Transcatheter Valve Implant Rotation and Self-Expansion Control

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Solution Overview

Problem

Existing transcatheter techniques for delivering and deploying prosthetic heart valves face challenges in engaging, loading, translating, repositioning, resheathing, and deploying expandable stents within heart chambers efficiently.

Innovation Solution

The development of an implant apparatus with a self-expandable design using superelastic materials like NiTiCu and a swivel body mechanism for controlled deployment, allowing for precise positioning and rotation of the implant within the heart chamber.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a prosthetic valve is mounted within a stented frame that is collapsed and advanced through a sheath, then the valve can be delivered percutaneously to the heart, but the frame must be expanded and positioned precisely within the heart chamber

Engineering Contradiction:
Improvedelivery procedureVSAvoidpositioning precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The stented frame is designed to transition from a collapsed state during delivery to an expanded state at the deployment site. This dynamic transformation allows the frame to be compressed for percutaneous access while automatically expanding to provide precise positioning and structural support at the heart valve location

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The prosthetic valve is pre-mounted within the stented frame in a collapsed configuration before delivery. This preliminary preparation allows the entire assembly to be advanced through the sheath and delivery catheter to the target site, after which the frame is expanded to secure the valve in its final positioned state

Inventive Principle:
Principle #10Preliminary action

2Productivity

If the stented frame is released from the catheter and expanded with the valve, then the valve achieves functional size, but controlling the expansion and positioning becomes more complex

Engineering Contradiction:
Improvedeployment efficiencyVSAvoiddeployment mechanism
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The delivery system is divided into distinct functional components: the stented frame, the prosthetic valve, the sheath, and the delivery catheter. This segmentation allows each component to be optimized independently while working together as an integrated system for controlled deployment

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The stented frame with the mounted prosthetic valve is nested within the sheath, which in turn is positioned within the delivery catheter. This nested configuration allows all components to be advanced together through the vasculature and enables controlled deployment at the target site by sequentially releasing constraints

Inventive Principle:
Principle #7Nested doll (Nesting)

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 efficient and controlled delivery and deployment of prosthetic heart valves, enhancing the precision and effectiveness of transcatheter procedures by allowing for rotational alignment and secure anchoring within the heart chamber.

Implementation Method 1

The development of an implant apparatus with a self-expandable design using superelastic materials like NiTiCu

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentUS12588988B2Implant delivery
Publication Date: 2026.03.31 4C MEDICAL TECHNOLOGIES INC
  • US12588988B2 patent drawing
  • US12588988B2 patent drawing
  • US12588988B2 patent drawing

AI summary

Apparatus and methods for an implant are provided. The implant may have a constrained configuration and a relaxed configuration. The implant may include a strut having an end that may be captured by a hub and may define a reference angle in the relaxed configuration. The implant may include a swivel body that may engage a shaft of a delivery cable and may be rotated through the reference angle. The apparatus may include a pusher catheter to push the implant. The delivery cable may engage the implant. The apparatus may include gauge handle that may include a force gauge to indicate the presence of a force acting on the implant. The apparatus may include a bushing that may be fixed to an end of a pusher catheter. The bushing may move along a delivery catheter lumen and may guide the implant to a keyed position at the bushing.