TSPACE® 3D
Transforaminal Interbody Fusion System
The Technology of laser sintering – a well-established additive layer by layer process
Additive manufacturing – 3D printing – means a layer by layer process to design a device using laser beam and metal powder. This innovative laser beam melting technology is of growing importance in the manufacture of implants, as it allows to create various fine and porous surface structures with the aim to support bone-ingrowth. Homogenous or heterogeneous lattice structures or combinations of various kinds of structures and surfaces are generally conceivable.
- Direct assembly of the component based on 3D-CAD data
- Design freedom
We combined our long-time experience in designing and manufacturing spinal implants with latest technology and produce in-house our AESCULAP® 3D Cages.
Intendend Use
- Stabilization of the lumbar and thoracic spine through transforaminal approach, monosegmental and multisegmental.
- Always use TSPACE® 3D in conjunction with an internal fixator.
- TSPACE® 3D can be implanted through an open or minimally invasive transforaminal access.
Implant Design
- Solid frame without sharp edges for biomechanical stability and smooth insertion into the disc space minimizing the risk to injure surrounding soft tissue.
- Open porous structure designed to provide primary and secondary stability.
- The implant’s anatomical endplate design provides a good contact area between implant and vertebral endplates whilst allowing addition of bone material to enable bone growth through the center of the implant.
- Bulleted nose for smooth insertion into the disc space.
- The articulating interface allows a firm connection to the inserter until the final implant positioning is achieved, thus enabling a controlled insertion.
- Good visibility in X-ray to localize implant positioning.[1], [2]
[1] Usability-Test, Usability Validation of AESCULAP® TSPACE® 3D Cages, Tubingen, 2019. The usability of the AESCULAP® 3D Cage System TSPACE® 3D was tested in April 2019, in a cadaver workshop with six independent test persons as intended users (surgeons specialized in spinal surgery or comparable fields). Parameters such as implant visibility under x-ray control, mechanical stability of the implant/instrument interface and implant surface evaluation in terms of tissue injury risk were tested among others. Acceptance criteria were fulfilled for all the above-mentioned parameters. All test users confirmed the absence of critical features that must be improved prior to clinical use.
[2] Rehnitz, Christoph, PD Dr. med. Radiological image evaluation of AESCULAP® interbody fusion devices, Heidelberg, 2019. CT and X-ray visualization of different AESCULAP® interbody fusion cages (full titanium, porous Ti6Al4V and PLASMAPOREXP® cages) was tested in a cadaver setup. A radiologist evaluated the implant visibility and the presence of artefacts that may limit the visualization of adjacent structures. Visualization and assessment of implant position was achieved in X-ray and CT for all tested cages. Minor artefacts were visible in CT reconstructions in the surrounding of porous Ti6Al4V and full titanium implants. Porous Ti6Al4V implants showed slightly fewer artefacts in CT in comparison to full titanium implants. The minor artefacts observed did not limit the assessment of the surrounding anatomical structures.