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Covered Flow Diverters for Aneurysm Treatment

By admin September 1, 2025 0 Comments

Covered Flow Diverters for Aneurysm Treatment: A Breakthrough in Endovascular Therapy

Covered flow diverters for aneurysm treatment are advanced endovascular devices that improve patient outcomes by accelerating vessel healing, reducing complications, and shortening recovery time. This article explores how these devices use specialized covering technologies—including polymeric, bioactive, and drug-eluting layers—to enhance the treatment of intracranial aneurysms and other vascular disorders.

By the end of this article, you’ll understand why covered flow diverters are becoming a cornerstone in modern aneurysm management.

What Are Covered Flow Diverters?

Covered flow diverters for aneurysm treatment are stent-like devices inserted into blood vessels to redirect blood flow away from aneurysms. They are commonly used for:

  • Intracranial aneurysms (especially large or wide-necked)

  • Arteriovenous malformations (AVMs)

  • Carotid-cavernous fistulas (CCFs)

Unlike traditional coiling techniques, covered flow diverters focus on long-term vessel remodeling, making them highly effective for complex aneurysm treatment. Learn more about endovascular devices and procedures.

Benefits of Covered Flow Diverters for Aneurysm Treatment

Adding coverings to flow diverters provides several advantages:

  • Accelerated endothelialization – faster regrowth of the vessel lining

  • Improved biocompatibility – reduced inflammation and clotting risks

  • Higher aneurysm occlusion rates – better long-term closure

  • Shorter patient recovery – fewer complications and quicker stabilization

  • Reduced hospital stays – lower healthcare costs

For additional clinical insights, see this review on aneurysm treatment outcomes (outbound link).

Covering Technologies in Flow Diverters

Different coatings enhance the performance of covered flow diverters for aneurysm treatment:

Polymeric Coatings

Polyurethane, polycarbonate urethane (ChronoFlex®), and fluoropolymers provide controlled porosity and smooth surfaces to support faster vessel healing.

Bioactive Coatings

Incorporating extracellular matrix proteins, adhesion peptides, or growth factors stimulates natural tissue regeneration.

Drug-Eluting Coatings

Controlled release of agents like sirolimus or heparin prevents thrombosis and promotes endothelialization.

Hybrid Approaches

Combining polymeric, bioactive, and drug-eluting strategies maximizes device performance.

Challenges of Covered Flow Diverters for Aneurysm Treatment

Despite their promise, covered flow diverters for aneurysm treatment face challenges:

  • Maintaining flexibility and deliverability despite additional layers

  • Ensuring long-term durability without delamination or degradation

  • Meeting regulatory and clinical validation requirements

Ongoing research in biomaterials and coatings is helping to overcome these limitations. For more information, see our vascular device research page.

Conclusion: The Future of Aneurysm Treatment

Covered flow diverters for aneurysm treatment represent a breakthrough in endovascular therapy. By reducing the time to full therapeutic effect, these devices improve patient outcomes, shorten recovery time, and decrease hospital stays. As innovations in covering technologies continue, these devices are poised to become a cornerstone in the treatment of intracranial aneurysms and complex vascular pathologies.

👉 Stay updated on advanced covering technologies and the latest in vascular device innovation by following our blog.

Medibrane

Expandable Sheaths in Minimally Invasive Medicine: FDA Approvals, Clinical Impact, and Future Applications

By admin August 26, 2025 0 Comments

Expandable sheaths are reshaping minimally invasive medicine. By allowing larger devices to be delivered through smaller access sites, they make procedures safer and recovery faster. Once limited to a handful of uses, these devices are now expanding into new clinical fields—improving outcomes for patients, surgeons, and healthcare systems alike.

What Are Expandable Sheaths in Minimally Invasive Medicine?

Expandable sheaths are introducers that can widen inside the vessel after insertion. This flexibility allows larger devices to be inserted without causing trauma to the artery. Their main advantage is reducing vascular complications such as bleeding, dissection, and stenosis, while maintaining procedural efficiency.

