Medical Device Components and Assembly Applications - Minnesota Rubber & Plastics

Medical Grade Tubing & Hose

Karl Spilseth — Wed, 22 Mar 2023 03:50:34 +0000

Innovative, custom solutions

Meeting your quality and application requirements

Trelleborg Medical Solutions develops, manufactures and supplies tubing & hose for medical and pharmaceutical applications in a variety of high performance materials. The tubing and hose is extruded in clean-room facilities using Good Manufacturing Practices (GMP).

Silicone tubing, because of its unique biocompatibility and physical durability, plays a fundamental role in a myriad of healthcare applications. Inside the body it is used as insulation on electrical stimulation devices, as conduits for delivering and removing fluids, and as catheters for various types of interventional therapies. Outside the body it is ideally suited for applications including blood oxygenation as well as many pharmaceutical manufacturing processes.

Case studies in applying advanced extrusion technologies for medical device design

Find out how the GeoTransTM extrusion process can support the design of intricate and complicated medical devices.

Tubing & Hose Products

Reinforced Tubing

Silicone Tubing

Tubing and Hose Fittings

Multi-Lumen Tubing

Peristaltic Tubing

Tools & Literature

Tubing, Hoses & Sheeting

For Healthcare and Medical Applications

Fighting Hospital Acquired Infection

Exploring methods of combining silicone tubing with APIs

Tubing & Hose Selector

Easily choose the correct tubing and hose for your application

Tubing & Hose Selector

Our popular engineering tool at your fingertips

Application Examples

Bioprocessing Flow Tubing

Customer: Bioprocessing Equipment Manufacturer
Application: Bioprocessing Flow Tubing

Issues:

Desired flow rates not being achieved
Tubing collapsing due to large suction pressure from rotary lobe style pump

Solution

Tubing wall was increased to 0.48 mm / .188 inch from 0.32 mm / .125 inch while maintaining the same inner diameter.
The customer required a high flow rate discharge due a large volume bottom outlet disposable biobag. This involved switching from a peristaltic pump to a rotary lobe style pump. Thicker wall tubing prevented the tubing from collapsing and the specified flow rates are being met.

Central Vascular Access Catheters

Components For Disposables

Customer: Catheter Manufacturer
Application: Multi-lumen tubing and liquid injection over-molding connectors for Central Vascular Access Catheters

Issues:

Maintaining orientation of feeding lines
Cleanroom production require

Solution

Multi-lumen tubing and overmolded connectors utilizing combined high-precision liquid injection molding and extrusion production techniques
Gish Biomedical of Rancho Santa Margarita, California, awarded Trelleborg Sealing Solutions Northborough a contract to produce multi-lumen tubing and liquid injection over-molding connectors for their Central Vascular Access Catheters. The award was based on our years of experience within the life science market producing high quality engineered solution

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Finished Medical Devices

windmill — Wed, 22 Mar 2023 03:32:24 +0000

Integrating drug, device, and/or biological elements into a single therapeutic entity.

Production and assembly of medical devices

Trelleborg Healthcare & Medical partners supports customers with the production and assembly of finished medical devices, which meet all quality and regulatory requirements.

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The FDA defines a Finished Medical Device as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

Our Trelleborg Healthcare & Medical experts support customers in developing and assembling the medical device they require:

Routine sub-assemblies involving silicone, metal, plastic and ceramic components
Shunts formed from porcine-derived polymer
Complete manufacture of fully functional neurological implants
Device expertise is as varied as the requirements of our customers

Two examples of our medical device capabilities:

Implantable neurological sensing device

Silicone components including die-cut reinforced sheeting, a molded electrode positioner and tubing were assembled into an eight-electrode array.

The assembly process included fixtured positioning, bonding, laser welding, micro-crimping, laser stripping, and custom tray packaging. Pass-fail functional testing evaluated both electrical resistance and capacitance.

Novel mammary implant

The bill of materials involves 38 parts including dipped shells, precision molded valve components and extruded tubing. The process batch record fully details 58 discrete assembly steps beginning with line clearance and ending with product release as sterile finished goods. Serialized inner tray and shelf box labels are printed and controlled on-site. Each implant is laser etched with corresponding serial identification.

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Drug Elution Technologies

windmill — Wed, 22 Mar 2023 03:27:50 +0000

Expertise in combining polymers with active pharmaceutical ingredients (APIs) to produce implantable drug delivery systems and combination devices.

Whether enhancing a device by adding anti-inflammatory compounds or delivering pharmaceuticals via a controlled drug delivery system, Trelleborg can provide targeted delivery solutions that significantly improve patient quality of life.

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Technological advancements in controlled drug delivery products offer medical device manufacturers and pharmaceutical companies the opportunity to develop smaller, less invasive, and more effective products. Silicone materials provide many advantages and are commonly used in drug delivery applications, while alternative polymer excipients can also provide distinct advantages based on desired outcomes for the therapy being developed.

