AU2014100880A4 - ?TLIF in a box? is a concept that has been developed to facilitate minimally invasive spinal surgery in a way that provides substantial improvement in efficiency and cost effectiveness. The ?TLIF in a box? concept requires the surgeon to be interactive in the planning of surgery in such a way that surgical planning can be predetermined and a patient specific solution be pre-packaged to facilitate lumbar interbody fusion. Surgeons with only basic equipment can perform state of the art lumbar interbody fusion surgery at any standard hospital facility throughout the world. - Google Patents

Abstract

"TLIF in a box" is a concept that has been developed to facilitate minimally invasive spinal surgery in a way that provides substantial improvement in efficiency and cost effectiveness. The "TLIF in a box" concept requires the surgeon to be interactive in the planning of surgery in such a way that surgical planning can be predetermined and a patient specific solution be pre-packaged to facilitate lumbar interbody fusion. "TLIF in a box" concept has been developed so that surgeons with only basic equipment can perform state of the art lumbar interbody fusion surgery at any standard hospital facility throughout the world. "TLIF in a box" packages the spinal device technology into a small sterilised set of instruments and devices that can be packaged and easily transported. tbJ ;5 o rD rrD 77 00o~m _0-iC) 0 0 Cr r 0 (D r) 0 3 CrO _0 Cr Er artD ~rtD

Description

EDITORIAL NOTE THERE ARE 3 PAGES OF DESCRIPTION TLIF in a box Introduction Minimally invasive spinal (MIS) surgery is becoming the standard care for the treatment of spinal disorders. The evolution of MIS surgery has been dependent on the development of new technologies. Such technologies include; prosthetic devices such as screws and rods, interbody fusion cages and access retractors to allow the surgeon to perform placement of such devices via small incisions and openings into the patient's body. In regard to the lumbar spine, minimally invasive surgical technique will be applied to the operation of transforaminal lumbar interbody fusion (TLIF). A minimally invasive transforaminal lumbar interbody fusion or TLIF can be performed by four small 2cm incisions in the lumbar region. Into the incisions it us used to place pedicle screws, one of the incisions is used to place a retractor system so that the surgeon can see the anatomical elements such as the nerve roots and intervertebral disc. The surgeon uses a retractor to perform laminectomy to decompress the associated exiting nerve roots, perform lumbar discectomy and prepare the interbody space and then place bone graft and an interbody cage to facilitate interbody fusion. The MIS TLIF has evolved to a stage where a surgery can be performed in a highly repeatable fashion with a high degree of safety and repeatability of outcome. MIS TLIF is a suitable procedure to treat any level in the lumbar spine for most of the common pathologies that the spinal surgeon encounters. In order to evolve this procedure to a greater level of ergonomic efficiency and safety and best possible patient outcomes, 3D printing and rapid prototype technology have now been used to facilitate these outcomes. "TLIF in a box" is a concept that has been developed to facilitate minimally invasive spinal surgery in a way that provides substantial improvement in efficiency and cost effectiveness. The "TLIF in a box" concept requires the surgeon to be interactive in the planning of surgery in such a way that surgical planning can be predetermined and a patient specific solution be pre-packaged to facilitate lumbar interbody fusion. "TLIF in a box" concept has been developed so that surgeons with only basic equipment can perform state of the art lumbar interbody fusion surgery at any standard hospital facility throughout the world.

2 "TLIF in a box" packages the spinal device technology into a small sterilised set of instruments and devices that can be packaged and easily transported. "TLIF in a box" requires: 1. CT scan of the spine to be performed preoperatively 2. The surgeon requires a computer with internet access 3. The hospital requires an operating theatre with an image intensifier and a radiolucent operating table. With these basic requirements, a surgeon anywhere in the world can perform a minimally invasive transforaminal lumbar interbody fusion safely, efficiently and in a highly cost effective manor. The surgeon can have patient specific instruments and retractors and the highest quality prosthetic devices to perform surgical intervention. It is anticipated that a "TLIF in a box" package will contain the following: 1. A patient specific template to map skin incisions and assist with trajectory placement of Jam Shidi needles. 2. Nitolon K-wires 3. Jam Shidi needles 4. Tissue dilators with both electrocautery and neural monitoring capacity 5. Patient specific smart tube retractors for bone graft harvesting and interbody fusion cage delivery purposes. Such retractors will have incorporated within them fixation aids to the patient anatomy. Trajectory guides for K-wire assisted placement. Suction and irrigation channels, illumination mechanism, electrocautery and electrophysiological monitoring capacity. Patient specific contour matching is incorporated within the retractor. 6. Predetermined off the shelf devices including pedicle screws, interconnecting rods, lockers. 7. Intervertebral cage preferably distractible in a 3-dimensional fashion. 8. Bone substitute to repair the bone donor site and for interbody or posterolateral fusion augmentation. 9. Taps to assist with pedicle screw placement. 10. Disposable drill bit 11. Disposable bone mill attachment 12. Bone morphogenic protein in a predetermined volume 3 It is anticipated that the contents of the "TLIF in a box" will be disposable and single use only. The components will be provided sterile. It is anticipated that a biomodel of the spine will be provided to the surgeon prior to delivery of the "TLIF in a box" to facilitate preplanning characterisation of components of a "TLIF in a box". It is anticipated that a standard set of reusable instruments will be required at the hospital, such instruments would include: * Distractor and instruments * Appropriate osteotomes * Instruments to facilitate preparation of the interbody space for bone grafting and cage placement * Power driver for placement of pedicle screws * Bone mill for preparation of bone graft * High speed electric drill * Standard instruments to perform lumbar spinal surgery Paul D'Urso 21 July 2014

Claims (1)

1. 3-D printer device. Incorporated into the device is a fixation point corresponding to the intersection of the vector with the selected anatomy. The fixation point is used by way of a cannulated screw which is guided down the K-wire inserted into the patient's bone in such a way that the retractor is then secured to the bone. It can be appreciated that a cannulated screw is one embodiment of a device to secure the retractor. Other embodiments may include staples or pins. Step 6. Incorporated into the retractor, computer aided design can allow for specific grooves, channels or instruments to conform with the contour of the retractor in such a way as to 2 mark, localise or perform predetermined surgical intervention. In this way, the access device can be used to guide instruments; for example to perform osteotomy, monitor neural function, guide instruments to perform intervertebral disc clearance and preparation and to guide, place and deliver an intervertebral cage prosthesis in an accurate manner. Such a patient specific retractor may also incorporate ancillary channels to allow suction of fluid from the internal aperture of the device or irrigation of fluid into the internal aperture of the device. Step 7. The dilators to be used to assist in placement of the access device may incorporate components that allow electrocautery by way of diathermy to be used at the tip of the dilator where the interface of tissue and bone occurs. Such dilators may also include components that allow neurophysiological monitoring of the surrounding tissue and associated structures. Such dilators may also contain channels to allow irrigation and suction to occur. Step 8. Such a patient specific access retractor may also incorporate components to allow electrophysiological monitoring of surrounding structures and tissue. Step 9. Such a patient specific retractor may also incorporate components to allow diathermy and cauterisation of surrounding tissue. Such an access retractor may be impregnanted with antimicrobial substance or surface coating to reduce the risk of infection. Step 10. Such a patient specific retractor may incorporate within it radio-opaque markers to allow verification of positioning by way of image intensification, but not to the extent that they would obscure patient anatomy. Step 11. Such a patient specific retractor may facilitate localisation to other areas of anatomy for example to harvest bone graft without instruments for the purpose of harvesting bone graft and reconstructing donor site anatomy. Paul D'Urso 12 July 2014