FDA-Approved Expandable Sheaths for Minimally Invasive Procedures

Several devices are already FDA-approved and in wide clinical use:

  • Medtronic Solopath™ Balloon-Expandable Sheath – FDA-cleared in 2018 for TAVR. Trial data showed a 52% reduction in vascular complications compared to standard sheaths.

  • Edwards Lifesciences eSheath® – FDA-approved for Sapien 3/Ultra valves. The PARTNER 3 trial showed a 40% reduction in major vascular complications.

  • Gore DrySeal Flex Introducer Sheath – FDA-approved for TEVAR/EVAR. Registry studies reported a 35% lower rate of access-site hematomas.

Clinical Impact of Expandable Sheaths

Expandable sheaths improve outcomes across multiple procedures:

  • TAVR – Vascular complications reduced from 10–15% to 5–7%, with shorter ICU stays.

  • TEVAR/EVAR – Access-site injury reduced from 8–12% to 4–6%.

  • Lead extraction – Vascular trauma cut in half, lowering procedural mortality.

Fewer complications mean fewer transfusions, faster recovery, and shorter hospitalizations.

Future Applications of Expandable Sheaths

The potential of expandable sheaths extends beyond current uses:

  • TMVR (Transcatheter Mitral Valve Replacement): Could cut iliac artery injuries by half.

  • Peripheral artery interventions: Projected to lower complication rates from up to 18% to around 8%.

  • Pediatric procedures: Smaller expandable sheaths may reduce femoral artery stenosis to 2–4%.

  • Neurovascular interventions: Controlled expansion could lower embolism risk to 2–3%.

  • High-risk PCI: Safer delivery of mechanical support devices with fewer vascular injuries.

Benefits for Patients, Surgeons, and Healthcare Systems

  • Patients – Faster recovery, fewer complications, shorter hospital stays.

  • Surgeons – Easier procedures, less risk of vascular injury, reduced operating time.

  • Healthcare systems and insurers – Lower readmission rates and cost savings of $3,000–5,000 per case.

Challenges and Barriers to Adoption

Despite clear benefits, adoption of expandable sheaths faces:

  • Higher upfront cost (20–30% more than standard sheaths)

  • Need for surgeon training in expansion techniques

  • Limited compatibility with all devices

Ongoing innovation and cost reduction are expected to broaden adoption.

Conclusion

Expandable sheaths in minimally invasive medicine are a game-changer. FDA-approved devices already show dramatic reductions in vascular complications, and expanding their use could prevent thousands of complications annually. Patients recover faster, surgeons gain procedural confidence, and healthcare systems save costs—highlighting the transformative potential of this technology.

Medibrane

Mechanical Properties of Vascular Grafts: Key Insights and Innovations

By admin June 9, 2025 0 Comments

Mechanical properties of vascular grafts play a critical role in medical procedures, serving as substitutes for damaged or diseased blood vessels. Ensuring the right mechanical characteristics is essential for long-term graft functionality and patient safety. This article explores the key mechanical properties required for vascular grafts, the challenges in balancing them, and the latest innovations in materials and manufacturing techniques.

Key Mechanical Properties of Vascular Grafts

Understanding the mechanical properties of vascular grafts is crucial for designing effective implants. The most important properties include:

  • Compliance: The ability of a graft to expand and contract with pulsatile blood flow. Mismatched compliance can lead to complications such as intimal hyperplasia.

  • Tensile Strength: Measures resistance to longitudinal and circumferential stress, preventing structural failure.

  • Burst Pressure: Defines the maximum pressure a graft can endure before rupture, ensuring durability under physiological conditions.

  • Suture Retention Strength: Evaluates the graft’s ability to hold sutures without tearing, which is critical during surgical implantation.

  • Elastic Recovery: The capacity to return to its original shape after deformation, ensuring consistent performance.

  • Stiffness: Resistance to deformation under force, which should ideally align with the mechanical properties of native vessels.

  • Wall Thickness: Influences strength, compliance, and the ability to mimic natural vessels.

  • Dynamic Compliance: Expansion and contraction under pulsatile flow, crucial for maintaining proper circulation.

  • Internal Diameter: Must match the native vessel to prevent flow disturbances and thrombosis.

