Endovascular splinting devices and methods

Abstract

A method for placing a splint assembly transverse a heart chamber includes providing an elongate member having a first end and a second end and a deployable heart-engaging assembly connected to at least the first end. The method includes advancing the elongate member through vasculature structure and into the heart chamber such that the first end of the elongate member extends through a first location of a wall surrounding the heart chamber and the second end extends through a second location of the heart chamber wall substantially opposite the first location. A deployable heart-engaging assembly is deployed such that it engages with a first exterior surface portion of the heart chamber wall adjacent the first location. The elongate member is secured with respect to the heart with a second heart-engaging assembly connected to the second end. The second heart-engaging assembly engages with a second exterior surface portion of the heart chamber wall adjacent the second location. A splint assembly includes an expandable heart-engaging assembly formed partially from portions forming the elongate member of the splint assembly. A delivery tool includes a tubular member configured to be advanced through vasculature structure and has a curved distal end.

What is claimed is:  
     
         1 . A method for placing a splint assembly transverse a heart chamber, the method comprising: 
 providing an elongate member having a first end and a second end and a deployable heart-engaging assembly connected to said first end;    advancing the elongate member through vasculature structure and into the heart chamber such that the first end of the elongate member extends through a first location of a heart chamber wall and the second end extends through a second location of a heart chamber wall substantially opposite the first location;    deploying the deployable heart-engaging assembly such that it engages with a first exterior surface of a heart chamber wall adjacent the first location; and    securing the elongate member with respect to the heart chamber with a second heart-engaging assembly connected to the second end, said second heart-engaging assembly engaging with a second exterior surface of a heart chamber wall adjacent the second location.    
     
     
         2 . The method of  claim 1 , wherein the chamber is a left ventricle of the heart.  
     
     
         3 . The method of  claim 2 , wherein the elongate member is advanced through a guide device endovascularly inserted into the right ventricle.  
     
     
         4 . The method of  claim 3 , wherein the guide device is a catheter.  
     
     
         5 . The method of  claim 3 , wherein inserting the guide device includes extending the guide device across the left ventricle from the right ventricle through the first location on a free wall surrounding the left ventricle and through the second location on a septal wall.  
     
     
         6 . The method of  claim 3 , wherein inserting the guide device includes stabilizing the guide device with respect to the left ventricle.  
     
     
         7 . The method of  claim 6 , wherein the stabilizing includes inflating balloons disposed proximate a distal end of the guide device.  
     
     
         8 . The method of  claim 7 , wherein the stabilizing includes inflating a first balloon adjacent the first exterior surface of the heart chamber wall and a second balloon adjacent an interior surface of the heart chamber wall.  
     
     
         9 . The method of  claim 2 , wherein the inserting includes inserting a guide device into the left ventricle without first entering another heart chamber.  
     
     
         10 . The method of  claim 9 , wherein the guide device includes a first guide member and a second guide member, said first guide member being configured to extend toward a first interior surface of the chamber wall at the first location and said second guide member being configured to extend toward a second interior surface of the chamber wall at the second location.  
     
     
         11 . The method of  claim 10 , wherein the inserting includes stabilizing said first guide member at the first interior surface and the second guide member at the second interior surface.  
     
     
         12 . The method of  claim 11 , wherein the stabilizing includes inflating balloons disposed proximate the distal end of each of the first and second guide members.  
     
     
         13 . The method of  claim 12 , wherein the stabilizing includes inflating a first balloon on each of the first and second guide members adjacent the first and second exterior surfaces of the chamber wall respectively and a second balloon on each of the guide members adjacent the first and second interior surfaces of the chamber wall.  
     
     
         14 . The method of  claim 10 , wherein the first and second guide members are adjustably curvable catheters.  
     
     
         15 . The method of  claim 1 , wherein the deploying the first heart-engaging assembly includes expanding at least a portion of the assembly.  
     
     
         16 . The method of  claim 15 , wherein the expanding includes applying a outwardly directed force from within the portion of the assembly.  
     
     
         17 . The method of  claim 16 , wherein the applying includes inflating the portion of the assembly.  
     
     
         18 . The method of  claim 1 , wherein at least a portion of the first heart-engaging assembly is integrally formed with the elongate member.  
     
     
         19 . The method of  claim 1 , wherein the securing with the second heart-engaging assembly includes adjusting a length of the elongate member between the first and second locations.  
     
     
         20 . The method of  claim 19 , wherein the adjusting the length includes changing the cross-sectional shape of the heart chamber.  
     
     
         21 . The method of  claim 19 , wherein the adjusting the length includes changing the radius of curvature of the heart chamber.  
     
     
         22 . The method of  claim 1 , further comprising inserting a guide device through vasculature structure and into the heart, wherein the advancing includes advancing the elongate member through the guide device.  
     
     
         23 . The method of  claim 22 , wherein inserting the guide device includes inserting the guide device through the chamber wall at the first and second locations.  
     
     
         24 . The method of  claim 23 , wherein the inserting through the chamber wall includes advancing the guide device over a needle extending through the chamber wall at the first and second locations.  
     
     
         25 . The method of  claim 24 , wherein the needle extends from a distal end of the guide device to extend through the chamber wall.  
     
