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Polymer solution casting The polymer solution casting process utilizes a
mandrel A mandrel, mandril, or arbor is a gently tapered cylinder against which material can be forged or shaped (e.g., a ring mandrel - also called a triblet - used by jewelers to increase the diameter of a wedding ring), or a flanged or tapered or ...
, or inner diameter mold, that is immersed in a tank of polymer solution or liquid plastic that has been specifically engineered for the process. Due to a combination of thermal and frictional properties, the polymer solution then forms a thin film around the mold.Solvent cast technology - a versatile tool for thin film production
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The mold is then extracted from the tank in a precisely controlled manner, followed by a curing or drying process. Once the first layer of thin film is appropriately solidified, secondary features can be added to the product such as braided or coiled wire, laser-cut hypotubes or engineered metal reinforcements to prevent kinking, or imaging targets specific to the intended medical application. Multiple casting steps can then be repeated to encapsulate the reinforcements, build up wall thickness, add additional lumens and optimize column strength. The part is then removed from the mold after it is cured or solidified. The most notable attribute of this thin-film process technology is the ability to alternate the material properties (i.e. strength,
durometer The Shore durometer is a device for measuring the hardness of a material, typically of polymers. Higher numbers on the scale indicate a greater resistance to indentation and thus harder materials. Lower numbers indicate less resistance and soft ...
, color,
lubricity Lubricity is the measure of the reduction in friction and/or wear by a lubricant. The study of lubrication and wear mechanisms is called tribology. Measurement of lubricity The lubricity of a substance is not a material property, and cannot be m ...
) amongst the individual layers or even down the length of the part, resulting in a feature-rich single-piece construction. This process also allows other components to be incorporated into the structure of the part during the layering processes, such as injection molded components and extruded tubes made of high performance polymers such as
PTFE Polytetrafluoroethylene (PTFE) is a synthetic fluoropolymer of tetrafluoroethylene that has numerous applications. It is one of the best-known and widely applied PFAS. The commonly known brand name of PTFE-based composition is Teflon by Chem ...
,
PEBAX Polyether block amide or PEBA is a thermoplastic elastomer (TPE). It is known under the tradename of PEBAX® (Arkema) and VESTAMID® E ( Evonik Industries). It is a block copolymer obtained by polycondensation of a carboxylic acid polyamide ( PA6 ...
, and
polyimide Polyimide (sometimes abbreviated PI) is a polymer containing imide groups belonging to the class of high-performance plastics. With their high heat-resistance, polyimides enjoy diverse applications in roles demanding rugged organic materials, e.g ...
. Another notable advantage of polymer solution casting technology is that the total manufacturing cost for both prototyping and production volumes are frequently less than the conventional technologies. This cost benefit results from the use of inexpensive molds coupled with the scalability and adaptability of the manufacturing line. As a result, new products and processes are readily developed and implemented, facilitating cost-effective creation of very feature rich and complex
catheters In medicine, a catheter (/ˈkæθətər/) is a thin tube made from medical grade materials serving a broad range of functions. Catheters are medical devices that can be inserted in the body to treat diseases or perform a surgical procedure. Cat ...
. Since the 1990s, Avalon Laboratories and Piper Plastics Corp. have aggressively pioneered polymer solution casting technology, focusing on complex medical devices. The history of these technologies dates back to many highly regarded names in the medical industry including
Medtronic Medtronic plc is an American medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it ...
, BioMedicus, Bard,
Terumo was founded in 1921 as Red Line Thermometer Corporation by a group of medical scientists led by Dr. Kitasato Shibasaburō to produce medical thermometers in Japan. The company's first product was "Jintan Taionkei", the first Japanese-made the ...
, Research Medical Inc., Shiley, Polaris Plastics, and Caplugs.


