Delivery device, systems and methods of use

Abstract

Devices, systems, methods and kits are provided for delivering interventional devices to a target location with a body. Such interventional devices particularly include fixation devices or any devices which approximate tissue, such as valve leaflets. The delivery devices and systems direct the interventional device to the target location through a minimally invasive approach, such as through the patient's vasculature, and provide for manipulation of the interventional device at the target location, such as to approximate tissue. Optionally, the delivery devices and systems may provide for decoupling of the interventional device, allowing the interventional device to be left behind as an implant.

1 . A delivery device comprising: 
 an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween; and    at least one flexible tubular guide extending through the main lumen, the at least one flexible tubular guide having a first end constrained within the shaft, at or near the distal end of the shaft and a second end constrained, at or near the proximal end of the shaft, the at least one flexible tubular guide unconstrained relative to the shaft in at least one location between the first and second ends so as to be laterally moveable within the main lumen, at least a portion of the at least one flexible tubular guide being both flexible and tubular.    
     
     
         2 . A delivery device as in  claim 1 , wherein the main lumen is occupied by fluid.  
     
     
         3 . A delivery device as in  claim 1 , wherein the at least one flexible tubular guide comprises at least two flexible tubular guides.  
     
     
         4 . A delivery device as in  claim 3 , wherein the at least one flexible tubular guide comprises at least three flexible tubular guides.  
     
     
         5 . A delivery device as in  claim 4 , wherein the at least one flexible tubular guide comprises at least four flexible tubular guides.  
     
     
         6 . A delivery device as in  claim 1 , wherein the at least one flexible tubular guide comprises a coil.  
     
     
         7 . A delivery device as in  claim 1 , further comprising an interventional element coupled to the distal end of the shaft.  
     
     
         8 . A delivery device as in  claim 7 , wherein the interventional element is removably coupled.  
     
     
         9 . A delivery device as in  claim 7 , wherein the interventional element is adapted for tissue approximation.  
     
     
         10 . A delivery device as in  claim 7 , wherein the interventional element is adapted for coaptation of valve leaflets.  
     
     
         11 . A delivery device as in  claim 7 , wherein the interventional element has first and second tissue engaging elements adapted for engaging tissue therebetween.  
     
     
         12 . A delivery device as in  claim 1 , wherein the shaft and the interventional element are adapted for positioning through a blood vessel.  
     
     
         13 . A delivery device as in  claim 1 , further comprising an actuation element movably disposed in one of the at least one flexible tubular guide, the actuation element adapted for coupling with at least one movable element of an interventional element so that movement of the actuation element causes movement of the at least one movable element.  
     
     
         14 . A delivery device as in  claim 13 , wherein the at least one movable element comprises first and second tissue engaging elements and wherein the actuation element comprises an actuator rod adapted so that movement of the actuator rod moves the first and second tissue engaging elements.  
     
     
         15 . A delivery device as in  claim 13 , wherein the actuation element comprises a flexible line.  
     
     
         16 . A delivery device as in  claim 15 , wherein the at least one movable element comprises a proximal element and wherein the flexible line comprises a proximal element line adapted so that movement of the proximal element line actuates the proximal element.  
     
     
         17 . A system for approximating tissue at a treatment site comprising: 
 an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;    at least one flexible tubular guide extending through the main lumen, the at least one flexible tubular guide having a first end constrained, at or near the distal end of the shaft and a second end constrained within the shaft, at or near the proximal end of the shaft and being unconstrained in at least one location between the first and second ends so as to be laterally movable within the main lumen;    an actuation element movably disposed in the tubular guide; and    an approximation device coupled to the distal end of the shaft, the approximation device having first and second engaging elements for engaging tissue therebetween, at least one of the engaging elements being movable and coupled to the actuation element.    
     
