LAYERED MATERIALS FOR IMPLANTS
Layered materials for using in implants, such as hernia repair implants. The layered materials may include a first layer including a substrate (e.g., mesh) and a second layer including a sheet of anti-adhesive material. The layers may be attached at small attachment sites that are separated by regions in which the layers are not attached, to provide a highly compliant implant. The compliance of the implant may match that of a patient's body upon implantation and/or over time following implantation.
1 . A hernia repair graft comprising:
a multiple layered structure, comprising:
a first layer;
a first stitching embroidered into the first layer in a first pattern;
a second layer comprising one or more sheets of material having anti-adhesion properties; and
a second stitching embroidered into the first and second layers in a second pattern, wherein the second stitching attaches the first layer to the second layer at a plurality of discrete attachment sites, wherein adjacent regions of the first and second layers between the plurality of discrete attachment sites may slide relative to each other.
2 . The hernia repair graft of claim 1 , wherein the first stitching is formed of a bioabsorbable material.
3 . The hernia repair graft of claim 1 , wherein the first layer is formed of a non-absorbable material.
4 . The hernia repair graft of claim 1 , wherein the one or more sheets of material having anti-adhesion properties comprises a medical textile material.
5 . The hernia repair graft of claim 1 , wherein the one or more sheets of material having anti-adhesion properties comprises an extracellular matrix (ECM) material.
6 . The hernia repair graft of claim 1 , wherein the one or more sheets of material having anti-adhesion properties comprises a biodegradable material.
7 . The hernia repair graft of claim 1 , wherein the one or more sheets of material having anti-adhesion properties comprises a non-resorbable material.
8 . The hernia repair graft of claim 1 , wherein the one or more sheets of material having anti-adhesion properties comprise one or more of: comprise chitosan, collagen, hyaluronic acid, icodextrin, fibrin, poly(L-lactide-co-D,L-lactide)/polylactic acid, polydioxanone, polytetrafluoroethylene, oxidized regenerated cellulose (ORC) and a hydrogel.
9 . The hernia repair graft of claim 1 , wherein the second stitching is made of an anti-adhesive material.
10 . The hernia repair graft of claim 1 , wherein the first pattern is different than the second pattern.
11 . The hernia repair graft of claim 1 , wherein the first layer comprises a mesh.
12 . The hernia repair graft of claim 11 , wherein the mesh is a knitted mesh.
13 . The hernia repair graft of claim 11 , wherein the mesh comprises one or more of polypropylene, polytetrafluoroethylene (PTFE), nylon and polyester.
14 . The hernia repair graft of claim 1 , wherein the first layer has open cell pore of between 0.5 mm and 6 mm diameter.
15 . The hernia repair graft of claim 1 , wherein the second layer comprises one sheet of the material having anti-adhesion properties.
16 . The hernia repair graft of claim 1 , wherein the second layer comprises two or more sheets of the material having anti-adhesion properties.
17 . A method for repairing a hernia in a subject, the method comprising:
implanting a hernia repair graft into the subject's body, wherein the hernia repair graft comprises:
a multiple layered structure, comprising:
a first layer;
a first stitching embroidered into the first layer in a first pattern;
a second layer comprising one or more sheets of material having anti-adhesion properties; and
a second stitching embroidered into the first and second layers in a second pattern, wherein the second stitching attaches the first layer to the second layer at a plurality of discrete attachment sites;
wherein implanting the hernia repair graft includes positioning the second layer in contact with a body wall tissue; and
wherein the implanted hernia repair graft allows the first and second layers between the plurality of discrete attachment sites to slide relative to each other.
18 . The method of claim 17 , wherein a compliance of the multiple layered structure is configured to increase over time following implantation of the hernia repair graft within the subject's body as a bioabsorbable material of the first stitching is resorbed by the subject's body.
19 . A method of forming a hernia repair graft, the method comprising:
forming a multiple layered structure by:
embroidering a first stitching into a first layer, wherein the first stitching is embroidered in a first pattern; and
embroidering a second stitching into the first layer and a second layer to attach the first and second layers at a plurality of discrete attachment sites, wherein the second layer includes one or more sheets of material having anti-adhesion properties, wherein the second stitching is embroidered in a second pattern, and wherein adjacent regions of the first and second layers between the plurality of discrete attachment sites may slide relative to each other.
20 . The method of claim 19 , wherein the first stitching is formed of a bioabsorbable material.