Tavi anchoring assist device

An anchoring assistance device delivery system, comprising:

• a delivery sheath having at least one lumen extending longitudinally therethrough and an actuator mechanism disposed at a proximal end of the delivery sheath;
• an elongate deployment member extending from the actuator mechanism to an anchoring assistance device disposable within a distal portion of the delivery sheath, the anchoring assistance device comprising:
• an expandable scaffold including a mid-body section defining a central longitudinal axis, the expandable scaffold having a cusp interface section extending axially from a distal end of the mid-body section, and a crown end arrangement extending axially from a proximal end of the mid-body section;
• wherein the expandable scaffold is configured to expand radially outward from a delivery configuration to a deployed configuration;
• wherein the cusp interface section includes a plurality of loop portions arranged at radial intervals about the central longitudinal axis of the expandable scaffold, each loop portion being configured to be positioned adjacent a leaflet of an aortic valve;
• wherein each loop portion is circumferentially spaced apart from another loop portion by a region having a deployment ring, the region being configured to span a commissure of the aortic valve and extending distally a shorter distance from the distal end than the loop portions;
• wherein the elongate deployment member is configured to releasably engage with the deployment rings such that the elongate deployment member actuates the expandable scaffold from the delivery configuration to the deployed configuration in response to activation of the actuator mechanism.

A medical implant system, comprising:

• a delivery sheath having at least one lumen extending longitudinally therethrough and an actuator mechanism disposed at a proximal end of the delivery sheath;
• an anchoring assistance device comprising an expandable scaffold including a mid-body section defining a central longitudinal axis, the expandable scaffold having a cusp interface section extending axially from a distal end of the mid-body section, and a crown end arrangement extending axially from a proximal end of the mid-body section;
• and
• a replacement heart valve implant;
• wherein the expandable scaffold is configured to expand radially outward from a delivery configuration to a deployed configuration;
• wherein the cusp interface section includes a plurality of loop portions arranged at radial intervals about the central longitudinal axis of the expandable scaffold, each loop portion being configured to be positioned adjacent a leaflet of an aortic valve;
• wherein each loop portion is circumferentially spaced apart from another loop portion by a region having a deployment ring, the region being configured to span a commissure of the aortic valve and extending distally a shorter distance from the distal end than the loop portions;
• wherein an elongate deployment member extends from the actuator mechanism to the anchoring assistance device, the anchoring assistance device being disposable within a distal portion of the delivery sheath;
• wherein the elongate deployment member is configured to releasably engage with the deployment rings to actuate the expandable scaffold from the delivery configuration to the deployed configuration;
• wherein the replacement heart valve implant is configured to be at least partially disposed within the expandable scaffold in the deployed configuration.