Device and method for establishing an artificial arterio-venous fistula

Abstract

A shunt rivet for implantation in the aorta and inferior vena cava to treat chronic obstructive pulmonary disease, and a method of treating chronic obstructive pulmonary disease.

1 . A device for establishing and maintaining an arterio-venous fistula, said device comprising: 
 a wire frame structure defining a tube having a central section, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members;    wherein the proximal clinch members are resiliently biased to curve radially outward from the tube;    wherein the distal clinch members are resiliently biased to curve radially outward from the tube; and    wherein the central section is resiliently biased to open to an unrestrained diameter, and is plastically deformed to a larger diameter.    
   
   
       2 . The device of  claim 1  wherein the central section is formed of a plurality of waist segments, and the distal clinch members comprise longitudinally extending arcs interconnecting adjacent waist segments.  
   
   
       3 . The device of  claim 1  wherein the distal clinch members and the proximal clinch members establish a grip range of about 3 mm.  
   
   
       4 . The device of  claim 1  wherein the distal clinch members and the proximal clinch members establish a grip range of about 3 mm and exert a compressive force on any intervening material of about 0.1 to 1.5 ounces.  
   
   
       5 . The device of  claim 1  wherein the proximal clinch members are further resiliently biased to evert toward the distal clinch members.  
   
   
       6 . The device of  claim 1  wherein the proximal clinch members are further resiliently biased to form a horn shaped flange.  
   
   
       7 . A device for establishing and maintaining an arterio-venous fistula, said device comprising: 
 a wire frame structure defining a tube having a central section, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members;    wherein the proximal clinch members are reflexed relative to the central section;    wherein the distal clinch members are reflexed relative to the central section; and    wherein the central section is resiliently biased to open to an unrestrained diameter, and    at least one of said clinch members has a lanceolate shape.    
   
   
       8 . The device of  claim 7  wherein the central section is formed of a plurality of waist segments, and the clinch members span interconnecting adjacent waist segments.  
   
   
       9 . The device of  claim 7  wherein the distal clinch members and the proximal clinch members establish a grip range of about 3 mm.  
   
   
       10 . The device of  claim 7  wherein the distal clinch members and the proximal clinch members establish a grip range of about 3 mm and exert a compressive force on any intervening material of about 0.1 to 1.5 ounces.  
   
   
       11 . The device of  claim 7  wherein the proximal clinch members are further resiliently biased to evert toward the distal clinch members.  
   
   
       12 . The device of  claim 7  wherein the proximal clinch members are further resiliently biased to form a horn shaped flange.  
   
   
       13 . A method of forming a medical device comprising: 
 forming a generally tubular structure having a central section with a first diameter, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members;    training the distal clinch members to be resiliently biased to bend radially outwardly from the central section;    training the proximal clinch members to be resiliently biased to bend radially outwardly from the central section;    expanding the central section through plastic deformation to second diameter.    
   
   
       14 . The method of  claim 13  further comprising the steps of: 
 after training the proximal and distal clinch members, resiliently compressing the tubular structure to maintain a generally tubular shape and restraining the compressed tubular structure;    releasing the tubular structure to permit resilient expansion of the distal clinch members;    thereafter performing the step of expanding the central section through plastic deformation to a second diameter.    
   
   
       15 . The method of  claim 13  further comprising the steps of: 
 after training the proximal and distal clinch members, resiliently compressing the tubular structure to maintain a generally tubular shape and restraining the compressed tubular structure;    introducing the compressed structure percutaneously to a site within the body;    inserting the structure through apposing apertures in the aorta wall and vena cava wall of a patient such that the distal clinch members protrude into the vena cava of the patient and the central section is disposed within the apertures; and thereafter    releasing at least a portion of the tubular structure to permit resilient expansion of the distal clinch members; and thereafter    performing the step of expanding the central section through plastic deformation to a second diameter.    
   
   
       16 . The method of  claim 13  further comprising the steps of: 
 after training the proximal and distal clinch members, resiliently compressing the tubular structure to maintain a generally tubular shape and restraining the compressed tubular structure; and thereafter    inserting the structure through apposing apertures in the aorta wall and vena cava wall of a patient such that the distal clinch members protrude extend into the vena cava of the patient and the central section is disposed within the apertures; and thereafter    releasing the distal clinch members to permit resilient expansion of the distal clinch members; and thereafter performing the step of expanding the central section through plastic deformation to second diameter; and    releasing the proximal clinch members to permit resilient expansion of the proximal clinch members.    
   
   
       17 . The method of  claim 13  further comprising: 
 forming the tubular structure from a pseudoelastic material, said pseudoelastic material being psuedoelastic at body temperature.    
   
   
       18 . The method of  claim 13  further comprising: 
 forming the tubular structure from a resilient material.    
   
   
       19 . A method of treating COPD comprising: 
 providing a device having a central tubular section with a first diameter, a proximal clinch section defined by one or more clinch members, and a distal clinch section defined by one or more clinch members; said distal clinch members being resiliently or pseudoelastically biased to bend radially outwardly from the central section; said proximal clinch members being resiliently or pseudoelastically biased to bend radially outwardly from the central section;    making a first perforation or aperture or hole or incision through the aorta of the patient and a second incision in the vena cava of the patient, said first and second incisions being in apposition so as to permit insertion of the device through both incisions;    compressing the device into a generally tubular configuration and inserting the device into the distal end of a catheter, and percutaneously inserting the device into the perforation or aperture or hole or incision so that the distal clinch members extend into the vena cava and the proximal clinch members extend into the aorta, and releasing the distal clinch members from the catheter to allow the distal clinch members to resiliently or pseudoelastically bend outwardly to form a distal clinch operable to impinge on the vena cava wall proximate the incision; and releasing the proximal clinch members from the catheter to allow the proximal clinch members to resiliently or pseudoelastically bend outwardly to form a proximal clinch operable to impinge on the aorta wall proximate the incision; and    expanding the central section through plastic deformation to a second diameter.