Devices, systems, and methods for reshaping a heart valve annulus, including the use of magnetic tools
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.
1. A method of treatment a human or veterinary patient involving two adjacent bodily structures comprising:
providing a first catheter having a first interior channel, the first catheter having a first orifice between said first interior channel and an exterior of the catheter, said first catheter having a first magnetically attracting tip, said first magnetically attracting tip comprising a ferromagnetic material located in a length of said first catheter that includes said first orifice, said first magnetically attracting tip having a polarity parallel to said first interior channel;
providing a second catheter having a second interior channel, the second catheter having a second orifice between said second interior channel and an exterior of the second catheter through a side wall of said second catheter, said second catheter having a second magnetically attracting tip, said second magnetically attracting tip comprising a ferromagnetic material, located in a length of said second catheter that includes said second orifice, said second magnetically attracting tip comprised of three magnetic sections, a first magnetic section, a middle magnetic section and a third magnetic section, said first and third magnetic sections having opposing polarity, and said middle magnetic section having its polarity oriented perpendicular to the polarity of said first and second section, said second orifice located in said middle magnetic section, wherein the second catheter includes a radio-opaque marker disposed along a distal portion thereof to indicate a rotational orientation of the second orifice;
locating said first catheter within a first body structure;
locating said second catheter within a second body structure adjacent the first body structure;
positioning the second catheter to rotationally align the second orifice of the second catheter with the first orifice of the first catheter by observing the radio-opaque marker on the second catheter under image guidance;
placing said first magnetically attracting tip within said first body structure adjacent said second magnetically attracting tip with a layer of tissue between said first magnetically and second magnetically attracting tips such that said first and second magnetically attracting tips 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 magnetically attracting tip and the second catheter magnetically attracting tip are arranged so that when they are brought into close proximity but on opposite sides of a layer of tissue they align with sufficient stability to remain aligned even should the body structure encounter movement.
3. The method according to claim 2 wherein the body structure is the human heart and the movement is the beating of the heart.
4. The method according to claim 1 , wherein the piercing device is a needle with a suture.
5. The method according to claim 1 , wherein the piercing device is a sharpened tip guide wire.
6. The method according to claim 1 , wherein the piercing device is a hollow coring tip.
7. The method according to claim 1 , wherein the piercing device is a multi-bladed cutting tip.
8. The method according to claim 1 , wherein the piercing device is a flattened puncturing wire.
9. 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 into the first catheter channel.
10. The method according to claim 9 wherein said first location and said second location are at a location on the same part of on the body of the patient.
11. The method according to claim 1 wherein the layer of tissue includes the tissue between the interior of the left atrium and the interior of the great cardiac vein.
12. 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.
13. The method according to claim 12 wherein the said first and said second locations are at a location on the same part of the body of the patient.
14. The method according to claim 1 wherein the distal portion of said second interior channel forms of a ramp between said second interior channel and said second orifice.
15. The method according to claim 1 , wherein positioning the second catheter comprises rotating the second catheter until the radio-opaque marker indicates rotational alignment of the second orifice with the first orifice.