The CardioInsight system uses a 252-electrode sensor vest that is worn by the patient to pair body surface electrical data with heart-torso anatomy.
Dublin, Ireland – Medtronic plc has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CardioInsight noninvasive 3D mapping system. The CardioInsight system is used to map a wide range of irregular heart rhythms in the upper and lower chambers of the heart, and provides electroanatomic 3D maps of the heart. The system was first used commercially in the U.S. by Vivek Reddy, M.D., director of cardiac arrhythmia services at the Mount Sinai Hospital and the Mount Sinai Health System, New York.
Cardiac mapping – typically accomplished by inserting a catheter into the heart via an artery or vein – allows physicians to locate the origin of a patient's irregular heart rhythms (arrhythmias). In contrast, the CardioInsight system is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure.
(Left) The CardioInsight Mapping Vest is supplied non-sterile and packaged individually. It is a single use device. 1. Liner 2. Conductive gel 3. Adhesive 4. Sensor 5. Spandex 6. Dielectric 7. Circuit trace 8. Polyester
"By offering this noninvasive approach, we are effectively streamlining the clinical procedure planning process for clinicians, and making it easy for patients to receive precise mapping results from their providers right at their bedside," said Dr. Reddy. "This system shifts mapping away from the EP lab, potentially saving time and enhancing the patient experience." Dr. Reddy receives financial compensation as a consultant to Medtronic, as well as research grant support from Medtronic.
Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. Medtronic acquired CardioInsight in 2015, now part of the Medtronic AF Solutions business in the Cardiac Rhythm and Heart Failure division.
"The CardioInsight system further expands the portfolio of solutions available for common and complex arrhythmias," said Colleen Fowler, vice president and general manager of the AF Solutions business. "This technology - which has been in development for decades - is now poised to drive greater physician insights and new advancements in the study and treatment of infrequent, unstable cardiac rhythms in a noninvasive, patient-friendly manner."
In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
About Medtronic Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
The catheter in the photo above is an example of FEP IV catheter tubing.
Graham Engineering Corp. often receives inquiries from medical tubing processors with an interest in venturing into the world of fluoropolymers. Materials such as FEP, PFA, PVDF, and ETFE are known for their excellent physical properties and hold promise for many medical applications, such as micro-tubing for intravenous (IV) catheters and insulin infusion, single- and multi-lumen tubing for endoscopy and cardiology devices, and heat-shrink tubing used as a manufacturing aid for catheter reflow purposes.
Since Graham Engineerins’ American Kuhne extrusion systems have been employed for such applications, here are some important considerations that we have identified regarding extrusion equipment and safety related to processing fluoropolymers.
Components that encounter molten resin such as the die head, tooling, adapter, breaker plate, and screw should be made of corrosion-resistant metals with high nickel content like Inconel 625 or Hastelloy C276. For corrosion protection of the extruder barrel, I recommend a tungsten carbide/nickel-based bimetallic barrel liner such as X800. For small medical extruders, 1.25" (32mm) and smaller, the entire backing material of the bimetallic barrel is solid Inconel and the liner material is X800.
The typical fluoropolymer screw is a single-flight design with a 3:1 compression ratio. In some cases, a low-shear Saxton-type distributive mixer is included at the end of the screw. Although Inconel and Hastelloy are corrosion resistant, these specialty metals have low torsional strength compared to common screws that are made of 4140 or 4340 heat-treated steel. For instance, Hastelloy 625 has a yield strength of approximately 52,000 psi (359 MPa), about half that of 4140 steel at 28Rc to 32Rc. Inconel 625 is a little stronger than Hastelloy C276 but is not as corrosion resistant. Care must be taken to avoid screw breakage when using an Inconel or Hastelloy screw while processing other high temperature polymers that are not corrosive such as PEEK, Polysulfone (PSU), and Polyetherimide (PEI). For example, a 1" (25mm) extruder with a 5HP motor geared for 100RPM screw speed is very likely to snap a screw made from Hastelloy 625 during a cold start situation.
(Left) Magnified view of a melt-fractured surface on an FEP tube.
