Soft tissue implant with micron-scale surface texture to optimize anchorage

Claim 2

A soft tissue implant device to be at least partially embedded at an implantation site in organic tissue of a living organism while promoting anchorage of the device at the implantation site and the growth of collagen at the implantation site, without causing encapsulation of the embedded portion of the device and without causing inflammatory tissue at the implantation site, the device comprising: (a) a body; (b) a surface layer secured to said body and extending over a sufficient portion of said body so that only said surface layer contacts the organic tissue at the implantation site; (c) said surface layer defining a plurality of three-­dimensional features; (d) said features defining an exterior surface for presenting itself to living cells in organic tissue at the implantation site; (e) said exterior surface defining a plurality of spaces for presenting themselves to living cells adjacent said exterior surface; (f) each said space having a bridging distance being the minimum distance an adjacent cell must stretch to span diametrically across said space, said bridging distance being measured in a direction parallel to said exterior surface at said space; and (g) said plurality of spaces having a mean bridging distance ranging from greater than 1.0 micron to less than 4.0 microns, e.g. within the range from 1.4 microns to 1.9 microns.

Claim 3

A device as in claim 1, wherein said exterior surface is substantially free of indentations having a bridging distance greater than 10.0 microns and less than 1,000 microns.

Claim 4

A device as in claim 2, wherein a pair of substantially parallel ridges define a narrow elongated channel defining each said space and the width of said channel defines said bridging distance.

Claim 5

A device as in claim 2, wherein a closed perimeter defines each said space therewithin, for example to define a pore.

Claim 6

A device as in claim 2, wherein said surface layer defines a plurality of recesses, each said space defining an opening to at least one said recess.

Claim 7

A device as in claim 5, wherein each said recess has a depth of at least 1.0 micron.

Claim 8

A device as in claim 5, wherein at least two of said recesses are interconnected beneath said exterior surface.

Claim 9

A device as in claim 2, wherein at least one closed perimeter defines on said exterior surface a solid surface portion therewithin.

Claim 10

A device as in claim 8, wherein: (a) said surface layer defines a plurality of projections; (b) each said solid surface portion defining the exterior surface of one of said plurality of projections; and (c) each said projection being separated by at least one said space from each adjacent projection.

Claim 11

A device as in claim 9, wherein: (a) each said projection defining a bridging distance relative to each adjacent projection, each said bridging distance being the smallest distance measured in a direction parallel to said exterior surface and separating each said closed perimeter of each said projection from each said closed perimeter of each said adjacent projection; (b) each said projection having a breadth dimension, said projection breadth dimension being the smallest diametric dimension measured across said solid surface portion of said projection and measured in a direction parallel to said exterior surface; and (c) said plurality of projections having a mean breadth dimension ranging from 0.10 micron to 2.0 microns.

Claim 12

A device as in claim 10, wherein said surface layer comprises a textured polymer fiber fabric, and each said recess is defined by at least one fiber of a textured polymer fiber fabric.

Claim 13

A device as in claim 9, wherein said plurality of spaces are integral with one another and define a continuum that separates each said projection from each nearest projection.

Claim 14

A device as in claim 9, wherein each said projection is defined by a raised bead or by a column, or by a positively casted peak.

Claim 15

A soft tissue implant device to be at least partially embedded at an implantation site in organic tissue of a living organism while promoting anchorage of the device at the implantation site and the growth of collagen at the implantation site, without causing encapsulation of the embedded portion of the device and without causing inflammatory tissue at the implantation site, the device comprising: (a) a body; (b) a surface layer secured to said body and extending over a sufficient portion of said body so that only said surface layer contacts the organic tissue at the implantation site; (c) said surface layer defining a plurality of three-­dimensional features; (d) said features defining an exterior surface for presenting itself to living cells in organic tissue at the implantation site; (e) said exterior surface defining a plurality of openings, each said opening being bounded in said exterior surface by a closed perimeter; (f) each said closed perimeter of each said opening defining a bridging distance being the minimum diametric distance an adjacent cell must stretch to span across said opening, said bridging distance being measured in a direction parallel to said exterior surface at said opening; (g) said plurality of openings having a mean bridging distance ranging from greater than 1.0 micron to less than 4.0 microns; and (h) at least one of said features being a recess extending from an opening in said exterior surface and into said surface layer toward said body.

