Percutaneous mitral annulplasty with cardiac rhythm management

Abstract

A minimally invasive method of performing mitral annuloplasty is disclosed. An implantable device is positioned within the coronary sinus and tightened around the mitral annulus. Mitral valve regurgitation is monitored before, during, and/or after the tightening step. An on-going drug therapy may be determined, taking into account post-implantation hemodynamic function.

1 . A medical apparatus, for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:
 an elongate body sized for implantation at least partially within the coronary sinus, the elongate body having a proximal end and a distal end and being movable between a first configuration for transluminal delivery to at least a portion of the coronary sinus and a second configuration for remodeling the mitral valve annulus from within the coronary sinus, the elongate body in the second configuration being configured to exert, while residing completely within the vasculature system, a force against a wall of the coronary sinus sufficient to reduce mitral regurgitation by a therapeutically effective amount;   a forming element attached to the elongate body at a point of attachment for manipulating the elongate body between the first configuration and the second configuration, wherein the forming element is slidably contained within the elongate body between the attachment point and the proximal end; and   a cardiac pacing electrode, carried by the elongate body and configured to be implanted in the coronary sinus with the elongate body;   wherein a portion of the forming element is configured to be removable after implantation of the elongate body within the coronary sinus while a remaining portion of the forming element is contained within the elongate body;   wherein the cardiac pacing electrode remains with the elongate body in the coronary sinus (i) after the elongate body is manipulated between the first configuration and the second configuration, (ii) after implantation of the elongate body within the coronary sinus, and (iii) after the portion of the forming element is removed from the coronary sinus.   
     
     
         2 . The medical apparatus according to  claim 1 , wherein the electrode comprises an axially extending strip. 
     
     
         3 . The medical apparatus according to  claim 1 , wherein the forming element is movable relative to the elongate body in order to adjust the elongate body within the coronary sinus between the first and second configurations. 
     
     
         4 . The medical apparatus according to  claim 1 , wherein the elongate body defines an arc when in the second configuration. 
     
     
         5 . The medical apparatus according to  claim 4 , wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm. 
     
     
         6 . The medical apparatus according to  claim 1 , further comprising a lock, for retaining the elongate body in the second configuration. 
     
     
         7 . The medical apparatus according to  claim 6 , wherein the lock comprises an interference fit. 
     
     
         8 . The medical apparatus according to  claim 6 , wherein the lock comprises an engagement surface, which is movable between a first, disengaged configuration and a second, engaged configuration. 
     
     
         9 . The medical apparatus according to  claim 1 , further comprising a coating on the body. 
     
     
         10 . The medical apparatus according to  claim 1 , wherein the apparatus is movable from the first configuration to the second configuration in response to proximal retraction of the forming element. 
     
     
         11 . The medical apparatus according to  claim 1 , wherein the apparatus is movable from the first configuration to the second configuration in response to distal advancement of the forming element. 
     
     
         12 . The medical apparatus according to  claim 1 , further comprising an anchor for retaining the apparatus at a deployment site within a vessel. 
     
     
         13 . The medical apparatus according to  claim 12 , wherein the anchor comprises a distal extension of the apparatus. 
     
     
         14 . The medical apparatus according to  claim 12 , wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel. 
     
     
         15 . The medical apparatus according to  claim 12 , wherein the anchor comprises at least one barb for piercing the wall of the vessel. 
     
     
         16 . The medical apparatus according to  claim 12 , wherein the apparatus has an axial length of no more than about 10 cm. 
     
     
         17 . The medical apparatus according to  claim 1 , wherein the maximum cross sectional dimension through the apparatus is no more than about 10 mm 2 . 
     
     
         18 . The medical apparatus according to  claim 1 , further comprising an axially extending support in the body, attached to the forming element. 
     
     
         19 . The medical apparatus according to  claim 1 , comprising only one forming element attached to the elongate body at the point of attachment for manipulating the elongate body between the first configuration and the second configuration. 
     
     
         20 . The medical apparatus of  claim 1 , wherein the forming element:
 is disposed along a core of the elongate body;   is axially fixedly attached to the elongate body;   comprises a memory material that is formed such that, when the elongate body is positioned within the at least portion of the coronary sinus, the memory material provides a force effective to move the elongate body from the first configuration to the second configuration.   
     
     
         21 . The medical apparatus of  claim 20 , wherein the memory material comprises a NiTi alloy. 
     
     
         22 . The medical apparatus of  claim 1 , wherein the forming element comprises at least one of a polymeric wire, a polymeric strand, a metal wire, a metal strand, a multifilament line, a multifilament braided line, a multifilament woven line, a metal ribbon, and a polymeric ribbon. 
     
     
         23 . A medical apparatus, for treating a mitral valve of a patient, comprising:
 an elongate body sized and configured to be implanted at least partially within the coronary sinus of a patient's heart, the elongate body being movable between a delivery configuration and a deployment configuration, the elongate body in the deployment configuration, when implanted at least partially within the coronary sinus, being configured to apply a force against a wall of the coronary sinus sufficient to reduce mitral regurgitation by a therapeutically effective amount;   a forming element coupled with the elongate body for manipulating the elongate body between the delivery configuration and the deployment configuration, the forming element having a first portion that is configured to be removed from the patient after implantation of the elongate body in the coronary sinus; and   a cardiac electrode, carried by the elongate body and configured to remain with the elongate body after the first portion of the forming element is removed from the patient after implantation of the elongate body in the coronary sinus.   
     
     
         24 . The medical apparatus of  claim 23 , wherein the elongate body is movable from the delivery configuration to the deployment configuration in response to relative movement between the forming element and the elongate body. 
     
     
         25 . The medical apparatus of  claim 23 , wherein the elongate body is arcuate when in the deployment configuration. 
     
     
         26 . The medical apparatus of  claim 23 , wherein the elongate body is configured to remain in the deployment configuration after the first portion of the forming element is removed from the patient. 
     
     
         27 . The medical apparatus of  claim 26 , further comprising a lock that retains the elongate body in the deployment configuration after the first portion of the forming element is removed. 
     
     
         28 . The medical apparatus of  claim 23 , wherein the forming element is coupled with the elongate body at a point of attachment positioned at a distal portion of the elongate body. 
     
     
         29 . The medical apparatus of  claim 28 , wherein the forming element remains coupled with the elongate body at the point of attachment after the first portion of the forming element is removed from the patient. 
     
     
         30 . The medical apparatus of  claim 23 , wherein the electrode is configured to be in electrical communication with a cardiac rhythm management device. 
     
     
         31 . A medical apparatus, for treating a mitral valve of a patient, comprising:
 an elongate body that, when implanted within the coronary sinus of the patient's heart, is configured to exert a force against a wall of the coronary sinus sufficient to reduce mitral regurgitation by a therapeutically effective amount;   a forming element coupled with and shaping the elongate body, the forming element having a first portion that is removed from the patient after implantation of the elongate body in the coronary sinus; and   a cardiac electrode, in or on the elongate body, configured to maintain electrical coupling with a cardiac rhythm management device after implantation of the elongate body in the coronary sinus.