Applications

Women’s Health
Ocular Drug Delivery Systems
Cancer Treatment
Wound Care
Steroidal Collars
Pacemaker Leads

Silicone is extremely versatile and delivers unmatched biocompatibility, making ideal for use in a broad range of applications, including targeted and controlled-release drug delivery systems.

Resources

Whitepaper

This whitepaper reviews the methods for introducing an API to raw silicone and explores a new means of formulation, with test results proving the effectiveness of each.

Download the Whitepaper

Introducing APIs to silicone & controlling elution rates webinar

This webinar takes a deep-dive into the manufacturing methods used to produce implantable drug delivery systems and combination products and includes details on patient impact, use cases, market outlook while covering several case studies.

Watch the webinar

Podcast

With pharma’s focus on the extension of drug release windows, new technologies are needed to lengthen that duration. This podcast offers insights into how long acting implantables and polymeric drug delivery can address that need.

Listen to the podcast

Implantable drug delivery webinar

This webinar gives an overview of implantable drug delivery systems. It explores use cases in the market today, market trends, manufacturing considerations and methods of formulation.

Watch the webinar

Introducing APIs to Silicone

Adding an API to Raw Silicone

Introducing an API into silicone usually involves the combination of Liquid Silicone Rubber (LSR) with an API before fabrication into a silicone part. The API combines with both parts of the raw silicone just before manufacturing it into its final form via extrusion, molding, or sheeting processes.

Impregnating Vulcanized Silicone with an API

Another method of introducing an active pharmaceutical ingredient to silicone is to immerse a finished silicone part in a drug-loaded solvent, which causes swelling and allows the API to impregnate the silicone matrix.

Membrane-Controlled Elution Rates

Using a silicone membrane also enables manufacturers to control the elution rate. A commonly used method is to apply a membrane, such as an extruded silicone tube, to a drug-loaded core to modulate its release profile.

Advantages of API Elution

Controlled release of an API enables a consistent concentration of the drug, in contrast to bolus-style delivery which fluctuates within the therapeutic range.
Implanted targeted drug delivery systems can provide a targeted release of pharmaceutical ingredients to a specific site within the body.
As opposed to systemic administration, controlled drug delivery systems allow for longer-term dosages while minimizing adverse side effects.
Combination products can offer significant advantages when patient compliance is a high-risk element of other existing therapies on the market.
Patient’s quality of life can be improved by minimizing the effort they have to put in to manage a condition that is particularly high maintenance.
Lowered dosage requirements may be possible through targeted drug delivery systems.
Simplified treatment regimens lead to fewer visits to the practitioner, relieving the strain on health services.

Have questions about a product application you’re working on?

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Engineered Coated Fabrics

windmill — Wed, 22 Mar 2023 03:09:00 +0000

Engineering polyurethane solutions for global challenges in the Healthcare & Medical sector

Trelleborg Engineered Coated Fabrics produces the highest quality fabrics in the medical and healthcare industries, including sector-leading Dartex® polyurethane coatings.

Working closely with clinicians and professionals, Trelleborg undertakes technical research and collaborates with key industry bodies to ensure that we are at the forefront of specialist technical textiles; delivering key components for optimum patient outcomes and understanding the key issues facing medical device manufacturers today.

Support Surfaces & Seating

Medical support surface fabrics with immersion, envelopment and breathability properties are key to help prevent avoidable pressure ulcers.

Support Surfaces

Air mattress cells
Mattress covers – top
Mattress covers – base
Moving & handling
Prosthetics / Orthotics
Positioning devices
Theatre tables
Trolleys & Stretchers

Seating

Cushions
Recliner chairs
Postural Seating
Specialist Seating
Wheelchairs

Surgical Uses

Utilizing polyurethane-coated fabrics for surgical use ensures durability, skin safety and no risk of compromise through failure with pinholes.

Blood Analysing System Port Gaskets
Breathing Mask Dam (pin-hole free)
Drug delivery systems
Endoscopy bags
Laparoscopy inflatables/ bags
Oxygen Delivery System Valves
Thermal Packs
Tourniquets
Wound retractors

Wearable Uses

Breathable, comfortable fabrics designed with the user experience in mind, yet practical and safe for use within a Healthcare & Medical environment.

Patient
- Blood pressure cuffs
- Orthopedic Inflatable Splints & Supports
- Prosthetics
Medical professional
- Aprons
- Reusable Cleanroom Shoe Covers
- Surgical Gowns
- X-Ray Protective Shielding

Have questions about a product application you’re working on?

