Tag Archives: TPU

Introduction to Stents and Scaffold-Based Medical Applications

Stents and scaffold-based devices play a key role in treating a range of medical conditions, including those in cardiology, gastroenterology, urology, and pulmonology. These devices often require protective covers for specific purposes. For instance, covers help seal, redirect fluids, prevent migration, and safeguard surrounding tissues from damage.

Types of Covers for Stents

The materials used to cover stents can be either porous or non-porous. The choice depends on the stent’s function, the target tissue, and the duration of device usage. For example, porous covers support tissue ingrowth, while non-porous covers are more effective for sealing or fluid redirection.

Shift Towards Minimally Invasive Procedures

In recent years, the medical field has shifted toward minimally invasive procedures. This trend often involves the use of self-expandable and balloon-expandable stents, which has significantly impacted the materials and technologies used in stent covers. A key challenge in this area is crimping stent grafts to fit into narrow delivery systems. As a result, factors such as crimping force and loading force are critical in the design process.

Polyurethane: A Versatile Solution

Polyurethane is a copolymer created by reacting polyols with diisocyanates. This material is highly versatile and can be engineered to offer important properties such as biocompatibility and hemocompatibility. Additionally, it is durable, elastic, and resistant to abrasion, making it an ideal choice for medical device coatings. Given its excellent performance, polyurethane has long been a trusted material in the medical device industry.

Thermoplastic Polyurethanes (TPUs)

Thermoplastic polyurethanes (TPUs) belong to the thermoplastic elastomer family. These materials provide high strength, elasticity, and resistance to abrasion, making them particularly useful for stent covers. Manufacturers typically dissolve TPUs in a solvent, and then apply them to stents using either dip or spray coating techniques. Both methods create impermeable covers with a thin, uniform thickness.

Dip and Spray Coating Technologies

Dip coating is a well-established method for applying thin, consistent covers. On the other hand, spray coating uses a nozzle to atomize the polymer into fine droplets, which are then deposited onto the stent. This process eliminates gravitational forces, resulting in a more uniform coating. In both methods, the goal is to create impermeable covers with a thickness range of 15-100 µm.

TPU Lamination Technology

Medibrane’s engineers have developed TPU lamination techniques that allow for the creation of thin, precise covers for complex stent geometries. In this method, TPU is dissolved into a solution, molded into a tube, and then laminated onto the stent using heat and pressure. This technique enables selective covering and helps minimize the crimping profile, making it ideal for applications that require ultra-thin covers.

Porous TPU Stent Covers

In some cases, Medibrane can laser-drill holes into TPU covers, creating a porous structure that promotes tissue ingrowth. This feature improves clinical outcomes by preventing migration, which is particularly beneficial for stent grafts that require a thin, porous cover.

Porous TPU Stent Covers

Polyurethane Covering Technologies:

  • Dip covering
  • Spray covering
  • TPU lamination

Polyurethane Covering Is Suitable For:

  • Non-vascular stent
  • Peripheral stent grafts
  • Clot retrievers
  • Filtration devices
  • Intra vascular pump
  • Hypo tubes
  • Intra bronchial valve

Specification:

  • Wall thickness range: 15-100 µm
  • Coating Tolerance: ± 15% of nominal thickness
  • Coating weight tolerance: ± 15% of nominal weight
 

Stent-grafts and scaffold-based medical devices treat various conditions in cardiology, gastroenterology, neurology, urology, pulmonology, and more. These devices often require covers for multiple clinical outcomes, such as sealing, leak prevention, tissue ingrowth, or tissue restriction. At Medibrane, we use clinically investigated polymers with a long history in the medical device industry, including medical-grade silicone, Dacron, ePTFE, and thermoplastic polyurethanes. The selected polymer and covering technology influence critical cover parameters, such as thickness, radial strength, crimping profile, and whether the cover is porous or non-porous.

Biocompatible Polymers Used for Stent Covering

Biocompatibility is the ability of a material to perform with an appropriate host response in a specific application (Williams, 2008). However, biocompatibility depends not only on the material but also on the device parameters. Therefore, the implant site, duration, and intended use must be carefully considered.

Medibrane’s Unique Adhesion Platform

Our engineers focus on improving adhesion forces as the first step for all covering options. Metal scaffolds and polymer covers typically do not bond easily, so we begin by activating the metal surface, changing its chemistry to enhance mechanical attachment between the cover and stent. The second step is encapsulation coating, where the polymeric coating wraps around the stent’s struts to form a closed loop. The polymer cover is then applied onto this loop, creating a strong connection between the cover and the encapsulated polymer.

Lamination Covering Technology

We use lamination technology to bond polymers to the inner or outer diameter of the stent, or both. By applying temperature and pressure, we connect the cover to the metal frame. Lamination of two layers generates a “sandwich-like” structure, creating a strong bond in the overlap area. This technique is suitable when increased thickness and crimping profile are not problematic. Medibrane’s innovative sutureless lamination technology addresses the challenge of covering with a single polymer layer, while maintaining strong adhesion forces between the polymer cover and the metal stent. This technology is especially useful when cover thickness and crimping profile are critical. One of its advantages is the ability to generate a cover with selective bonding.

Selective Bonding Cover

The medical industry has shifted to minimally invasive procedures using self-expandable and balloon-expandable stents. This shift has driven changes in the polymers and technologies used for stent coverings. As stent grafts must be crimped and inserted into narrow delivery systems, properties such as crimping force and loading force are essential. The trend towards minimizing cover thickness and crimping profile has increased the use of polymers and technologies that enable low cover thickness.

Reducing cover thickness can be achieved by using only one layer of polymer on the inner or outer diameter. Another option is choosing materials like polyurethane to create ultra-thin covers. Selective bonding, a technique developed by our engineering team, enables the reduction of crimping profile and cover thickness. With selective bonding, the membrane attaches to the stent only at specific regions, reducing radial force and crimping profile.

Covering Technologies:

  • Polymer Lamination

Covering Materials:

  • TPU
  • ePTFE
  • Dacron

Materials

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