Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI. 

FDA registered. Hydromer is ISO 9001:2015 certified with TUV Rheinland of North America. ISO 13485:2016 is certified with BSI.

The Importance and Benefits of Thromboresistant Coatings

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Thrombosis is the formation of blood clots within blood vessels. It poses a significant challenge in medical treatments and device implantations. Thrombosis can cause severe complications, such as stroke, heart attack, and pulmonary embolism. This is why preventing it is very important, especially for medical devices that come into direct contact with blood. Currently, breakthroughs have been made in reducing this problem. One key reason is the development of innovative thromboresistant coatings. These medical coatings reduce thrombosis as well as improved biocompatibility and functionality for any medical device. 

In this article, we will discuss what thromboresistant coatings are, their benefits, medical applications, and substrates they work well with. We also provide supporting evidence from recent studies that show why these coatings are helping reduce this major issue.

What Are Thromboresistant Coatings?

These coatings are specialized surface treatments or layers that are applied on medical devices. Many of these coatings are hydrophilic in nature. In general, they help to minimize the chance of thrombus (blood clot) formation. 

Such coatings do this in one of two ways. First, they reduce the adsorption of proteins, which triggers clotting. Second, they work through the active promotion of anticoagulant properties. 

These coatings are engineered using biocompatible materials, which allow them to be used inside the body. They also often have incorporated anticoagulant agents such as heparin or synthetic polymers, which are designed to resist clot formation.1-3

Why Are these Coatings Important?

Medical devices like catheters, stents, and vascular grafts have become indispensable to modern medicine. However, these devices carry the risk of inducing thrombus (blood clots) formation. This can further lead to atrial fibrillation, strokes, or even heart attacks.

Why does this happen? 

Usually, the interaction between blood and a foreign surface tends to trigger the normal clotting cascade initiated in the body. The complications can be fatal. 

Thromboresistant coatings address this issue by reducing clotting risk. In addition, they do it without requiring excessive systemic anticoagulant therapy, which can carry its own risks, such as bleeding complications. 

These coatings improve the biocompatibility of the medical device. The result is an increase in the medical device’s life as well as a positive increase in terms of patient outcomes.4

Benefits of Antithrombogenic Coatings

This class of coatings offer many benefits to both medical device manufacturers as well as patients. We discuss the main benefits below. 

1. Enhanced Biocompatibility 5

Thromboresistant coatings reduce clot formation on coated polyurethane tubing

One of the primary benefits of thrombus reduction coatings is their ability to improve the compatibility of medical devices with the human body. By minimizing the immune and coagulative responses, these coatings ensure that devices can remain in situ longer without complications.

2. Reduced Dependence on Systemic Anticoagulants 6

When thromboresistant-coated devices are used the result is minimal use of systemic anticoagulants. This prevents the side effects associated with excessive bleeding and drug interactions.

3. Improved Device Longevity 7

Thrombus resistant coatings prevent clotting, thereby retaining the functionality of devices over a period of time. This is especially important for long-term implants like vascular grafts and heart valves.

4. Lowered Risk of Complications 7

Minimizing thrombosis safeguards the patient better. It also leads to fewer re-interventional procedures, which are costly and have additional risks.

Applications of Thromboresistant Coatings in Medicine 2, 6-9

Antithrombogenic coatings are used in a wide range of medical applications

Thromboresistant coatings are vital for any medical devices that come into direct contact with blood. In other words, they have immense importance in several medical applications. These coatings are useful for guide wires, catheters, stents, implants, lenses, balloons, pacemaker leads, and many more. 

Some of the common applications where these coatings are used are discussed in more detail below:

1. Vascular Grafts and Stents

Vascular grafts and stents are commonly used to restore blood flow in obstructed vessels. When thromboresistant coatings are not used these devices are prone to clot formation, which can lead to restenosis (narrowing or blockage of an artery) or device failure.

2. Catheters

These coatings are used for many catheter applications. Examples include central venous catheters, dialysis catheters, and urinary catheters. The coatings reduce the clots or chances of infection. The result is smooth operation without frequent replacements.

3. Heart Valves

Mechanical and bio-prosthetic heart valves must have an anti-thrombus coating for blood fluidity without clotting. In addition, these coatings enhance the devices’ durability and performance.