Fluoropolymers have high melting points. For instance, PFA has a melting point at about 305°C (581°F). The barrel set points for FEP are in the 600°F to 740°F range, so the extruder barrel heaters should be made from cast bronze and rated up to 480°C (900°F). Due to the high operating temperatures, a special dual-layer barrel safety shroud should be used over the barrel to protect the operator from burns.
Fluoropolymers are also highly susceptible to melt fracture (“shark skin” appearance) on the surface of tubing, caused by excessive shear in the die tooling gaps as output rates are increased. The typical approach to avoiding melt fracture is to use larger tooling gaps, which means making the tubing with a larger drawdown. Tooling drawdowns of 3:1 to 20:1 are common for many polymers, whereas processors of fluoropolymers have used drawdowns of 50:1 or greater.
Proper safety measures are important to consider when processing fluoropolymers. According to the “Guide to the Safe Handling of Fluoropolymer Resins,” published by the Fluoropolymers Division of the Plastics Industry Association (formerly SPI), gases, vapors, and fumes released during the extrusion of fluoropolymers may be harmful to human health.
Vapors and fumes released during extrusion and while cleaning the die head can cause flu-like symptoms (chills, headaches, fever) that typically pass within 24 to 48 hours. The corrosive gases should be captured immediately and removed with an exhaust ventilation system that includes extraction hoods, ducting, and a fan. Extraction hoods should be placed above the die head and, for large-diameter tubing, an additional extraction hood over the area where the tubing is cut to length. Sealed packages of fluoropolymer resins should only be opened in well ventilated areas. Consult the resin supplier’s MSDS for specific recommendations.
For more information about processing fluoropolymers contact Steve Maxson, business development director – extrusion, Graham Engineering Corp.
Expanded product line at DesignPoint now includes Markforged 3D printers, enabling manufacturing customers to create high-strength parts.
Clark, New Jersey – Officials from DesignPoint, a provider of solutions for product design, engineering, manufacturing, and 3D printing in the Northeast and Mid-Atlantic states, announce that Markforged 3D printers will now be included in its solution offerings. DesignPoint serves engineering and manufacturing companies with 3D software and hardware solutions for product development. Markforged is a leader in 3D printing, additive manufacturing (AM) – with the use of advanced materials for producing high-strength parts. The Markforged 3D printer can print using fiberglass, carbon fiber, Kevlar, and metal (coming in Q3) – this enables parts to be created for functional prototypes, jigs/fixtures/tooling for manufacturing or even as finished production parts.
“The capabilities in additive manufacturing have continued to evolve,” states Allan Pincus, director of 3D printing technology at DesignPoint. “3D printing is no longer a competitive advantage, it has become a competitive necessity for companies that develop or manufacture products. Markforged expands these possibilities with the ability to create the highest strength 3D printed parts, greatly impacting the following key use cases: 1) functional prototypes, 2) tools, jigs, and fixtures, and 3) use as production parts for the right end-user applications.”
Markforged lies at the intersection of industrial 3D printing and real-world fabrication. It merges the reliability of high-quality 3D printers with the strength of machined metal parts. These metal like parts dramatically expand the potential use of 3D printed parts. For instance, a manufacturing engineer can design a jig, fixture, or special tooling, create it, and then use it in actual production. Still, other companies are using Markforged printed parts in their final assemblies.
“We are very selective when partnering with value-added resellers, states Matt Katzman, director, worldwide sales at MarkForged. “DesignPoint's philosophy of ‘more is possible’ aligns well with our own. Markforged is pushing the envelope in additive manufacturing, and we are confident DesignPoint will be a great partner in delivering more efficient product development and manufacturing to clients with our technology.”
About DesignPoint DesignPoint provides a complete set of software solutions and 3D printers for companies who design and manufacture products in the Northeast and Mid-Atlantic states. For 3D software, DesignPoint is an authorized value-added reseller for SOLIDWORKS, DriveWorks, and SolidCAM. For 3D printers, DesignPoint is an authorized value-added reseller of Markforged and 3DSystems. DesignPoint offices are located in Lancaster, Pennsylvania.; Philadelphia, Pennsylvania; and Clark, New Jersey.
