Methods for preparing biopolymer foams

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert

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424425, 514773, 514774, A61F 202, A01N 2516

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059484292

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

Collagen sponges or foams have been used as hemostatic agents and more recently as scaffolds for tissue repair in vivo and as research tools in vivo for seeding various cell types to study cell functions in three dimensions. Collagen sponges have a low immunogenicity and consist of a naturally occurring structural protein to which cells can attach, interact with and degrade. In vivo they are bioabsorbable. However, sponges are usually crosslinked to provide the degree of wet strength and measured resistance to dissolution needed for many of the above-referenced uses. In general, crosslinking reduces or degrades the normal binding sites seen by other molecules and cells in cell and tissue interactions with the extracellular matrix that surrounds cells. Further, collagen sponges, gelatin sponges or polyvinyl alcohol sponges lack biological activity typically present in the extracellular matrix environment of cells. However, because of their deficiencies, crosslinked collagen sponges induce little regeneration in vitro or serve poorly as histiotypic and organotypic models in vitro.
A need exist, therefore, for an improved biopolymer foam that overcomes or minimizes the above-mentioned problems.


SUMMARY OF THE INVENTION

The invention includes a sponge and method for forming a foam having extracellular matrix particulates.
The sponge is formed with a biopolymer foam and extracellular matrix particulates. The method includes forming a biopolymer solution and polymerizing the biopolymer in the biopolymer solution, thereby forming a biopolymer lattice. The biopolymer lattice is crosslinked to form a foam, which is freeze-dried. Extracellular matrix particulates suspended in a solution of collagen are applied to the freeze-dried foam, thereby forming the foam having extracellular matrix particulates.
The present invention has many advantages. One advantage is that a three-dimensional model system can be formed, which has many uses. These uses include a device for conducting basic or applied research, a device which can be seeded with abnormal cells to study disease states including cancer, a device which can serve as a diagnostic test for determining chemotherapeutic strategies by selecting for agents capable of killing cancer cells cultivated in or on the foams, and a device for testing the toxicity of various substances to which cells in or on the foams are exposed.


DETAILED DESCRIPTION OF THE INVENTION

The features and other details of the method and composition of the invention will now be more particularly described and pointed out in the claims. It will be understood that the particular embodiments of the invention are shown by way of illustration and not as limitations of the invention. The principal features of this invention can be employed in various embodiments without departing from the scope of the invention. All parts and percentages are by weight unless otherwise specified.
A suitable biopolymer is one that can form a biocompatible foam or sponge-like structure. The biopolymer is non-toxic and bioabsorbable. Further, the product of degradation of the biopolymer is non-toxic. These biopolymer include collagen, alginic acid, polyvinyl alcohol, proteins, such as laminin, fibronectin or fibrinogen activated with thrombinto form fibrin. A preferred source material for a biopolymer consists of collagen and, in particular, the skins from near-term, domestic porcine fetuses which are harvested intact, enclosed in their amniotic membranes. Collagen can be derived from other suitable animal source, such as porcine, bovine, ovine or marine animals and from many tissues, such as dermis, tendons, dental and connective tissue, as well as others. Embryonic and fetal tissues are advantageous because they include various molecular factors which are present in normal tissue at different stages of animal development. A mix of biopolymers can be used. In one embodiment, the biopolymers are collagen and fibronectin. The biopolymer can be used to create foams in the form of strips, sheet

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