Two Component Mitral Valve System Methods

Abstract

A method for transcatheter delivery to a native heart valve needing replacement. A first component is attached to the native annulus upstream of the native leaflets maintaining native leaflet function, and is held to the native annulus by barbs that are activated by a torus balloon after the first component is fully expanded. The torus balloon can be implanted along with the support frame. A limiting cable restricts further expansion of the first component and holds a second component that contains the replacement leaflets.

1 . A method for placing a device delivered via transcatheter methods within native heart valve tissues of a native heart valve comprising the steps;
 A. providing a support frame, said support frame configured to be enlarged from a smaller diameter to a larger diameter, said support frame having fixation members attached to said support frame,   B. expanding said support frame from said smaller diameter to said larger diameter and into contact with the native heart valve tissues while maintaining said fixation members in an inactive configuration that does not restrict movement between said support frame and the native heart valve tissues,   C. activating said fixation members to an active configuration placing at least a portion of said fixation members into contact with the native heart valve tissues to prevent movement of said support member relative to the native heart valve tissues,   D. wherein an inside luminal region of said support frame is configured to provide passage for blood flow through said inside luminal region preferably without restriction of blood flow through said device during said expansion of said support member and during said activation of said fixation members to said active configuration.   
     
     
         2 . The method of  claim 1  wherein said support frame is placed upstream of native valve leaflets of the heart valve thereby not affecting function of native valve leaflet cusps of the native heart valve during said placing of said support frame. 
     
     
         3 . The method of  claim 1  wherein said fixation members comprise a plurality of barbs having said inactive configuration with said support frame in said expanded configuration prior to said expanding of said support member. 
     
     
         4 . The method of  claim 1  further comprising the step of positioning said support frame adjacent the native heart valve tissues prior to inflation of a torus balloon, said torus balloon being positioned adjacent to said fixation members to activate said fixation members. 
     
     
         5 . The method of  claim 4  further comprising the step of recapturing said support frame into a support frame delivery catheter following said expansion of said support frame and prior to activating said fixation members. 
     
     
         6 . The method of  claim 4  further comprising the step of detaching said torus balloon from an inflation tubing configured for inflating said torus balloon with inflation medium, said detaching step following activation of said fixation members. 
     
     
         7 . The method of  claim 6  wherein said torus balloon has an open balloon inflation port on said torus balloon for drainage of said inflation medium out of said torus balloon following said detaching step. 
     
     
         8 . The method of  claim 6  wherein said torus balloon has a valve located within said torus balloon for retaining said inflation medium within said torus balloon. 
     
     
         9 . The method of  claim 4  wherein said torus balloon is permanently attached to said support frame and is thereby configured to be implanted along with said support frame within the native heart valve tissues. 
     
     
         10 . The method of  claim 4  further comprising the step of removing said torus balloon from said support frame, said torus balloon not being configured for implantation along with said support frame within the native heart valve tissues. 
     
     
         11 . The method of  claim 1  wherein said support frame has a locking region, said locking region being located on said support frame and having a geometrical shape configured to lock with an expandable valve frame having replacement leaflets attached thereto, said expandable valve frame being placed within said inside luminal region of said support frame. 
     
     
         12 . The method of  claim 1  wherein said device further comprises an expandable valve frame and said method further comprising the steps;
 A. placing said expandable valve frame via a valve frame delivery sheath within said inside luminal region of said support frame, said expandable valve frame having replacement leaflets attached thereto, said replacement leaflets configured to direct the blood flow in a downstream direction, 
 B. expanding said valve frame within said inside luminal region of said support frame such that said valve frame does not move axially with respect to said support frame. 
 
     
     
         13 . A method of catheter delivery of a device to a native heart valve and attaching said device to native heart valve tissues for implantation within the native heart valve, said method comprising;
 A. placing a support frame in an unexpanded configuration within the native heart valve tissues, said support frame having a balloon attached to said support frame in an uninflated configuration, said support frame having fixation members attached along a support frame perimeter,   B. expanding said support frame into contact with the native heart valve tissues with said balloon in an uninflated configuration, said fixation members having an inactive configuration that does not contact the native heart valve tissues during said expansion of said support frame,   C. inflating said balloon to activate said fixation members into contact with the native heart valve tissues,   D. whereby said fixation members are configured to attach said support frame to the native heart valve tissues to prevent migration of said support frame relative to the native heart valve tissues.   
     
     
         14 . The method of  claim 13  further comprising the step of detaching said balloon from an inflation tube for inflating said balloon thereby providing said support frame and said balloon to be implanted into the native heart valve tissues. 
     
     
         15 . The method of  claim 13  wherein said device further comprises an expandable valve frame and said method further comprising the steps;
 A. placing said expandable valve frame within an inside luminal region of said support frame, said valve frame having replacement leaflets attached to said valve frame, 
 B. expanding said valve frame within said support frame, said valve frame making contact with said support frame and thereby not moving axially with respect to said support frame. 
 
     
     
         16 . The method of  claim 13  wherein said support frame has an open central region configured to provide passage for unrestricted blood flow axially through said open central region during inflation of said balloon. 
     
     
         17 . A method for placing a device delivered by a catheter within a native heart valve tissues comprising the steps;
 A. providing a support frame having fixation members attached to said support frame, said support frame having an expansion member attached to said support frame,   B. expanding said support frame within the native heart valve tissues while maintaining said fixation members in an inactive configuration within said support frame, said expansion member being in a nonexpanded configuration during said expansion of said support frame,   C. expanding said expansion member to an expanded configuration to affect an activation of said fixation members, activation of said fixation members placing at least a portion of said fixation members into the native heart valve tissues,   D. wherein an inside luminal region of said support frame is configured to provide passage for blood flow through said inside luminal region with said expansion member in said expanded configuration.   
     
     
         18 . The method of  claim 17  further comprising the steps of;
 A. placing a valve frame within said inside luminal region of said support frame, said valve frame having replacement leaflets attached to said valve frame, said replacement leaflets configured to direct the blood flow in a downstream direction, 
 B. expanding said valve frame within said inside luminal region of said support frame such that said valve frame contacts said support frame whereby said valve frame thereafter does not move relative to said support frame. 
 
     
     
         19 . The method of  claim 17  wherein said fixation members are activated after said support frame is fully expanded into contact with the native heart valve tissues. 
     
     
         20 . The method of  claim 18  wherein frictional forces from said expanding of said valve frame into contact with said support frame holds said valve frame from movement relative to said support frame.