The cost of treating lower back pain in the US has been estimated at $90bn per year in 2008, with a further $10bn-20bn in costs through lost productivity. A significant portion of the expense is attributable to spinal fusion surgery. Melbourne-based company Anatomics seeks to improve the efficiency of fusion surgery by reducing the manufacturing and supply cost of equipment and optimising the workflow within surgery without compromising clinical outcomes.

Anatomics has developed an innovative solution involving a custom patient-specific kit, SpineBox, that is 3D-printed using EOS’ selective laser sintering (SLS) technology in Nylon 12 powder. The SpineBox kit greatly simplifies minimally invasive transforaminal lumbar fusion surgery (MIS TLIF) and can be adapted to support most spinal fusion techniques.

Anatomics is an Australian-owned medical device company that has been manufacturing and marketing surgical products to surgeons locally and internationally since 1996. Anatomics pioneered CT scan-derived surgical implant technology and was first to market with an innovative, quality product that assisted surgeons to produce better surgical outcomes and save valuable operating theatre time. The company’s customers include neurosurgeons, plastic & reconstructive surgeons, oral & maxillofacial surgeons, orthopaedic surgeons, ENT surgeons and thorasic surgeons.

Using patient imaging in the form of computed tomography (CT) data together with custom planning software developed by Anatomics, a patient-specific solution is designed involving screws, rods and an intervertebral spacer (cage) for each MIS TLIF procedure. A 1:1 scale model of the patient’s spine is 3D printed with stereolithography apparatus (SLA) or EOS SLS from Nylon 12, and provided for the surgeon and patient to verify the surgical plan pre-operatively.

Patient-specific SpineTube muscle retractors and anatomically matched templates for surgery are also manufactured from EOS SLS Nylon 12 and sterilised. Based on preoperative measurements, the required titanium implants are pre-ordered and packaged with the SLS Nylon 12 instruments and provided as a SpineBox kit to the hospital before surgery.

The pre-planned specifications for the spinal construct can be mapped into the bony spine from the skin surface using the template and stainless steel pins known as Kirschner wires, with minimal radiography. Once deployed, the Kirschner wires provide a railroad for all subsequent instrumentation. The patient-specific SpineTube muscle retractor manufactured to match the skin to spine depth is then temporarily affixed to the spine with an insert and locking screw. The unique insert doubles as an osteotomy guide. Together, these novel 3D-printed instruments facilitate nerve decompression, fusion cage implantation, and accurate completion of the spinal construct.

Anatomics had a simple decision to make when deciding on the optimal technology for the required 3D printed components. EOS SLS Nylon 12 was the obvious choice as it is the virtual standard for highly accurate, biocompatible (for transient use), and mechanically strong components for surgical cutting and drilling guides worldwide. EOS’s reputation for engineering and after-sales support excellence was also a critical factor that swayed Anatomics behind EOS technology.

Spinal surgery is a complicated business requiring an extensive, costly support network. The SpineBox method of pre-planning surgery and manufacturing customised devices developed by Anatomics and enabled by EOS has the potential to realise significant time and cost benefits to the healthcare system. As of August 2019, the system has been used in more than 300 patients in Australia, and Anatomics is set to export the technology globally in 2020.

EOS will be a critical supply partner in that global expansion. Medical companies in Australia have increasingly come to rely on EOS’s additive manufacturing solutions to produce orthopaedic implants, surgical instruments, orthotics, orthosis, dental devices and other medical devices.

John Hart offers world-class additive manufacturing solutions from EOS in Australia. As well as the necessary materials and systems for additive manufacturing, EOS provides comprehensive market knowledge and a precise understanding of specific development processes in the field of medical technology enable EOS to collaborate closely with a strong network of partners. From rapid prototyping to series production, EOS provides comprehensive and competent advice and continuous support to customers during the entire development and production process.

Every person is unique. Therefore, optimal patient care requires medical products that provide a perfect fit. There is a high demand for one-off components and components produced in small production runs whose materials and manufacturing standards have to fulfil extremely stringent quality requirements. This also applies to specialised surgical instruments and medical devices. In addition, these products must be made available quickly and cost-effectively.

Additive manufacturing is meeting these exact requirements while paving the way for improved, patient-specific medical care. Additive manufacturing enables producers to come up with faster, more flexible and more cost-effective development and production methods. Unlike conventional manufacturing methods, it allows maximum design flexibility, enabling the implementation of innovative functions. Consequently, test series, prototypes, patient-specific one-off parts and small production runs can be manufactured at a profit.

www.johnhart.com.au/additive-manufacturing
www.anatomics.com