Resorbable collagen membrane for use in guided tissue regenerati

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...

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424443, 424402, A01N 2534, A61L 1516

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active

058372784

DESCRIPTION:

BRIEF SUMMARY
The present invention is concerned with wound healing and in particular with the use of a collagen-containing membrane in guided tissue regeneration.
In any situation, such as following surgery especially oral or dental surgery, where wound healing is desirable, it has proved to be difficult to provide conditions which prevent ingrowth of other tissues into the area where regeneration is required. Thus, for example, where a substantial portion of a tooth root is removed due to decay or disease, it is desirable that healthy bone regeneration occurs to replace the bone tissue removed. However, it has been found that the cavity left by removal of the bone is quickly filled by connective tissue and that this ingrowth of connective tissue effectively prevents bone regeneration.
In order to overcome such difficulties the technique known as "guided tissue regeneration" has been developed. In this method a membrane is surgically inserted around the periphery of the wound cavity. The membrane prevents or hinders the invasion of the wound cavity by unwanted cell types and thus allows the preferred cells to grow into the cavity, thereby healing the wound.
Two membrane types are currently used in guided tissue regeneration:
1) Synthetic, non-resorbable PTFE membranes, such as Goretex (trade mark); and
2) Synthetic resorbable membranes formed from glycolide and lactide copolymers.
However, both of these membrane types suffer from serious disadvantages. The PTFE membrane, although exhibiting suitable characteristics of porosity, strength and flexibility, remains non-resorbable and therefore a second surgical operation is required to remove the membrane. The requirement for further surgical procedures may be traumatic for the patient and may also damage the new tissue regenerated thus extending the treatment period.
The second membrane type is woven from glycolide and lactide copolymer fibres. Whilst this membrane is resorbable the breakdown products are irritant and this irritance may have undesirable effects on the patient.
Both prior art membranes act as filters, allowing liquids to pass freely and forming a barrier to cells. However, the membrane surface is not "cell-friendly", ie. it does not stabilise blood clots or support cell growth. Consequently, neither of the prior art membranes provide optimal conditions for cell growth and wound healing.
We have now found a membrane with ideal characteristics for guided tissue regeneration.
The present invention provides a resorbable collagen membrane for use in guided tissue regeneration wherein one face of said membrane is fibrous thereby allowing cell growth thereon and the opposite face of said membrane is smooth, thereby inhibiting cell adhesion thereon.
The two opposing sides or faces of the membrane thus have different textures which affect cell growth in different ways.
The smooth side acts as a barrier or filter to hinder cell ingrowth and will prevent undesirable cell types from colonising the cavity described by the membrane through physical separation. By contrast, the fibrous side of the membrane is haemostatic (stabilises blood clots) and aids cell growth by providing a suitable support for the new cells. In use, therefore, the membrane should be inserted with the smooth side outermost and the fibrous side facing the cells where regeneration is desired.
The membrane for use in guided tissue regeneration according to the present invention may be derived from a natural collagen membrane. Being derived from a natural source, the membrane for use in the present invention is totally resorbable in the body and does not form toxic degradation products.
Further the membrane has a tear strength and tear propagation resistance comparable to that of textile material in both wet and dry states. The membrane can therefore be surgically stitched if required. The membrane material is strongly hydrophilic and has good adherence when wet allowing several layers to be stacked together. When moist the material is very elastic which allows irregularly shaped or uneven wounds to b

REFERENCES:
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patent: 4185011 (1980-01-01), Eckmayer et al.
patent: 4674488 (1987-06-01), Nashef et al.
patent: 4725671 (1988-02-01), Chu et al.
patent: 5028695 (1991-07-01), Eckmayer et al.
patent: 5573771 (1996-11-01), Geistlich et al.

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