Methods and systems for forming implants with selectively exposed mesh for fixation and related implants
View Patent ↗Molded orthopaedic implants include at least one mesh substrate having opposing upper and lower primary surfaces. At least a major portion of the mesh substrate lower primary surface is integrally moldably attached to the molded implant body. The mesh substrate has at least one selectively exposed region devoid of molded material that exposes at least a portion of the mesh substrate upper surface to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate.
1. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the at least one exposed region is a plurality of discrete spaced apart exposed regions that extend through the upper primary surface and extend a partial thickness into the mesh substrate.
2. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the at least one exposed region is a plurality of discrete spaced apart exposed regions extending wholly through the mesh substrate.
3. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body, and
further comprising an intermediate material layer residing between the lower primary surface of the mesh substrate and an upper portion of the molded body whereby the intermediate material layer resides proximate to the at least one exposed mesh substrate region,
wherein the mesh substrate is an outer mesh substrate adapted to contact local tissue when implanted, and wherein the intermediate layer comprises a second inner mesh substrate with a smaller pore size than the outer mesh substrate and that is sized and configured in small sections that cooperate with the outer mesh substrate to define the at least one exposed region.
4. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body, and
further comprising an intermediate material layer residing between the lower primary surface of the mesh substrate and an upper portion of the molded body whereby the intermediate material layer resides proximate to the at least one exposed mesh substrate region,
wherein the intermediate layer comprises a plurality of spaced apart pieces of a material that is resorbable or a resorbable material with a plurality of spaced apart apertures that provides the at least one exposed region in the mesh substrate.
5. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body, and
further comprising at least one temporary material that resides on an outermost portion of the upper primary surface of the mesh substrate and is removed prior to implantation or resorbed in situ to define the at least one exposed region.
6. An implant according to claim 5 , wherein the molded implant comprises molded PVA hydrogel, and wherein the temporary material comprises moldable silicone that is peelably removable from the mesh substrate.
7. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the molded implant comprises molded PVA hydrogel, and wherein the implant further comprises at least one temporary material that resides on portions of the upper primary surface of the mesh substrate and is resorbable in situ to define the selectively exposed regions.
8. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the molded implant comprises molded PVA hydrogel, wherein the implant further comprises at least one removable mesh peel layer residing on the upper primary surface of the mesh substrate, the mesh peel layer comprising a resorbable biocompatible salt, and wherein the mesh peel layer is removable from the molded implant prior to implantation to expose the at least one exposed region in the mesh substrate.
9. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the mesh substrate comprises a knitted polyester fabric, and wherein the at least one selectively exposed region is a plurality of spaced apart selectively exposed regions on the upper and lower surfaces of the implant.
10. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the mesh substrate is a polyester mesh, and wherein the at least one selectively exposed region is a plurality of spaced apart selectively exposed regions on the upper and lower surfaces of the implant.
11. A molded orthopaedic implant comprising at least one mesh substrate having a thickness of between about 0.5 mm to about 5 mm, having opposing upper and lower primary surfaces, wherein at least a major portion of the mesh substrate lower primary surface is integrally moldably attached to a molded primary implant body, wherein the mesh substrate has at least one selectively exposed region devoid of molded material associated with the molded primary implant body that exposes a portion of an outermost surface of the mesh substrate to at least a partial thickness of the mesh substrate so as to allow for tissue in-growth in the at least one exposed region of the mesh substrate, and wherein the at least one mesh substrate outermost surface has regions that include the molded material associated with the primary implant body,
wherein the implant is a spinal disc replacement implant that has a plateless, non-articulating unitary solid body of crystalline hydrogel, and wherein the at least one mesh substrate is at least three mesh substrates integrally molded to the implant body, a first piece of mesh material disposed about an annulus outer surface of the body, a second piece of mesh material covering at least a portion of the superior surface of the body, and a third piece of mesh material covering at least a portion of an inferior surface of the body, wherein the second and third pieces have a lesser thickness than the annulus piece, and wherein the second and third pieces both comprise a plurality of the selectively exposed regions, with the selectively exposed regions being spaced apart regions on the outermost surface that are separated by mesh regions filled with moldable material on the outermost surface, wherein the selectively exposed regions are configured to allow for tissue in-growth.