4. Extracorporeal Circulation Devices

These coatings are also used for devices like oxygenators and extracorporeal membrane oxygenation circuits. The coatings maintain functionality during critical procedures.

5. Drug Delivery Systems

Antithrombogenic coatings are also applied to drug-eluting stents and other systems where preventing thrombosis is crucial for effective drug release and delivery.

Evidence and Results from Studies

Numerous studies have demonstrated the positive benefits of these functional coatings in medical applications:

Heparin-Coated Devices 1, 2, 8

Heparin is one of the most commonly used anticoagulants in coating formulations. Studies have shown that heparin-coated stents significantly reduce the risk of restenosis (narrowing of blocking) compared to uncoated ones. Several studies have demonstrated a reduction in thrombotic events in patients with heparin-coated catheters.

Polyethylene Glycol (PEG) Coatings7, 16

PEG-based coatings have shown promise in reducing protein adsorption and platelet activation. Several researches have highlighted the effectiveness of PEG coatings in improving blood compatibility without compromising device performance. 

Hydrophilic Coatings17-19

Hydrophilic coatings are water-loving, biocompatible coatings. This type of medical coating attracts water molecules, which creates a hydration layer that prevents protein and platelet adhesion. As an example, studies have indicated that hydrophilic-coated catheters exhibited a significant reduction in thrombosis.

Hydromer® Thromboresistant Medical Device Coatings

Hydromer, Inc. offers specialized thromboresistant coatings designed to enhance the safety and efficacy of medical devices that come into contact with blood. Hydromer’s Thromboresistant Coatings are “slippery-when-wet” and non-leaching. They minimize blood adhesion to device surfaces, which reduces the risk of clot formation that can lead to conditions such as atrial fibrillation, strokes, or heart attacks. 

Hydromer’s new HydroThrombX™ Coating further advances this technology by providing superior thromboresistance, ensuring enhanced performance and durability for blood-contacting medical devices.

Suggested Applications:

  • Guidewires
  • Catheters
  • Stents
  • Implants
  • Lenses
  • Balloons
  • Pacemaker leads
  • Shunts
  • Micropuncture and standard access kits

Compatible Substrates:

  • Polyurethane
  • PVC
  • Chronoflex
  • Silicone

In addition, all of our coating products can be custom formulated to meet your product’s specific requirements. No matter what stage you are in we can help from R&D to contract manufacturing. 

Hydromer Medical Coatings Contract Services

In addition, our company offers comprehensive R&D and contract coating services. Our facilities are ISO-certified, and they are equipped to handle projects ranging from prototypes to market-ready devices. 

Key Features of Hydromer’s Contract Coating Services:

  • Versatile Application Methods: Our facilities are equipped to accommodate various coating techniques. We have equipment to apply our coatings using dip, spray, spin, and a proprietary meniscus coating. No matter what your needs we can accommodate diverse device geometries and substrate materials. 
  • Customized Formulations: Hydromer offers standard as well as customized coating formulations to meet your project’s specific needs. 
  • Comprehensive Support: Our services go well beyond just coatings. We also offer a full range of technical and regulatory advisory services throughout your project’s lifecycle. 
  • Custom Equipment Solutions: Hydromer does more than just contract coating. We can design and build custom, turnkey equipment specifically for your coating application. This equipment can be used for your products either at your manufacturing site or at our location. 
  • Technology Transfer: If you chose to apply coatings at your site we also provide comprehensive technology transfer services. This helps to transition the coating process into your location. 

Conclusion

The invention of thromboresistant coatings in medical technology has marked a crucial milestone for ensuring the safety and efficacy of blood-contact devices. These coatings have drastically minimized the risks associated with thrombosis. As a result, they have greatly improved patient outcomes. They have also helped to unlock new ways to innovate novel treatments. As research continues to evolve, we can expect even more effective and versatile solutions that push the boundaries of what’s possible in modern medicine. In this area,  Hydromer provides custom solutions to meet client-specific requirements.  Our company offers coating solutions that help medical device companies improve patient safety and clinical outcomes as well as extend the functional lifespan of the devices. 

References

1. Drozd NN, Lunkov AP, Shagdarova BT, Zhuikova YV, Il’ina AV and Varlamov VP. Chitosan/heparin layer-by-layer coatings for improving thromboresistance of polyurethane. Surfaces and Interfaces. 2022; 28: 101674.

