Implantable devices for controlling the internal circumference of an anatomic orifice or lumen

Abstract

An implantable device for controlling the circumference of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implants area 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 producers 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 . An implantable device system for controlling at least one of the shape and size of an anatomical orifice or lumen, comprising:
 an adjustable implantable device adapted for attachment to an anatomical orifice or lumen, said implantable device including an adjustable member configured to adjust at least one of the shape and size of the implantable device; and   an adjustment tool configured to be releasably connected to the adjustable member such that the adjustment tool can be used to activate and control adjustment of the implantable device;   wherein the adjustment member and the adjustment tool are configured to be attached and subsequently reattached to each other when the implantable device is positioned in situ to the anatomical orifice or lumen.   
     
     
         2 . The system of  claim 1 , wherein the adjustable member includes an adjustment element configured for releasably connecting and reconnecting the adjustment tool to the adjustable member. 
     
     
         3 . The system of  claim 1 , wherein the adjustable implant device comprises a prosthetic heart valve. 
     
     
         4 . The system of  claim 3 , wherein the adjustable implantable device comprises an annuloplasty ring. 
     
     
         5 . The system of  claim 3 , wherein the adjustment tool is mechanically connected to the adjustable member. 
     
     
         6 . An adjustable implantable device system for an anatomic orifice or lumen in a mammalian body, comprising:
 an implantable adjustable implant device having an adjustable member operative to adjust the annular dimension or shape of the implant device when attached to an adjustment tool, the implant device configured to be attached to tissue within a mammalian body adjacent the anatomic orifice or lumen; and   an adjustment tool having a proximal end and a distal end, the distal end and the adjustable member configured to be attached and subsequently reattached to each other when the implant device is implanted in the mammalian body with the proximal end arranged extracorporeal of the mammalian body;   wherein the distal end of the adjustment tool is operative when attached and reattached to the adjustable member to initiate adjustment of the implant device, in situ, while the proximal end of the adjustment tool is arranged extracorporeal.   
     
     
         7 . The system of  claim 6 , wherein the adjustable implant device comprises a prosthetic heart valve. 
     
     
         8 . The system of  claim 7 , wherein the adjustable implantable device comprises an annuloplasty ring. 
     
     
         9 . The system of  claim 7 , wherein the adjustment tool is mechanically connected to the adjustable member. 
     
     
         10 . The system of  claim 7 , wherein the adjustable member includes an assembly operative for adjusting the prosthetic heart valve by rotation of the adjustment tool when connected thereto. 
     
     
         11 . An adjustable implantable device system for an anatomic orifice or lumen in a mammalian body, comprising:
 an adjustable implant device including an adjustable member configured to adjust an annular dimension of the implant device from a first dimension to one of a range of second dimensions when attached to an adjustment tool, the implant device configured to be attached to tissue within a mammalian body adjacent the anatomic orifice or lumen; and   an adjustment tool configured to activate adjustment of the implant device from the first dimension to one of the range of second dimensions, wherein the adjustable member and the adjustment tool having an end are configured for releasable attachment and reattachment to one another in situ;   wherein, when the adjustment tool is attached within a mammalian body to the adjustable member of the implant device, the adjustment tool is operative by rotation thereof to initiate adjustment of the annular dimension of the implant device over the range from the first dimension to the second dimensions in situ; and   wherein the adjustment tool is detachable from the adjustable member after adjustment of the implant device in situ and is subsequently reattachable to the adjustable member in situ after being withdrawn from within the mammalian body.   
     
     
         12 . The system of  claim 11 , wherein the adjustable implant device comprises a prosthetic heart valve. 
     
     
         13 . The system of  claim 12 , wherein the adjustable implantable device comprises an annuloplasty ring. 
     
     
         14 . The system of  claim 12 , wherein the adjustable member includes an adjustment element configured for releasably connecting and reconnecting the adjustment tool to the adjustable member. 
     
     
         15 . The system of  claim 11 , wherein the adjustment tool is remotely operative by engagement of the proximal end for adjusting the implant device. 
     
     
         16 . An adjustable implantable device system for adjusting the dimensions of an anatomic orifice or lumen in a mammalian body, comprising:
 an adjustable prosthetic heart valve configured to adjust an annular dimension of the prosthetic heart valve from a first dimension to one of a range of second dimensions, the prosthetic heart valve having an interface location configured to be releasably attached to an adjustment tool, the prosthetic heart valve configured to be attached to tissue within a mammalian body adjacent the anatomic orifice or lumen; and   an adjustment tool configured to activate adjustment of the prosthetic heart valve from the first dimension to one of the range of second dimensions;   wherein, the interface location and the adjustment tool are configured to be releasably attached and subsequently reattached to each other within a mammalian body, the adjustment tool being operative to initiate adjustment of the annular dimension of the prosthetic heart valve over the range from the first dimension to the second dimensions in situ; and   wherein the adjustment tool is detachable from the interface location of the prosthetic heart valve after adjustment thereof and is subsequently reattachable to the interface location after being withdrawn from within the mammalian body.   
     
     
         17 . The system of  claim 16 , wherein the annular dimension can be adjusted to provide leaflet coaptation of an anatomic orifice. 
     
     
         18 . The system of  claim 16 , wherein the adjustable member is configured to non-uniformly adjust an annular dimension of the prosthetic heart valve. 
     
     
         19 . The system of  claim 16 , wherein the adjustment tool comprises a distal end and a proximal end, said distal end being removably coupled to said interface location and extending therefrom such that adjustments to the prosthetic heart valve can be made from the proximal end. 
     
     
         20 . The system of  claim 19 , wherein said adjustments of the prosthetic heart valve can be performed after resumption of physiologic flow in the orifice or lumen. 
     
     
         21 . The system of  claim 19 , wherein the distal end of the adjustment tool is mechanically attached to the interface location of the implant body. 
     
     
         22 . The system of  claim 16 , wherein the interface location comprises an adjustment element configured for releasable connection to the adjustment tool. 
     
     
         23 . The system of  claim 22 , wherein the adjustment element includes an assembly operative for adjusting the prosthetic heart valve from the first dimension to the second dimension by rotation of the adjustment tool when connected thereto.