Annuloplasty procedures, related devices and methods
Devices and methods are disclosed for the treatment or repair of regurgitant cardiac valves, such as a mitral valve. An illustrative annuloplasty device can be placed in the coronary sinus to reshape the mitral valve and reduce mitral valve regurgitation. An improved protective device can be placed between the annuloplasty device and an underlying coronary artery to inhibit compression of the underlying coronary artery by the annuloplasty device in the coronary sinus. In addition, the protective device can inhibit compression of the coronary artery from inside the heart, such as from a prosthetic mitral valve that exerts radially outward pressure toward the coronary artery. The annuloplasty device can also create an artificial inner ridge or retaining feature projecting into the native mitral valve region to help secure a prosthetic mitral valve.
1 . An implant, comprising:
a) a bridge having a proximal end, a distal end, and an arched portion defined between the proximal end and the distal end of the bridge;
b) an elongate inner tether coupled to the bridge including radiopaque material along its length;
c) an outer sheath material surrounding and encasing the bridge and elongate inner tether; and
d) a guidewire coupled to and extending from a distal end region of the outer sheath material.
2 . The implant of claim 1 , further comprising an encasement surrounding the arch and a portion of the elongate inner tether that is co-incident with the bridge.
3 . The implant of claim 2 , wherein the encasement is a polymeric tube that is shrunk around the bridge and elongate inner tether.
4 . The implant of claim 1 , wherein the elongate inner tether traverses at least one opening defined through the bridge.
5 . The implant of claim 4 , wherein the elongate inner tether passes over a top of the arch, through an opening near each end of the bridge, and underneath end portions of the bridge.
6 . The implant of claim 5 , further comprising a respective strain relief section of varying durometer along its length surrounding each end of the bridge, wherein the elongate inner tether passes through each respective strain relief section.
7 . The implant of claim 1 , further comprising a removable proximal push tube disposed within the outer sheath material, a distal end of the proximal push tube abutting a proximal end region of the bridge, wherein the inner elongate tether passes through a central lumen of the proximal push tube.
8 . The implant of claim 7 , further comprising a removable distal pull tube disposed within the outer sheath material, a proximal end of the distal push tube abutting a distal end region of the bridge, wherein the inner elongate tether passes through a central lumen of the distal push tube.
9 . The implant of claim 8 , wherein the proximal push tube and distal pull tube are each made at least in part from polymeric material.
10 . The implant of claim 1 , wherein the inner tether includes a radiopaque wire inserted therein along its length.
11 . The implant of claim 1 , wherein outer inner tether includes radiopaque material embedded therein along its length.
12 . The implant of claim 1 , wherein the outer sheath material is coupled to a first portion of a crimp, and further wherein the guidewire is coupled to a second portion of the crimp.
13 . The implant of claim 12 , wherein relative sliding movement of the guidewire and the outer sheath material is prevented by being coupled to the crimp.
14 . An implant, comprising:
a) an elongate inner tether coupled to the bridge including radiopaque material along its length;
b) an outer sheath material surrounding and encasing the bridge and elongate inner tether; and
c) a guidewire coupled to and extending from a distal end region of the outer sheath material.
15 . The implant of claim 14 , further comprising an encasement surrounding a portion of the elongate inner tether.
16 . The implant of claim 15 , wherein the encasement is a polymeric tube that is shrunk around the elongate inner tether.
17 . The implant of claim 14 , further comprising a removable proximal push tube disposed within the outer sheath material, a distal end of the proximal push tube being located in a central region of the implant, wherein the inner elongate tether passes through a central lumen of the proximal push tube.
18 . The implant of claim 17 , further comprising a removable distal pull tube disposed within the outer sheath material, a proximal end of the distal push tube being located in the central region of the implant, wherein the inner elongate tether passes through a central lumen of the distal push tube.
19 . The implant of claim 14 , wherein the inner tether includes a radiopaque wire inserted therein along its length.
20 . The implant of claim 14 , wherein the outer sheath material is coupled to a first portion of a crimp, and further wherein the guidewire is coupled to a second portion of the crimp.