Improved <i>ex vivo</i> blood compatibility of central venous catheter with noble metal alloy coating

Homann, Manijeh Vafa; Johansson, Dorota; Wallén, Håkan; Sánchez, Javier

doi:10.1002/jbm.b.33403

Cited by 18 publications

(19 citation statements)

References 26 publications

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“…The Chandler loop is an in vitro thrombogenicity testing system originally described by Chandler in 1958 . In the intervening years, variations on the Chandler loop system have been used to evaluate many materials and devices intended for direct contact with flowing blood, including stents, artificial heart valves and catheters . These studies have typically evaluated cell‐based indicators of thrombogenicity such as platelet activation or platelet adhesion to material, and soluble serum markers including proteins such as thrombin‐antithrombin III complex and prostaglandin metabolism products such as thromboxane B 2 .…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies using the Chandler loop has predominantly used blood from human donors . The use of human blood has obvious relevance in modeling materials or devices intended for use in human patients.…”

Section: Discussionmentioning

confidence: 99%

“…In the case of catheters and other devices intended for placement within blood vessels, testing models should seek to mimic blood flow within a tubular structure, including velocity of flow and other aspects of fluid dynamics. While no current in vitro model can perfectly model the dynamic intravascular environment, the original Chandler loop model, and its subsequent variations, are widely used methods that provide a simple and cost‐effective approach that can mimic important aspects of the vascular space …”

Section: Introductionmentioning

confidence: 99%

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Comparison of catheter thrombogenicity in a modified chandler loop model using goat blood

Olsen

Long

2018

J Biomedical Materials Res

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Thrombogenicity testing is a key component in the development of medical devices intended for contact with blood. The Chandler loop system has previously been used as an in vitro thrombogenicity testing method. In this study, we used a modified version of the Chandler loop model to evaluate its capacity to detect differential thrombogenic potential of different catheter materials using goat blood. We also sought to determine the optimal experimental conditions for detecting the thrombogenicity of catheter material. Using the Chandler loop system with goat blood we demonstrated that silicone catheters had a stronger thrombogenicity as compared to polyurethane catheters as evidenced by significantly larger thrombi (p < 0.001) and higher infusion pressures (p < 0.05). This is consistent with many, but not all, previous in vitro and in vivo studies comparing polyurethane to silicone catheters. The use of this modified Chandler loop system with goat blood may provide an additional in vitro testing platform for thrombogenicity testing of catheters. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 106A: 3143-3151, 2018.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Comparison of catheter thrombogenicity in a modified chandler loop model using goat blood

Olsen

Long

2018

J Biomedical Materials Res

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“…Subchronic or chronic implantation testing can take even more time [192]. After the tests are completed, and all data has been collected, the FDA recommends that an expert interpret both the data and test results [193]. The expert can then decide on whether the existing data provides enough information to make a conclusion on the device's biocompatibility.…”

Section: Conducting Biocompatibility Testsmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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“…These technologies have shown a range of improvements but none have prevented the adhesion of biologic material entirely (12)(13)(14)(15)(16). These technologies have shown a range of improvements but none have prevented the adhesion of biologic material entirely (12)(13)(14)(15)(16).…”

mentioning

confidence: 99%

Relationship Between Central Venous Catheter Protein Adsorption and Water Infused Surface Protection Mechanisms

et al. 2018

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Central venous catheters (CVCs) are implanted in the majority of dialysis patients despite increased patient risk due to thrombotic occlusion and biofilm formation. Current solutions remain ineffective at preventing these complications and treatment options are limited and often harmful. We present further analysis of the previously proposed water infused surface protection (WISP) technology, an active method to reduce protein adsorption and effectively disrupt adsorbed protein sheaths on the inner surface of CVCs. A WISP CVC is modeled by a hollow fiber membrane (HFM) in a benchtop device which continuously infuses a saline solution across the membrane wall into the blood flow, creating a blood-free boundary layer at the lumen surface. Total protein adsorption is measured under various experimental conditions to further test WISP performance. The WISP device shows reduced protein adsorption as blood and WISP flow rates increase (P < 0.040) with up to a 96% reduction in adsorption over the no WISP condition. When heparin is added to the WISP flow, protein adsorption (0.097[+0.035/-0.055] µg/mm ) is reduced when compared to both bolus administration and nondoped WISP, 0.406(+0.056/-0.065) µg/mm (P = 0.001) and 0.191 (+0.076/-0.126) (P = 0.029), respectively. Additionally, when heparinized WISP is applied to a preadsorbed protein layer, 0.375(+0.114/-0.164) µg/mm , it displays the ability to reduce the previously-adsorbed protein, 0.186(+0.058/-0.084) µg/mm (P = 0.0012), suggesting aptitude for intermittent treatments. The WISP technology not only shows the ability to reduce protein adsorption, but also the ability to remove preadsorbed material by effectively delivering drugs to the point of adsorption; functionalities that could greatly improve clinical outcomes.

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Improved ex vivo blood compatibility of central venous catheter with noble metal alloy coating

Cited by 18 publications

References 26 publications

Comparison of catheter thrombogenicity in a modified chandler loop model using goat blood

Comparison of catheter thrombogenicity in a modified chandler loop model using goat blood

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Relationship Between Central Venous Catheter Protein Adsorption and Water Infused Surface Protection Mechanisms

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