A new flexible fixation device for the lumbar spine has been developed. This paper describes the development and evaluation of two surgical instruments required for implanting this device. Prototypes were designed, manufactured and then evaluated for use in surgery. Further evaluation was performed, if necessary, and the design finalized, in accordance with BS EN 12011. This process involved close collaboration between engineers and surgeons.
BS EN 12011: 1998 Instrumentation to be Used in Conjunction with Non-active Surgical Implants. General Requirements, 1998 (British Standards Institute, London).
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PappT.PorterR. W.AspdenR. M.ShepherdJ. A. N.An in vitro study of the biomechanical effects of flexible stabilisation on the lumbar spine. Spine, 1997, 22, 151–155.
3.
LeahyJ. C.MathiasK. J.HeatonA.ShepherdD. E. T.HukinsD. W. L.DeansW. F.BrianM. W.WardlawD.Design of spinous process and laminar hooks for flexible fixation of the lumbar spine. Proc. Instn Mech. Engrs, Part H, Journal of Engineering in Medicine, 2000, 214 (accepted).
4.
ASTM F1717 Standard Test Methods for Static and Fatigue for Spinal Implant Constructs in a Corpectomy Model, 1996 (American Society for Testing and Materials, Philadelphia, Pennsylvania).
5.
LeahyJ. C.MathiasK. J.HukinsD. W. L.ShepherdD. E.T.DeansW. F.Mechanical testing of a flexible fixation device for the lumbar spine. Proc. Instn Mech. Engrs, Part H, Journal of Engineering in Medicine, 2000, 214 (accepted).
GardnerA. D. H.Lumbo-sacral and spondyl-pelvic arthrodesis. In Lumbar Spine Disorders: Current Concepts (Eds AspdenR. M.PorterR. W.), 1995, pp. 185–208 (World Scientific, Singapore).
8.
CrenshawA. H.Campbell's Operative Orthopaedics, 7th edition, 1987, p. 2535 (The C. V. Mosby Company, USA).
9.
Medical Device Directive. Official J. European Community, 1993, 36, 1–43.