Apparatus and methods for removal of heart valve ligation clip
Aspects of the disclosure include apparatuses for and methods of removing a ligation clip interconnecting two mitral valve leaflets. Methods can include providing a mitral valve having first and second valve leaflets interconnected with a ligation clip. The ligation clip includes a base supporting a first and second retaining arms each having an end opposite the base. The first and second valve leaflets are compressed between the first and second retaining arms. The methods further include physically separating the ligation clip from both of the first and second leaflets with the apparatus, which is configured to dislodge the first and second leaflets from the ligation clip. The apparatuses are further configured to withdraw the ligation clip from the patient along with the apparatus.
1 . A clip removal apparatus for removing a tissue ligation clip that includes a pair of pivotably coupled tissue engaging elements, the apparatus comprising:
an outer delivery sheath defining a lumen and terminating at a distal end;
a wedge assembly including a tapered wedge member including a blunt tip, the tapered wedge member slidably positioned coaxially with respect to the sheath, the wedge assembly including a delivery arrangement in which the tapered wedge member is positioned within the lumen and a deployed arrangement in which the tapered wedge member is positioned outside the lumen wherein the tapered wedge member is configured to be advanced between the tissue engaging elements of the tissue ligation clip to pivot open the tissue engaging elements to non-destructively remove the tissue ligation clip; and
a backstop assembly including a backstop member, the backstop member slidably positioned coaxially with respect to the sheath, the backstop assembly including a delivery arrangement in which the backstop member is positioned within the lumen and a deployed arrangement in which the backstop member is positioned outside the lumen, wherein the backstop member is configured to surround at least a portion of the tissue ligation clip while the tapered wedge member is advanced between the tissue engaging elements of the tissue ligation clip, wherein the backstop member is positioned over a first support, the first support including a loop snare.
2 . The apparatus of claim 1 , wherein the backstop assembly further includes a support slidably positioned within the sheath; wherein the support has an extension portion connected to a distal end portion, the backstop assembly including a delivery arrangement in which the distal end portion is positioned within the lumen and a deployed arrangement in which the distal end portion is positioned outside of the lumen; wherein the distal end portion of the support includes the backstop member.
3 . The apparatus of claim 1 , wherein the wedge assembly further includes a wedge support slidably positioned within the sheath, wherein the wedge support has an extension portion connected to a distal end portion, the wedge assembly including a delivery arrangement in which the distal end portion is positioned within the lumen and a deployed arrangement in which the distal end portion is positioned outside of the lumen, and further wherein the distal end portion of the wedge support includes the tapered wedge member.
4 . The apparatus of claim 1 , wherein the backstop member includes a mesh material.
5 . The apparatus of claim 4 , wherein the mesh material is shape memory metal mesh.
6 . The apparatus of claim 1 , wherein the backstop member includes a plurality of outwardly extending extensions.
7 . The apparatus of claim 6 , wherein the plurality of outwardly extending extensions are flexible.
8 . The apparatus of claim 1 , further comprising a second support that can be inserted through the loop snare.
9 . The apparatus of claim 1 , further comprising a first grasper and a second grasper slidably positioned within the sheath, each grasper including a distal end portion; wherein the respective distal end portions of the first and second graspers are angled toward each other when the first and second graspers are positioned at least partially outside of the sheath.
10 . A clip removal apparatus for removing a tissue ligation clip that includes a pair of pivotably coupled tissue engaging elements, the apparatus comprising:
an outer delivery sheath defining a lumen and terminating at a distal end;
a shaft slidably disposed within the lumen of the outer delivery sheath;
a wedge assembly including a tapered wedge member including a blunt tip, the wedge assembly including a delivery arrangement in which the tapered wedge member is positioned within a first lumen of the shaft and a deployed arrangement in which the tapered wedge member is positioned outside the first lumen, wherein the tapered wedge member is configured to be advanced between the tissue engaging elements of the tissue ligation clip to pivot open the tissue engaging elements to non-destructively remove the tissue ligation clip;
a backstop assembly including a backstop member, the backstop assembly including a delivery arrangement in which the backstop member is positioned with a second lumen of the shaft a deployed arrangement in which the backstop member is positioned outside the second lumen with at least a portion of the backstop member disposed distal of a distal end of the tapered wedge member with the tapered wedge member and the backstop member in the deployed arrangement such that the backstop member is disposed distal of a distal end of the tissue ligation clip to capture the tissue ligation clip while the tapered wedge member is advanced between the tissue engaging elements of the tissue ligation clip,
wherein the backstop assembly further includes a first support slidably positioned within the second lumen in the delivery arrangement, wherein in the deployed arrangement a distal end portion of the support is positioned outside of the second lumen and includes the backstop member, and
wherein the first support includes a loop snare at the distal end portion.
11 . The apparatus of claim 10 , further comprising a second support slidably within a third lumen of the shaft in the delivery arrangement, the second support configured to be inserted through the loop snare with the first support and the second support in the deployed arrangement.
12 . The apparatus of claim 10 , wherein the backstop member includes a mesh material.
13 . The apparatus of claim 12 , wherein the mesh material is shape memory metal mesh.
14 . The apparatus of claim 10 , wherein the backstop member includes a plurality of outwardly extending extensions.
15 . The apparatus of claim 14 , wherein the plurality of outwardly extending extensions are flexible.
16 . The apparatus of claim 10 , further comprising a first grasper and a second grasper slidably positioned within the sheath, each grasper including a distal end portion, wherein the respective distal end portions of the first and second graspers are angled toward each other when the first and second graspers are positioned at least partially outside of the sheath.