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A method to determine the kink resistance of stents and stent delivery systems according to international standards

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Current Directions in Biomedical Engineering
From the journal Current Directions in Biomedical Engineering Volume 2 Issue 1

Abstract

The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius.

Keywords: delivery system; FDA; ISO; kink resistance; standard; vascular stents

1 Introduction and background

Vascular stents must resist not only the radial load caused by the vessel wall and the blood pressure, but also additional mechanical loads from the surrounding depending on the position in the body. Coronary stents, e.g. implanted into the right coronary artery (RCA), are stressed because of the excessive movement of the RCA and repetitive kinking during the cardiac cycle [1]. In peripheral arteries like the carotid artery or the superficial femoral artery high stress of the implanted stents result from large deformations of the vessel during body motion as well as high tortuosities of the vessels [1], [2].

To reduce the risk of in-stent restenosis caused by a stent indicated lumen loss of the vessel the kink behavior of stents is of particular interest for clinicians, stent manufacturers and regulatory.

This study presents methods to determine the kink resistance of balloon expandable as well as self-expandable stents and of stent delivery systems according to international standards.

2 Requirements of international standards

The FDA guidance document no. 1545 recommends determining the kink resistance of stents for peripheral indications, where bending of the implant during normal body motion is expected. The smallest radius of curvature that the stent can withstand without kinking should be determined and the stent recovery of its original size and shape should be demonstrated. Secondly it is recommended to demonstrate that the stent delivery system will not kink at an appropriate bending radius [3].

The ISO 25539-2 standard claims for the smallest radius of curvature that the stent can adapt without kinking or a lumen loss of more than 50%. Furthermore the recovery of the stent after bending has to be recognized. In the appendix of the standard test methods are described in more detail, applicable for both balloon expandable and self-expandable stents, respectively. The two test methods described differ in the used test equipment: The stent within a silicone tube is bent around different mandrels (test method A) and the stent is released in a rigid model with bend (test method B). For both methods the minimum bending radius, as well as a kinking or a significant lumen reduction should be documented. The bending radius is reduced until kinking or a significant lumen loss could be determined. After the bent state is documented, the stent has to be examined without external load to determine the stent recovery [4].

In addition the ISO standard claims to test the bendability of the stent delivery system with respect to a clinical relevant curvature [4].

3 Material and methods

For all investigations each a commercially available balloon expandable stent 2.25 × 30 mm, a self-expandable stent 8 × 40 mm and stent delivery system were used.

3.1 Kink resistance of expanded stents

For determination of the kink resistance of the stents a special test setup inside a 37°C water bath was used (see Figure 1). The test setup consists of a mandrel with diameters from 5 to 15 mm in 2.5 mm steps and from 15 to 65 mm in 5 mm steps. As described for test method A in the ISO 25539-2, D.5.3.6.5, a silicone tube was used as implantation vessel [4].

Figure 1 Test setup for determination of kink resistance of stents.
Figure 1

Test setup for determination of kink resistance of stents.

Figure 2 Silicone tube with implanted stent: In original configuration (left) and in bent configuration (right).
Figure 2

Silicone tube with implanted stent: In original configuration (left) and in bent configuration (right).

The balloon expandable stent as well as the self-expanding stent were implanted into a silicone tube of appropriate dimensions (vessel diameter as intended for each stent). The silicone tube with implanted stent can be clamped inside the test setup and a force can be applied at both ends by a spring to guarantee a 180° adaption of the tubing to the mandrel. Outside the water bath a digital camera (CANON EOS 350D) was mounted on a tripod to generate the images for visual investigation and measurements of the kink behavior of the stents. The camera position was not changed during the whole test. The maximum magnification was used for every photograph.

3.1.1 Reference measurement

To determine the diameter of the stent inside the silicone tube in original state, serving as reference diameter, the silicone tube with implanted stent was clamped at the upper clamp. The silicone tube with stent was positioned central on the largest diameter of the mandrel. The tube has to be free from air bubbles and remained for 1 min inside the water bath to allow warming up. This configuration was documented with the digital camera.

The reference diameter of the examined stent dstent was determined with an image editor (GIMP, GNU Image Manipulation Program) by counting the number of pixels in the image of the stent diameter (dstentPx) as well as of the largest mandrel diameter to be used for the test (dmandrelPx) and then using eq. 1.

(1)dstent=dstentPx×dmandreldmandrelPx

For further calculations this reference diameter is herein after referred to as d0.

3.1.2 Determination of lumen loss/kinking during bending

To determine the lumen loss of the stent during bending the silicone tube with stent was clamped at the upper and lower clamps. The stent hast to be aligned symmetrical with respect to the clamps and the mandrel. The spring force was adjusted in a way that the silicone tube was adapted to the mandrel at least 180°, but did not flatten out. This configuration was then documented with the digital camera. The stent diameter in bend state was determined according to eq. 1 by using the known diameter of the mandrel as absolute dimension.