2. Zhao J, Falotico R, Nguyen T, et al. A nonelutable low‐molecular weight heparin stent coating for improved thromboresistance. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2012; 100: 1274-82.

3. Jordan SW and Chaikof EL. Novel thromboresistant materials. Journal of vascular surgery. 2007; 45: A104-A15.

4. Henkes H, Bhogal P, Aguilar Pérez M, et al. Anti-thrombogenic coatings for devices in neurointerventional surgery: case report and review of the literature. Interventional Neuroradiology. 2019; 25: 619-27.

5. Fischer M, Maitz MF and Werner C. Coatings for biomaterials to improve hemocompatibility. Hemocompatibility of biomaterials for clinical applications. Elsevier, 2018, p. 163-90.

6. Zhang M, Pauls JP, Bartnikowski N, et al. Anti-thrombogenic surface coatings for extracorporeal membrane oxygenation: a narrative review. ACS Biomaterials Science & Engineering. 2021; 7: 4402-19.

7. Zawidlak-Węgrzyńska B, Rydz J, Musioł M and Radziwon-Balicka A. Polymer-Drug Anti-Thrombogenic and Hemocompatible Coatings as Surface Modifications. Pharmaceutics. 2024; 16: 432.

8. Lee KH, Han JK, Byun Y, et al. Heparin-coated angiographic catheters: an in vivo comparison of three coating methods with different heparin release profiles. CardioVascular and Interventional Radiology. 2004; 27: 507-11.

9. Lancellotti P, Aqil A, Musumeci L, et al. Bioactive surface coating for preventing mechanical heart valve thrombosis. Journal of Thrombosis and Haemostasis. 2023; 21: 2485-98.

10. Tan Q, Ji J, Barbosa MA, Fonseca C and Shen J. Constructing thromboresistant surface on biomedical stainless steel via layer-by-layer deposition anticoagulant. Biomaterials. 2003; 24: 4699-705.

11. Zhang K, Liu T, Li JA, Chen JY, Wang J and Huang N. Surface modification of implanted cardiovascular metal stents: from antithrombosis and antirestenosis to endothelialization. Journal of Biomedical Materials Research Part A: An Official Journal of The Society for Biomaterials, The Japanese Society for Biomaterials, and The Australian Society for Biomaterials and the Korean Society for Biomaterials. 2014; 102: 588-609.

12. Leake DL, Cenni E, Cavedagna D, Stea S, Ciapetti G and Pizzoferrato A. Comparative study of the thromboresistance of Dacron® combined with various polyurethanes. Biomaterials. 1989; 10: 441-4.

13. Lukas K, Stadtherr K, Gessner A, et al. Effect of Immobilized Antithrombin III on the Thromboresistance of Polycarbonate Urethane. Materials. 2017; 10: 335.

14. Sheng K, Gao Y, Bao T and Wang S. Covalent coating strategy for enhancing the biocompatibility and hemocompatibility of blood-contacting medical materials. Pharmaceutical Science Advances. 2023; 1: 100001.

15. Shankar D, Jayaganesh K, Gowda N, Lakshmi KS, Jayanthi KJ and Jambagi SC. Thermal spray processes influencing surface chemistry and in-vitro hemocompatibility of hydroxyapatite-based orthopedic implants. Biomaterials Advances. 2024; 158: 213791.

16. Wattendorf UTA and Merkle HP. PEGylation as a tool for the biomedical engineering of surface modified microparticles. Journal of pharmaceutical sciences. 2008; 97: 4655-69.

17. Wei Q, Becherer T, Angioletti‐Uberti S, et al. Protein interactions with polymer coatings and biomaterials. Angewandte Chemie International Edition. 2014; 53: 8004-31.

18. Crago M, Lee A, Hoang TP, Talebian S and Naficy S. Protein Adsorption on Blood-Contacting Surfaces: A Thermodynamic Perspective to Guide the Design of Antithrombogenic Polymer Coatings. Acta biomaterialia. 2024.

19. Liu L, Yu H, Wang L, et al. Heparin-network-mediated long-lasting coatings on intravascular catheters for adaptive antithrombosis and antibacterial infection. Nat Commun. 2024; 15: 107.

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