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 and surrounded 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 defining a statistical mean bridging distance ranging from greater than 1.4 microns to less than 1.9 microns with a standard deviation of less than 65% of said mean bridging distance.

Claim 3

A device as in claim 1, wherein: said statistical mean bridging distance falls within the range from 1.4 microns to 1.9 microns.

Claim 4

A device as in claim 1, wherein: substantially all of the individual bridging distance measurements are within the ranges of from 0.1 to 10.0 microns and 1,000 microns and greater.

Claim 5

A device as in claim 3, 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 6

A device as in claim 3, wherein: a closed perimeter defines each said space therewithin.

Claim 7

A device as in claim 5, wherein: each said closed perimeter defines a pore.

Claim 8

A device as in claim 3, wherein: said surface layer defines a plurality of recesses, each said space defining an opening to at least one said recess.

Claim 9

A device as in claim 7, wherein: each said recess has a depth of at least 1.0 micron.

Claim 10

A device as in claim 7, wherein: at least one of said recesses has a depth of at least 150 microns.

Claim 11

A device as in claim 7, wherein at least two of said recesses are interconnected beneath said exterior surface.

Claim 12

A device as in claim 7, wherein: adjacent ones of said recesses are of substantially uniform depth dimension.

Claim 13

A device as in claim 3, wherein: said exterior surface having at least one closed perimeter defining a solid surface portion therewithin.

Claim 14

A device as in claim 12, 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 15

A device as in claim 13, 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 16

A device as in claim 14, wherein: (a) said surface layer defines a plurality of recesses, each said space defining an opening to at least one said recess; and (b) each said projection having a sidewall defining at least a portion of at least one adjacent recess.

Claim 17

A device as in claim 15, wherein: said plurality of projections are integral with one another and defines a continuum that separates each said recess from each nearest recess.

Claim 18

A device as in claim 16, 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 19

A device as in claim 13, wherein: said plurality of spaces are integral with one another and defines a continuum that separates each said projection from each nearest projection.

Claim 20

A device as in claim 13, wherein: each said projection is defined by a raised bead.

Claim 21

A device as in claim 13, wherein: each said projection is defined by a column.

Claim 22

A device as in claim 13, wherein: each said projection is defined by a positively casted peak.

Claim 23

A device as in claim 13, wherein: adjacent ones of said projections are of substantially uniform height dimension.

Claim 24

A device as in claim 13, wherein: adjacent ones of said projections are of substantially uniform breadth dimension.

Claim 25

A device as in claim 1, wherein: said surface layer is integral with said body.

Claim 26

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 defining a statistical mean bridging distance ranging from greater than 1.4 microns to less than 1.9 microns with a standard deviation of less than 65% of said mean bridging distance; 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 27

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 defining a statistical mean bridging distance ranging from greater than 1.4 microns to less than 1.9 microns with a standard deviation of less than 65% of said mean bridging distance; 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 28

A soft tissue implant device to be at least partially embedded at an implantation site and surrounded 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 forming a statistical 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 forming a statistical mean breadth dimension ranging from 0.10 micron to 2.0 microns.

Claim 29

A soft tissue implant device to be at least partially embedded at an implantation site and surrounded 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 forming a statistical 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 forming a statistical mean breadth dimension ranging from 0.10 micron to 2.0 microns.