The lumen loss Δds of the examined stent while bent around the respective radius (=radius of the mandrel + wall thickness of the used silicone tube) was calculated according eq. 2, with d0 as reference stent diameter in original state and dS as stent diameter in bend state.

(2)Δ⁢dS=d0−dSd0×100%

Measurements of elastic recovery were conducted after every bending step.

3.1.3 Determination of the residual diameter change after bending

After each bending step of this test method the residual stent diameter was measured. Therefore the silicone tube was released from the lower clamp to straighten up the stent. The upper clamp was kept close. This configuration of the released stent within the silicone tube was documented with the digital camera.

The stent diameter in released state was determined according to eq. 1 as described above. The residual diameter change Δdres was calculated as difference between the reference stent diameter d0 and the diameter of the stent after bending d1 and then related to the reference stent diameter. The stent recovery is given in percent (eq. 3).

(3)Δ⁢dres=d0−d1d0×100%

3.2 Kink resistance of stent delivery systems

The test to determine the kink resistance of the stent delivery system concentrates on the distal tube of the stent system since this is the part of the catheter which is intended to be exposed to the most challenging curvatures during stent application.

Before the measurement of the kink radius the stent system was stored for 1 min in 37°C heated water. The test was also performed in the 37°C heated water environment. No guide wire was used to realize worst case conditions. The measurement was conducted by bending the distal tube of the test specimen around a mandrel with a given radius (Figure 3).

Figure 3 Distal part of the stent delivery system bent around mandrel for determination of kink resistance.
Figure 3

Distal part of the stent delivery system bent around mandrel for determination of kink resistance.

The photographic documentation was done with the help of an incident light microscope (Olympus SZX16) and the integrated digital camera (Olympus UC30). The test was repeated with different mandrel radii. The smallest radius without kinking was documented.

4 Results

The results of determining the kink resistance of the balloon expandable stent and the self-expandable stent are displayed in Figures 4 and 5.

Figure 4 Lumen loss and residual diameter change of a balloon expandable stent dependent on the bending radius.
Figure 4

Lumen loss and residual diameter change of a balloon expandable stent dependent on the bending radius.

Figure 5 Lumen loss and residual diameter change of a self-expanding stent dependent on the bending radius.
Figure 5

Lumen loss and residual diameter change of a self-expanding stent dependent on the bending radius.

Kinking or more than 50% lumen loss occurred at a bending radius of 3.5 mm and 21.0 mm for the balloon expandable stent or self-expanding stent, respectively. The residual diameter change after diameter reduction of more than 50% was about 42% for the balloon expandable stent and about 2% for the self-expandable stent.

The stent delivery system showed no kinking down to a bending radius of 2 mm.

5 Conclusion

In this study two methods were presented to determine the kinking resistance of stents and stent delivery systems according to international standards.

With the described methods it is possible to determine the lumen loss and the residual diameter change for every bending radius, so that the minimum curvature for each stent can be derived where the lumen loss is smaller than 50%. Methods are applicable for balloon expandable stents as well as for self-expanding stents.

Both, the lumen loss as well as the residual diameter change depend on the stent diameter, the stent design and of course the stent material. The residual diameter change of the balloon expandable stent increases with decreasing bending radius. At the smallest radius where the lumen loss was smaller than 50% (31% at 21 mm bending radius) the residual diameter change was already 22%. Plastic deformation is expected to occur at balloon expandable stents because it is mandatory for stent expansion.

Even the super elastic self-expandable nitinol stent showed small residual diameter changes, which refer to the interaction or restrictions of the stent and the silicone tube.

The presented method is limited in a way that it is not possible to create an exact 50% lumen loss of the tested stent to determine the exact minimum bending radius, because of the used stepped mandrel. The use of further steps to gain accuracy of the minimum bending radius would be possible but would complicate the test setup and reduce the universal usability for small and large stents.

Measurement accuracy depends on the camera setup used. It was in the range of ±0.07 mm (±2 Px), and thus well acceptable compared to the bending radii of inspected stents.

Transparency of the silicone tube is mandatory. The use of refractive index adjusted fluids could potentially gain accuracy [5].

The use of a rigid and curved vessel model (ISO method B) might also be appropriate. However, the presented method can use one stent for measurement of kink radius by bending it multiple times to decreasing radii. It appears to be an economic approach providing all necessary information.

Acknowledgement

Financial support by the European Ministry of Education and Research (BMBF) within RESPONSE “Partnership for Innovation in Implant Technology” is gratefully acknowledged.

Author’s Statement

Research funding: The author state no funding involved. Conflict of interest: Authors state no conflict of interest. Material and Methods: Informed consent: Informed consent is not applicable. Ethical approval: The conducted research is not related to either human or animal use.

