Porous hydrophilic materials, chambers therefrom, and devices comprising such chambers and biologically active tissue and methods of preparation
First Claim
1. A synthetic, hydrophilic, polymeric material of a polymer of at least one monomer from the group consisting of a monoalkylene glycol monoester of methacrylic acid, a polyalkylene glycol monester of methacrylic acid, a monoalkylene glycol monoester of crylic acid, a polyalkylene glycol monoester, a N-alkyl substituted acrylamide, a N,N-dialkyl substituted acrylamide, a N-alkyl substituted methacrylamide, a N,N-dialkyl substituted methacrylamide, N-vinylpyrrolidone, an alkyl substituted N-vinylpyrrolidone, and vicinal epoxy alkyl 2-alkenoate, characterized by:
- water-insolubility;
water-swellability;
biological inertness;
non-toxicity to and compatibility with living tissue;
retention of structural integrity over long periods of time in contact with body fluids;
a water-uptake capability when in osmotic equilibrium with water of from 5 to 4000 weight percent based on the weight of said hydrophilic material to form a hydrogel;
an ultimate strength of about 3 g/mm2 to 200 g/mm2, an initial tear strength of 0.1 g/mm2 to 20 g/mm2, and a progagation tear strength of 0.5 g/mm to 10 g/mm; and
3-dimensional, reticulum-like porosity in which at least about 75 percent of the remaining pores, as determined under a scanning electron microscope, are characterized by an average diameter, not exceeding about 10 microns and in which below about 25 percent of the pores are characterized by an average diameter generally sufficiently small so as to prevent an immune rejection when said hydrophilic material containing biologically active tissue therein is in contact with living tissue environment, the geometry of such permitting the ingress or egress of a steroid.
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Abstract
Hydrophilic polymeric chambers for encapsulating biologically active tissue and methods for their preparation. The tissue refers to those essential cellular components of a particular organ that is capable of receiving, modifying or secreting hormones. A device comprising such chamber and such tissue is fabricated and implanted in a living body so that said tissue is permitted normal function without being rejected by the host'"'"'s immunological system. The viability of the tissue in the device is maintained by a correlation of factors including pore size and membrane thickness of the hydrophilic chamber. To maintain the viability of the tissue, the implanted device allows the inflow of essential nutrients and gases, and outflow of metabolites and products while simultaneously excluding the ingress of cellular components of the host'"'"'s immunological system.
199 Citations
43 Claims
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1. A synthetic, hydrophilic, polymeric material of a polymer of at least one monomer from the group consisting of a monoalkylene glycol monoester of methacrylic acid, a polyalkylene glycol monester of methacrylic acid, a monoalkylene glycol monoester of crylic acid, a polyalkylene glycol monoester, a N-alkyl substituted acrylamide, a N,N-dialkyl substituted acrylamide, a N-alkyl substituted methacrylamide, a N,N-dialkyl substituted methacrylamide, N-vinylpyrrolidone, an alkyl substituted N-vinylpyrrolidone, and vicinal epoxy alkyl 2-alkenoate, characterized by:
- water-insolubility;
water-swellability;
biological inertness;
non-toxicity to and compatibility with living tissue;
retention of structural integrity over long periods of time in contact with body fluids;
a water-uptake capability when in osmotic equilibrium with water of from 5 to 4000 weight percent based on the weight of said hydrophilic material to form a hydrogel;
an ultimate strength of about 3 g/mm2 to 200 g/mm2, an initial tear strength of 0.1 g/mm2 to 20 g/mm2, and a progagation tear strength of 0.5 g/mm to 10 g/mm; and
3-dimensional, reticulum-like porosity in which at least about 75 percent of the remaining pores, as determined under a scanning electron microscope, are characterized by an average diameter, not exceeding about 10 microns and in which below about 25 percent of the pores are characterized by an average diameter generally sufficiently small so as to prevent an immune rejection when said hydrophilic material containing biologically active tissue therein is in contact with living tissue environment, the geometry of such permitting the ingress or egress of a steroid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
- water-insolubility;
Specification
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- Resources
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Current AssigneeGP Strategies Corporation (Learning Technologies Group Plc)
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Original AssigneeGP Strategies Corporation (Learning Technologies Group Plc)
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InventorsRonel, Samuel H., D'Andrea, Mark J., Dobelle, William H., Hashiguchi, Hiroshi, Klomp, Gregory F.
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Primary Examiner(s)Rosenbaum, C. Fred
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Application NumberUS06/073,680Time in Patent Office785 DaysField of Search128/130, 128/260, 128/261, 128/268, 424/14-22, 424/81, 521/61US Class Current424/424CPC Class CodesA61K 9/0024 Solid, semi-solid or solidi...A61K 9/0092 Hollow drug-filled fibres, ...A61K 9/1635 obtained by reactions only ...A61K 9/2027 obtained by reactions only ...A61L 2300/30 Compounds of undetermined c...A61L 2300/43 Hormones, e.g. dexamethasoneA61L 27/54 Biologically active materia...Y10T 428/13 Hollow or container type ar...