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Cardiovascular

Erin Rubenstein — Thu, 28 Apr 2022 15:55:00 +0000

Application

Implant Tools for Cardiovascular Surgical Applications

Minnesota Rubber & Plastics cardiovascular components and surgical instruments feature ergonomic designs and surface areas that make it easy for surgeons to control the tools by grasping the wheel and release switch. The instrument’s molded parts are created with a polycarbonate resin that withstands ETO sterilization.

Our design team leveraged DFM expertise and created the tool’s internal components and snap-fit design. The challenge was squeezing several components to fit perfectly and operate flawlessly in a compact tool. A Santoprene elastomer formulation was used to overmold each component since the tool is designed for chest cavity insertion. Additionally, colorization can be used to complement your company’s branding requirements.

The development of this precision instrument demanded component level accuracy as well as DFM expertise and deep experience in advanced materials and injection molding.

Benefits

Robust Materials Hold up to Sterilization and Surgical Environments

Implant tools, like most medical devices, have restrictions and functional requirements that limit material choices. All materials used in the steerable epicardial lead implant device, for example, must hold up to ETO sterilization and demanding surgical procedures.

Minnesota Rubber & Plastics works with customers to design and develop high-quality and reliable products to access critical care procedures. From lead implant tools to introducers and sheaths that provide entry points for lead placement or other vascular procedures, our product development engineers collaborate with you to create custom designs and materials for cardiovascular applications.

In fact, our technical team of engineers and scientists develop and refine solutions for the most demanding applications—including integrated assemblies and LSR hemostasis slit valves. Years of product experience and leveraging tools like FEA analysis, Moldflow and DFM, separate us from competing firms.

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Diabetes

windmill — Thu, 28 Apr 2022 15:54:00 +0000

Application

Custom Molded Rubber Seals for Insulin Delivery Systems

Minnesota Rubber & Plastics provides medical device manufacturers with custom molded rubber seals for insulin pumps. This precision pump is the heart of continuous glucose monitoring devices, which are carried at all times by Type I diabetics.

Insulin pumps, reservoirs, and their internal components are engineered to perform flawlessly every hour of every day. There’s no latitude for system failures, such as leaks or material breakdowns. Many of our custom elastomer formulations are manufactured to stringent regulations such as ISO 10993 part 5, and USP Class VI.

Benefits

Lab-Developed Custom Rubber Seals that Hold Up for Years

The formulations for our insulin pump rubber seals were developed in our advanced materials lab by a team of dedicated materials engineers and scientists. These seals must prevent leaks while not degrading the seals or contaminating insulin.

Fully-Equipped Advanced Materials Lab

One of the reasons medical device companies prefer working with Minnesota Rubber & Plastics is our steadfast dedication to the scientific method for developing materials. Our advanced materials lab features a broad range of analytical equipment, including:

-Infrared Spectrometer (FTIR)
-Infrared Microscope
-Differential Scanning Calorimetry (DSC)
-Thermogravimetric Analysis (TGA)
-Rubber Process Analyzer (RPA)
-Moving Die Rheometer (MDR)
-UV-Vis Spectrophotometer

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Other Resources

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Diagnostics

Erin Rubenstein — Thu, 28 Apr 2022 15:54:00 +0000

Application

Diagnostic Testing Systems—COVID-19, Cancer, Viruses, GI, Blood, and More

Minnesota Rubber & Plastics has partnered with numerous medical companies to design and manufacture a wide range of medical diagnostic testing systems.

These point-of-care diagnostic testing systems are critical to address immediate patient needs such as those impacted by COVID-19. Our quick and rapid response to partner with customers that have received EUA (Emergency Use Authorizations) for their devices is helping to bring accurate and reliable testing systems to the market in response to this global pandemic.

Additionally, we help develop and manufacture cancer diagnostic systems. These systems include tissue-based diagnostic solutions and personalized treatment options like immunotherapies, which encourage the body’s immune system to target and kill cancer cells.

Other diagnostics include tests for blood culture identification, gastrointestinal conditions, meningitis, encephalitis, pneumonia and other viruses.

Benefits

Custom Materials and Components that Complement any Reagent

The biggest challenge to developing components for diagnostic testing is formulating materials that can sustain chemical reactions with our clients’ proprietary reagents.

Because reagents are considered industry secrets, our chemists and scientists work methodically, yet swiftly, to find a material that complements the company’s reagent, while maintaining component integrity.

