Method and device to treat kidney disease

Abstract

The invention relates to a method and device for dialysis and or bulk fluid removal by generating a fibrosis chamber within a body cavity and performing dialysis or bulk fluid removal. An implantable medical device is described having a fibrosis chamber and a pump. A dialysis chamber and an optional electrodialysis unit can further be provided. An additional controller uses sensory feedback to regulate the fluid levels by altering the extracellular fluid retention within the fibrosis chamber. This device can be used for the treatment of patients with chronic kidney disease who may also be suffering from cardiorenal syndrome and hypertension.

1 . A method, comprising the steps of:
 inducing a pressure difference across the peritoneum of a patient to increase a total volume of peritoneal fluid in an implanted medical device,   performing one or more steps selected from the group consisting of:   1) dialyzing the blood across the peritoneal membrane, wherein peritoneal fluid is conveyed to a space inside of the implanted medical device and then conveyed to a dialysis chamber having a dialysate to reduce the concentration of waste components in the peritoneal fluid conveyed to the implanted medical device;   2) dialyzing the blood across the peritoneal membrane, wherein peritoneal fluid is conveyed to an inside of the implanted medical device and then contacted with a dialysis chamber having dialysate to reduce the concentration of waste components in the peritoneal fluid conveyed to the implanted medical device and using an electrical potential to regenerate the dialysate; and   3) removing excess fluid from the patient by removing at least part of the fluid from the implanted medical device from the patient, and   inducing a pressure difference across the peritoneum to decrease the total volume of fluid in the implanted medical device and return fluid from inside the medical device to the patient.   
     
     
         2 . The method of  claim 1 , further comprising the step of cleansing the dialysate in a closed loop. 
     
     
         3 . The method of  claim 1 , further comprising the step of directing at least part of the peritoneal fluid to the patient's urinary bladder. 
     
     
         4 . The method of  claim 1 , wherein the dialysis chamber or an electrodialyzer for using an electrical potential to regenerate the dialysate is located extracorporeally. 
     
     
         5 . The method of  claim 4 , wherein the electrodialyzer further comprises an adjustable voltage generator to generate electrical fields of varying magnitudes for selective removal of waste components. 
     
     
         6 . The method of  claim 3 , further comprising a pump to assist and/or control flow of the peritoneal fluid through a catheter to the patient's urinary bladder. 
     
     
         7 . The method of  claim 6 , further comprising piezoelectric vibrators placed adjacent to the catheter to reduce calcification of the catheter. 
     
     
         8 . The method of  claim 1 , further comprising regenerating the dialysate from the dialysis chamber using a dialysate cleansing unit. 
     
     
         9 . The method of  claim 8 , wherein the dialysate cleansing unit comprises sorbent packages. 
     
     
         10 . The method of  claim 9 , wherein the sorbent packages are replaceable. 
     
     
         11 . The method of  claim 1 , further comprising supplying a fresh supply of dialysate to the dialysate chamber. 
     
     
         12 . The method of  claim 1 , wherein the implanted medical device comprises a partially porous mesh that forms a fibrosis cage upon implantation into a patient, the fibrosis cage defining a space for accessing fluid from the patient. 
     
     
         13 . The method of  claim 12 , wherein the mesh is treated with at least one of a surface coating of fibrosis-inducing agents, and extracellular matrix components to promote growth of fibrous tissue. 
     
     
         14 . The method of  claim 12 , wherein the implanted medical device further comprises a pumping means for pumping fluid into and out of the fibrosis cage. 
     
     
         15 . The method of  claim 12 , wherein the fibrosis cage further comprises a material impermeable to cells surrounding the partially porous mesh. 
     
     
         16 . The method of  claim 14 , wherein the pumping means is one selected from the group consisting of a bellows pump, a peristaltic pump, a pulsatile pump, an impeller pump, and a syringe pump, said pump means positioned inside the partially porous mesh, outside the partially porous mesh or adjacent to the partially porous mesh. 
     
     
         17 . The method of  claim 14 , wherein the pumping means is regulated to not exceed a maximum pressure difference of any one of 5, 15, 20, 25, 30, 35, 40, 45 and 50 mmHG, wherein the pressure difference is a pressure difference between the inside of the fibrosis cage and a peritoneal cavity of a patient. 
     
     
         18 . The method of  claim 1 , wherein the implanted medical device further comprises a controller for regulating the fluid volume of the patient and adjusting a clearance rate of the patient. 
     
     
         19 . The method of  claim 1 , wherein the implanted medical device further comprises a means for sensing a fluid volume of the patient, wherein the means for sensing fluid volume is an electrical impedance plethysmography or an arterial pressure measurement. 
     
     
         20 . The method of  claim 1 , wherein the implanted medical device is powered by any selected from the group consisting of an internal battery, an externally coupled power source and a rechargeable battery wherein the rechargeable battery is rechargeable by wireless energy transfer.