US2018318083A1PendingUtilityA1

Mitral leaflet tethering

Assignee: PIPELINE MEDICAL TECH INCPriority: Dec 30, 2015Filed: Jun 29, 2018Published: Nov 8, 2018
Est. expiryDec 30, 2035(~9.4 yrs left)· nominal 20-yr term from priority
A61F 2/2457A61B 2017/00876A61B 2017/048A61B 2017/0441A61B 2017/0419A61B 2017/00292A61B 17/0401A61F 2230/0091A61F 2220/0008A61M 25/0147A61F 2220/0016A61B 2017/0427A61F 2/2466A61M 25/0054A61B 2017/0409A61B 17/0469
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Claims

Abstract

This disclosure includes apparatuses and techniques to access the right ventricle via trans-femoral vein threading a catheter or catheters to the apex or bottom of the right ventricle. Piercing through the venous or right side of the heart in the interventricular septal wall to access the left ventricle a catheter can be passed to turn upward pointing to the mitral valve. From this access point in the left ventricle the flail mitral leaflet can be sutured and tethered pulling it back into position and reattached with a grounding anchor in the right ventricle or imbedding the anchor into the septal wall. The interventricular septal wall crossing technique could include the passing of a coaxial catheter through the first access catheter where the first access catheter could act as a guide to direct the internal or second coaxial catheter toward the flail mitral leaflet.

Claims

exact text as granted — not AI-modified
1 - 11 . (canceled) 
     
     
         12 . A catheter-based system for mitral chordal repair, the catheter-based system comprising:
 a steerable catheter configured to extend through a septal wall to access a mitral valve, the steerable catheter including wires extending from a handle at a proximal portion of the steerable catheter to a distal portion of the steerable catheter, the wires configured to actively deflect the steerable catheter through a predetermined curve to position a distal tip of the steerable catheter adjacent a mitral leaflet;   a ventricular anchor coupled to a first suture, the ventricular anchor configured for delivery through the septal wall and through the mitral valve in order to attach to tissue in a left ventricle;   a piercing tool configured to thread a second suture through the mitral leaflet at a leaflet attachment site, the second suture extending from a first side of the mitral leaflet;   a strain relieving pledget configured to distribute local forces at the leaflet attachment site, the pledget being configured for placement on a second side of the mitral leaflet opposite the first side of the mitral leaflet; and   a securement member for adjustably coupling the first and second sutures in order to tether the mitral leaflet to the tissue of the left ventricle.   
     
     
         13 . The catheter-based system of  claim 12 , wherein the steerable catheter includes slots configured to collapse as tension is applied to the wires to curve the steerable catheter through the predetermined curve. 
     
     
         14 . The catheter-based system of  claim 12 , wherein the steerable catheter is a first catheter, the catheter-based system further comprising a second catheter configured to guide the first catheter through the septal wall and toward the mitral leaflet. 
     
     
         15 . The catheter-based system of  claim 14 , wherein the piercing tool is configured to pass through the second catheter. 
     
     
         16 . The catheter-based system of  claim 14 , wherein the first catheter and the second catheter are coaxial. 
     
     
         17 . The catheter-based system of  claim 14 , wherein the second catheter is a steerable catheter. 
     
     
         18 . The catheter-based system of  claim 12 , further comprising rotational screws configured to translate rotational motion into longitudinal forces on the wires. 
     
     
         19 . The catheter-based system of  claim 12 , wherein the predetermined curve positions a distal tip of the steerable catheter upwards to point towards the ventricle side of the mitral valve. 
     
     
         20 . The catheter-based system of  claim 12 , wherein the steerable catheter is configured to hold the mitral leaflet for suture piercing and tethering. 
     
     
         21 . The catheter-based system of  claim 12 , wherein the predetermined curve is a curve of about 180 degrees. 
     
     
         22 . The catheter-based system of  claim 12 , wherein the steerable catheter includes slots configured to collapse as tension is applied to the wires to curve the steerable catheter through the predetermined curve, and wherein the slots are laser-cut into one side of the steerable catheter. 
     
     
         23 . The catheter-based system of  claim 12 , wherein the steerable catheter includes slots configured to collapse as tension is applied to the wires to curve the steerable catheter through the predetermined curve, and wherein the slots are formed into one or more of the following: chevron, angled, and radiused shapes. 
     
     
         24 . The catheter-based system of  claim 12 , wherein the ventricular anchor includes a strain relief at an anchor exit, the strain relief configured to reduce fretting of the first suture. 
     
     
         25 . The catheter-based system of  claim 12 , wherein the ventricular anchor includes a main body and barbs extending at an acute angle from an outer surface of the main body. 
     
     
         26 . The catheter-based system of  claim 12 , wherein the ventricular anchor is a coiled anchor. 
     
     
         27 . The catheter-based system of  claim 12 , wherein the securement member is configured to adjustably secure proper positioning of the mitral leaflet. 
     
     
         28 . The catheter-based system of  claim 27 , wherein the securement member is a sliding one-way stopper. 
     
     
         29 . The multi-catheter system of  claim 12 , wherein the ventricular anchor is configured to couple to tissue directly below the attachment point of the mitral leaflet. 
     
     
         30 . A multi-catheter system for mitral chordal repair, the multi-catheter system comprising:
 a first catheter configured to traverse a septal wall to provide access to a mitral valve;   a second catheter including means for steering the second catheter to locate a piercing tool through a mitral leaflet; the second catheter securing a pledget and a suture to the mitral leaflet;   a ventricular anchor configured for delivery through the septal wall and through the mitral valve in order to attach to tissue in a left ventricle; and   means for adjustably joining the suture to the ventricular anchor to tether the mitral leaflet to the ventricular anchor.   
     
     
         31 . The multi-catheter system of  claim 30 , wherein the ventricular anchor includes a strain relief at an anchor exit, the strain relief configured to reduce fretting of a suture attached to the ventricular anchor. 
     
     
         32 . The multi-catheter system of  claim 30 , wherein the ventricular anchor is configured for delivery via the first catheter and is configured to attach to tissue in a left ventricle directly below the mitral leaflet.

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