Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Patent
1994-05-24
1998-04-07
Schmidt, Jeffrey A.
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
606154, 623 1, 623 12, A61B 1700
Patent
active
057358630
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention concerns a medical device comprised of a biodegradable guide channel for use in repair and regeneration of nerve tissue, and for the treatment of trauma to peripheral nerves, as well as methods for the preparation of the guide channels and methods of use.
BACKGROUND OF THE INVENTION
Studies to find alternatives to the surgical techniques commonly used for the treatment of trauma to peripheral nerves have led researchers to experiment with various types of nerve guides as aids in the regeneration of damaged nerves. Most of the research in this field has been focalized on the use of channels or tubular guides which hold the nerve stumps in position while regeneration takes place, biological conditions permitting. These miniature pipelines also avoided or delayed the effects of infiltration involving the connective tissue. Examples of such channels or guides are obtained from various polymers or their derivatives (Ducker et al.: vol. 28, J. Neurosurg. 582-587, 1968; Midgley et al.: vol. 19, Surgical Forum, 519-528, 1968; Lundborg et al.: vol. 41, J. Neuropath. in Exp. Neurol., 412-422, 1982; Molander et al.: vol. 5, Muscle & Nerve, 54-58, 1982; Uzman et al.: vol. 9, J. Neurosci. Res. 325-338, 1983; Nyilas et al.: vol. 29, Transactions Am. Soc. Artif. Internal Organs, 307-313, 1983; U.S. Pat. No. 4,534,349, 1985).
Moreover, to increase functional recovery of the damaged nerve, tubular guides have been prepared with biological polymers (or mixtures of the same) traditionally used in nerve repair (Madison et al.: vol. 44, Brain Res., 325-334., 1985; Yannas et al.: vol. 11, Trans. Soc. Biomat. 146, 1985; Williams et al.: vol. 264, J. Comp. Neurol. 284-290, 1987). There have also been studies to assess the possibility of incorporating various growth factors in the guides (Politis et al.: vol. 253, Brain Res. 1-12, 1982; Aebischer et al.: PCTWO 90/05552).
The problem with using growth factors in guides by the known methods is that the guides are not stable in aqueous solutions, their half-life is measurable in hours rather than weeks, while complete nerve regeneration takes weeks. In these conditions release of the factors cannot be controlled and they are often administered in bolus. Consequently long-term stimulation of the nerve cells involved in regeneration is impossible.
Further progress in the field of nerve guides has been made with the preparation of polymers with which to obtain biocompatible and biodegradable guides which remain in place for varying time periods according to the degree of chemical modification performed on the natural polymer, the type of substitute used (Favero G. et al.: XXXVI Trans. Am. Soc. Artif. Organs, M291-M294, 1990).In this case, too, the nerve stumps are fixed inside the guide by means of a suture, but given the nature of the material used it is possible to obtain selective transport of matter through the channel membrane, thereby creating the ideal environment round the regenerating nerve. These materials combine the advantages of a reabsorbable guide for nervous regeneration with the possibility of creating the best environment for growth. Various methods have been proposed for the construction of guides using biocompatible and bioabsorbable material. The simplest and quickest method is by extruding a biocompatible and bioabsorbable material through a suitable die. The use of guides made with some biocompatible and bioabsorbable materials and produced by extrusion or other manufacturing techniques is limited by their tendency to tear while being surgically stitched to the nerve stump.
There remains, therefore, a need for biocompatible and bioabsorbable guide channels for use in the treatment of damaged nerves, wherein the guide channels are resistant to tearing and provide an enhanced environment for nerve growth in combination with growth factors which stimulate, enhance, or promote nerve regeneration, growth and repair.
SUMMARY OF THE INVENTION
The present invention, therefore, provides improved guide channels comprised o
REFERENCES:
patent: 4534349 (1985-08-01), Barrows
patent: 4851521 (1989-07-01), della Valle
patent: 5147399 (1992-09-01), Dellon et al.
Madison et al., Brain Research, 447, 325-334 (1988).
Favaro et al., Trans. Am. Soc. Artif Intern. Organs, 36 M291-M294 (1990).
Williams et al., J. Comparative Neurology, 264, 284-290 (1987).
Politis et al., Brain Research, 253, 1-12 (1982).
Yannas et al., Trans. Soc. Biomat., p. 146 (1985).
Callegaro Lanfranco
della Valle Francesco
Romeo Aurelio
FIDIA S.p.A.
Schmidt Jeffrey A.
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