Method of attaching an apical cuff to heart tissue
View Patent ↗An apical cuff axial compression assembly including a ring member for coupling an apical cuff of a Ventricular Assist Device pump, to left ventricular apical tissue. Tissue anchors are employed to engage with the ring member and the apical cuff to exert direct or axial compression of the ring member to the apical cuff and to the left ventricular apical tissue. A first variant includes an axial compression ring and a plurality of openings to accommodate the tissue anchors. A second variant includes a segmented axial compression ring composed of a plurality of arcuate members, which may be contiguous or joined to each other or not. Each of the plurality of arcuate members has at least one tissue anchor opening passing there through.
1 . A method of attaching an apical cuff to a heart, the apical cuff having an annular frame defining a central opening and an annular sewing skirt, the method comprising the steps of:
coupling at least one axial compression member to the apical cuff, the at least one axial compression member defining a central opening and having a plurality of tissue anchor openings passing axially through the at least one axial compression member, the at least one axial compression member configured to apply pressure to the annular sewing skirt, and the heart tissue;
pre-driving a plurality of tissue anchors into each of the plurality of tissue anchor openings and partially into the annular sewing skirt;
removably coupling the apical cuff, the at least one axial compression member, and the plurality of tissue anchors to a delivery tool, the delivery tool configured to allow each of the plurality of tissue anchors to be driven through the plurality of tissue anchor openings and apply an axially compressive force that is distributed substantially evenly about a circumference of the at least one axial compression member when the plurality of tissue anchors pass into and through the sewing skirt of the apical cuff and into the cardiac tissue.
2 . The method of claim 1 , wherein the step of coupling the at least one axial compression member to the apical cuff further comprises coupling at least one ring member to the axial cuff and is configured to axially bear onto the sewing ring and not directly axially bear onto the apical cuff.
3 . The method of claim 2 , wherein the at least one ring member further comprises plural arcuate sections arranged to form a ring member.
4 . The method of claim 2 , wherein the at least one ring member further comprises a unitary ring member.
5 . The method of claim 1 , wherein the step of coupling the at least one axial compression member further comprises the step of axially aligning the plurality of tissue anchor openings with the annular sewing skirt such that the plurality of tissue anchor openings are radially inward from an outer perimeter of the annular sewing skirt.
6 . The method of claim 1 , wherein the step of coupling the at least one axial compression member further comprises abutting the at least one axial compression member with a proximal surface of the annular sewing skirt.
7 . The method of claim 1 , wherein the step of coupling at least one axial compression member to the apical cuff further comprises the step of providing an axial compression member having at least one of a plurality of secondary openings, the secondary openings having a different opening configuration than the plurality of first openings.
8 . The method of claim 1 , wherein the step of pre-driving a plurality of tissue anchors further comprises the step of providing the plurality of tissue anchors, each of the plurality of tissue anchors having a tissue anchor head with a driver engagement and a helical coil projecting from a distal surface of the tissue anchor head.
9 . The method of claim 8 , wherein the step of pre-driving the plurality of tissue anchors further comprises the step of providing the plurality of tissue anchors having a clocking indicia associated with the tissue anchor head, the clocking indica being in axial alignment with a distal tip of the helical coil projection.
10 . The method of claim 8 , wherein each of the plurality of tissue anchor openings in the at least one axial compression member is further configured with a tapered tissue anchor opening profile configured to mate with the tissue anchor head.
11 . The method of claim 1 , wherein the step of removably coupling the apical cuff, the at least one axial compression member, and the plurality of tissue anchors to the delivery tool, further comprises the step of loading the apical cuff coupled to the at least one axial compression member and the plurality of tissue anchors into a loading tray, then removably coupling the loading tray to the delivery tool.
12 . The method of claim 11 , wherein the delivery tool further comprises a coupling configured to removably couple with the loading tray and engage the apical cuff, axial compression member and the plurality of tissue anchors with the delivery tool.
13 . The method of claim 12 , wherein the delivery tool further comprises at least one of a plurality of drivers configured to engage the plurality of tissue anchors and drive the plurality of tissue anchors through the annular sewing skirt and into heart tissue.
14 . The method of claim 13 , wherein the delivery tool further comprises a delivery tool housing that retains each of the plurality of tissue anchors in a corresponding delivery tool channel in the delivery tool housing until release of the plurality of tissue anchors from the corresponding delivery tool channel.
15 . The method of claim 1 , wherein the step of pre-driving a plurality of tissue anchors further comprises the step of providing the plurality of tissue anchors, each of the plurality of tissue anchors having a tissue anchor head with a driver engagement and a helical coil projecting from a distal surface of the tissue anchor head.
16 . A method of attaching an apical cuff to a heart, the apical cuff having an annular frame defining a central opening and an annular sewing skirt, the method comprising the steps of:
coupling at least one axial compression member to the sewing ring such that the axial compression member bears against the sewing ring and not directly onto the apical cuff, the at least one axial compression member defining a central opening and having a plurality of tissue anchor openings passing axially through the at least one axial compression member, the at least one axial compression member configured to apply pressure to the annular sewing skirt, and the heart tissue;
pre-driving a plurality of tissue anchors into each of the plurality of tissue anchor openings and partially into the annular sewing skirt;
removably coupling the apical cuff, the at least one axial compression member, and the plurality of tissue anchors to a delivery tool, the delivery tool configured to allow each of the plurality of tissue anchors to be driven through the plurality of tissue anchor openings and apply an axially compressive force that is distributed substantially evenly about a circumference of the at least one axial compression member when the plurality of tissue anchors pass into and through the sewing skirt of the apical cuff and into the cardiac tissue.
17 . The method of claim 16 , wherein the at least one ring member further comprises plural arcuate sections arranged to form a ring member.
18 . The method of claim 16 , wherein the at least one ring member further comprises a unitary ring member.
19 . The method of claim 16 , wherein the step of coupling the at least one axial compression member further comprises the step of axially aligning the plurality of tissue anchor openings with the annular sewing skirt such that the plurality of tissue anchor openings are radially inward from an outer perimeter of the annular sewing skirt.
20 . The method of claim 16 , wherein the step of removably coupling the apical cuff, the at least one axial compression member, and the plurality of tissue anchors to the delivery tool, further comprises the step of loading the apical cuff coupled to the at least one axial compression member and the plurality of tissue anchors into a loading tray, then removably coupling the loading tray to the delivery tool.
21 . The method of claim 20 , wherein the delivery tool further comprises a coupling configured to removably couple with the loading tray and engage the apical cuff, axial compression member and the plurality of tissue anchors with the delivery tool.
22 . The method of claim 21 , wherein the delivery tool further comprises at least one of a plurality of drivers configured to engage the plurality of tissue anchors and drive the plurality of tissue anchors through the annular sewing skirt and into heart tissue.