Experimental and mathematical characterization of coronary polyamide-12 balloon catheter membranes

Geith, Markus A; Eckmann, Jakob D; Haspinger, Daniel Ch.; Agrafiotis, Emmanouil; Maier, Dominik; Szabo, Patrick; Sommer, Gerhard; Schratzenstaller, Thomas; Holzapfel, Gerhard

doi:10.1371/journal.pone.0234340

Cited by 5 publications

(5 citation statements)

References 28 publications

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“…For all catheters, the variance of the balloon WT is higher than that of the shafts. This might be due to balloon fabrication [ 33 ]. A multilayer IS is visible for some catheters, like the NC Emerge, Maverick2, and the NC Trek.…”

Section: Discussionmentioning

confidence: 99%

Design of percutaneous transluminal coronary angioplasty balloon catheters

Amstutz,

Behr,

Krebs

et al. 2023

BioMed Eng OnLine

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Background Eight commercially available percutaneous transluminal coronary angioplasty (PTCA), including semi-compliant and non-compliant balloons, have been assessed in detail on their tip, balloon, shaft, RX-Port, and hypotube design. Important performance characteristics such as tip deformation, balloon elongation, and deflation rate have been quantified. Methods Five catheters of each model were evaluated during various tests. The robustness of the tips was evaluated through compression, measuring any occurrence of damage. The longitudinal growth of the balloons was recorded during inflation up to Rated Burst Pressure (RBP). The forces required to move the catheter forward and retract it into the guide catheter were measured in a simulated use test setup. The deflation behavior was studied by measuring extracted contrast media over time. Furthermore, balloon compliance and catheter dimensions were investigated. Results The outer dimensions of the catheter were found to be smallest at the hypotube (0.59–0.69 mm) and highest at the balloon, respectively, the crossing profile (0.9–1.2 mm). The tip diameter increased after compression by 1.7–22%. Cross-sections of the folded balloons revealed a tri- and two-fold, respectively. The measured balloon elongation ranged from 0.6 to 2.0 mm. After the inflation of the balloon, an increase in friction between the guide wire and the catheter was observed on four catheters. A maximum increase of 0.12 N to 1.07 N was found. Cross-sections of the RX-Port revealed a semicircular-shaped inflation lumen and a circular guide wire lumen. The measured deflation rate ranged from 0.004 to 0.013 µL/s, resulting in an estimated balloon deflation time of 10.2–28.1 s. Conclusion This study provides valuable insights into the design characteristics of RX PTCA balloon catheters, which can contribute to facilitating the development of improved catheter designs and enhancing clinical outcomes. Distinctions between SC and NC catheters, such as balloon performance and dimensions, are evident. It is important to note that no single catheter excels in all aspects, as each possesses unique strengths. Therefore, it is essential to consider individual intervention requirements when selecting a catheter. The research also identifies specific catheter weaknesses, such as reduced wall thickness, fringes at the tip, and reduced performance characteristics.

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Section: Discussionmentioning

confidence: 99%

Design of percutaneous transluminal coronary angioplasty balloon catheters

Amstutz,

Behr,

Krebs

et al. 2023

BioMed Eng OnLine

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“…Nylon-12 (polyamide) and Pebax are the two materials most commonly used in balloons [ 15 , 25 , 26 ]. Two materials were used in this study: Grilamid L25 (nylon 12) from EMS and Pebax ® 7033 SA 01 MED resin (a thermoplastic elastomer from Arkema).…”

Section: Methodsmentioning

confidence: 99%

“…An elasto-plastic material with an arbitrary stress as a function of strain curve and an arbitrary strain rate dependency can be defined using MAT_89 in LS-DYNA [ 27 ]; the model was selected, and the stress–strain curve was input to fit the material properties. The densities, moduli of elasticity, and Poisson’s ratios of nylon and Pebax [ 15 ] are shown in Table 1 . Clearly, nylon-12 is the stiffer of the two materials.…”

Section: Methodsmentioning

confidence: 99%

“…There have been many studies that have conducted experiments and simulations on balloons from various perspectives. Geith et al [ 15 ] proposed a simple, microstructurally motivated constitutive model aimed at mimicking the pronounced anisotropic material response observed in the performed experiments. Helou et al [ 16 ] presented a modeling method for simulating percutaneous transluminal angioplasty (PTA) endovascular treatment and evaluated the effects of balloon design, plaque composition, and balloon sizing on acute post-procedural outcomes after PTA.…”