How We Develop Custom Materials

To optimize how our custom materials complement proprietary reagents, we leverage our advanced materials lab. Materials experts adhere to the scientific method and use a broad range of analytical instruments to perfect ideal materials:

Infrared Spectrometer (FTIR)
Infrared Microscope
Differential Scanning Calorimetry (DSC)
Thermogravimetric Analysis (TGA)
Rubber Process Analyzer (RPA)
Moving Die Rheometer (MDR)
UV-Vis Spectrophotometer

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Surgical Instruments

Erin Rubenstein — Thu, 28 Apr 2022 15:53:00 +0000

Application

Custom Molded Surgical and Orthopedic Instruments

Minnesota Rubber & Plastics helps medical device companies design and manufacture advanced surgical and orthopedics devices. These include:

Overmolded handles and devices
Components and sub-assemblies for surgery
Endoscopes and other imaging and positioning devices for Minimally Invasive Surgery (MIS)
Single-use devices for cardiovascular and orthopedic and general surgical procedures
Mixing and delivery systems seals and components

When required, our products comply with USP Class VI standards. Additionally, our advanced polymers and formulations—including polyethersulfone grades—resist chemicals and bodily fluids including enzymatic soaking agents, high-level disinfectants, blood reagents, and anesthetics.

For years, we’ve worked with medical device manufacturers and designers to provide them with a wide spectrum of colors and polymers that offer the following features at elevated temperatures:

Sterilizability
Chemical compatibility
Biocompatibility
Durability
Hydrolytic stability
Bond Integrity

Benefits

Advanced Polymers Retain 85%–100% Hydrolytic Stability

Minnesota Rubber & Plastics provides both transparent and opaque molded colors with our polymers, which gives designers and companies unlimited options for customizing colors to help you comply with your brand standards.

What’s more, designers can use transparent color combinations to create modern, vibrant effects. Additionally, all of our materials can be autoclaved for repeated use. In fact, our polymers retain 85%–100% hydrolytic stability after long-term exposure (two years continuous). Which means the surgical instruments and devices we’ll last longer—through thousands of procedures.

Have questions about a product application you’re working on?

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Structural Heart

Erin Rubenstein — Thu, 28 Apr 2022 15:53:00 +0000

Application

Structural Heart Instruments and Devices

Minnesota Rubber & Plastics partners with medical device companies to produce implantable heart valve components, delivery system seals, homeostasis valves and components and surgical instruments used in the structural heart space. The thin cross-section and complex geometry of the heart valve components are manufactured out of long-term implantable biocompatible materials. Molded with high-performance thermoplastics, these intricate, yet robust devices are designed to “live” within the human body for 10–20 years or more.

Custom-Designed Surgical Instruments for Implanting & Sizing

Along with custom structural heart valve components we manufacture for medical device firms, we also design and manufacture critical components for the instruments surgeons use to place and size valves within patients. These instruments are used in surgical heart valve replacement procedures.

To complement the structural heart surgical space, we work closely with customers developing and manufacturing components within the minimally invasive procedural space, as well.

Minnesota Rubber & Plastics supports cutting-edge minimally invasive surgery within the structural heart space through the development and manufacturing of delivery systems components used in transcatheter aortic valve replacements (TAVR) and transcatheter mitral valve repairs (TMVR).

We design and manufacture critical components for these instruments with custom EPDM, LSR and HCR elastomer materials.

Homeostasis valves
Plunger seals
Custom O-rings, lip seals, and Quad rings
Diaphragm seals

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Benefits

Designed Structural Heart Valves and Components Last for Decades

We work with medical device leaders to design and manufacture structural heart components using high-performance biocompatable thermoplastics, silicone and rubber products.

The rubber materials perfected in our advanced materials laboratory are formulated to comply with stringent regulations such as ISO 10993 part 5, and USP Class VI.

Our science-based approach to designing and refining heart valves and similar components results in products that work flawlessly for decades.

Surgeons also rely on trusted Minnesota Rubber & Plastics tools to properly size and implant these highly-refined heart valves.

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Cell Therapy

Erin Rubenstein — Thu, 28 Apr 2022 15:53:00 +0000

Application

LSR Membrane Integrated Thermoplastic Assemblies

Minnesota Rubber & Plastics is a leading designer and manufacturer of customer liquid silicone rubber (LSR) thin film membranes in cell therapy applications. These versatile culture devices can turn 300 million cells into 100 billion in just 11 days.

To generate this high rate of cell growth, a convection process is used as opposed to diffusion. This is the key to achieving maximum cell growth with uninterrupted access to nutrients.

The finished assembly—which properly positions and holds the LSR thin-film membranes—consists of an incubator shelf, and a high nutrient-capacity bottle supported with a ring at the base, and a cap on top.

To maintain sterile conditions during manufacturing, all molding, assembly and packaging operations take place in USA-based Minnesota Rubber & Plastics ISO Class 7 clean rooms.

Benefits

An Improved Design Lowers Product Costs

The improved design of our next-generation thermoplastic assemblies resulted in fewer components, which helped drive down material and manufacturing costs. At the same time, the design and custom resins of these devices meet FDA registered Class 1 medical device requirements.

Minnesota Rubber & Plastics material formulations are compliant with ISO 10993 and USP Class VI.

Have questions about a product application you’re working on?

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