Tag Archives: Sutureless Lamination

Medibrane’s Sutureless Lamination Technology: Transforming Stent Covers

At Medibrane, our Sutureless Lamination technology revolutionizes how we cover stents and implants. Our expert team developed this unique solution after extensive research into medical device requirements and the biomedical industry. This technology replaces the traditional suturing method, providing a fast, reliable, and easy-to-manufacture process to create high-quality stent covers.

Types of Covered Stents

Covered stents are commonly used in various medical applications, such as abdominal aortic aneurysm vascular stents and gastrointestinal tract non-vascular stents. These stents are typically covered with materials like Polyethylene terephthalate (PET), Polyester, or polytetrafluoroethylene (PTFE). Fabric covers are also essential for structural heart devices, including heart valves, left atrial appendage devices, and mitral valve clips.

The Advantages and Challenges of Fabric Covers

Fabric covers provide key benefits, such as directing fluid and allowing tissue ingrowth. Their porous structure helps with both sealing and tissue attachment. However, the same porous quality can lead to blood clot accumulation, which limits the use of fabric covers in vascular stents for smaller blood vessels.

Overcoming Suturing with Innovative Technology

Previously, fabric coverings relied on suturing, a manual and time-consuming process. Medibrane’s experts solved this problem by developing the Adhesion Platform, which laminates the fabric to the stent without using sutures.

Medibrane’s Adhesion Platform: Ensuring Strong Bonds

The Adhesion Platform was designed to improve adhesion between the metal stent and the fabric covering. This platform ensures a strong, long-lasting attachment, which is critical for the success of the stent. With this technology, Medibrane’s team created the Sutureless Lamination method, which achieves excellent adhesion without the need for sutures.

Key Benefits of Sutureless Lamination Technology:

  • Low covering thickness
  • Low crimping profile
  • Fully automated process
  • Faster manufacturing time
  • Reduced friction during delivery

Ideal Applications for Sutureless Lamination of Fabric:

  • Heart valves
  • Abdominal aortic aneurysm vascular stents
  • Non-vascular stents
  • Left atrial appendage implant
  • Acute heart failure devices

Specifications:

  • Available in single or double layers (inner diameter or both inner and outer cover layers)
  • Wall thickness range: 60 – 200 µm

What is ePTFE?

ePTFE (expanded Polytetrafluoroethylene) is a lightweight and strong material that is biocompatible and biostable. It is chemically inert, resistant to degradation by biological fluids, and, most importantly, it can be stretched and deformed. Additionally, ePTFE comes in various forms such as tapes, membranes, films, tubes, fibers, sheets, and rods.

Microporous Structure for Medical Use

The material’s microporous structure makes it ideal for a wide range of medical applications. For instance, it enables tissue in-growth, which prevents migration. Thanks to its biocompatible nature and deformation capabilities, ePTFE has become a preferred material in the medical device industry.

ePTFE in the Medical Device Industry

The medical device industry quickly adopted ePTFE. Today, it is widely used across various medical markets, including self-expandable metallic stents for gastroenterology and vascular covered stents, such as abdominal aortic aneurysm stents. In addition, ePTFE is commonly used in cardiology, for structural heart devices like heart valves, septal occluders, left atrial appendage implants, and mitral valve clips.

Overcoming Suturing Challenges

Previously, ePTFE was applied to medical devices using suturing, a manual and time-consuming procedure. However, Medibrane’s experts have overcome this challenge. By developing the innovative Sutureless Lamination Technology through our unique Adhesion platform, we eliminated the need for sutures. This approach ensures strong adhesion and long-term attachment to the metal frame.

Medibrane’s Adhesion Platform

Our Adhesion platform works in two stages:

  1. Surface Treatment: We prepare the metal surface for bonding with the polymeric material using various techniques.
  2. Encapsulation Coating: A polymeric membrane coats the device’s struts, ensuring a mechanical attachment between the polymer and frame, which leads to improved adhesion.

Sutureless Lamination Technology: Key Advantages

  • Low wall thickness
  • Low crimping profile
  • Automated technology
  • Faster manufacturing time
  • Smaller delivery forces

ePTFE Advantages in the Medical Industry

  • Sealing: ePTFE provides essential sealing for different medical stents, ensuring blood and fluid redirection.
  • Tissue In-growth: Its microporous structure allows tissue in-growth, preventing migration, which is critical for numerous medical applications.
  • Biostability: ePTFE remains stable and durable over time, making it a reliable material in medical devices.

Sutureless Lamination of ePTFE: Applications

The Sutureless Lamination of ePTFE is ideal for covering:

  • Heart Valves
  • Left Atrial Appendage Implants
  • Mitral Valve Clips
  • Septal Occluders
  • Peripheral Covered Stents

Specifications

  • Single or double layer (Inner diameter or both inner and outer cover layers)
  • Wall-thickness range: 60 – 200 [µm]

Materials

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