Method and system for in situ tissue expansion

Abstract

Tissue expansion system includes a pump, a controller, and inflatable bladder, and a pressure sensor. The pump is adapted for substantially continuous operation in response to a pressure within a subcutaneously implanted inflatable bladder. The pump is thus able to deliver inflation medium to the bladder when the pressure within the bladder is below a predetermined lower threshold while stopping delivery of the fluid when the pressure rises above a higher threshold or reaches a predetermined maximum volume.

1 . A system for expanding tissue, said system comprising:
 an expandable bladder adapted to be located beneath a region of skin to be expanded;   a pump adapted to be connected to a source of inflation medium and to deliver said inflation medium to the expandable bladder;   a pressure sensor adapted to monitor pressure within the expandable bladder on a substantially continuous basis;   a controller which receives pressure data from the pressure sensor and controls the pump to deliver inflation medium to the bladder when the pressure falls below a lower threshold value; and   a portable carrier which holds the pump, pressure sensor, and controller, wherein the portable carrier is adapted to be worn by a patient.   
     
     
         2 . The system of  claim 1 , wherein the portable carrier comprises a vest, a backpack, or a belt. 
     
     
         3 . The system of  claim 1 , wherein the controller is programmed to deliver inflation medium until the pressure reaches an upper threshold value. 
     
     
         4 . The system of  claim 3 , wherein the upper threshold level is in the range from 5 mmHg to 35 mmHg. 
     
     
         5 . The system of  claim 1 , wherein the target total volume of inflation medium is in the range from 150 cc to 800 cc. 
     
     
         6 . The system of  claim 5 , wherein the target total volume of inflation medium is in the range from 200 cc to 600 cc. 
     
     
         7 . The system of  claim 1 , wherein the expandable bladder is configured to be placed in a subpectoral pocket of the patient following a mastectomy. 
     
     
         8 . The system of  claim 7 , wherein the expandable bladder is initially inflated with a volume of saline in the range from 50 cc to 100 cc. 
     
     
         9 . The system of  claim 1 , wherein the controller is programmable. 
     
     
         10 . The system of  claim 1 , wherein the predetermined interval is at least one hour. 
     
     
         11 . The system of  claim 1 , wherein the inflation medium comprises saline. 
     
     
         12 . The system of  claim 1 , wherein the controller is configured to control the pump to deliver the inflation medium, terminate delivery of the inflation medium, and resume delivery of the inflation medium after the predetermined interval, and 
     
     
         13 . The system of  claim 1 , wherein the controller is programmed to stop delivering inflation medium after a target total volume of inflation medium has been delivered to the patient, the target total volume of inflation medium comprising a plurality of the predetermined volumes delivered. 
     
     
         14 . The system of  claim 1 , wherein the pressure sensor is located in an external portion of the source of inflation medium. 
     
     
         15 . The system of  claim 1 , wherein the pressure sensor is located within the expandable bladder. 
     
     
         16 . The system of  claim 1 , wherein the pressure sensor is operably coupled to the expandable bladder by a connecting tube between the expandable bladder and the pump. 
     
     
         17 . The system of  claim 1 , wherein the expandable bladder is configured to be placed in the submuscular or subcutaneous pocket with or with an acellular dermal matrix. 
     
     
         18 . The system of  claim 1 , wherein the expandable bladder is formed of an inelastic material, and wherein the expandable bladder comprises a pleat, a fold, a roll, or any combination thereof. 
     
     
         19 . The system of  claim 1 , wherein the expandable bladder comprises an expandable wall formed from an elastic material. 
     
     
         20 . The system of  claim 1 , wherein the controller controls the pump to deliver preselected inflation volumes of the inflation medium to the bladder when the pressure falls below the lower threshold value.