Breast implant wraps to limit movement of breast implants and related methods

Abstract

Described herein are breast implant fixation devices for use in breast reconstruction and breast augmentation. Novel wraps are designed to avert lateral displacement and bottoming out of breast implants, reduce capsular contraction and implant extrusion, eliminate skin indentations and ripples caused by breast implants, and reduce or eliminate palpability. The wraps are adapted to securely fold around the breast implants, limiting relative movement between the wrap and breast implant and reducing wrinkles. Tissue in-growth into the wraps limits movement of the wrap-breast implant assembly and thereby limits movement of the breast implant.

1 - 59 . (canceled) 
     
     
         60 . A breast implant wrap for limiting movement of the breast implant in a patient comprising:
 a two dimensional first configuration, said first configuration further comprising a cover section, and a plurality of base sections radially extending from the cover section; and   a second three dimensional configuration comprising a shape and size to at least partially cover the breast implant when each of the base sections is folded around the breast implant and secured to one another, and wherein at least one of the plurality of base sections and cover section comprises a plurality of pores.   
     
     
         61 . The wrap of  claim 60 , wherein the average diameter of the pores in the cover section is smaller than the average diameter of the pores in the plurality of base sections. 
     
     
         62 . The wrap of  claim 60 , wherein the wrap has one or more of the following pore sizes: an average pore diameter in the cover section of the wrap between 0.1 and 1 mm, and an average pore diameter in the plurality of base sections between 0.5 and 3 mm. 
     
     
         63 . The wrap of  claim 60 , wherein the plurality of base sections are formed from a first mesh, and the cover section is formed from a second mesh, and wherein the first and second meshes are formed from fibers and the average diameter of the fibers forming the first mesh is larger than the average diameter of the fibers forming the second mesh. 
     
     
         64 . The wrap of  claim 60 , wherein the thickness of the cover section is greater than the thickness of the plurality of base sections. 
     
     
         65 . The wrap of  claim 60 , wherein the cover section has a greater elasticity than the plurality of base sections. 
     
     
         66 . The wrap of  claim 60 , wherein the wrap is formed of one or more of the following:
 (i) a textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh, and   (ii) a resorbable polymer, wherein the resorbable polymer is poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof,   wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen and hyaluronic acid,   wherein the endotoxin content of the wrap is less than 20 endotoxin units, and/or   wherein the wrap is sterile.   
     
     
         67 . A breast implant wrap for limiting movement of the breast implant in a patient comprising:
 a two dimensional first configuration, said first configuration further comprising a cover section, and a plurality of base sections radially extending from the cover section; and   a second three dimensional configuration comprising a shape and size to at least partially cover the breast implant when each of the base sections is folded around the breast implant and secured to one another, and wherein the cover section has a greater elasticity than the plurality of base sections.   
     
     
         68 . The wrap of  claim 67 , wherein the cover section has an elasticity range selected from the group consisting of 15-75% and 30-65%, and/or wherein the plurality of base sections have an elasticity range selected from the group consisting of 5-25% and 8-20%. 
     
     
         69 . The wrap of  claim 67 , wherein the plurality of base sections are formed from a first mesh, and the cover section is formed from a second mesh, and wherein the elasticity of the second mesh is greater than the elasticity of the first mesh. 
     
     
         70 . The wrap of  claim 67 , wherein at least one of the plurality of base sections and cover section comprises a plurality of pores. 
     
     
         71 . The wrap of  claim 67 , wherein the thickness of the cover section is greater than the thickness of the plurality of base sections. 
     
     
         72 . The wrap of  claim 67 , further comprising one or more tabs for anchoring the wrap to the patient's chest wall to prevent movement of the breast implant. 
     
     
         73 . The wrap of  claim 67 , wherein the wrap is formed of one or more of the following:
 (i) a textile, woven textile, non-woven textile, monofilament mesh, or multifilament mesh, and   (ii) a resorbable polymer, wherein the resorbable polymer is poly-4-hydroxybutyrate or copolymer thereof, or poly(butylene succinate) or copolymer thereof,   wherein the wrap comprises one or more of an additive, bioactive agent, antibiotic, antimicrobial, autologous fat, fat lipoaspirate, injectable fat, adipose cells, stem cells, collagen and hyaluronic acid,   wherein the endotoxin content of the wrap is less than 20 endotoxin units, and/or   wherein the wrap is sterile.   
     
     
         74 . A breast implant wrap for limiting movement of the breast implant in a patient comprising:
 a two dimensional first configuration, said first configuration further comprising a cover section, and a plurality of base sections radially extending from the cover section; and   a second three dimensional configuration comprising a shape and size to at least partially cover the breast implant when each of the base sections is folded around the breast implant and secured to one another, and wherein the thickness of the cover section is greater than the thickness of the plurality of base sections.   
     
     
         75 . The wrap of  claim 74 , wherein the wrap has one or more of the following thicknesses: a thickness of the cover section of the wrap being 0.5-10 mm, and a thickness of the plurality of base sections being 0.2-0.6 mm. 
     
     
         76 . The wrap of  claim 74 , wherein the thickness of the cover section is wider in the area in contact with the top of the breast implant than in the area in contact with the bottom of the breast implant. 
     
     
         77 . The wrap of  claim 74 , wherein the cover section has a pre-set or shape memory that matches the curvature of the top of the breast implant. 
     
     
         78 . The wrap of  claim 74 , wherein the cover section has a greater elasticity than the plurality of base sections. 
     
     
         79 . The wrap of  claim 74 , wherein at least one of the plurality of base sections and cover section comprises a plurality of pores. 
     
     
         80 . A method of making a breast implant fixation device to limit movement of a breast implant in a patient comprising: forming a two-dimensional wrap in a shape and size to at least partially cover the breast implant, wherein the wrap comprises a plurality of base sections and a cover section, and wherein at least one of the plurality of base sections and the cover section comprises a plurality of pores.