Materials

Polymer solution casting technology can be deployed utilizing a host of different polymer materials depending on the application and design inputs, including those used in Class I, II and III medical devices,Polymers in Medicine II
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and for the preparation of
polymer electrolytes A polymer electrolyte is a polymer matrix capable of ion conduction. Much like other types of electrolyte—liquid and solid-state—polymer electrolytes aid in movement of charge between the anode and cathode of a cell. The use of polymers as an ...
. The earliest and most commonly found materials were polyvinyl chlorides ( PVC) due to their advantages in cost, physical properties and clarity. Over the past twenty years, there has been scrutiny of the long term health effects of the PVC base materials relating to the plasticizers and stabilizers which are needed to ensure adequate shelf life of sterilized product. More recently, newly engineered formulations have eliminated these biocompatibility concerns while extending the shelf life, and PVC has re-emerged as a preferred polymer for use in interventional and surgical applications.
Polyurethane Polyurethane (; often abbreviated PUR and PU) refers to a class of polymers composed of organic chemistry, organic units joined by carbamate (urethane) links. In contrast to other common polymers such as polyethylene and polystyrene, polyurethan ...
has emerged as another polymer that meets the medical device market's demands for thinner wall sections, longer lengths and extended blood exposure. The high strength and range of properties make these materials an excellent choice for soft
elastomer An elastomer is a polymer with viscoelasticity (i.e. both viscosity and elasticity) and with weak intermolecular forces, generally low Young's modulus and high failure strain compared with other materials. The term, a portmanteau of ''elastic ...
applications. Among the first commercial polyurethane medical products were non-allergenic
medical gloves Medical gloves are disposable gloves used during medical examinations and procedures to help prevent cross-contamination between caregivers and patients. Medical gloves are made of different polymers including latex, nitrile rubber, polyvinyl c ...
, developed as a response to latex allergies. These advanced polymers offer a full range of physical properties, improved biocompatibility, and lubricous properties by way of custom formulations and coatings. Another material choice for polymer solution casting is silicone urethane copolymers, which are among the most biocompatible synthetic materials. This class of medical grade material was developed for long-term implantable device applications and offers the physical characteristics of high elongation, low
modulus of elasticity An elastic modulus (also known as modulus of elasticity) is the unit of measurement of an object's or substance's resistance to being deformed elastically (i.e., non-permanently) when a stress is applied to it. The elastic modulus of an object is ...
, excellent recovery, and resistance to chemicals, oil, and
UV light Ultraviolet (UV) is a form of electromagnetic radiation with wavelength from 10 nm (with a corresponding frequency around 30  PHz) to 400 nm (750  THz), shorter than that of visible light, but longer than X-rays. UV radiation i ...
. While there exists a number of materials to choose from while deploying polymer solution casting technology, the material science work continues in the areas of wall thickness, strength, lubricity, biocompatibility and clarity as well as interactions of the liquid polymers with extruded and injection molded components.


Medical Device Applications

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Cardiovascular The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
* Neurovascular *
Peripheral A peripheral or peripheral device is an auxiliary device used to put information into and get information out of a computer. The term ''peripheral device'' refers to all hardware components that are attached to a computer and are controlled by th ...
Vascular Blood vessels are the structures of the circulatory system that transport blood throughout the human body. These vessels transport blood cells, nutrients, and oxygen to the tissues of the body. They also take waste and carbon dioxide away from ...
* Interventional
Cardiology Cardiology () is a branch of medicine that deals with disorders of the heart and the cardiovascular system. The field includes medical diagnosis and treatment of congenital heart defects, coronary artery disease, heart failure, valvular he ...
*
Urology Urology (from Greek οὖρον ''ouron'' "urine" and '' -logia'' "study of"), also known as genitourinary surgery, is the branch of medicine that focuses on surgical and medical diseases of the urinary-tract system and the reproductive org ...
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Oncology Oncology is a branch of medicine that deals with the study, treatment, diagnosis and prevention of cancer. A medical professional who practices oncology is an ''oncologist''. The name's etymological origin is the Greek word ὄγκος (''ó ...
* Ear Nose Throat *
Gastro-intestinal The gastrointestinal tract (GI tract, digestive tract, alimentary canal) is the tract or passageway of the digestive system that leads from the mouth to the anus. The GI tract contains all the major organs of the digestive system, in humans an ...
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Gynecology Gynaecology or gynecology (see spelling differences) is the area of medicine that involves the treatment of women's diseases, especially those of the reproductive organs. It is often paired with the field of obstetrics, forming the combined ar ...
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Diabetes Diabetes, also known as diabetes mellitus, is a group of metabolic disorders characterized by a high blood sugar level (hyperglycemia) over a prolonged period of time. Symptoms often include frequent urination, increased thirst and increased ...
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Radiology Radiology ( ) is the medical discipline that uses medical imaging to diagnose diseases and guide their treatment, within the bodies of humans and other animals. It began with radiography (which is why its name has a root referring to radiati ...
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Venous Veins are blood vessels in humans and most other animals that carry blood towards the heart. Most veins carry deoxygenated blood from the tissues back to the heart; exceptions are the pulmonary and umbilical veins, both of which carry oxygenate ...
disease *
Microbiology Microbiology () is the scientific study of microorganisms, those being unicellular (single cell), multicellular (cell colony), or acellular (lacking cells). Microbiology encompasses numerous sub-disciplines including virology, bacteriology, ...
* Ophthalmic *
Interventional pulmonology Interventional pulmonology (IP, also called interventional pulmonary medicine) is a maturing medical sub-specialty from its parent specialty of pulmonary medicine. It deals specifically with minimally invasive endoscopic and percutaneous procedure ...
*
Orthopedics Orthopedic surgery or orthopedics ( alternatively spelt orthopaedics), is the branch of surgery concerned with conditions involving the musculoskeletal system. Orthopedic surgeons use both surgical and nonsurgical means to treat musculoskeletal ...
*
Percutaneous {{More citations needed, date=January 2021 In surgery, a percutaneous procedurei.e. Granger et al., 2012 is any medical procedure or method where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using ...
Valve Therapy * Structural Heart therapy


References

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External links


MPMN Website
Plastics industry