  • Viscoelasticity: A time-dependent response to stress, mimicking natural vessel behavior.

Challenges in Balancing Mechanical Properties

Designing vascular grafts requires careful trade-offs:

  • Compliance vs. Strength: High compliance increases flexibility but may reduce tensile strength and burst pressure.

  • Wall Thickness vs. Compliance: Thicker walls enhance strength and suture retention but can reduce natural vessel mimicry.

  • Stiffness vs. Compliance: While structural integrity is critical, excessive stiffness may lead to graft-vessel mismatch.

  • Elastic Recovery vs. Viscoelasticity: Balancing immediate shape recovery with natural time-dependent behavior is challenging.

  • Internal Diameter vs. Wall Thickness: Small-diameter grafts make this balance particularly difficult.

  • Material Limitations: No single material meets all mechanical requirements, often necessitating composites.

  • Long-Term Stability vs. Initial Properties: Maintaining performance over time without degradation is a key concern.

Recent Advancements in Vascular Grafts

Recent developments aim to optimize the mechanical properties of vascular grafts:

Synthetic Materials

  • Expanded PTFE (ePTFE): Offers high tensile strength and burst pressure, ideal for large-diameter grafts.

  • Thermoplastic Polyurethane (TPU): Provides flexibility and durability, optimizing tensile strength, compliance, and burst pressure.

  • Polyethylene Terephthalate (PET) Fabric: Balances durability, tensile strength, and compliance.

Composite and Hybrid Materials

  • Layered and Hybrid Grafts: Combining synthetic and natural materials improves mechanical performance and biocompatibility.

  • Electrospinning: Advanced technique for creating nanofibrous scaffolds with precise mechanical properties. Used with polyurethanes and biodegradable polymers like PCL, it allows customization of graft mechanics.

Conclusion

The mechanical properties of vascular grafts are fundamental to their effectiveness and longevity. Achieving the ideal balance between compliance, tensile strength, and durability remains challenging. Nevertheless, innovations such as composite grafts and electrospinning are driving next-generation solutions.

As technology advances, we move closer to creating vascular grafts that fully replicate native vessel behavior, ultimately improving outcomes in cardiovascular procedures.

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The Future of Peripheral Vascular Stents

By admin June 9, 2025 0 Comments

Technological advancements in peripheral vascular stents are revolutionizing the management of Peripheral Arterial Disease (PAD), providing safer, more effective solutions for patients. Among the primary options are bare metal stents (BMS) and covered stents, each offering distinct benefits and limitations. This article offers a detailed comparison of these devices, covering design, clinical applications, advantages, limitations, and evidence-based outcomes, while exploring the future of stent technologies in vascular treatment.

What Are Peripheral Vascular Stents? Types & Applications

Peripheral vascular stents are self-expanding devices designed to keep blood vessels open and prevent restenosis.
They are commonly used in:

  • Peripheral Arterial Disease (PAD): Treating atherosclerotic blockages in iliac, femoral, or popliteal arteries.

  • Aneurysms: Providing structural support to weakened vessel walls.

  • Vessel Occlusions: Managing blockages in smaller peripheral arteries.

Types of Peripheral Vascular Stents

  1. Bare Metal Stents (BMS): Made from nitinol or stainless steel, relying on natural endothelialization for vessel healing.

  2. Covered Stents: Combine a metallic framework with a polymeric or fabric coating (e.g., ePTFE, Dacron) to improve sealing and reduce complications.

  3. Hybrid Stents: Merge the features of BMS and covered stents, offering specialized solutions for complex lesions.

For more detailed information, check our guide on ePTFE-coated stents.

Covered vs. Bare Metal Stents: A Comparative Review

Bare Metal Stents (BMS)

BMS are commonly used for short lesions in large arteries, valued for their simplicity and flexibility.

Advantages:

  • Superior trackability in tortuous anatomy

  • Cost-effective compared to covered stents

  • Smaller delivery systems for challenging anatomies

Limitations:

  • Higher restenosis rates (20–40%) due to intimal hyperplasia

  • Lack of sealing properties, unsuitable for aneurysms or vessel perforations

Covered Stents

Covered stents combine a metallic scaffold with a coating for enhanced sealing and protective functions.

