Heart Valve Deployment Tool Actuator and Anchor Locking
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Solution Overview
Problem
Current medical implant deployment tools face challenges in delivering and deploying replacement heart valves endovascularly, particularly in applying sufficient expansion force against native valve tissue and maintaining the implant in an expanded configuration, while ensuring controlled detachment and retrieval.
Innovation Solution
A deployment tool with actuators providing an axially directed force and mechanical advantage to expand and lock the anchor of the replacement heart valve, featuring a sheath actuator, anchor actuator, and feedback mechanism to manage deployment operations, ensuring precise control and sequential actuation of multiple elements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If an actuator is used to expand the anchor from a delivery shape to a deployed shape, then the implant can be delivered minimally invasively, but the actuator must perform multiple operations over a long distance which increases device complexity
Solution Approach 1:
The deployment tool is divided into multiple functional segments: a delivery catheter for transport, an expandable anchor for deployment, and a locking mechanism for stabilization. Each segment performs a specific function, allowing the complex deployment operation to be broken down into manageable steps while maintaining minimal invasiveness.
Solution Approach 2:
The anchor is nested within the delivery catheter during transport, and the locking mechanism is integrated into the anchor structure. This nested arrangement allows the implant to be delivered through a small access point while enabling complex deployment operations at the target location without increasing the access site size.
2Reliability
If expansion force is applied to the anchor to deploy against native valve tissue, then the valve replacement is successful, but the force transmission over long distance reduces reliability
Solution Approach 1:
The anchor is pre-formed in a compressed delivery shape that fits within the catheter. Upon arrival at the target location, the actuator applies force to expand the anchor to its deployed shape, and the locking mechanism immediately secures it in place. This preliminary preparation ensures that when force is applied, the anchor is ready to engage with the native valve tissue reliably.
Solution Approach 2:
The locking mechanism acts as an intermediary between the actuator and the anchor, amplifying and stabilizing the force transmission. Once the actuator applies initial expansion force, the locking mechanism engages to maintain the expanded state and transmit the necessary force to secure the valve against the native tissue, compensating for the long distance force transmission.
3Stability of the object's composition
If a locking mechanism is added to maintain the implant in expanded configuration, then deployment stability is improved, but the device complexity increases
Solution Approach 1:
The locking mechanism is merged with the anchor structure, where the anchor itself serves as both the expansion element and the locking component. The locking elements are integrated into the anchor's geometry, allowing the same structure to provide both deployment and stabilization functions without adding separate complex locking devices.
Solution Approach 2:
The anchor is designed to be self-locking through its geometric configuration. When the actuator expands the anchor, the structure automatically engages its locking elements to maintain the expanded state. This self-service capability reduces the need for additional complex locking mechanisms while ensuring stable deployment.
4Manufacturing precision
If multiple actuators are used for sequential operations (sheath movement, anchor expansion, locking, unlocking), then operational precision is improved, but the handle complexity increases
Solution Approach 1:
A single actuator is designed to perform multiple functions through sequential operation. The same actuator mechanism can move the sheath, expand the anchor, and engage or disengage the locking mechanism by changing its operational mode or position. This multi-functional design reduces the number of separate actuators needed while maintaining precise sequential control.
Solution Approach 2:
The actuator is designed with dynamic capabilities to switch between different operational states. Through controlled movement and position changes, the single actuator can dynamically perform multiple deployment operations in sequence, providing precise control over each step without requiring multiple static actuators.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables effective endovascular deployment of heart valves with controlled expansion, locking, and retrieval, providing a mechanical advantage for force transmission and feedback for successful implant placement and maintenance.
Implementation Method 1
an actuator adapted to exert an axially directed force on the anchor
Implementation Method 2
expansion of the replacement valve against the inward force of the tissue in and around the patient's native valve
Data Source
AI summary
An apparatus for endovascularly replacing a patient's heart valve. In some embodiments, the apparatus includes a replacement heart valve implant comprising a valve and an expandable anchor; and a deployment tool adapted to endovascularly deliver the replacement heart valve implant to an implant site within the patient, the deployment tool comprising an actuator adapted to exert an axially directed force on the anchor. The invention also provides a method for endovascularly replacing a heart valve of a patient. In some embodiments, the method includes the steps of endovascularly delivering a replacement heart valve implant having a valve and an anchor to an implant site within the patient; and applying an axially directed force from an actuator outside of the patient to the anchor. In invention also provides deployment tools for performing the method.