Prosthetic Heart Valve Delivery Steering for Precise Positioning

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Solution Overview

Problem

Existing delivery devices for prosthetic heart valves have a large crimp profile, inhibiting advancement through the vasculature and compromising precision in positioning, and lack sufficient control mechanisms for accurate implantation.

Innovation Solution

A delivery apparatus with a handle, first and second shafts, and a steering assembly that allows for longitudinal motion and flexing of the second shaft relative to the first, enabling precise positioning and reduced profile for prosthetic valve deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the catheter assembly is designed with a smaller profile to facilitate advancement through the vasculature, then the ease of operation is improved, but the flexural strength of the catheter assembly is reduced

Engineering Contradiction:
Improveease of advancement through vasculatureVSAvoidflexural strength of catheter assembly
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The catheter assembly is divided into multiple shafts (first shaft and second shaft) with different structural characteristics. The first shaft provides structural support while the second shaft accommodates the prosthetic valve, allowing each segment to be optimized for its specific function - the first shaft maintains strength while the second shaft achieves smaller profile.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The second shaft is disposed within the first shaft in a nested configuration. This nesting allows the prosthetic valve delivery system to achieve a smaller overall profile for vascular advancement while the outer first shaft maintains the necessary flexural strength and structural integrity.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Adaptability or versatility

If the delivery device is made relatively long to reach the implantation site, then the adaptability is improved, but the manufacturing precision of valve positioning is worsened due to unwanted movement

Engineering Contradiction:
Improveability to reach implantation siteVSAvoidprecision of valve positioning
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The steering assembly enables dynamic control of the catheter's distal end through longitudinal motion and flexing. This dynamic capability allows the physician to adjust the positioning of the prosthetic valve in real-time during the procedure, compensating for the length of the delivery device and maintaining precise control over valve placement.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The steering assembly changes the physical parameters of the second shaft by inducing flexing and longitudinal motion. This allows the distal end of the catheter to be positioned independently from the handle, enabling precise valve placement despite the overall length of the delivery device.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If the catheter assembly is reduced in diameter to minimize profile, then the ease of operation is improved, but the flexural strength is reduced complicating advancement and positioning

Engineering Contradiction:
Improveease of advancement through vasculatureVSAvoidease of advancement and positioning
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

The catheter is segmented into multiple functional shafts where the first shaft provides structural support and the second shaft provides flexibility and access. This segmentation allows the overall assembly to achieve a reduced diameter while maintaining the necessary mechanical properties for advancement and positioning through the vasculature.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3432835B1Delivery system for prosthetic heart valve
Publication Date: 2025.09.17 EDWARDS LIFESCIENCES CORP
  • EP3432835B1 patent drawingFigure 1
  • EP3432835B1 patent drawingFigure 2~3
  • EP3432835B1 patent drawingFigure 4~6

AI summary

A delivery apparatus for implanting a prosthetic implant in a native lumen of the body includes a handle portion, and a first shaft extending from and movable relative to the handle portion. The first shaft has a proximal end portion coupled to the handle portion and a distal end portion. The delivery apparatus further includes a second shaft extending from the handle portion and coaxially disposed within the first shaft. The second shaft has a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic implant in a radially compressed state. The handle portion of the delivery apparatus also includes a steering assembly configured to move the first shaft longitudinally relative to the second shaft while concurrently flexing the second shaft.