Authors :
Dr. Deveshkumar Kothwala; Shaikh Amirhamzah; Mistry Himanshu; Bulsara Jugal Anilkumar
Volume/Issue :
Volume 10 - 2025, Issue 6 - June
Google Scholar :
https://tinyurl.com/4mfu3j84
Scribd :
https://tinyurl.com/5n7rfynb
DOI :
https://doi.org/10.38124/ijisrt/25jun1334
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Abstract :
The performance of distal access catheters is critical for their effectiveness in medical procedures. This study
aimed to evaluate the mechanical properties and performance characteristics of a designed distal access catheter through a
series of quality control (QC) tests. Six primary tests were conducted: friction, bond strength, stiffness, tensile strength, tip
compression, and push report. The friction test evaluated the ease of insertion, while the bond strength test assessed the
integrity of material connections. Stiffness and tensile tests were performed to measure flexibility and durability, while the
tip compression and push tests examined the catheter’s ability to withstand operational forces. Results showed that the
catheter met or exceeded all relevant performance standards, demonstrating high bond strength, optimal stiffness for
navigation, and minimal friction during insertion. The catheter also exhibited excellent compressive resistance and push
performance, confirming its suitability for clinical use. These findings suggest that the tested catheter design provides robust
performance, ensuring enhanced reliability and safety for medical procedures requiring distal access. However, some
limitations include uncertain long-term performance, potential procedural complexity, high costs, untested device
compatibility, limited sample size, and risk of material fatigue. Future work will focus on long-term testing and further
optimization of the catheter design. Statistical analysis confirmed repeatability and reproducibility, with minor variations
within acceptable limits. The study establishes a link between the catheter’s mechanical properties and clinical efficacy,
suggesting improved procedural efficiency and reduced vessel trauma. However, limitations such as long-term performance
uncertainties and potential material fatigue remain. Future work will focus on long-term testing and further optimization
of the catheter design. Although this study primarily evaluates the mechanical integrity of the catheter, the findings have
significant clinical implications. A well-balanced combination of flexibility, pushability, and compressive resistance
contributes to procedural success by enabling smoother navigation and reducing complications. Future research will aim to
correlate these mechanical characteristics with real-world clinical outcomes, including procedural success rates, physician
ease of use, and potential complication rates.
Keywords :
Distal Access Catheter, Mechanical Properties, Quality Control Tests, Bond Strength, Stiffness, Push Performance.
References :
- Baim, D. S., & Wiedemann, M. (2001). Coronary artery catheterization: Advances in catheter technology. Journal of the American College of Cardiology, 38(1), 1-8.
- Kress, A., & Schorlemmer, A. (2009). Advances in catheter technology: Materials and design. BioMedical Engineering Online, 8(1), 1-10.
- Wang, J., & Li, Z. (2015). Frictional behavior of flexible catheters for minimally invasive procedures: A laboratory study. Journal of Biomechanics, 48(4), 850-855.
- Zhang, Y., & Liao, X. (2014). Friction coefficient analysis of catheters used in interventional cardiology. Journal of Materials Science: Materials in Medicine, 25(7), 1679-1685.
- Kumar, S., & Sharma, S. (2017). Bond strength in catheter construction: Improving material adhesion for enhanced durability. Journal of Applied Polymer Science, 134(8), 451-458.
- Johnson, M. B., & Anderson, M. E. (2012). Assessment of bond strength in catheter designs for cardiovascular interventions. Journal of Biomedical Materials Research, 100(6), 1454-1460.
- Brown, R., & Stevens, D. (2013). Mechanical properties and design of flexible catheters for vascular interventions. Journal of Biomechanics, 46(12), 2120-2125.
- Wang, X., & Cao, S. (2011). Stiffness and flexibility in catheter designs: A critical review of material properties. Medical Devices: Evidence and Research, 4, 25-35.
- Smith, T., & Martin, J. (2016). Tensile testing of catheter materials and their impact on product durability. Journal of Biomedical Engineering, 38(9), 348-354.
- Patel, A., & Singh, R. (2014). Tensile strength of polymer-based medical devices: A review of standards and testing methodologies. Journal of Medical Devices, 8(3), 123-128.
- Huang, X., & Liu, Y. (2018). Compression resistance and pushability of vascular access catheters in clinical settings. Journal of Clinical Interventional Medicine, 29(11), 2345-2351.
- Hall, L., & Thompson, A. (2017). The role of compression resistance in catheter performance. Journal of Interventional Medicine, 24(4), 567-574.
- American Society for Testing and Materials (ASTM). (2015). ASTM F1545-15 Standard Guide for Testing of Catheters. ASTM International.
- ISO 10555-1:2013. (2013). Sterile, single-use intravascular catheters—Part 1: General requirements. International Organization for Standardization (ISO).
- Garcia, C. M., & Xu, Y. (2019). Performance and safety of distal access catheters in clinical practice: A multicenter review. Journal of Vascular Interventional Radiology, 30(6), 890-895.
The performance of distal access catheters is critical for their effectiveness in medical procedures. This study
aimed to evaluate the mechanical properties and performance characteristics of a designed distal access catheter through a
series of quality control (QC) tests. Six primary tests were conducted: friction, bond strength, stiffness, tensile strength, tip
compression, and push report. The friction test evaluated the ease of insertion, while the bond strength test assessed the
integrity of material connections. Stiffness and tensile tests were performed to measure flexibility and durability, while the
tip compression and push tests examined the catheter’s ability to withstand operational forces. Results showed that the
catheter met or exceeded all relevant performance standards, demonstrating high bond strength, optimal stiffness for
navigation, and minimal friction during insertion. The catheter also exhibited excellent compressive resistance and push
performance, confirming its suitability for clinical use. These findings suggest that the tested catheter design provides robust
performance, ensuring enhanced reliability and safety for medical procedures requiring distal access. However, some
limitations include uncertain long-term performance, potential procedural complexity, high costs, untested device
compatibility, limited sample size, and risk of material fatigue. Future work will focus on long-term testing and further
optimization of the catheter design. Statistical analysis confirmed repeatability and reproducibility, with minor variations
within acceptable limits. The study establishes a link between the catheter’s mechanical properties and clinical efficacy,
suggesting improved procedural efficiency and reduced vessel trauma. However, limitations such as long-term performance
uncertainties and potential material fatigue remain. Future work will focus on long-term testing and further optimization
of the catheter design. Although this study primarily evaluates the mechanical integrity of the catheter, the findings have
significant clinical implications. A well-balanced combination of flexibility, pushability, and compressive resistance
contributes to procedural success by enabling smoother navigation and reducing complications. Future research will aim to
correlate these mechanical characteristics with real-world clinical outcomes, including procedural success rates, physician
ease of use, and potential complication rates.
Keywords :
Distal Access Catheter, Mechanical Properties, Quality Control Tests, Bond Strength, Stiffness, Push Performance.