs a task. MIRAI skills are not programs, they are collected intuitions of human movement that MIRAI transfers to robots.

New funding plans: Expanding operations

The new funding is going to be used to expand operations in the US, ramp up sales efforts and expand to more robot platforms. Micropsi Industries hired robotics expert Prof. Dominik Bösl as managing director to be in charge of the company’s ambitious technology roadmap. Prof. Bösl previously held positions at Festo, Kuka, and Microsoft.

“Intelligent robot automation could tap into a currently locked productivity pool," says Rauno Miljand, managing partner at Metaplanet. "The end-to-end learning solution built by Micropsi is one of the most advanced systems in the market and is well-positioned to unlock potential in a wide array of industrial settings. The ease of use and the fast learning cycle make it one of the most scalable platforms in the industry.”

Enabling innovation in wearable technology.

Remote patient monitoring and the measurement of human body movement are increasingly becoming a vital part of how physicians, therapists, and other healthcare providers diagnose, monitor, treat and prevent chronic diseases.

Parker Hannifin’s FlexSense is a vital sensing technology that enables sophisticated new innovations to become reality in wearable tech for health care applications. FlexSense is being integrated into medical applications such as compression therapy, orthopedics, physical therapy and fall reduction. These application help improve patient outcomes, reduce healthcare costs, provide independent living choices for an aging population, and encourage patients to assume a more active role in their care.

FlexSense is stretchable, compressible, wearable, and wireless sensor technology designed to deliver medically precise human body motion measurements. The sensors are customizable for wearable applications in athletics, health, and wellness. The form, function and physical properties of the sensors are customized according to application requirements for use on textiles such as shoes, socks, insoles, and shirts.

“We are just scratching the surface on the innovations that FlexSense can enable,” says Tim Mannchen, EAP Market Development at Parker. “Anywhere precise measurement of human body movement is needed, is where we will excel. We have had several customers approach us after their innovation aspirations were not achievable with alternative sensing technologies. After Parker engineers and FlexSense technology were applied to the problem, sophisticated new-to-the-world applications have been successfully completed and brought to market.

“As several years’ worth of natural market evolution and telehealth adoption took place in only months during the pandemic, we believe patients, providers and payers will continue to support wearable health technology. Remote patient monitoring (RPM) presents many opportunities to improve outcomes, reduce costs and support care-at-home models that will become so important in the future.

“For example, we envision patients with chronic disease such as heart failure helping to improve their own outcomes by being an active participant in monitoring their own weight change and swelling with wearables equipped with FlexSense technology.”

FlexSense sensors are made of a silicon-based material and conductive ink that can withstand use environments including heat, cold, and shock to dust, vibration, and moisture. The sensors are soft, flexible, conformable, and durable and can be used as a stretch or pressure sensor, rapidly capturing precise measurements of movement.

Healthcare – Limiting elderly falls FlexSense technology has been incorporated into insoles, which perform assessments of the wearer’s ability to balance and walk. Based on the data collected during the assessment, the application guides the patient through at-home exercises that enhance gait and balance capability. In patient trials this application has been shown to help reduce the incidence of falling by up to 24 percent.

Healthcare – Predicting, preventing, and rehabilitating Injury FlexSense is a difference-making sensing technology that enables the most advanced Musculoskeletal (MSK) solution available in digital health. Joint movement plus soft tissue movement is measured from temporarily worn sensors, providing a complete picture of MSK health that has not been possible before without expensive imaging studies. The application can identify future injury possibility, provide injury preventing exercise regimes and measure progress during rehabilitation from orthopedic injury.

Athletics – Measuring breathing performance A company is leveraging FlexSense technology for its new “smart shirt” that athletes wear during exercise to measure respiration. The application provides exercise coaching that improves aerobic and anaerobic breathing as a means to improve athletic performance. In the past, measurement of aerobic and anerobic breathing was available to elite athletes using laboratory-based equipment. Now, thanks in part to FlexSense, this becomes available as wearable technology at a fraction of the cost.

Healthcare – Remotely monitoring heart failure patients Another potential application is a remote patient monitoring (RPM) tool for heart failure patients. Sensors embedded in textiles could monitor critical symptoms associated with heart failure, like weight change and swelling. By gaining access to this information much earlier during the period when the patient’s condition is declining, providers can react sooner with treatment that can often be provided on an outpatient basis before the patient’s condition worsens to the point where costly hospitalizations and emergency room visits are necessary.