Systems and devices for soft tissue augmentation

Abstract

Medical devices, systems and kits for filling tissue are disclosed. The device has a first configuration wherein the device can pass through a small catheter or needle placed in the tissue to be filled and a second configuration in which the device is expandable to a predetermined or customizable shape. In one application, the device is adapted to be placed into the skin to reduce facial wrinkles or augment facial features such as the lips. Kits and systems include multiple device sizes, filler tubes, and filler media.

1 . A tissue augmentation system, comprising: 
 a tubular channel adapted to be placed within human tissue;    a tissue dilator adapted to pass through the tubular channel; and    a tissue filling device having a first configuration and a second configuration, wherein the first configuration is adapted to fit through the tubular channel and the second configuration is formed to fill the tissue, where said device is transformable from the first configuration to the second configuration upon introduction of a filler into the device after the device has been delivered into said tissue through the tubular channel.    
   
   
       2 . The system of  claim 1  where the tubular channel is a needle.  
   
   
       3 . The system of  claim 1  where the tubular channel is a catheter.  
   
   
       4 . The system of  claim 1  where the tissue is the skin.  
   
   
       5 . A kit, for augmenting tissue, comprising: 
 a plurality of elongate, flexible bodies, each of which is transformable from a first configuration for implantation to a second configuration for augmentation, provided in a plurality of sizes and shapes;    at least one suture attached to each body;    a deployment tube for delivering the body to a treatment site;    a filler tube for permitting access to the interior of the body; and    a filler, for transforming the body from the first configuration to the second configuration.    
   
   
       6 . A kit for augmenting tissue, comprising: 
 at least one elongate, flexible body, which is transformable from a first configuration for implantation to a second configuration for augmentation;    a suture attached to the body;    a filler tube for permitting access to the interior of the body;    a filler, for transforming the body from the first configuration to the second configuration; and    at least one needle attached to one of the body or the suture.    
   
   
       7 . The kit for augmenting tissue of  claim 6 , wherein at least one region of said body is not transformable and is configured to pass the suture therethrough.  
   
   
       8 . A kit as in  claim 6 , wherein the body comprises a tubular sleeve.  
   
   
       9 . A kit as in  claim 6 , wherein the body comprises a plurality of internal compartments.  
   
   
       10 . A kit as in  claim 6 , wherein the filler comprises a liquid.  
   
   
       11 . A kit as in  claim 6 , wherein the filler is polymerizable in situ.  
   
   
       12 . A kit as in  claim 6 , further comprising a syringe for injecting the filler into the filler tube.  
   
   
       13 . A tissue augmentation device, comprising: 
 an elongate flexible body, having a proximal end and a distal end, said body being transformable from a first configuration for implantation to a second configuration for augmentation;    at least a first port on the proximal end, for accessing the interior of the body; and    a suture extending from the distal end.    
   
   
       14 . The tissue augmentation device of  claim 13 , further comprising a needle on the suture.  
   
   
       15 . The tissue augmentation device of  claim 13 , wherein the body comprises a tubular sleeve.  
   
   
       16 . The tissue augmentation device of  claim 13 , wherein the body comprises a sleeve with a flattened cross section.  
   
   
       17 . The tissue augmentation device of  claim 13 , wherein the body comprises a sleeve composed of two sheets of material, the sheets of material bound together along the periphery of the sheets.  
   
   
       18 . The tissue augmentation device of  claim 13 , wherein the body comprises two concentric tubular layers.  
   
   
       19 . The tissue augmentation device of  claim 13 , further comprising a second port for accessing the interior of the body.  
   
   
       23 . The tissue augmentation device of  claim 13 , further comprising a valve for closing the port.  
   
   
       24 . The tissue augmentation device of  claim 13 , further comprising at least two compartments within the flexible body.