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stent coating adhesion testing failure analysis drug eluting stent coating

Application Note | Stent Coating Adhesion Testing

Stent Coating Adhesion and Delamination Analysis Using Nano Scratch Testing

Quantifying Coating Failure and Adhesion Performance on Drug-Eluting Stents

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stent coating adhesion testing nano scratch delamination critical load

Research & Experimental Testing

Duanjie Li, PhD

Visual Design & Editorial

Andrew Shore

Einführung

Blood is carried through arteries from the heart to the rest of the body. Any weakening or blockage of these vessels can pose significant health risks and may become life-threatening. A stent is a small mesh tube inserted into the lumen of a blood vessel to treat narrowed or weakened arteries. Stent implantation is now a widely used procedure to support the arterial wall and restore blood flowᶦ.

Metal stent mesh geometry illustrating the structural complexity of vascular implant design.

Why coating adhesion matters in drug-eluting stents

Drug-eluting stents represent a major advancement in stent technology. They incorporate a biodegradable, biocompatible polymer coating that enables controlled drug release at the arterial site, helping to inhibit intimal thickening and reduce the risk of restenosisᶦᶦ.

A critical concern in these systems is the delamination of the polymer coating from the metallic stent substrate. This coating carries the drug-eluting layer, and its adhesion directly impacts device performance and reliability.

To improve coating adhesion, stents are often designed with complex geometries. In this study, the polymer coating is located at the bottom of grooves within the stent mesh. This configuration presents a significant challenge for adhesion measurement.

A reliable method is required to quantitatively evaluate the interfacial strength between the polymer coating and the metal substrate. The small diameter of the stent mesh, comparable to a human hair, combined with its three-dimensional geometry, requires:

  • ultrafine X-Y positioning accuracy
  • precise control of applied load
  • accurate depth measurement during testing

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Measurement Method

Nano scratch testing is performed using the NANOVEA PB1000 Mechanischer Tester, in Nano Scratch Mode, to evaluate the cohesive and adhesive strength of the polymer coating on the metal mesh of stent samples.

Controlled scratch measurements are carried out on stent geometries with dimensions comparable to a human hair, enabling precise evaluation of coating adhesion on complex stent structures.

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Testbedingungen

1. Regular Stent Samples

The stent is fixed on the sample stage, with a support wire inserted inside the stent tube to ensure stability during nano scratch testing. The NANOVEA Mechanical Tester is used to perform nano scratch measurements using the parameters summarized in Table 1, to evaluate the cohesive and adhesive strength of the polymer coating on the metal substrate.

ParameterValue
Load typeProgressiv
Initial load0.05 mN
Final load300 and 100 mN
Sliding speed0.5 mm/min
Sliding distance0.5 mm
Indenter geometryKonisch
Indenter material (tip)Diamant
Radius der Eindringkörperspitze20 µm
Temperatur24°C (room)

Tabelle 1: Test parameters for nano scratch measurements on regular stent samples

2. Grooved Stent Samples

The SEM image in Fig. 1 shows the cross-section of the stent sample. The stent features a groove with a depth of approximately 30 µm. The polymer coating, with a thickness of 10.8 µm, is located at the bottom of the groove.

Standard 60° conical diamond tips are not sharp enough to reach the bottom of the groove without contacting the sidewalls. Therefore, a sharper 40° conical diamond tip is used in this study (Fig. 2).

Nano scratch measurements are performed using the parameters summarized in Table 2.

Parameter Value
Load type Progressiv
Initial load 0.1 mN
Final load 300 mN
Ladegeschwindigkeit 300 mN/min
Scratch length 0.25 mm
Scratch speed 0.25 mm/min
Indenter geometry 40° cone
Indenter material (tip) Diamant
Radius der Eindringkörperspitze 5 µm

Table 2: Test parameters for nano scratch measurements on grooved stent samples

stent groove cross section polymer coating thickness adhesion analysis nano scratch testing

Fig. 1: SEM cross-section of a grooved stent showing polymer coating located at the bottom of the groove, highlighting the challenge of coating adhesion measurement in recessed geometries.

nano scratch diamond tip 40 degree stent groove coating adhesion testing schematic

Fig. 2: Schematic of a 40° conical diamond tip designed for nano scratch testing inside stent grooves, enabling accurate adhesion measurement without sidewall interference.