Claim 16

A soft tissue implant device to be at least partially embedded at an implantation site in organic tissue of a living organism while promoting anchorage of the device at the implantation site and the growth of collagen at the implantation site, without causing encapsulation of the embedded portion of the device and without causing inflammatory tissue at the implantation site, the device comprising: (a) a body; (b) a surface layer secured to said body and extending over a sufficient portion of said body so that only said surface layer contacts the organic tissue at the implantation site; (c) said surface layer defining a plurality of three-­dimensional features; (d) said features defining an exterior surface for presenting itself to living cells in organic tissue at the implantation site; (e) said exterior surface defining a plurality of openings, each said opening being bounded in said exterior surface by a closed perimeter; (f) each said closed perimeter of each said opening defining a bridging distance being the minimum diametric distance an adjacent cell must stretch to span across said opening, said bridging distance being measured in a direction parallel to said exterior surface at said opening; (g) said plurality of openings having a mean bridging distance ranging from greater than 1.0 micron to less than 4.0 microns; and (h) at least one of said features being a recess extending from an opening in said exterior surface and into said surface layer toward said body.

Claim 17

A soft tissue implant device to be at least partially embedded at an implantation site in organic tissue of a living organism while promoting anchorage of the device at the implantation site and the growth of collagen at the implantation site, without causing encapsulation of the embedded portion of the device and without causing inflammatory tissue at the implantation site, the device comprising: (a) a body; (b) a surface layer secured to said body and extending over a sufficient portion of said body so that only said surface layer contacts the organic tissue at the implantation site; (c) said surface layer defining a plurality of three-­dimensional features; (d) said features defining an exterior surface for presenting itself to living cells in organic tissue at the implantation site; (e) said exterior surface defining a plurality of solid surface portions, each said surface portion being bounded in said exterior surface by a closed perimeter; (f) a plurality of said surface layer features defining, respectively, a plurality of projections, and each said solid surface portion defining the exterior surface of one of said plurality of projections; (g) a plurality of spaces defined in said exterior surface and separating each said solid surface portion from each adjacent solid surface portion; (h) a plurality of bridging distances defined between each said closed perimeter of each said exterior surface portion and each closed perimeter of each adjacent surface portion, each said bridging distance being the minimum diametric distance an adjacent cell must stretch to span between the closest point on the perimeter of each exterior surface portion and the perimeter of each adjacent exterior surface portion, each said bridging distance being measured in a direction parallel to said exterior surface at said exterior surface portions at each end of said bridging distance; (i) said plurality of exterior surface portions having a mean bridging distance ranging from greater than 1.0 micron to less than 4.0 microns; (j) each said projection having a breadth dimension, said projection breadth dimension being the smallest diametric dimension of said exterior surface portion measured across said solid surface portion and in a direction parallel to said exterior surface; and (k) said plurality of projections having a mean breadth dimension ranging from 0.10 micron to 2.0 microns.

Claim 18

A soft tissue implant device to be at least partially embedded at an implantation site in organic tissue of a living organism while promoting anchorage of the device at the implantation site and the growth of collagen at the implantation site, without causing encapsulation of the embedded portion of the device and without causing inflammatory tissue at the implantation site, the device comprising: (a) a body; (b) a surface layer secured to said body and extending over a sufficient portion of said body so that only said surface layer contacts the organic tissue at the implantation site; (c) said surface layer defining a plurality of three-­dimensional features; (d) said features defining an exterior surface for presenting itself to living cells in organic tissue at the implantation site; (e) said exterior surface defining a plurality of solid surface portions, each said surface portion being bounded in said exterior surface by a closed perimeter; (f) a plurality of said surface layer features defining, respectively, a plurality of projections, and each said solid surface portion defining the exterior surface of one of said plurality of projections; (g) a plurality of spaces defined in said exterior surface and separating each said solid surface portion from each adjacent solid surface portion; (h) a plurality of bridging distances defined between each said closed perimeter of each said exterior surface portion and each closed perimeter of each adjacent surface portion, each said bridging distance being the minimum diametric distance an adjacent cell must stretch to span between the closest point on the perimeter of each exterior surface portion and the perimeter of each adjacent exterior surface portion, each said bridging distance being measured in a direction parallel to said exterior surface at said exterior surface portions at each end of said bridging distance; (i) said plurality of exterior surface portions having a mean bridging distance ranging from greater than 1.0 micron to less than 4.0 microns; (j) each said projection having a breadth dimension, said projection breadth dimension being the smallest diametric dimension of said exterior surface portion measured across said solid surface portion and in a direction parallel to said exterior surface; and (k) said plurality of projections having a mean breadth dimension ranging from 0.10 micron to 2.0 microns.