Advantages:

  • Improved occlusion rates for complex lesions

  • Sealing capacity for aneurysms and perforations

  • Lower risk of thrombosis compared to BMS

Limitations:

  • Reduced flexibility, challenging deployment in tortuous vessels

  • Higher cost

  • Requires larger sheath sizes

Key Benefits with Advanced Coatings:

  • Faster endothelialization and healing

  • Improved biocompatibility, reducing inflammation

  • Increased complete occlusion rates in long lesions and aneurysms

  • Lower perioperative risks, such as thrombosis and infection

Challenges and Considerations

Despite their advantages, covered stents face some challenges:

  • Material biocompatibility concerns may lead to inflammation or tissue growth

  • Reduced flexibility may limit use in tortuous or calcified vessels

  • Long-term durability and material degradation

  • Regulatory approval requires extensive clinical testing

The Future of Peripheral Vascular Stents

Covered and hybrid stents are shaping the future of PAD treatment. With advances in material science, drug-eluting coatings, and bioactive surfaces, these stents are expected to overcome current limitations and enhance patient outcomes. They will likely become central to the management of complex vascular conditions.

Explore our peripheral vascular stent portfolio to learn more about our products and innovative coatings.

Medibrane

Dacron vs ePTFE for Vascular Device Covers: Applications & Selection

By admin June 9, 2025 0 Comments

Selecting the right material for Dacron vs ePTFE vascular covers is essential for clinical success. Both materials offer unique properties for stents, grafts, and structural heart devices. This article highlights their advantages, disadvantages, and ideal applications to help guide material selection.

Advantages and Disadvantages of Dacron Vascular Covers

Advantages:

  • Strong Mechanical Properties: Provides reliable structural support.

  • Porous Structure: Facilitates tissue ingrowth and reduces device migration.

  • Suitable for Larger Vessels: Ideal for vessels >10mm and structural heart devices.

  • Ease of Suturing: Simplifies surgical procedures.

Disadvantages:

  • Initial Inflammation: The woven structure can trigger early inflammatory response.

  • Potential Complications: May cause thrombosis, intimal hyperplasia, calcification, and chronic inflammation.

  • Suturing Requirements: Time-consuming and may increase cover thickness.

Advantages and Disadvantages of ePTFE Vascular Covers

Advantages:

  • Excellent Biocompatibility: Highly compatible with body tissues.

  • Lower Thrombogenicity: Reduced risk of thrombosis compared to Dacron.

  • Porous Structure & Controlled Porosity: Promotes tissue integration.

  • Suitable for Smaller Vessels: Performs well in vessels <6mm.

Disadvantages:

  • Difficulty Suturing: More challenging to stitch than Dacron.

  • Potential Complications: Can still lead to intimal hyperplasia and calcification.

  • Higher Cost: Generally more expensive than Dacron.

Applications of Dacron

  • Large-Diameter Vascular Grafts (>10mm): High patency rates (>85% at 5 years) and structural support.

  • Structural Heart Devices: Heart valve sewing rings, annuloplasty rings.

  • Hernia Repair Meshes: Durable support for abdominal wall defects.

  • Ligament and Tendon Reconstruction: Used as artificial ligaments or reinforcement.

  • Sutures: Non-absorbable sutures for long-term wound closure.

  • Fabric-Covered Stents: Provides durable coverage promoting tissue integration.

Applications of ePTFE

  • Small-Diameter Vascular Grafts (<6mm): Reduced thrombogenicity and optimized tissue integration.

  • Hemodialysis Access Grafts: Lower infection rates and easy needle puncture.

  • Aortic Replacement: Withstands high pressure and flow, customizable for flexibility.

  • Cardiovascular Patches: Used in congenital heart defect repairs and vessel reconstructions.

  • Endovascular Stent Grafts: Low profile, conforms to vessel walls, reduces endoleaks.

  • Soft Tissue Augmentation: Plastic surgery for facial reconstruction and body contouring.