     
         26 . A splint assembly for treating a heart, the splint assembly comprising: 
 an elongate member configured to extend transverse a chamber of the heart; and    at least one heart-engaging assembly formed at least partially from portions forming said elongate member, said heart-engaging assembly having a collapsed configuration adapted to travel through a heart wall and an expanded configuration adapted to engage the heart wall.    
     
     
         27 . The splint assembly of  claim 26 , wherein the elongate member has a braided configuration.  
     
     
         28 . The splint assembly of  claim 27 , wherein the elongate member is braided with a plurality of bundles.  
     
     
         29 . The splint assembly of  claim 26 , wherein the heart-engaging assembly further comprises a collapsible ring, the portions of the elongate member being secured around the ring.  
     
     
         30 . The splint assembly of  claim 30 , wherein the portions of the elongate member and the ring form a spoke-like shape in the expanded configuration.  
     
     
         31 . The splint assembly of  claim 30 , wherein the portions are bundles forming a braided elongate member.  
     
     
         32 . The splint assembly of  claim 31 , wherein the bundles are unbraided toward the end of the elongate member forming the heart-engaging assembly.  
     
     
         33 . The splint assembly of  claim 29 , wherein the ring is made of an elastic material.  
     
     
         34 . The splint assembly of  claim 26 , wherein the heart-engaging assembly is configured to be held in the collapsed configuration by a compressive force.  
     
     
         35 . The splint assembly of  claim 27 , wherein the elongate member is relatively loosely braided at a location proximate the heart-engaging assembly.  
     
     
         36 . The splint assembly of  claim 26 , wherein the heart-engaging assembly includes a wire within the portions of the elongate member.  
     
     
         37 . The splint assembly of  claim 36 , wherein at least a portion of the wire has a spiral configuration in the absence of a compressive force exerted on the wire.  
     
     
         38 . The splint assembly of  claim 36 , wherein at least a portion of said wire is configured to create an outward force on the portions of the elongate member to thereby expand the portions.  
     
     
         39 . The splint assembly of  claim 26 , wherein the heart-engaging assembly includes an inflatable member inserted within the portions of the elongage member.  
     
     
         40 . The splint assembly of  claim 39 , wherein inflation of the inflatable member is configured to create an outward force on the portions of the elongate member to thereby expand the portions.  
     
     
         41 . The splint assembly of  claim 40 , wherein the inflatable member is configured to be inflated with a hardenable material.  
     
     
         42 . A delivery tool for delivering a transventricular splint assembly to a chamber of the heart, the delivery tool comprising: 
 a tubular member having a distal end and a proximal end, the distal end having a curved configuration and the tubular member defining a lumen configured to carry at least a portion of the splint assembly; and    at least one support mechanism disposed proximate the distal end of the tubular member, the support mechanism being configured to stabilize the tubular member with respect to a heart wall surrounding the chamber,    wherein the tubular member is configured to be advanced through vasculature structure and into the heart chamber.    
     
     
         43 . The delivery tool of  claim 42 , wherein the support mechanism includes at least one inflatable member configured to engage the heart wall.  
     
     
         44 . The delivery tool of  claim 43 , wherein the support mechanism includes at least two inflatable members, one of the inflatable members being configured to engage an interior surface portion of the heart wall and the other of the inflatable members being configured to engage an exterior surface portion of the heart wall adjacent the interior surface portion.  
     
     
         45 . The delivery tool of  claim 44 , wherein the two inflatable members are balloons.  
     
     
         46 . The delivery tool of  claim 44 , wherein the two inflatable members are in fluid communication with separate lumens defined by the tubular member.  
     
     
         47 . The delivery tool of  claim 44 , wherein the two inflatable members are configured to be inflated with a fluid capable of providing visualization of the members from outside the heart chamber.  
     
     
         48 . The delivery tool of  claim 42 , wherein the support mechanism includes a support wire configured to engage the heart wall.  
     
     
         49 . The delivery tool of  claim 48 , wherein the support wire is configured to engage an interior surface of the heart wall.  
     
     
         50 . The delivery tool of  claim 49 , wherein the support wire is configured to engage the interior surface of the heart wall at two substantially opposite locations of the chamber.  
     
     
         51 . The delivery tool of  claim 42 , wherein the tubular member is configured to be advanced through a portion of the heart wall.  
     
     
         52 . The delivery tool of  claim 42 , further comprising a guidewire configured to be extended from the tubular member past the distal end of the tubular member.  
     
     
         53 . The delivery tool of  claim 42 , further comprising: 
 a second tubular member having a distal end and a proximal end, the distal end of the second tubular member having a curved configuration and the second tubular member defining a lumen configured to carry at least a portion of the splint assembly; and    at least one support mechanism disposed proximate the distal end of the second tubular member, the support mechanism of the second tubular member being configured to stabilize the second tubular member with respect to a heart wall surrounding the chamber,    wherein the second tubular member is configured to be advanced through vasculature structure and into the heart chamber along with the first tubular member.    
     
     
         54 . The delivery tool of  claim 53 , wherein the first and second tubular members are configured to be advanced through substantially opposite portions of the heart wall.  
     
     
         55 . The delivery tool of  claim 53 , wherein the distal ends of the first and second tubular members curve in substantially opposite directions when the tubular members are advanced into the heart chamber.  
     
     
         56 . The delivery tool of  claim 53 , further comprising first and second guidewires configured to extend respectively from first and second tubular members past the distal ends of the first and second tubular members.