Devices, Systems, and Methods for Reshaping a Heart Valve Annulus, Including the Use of Magnetic Tools

Abstract

Implants or systems of implants and methods apply a selected force vector or a selected combination of force vectors within or across the left atrium, which allow mitral valve leaflets to better coapt. The implants or systems of implants and methods make possible rapid deployment, facile endovascular delivery, and full intra-atrial retrievability. The implants or systems of implants and methods also make use of strong fluoroscopic landmarks. The implants or systems of implants and methods make use of an adjustable implant and a fixed length implant. The implants or systems of implants and methods may also utilize a bridge stop to secure the implant, and the methods of implantation employ various tools.

I/We claim: 
     
         1 . A method of treatment a human or veterinary patient involving two adjacent bodily structures comprising:
 providing a first catheter having a first distal end and a first interior channel, the first catheter having a first orifice between said first interior channel and the exterior of the catheter in the vicinity of the first distal end, said first catheter having a first magnetically attractable section located in the vicinity of said first orifice;   providing a second catheter having a second distal end and a second interior channel, the second catheter having a second orifice between said second interior channel and the exterior of the second catheter in the vicinity of the second distal end, said second catheter having a magnetically attracting section located in the vicinity of said second orifice;   locating said first catheter within a first body structure;   locating said second catheter within a second body structure adjacent body structure;   placing said first magnetically attractable section within said first body structure adjacent said second magnetically attracting section with a layer of tissue between said first and second magnetically sections such that said first and second magnetically attractable sections align and magnetically couple to each other with first and second orifices opposed to each other but separated by the layer of tissue between them; and   passing a piercing device through the first orifice, through the layer of tissue, and into the second orifice.   
     
     
         2 . The method according to  claim 1 , wherein the first catheter further comprises a first catheter magnetically attracting section and second catheter further comprises catheter magnetically attractable section. 
     
     
         3 . The method according to  claim 2  wherein the first catheter magnetically attractable and first catheter magnetically attracting section and the second catheter magnetically attractable and the second catheter magnetically attracting section are arranged so that when they are brought into close proximity but on opposite sides of a layer of tissue, they align in a stable configuration that aligns the first catheter orifice with the second catheter orifice with sufficient stability to remain aligned in said configuration even should the body structure encounter movement. 
     
     
         4 . The method according to  claim 3  wherein the body structure is the human heart and the movement is the beating of the heart. 
     
     
         5 . The method according to  claim 1 , where said magnetically attractable and magnetically attracting sections are magnets having opposite poles. 
     
     
         6 . The method according to  claim 1 , wherein the piercing device is a needle with a suture. 
     
     
         7 . The method according to  claim 4 , wherein the piercing device is a sharpened tip guide wire. 
     
     
         8 . The method according to  claim 1 , wherein the piercing device is a hollow coring tip. 
     
     
         9 . The method according to  claim 1 , wherein the piercing device is a multi-bladed cutting tip. 
     
     
         10 . The method according to  claim 1 , wherein the piercing device is a flattened puncturing wire. 
     
     
         11 . The method according to  claim 1 , wherein the first orifice has a funnel shape, whereby the piercing structure passing through the layer of tissue would be directed from the exterior of the catheter to the catheter channel. 
     
     
         12 . The method according to  claim 1  wherein the layer of tissue includes the tissue between the interior of the left aorta and the interior of the great cardiac vein. 
     
     
         13 . The method according to  claim 1  wherein said first catheter has a first proximal end exiting the body of the patient at a first location;
 said second catheter has a second proximal end exiting the body of the patient at a second location; and 
 said method further comprises passing a guide wire into said first proximal end, through first catheter channel, out said first orifice, through said layer of tissue, into said second orifice, through said second catheter channel out said second proximal end and thus out of the body of the patient at said second location. 
 
     
     
         14 . The method according to  claim 10  wherein the said first and said second locations are at different places on the body of the patient. 
     
     
         15 . The method according to  claim 11  wherein said first location and said second location are at approximately the same location on the body of the patient. 
     
     
         16 . An implant system comprising
 a first catheter, comprising a first catheter body sized and configure for axial advancement over a guide wire, the first catheter body including a guide wire lumen and an auxiliary lumen independent of the guide wire lumen, said first catheter including an elongated shaft having a distal end, and a first head carried at the distal end in which the distal opening is formed, wherein the first head includes magnetic or ferromagnetic materials,   a second catheter, comprising a second catheter body sized and configure for axial advancement over a guide wire, the second catheter body including a distal end and an inner lumen, said second catheter including a second head and a lumen extension that communicates with the inner lumen of the second catheter body, wherein the second head includes magnetic or ferromagnetic materials;   whereby the magnetic or ferromagnetic materials of said first head and of said second head couple with one another to accommodate passage of an operative component between the first and second catheters.   
     
     
         17 . The implant system of  claim 16  wherein the operative component includes a sharp distal tip to pierce tissue. 
     
     
         18 . The implant system of  claim 16  further comprises
 a first wire sized for passage through the guide wire lumen of the first catheter body, the guide lumen extension of the first head, and the guide lumen exit opening of the first head, to serve as the guide wire for the first catheter body for axially advancement of the first catheter body; and 
 a second wire sized for passage through the inner lumen of the second catheter body, the lumen extension of the second head, and the lumen exit opening of the second head, to serve as the guide wire for the second catheter body for axial advancement of the second catheter body to magnetically couple the distal region of the second head to the middle region of the first head. 
 
     
     
         19 . A system according to  claim 17  wherein the lumen exit opening at the distal end of the second head includes an interior surface shaped as a funnel to guide entry of the sharp distal tip from the auxiliary lumen exit opening at the middle region of the first head into the lumen exit opening. 
     
     
         20 . A system according to  claim 16  wherein a first retaining structure is coupled to the first catheter head and a second retaining structure is coupled to the elongated shaft, the first retaining structure being engagable with the second structure to limit the rotation of the first catheter head relative to the elongated shaft.