  • Patches for Vessel Repair: Smaller vessels benefit from lower thrombogenicity and better handling.

Combined Applications

  • Hybrid Vascular Grafts: Combines Dacron and ePTFE for complex reconstructions.

  • Composite Hernia Meshes: Leverages both materials for strength and tissue integration.

Conclusion: Choosing the Right Material

The choice between Dacron and ePTFE depends on clinical requirements:

  • Dacron: Best for larger vessels and high-stress areas due to strength and ease of suturing.

  • ePTFE: Ideal for smaller vessels where biocompatibility and reduced thrombogenicity are essential.

Ongoing research continues to refine both materials, enhancing their performance and expanding their medical applications.

Medibrane

What is Medibrane’s MicroLayer Technology

By admin October 10, 2024 0 Comments

Precision in Modern Medical Devices

In today’s world of advanced medical technologies, precision is crucial, especially in developing minimally invasive devices. The growing demand for microlayer tubes made from low durometer materials is driving significant advancements in the field. While extruded tubes have traditionally been used for applications requiring stiffness and thick walls, they face challenges when applied to miniature devices with ultra-thin walls—such as those measuring 0.001″. This is where microlayer tubes make a difference.

The Advantages of Medibrane’s Microlayer Technology

At Medibrane, we offer a diverse selection of microlayer tubes designed to meet the most stringent requirements. These tubes feature a minimum wall thickness of just 0.00059″ and diameters ranging from 0.00394″ to 0.984″. Moreover, our proprietary polymer deposition methods enable us to create layers as thin as 0.0001″, achieving tolerances as precise as +/- 0.0002″.

Unparalleled Control and Flexibility

One of the standout benefits of microlayer tubes is their ability to provide superior control over wall thickness. As a result, inner lumen space is maximized, while the overall device profile remains minimal. Additionally, these tubes feature variable durometers along their length, enhancing flexibility and adaptability for diverse applications.

Meeting Manufacturing Challenges

Historically, producing large bore polymer tubing with ultra-thin walls posed significant challenges. However, Medibrane’s microlayer technology overcomes these obstacles. By leveraging innovative techniques, we can manufacture tubing that meets the needs of even the most demanding applications.

Material Adaptability for Custom Solutions

Our microlayer technology supports various durometer polyurethane resins, ranging from 55 shore D to 40 shore A. This flexibility allows us to cater to specific project requirements, ensuring optimal performance every time.

Practical Benefits for Medical Applications

In addition to their precision, microlayer tubes offer other key advantages. For instance, they significantly reduce the tackiness of soft materials. This characteristic is critical in applications requiring smooth and non-sticky surfaces, such as neurovascular microcatheters and large-diameter delivery systems for structural heart devices.

Transforming the Medical Industry

As the demand for precision in minimally invasive devices continues to grow, microlayer tubes are poised to revolutionize the industry. Their exceptional control over wall thickness and ability to adapt to various durometers make them invaluable for developing advanced medical technologies.

Learn more about our advanced polymer solutions, or explore our custom coating processes that complement microlayer tubing.
For a quick purchase of our microlayer tubes, visit us on Chamfr.

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Applying Polymeric Covers to Stents and Laser Cut Hypotubes with Elad Einav of Medibrane

By admin October 10, 2024 0 Comments

In this podcast episode, Elad Einav, a team member at Medibrane, discusses the innovative application of polymeric covers for stents and laser-cut hypotubes. Elad shares insights into how these advanced materials enhance the performance of therapeutic catheters and implants used in medical procedures.

Key Topics Covered in This Podcast:

  • The traditional labor-intensive process of attaching polymeric covers to stents using hand-sewn sutures, and the game-changing advantages of Medibrane’s suture-less lamination technology.
  • The selective bonding technique for polymeric covers to self-expanding scaffold segments, which helps reduce radial crimping forces and achieve low delivery profiles.
  • The early-stage process of applying ultra-thin-wall polyurethane covers to the outer diameter of laser-cut hypotubes, allowing for variable thickness and durometer along the length of the hypotube.

