Method and apparatus for removing heart valve therapy
A retrieval catheter and methods of use are described for removing a heart valve therapy such as a leaflet clip or artificial leaflet cord. The retrieval catheter can include a cutting element and a basket, piercing element, clamping mechanism, or similar grasping device. The method includes delivering a catheter to the region of the heart valve therapy and then manipulating the catheter and associated instruments to cut tissue as necessary and then remove the heart valve therapy and withdraw the catheter.
1 . A system for removing a heart valve therapy, comprising:
an outer tubular sheath;
a cutting element comprising a first cutting loop connected to a first inner control member and movable from a first compressed configuration within the outer tubular sheath to a second expanded configuration outside of the outer tubular sheath; wherein in the second expanded configuration of the cutting element, a plane aligned across an opening of the first cutting loop is angled between 45 degrees and 135 degrees relative to a longitudinal axis of the first inner control member and wherein the opening of the first cutting loop is positioned asymmetrically to a side of the longitudinal axis of the first inner control member so that the opening of the first cutting loop is rotatable to a plurality of asymmetric locations around the longitudinal axis of the first inner control member; and,
a basket connected to a second inner control member and movable from a first compressed configuration within the outer tubular sheath to a second expanded configuration outside of the outer tubular sheath; wherein in the second expanded configuration of the basket, a plane aligned across an opening of the basket is angled between 45 degrees and 135 degrees relative to a longitudinal axis of the second inner control member, the opening of the basket is positioned asymmetrically to a side of the longitudinal axis of the second inner control member so that the opening of the of the basket is rotatable to a plurality of asymmetric locations around the longitudinal axis of the second inner control member, and the opening of the basket opens in a proximal direction.
2 . The system of claim 1 , wherein the plane of an opening of the first cutting loop is angled at about 90 degrees relative to the longitudinal axis of the first inner control member.
3 . The system of claim 1 , wherein the plane of an opening of the basket is angled at about 90 degrees relative to the longitudinal axis of the second inner control member.
4 . The system of claim 1 , wherein the first cutting loop comprises one or more insulated portions and one or more uninsulated portions positioned to contact valve tissue.
5 . The system of claim 1 , wherein the first cutting loop comprises a single wire composed of a single conductive material, two or more wires that are each composed of a different conductive material, or a wire having a plurality of strands that are composed of different conductive material.
6 . The system of claim 1 , wherein the first cutting loop has one or more uninsulated portions limited to only a radially inner surface of the second expanded configuration of the cutting element.
7 . The system of claim 1 , wherein the basket further comprises a plurality of loops positioned around the opening, and a cinch wire positioned through the plurality of loops; wherein moving the cinch wire proximally into the outer tubular sheath closes the opening of the basket.
8 . The system of claim 1 , wherein the basket further comprises a plurality of loops positioned around the opening of the basket, wherein the cutting element is positioned through the plurality of loops and wherein moving the cutting element proximally into the outer tubular sheath closes the opening of the basket.
9 . The system of claim 1 , further comprising a steerable inner catheter having a passage sized to accommodate passage of the outer tubular sheath, and an outer guide catheter having a passage sized to accommodate passage of the steerable inner catheter.
10 . The system of claim 1 , wherein the cutting element further comprises a second cutting loop.
11 . The system of claim 10 , wherein the second cutting loop is connected to a third inner control member movable within the outer tubular sheath.
12 . The system of claim 1 , wherein the first cutting loop is circular, oval, or saddle shaped.
13 . The system of claim 1 , wherein the basket is composed of a plurality of braided wires, each of which is composed of a shape memory material.
14 . The system of claim 13 , wherein the plurality of braided wires have an electrically insulating coating on their outer surface.
15 . The system of claim 1 , wherein the basket is composed of silicone, PET, polyester, nylon, polypropylene, or Kevlar.
16 . The system of claim 1 , wherein the basket is composed of a polymer in a braid, mesh, weave, knit, or injection molded shape.
17 . The system of claim 1 , wherein the basket is composed of a laser-cut metal having a plurality of pores.
18 . The system of claim 1 , wherein the first cutting loop has side portions that form a saddle shape.
19 . The system of claim 18 , wherein the side portions dip downward and upward in a wave shape.
20 . The system of claim 1 , wherein the first cutting loop comprises a plurality of uninsulated regions that can be electrically activated individually at different times or all together at a same time.
21 . The system of claim 1 , wherein the first cutting loop is electrically isolated from the basket.
22 . The system of claim 21 , wherein the basket further comprises a cinching loop to close a top of the basket and the first cutting loop is also electrically isolated from the cinching loop.
23 . A system for removing a heart valve therapy, comprising:
an outer tubular sheath;
a cutting element comprising a first cutting loop connected to a first inner control member and movable from a first compressed configuration within the outer tubular sheath to a second expanded configuration outside of the outer tubular sheath; wherein in the second expanded configuration of the cutting element, a plane aligned across an opening of the first cutting loop is angled between 45 degrees and 135 degrees relative to a longitudinal axis of the first inner control member and the opening of the first cutting loop is completely positioned to a side of the longitudinal axis of the first inner control member and is rotatable to a plurality of different positions around the longitudinal axis of the first inner control member; and, a basket connected to the first inner control member and movable from a first compressed configuration within the outer tubular sheath to a second expanded configuration outside of the outer tubular sheath; wherein in the second expanded configuration of the basket, a plane aligned across an opening of the basket is angled between 45 degrees and 135 degrees relative to the longitudinal axis of the first inner control member and the opening of the basket is positioned completely to a side of the longitudinal axis of the first second inner control member and opens in a proximal direction and is rotatable to a plurality of different positions around the longitudinal axis of the second inner control member.
24 . A method of treating a heart valve, comprising:
positioning a steerable guide catheter transeptally into a left atrium of a heart;
positioning a first cutting loop connected to a first inner control member outside of an outer tubular sheath and into a left ventricle of a heart so that a plane of an opening of the first cutting loop is angled between 45 degrees and 135 degrees relative to an axis of the first inner control member and the first cutting loop is positioned to a side of the axis of the first inner control member;
moving the first cutting loop so that a heart valve therapy connected to mitral valve leaflets passes through the first cutting loop;
electrically activating the first cutting loop and cutting tissue to free the heart valve therapy; and,
capturing the heart valve therapy within a receptacle and removing the heart valve therapy from the heart.
25 . The method of claim 24 , further comprising decreasing a diameter of an opening of the receptacle.
26 . The method of claim 25 , wherein activating the first cutting loop further comprises delivering radio frequency current to one or more electrodes of the first cutting loop.
27 . The method of claim 25 , wherein positioning the first cutting loop connected to the first inner control member so that the plane of the opening of the first cutting loop is angled between 45 degrees and 135 degrees relative to the axis of the first inner control member further comprises positioning the first cutting loop so that the plane of the opening of the first cutting loop is about 90 degrees relative to the axis of the first inner control member.
28 . The method of claim 25 , wherein electrically activating the first cutting loop includes closing the opening of the first cutting loop around the tissue.
29 . The method of claim 25 , wherein the first cutting loop comprises a wave shape in which side portions of the first cutting loop form a dip.
30 . The method of claim 29 , wherein the first cutting loop comprises one or more insulated portions and wherein the first cutting loop comprises one or more uninsulated portions at a distal region of the first cutting loop.
31 . The method of claim 25 , further comprising positioning a second loop within the left ventricle of the heart.
32 . The method of claim 31 , wherein the first cutting loop is activated independently of the second loop.