Low profile transseptal catheter and implant system for minimally invasive valve procedure
A method of replacing a native heart valve utilizing a support structure comprising a first fastener, a second faster, a first leaflet brace, and a second leaflet brace. The first leaflet brace is configured to be advanced over a first guide wire to be adjacent to a portion of a first native leaflet. The second leaflet brace is configured to be advanced over a second guide wire to be adjacent to a portion of a second native leaflet. The first fastener and the second fastener are configured to be advanced over the first and second guide wires to respectively engage with first and second ends of the first leaflet brace and the second leaflet brace. A replacement heart valve is deployed within the native heart valve, thereby capturing the first and second leaflets between the support structure and the replacement heart valve.
1 . A delivery assembly comprising:
at least one introducer sheath;
a first guide catheter and a first guide wire insertable through the first guide catheter for forming a posterior loop around a first leaflet of a native heart valve;
a second guide catheter and a second guide wire insertable through the second guide catheter for forming an anterior loop around a second leaflet of a native heart valve;
a first tubular leaflet brace slidable over the posterior loop formed by the first guide wire;
a second tubular leaflet brace slidable over the anterior loop formed by the second guide wire; and
a first fastening catheter and a first fastener disposed on a distal end portion of the first fastening catheter, the first fastening catheter configured to push the first fastener over a first portion of each of the first guide wire and the second guide wire to couple the first fastener with a first end portion of each of the first tubular brace and the second tubular brace.
2 . The delivery assembly of claim 1 , further comprising:
a second fastening catheter and a second fastener disposed on a distal end portion of the second fastening catheter, the second fastening catheter configured to push the second fastener over a second portion of each of the first guide wire and the second guide wire to couple the second fastener with a second end portion of each of the first tubular brace and the second tubular brace.
3 . The delivery assembly of claim 2 , further comprising:
a prosthetic heart valve; and
a valve delivery catheter having the prosthetic heart valve coupled to a distal end portion thereof in a radially compressed state, the valve delivery catheter configured to position the radially compressed prosthetic heart valve within a support ring formed by the first and second tubular braces and the first and second fasteners and to transition the radially compressed prosthetic heart valve to a radially expanded state for capture of the first leaflet between the first tubular brace and the prosthetic heart valve and capture of the second leaflet between the second tubular brace and the prosthetic heart valve.
4 . The delivery assembly of claim 2 , wherein each of the first fastener and the second fastener comprises a metallic body having first and second, side-by-side apertures extending therethrough, wherein the first aperture receives the first guide wire and the second aperture receives the second guide wire.
5 . The delivery assembly of claim 2 , wherein the first fastener is sized and shaped for frictional engagement with the first end portions of the first and second tubular braces, and wherein the second fastener is sized and shaped for frictional engagement with the second end portions of the first and second tubular braces.
6 . The delivery assembly of claim 2 , wherein the first fastener is secured to a distal face of the first fastening catheter and the second fastener is secured to a distal face of the second fastening catheter.
7 . The delivery assembly of claim 1 , further comprising:
a first snare catheter and a first snare wire insertable through the first snare catheter; and
a second snare catheter and a second snare wire insertable through the second snare catheter.
8 . The delivery assembly of claim 7 , wherein the first snare wire is configured to capture a distal end portion of the first guide wire for the formation of the posterior loop, and wherein the second snare wire is configured to capture a distal end portion of the second guide wire for the formation of the anterior loop.
9 . The delivery assembly of claim 8 , wherein each of the first guide wire and the second guide wire is a ringed end guide wire.
10 . The delivery assembly of claim 9 , wherein the ringed end guide wire comprises a curved distal end portion comprising an at least partially ringed structure.
11 . The delivery assembly of claim 1 , wherein each of the first guide catheter and the second guide catheter is a double bend guide catheter configured to form a first bend on an atrial side of the native heart valve and a second bend on a ventricular side of the native heart valve.
