Heart Valve Delivery Nosepiece for Navigating Anatomical Obstacles

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Solution Overview

Problem

Dilation of the heart valve annulus due to ischemic heart disease prevents the valve leaflets from fully coapting, leading to regurgitation and decreased cardiac output, necessitating improved implantation techniques for prosthetic cardiac valves.

Innovation Solution

A delivery tool with a balloon at its distal portion, a sheath for retaining the implant, and a housing with a helical track, allowing for controlled deployment of the implant through the vasculature using a controller with an actuator to slide the housing longitudinally.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a delivery tool is advanced through the vasculature to implant a prosthetic valve, then the valve can be replaced to improve cardiac function, but the tool encounters anatomical obstacles and implanted obstacles that block progression

Engineering Contradiction:

Improvenavigation through vasculatureVSAvoidanatomical obstacles

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The delivery tool incorporates a balloon with a tapered surface that forms a rounded, curved nosecone shape at its distal end. This curved geometry allows the tool to smoothly navigate around anatomical obstacles such as calcified structures and previously implanted devices in the vasculature, preventing snagging and enabling successful delivery to the target site.

Inventive Principle:

Principle #14Spheroidality (Curvature)

2Ease of operation

If the delivery tool structure is made robust to handle anatomical obstacles, then navigation capability improves, but the device complexity increases

Engineering Contradiction:

Improvenavigation capabilityVSAvoidtool structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The delivery tool employs a compliant balloon structure made of flexible material that can deform and adapt to encountered obstacles. This flexible shell approach provides navigation capability through anatomical barriers without requiring complex rigid mechanical structures, thereby maintaining relative simplicity of the overall device while achieving robust navigation performance.

Inventive Principle:

Principle #30Flexible shells and thin films

3Manufacturing precision

If the implant is retained securely on the delivery tool, then deployment precision improves, but the mechanism for retention and release becomes more complex

Engineering Contradiction:

Improvedeployment precisionVSAvoidretention mechanism

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The delivery tool utilizes a helical track mechanism where the implant is engaged at multiple points around its circumference. This distributed engagement creates equipotential retention forces that securely hold the implant in position during delivery, ensuring precise deployment when released without requiring asymmetric or complex retention structures.

Inventive Principle:

Principle #12Equipotentiality

4Adaptability or versatility

If the delivery tool includes multiple components for navigation and deployment, then functionality improves, but the overall system complexity increases

Engineering Contradiction:

Improvedelivery functionalityVSAvoidsystem structure

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The delivery tool integrates multiple functions into unified components: the balloon serves both as a navigation aid with its tapered nosecone and as a deployment mechanism through controlled inflation; the helical track combines retention and release functions. This merging of functions reduces the number of separate components needed, thereby decreasing overall system complexity while maintaining full delivery functionality.

Inventive Principle:

Principle #5Merging (Combining)

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

Facilitates smooth navigation of the implant past anatomical obstacles and enables precise deployment of prosthetic cardiac valves, reducing tissue interference and improving cardiac function.

Implementation Method 1

The balloon facilitates movement of the distal portion of the tool past potential anatomical and/or implanted obstacles, e.g., by providing a tapered surface

Methodology Applied

Scientific EffectTapered surface geometry:

Implementation Method 2

Rotation of the actuator draws the housing proximally with respect to the implant by sliding an engaging element of the actuator along the track

Methodology Applied

Scientific EffectHelical mechanical conversion: Helix

Data Source

PatentUS12611305B2Minimally-invasive delivery systems

Publication Date: 2026.04.28 CARDIOVALVE LTD

AI summary

A method includes delivering an implant to a heart of a patient using a delivery tool that includes a nosepiece that is fixed to a shaft and distal to an implant, and an expandable element proximal to the nosepiece. Maximally-expanded, the expandable element (i) has an expanded external diameter at its widest part that is smaller than the expanded internal diameter of a lumen of the frame of the implant and (ii) tapers proximally away from the widest part and from the nosepiece. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. The method includes, following implantation of the implant, withdrawing the expandable element proximally through the lumen of the implant, between leaflets of the implant, and out of the lumen. Other applications are also described.