POROUS MATERIALS, METHODS OF MAKING AND USES
The present specification discloses porous materials, methods of forming such porous materials, biocompatible implantable devices comprising such porous materials, and methods of making such biocompatible implantable devices.
1 . A porous material comprising a non-degradable, biocompatible elastomer matrix defining an array of interconnected pores, wherein the material has a porosity of at least 40% and wherein the material exhibits an elastic elongation of at least 80%.
2 . The porous material of claim 1 , wherein the elastomer matrix comprises a silicone-based elastomer.
3 . The porous material of claim 1 , wherein the material exhibits a reversible elastic elongation of at least 90%.
4 . The porous material of claim 1 , wherein the material exhibits an ultimate strength of at least 1 MPa.
5 . The porous material of claim 1 , wherein the material exhibits a flexural strength of at most 50 MPa.
6 . The porous material of claim 1 , wherein the material exhibits a compressibility of at most 30 kPa.
7 . A biocompatible implantable device comprising a layer of porous material, wherein the material has a porosity of at least 40%, wherein the material exhibits an elastic elongation of at least 80%, and wherein the layer of porous material has a thickness of at least 300 μm.
8 . The biocompatible implantable device of claim 7 , wherein the device is a breast implant.
9 . A method for making biocompatible implantable device comprising the steps of:
a) preparing a surface of a biocompatible implantable device to receive a porous material; and
b) attaching a porous material to the prepared surface of the biocompatible implantable device,
wherein the material has a porosity of at least 40%, wherein the material exhibits an elastic elongation of at least 80%, and wherein the layer of porous material has a thickness of at least 300 μm.
10 . The method for making biocompatible implantable device of claim 9 , wherein the device is a breast implant.
11 . A method for forming a porous material, the method comprising the steps of:
a) coating porogens with an elastomer base to form an elastomer coated porogen mixture;
b) treating the elastomer coated porogen mixture to form a porogen scaffold comprising fused porogens and cure the elastomer, wherein the porogen scaffold comprises a three-dimensional structure where substantially all the fused porogens are each connected to at least four other fused porogens, and wherein the diameter of substantially all the connections between each fused porogen in between about 15% to about 80% of the mean porogen diameter; and
c) removing the porogen scaffold, wherein porogen scaffold removal results in a porous material, the porous material comprising a non-degradable, biocompatible, elastomer matrix defining an array of interconnected pores, wherein the material has a porosity of at least 40% and wherein the material exhibits an elastic elongation of at least 80%.
12 . A method for making biocompatible implantable device comprising the steps of:
a) preparing the surface of a device to receive a porous material;
b) attaching a porous material to the prepared surface of the device, wherein the material has a porosity of at least 40%, wherein the material exhibits an elastic elongation of at least 80%, and wherein the layer of porous material has a thickness of at least 300 μm.
13 . A method for making biocompatible implantable device comprising the step of:
a) coating a mandrel with an elastomer base;
b) curing the elastomer base to form a base layer;
c) coating the cured base layer with an elastomer base;
d) coating the elastomer base with porogens to form an elastomer coated porogen mixture;
e) treating the elastomer coated porogen mixture to form a porogen scaffold comprising fused porogens and cure the elastomer base, wherein the porogen scaffold comprises a three-dimensional structure where substantially all the fused porogens are each connected to at least four other fused porogens, and wherein the diameter of substantially all the connections between each fused porogen in between about 15% to about 40% of the mean porogen diameter; and
f) removing the porogen scaffold, wherein porogen scaffold removal results in a porous material, the porous material comprising a non-degradable, biocompatible, elastomer matrix defining an array of interconnected pores, wherein the material has a porosity of at least 40%, wherein the material exhibits an elastic elongation of at least 80%, and wherein the layer of porous material has a thickness of at least 300 μm.
14 . The method of claim 13 , wherein steps (c) and (d) are repeated at least once.
15 . The method of claim 13 , wherein steps (c) and (d) are repeated at least repeated twice.