Ergebnisse und Diskussion

The stent mesh has a diameter of approximately 100 μm, comparable to a human hair. Precise positioning is therefore critical to ensure the scratch test is performed at the center of the stent mesh. The NANOVEA Mechanical Tester provides X–Y positioning accuracy down to 0.25 μm, enabling accurate test placement under the integrated optical microscope.

1. Regular Stent Samples

Nano scratch testing is performed with a progressively increasing load up to 300 mN. The full scratch track on the stent is shown in Fig. 3a, while failure behavior at different stages is presented in Fig. 3b and 3c.

Two critical loads are identified:

  • Lc1: the load at which the first visible damage appears on the coating
  • Lc2: the load at which the coating is fully removed and the substrate is exposed

The evolution of coefficient of friction (COF) and penetration depth is shown in Fig. 4, providing insight into the progression of coating failure during the test.

The first signs of coating damage appear at Lc1 ≈ 14.5 mN. As the applied load increases, the diamond tip progressively penetrates the polymer coating, resulting in a wider and deeper scratch track. During this phase, the COF increases from approximately 0.05 to 0.7.

At Lc2 ≈ 78.1 mN, the coating is fully delaminated from the metal substrate. Beyond this point, as the load continues to increase, both COF and penetration depth remain relatively stable due to the mechanical support of the underlying metal substrate.

nano scratch track stent coating progressive load adhesion testing

(a) Full Scratch Track

(b) Lc1 ≈ 14.5 mN

stent coating delamination lc2 nano scratch 78.1 mN adhesion testing

(c) Lc2 ≈ 78.1 mN

Fig. 3: Nano scratch track on a stent coating under progressively increasing load, showing (a) full scratch path, (b) initial coating failure at Lc1 ≈ 14.5 mN, and (c) complete coating delamination at Lc2 ≈ 78.1 mN.

nano scratch testing stent coating coefficient of friction depth progression adhesion failure

Fig. 4: Evolution of coefficient of friction (COF) and penetration depth during nano scratch testing of a stent coating under progressively increasing load, showing the progression of coating failure and transition to substrate support.

Failures during nano scratch testing up to a maximum load of 300 mN occur at critical loads below 100 mN. To enable a more quantitative comparison of coating performance, additional tests are performed with a maximum load of 100 mN on two stent samples, referred to as Sample 1 and Sample 2.

Fig. 5 compares the scratch tracks of Sample 1 and Sample 2 after nano scratch testing. Sample 1 exhibits the first sign of coating damage at a critical load of Lc1 ≈ 13.2 mN, while Sample 2 shows initial failure at a higher load of Lc1 ≈ 21.1 mN.

Coating delamination occurs at 62.5 mN for Sample 1. In contrast, the coating on Sample 2 remains intact throughout the test, continuing to protect the metal substrate under the same loading conditions.

This behavior is further reflected in the evolution of coefficient of friction (COF) and penetration depth, as shown in Fig. 6. When the diamond tip penetrates through the coating and contacts the metal substrate in Sample 1, the COF reaches a peak while the penetration depth decreases due to the increased stiffness of the underlying substrate.

stent coating sample 1 early failure nano scratch track delamination adhesion testing

(a) Sample 1 – Early Coating Failure

stent coating sample 2 high adhesion nano scratch track minimal damage testing

(b) Sample 2 – Improved Coating Integrity

Fig. 5: Comparison of nano scratch tracks for two stent coatings, showing (a) early coating failure and delamination in Sample 1, and (b) improved coating integrity in Sample 2 under the same loading conditions.

nano scratch testing stent coating COF depth comparison sample 1 sample 2 adhesion performance

Fig. 6: Comparison of coefficient of friction (COF) and penetration depth for Sample 1 and Sample 2 during nano scratch testing, showing earlier substrate contact and higher friction response in Sample 1, indicating weaker coating adhesion.

2. Grooved Stent Samples

As shown in Fig. 1 and Fig. 7, the grooved stent mesh has a diameter of approximately 90 μm, comparable to a human hair. The groove has a width of ~50 μm and a depth of 30 μm. This geometry presents a significant challenge for nano scratch testing, particularly for evaluating coating adhesion at the bottom of the groove.

Precise positioning is critical to locate the scratch test within the groove. The nano scratch test is performed with a progressively increasing load up to 300 mN. The full scratch tracks of grooved stent Samples 3 and 4 are compared in Fig. 7.

