Medical Device

Medical devices can be comprised of a diverse selection of materials that are used in and around the body. It is important to know which materials the body will accept upon implantation and their mechanical properties once implanted. At Ebatco, material testing is handled by our skilled team of laboratory scientists. Our laboratory scientists use the utmost care when handling customer samples, conduct material testing efficiently and accurately, and prepare professional reports that give results both numerically and graphically. The services and data that Ebatco provides will integrate well into your company’s development or verification plan.

Whether testing the hardness of your hip implants or the surface roughness of your implantable electronic, Ebatco has you covered. It is essential to understand the material properties of marketable medical devices because human lives are affected upon implantation. It is important to understand adhesion properties and the body’s ability to incorporate the material into its internal system. Let our team of scientists perform precise testing to provide the desired knowledge about a given material’s properties.

Ebatco has a wide array of material testing instrumentation that allows for a versatile user experience. Our full-service laboratory can support your needs during the early stages of your product development, later stages of development, and also post-market sample testing and verification. Ebatco has instrumentation to complete mechanical testing, in the micro- and nano- scale, on material samples. If you have any questions about the services or instrumentation available at Ebatco, feel free to call or email and a member of our team will be able to further assist you.

Applications

“Ebatco offers quality analytical services with a remarkable turnaround time. As a subcontractor, Ebatco has expanded the offerings of our company’s services which has enabled us to grow revenue with new contracts.” -Robert Kellar, President, Bioengineering Firm

“We used the Zeta potential and the contact angle services-both were very helpful.” –Tony Anderson, Senior Scientist, Drug Delivery Medical Device Company

For more information please read our application notes:
Advancing and Receding Angles of biomedical catheters
Friction of Contact Lenses in Saline Solution
Glass Transition Temperature Measurements Using Dynamic Mechanical Analysis
In-situ and Small-Volume Fracture Toughness Measurement via Nanoindentation
Interfacial adhesion evaluation of paint coating on Pepsi Can through Scratch Testing
Light Load Reciprocating Wear of Computer Hard Disk Coatings
Melting Temperature and Latent Heat of Fusion of Indium
Micro Contact Angle Measurements on Single Particles, Filaments and Patterned Surfaces
Nanoindentation for hardness and elastic modulus measurements at nanoscale
Particle Sizing of Tap and Bottled Water
Refractive Index Measurements to Compare Chemical Purity
Scratch Failure Characteristics of DLC Coating on M2 Steel
SEM EDS Analysis on Scratch Failure of PTFE Coated Stainless Steel Guide Wire
Surface and Interfacial Tension of Liquids
Wear Resistance Evaluation and Debris Generation Study through Nano Wear
Zeta Potentials of Solid Surfaces

SEM EDS Analysis on Scratch Failure of PTFE Coated Stainless Steel Guide Wire

Coatings are used on a wide variety of substrates such as metals, alloys, semiconductors, polymers, biomedical devices for decorative or functional purposes. The adhesion behaviors of coatings are essential to their applications. Scratch test is one of the broadly used, fast, and effective methods to evaluate coating adhesion properties. During a scratch test, a stylus or scratch tip gradually penetrates into a coating under a progressive load while it also moves across the coating sample. The normal load at which the coating fails due to delamination or other separation mechanisms is called the critical load of interfacial adhesion failure. The critical load of interfacial adhesion failure is related to the practical adhesion strength of the coating to the substrate. One complementary technique for analyzing scratch failure of coating is Scanning Electron Microscopy (SEM) equipped with Energy Dispersive X-ray Spectroscopy (EDS). Working in tandem, SEM and EDS analyses can reveal a tremendous amount of useful information on scratch failure processes and mechanisms, as well as material anti-scratch properties. With the SEM system, micrographs can be taken for morphological inspection in order to understand how the scratch surface is forming and changing. The SEM micrographs of the scratch surfaces can reveal much more details as a result of SEM’s larger depth of field, higher resolution and greater magnification than the optical microscope available on a scratch tester. In addition to SEM observations, the EDS system can further assist in identifying and quantifying the chemical compositions of the micro areas of interest by measuring the characteristic X-rays produced by atoms that are present in the coating and substrate materials.

PTFE coated stainless steel guide wires are popular in many medical applications. PTFE coatings are applied to the wire surface for smooth surface finish, reduced friction, increased lubricity and durability of the guide wire. Obviously the PTFE coating adhesion to the guide wire is critical not only for the desired functionalities but also for the health and safety of the patient to whom the guide wire is to be used. An undesired issue would be flaking of the coating material due to adhesion problems, which could lead to blockage of a passage or clogging of blood vessels. Figure 1 is an SEM image of a PTFE coated stainless steel guide wire after scratch test. Blue color box Zone 1 includes scratch before interfacial adhesion failure, transitional Zone 2 in which adhesion failure occurred, steady scratch Zone 3 and scratch end Zone 4. The bright scratch track in Zones 2-4 indicates non-existence of the PTFE coating and exposure of the stainless steel substrate.

Figure 2 shows the elemental profiles of Zone 1 with the EDS line scanning across the entire scratch. The EDS compositional analysis has verified the morphological interpretations of the SEM image; the coating has in deed delaminated in Zone 2 where element Fe from stainless steel substrate increases and C and F from the PTFE coating decreases. The zoom-in SEM images and EDS elemental Hypermaps of the Zones 2-4 presented in Figure 3 provides further details of the elemental distributions of the coating and substrate materials along the scratch.