The company is currently investing in the expansion of its medical technology division worldwide.
Detroit, Michigan – Global technology company Freudenberg is developing products that make delivering drug treatment for some of the most common diseases more precise and the healing process faster.
More than 1 million Americans are diagnosed with cancer every year, more than 29 million Americans have diabetes and almost 6 million suffer from chronic wounds. These are just a few examples of illnesses whose successful outcomes depend on precise and long-term parenteral delivery of medication to a patient's body. Freudenberg's innovations improve treatment delivery systems.
Treatment for esophageal and tracheal cancer involves use of coated catheters and stents that dispense active agents into the body, precisely where they are needed, and expand the affected vessels. Freudenberg Medical develops and manufactures those and other innovative drug device combination products. The special composition of the coating and the innovative coating process improves the drug effectiveness and ensures a longer-lasting effect with just a third of the required amount. Consequently, this reduces side effects for the patient and minimizes toxic waste in the clinic, and ultimately reduces environmental impact and achieves cost savings for the healthcare system.
Diabetes patients depend on insulin to regulate their blood glucose levels. Wearable insulin pumps improve life quality for diabetes sufferers by eliminating individual insulin injections and delivering insulin more accurately. Freudenberg Sealing Technologies supplies sealing solutions for these mobile pumps. A special rod seal reduces friction to a minimum, resulting in less wear. As a result, the minimum life expectancy of the pumps can be guaranteed for a period of four years, ensuring trouble-free application.
In treating chronic wounds a variety of different dressing materials are available to doctors and nurses for medical wound care. Gelatinizing nonwoven wound dressings from Freudenberg Performance Materials (FPM) accelerate the healing process.
The innovative nonwoven material gels as soon as it comes into contact with other liquids. The dressings keep the wound moist and remain stable despite rapidly absorbing the wound secretion, securely covering the wound. In addition, Freudenberg offers innovative foam systems that add special properties to conventional wound dressings, protecting the wound from drying out and consequently promoting healing. Their antimicrobial properties also prevent inflammation.
Additionally, FPM's transdermal drug delivery patches help deliver a specified dosage of active pharmaceutical ingredient (API) into the bloodstream by adhering the patch onto the patient's skin. The patches can be used for various treatments such as pain relief, hypertension, Alzheimer's disease or hormone replacement therapy. They can be worn anywhere between a couple of hours to as long as a week at a time, allowing for painless, direct to bloodstream delivery while bypassing the liver's metabolic activity.
Scaffolene technology is another Freudenberg innovation used in pharmaceutical applications for parenteral drug administration. These nonwovens are made from biodegradable raw materials, which are metabolized in the body. For the patient, that means that no additional procedure is needed to remove the drug delivery device. Medicines, enzymes or growth hormones can all be incorporated into the nonwovens. Scaffolene technology has found applications in surgery, wound healing, drug delivery and regenerative medicine. A European manufacturer of hemostatic products partnered with Freudenberg and introduced a product with scaffolene technology at the end of 2015. Following the positive response from users and physicians worldwide, further product launches are planned in the near future, including cooperation with a U.S. partner on a project in the field of bioactive wound care.
The Freudenberg Group continues to invest globally in the expansion of the company's medical technology division with the aim of further extending its innovation strength and ensuring long-term market success. From Shenzhen, China to Carrick-on-Shannon, Ireland; Kaiserslautern, Germany to Carpinteria, California, Freudenberg has invested in building new facilities or expanding and modernizing the existing ones to better serve local markets and ensure long-term market success.
About the Freudenberg Group Freudenberg is a global technology group that strengthens its customers and society long-term through forward-looking innovations. Together with its partners, customers and the world of science, the Freudenberg Group develops leading-edge technologies, and excellent products, solutions and services for more than 30 market segments and for thousands of applications: seals, vibration control components, nonwovens, filters, specialty chemicals, medical products, IT services and the most modern cleaning products. Innovation strength, strong customer orientation, diversity and team spirit are the cornerstones of our Group. Commitment to excellence, reliability and pro-active, responsible action belong to the company's core values lived for more than 165 years.