This episode provides valuable insights into the revolutionary approach to improving the functionality and durability of medical devices. Don’t miss out on this informative discussion!

Listen Now:

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The Neurological Catheter Case Study by Medibrane

By admin October 10, 2024 0 Comments

The world of neurological surgeries presents numerous challenges, especially when it comes to catheter design. One of the key issues is the ability to create a catheter that can navigate the brain’s intricate blood vessels with enhanced flexibility and a lower profile compared to the current solutions available in the market. Medibrane’s adhesion and coating technologies for catheters address these challenges head-on.

In this case study, we dive deep into the innovative adhesion and coating technologies for catheters developed by Medibrane. These technologies allow us to create catheters with improved flexibility, helping them better conform to the complex structures of the brain’s vasculature. By reducing the catheter’s profile, we enable better navigation and access to hard-to-reach areas, ultimately improving the precision and safety of neurological procedures.

The Medibrane team continuously works to refine these adhesion and coating technologies for catheters, ensuring that we meet the demands of modern neurological surgeries. We are proud of the advancements we’ve made in creating a more efficient and reliable catheter, enhancing both the medical procedure and patient outcomes.

Watch our case study video to learn more about the cutting-edge adhesion and coating technologies for catheters that are revolutionizing catheter design.

For more details, visit our Solutions Page and discover how Medibrane’s innovative approach is transforming medical device technologies.

Medibrane

Occluder Polymeric Coding Case Study

By admin October 10, 2024 0 Comments

When developing a long-term occluder, one of the biggest hurdles faced was the unexpectedly high loading forces, which made the device difficult to load into the sheath. In this case study, we reveal how Medibrane’s innovative coating and adhesion technologies played a crucial role in solving this challenge.

By combining advanced techniques such as braid expansion and Medibrane’s proprietary selective bonding technology, we were able to reduce the loading force and improve the device’s functionality. But how exactly did we achieve this? What were the key decisions that made the difference?

We invite you to watch the full case study video to learn how Medibrane overcame these obstacles and enhanced the occluder’s performance. The results were truly game-changing, but you’ll have to see the video to understand the full story.

For more insights, visit our Solutions Page and discover how Medibrane’s cutting-edge technologies can improve your medical devices.

Medibrane

The Challenge: High Loading Forces in Laparoscopic Device

By admin October 10, 2024 0 Comments

A customer approached Medibrane with a problem concerning a laparoscopic surgery device. The device’s polycarbonate component, which only contacts the skin for a maximum of 24 hours, may contain Bisphenol A (BPA). BPA is a chemical identified by the FDA as potentially hazardous. To ensure the device’s safety, the customer needed to determine if BPA was present and, if so, whether it exceeded safe levels.

Extractables vs. Leachables: Understanding the Difference

Before proceeding, it’s important to differentiate between extractables and leachables.

Extractables are chemicals that can be released from materials when exposed to specific solvents under controlled conditions. Manufacturers use these tests to identify all potential chemicals that might leach out under normal use conditions. This process helps detect risks before they impact the patient.

Leachables, on the other hand, are chemicals that migrate from the device into the body over time. They can lead to patient exposure and are a critical consideration in biocompatibility testing.

Medibrane’s Testing Process: Extractable Study

To address the customer’s concern, Medibrane conducted an extractable study of the laparoscopic device following ISO 10993-12 and ISO 10993-18 standards. First, we incubated the post-sterilized device in purified water at 37°C for 24 hours. Afterward, we analyzed the water for traces of BPA using High-Performance Liquid Chromatography (HPLC).

The Results: BPA Detected at Harmful Levels

Our testing revealed BPA in the water extraction. The concentration exceeded the allowable limits determined by a toxicologist. This result confirmed that the polycarbonate material in use was unsuitable for medical devices, as it posed a potential risk to patients.

The Solution: Switching to Medical-Grade Materials

Following our findings, the customer made the necessary adjustment: they replaced their polycarbonate supplier with a medical-grade material supplier. This ensured that the device met safety standards and removed any risk of harmful chemical exposure during use.

