Method of treating copd with artificial arterio-venous fistula and flow mediating systems

Abstract

A method for treatment of COPD, hypertension, and left ventricular hypertrophy, and chronic hypoxia including creation of an artificial arterio-venous fistula and installation of a flow mediating device proximate the fistula. The flow mediating device is operated to limit flow as medically indicated to provide the optimum amount of bypass flow.

We claim: 
     
         1 . A method of treating COPD in a patient, comprising:
 implanting a shunt between a first vessel and a second vessel such that an anatomical fistula forms, wherein blood flows through the shunt;   evaluating the patient after a stabilization period following the creation of the anatomical fistula, wherein the stabilization period is sufficient to allow for long-term remodeling of a heart of the patient;   adjusting the blood flow through the fistula by restricting flow through another region of the vasculature different from the shunt; and   controlling bypass blood flow through the fistula to treat COPD.   
     
     
         2 . The method of  claim 1 , further comprising determining a trade-off between a blood level, a cardiac output, and a heart rate of the patient. 
     
     
         3 . The method of  claim 1 , wherein the anatomical fistula is a side-to-side fistula. 
     
     
         4 . The method of  claim 1 , wherein blood flows through the shunt between the first vessel and the second vessel until a blood plasma oxygen level (PaO2) and mixed venous oxygen level (SvO2) increases between 20% to 25% relative to the blood flow without the shunt. 
     
     
         5 . The method of  claim 1 , wherein adjusting the blood flow through the fistula by restricting flow through another region of the vasculature different from the shunt occurs until a blood plasma oxygen level (PaO2) and mixed venous oxygen level (SvO2) level are between 10% to 20%. 
     
     
         6 . The method of  claim 1 , wherein the bypass blood flow is controlled with a flow mediating device, wherein the flow mediating device comprises an inflatable bladder system, and wherein the inflatable bladder system comprises an inflatable cuff configured to substantially surround a portion of the patient's vasculature proximate the fistula. 
     
     
         7 . The method of  claim 1 , wherein the bypass blood flow is controlled with a flow mediating device, wherein the flow mediating device comprises an inflatable bladder, and wherein the inflatable bladder is configured to impinge upon a portion of the patient's vasculature proximate the fistula. 
     
     
         8 . The method of  claim 1 , wherein controlling comprises operating a flow mediating device to mediate flow through the shunt. 
     
     
         9 . The method of  claim 1 , wherein the bypass blood flow is controlled with a flow mediating device, and wherein the flow mediating device is positioned on the first or second vessel downstream from the fistula. 
     
     
         10 . The method of  claim 1 , wherein the bypass blood flow is controlled with a flow mediating device, and wherein the flow mediating, device is positioned on the first or second vessel upstream from the fistula. 
     
     
         11 . The method of  claim 1 , wherein the anatomical fistula forms between a femoral artery and femoral vein of the patient. 
     
     
         12 . The method of  claim 1 , wherein the anatomical fistula forms between one of the following vein/artery pairs:
 the aorta and inferior vena cava, the femoral vein and the iliopopliteal vein or iliac vein, the carotid artery and the carotid vein or jugular vein, the brachial artery and brachial vein, and the brachio-cephallic artery and subclavian vein.   
     
     
         13 . The method of  claim 1 , wherein the bypass blood flow is controlled with a flew mediating device, and wherein the flow mediating device is positioned on the external surface of the first or second vessel. 
     
     
         14 . A method of treating COPD in a patient, comprising:
 implanting a shunt between a first vessel and a second vessel such that an anatomical fistula forms, wherein blood flows through the shunt;   evaluating the patient after a stabilization period following the creation of the artificial fistula;   adjusting the blood flow through the fistula by restricting flow through another region of the vasculature different from the shunt;   determining a trade-off between a blood level, a cardiac output, and a heart rate of the patient; and   controlling bypass blood flow through the fistula to treat COPD.   
     
     
         15 . The method of  claim 14 , wherein the anatomical fistula is a side-to-side fistula. 
     
     
         16 . The method of  claim 14 , wherein controlling comprises increasing the bypass blood flow such that cardiac output is increased. 
     
     
         17 . The method of  claim 14 , wherein adjusting the blood flow comprises throttling the blood flow through the first or second vessel to restrict the bypass blood flow through the fistula. 
     
     
         18 . The method of  claim 14 , wherein the bypass blood flow is controlled with a flow mediating device, and wherein the flow mediating device is positioned on the external surface of the first or second vessel. 
     
     
         19 . The method of  claim 14 , wherein the bypass blood flow is controlled with a flow mediating device, and wherein the flow mediating device does not contact the blood flow of the vein or the artery. 
     
     
         20 . A method of treating COPD in a patient, comprising:
 implanting a shunt between a first vessel and a second vessel of the patient; and   installing a flow mediating device separate from the shunt, wherein the flow mediating device is in contact against the first or second vessel such that substantial blood flow through the fistula between the first and second vessels is maintained when the flow mediating device is in use.