Section: Introductionmentioning

confidence: 99%

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Simulation and Experimental Investigation of Balloon Folding and Inserting Performance for Angioplasty: A Comparison of Two Materials, Polyamide-12 and Pebax

Lan

Zhang

Wang³

et al. 2023

JFB

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Background: A balloon dilatation catheter is a vital tool in percutaneous transluminal angioplasty. Various factors, including the material used, influence the ability of different types of balloons to navigate through lesions during delivery. Objective: Thus far, numerical simulation studies comparing the impacts of different materials on the trackability of balloon catheters has been limited. This project seeks to unveil the underlying patterns more effectively by utilizing a highly realistic balloon-folding simulation method to compare the trackability of balloons made from different materials. Methods: Two materials, nylon-12 and Pebax, were examined for their insertion forces via a bench test and a numerical simulation. The simulation built a model identical to the bench test’s groove and simulated the balloon’s folding process prior to insertion to better replicate the experimental conditions. Results: In the bench test, nylon-12 demonstrated the highest insertion force, peaking at 0.866 N, significantly outstripping the 0.156 N force exhibited by the Pebax balloon. In the simulation, nylon-12 experienced a higher level of stress after folding, while Pebax had demonstrated a higher effective strain and surface energy density. In terms of insertion force, nylon-12 was higher than Pebax in specific areas. Conclusion: nylon-12 exerts greater pressure on the vessel wall in curved pathways when compared to Pebax. The simulated insertion forces of nylon-12 align with the experimental results. However, when using the same friction coefficient, the difference in insertion forces between the two materials is minimal. The numerical simulation method used in this study can be used for relevant research. This method can assess the performance of balloons made from diverse materials navigating curved paths and can yield more precise and detailed data feedback compared to benchtop experiments.

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“…Past studies also focused on the manufacturing of PA 12 angioplasty balloons [ 9 , 10 ]. Recently, Geith [ 11 ] published for the first time the anisotropic mechanical behavior of a PA 12 balloon catheter membrane. However, to the author's knowledge no publication yet showed the influence of the temperature, water absorption and material processing methods on mechanical properties of PA 12.…”

Section: Introductionmentioning

confidence: 99%

Temperature-dependent tensile properties of polyamide 12 for the use in percutaneous transluminal coronary angioplasty balloon catheters

et al. 2021

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Background Percutaneous transluminal coronary angioplasty (PTCA) balloon catheters must withstand high pressures required for the lesion treatment, pushing loads during insertion, and pulling loads during withdrawal. These loads pose a challenge especially for polymeric tubular shafts with small cross sections. In order to enable new design innovations and to better understand the mechanics of current catheter technologies, the tensile properties of polyamide (PA) 12 were investigated. PA 12 dog bone specimens and medical PA 12 tubes were either stored at ambient temperature and humidity or conditioned in water, and subjected to tensile loads at different temperatures. In addition, the effect on the tensile properties of the necking process, a forming process to reduce the wall thickness of the tubes, was determined. Results The tested tubes showed a reduction in both Young’s Modulus (− 41.5%) and yield stress (− 29.2%) compared to standardized specimens. Furthermore, an increase in temperature and water absorption softens the material and reduces the mechanical properties like the Young’s Modulus and the yield stress. It was found that the material strengthens during the necking process. Likely due to the orientation of the polymers chain molecules in load direction (Rösler et al., 2007), the Young’s Modulus of the material could be increased by 43.5%. Furthermore, the absence of a yield point after necking allows for a greater loading capacity of the material without unstable neck growth. Besides the strengthening, the ultimate strain is reduced by 50%. This indicates that the necking process induces plastic deformation. Conclusion The investigation showed that the environmental conditions like temperature and humidity can influence mechanical properties. It could also be shown that pre-forming processes such as necking can enhance the mechanical properties, such as the Young’s Modulus, while reducing the wall thickness. These findings suggest possible further development of catheters with a small cross section and higher mechanical strength and highlight the importance to account for the targeted operating temperature during the design process.

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Experimental and mathematical characterization of coronary polyamide-12 balloon catheter membranes

Cited by 5 publications

References 28 publications

Design of percutaneous transluminal coronary angioplasty balloon catheters

Design of percutaneous transluminal coronary angioplasty balloon catheters

Simulation and Experimental Investigation of Balloon Folding and Inserting Performance for Angioplasty: A Comparison of Two Materials, Polyamide-12 and Pebax

Temperature-dependent tensile properties of polyamide 12 for the use in percutaneous transluminal coronary angioplasty balloon catheters

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