The Importance of Early Testing in Medical Device Development

This case study highlights the importance of conducting extractable and leachable tests early in the product development process. By identifying potential risks before the device reaches the market, manufacturers can safeguard patient health and ensure the product’s safety. Medibrane’s expertise in testing and material analysis allows us to support our customers in creating safe, compliant medical devices.

Grape Output

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Tie layer for hypotubes

By admin October 9, 2024 0 Comments

Hypotubes play an essential role in advanced, minimally-invasive catheters used in the medical device industry. These tubes facilitate the deployment of self- or balloon-expandable medical devices, which are implanted for short or long periods across various medical applications. A hypotube is a metal tube with micro-features along its length, typically covered with a polymer jacket.

The polymer jacket serves multiple purposes. It minimizes tissue damage, reduces friction, and ensures the tube’s flexibility. Common materials for this coating include silicone, polyurethane, or PEBAX. Furthermore, the polymer prevents leaks and seals the hypotube when fluids or gases pass through it. However, metal and polymer typically do not bond easily. Without proper surface activation, the jacket may begin to delaminate over time, particularly at the ends.

Medibrane’s Tie Layer Technology

Bonding metal with polymer can be challenging, as these materials generally do not adhere well to each other. To address this issue, Medibrane’s engineers developed an innovative adhesion platform. The process begins with surface activation, which alters the metal’s chemistry. This modification improves the mechanical bond between the metal and the polymer jacket.

After surface activation, Medibrane applies an encapsulation coating. This forms a thin tie layer that creates a strong connection between the jacket and the encapsulated polymer. By utilizing this process, Medibrane ensures that the polymer remains securely attached to the metal, preventing delamination and ensuring long-term functionality.

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Polyurethane covers

By admin October 9, 2024 0 Comments

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
 
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Covers with Selective Bonding

By admin October 9, 2024 0 Comments

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
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Polymeric Stent Covers: Innovations in Medical Device Protection

By admin October 9, 2024 0 Comments

Polymeric Stent Covers: Medical Coverings for Stents and Medical Devices

Many medical applications require covers to achieve various clinical outcomes, such as preventing leaks, managing tissue ingrowth, restricting tissue growth, and controlling blood flow. Polymeric stent covers can be either porous or impermeable. The type of cover depends on the chosen biocompatible polymer and covering technology. Biocompatibility refers to the ability of a material to perform with an appropriate host response in a specific application. It is determined by the final device and not only by the material used. Factors such as the implant site, duration, and intended use must also be

Choosing the Right Biocompatible Polymers for Polymeric Stent Covers

At Medibrane, we use polymers that have been clinically tested and have a long history in the medical device industry. These include medical-grade silicone, Dacron, ePTFE, and various thermoplastic polyurethanes (TPU). The choice of polymer impacts the key parameters of the cover, including thickness, radial strength, crimping profile, and whether the cover is porous or non-porous. Our engineers have extensive experience with dipping, spraying, and lamination technologies. They can help you select the best polymer and technology based on your product’s cover specifications.

Medibrane’s Unique Adhesion Platform

Medibrane’s engineers use our unique adhesion platform to improve adhesion forces. The first step involves surface activation, which prepares the metal surface for bonding with the polymeric material. This process alters the chemistry of the metal surface, improving the mechanical attachment between the cover and the stent. Next, we apply an encapsulation coating. This coating surrounds the stent’s struts, forming a closed-loop that resembles a suturing technique. The polymer cover is then applied to this closed-loop, creating a strong bond.

Impermeable, Non-Porous Covers

Stents are covered with impermeable, non-porous covers to restrict tissue ingrowth, prevent leaks, redirect fluids, and enable fluid passage. Silicone and polyurethane are the most commonly used polymers to create these covers. The polymer is dissolved and applied to the metal frame using dipping or spraying technologies. These processes are popular because they offer fast, repetitive, and cost-effective manufacturing. Polyurethanes can also be used in lamination technology, where TPU is dissolved in solution and molded into a membrane. This membrane is then laminated with heat and pressure onto the stent. Lamination with just one thin layer reduces the cover thickness and crimping profile. These technologies are well-suited for a variety of geometries, offering high accuracy and low cover thickness. They meet the requirements of many medical stents, including neurovascular stent grafts, clot retrievals, ureteral stent grafts, and gastrointestinal stent grafts.