The critical load Lc is defined as the load at which the coating fails and the substrate becomes exposed. The evolution of normal load and penetration depth, shown in Fig. 8, provides further insight into the progression of coating failure during testing.

As the applied load increases, the diamond tip progressively penetrates the polymer coating, resulting in a deeper scratch track. When the critical load Lc is reached, the coating delaminates from the metal substrate.

Sample 3 exhibits coating failure at Lc ≈ 126 mN, while Sample 4 fails at a higher load of Lc ≈ 173 mN. This difference indicates stronger adhesion of the coating in Sample 4.

The measured critical loads enable quantitative comparison of coating adhesion performance. Under the same testing conditions, the coating on Sample 4 demonstrates higher resistance to delamination, making it the better-performing candidate in this study.

stent groove coating failure sample 3 nano scratch 126 mN adhesion testing

(c) Sample 3 – Coating Failure in Groove (Lc ≈ 126 mN)

stent groove coating adhesion sample 4 nano scratch 173 mN minimal failure testing

(d) Sample 4 – Higher Adhesion in Groove (Lc ≈ 173 mN)

Fig. 7: Nano scratch tracks inside stent grooves for Samples 3 and 4, showing (c) coating failure at Lc ≈ 126 mN in Sample 3 and (d) higher adhesion with delayed failure at Lc ≈ 173 mN in Sample 4.

(a) Sample 3 – Earlier Coating Failure (Lc ≈ 126 mN)

(b) Sample 4 – Delayed Failure and Higher Adhesion (Lc ≈ 173 mN)

Fig. 8: Evolution of normal load and penetration depth during nano scratch testing inside stent grooves for Samples 3 and 4, showing earlier coating failure in Sample 3 and delayed failure at higher load in Sample 4. The vertical green line indicates the critical load (Lc) where coating delamination occurs.

Schlussfolgerung

This study demonstrates the ability of the NANOVEA Mechanical Tester to quantitatively evaluate the cohesive and adhesive strength of polymer coatings on both regular and grooved stent geometries using nano scratch testing.

The recessed geometry of the stent grooves, approximately 50 μm wide and 30 μm deep, presents a significant challenge for coating adhesion measurement. The high X–Y positioning accuracy of 0.25 μm enables precise placement of the scratch test within these confined regions, allowing direct evaluation of coating performance where failure is most critical.

By applying a controlled, progressively increasing load, critical loads associated with coating failure can be identified and compared across samples. This approach enables reliable differentiation of coating adhesion performance and interfacial integrity, even on small, complex stent structures.

Referenzen

[I] http://www.nhlbi.nih.gov/health/health-topics/topics/stents
[II] http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S1405-99402006000300008

Frequently Asked Questions About Stent Coating Adhesion Testing

What is stent coating adhesion testing?

Stent coating adhesion testing evaluates how strongly a polymer coating is bonded to the metal substrate of a stent. Techniques such as nano scratch testing quantify the load at which coating damage and delamination occur, providing measurable indicators of adhesion strength.

What is critical load (Lc) in nano scratch testing?

Critical load (Lc) is the applied load at which a coating fails during a scratch test.

  • Lc1 corresponds to the first visible damage in the coating
  • Lc2 indicates complete coating removal and exposure of the substrate

These values are used to quantify and compare coating adhesion performance.

Why is coating adhesion important in drug-eluting stents?

Coating adhesion directly affects the reliability of drug-eluting stents. Poor adhesion can lead to coating delamination, which may compromise controlled drug release and increase the risk of device failure.

How do you measure coating adhesion inside stent grooves?

Measuring adhesion inside stent grooves requires high positioning accuracy and appropriate indenter geometry. Nano scratch testing with sharp diamond tips allows access to recessed coating regions, enabling direct evaluation of adhesion within complex stent geometries.

What does coefficient of friction (COF) indicate in scratch testing?

The coefficient of friction (COF) reflects changes in surface interaction during the scratch test. A sudden increase in COF often indicates coating failure and contact between the indenter and the underlying metal substrate.

How can nano scratch testing compare different coating formulations?

Nano scratch testing enables direct comparison of coatings by measuring critical loads under controlled conditions. Higher critical loads indicate stronger adhesion and improved resistance to delamination, allowing selection of better-performing coating systems.

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