     
         18 . An endovascular heart valve repair device comprising: 
 an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween, the elongated flexible shaft being adapted for positioning through a blood vessel into a chamber of the heart;    at least one flexible tubular guide extending from the proximal end to the distal end through the main lumen;    an actuation element movably disposed in one of the at least one flexible tubular guide; and    a fixation device releasably coupled to the distal end of the shaft and adapted for positioning in the chamber of the heart, the fixation device having at least one proximal element and at least one distal element adapted to engage a valve leaflet therebetween, at least one of the proximal and distal elements being coupled to the actuation element so that movement of the actuation element in relation to the at least one flexible tubular guide moves the at least one of the proximal and distal elements coupled thereto.    
     
     
         19 . An endovascular heart valve repair device as in  claim 18 , wherein the at least one proximal element and the at least one distal element comprise a pair of proximal elements and a pair of distal elements.  
     
     
         20 . An endovascular heart valve repair device as in  claim 18 , wherein the at least one flexible tubular guide comprises a coil.  
     
     
         21 . An endovascular heart valve repair device as in  claim 18 , wherein the actuation element comprises a rod.  
     
     
         22 . An endovascular heart valve repair device as in  claim 18 , wherein the actuation element comprises a flexible line.  
     
     
         23 . An endovascular heart valve repair device as in  claim 18 , wherein the at least one tubular guide comprises a second tubular guide.  
     
     
         24 . An endovascular heart valve repair device as in  claim 23 , further comprising a second actuation element disposed in the second tubular guide, wherein the other of the proximal and distal elements is coupled to the second actuation element.  
     
     
         25 . An endovascular heart valve repair device as in  claim 24 , wherein the second actuation element comprises a flexible line.  
     
     
         26 . A system as in  claim 18 , wherein the at least one flexible tubular guide is fixed to the shaft near the proximal end or near the distal end and is unconstrained therebetween so as to be laterally movable within the main lumen.  
     
     
         27 . A system for approximating tissue at a treatment site comprising: 
 an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;    first and second movable elements extending through the main lumen from the proximal to the distal end and being movable relative to the shaft; and    an approximation device releasably coupled to the distal end of the shaft, the approximation device having first and second engaging elements for engaging and holding a tissue portion therebetween in approximation with another tissue portion, the first engaging element being coupled to the first movable element so that manipulation of the first engaging element moves the first movable element and the second engaging element being coupled to the second movable element so that manipulation of the second engaging element moves the second movable element.    
     
     
         28 . A system as in  claim 27 , further comprising first and second flexible tubular guides extending from the proximal end to the distal end through the main lumen, the first and second tubular guides being fixed to the shaft near the proximal end or near the distal end and being unconstrained therebetween so as to be laterally movable within the main lumen, the first movable element extending through the first tubular guide and the second movable element movably disposed in the second tubular guide.  
     
     
         29 . A system as in  claim 27 , wherein the first moveable element comprises an actuator rod.  
     
     
         30 . A system as in  claim 27 , wherein the second movable element comprises a flexible line.  
     
     
         31 . A system as in  claim 27 , further comprising an actuator handle connected to the proximal end of the shaft, the actuator handle having a body and a first actuation element movably coupled thereto, the first actuation element being coupled to the first movable element.  
     
     
         32 . A system as in  claim 31 , wherein the actuator handle has a second actuation element moveably coupled thereto, the second actuation element being coupled to the second moveable element.  
     
     
         33 . A system for approximating tissue at a treatment site comprising: 
 an elongated flexible shaft having a proximal end, a distal end, and a main lumen therebetween;    first and second flexible tubular guides extending from the proximal end to the distal end through the main lumen, the first and second tubular guides being fixed to the shaft at a location within the shaft, near the proximal end or near the distal end and being unconstrained therebetween so as to be laterally movable within the main lumen;    a first movable element movably disposed in the first tubular guide;    a second movable element movably disposed in the second tubular guide; and    an approximation device coupled to the distal end of the shaft, the approximation device having first and second movable engaging elements for engaging therebetween, the first engaging element being coupled to the first movable element, the second engaging element being coupled to the second movable element.    
     
     
         34 . A system as in  claim 33 , further comprising an actuator rod extending from the proximal to the distal end through the main lumen and being movable relative to the shaft.  
     
     
         35 . A system as in  claim 33 , wherein the approximation device further comprises a locking mechanism.