Methods for controlling the internal circumference of an anatomic orifice or lumen

Abstract

A method for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural orifice or lumen which is either too large or too small. Implants are disclosed which employ various means for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the circumference of the implants after the resumption of normal flow of anatomic fluids in situ. Methods are disclosed for using the implants to treat heart valve abnormalities, gastroesophageal abnormalities, anal incontinence, and the like.

1 . A method of implanting a foldable prosthetic annular ring to a patient's heart comprising:
 providing a prosthetic annular ring folded inside a catheter for delivery to the patient's heart;   inserting the catheter through an anatomic passageway into a native recipient anatomic site of the patient's heart;   expelling the prosthetic annular ring from the catheter whereby the prosthetic annular ring has an unfolded configuration;   securing the prosthetic annular ring when in the unfolded configuration to adjacent tissue, said securing including application of external force to allow the prosthetic annular ring to attach to the adjacent tissue using a mechanical tissue interface system thereby holding the prosthetic annular ring in place; and removing the catheter from the anatomic passageway.   
     
     
         2 . The method of  claim 1 , wherein the mechanical tissue interface system comprises a plurality of retention barbs, said application of external force engages the retention barbs into the adjacent tissue. 
     
     
         3 . The method of  claim 1 , wherein said expelling comprises use of support arms attached to the prosthetic annular ring that expand to deploy said prosthetic annular ring from a folded configuration to an unfolded configuration having a radial dimension. 
     
     
         4 . The method of  claim 1 , wherein said prosthetic annular ring is expandable radially to anchor the prosthetic annular ring at an implantation position. 
     
     
         5 . The method of  claim 1 , wherein the prosthetic annular ring and the mechanical tissue interface system are integrated into a one-piece construction. 
     
     
         6 . A method of implanting a prosthetic heart valve, comprising:
 folding said prosthetic heart valve into a collapsed position;   inserting a catheter into a patient and guiding a distal end of said catheter to a position adjacent an implantation position in a patient's heart;   inserting said prosthetic heart valve when in the collapsed position into said catheter and steering said prosthetic heart valve to said distal end of said catheter using a guiding device;   guiding said prosthetic heart valve beyond said distal end of said catheter so as to cause said prosthetic heart valve to unfold to an unfolded position;   guiding the prosthetic heart valve to the implantation position;   securing the prosthetic heart valve to adjacent tissue, said securing including application of external force to allow the prosthetic heart valve to attach to the adjacent tissue using a mechanical tissue interface system.   
     
     
         7 . The method of  claim 6 , wherein the mechanical tissue interface system comprises a plurality of retention barbs, said application of external force engages retention barbs into the adjacent tissue. 
     
     
         8 . The method of  claim 6 , wherein the prosthetic heart valve is unfolded using support arms attached thereto that expand to deploy the prosthetic heart valve to the unfolded position having a radial dimension. 
     
     
         9 . The method of  claim 6 , wherein said prosthetic heart valve is expandable radially to anchor the prosthetic heart valve at the implantation position. 
     
     
         10 . The method of  claim 6 , wherein the prosthetic heart valve and the mechanical tissue interface system are integrated into a one-piece construction. 
     
     
         11 . A method for delivery of a foldable prosthetic heart valve, comprising:
 removably coupling a prosthetic heart valve to an expansion assembly, the prosthetic heart valve having a folded configuration and an unfolded configuration when coupled to the expansion assembly;   slideably mounting the expansion assembly coaxially within an interior of a catheter along with the prosthetic heart valve; and   moving the expansion assembly relative to the catheter from a first position, wherein the expansion assembly and the prosthetic heart valve in the fold configuration are arranged within the interior of the catheter, to a second position, wherein the expansion assembly and the prosthetic heart valve in the unfolded configuration are arranged outside the interior of the catheter.   
     
     
         12 . The method of  claim 11 , further including releasably coupling an adjustment tool to the prosthetic heart valve for adjusting at least one of the size and shape of the prosthetic heart valve. 
     
     
         13 . The method of  claim 11 , further including securing the prosthetic heart valve to tissue adjacent an anatomic orifice or lumen, said securing includes application of external force to allow the prosthetic heart valve to attach to the adjacent tissue using a mechanical tissue interface system thereby holding the prosthetic heart valve in place. 
     
     
         14 . The method of  claim 13 , wherein the mechanical tissue interface system comprises a plurality of retention barbs engaging the adjacent tissue. 
     
     
         15 . The method of  claim 13 , wherein the prosthetic heart valve and the mechanical tissue interface system are integrated into a one-piece construction. 
     
     
         16 . The method of  claim 11 , wherein the expansion assembly comprises a plurality of support arms that expand to deploy the prosthetic heart valve from the folded configuration to the unfolded configuration having a radial dimension. 
     
     
         17 . The method of  claim 11 , wherein said prosthetic heart valve is adapted to fit in a mitral valve opening of a heart. 
     
     
         18 . The method of  claim 11 , wherein said prosthetic heart valve is adapted to fit in an aortic valve opening of a heart. 
     
     
         19 . The method of  claim 11 , wherein said prosthetic heart valve is adapted to fit in a pulmonary valve opening of a heart. 
     
     
         20 . The method of  claim 11 , wherein said prosthetic heart valve is adapted to fit in a tricuspid valve opening of a heart.