Catheter-Delivered Artificial Leaflet for Precise Valve Repair
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Solution Overview
Problem
Existing medical devices face challenges in accurately delivering and positioning artificial leaflets to heart valves via a catheter, particularly in cases of incomplete coaptation or degenerative valve diseases, and existing solutions require invasive procedures or cardiopulmonary bypass.
Innovation Solution
A medical arrangement using a tissue anchoring device with a delivery and activated state, allowing an artificial leaflet to be introduced through a catheter, where the leaflet transitions from a compact delivery state to an expanded activated state, secured by shape memory materials or slidable fixing means, enabling precise placement and fixation to the annulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an artificial leaflet is delivered through a catheter, then the invasiveness of the procedure is reduced, but the precision of positioning and placement becomes more difficult
Solution Approach 1:
The artificial leaflet is divided into multiple segments or struts that can be independently positioned and deployed. This segmentation allows for precise placement of each component while maintaining a compact delivery profile through the catheter, resolving the contradiction between minimally invasive delivery and positioning precision.
Solution Approach 2:
The leaflet is pre-shaped and pre-positioned on the delivery catheter in a compressed state before insertion. This preliminary preparation ensures that once deployed, the leaflet achieves accurate positioning and proper geometric configuration without requiring complex real-time adjustments, thus maintaining precision while enabling minimally invasive delivery.
2Reliability
If the artificial leaflet is in an expanded form, then it provides adequate coverage and function, but it cannot be delivered through a catheter
Solution Approach 1:
The artificial leaflet is designed with a nested structure where multiple components are housed within each other in a compact configuration for delivery. Upon deployment, these nested components expand outward to form the full functional structure, allowing the device to transition from a small deliverable form to a large functional form that provides adequate coverage.
Solution Approach 2:
The leaflet employs dynamic transformation from a compressed delivery state to an expanded functional state. This dynamic capability allows the device to be delivered in a compact form through the catheter and then expand to provide adequate coverage and functional effectiveness at the target site, resolving the contradiction between deliverability and functional performance.
3Manufacturing precision
If traditional surgical procedures are used to repair leaflets, then accurate repair can be achieved, but cardiopulmonary bypass is required increasing surgical risks
Solution Approach 1:
The artificial leaflet acts as an intermediary device that can be delivered through a catheter and deployed at the target site without requiring open surgical exposure or cardiopulmonary bypass. This intermediary approach maintains repair accuracy by allowing precise positioning while improving surgical safety by avoiding the risks associated with traditional open heart surgery.
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 controlled and minimally invasive introduction of artificial leaflets, allowing for accurate repair or replacement of heart valve leaflets without cardiopulmonary bypass, reducing surgical risks and accelerating healing.
Implementation Method 1
The tissue anchoring device may comprise e.g. shape memory material in order to take the form in use when it is exposed to a suitable temperature, such as a blood circulation temperature.
Data Source
AI summary
A medical arrangement (100) comprises a tissue anchoring device (130) to be introduced around an annulus (20) and an artificial leaflet (101) to be introduced together with the tissue anchoring device (130) to an inner section of a valve tissue. The artificial leaflet (101) comprises a delivery state (102) and an activated state (103), wherein in said delivery state (102) the leaflet has a reduced form so that an area of the leaflet is smaller than in said activated state (103). In the activated state (103) artificial leaflet (101) has an expanded form and covers at least a portion of biological leaflets (22). The artificial leaflet (101) is transferable from the said delivery state (102) to the activated state (103) at the same, or even by a same back and forth movement, when the tissue anchoring device (130) is introduced to surround at least a circular portion of the annulus (20).