A Multi-component Fiber-reinforced PHEMA-based Hydrogel/HAPEX TM Device for Customized Intervertebral Disc Prosthesis

Abstract

Spinal disease due to intervertebral disc degeneration represents a serious medical problem which affects many people worldwide.

Disc arthroplasty may be considered the future ‘‘gold standard’’ of back pain treatment, even if problems related to available disc prostheses are considered. Hence, the aim of the present study was to improve the artificial disc technology by proposing the engineering of a pilot-scale device production process for a total multi-component intervertebral disc prosthesis. The device is made up of a poly(2-hydroxyethyl methacrylate)/poly(methyl methacrylate) (PHEMA/PMMA) (80/20 w/w) semi-interpenetrating polymer network (s-IPN) composite hydrogel reinforced with poly(ethylene terephthalate) (PET) fibers as annulus/nucleus substitute, and two hydroxyapatite-reinforced polyethylene composite (HAPEX^TM) endplates in order to anchor the multi-component device to the vertebral bodies. Static and dynamic—mechanical characterization show appropriate mechanical behavior. An example of engineering of a suitable pilot-scale device production process is also proposed in order to manufacture custom made implants.

Keywords

intervertebral disc reverse engineering technologies fiber-reinforced hydrogel customized prosthesis multi-component model mechanical testing.

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References

Bao, Q.B. , McCullen, G.M. , Higham, P.A. , Dumbleton, J.H. and Yuan, H.A. The Artificial Disc: Theory, Design and Materials, Biomaterials, 1996: 17: 1157-1167.

Traynelis, V.C. Spinal Arthroplasty, Neurosurg. Focus, 2002: 13: 1-7.

Bao, Q.B. and Yuan, H.A. Artificial Disc Technology, Neurosurg. Focus, 2000: 9: 1-7.

Goel, V.K. , Nishiyama, K. , Weinstein, J.N. and Liu, Y.K. Mechanical Properties of Lumbar Spinal Motion Segments as Affected by Partial Disc Removal, Spine, 1986: 11: 1008-1012.

Hanley Jr, E.N. and Shapiro, D.E. The Development of Low-back Pain After Excision of a Lumber Disc, J. Bone Joint Surg. (Am), 1989: 71-A: 719-721.

Markolf, K.L. and Morris, J.M. The Structural Components of the Intervertebral Disc, J. Bone Joint Surg. (Am), 1974: 56: 675-687.

Rothman, R.H. and Simeone, F.A. ( 1992). The Spine, 3rd edn, Philadelphia, WB Saunders Company.

Cassidy, J.J. , Hiltner, A. and Baer, E. Hierarchical Structure of the Intervertebral Disc, Connective Tissue Res., 1989: 23: 75-88.

Shikinami, Y. , Kotani, Y. , Cunningham, B.W. , Abumi, K. and Kaneda, K.A. Biomimetic Artificial Disc with Improved Mechanical Properties Compared to Biological Intervertebral Discs, Adv. Funct. Mater., 2004: 14: 1039-1046.

10.

Buttner-Janz, K. ( 1992). The Development of the Artificial Disc SB Charité , Dallas, Hundley & Associates .

11.

Serhan, H. , Kuras, J. , Mcmillin, C. and Persenaire, M. Spinal Disc Prosthesis, WO/1999/20209.

12.

Rohlmann, A. , Zander, T. and Bergmann, G. Effect of Total Disc Replacement with ProDisc on Intersegmental Rotation of the Lumbar Spine, Spine, 2005: 30: 738-743.

13.

Bonfield, W. , Wang, M. and Tanner, K.E. Interfaces in Analogue Biomaterials, Acta Mater., 1998: 46: 2509-2518.

14.

Ton That, P.T. , Tanner, K.E. and Bonfield, W. Fatigue characterization of a hydroxyapatite-reinforced polyethylene Composite. I. Uniaxial Fatigue, J. Biomed. Mater. Res., 2000: 51: 453-460.

15.

Ton That, P.T. , Tanner, K.E. and Bonfield, W. Fatigue Characterization of a Hydroxyapatite-reinforced Polyethylene Composite. II. Biaxial Fatigue, J. Biomed. Mater. Res., 2000: 51: 461-468.

16.

Gloria, A. , Causa, F. , De Santis, R. , Netti, P.A. and Ambrosio, L. Dynamic-mechanical Properties of a Novel Composite Intervertebral Disc Prosthesis , J. Mater. Sci.: Mater. Med., 2007: 18: 2159-2165.

17.

Ambrosio, L. , Causa, F. , De Santis, R. and Nicolais, L. Composite Biomimetic Total Intervertebral Disc Prosthesis, WO/2007/007284.

18.

Astm F. 2346 - 05. Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs, ASTM 2005.

19.

Peppas, N.A. ( 1987). Hydrogels in Medicine and Pharmacy, Florida, CRC Press, Boca Raton.

20.

Davis, P.A. , Huang, S.J. , Ambrosio, L. , Nicolais, L. and Ronca, D. A Biodegradable Composite Artificial Tendon , J. Mater. Sci.: Mater. Med. 1991: 3: 359-364.

21.

Netti, P.A. , Shelton, J.C. , Revell, P.A. , et al. Hydrogels as an Interface Between Bone and an Implant, Biomaterials, 1993: 14: 1098-1104.

22.

Hoffman, A.S. Hydrogels for Biomedical Applications, Adv. Drug Deliv. Rev. 2002: 43: 3-12.

23.

Ambrosio, L. , Netti, P.A. , Iannace, S. , Huang, S.J. and Nicolais, L. Composite Hydrogels for Intervertebral Disc Prostheses, J. Mater. Sci.: Mater. Med., 1996: 7: 251-254.

24.

Ambrosio, L. , De Santis, R. and Nicolais, L. Composite Hydrogels for Implants, Proc. Instn. Mech. Engrs. , 1998: 212: 93-99.

25.

Tanner, K.E. , Downes, R.N. and Bonfield, W. Clinical Application of Hydroxyapatite Reinforced Polyethylene, Brit. Cer. Trans., 1994: 93: 104-107.

26.

Cassidy, J.J. , Hiltner, A. and Baer, E. The Response of the Hierarchical Structure of the Intervertebral Disc to Uniaxial Compression, J. Mater. Sci.: Mater. Med., 1990: 1: 69-80.

27.

Martz, E.O. , Goel, V.K. , Pope, M.H. and Park, J.B. Materials and Design of Spinal Implants - A Review, J. Biomed. Mater. Res. (Appl. Biomater.), 1997: 38: 267-288.

28.

White, A.A. and Panjabi, M.M. ( 1990). Clinical Biomechanics of the Spine, Philadelphia, PA , J B Lippincott Co.

29.

Farfan, H.F. , Cossette, J.W. , Robertson, G.H. , Wells, R.V. and Kraus, H. The Effects of Torsion on the Lumbar Intervertebral Joints: The Role of Torsion in the Production of Disc Degeneration, J. Bone Joint Surg. (Am.), 1970; 52A: 468-497.