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US 8,475,503 B2Granted
Methods for forming implants with selectively exposed mesh for fixation and related implants
AssigneeMiMedx Group, Inc.
InventorsGuilhem Denoziere, Daniel Tomko, Anish Ghodadra
Life of this patent
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Abstract
Methods for forming molded orthopedic implants with 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 methods are carried out so that 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.
Claims19
A method of fabricating an implantable prosthesis, comprising:
- placing an inferior mesh layer on a floor of a three-dimensional mold;
- introducing moldable material into the mold;
- placing a superior mesh layer on a top surface of the moldable material in the mold;
- heating the mold with the moldable material to a desired temperature so that the mold is heated for a desired time;
- then
- forming a molded implant body formed by the heated moldable material whereby the mesh layers are integrally moldably attached to inferior and superior surfaces of the molded body formed by the moldable material;
- and
- selectively exposing at least one of the inferior and superior mesh layers so that at least one region is substantially devoid of the moldable material whereby the exposed region promotes tissue in-growth therein while at least a major portion of the mesh layers are integrally moldably attached to the molded body.
5 more elements
A method of fabricating an implantable prosthesis, comprising:
- placing an inferior mesh layer on a floor of a three-dimensional mold;
- introducing moldable material into the mold;
- placing a superior mesh layer on a top surface of the moldable material in the mold;
- heating the mold with the moldable material to a desired temperature so that the mold is heated for a desired time;
- then
- forming a molded implant body formed by the heated moldable material whereby the mesh layers are integrally moldably attached to the molded body formed by the moldable material;
- and
- selectively exposing at least one of the inferior and superior mesh layers so that at least one region is substantially devoid of the moldable material whereby the exposed region promotes tissue in-growth therein while at least a major portion of the mesh layers are integrally moldably attached to the molded body,
- wherein the selectively exposing step comprises placing an intermediate substantially impermeable layer between at least one of the superior layer or the inferior mesh layer and the moldable material to locally inhibit moldable material from entering selected regions of the superior mesh layer or the inferior mesh layer, respectively, during the forming step.
6 more elements
A method of fabricating an implantable prosthesis, comprising:
- placing an inferior mesh layer on a floor of a three-dimensional mold;
- introducing moldable material into the mold;
- placing a superior mesh layer on a top surface of the moldable material in the mold;
- heating the mold with the moldable material to a desired temperature so that the mold is heated for a desired time;
- then
- forming a molded implant body formed by the heated moldable material whereby the mesh layers are integrally moldably attached to the molded body formed by the moldable material;
- and
- selectively exposing at least one of the inferior and superior mesh layers so that at least one region is substantially devoid of the moldable material whereby the exposed region promotes tissue in-growth therein while at least a major portion of the mesh layers are integrally moldably attached to the molded body,
- wherein the selectively exposing step comprises flowing PVA hydrogel moldable material into the inferior and superior mesh layers during the forming step whereby a density gradient of the hydrogel moldable material extends in the mesh substrate whereby a lesser density of moldable material resides on an outermost bounds of the implant body.
6 more elements
A method of fabricating an implantable prosthesis, comprising:
- placing an inferior mesh layer on a floor of a three-dimensional mold;
- introducing moldable material into the mold;
- placing a superior mesh layer on a top surface of the moldable material in the mold;
- heating the mold with the moldable material to a desired temperature so that the mold is heated for a desired time;
- then
- forming a molded implant body formed by the heated moldable material whereby the mesh layers are integrally moldably attached to the molded body formed by the moldable material;
- and
- selectively exposing at least one of the inferior and superior mesh layers so that at least one region is substantially devoid of the moldable material whereby the exposed region promotes tissue in-growth therein while at least a major portion of the mesh layers are integrally moldably attached to the molded body,
- wherein the selectively exposing step comprises directing pressurized liquid to remove material throughout a target localized region in at least one of the superior and inferior mesh layers, and wherein the pressurized liquid is a jet stream of heated and pulsed sterile water or saline directed to expose a desired local area and/or volume of the superior and/or inferior mesh layers.
6 more elements
A method of fabricating an implantable prosthesis, comprising:
- placing an inferior mesh layer on a floor of a three-dimensional mold;
- introducing moldable material into the mold, wherein the moldable material includes PVA crystals and a liquid irrigation solution that defines a PVA hydrogel;
- placing a superior mesh layer on a top surface of the moldable material in the mold;
- heating the mold with the moldable material to a desired temperature so that the mold is heated for a desired time, wherein the heating is carried out to heat the mold with the moldable material to between about 80-200° C. for at least about 5 minutes to less than about 8 hours;
- then
- forming a molded implant body formed by the heated moldable material whereby the mesh layers are integrally moldably attached to the molded body formed by the moldable material;
- closing the mold before the forming step;
- selectively exposing at least one of the inferior and superior mesh layers so that at least one region is substantially devoid of the moldable material whereby the exposed region promotes tissue in-growth therein while at least a major portion of the mesh layers are integrally moldably attached to the molded body;
- and
- freezing and thawing the PVA hydrogel molded body a plurality of times after the heating to provide a crystalline implant body with a desired compressive modulus of elasticity.
7 more elements
Dependencies are inferred from the claim text.