Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1997-09-30
1999-10-26
Azpuru, Carlos
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
523115, A61F 206
Patent
active
059723718
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a biodegradable device to aid healing.
DESCRIPTION OF THE RELATED ART
Advances in surgical techniques, particularly micro-surgical techniques, have enabled operations for re-joining or aligning severed nerves and blood vessels to be undertaken. However, to be successful such operations still rely upon the natural healing and regeneration processes of the body. Thus, even where the surgeon has exerted considerable skill in aligning nerve ends, there will be cases where the parts of nerves fail to re-join, or where the healing process is so slow that the effector muscle has atrophied by the time that the motor nerve connection becomes effective.
Healing, for example nerve regeneration, remains an essentially biological process. Even the most advanced micro-surgical techniques for repairing damaged tissue members merely optimise the environment for the natural process. It is now believed that micro-surgery has maximised the mechanical processes for body repair, but a need still exists for enhancing the healing process still further.
Tubes have been used to repair severed nerves, but have enjoyed little success because the non-biodegradable tubes remained after the regenerating nerve had been established and impeded subsequent maturation of the nerve.
GB-A-2,099,702 describes a structural support member for skeletal and tissue members comprised of a biodegradable glass. However, for the healing process to be successful it is essential that the correct chemical environment is created to optimise the regeneration of the damaged body part, whilst protecting that part from the body's own defence system which can be activated against implanted foreign bodies.
In one aspect, the present invention provides a biodegradable device of hollow construction having first and second apertures, each aperture being adapted to receive a cut end of a tissue member which is secured therein by means of a fixant, and wherein at least part of the portion of said device between said apertures contains a substance to facilitate healing of said tissue member.
Generally the device will be tubular. For example the device may be an open-ended tube, the two open ends forming the apertures for receiving the ends of the cut tissue member.
For convenience of manufacture the device may be essentially an open-ended cylinder of uniform internal cross-section. Alternatively, the device may incorporate a reservoir portion, in which reserves of the substance are located. In this embodiment the device may be tubular, but have an internal cross-section of varying diameter, for example of increased diameter in the portion between said apertures. To optimise the healing together of the two cut ends secured in the device, the apertures may be arranged to face each other. However, in certain instances this arrangement may not be essential, and the aperatures need not be aligned.
The device of the present invention may be formed from a biodegradable glass. Such glasses are known to those skilled in the art and the composition of the glass may be adjusted to produce a glass composition that biodegrades over the period required, for example 1 to 6 months, or 1 to 3 months. Desirably the products resulting from degradation of the glass are physiologically compatible.
Additionally, the glass composition may itself be used as a vehicle to deliver biologically active agents in a controlled release manner over the period during which healing occurs. Controlled Release Glasses (CRG) are inorganic polymers, normally based on phosphates of sodium and calcium, which have been converted into a glassy form by melting the constituents at about 1000.degree. C. CRGs dissolve in water completely leaving no solid residue.
The rate of dissolution can be selected by adjustment of the composition and physical form of the CRG and is constant for as long as any of the material remains. The product can be produced in many physical forms; as a powder or granules, fibre or cloth, tubes, or as cast blocks of various shapes
REFERENCES:
patent: 3786817 (1974-01-01), Palma
patent: 4863668 (1989-09-01), Griffiths et al.
patent: 4963146 (1990-10-01), Li
Gilchrist Thomas
Healy David Michael
Azpuru Carlos
Giltech Limited
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