In 2015, the Freudenberg Group employed over 40,000 people in some 60 countries worldwide and generated sales of more than 7.5 billion Euros (including pro-rata consolidation of 50:50 joint ventures).
About Freudenberg Medical A global partner for the design, development and manufacture of innovative medical device technologies. With 11 manufacturing operations and more than 1,500 associates worldwide, Freudenberg Medical offers a wide range of capabilities from high precision silicone and thermoplastic components and tubing to coating technology, finished devices, and solutions for minimally invasive and catheter-based devices.
About Freudenberg Sealing Technologies As the leading specialist in sealing applications and their markets, Freudenberg Sealing Technologies is a supplier as well as a development and service partner serving customers in a wide variety of sectors including the automotive industry, civil aviation, mechanical engineering, shipbuilding, the food and pharmaceuticals industries, and agricultural and construction machinery. In 2015, Freudenberg Sealing Technologies generated sales of about €2.3 billion and employed more than 15,000 people. Freudenberg-NOK Sealing Technologies runs the business operations for Freudenberg Sealing Technologies in the Americas.
About Freudenberg Performance Materials Freudenberg Performance Materials is a leading global manufacturer of innovative technical textiles offering differentiated value propositions to a broad range of markets and applications such as apparel, automotive, building materials, hygiene, medical, shoe and leather goods as well as specialties. In 2015, the company generates sales of almost €980 million and has more than 25 manufacturing sites in 14 countries and more than 3.800 associates. Freudenberg Performance Materials has many years of experience in technical textiles and applications. The company attaches great importance to social and ecological responsibility.
Lee Spring adds more than 1,800 new products for 2017 and now offers more than 25,000 stock spring designs.
Brooklyn, New York – Lee Spring officials announced the release of their expanded 2017 product line in conjunction with the release of the 2017 Lee Spring Catalog. Lee Spring adds more than 1,800 new products for 2017 and now offers more than 25,000 stock spring designs. These products are available in stock and ready to ship from Lee Spring locations around the world. Lee Spring’s global operations serve a wide and diverse range of customers including an expanded presence in Europe.
To support demand for DIN range products, Lee Spring has introduced the DIN-Plus Series, a range of compression springs built on the DIN2098 Part 1 and 2 specifications, but with added corrosion resistance. The Lee Spring DIN-Plus Series has enhanced corrosion resistance, including passivation for the stainless steel range and zinc plating for the spring steel range. The DIN-Plus Series adds over 500 new products to the Lee Spring line.
Steve Kempf, Lee Spring CEO, states, “The new 2017 Lee Spring Catalog offers an expanded range of springs which are offered by all of our locations around the world. We have added to our size ranges and material options, and offer products in line with various specifications around the world, which also include both imperial and metric sizes. This expanded range of products allows us to offer a comprehensive selection of springs right from our inventory for fast delivery around the world.”
Lee Spring continues to look for ways to offer better corrosion resistance in all spring ranges, including compression, extension and torsion type springs. In 2017, Lee Spring has added more Stainless Steel 316 springs, which are available off the shelf and ready to ship, therefore bypassing the need for custom spring design, quoting and manufacturing. The ongoing expansion of Stainless Steel 316 adds more extension and torsion spring offerings to Lee Spring’s existing wide range of compression springs available.
The 2017 Lee Spring Catalog remains an important engineering and buyer’s resource for all types of springs. This year’s catalog now contains more than 380 pages of parts, specifications and pricing. Lee Spring stocks a wide range of springs for immediate delivery and custom springs are available, along with engineering and technical support. To request a free 2017 Lee Spring Catalog, visit leespring.com or call 888-777-4647.
About Lee Spring Lee Spring is a global manufacturer of mechanical springs and related products. Lee Spring carries a line of 25,000+ stock springs and manufacturers custom springs made to customer specifications. Established in 1918, Lee Spring is an ISO 9001 certified company headquartered in Brooklyn, NY USA and has multiple locations in the United States, as well as locations in Mexico, Europe, China and India.