References

[1] Adlakha S, Sheikh M, Wu J, Burket MW, Pandya U, Colyer W, et al. Stent fracture in the coronary and peripheral arteries. J Int Cardiol. 2010;23:411–9.10.1111/j.1540-8183.2010.00567.xSearch in Google Scholar PubMed

[2] Nikanorov A, Schillinger M, Zhao H, Minar E, Schwartz LB. Assessment of self-expanding nitinol stent deformation after chronic implantation into the femoropopliteal arteries. EuroIntervention. 2013;9:730–7.10.4244/EIJV9I6A117Search in Google Scholar PubMed

[3] Guidance for Industry and FDA Staff. Non-Clinical Engineering Tests and Recommended labelling for Intravascular Stents and Associated Delivery Systems. FDA document no. 1545, 2010.Search in Google Scholar

[4] ISO 25539-2(2012). Cardiovascular implants – endovascular devices – Part 2: vascular stents, 2012.Search in Google Scholar

[5] Quosdorf D. Experimentelle Untersuchungen zur Strömungsmechanik koronarer Stents bei stationärer und pulsatiler Anströmung. Dissertation, Menzel-Verlag; 2013.Search in Google Scholar

Published Online: 2016-9-30
Published in Print: 2016-9-1

©2016 Christoph Brandt-Wunderlich et al., licensee De Gruyter.

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

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https://doi.org/10.1515/cdbme-2016-0064
Keywords for this article
delivery system; FDA; ISO; kink resistance; standard; vascular stents
Creative Commons
BY-NC-ND 4.0

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  112. Automatic determination of lung features of CF patients in CT scans
  113. Image analysis of self-organized multicellular patterns
  114. Effect of key parameters on synthesis of superparamagnetic nanoparticles (SPIONs)
  115. Radiopacity assessment of neurovascular implants
  116. Development of a desiccant based dielectric for monitoring humidity conditions in miniaturized hermetic implantable packages
  117. Development of an artifact-free aneurysm clip
  118. Enhancing the regeneration of bone defects by alkalizing the peri-implant zone – an in vitro approach
  119. Rapid prototyping of replica knee implants for in vitro testing
  120. Protecting ultra- and hyperhydrophilic implant surfaces in dry state from loss of wettability
  121. Advanced wettability analysis of implant surfaces
  122. Patient-specific hip prostheses designed by surgeons
  123. Plasma treatment on novel carbon fiber reinforced PEEK cages to enhance bioactivity
  124. Wear of a total intervertebral disc prosthesis
  125. Digital health and digital biomarkers – enabling value chains on health data
  126. Usability in the lifecycle of medical software development
  127. Influence of different test gases in a non-destructive 100% quality control system for medical devices
  128. Device development guided by user satisfaction survey on auricular vagus nerve stimulation
  129. Empirical assessment of the time course of innovation in biomedical engineering: first results of a comparative approach
  130. Effect of left atrial hypertrophy on P-wave morphology in a computational model
  131. Simulation of intracardiac electrograms around acute ablation lesions
  132. Parametrization of activation based cardiac electrophysiology models using bidomain model simulations
  133. Assessment of nasal resistance using computational fluid dynamics
  134. Resistance in a non-linear autoregressive model of pulmonary mechanics
  135. Inspiratory and expiratory elastance in a non-linear autoregressive model of pulmonary mechanics
  136. Determination of regional lung function in cystic fibrosis using electrical impedance tomography
  137. Development of parietal bone surrogates for parietal graft lift training
  138. Numerical simulation of mechanically stimulated bone remodelling
  139. Conversion of engineering stresses to Cauchy stresses in tensile and compression tests of thermoplastic polymers
  140. Numerical examinations of simplified spondylodesis models concerning energy absorption in magnetic resonance imaging
  141. Principle study on the signal connection at transabdominal fetal pulse oximetry
  142. Influence of Siluron® insertion on model drug distribution in the simulated vitreous body
  143. Evaluating different approaches to identify a three parameter gas exchange model
  144. Effects of fibrosis on the extracellular potential based on 3D reconstructions from histological sections of heart tissue
  145. From imaging to hemodynamics – how reconstruction kernels influence the blood flow predictions in intracranial aneurysms
  146. Flow optimised design of a novel point-of-care diagnostic device for the detection of disease specific biomarkers
  147. Improved FPGA controlled artificial vascular system for plethysmographic measurements
  148. Minimally spaced electrode positions for multi-functional chest sensors: ECG and respiratory signal estimation
  149. Automated detection of alveolar arches for nasoalveolar molding in cleft lip and palate treatment
  150. Control scheme selection in human-machine- interfaces by analysis of activity signals
  151. Event-based sampling for reducing communication load in realtime human motion analysis by wireless inertial sensor networks
  152. Automatic pairing of inertial sensors to lower limb segments – a plug-and-play approach
  153. Contactless respiratory monitoring system for magnetic resonance imaging applications using a laser range sensor
  154. Interactive monitoring system for visual respiratory biofeedback
  155. Development of a low-cost senor based aid for visually impaired people
  156. Patient assistive system for the shoulder joint
  157. A passive beating heart setup for interventional cardiology training
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