12 . The delivery assembly of claim 1 , wherein each of the first tubular brace and the second tubular brace comprises an inner radiopaque layer covered by an outer tubing layer.
13 . The delivery assembly of claim 12 , wherein the outer tubing layer comprises a filamentous material.
14 . A delivery assembly comprising:
at least one introducer sheath;
a first guide catheter and a first guide wire insertable through the first guide catheter for forming a posterior loop around a first leaflet of a native heart valve;
a second guide catheter and a second guide wire insertable through the second guide catheter for forming an anterior loop around a second leaflet of a native heart valve;
a first tubular leaflet brace slidable over the posterior loop formed by the first guide wire;
a second tubular leaflet brace slidable over the anterior loop formed by the second guide wire;
a first fastening catheter and a first fastener, wherein the first fastening catheter is configured to frictionally couple the first fastener with a first end portion of each of the first tubular brace and the second tubular brace;
a second fastening catheter and a second fastener, wherein the second fastening catheter is configured to frictionally couple the second fastener with a second end portion of each of the first tubular brace and the second tubular brace;
a prosthetic heart valve; and
a valve delivery catheter having the prosthetic heart valve coupled to a distal end portion thereof in a radially compressed state.
15 . The delivery assembly of claim 14 , wherein the valve delivery catheter is configured to position the radially compressed prosthetic heart valve within a support ring formed by the first and second tubular braces and the first and second fasteners and to transition the radially compressed prosthetic heart valve to a radially expanded state for capture of the first leaflet between the first tubular brace and the prosthetic heart valve and capture of the second leaflet between the second tubular brace and the prosthetic heart valve.
16 . The delivery assembly of claim 14 , wherein the first fastening catheter is configured to push the first fastener over a first portion of each of the first guide wire and the second guide wire to engage the first fastener with the first end portion of each of the first tubular brace and the second tubular brace, and wherein the second fastening catheter is configured to push the second fastener over a second portion of each of the first guide wire and the second guide wire to engage the second fastener with the second end portion of each of the first tubular brace and the second tubular brace.
17 . The delivery assembly of claim 14 , wherein each of the first fastener and the second fastener comprises a metallic body having first and second, side-by-side apertures extending therethrough, wherein the first aperture receives the first guide wire and the second aperture receives the second guide wire.
18 . A delivery assembly comprising:
at least one introducer sheath;
a first guide catheter and a first guide wire insertable through the first guide catheter;
a first snare catheter and a first snare wire insertable through the first snare catheter, the first snare wire configured to capture a distal end portion of the first guide wire for forming a posterior guide wire loop around a first leaflet of a native heart valve;
a second guide catheter and a second guide wire insertable through the second guide catheter;
a second snare catheter and a second snare wire insertable through the second snare catheter, the second snare wire configured to capture a distal end portion of the second guide wire for forming an anterior guide wire loop around a second leaflet of the native heart valve;
a first tubular leaflet brace slidable over the posterior guide wire loop;
a second tubular leaflet brace slidable over the anterior guide wire loop;
a first fastening catheter and a first fastener, wherein the first fastening catheter is configured to frictionally couple the first fastener with a first end portion of each of the first tubular brace and the second tubular brace; and
a second fastening catheter and a second fastener, wherein the second fastening catheter is configured to frictionally couple the second fastener with a second end portion of each of the first tubular brace and the second tubular brace.
19 . The delivery assembly of claim 18 , further comprising:
a prosthetic heart valve; and
a valve delivery catheter having the prosthetic heart valve coupled to a distal end portion thereof in a radially compressed state, wherein the valve delivery catheter is configured to position the radially compressed prosthetic heart valve within a support ring formed by the first and second tubular braces and the first and second fasteners and to transition the radially compressed prosthetic heart valve to a radially expanded state for capture of the first leaflet between the first tubular brace and the prosthetic heart valve and capture of the second leaflet between the second tubular brace and the prosthetic heart valve.