Tissue expanders and methods of use thereof

Abstract

Tissue expanders and methods of their manufacture and use are disclosed herein. A tissue expander shell according to the present disclosure may include a shape and topography that facilitates uniform or substantially uniform expansion and contraction of the tissue expander. In at least one example, the shell may include a series of topographical features, such as ridges, grooves, channels, valleys, canals, protrusions, pleats, creases, or folds. In some embodiments, these features may have a curved or wavy cross sectional profile. For example, the shell may include a series of concentric curved ridges.

1 - 30 . (canceled) 
     
     
         31 . An implantable medical device comprising:
 a flexible shell defining a cavity and having a posterior side and an anterior side;   a fluid disposed within the cavity;   a plurality of ridges extending circumferentially about an apex of the anterior side of the flexible shell, each ridge curving in an arc from a first end to a second end;
 wherein the plurality of ridges are disposed in an alternating arrangement with a valley between adjacent ridges; and 
   at least one channel traversing the valley to connect two adjacent ridges.   
     
     
         32 . The implantable medical device of claim  1 , wherein the at least one channel extends radially outward from the apex. 
     
     
         33 . The implantable medical device of claim  1 , wherein the at least one channel includes:
 two or more channels that are circumferentially spaced about the apex.   
     
     
         34 . The implantable medical device of claim  1 , wherein the plurality of ridges includes at least three ridges, further comprising:
 a first channel connecting a first ridge to a second ridge adjacent to the first ridge and the first channel traversing the valley therebetween; and   a second channel connecting the second ridge to a third ridge and the second channel traversing the valley connected therebetween;   wherein the first channel, the second channel and the apex are not co-linear.   
     
     
         35 . The implantable medical device of claim  1 , wherein the flexible shell has a uniform thickness. 
     
     
         36 . The implantable medical device of claim  1 , wherein the flexible shell has a varied thickness. 
     
     
         37 . The implantable medical device of claim  1 , wherein the flexible shell is formed from at least one layer. 
     
     
         38 . The implantable medical device of claim  1 , wherein the flexible shell is formed from at least one biocompatible material;
 wherein the at least one biocompatible material is elastic and configured to maintain its shape after contraction.   
     
     
         39 . The implantable medical device of claim  8 , wherein the at least one biocompatible material includes at least one of silicone, polyurethane, polyurethane blends, polymers, polyethylene terephthalate, polyether block amide, or polyamide-12. 
     
     
         40 . The implantable medical device of claim  1 , wherein the fluid is a biocompatible gel. 
     
     
         41 . The implantable medical device of claim  1 , wherein at least a portion of the flexible shell includes at least one texture. 
     
     
         42 . An implantable medical device comprising:
 a flexible shell including:
 an outermost surface; 
 a plurality of layers;
 wherein each of the plurality of layers is formed from an elastic, biocompatible material configured to maintain its shape after contraction; 
 
 a posterior side and an anterior side; 
 the flexible shell defining a cavity; and 
 a plurality of ridges spaced around the outermost surface of the flexible shell, each ridge curving along the outermost surface of the flexible shell and forming an arc between a first end of each of the plurality of ridges and a second end of each of the plurality of ridges;
 wherein the plurality of ridges and a plurality of valleys are disposed in an alternating arrangement; and 
 
   a biocompatible fluid disposed within the cavity.   
     
     
         43 . The implantable medical device of claim  12 , wherein the outermost surface is at least partially textured. 
     
     
         44 . The implantable medical device of claim  12 , wherein the flexible shell has a uniform thickness. 
     
     
         45 . The implantable medical device of claim  12 , wherein the flexible shell has a varied thickness. 
     
     
         46 . The implantable medical device of claim  12 , wherein each ridge of the plurality of ridges has a variable height or the plurality of valleys has variable depth. 
     
     
         47 . The implantable medical device of claim  12 , further comprising:
 at least one channel traversing the valley and configured to connect two adjacent ridges.   
     
     
         48 . The implantable medical device of claim  12 , wherein each ridge is concentric. 
     
     
         49 . An implantable medical device comprising:
 a flexible shell defining a cavity, the flexible shell including:
 an outer surface having a topography including:
 a plurality of concentric ridges disposed circumferentially about an apex; and 
 a valley separating two adjacent ridges; 
 
 at least one layer formed from a first biocompatible material; and 
   a second biocompatible material disposed within the cavity.   
     
     
         50 . The implantable medical device of claim  19 , wherein the flexible shell formed from an elastic material configured to maintain its shape after contraction.