ElectroForce Testing Instruments for Wide Range of Medical Device Applications

Bose Corporation is well known for its range of high fidelity audio products. The company continues to grow its business, leveraging its intellectual assets in new areas such as medical device design and manufacture. The ElectroForce Systems Group of Bose offers sophisticated mechanical testing instruments to research and product development organizations worldwide.

Better Sound Makes Better Testing Equipment

It is a known fact that rendering sound with lifelike quality is possible only with extraordinary control of a loudspeaker’s motion. Bose engineers developed an innovative electromagnetic linear motor having a durable, patented moving-magnet design. This new motor along with a sophisticated test control system was used to create test instruments with high fidelity and precision. From this time on, the Bose ElectroForce Systems Group has helped researchers and manufacturers worldwide design better products enabling medical device companies bring products to market faster. Table 1 shows the unique breadth of Bose’ capabilities.

Table 1. Unique Breadth of Capabilities

Unique Breadth of Capabilities
Wide range of specimen types Forces range from a few grams to 15 kN to accommodate a wide range of specimens often on the same instrument
Accelerated fatigue testing Frequencies up to 300 Hz can reduce test time required for regulatory test protocols, introducing products to market more quickly
Multi-axial loading Ideal for analysis of isotropic/anisotropic properties and associated strains
Modular, versatile systems Components can be added or removed quickly, creating the configuration needed
Multiple control mode capability Flexibility to control the instrument in a variety of ways, including force, displacement, torque, rotation, and pressure, or combinations of each
Customizable test systems Systems can be configured to meet needs and modular design allows easy upgrades
Import external custom waveforms Enables users to import custom waveforms to replicate physiological conditions
Environmental chambers Stimulation and characterization in physiologically relevant environments, including saline baths and sterile chambers
Secure workspace environment Unique login credentials and electronic tracking complies with 21CFR11, ISO 13485, TGA Annex 11, and similar regulations
Displacement accuracies as low as 2 microns Calibrations done to a full order of magnitude better than ASTM E2390 Class A standards

Cardiovascular Devices

The ElectroForce cardiovascular instruments enable 10 year FDA in-vitro diametric distension tests to be done in just a few weeks. The instruments reduce test time and offer automated long-term control using the Bose proprietary high bandwidth, low distortion linear actuators. It is possible to develop fatigue life curves for NiTi, CoCr and SS stent materials using Bose cardiovascular instruments. The stent/graft testers enable fatigue testing for a wide range of stent sizes.

The Bose direct measurement system makes use of a laser measurement system capable of offering closed-loop feedback pulsatile distension. The company’s specially designed multi-specimen fixture (MSF) enables multi-specimen axial testing of devices. Bose advanced cardiovascular test instruments, including the multi-axial peripheral stent system (MAPS) and drug eluting stent system (DES), can conduct advanced fatigue tests that simulate in vivo conditions better.

ElectroForce® stent/graft 9120 test instrument

Figure 1. ElectroForce® stent/graft 9120 test instrument

Applications

The applications of ElectroForce cardiovascular instruments are:

  • Coronary and peripheral stents (straight, bent or bifurcated)
  • Grafts, leads, catheters and deployment devices
  • Guidewires, septal occluders, nitinol structures
  • Aneurysm clips, percutaneous heart valves, annuloplasty devices
  • Vena cava filters and structures

Orthopedic and Dental Devices

Unique testing and loading solutions are required for dental and orthopaedic applications. Bose offers a testing solution whether one is doing high cycle fatigue life characterization, multi-cyclic load characterization, low amplitude testing, more complex fatigue and fracture mechanics, or dynamic mechanical analysis.

Bose test instruments offer the performance and consistency needed to accomplish these tests and meet regulatory requirements. Test solutions are offered for device characterization in physiologically relevant or ambient conditions at a range of frequencies depending on the regulatory requirements. Furthermore, Bose WinTest® software aids research and development by having the ability to perform non-conventional tests that may fall outside of typical test procedures.

Bose offers a line of standard fixtures that can be used for a range of orthopaedic implant tests and customized solutions for lesser defined test methods. Bose test instruments are also suited for characterizing musculoskeletal tissues such as cartilage, tendon, ligament and bone.

ElectroForce 3510 instrument with hip implant fatigue fixture

Figure 2. ElectroForce 3510 instrument with hip implant fatigue fixture

Applications

The applications of Bose instruments for orthopedic and dental devices include:

  • Spinal devices
  • Small and large joint implants
  • Fracture fixation devices
  • Dental implants and restoratives
  • Device materials
  • Bone and cartilage
  • Tendon and ligament
  • Native constructs and engineered constructs

Reconstruction and Cosmetic Devices

Fatigue testing, wear testing and failure analysis of both biologic and synthetic materials is done by Bose® ElectroForce® instruments. The instruments have the ability to produce superior waveform fidelity and “true” sinusoidal waveform loading, offering more precise failure cycle testing on viscoelastic materials. WinTest® software can offer DMA results to help characterize the implant behavior. Bose has a wide range of compression platens and other fixtures to suit mechanical characterization of a variety of implants.

ElectroForce® 3510 instrument with silicone breast implant

Figure 3. ElectroForce® 3510 instrument with silicone breast implant

Applications

The applications of Bose ElectroForce instruments in reconstruction and cosmetic devices include:

  • Breast implants
  • Chin, jaw, or cheek implants
  • Buttock implant
  • Skin testing
  • Skin extenders
  • High fidelity and precision

Wound Care and Hernia Repair

Isotropic or anisotropic properties and viscoelastic behavior of the specimen is characterized using the ElectroForce planar biaxial TestBench instrument. The Bose test system

The TestBench instruments are provided with a modular design so that an optimal combination of actuators, motors and accessories. It creates the environmental conditions required for the sample in the heated bath while precisely controlling rotation, force or torque. Accessories such as digital video extensometers can help you get the data required.

ElectroForce planar biaxial TestBench instrument with hook grips in a heated saline bath

Figure 4. ElectroForce planar biaxial TestBench instrument with hook grips in a heated saline bath

Applications

The applications of Bose ElectroForce instruments in wound care and hernia repair are:

  • Hernia mesh
  • Wound care
  • Bandages
  • Artificial skin
  • Heart valves

Ophthalmic Devices and Testing

It is tough to test ophthalmic tissues and devices especially because of the small sample size and the low forces required. ElectroForce test systems can test both natural intraocular lens tissues and artificial contact lens in order to characterize compressive, tensile, and shear force limits, as well as cyclic stability and fatigue. Bose spring-loaded grips help in securing the specimen without damaging the tissues. It is possible to test specimens in hot saline baths or inside sterile BioDynamic® chambers in an incubator.

Ophthalmoscopic Image of Retinal Tissues

Figure 5. Ophthalmoscopic Image of Retinal Tissues

Applications

The applications of ElectroForce test systems in ophthalmic devices and testing are:

  • Intraocular lens
  • Contact lens
  • Lacrimal stents & tubes
  • Orbital implants
  • Cataract tension rings
  • Low-force control

Conclusion

Since the founding of Bose 40 years ago, Bose has been committed to electromagnetic technology and research. This ongoing effort caused the development of high-performance linear motors that feature non-friction moving magnet designs which enable lower force and higher frequency testing.

Bose ElectroForce systems show high flexibility, versatility and controllability. With more than 20 years of electromagnetic system engineering and test experience, the Bose ElectroForce Systems Group has established itself as an industry leader in electrodynamic testing and has an established track record of helping customers introduce the devices to market faster.

This information has been sourced, reviewed and adapted from materials provided by TA Instruments.

For more information on this source, please visit TA Instruments.

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