Porous Covers for Tissue Ingrowth

Porous covers enable tissue ingrowth, prevent migration, and redirect fluids. Dacron and ePTFE are commonly used for porous stent covers. These polymers are applied to the metal frame using suturing or lamination techniques. Historically, fabrics were sutured, as lamination of a single layer without surface activation could cause delamination. Two-layer lamination with fabric would result in a thick cover with a high crimping profile, which could completely constrain the stent. Suturing is manual, time-consuming, and harder to scale compared to automated processes. While suturing creates a single layer, the sutures themselves generate a “mini-layer” and stress at the suture points, which affects the crimping profile.

Lamination Technology for ePTFE Covers

ePTFE can be laminated in two layers using temperature and pressure, creating a “sandwich-like” cover. The two layers bond strongly at the overlapping area. Another lamination method is sintering, where two ePTFE sleeves are sintered together and then adhered to the metal stent. This process requires higher temperatures (up to 400°C) and should be used carefully to avoid affecting the thermal properties of the nitinol stent. These techniques are effective when an increase in thickness and crimping profile is not a concern.

Medibrane’s Innovative One-Layer Lamination Technology

Medibrane has developed a solution that allows for the lamination of a single layer of Dacron or ePTFE onto the stent, without the need for sutures, while still maintaining strong adhesion. This technology is made possible by our unique adhesion platform. Dacron and ePTFE are widely used in structural heart devices, such as heart valves, septal occluders, left atrial appendage implants, mitral valve clips, stents for blood vessels larger than 10mm to prevent blood clots, and many other applications.

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From Ideas to Prototypes

By admin October 9, 2024 0 Comments

From Ideas to Prototypes: Turning Concepts into Reality

Every medical innovation starts with an idea waiting to become a product. At Medibrane, our team of experienced engineers will guide you in selecting the right polymer and technology to cover your medical device. We support you throughout the design iterations, facilitating your R&D process from prototyping all the way through to design freeze.

Selecting the Right Polymer Cover for Your Application

Many medical applications require specific coverings for various purposes such as sealing, redirecting blood flow, enabling tissue regrowth, preventing migration, or protecting tissues from trauma. However, only a few service providers specialize in selecting the optimal polymer for each clinical application.

Our polymer research and knowledge center stays on the cutting edge of advancements in the field. With our extensive experience, we have compiled a portfolio of biocompatible polymers commonly used in medical devices. Our team helps customers choose the best polymer for each unique application, considering factors like the target site, geometry, and clinical, mechanical, and functional requirements. We use well-known, clinically researched polymers such as medical-grade Silicone, Dacron, ePTFE, and various thermoplastic Polyurethanes.

Why Stent Covering Technology Matters

Choosing the right polymer is only the first step. The next step is selecting the appropriate covering technology. This technology significantly impacts the final result by determining the thickness, radial strength, crimping profile, and the porosity or impermeability of the cover.

For instance, Polyurethane can create a non-porous cover when dip-coated. However, if a polyurethane membrane is laminated onto the stent and then perforated using a laser, it can create a porous cover. The choice of technology, therefore, plays a crucial role in the success of the stent covering.

Expertise in Various Materials and Technologies

At Medibrane, we understand the importance of responsiveness during the prototyping stage. Our experience and expertise in a wide range of materials and technologies allow us to offer flexible and effective solutions. We provide high-quality equipment for each design procedure and offer customers the flexibility to switch materials or technologies during the design phase. This approach also enables testing of different design approaches.

Our prototype production lab operates in a controlled environment, compliant with ISO 13485 standards, and is supervised by experienced project managers to ensure the highest quality.

Non-constant radial force may lead to migration

Constant radial force generated by homogenic cover thickness

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Suture less Fabric Lamination

By admin October 9, 2024 0 Comments

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
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ePTFE Covering

By admin October 9, 2024 0 Comments

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]

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