Prosthetic Heart Valve Delivery Rotation for Commissure Alignment

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Solution Overview

Problem

The challenge of aligning commissures of a prosthetic heart valve with native commissures during transcatheter implantation is difficult due to limited visualization of the surgical field, making it hard to achieve rotational alignment, which can lead to coronary obstruction and suboptimal valve function.

Innovation Solution

A delivery device with an inner shaft, outer shaft, and distal sheath that allows for rotational movement of the prosthetic heart valve through mechanisms like grooved tubes, worm gears, or pull wires, enabling active alignment of prosthetic heart valve commissures with native commissures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a collapsible prosthetic valve is delivered via catheter for less invasive implantation, then patient trauma is reduced and recovery is faster, but the ability to visualize and align commissures with native valve anatomy is significantly impaired

Engineering Contradiction:

Improvepatient traumaVSAvoidcommissure alignment capability

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent employs fluoroscopic imaging markers and radiopaque structures as intermediary elements that enable visualization of the prosthetic valve commissures during catheter-based delivery. These markers act as mediators between the surgeon's visual system and the otherwise invisible internal structures, allowing alignment assessment without requiring direct visual access to the surgical field.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces direct mechanical visualization and manual alignment methods with image-guided positioning systems. Fluoroscopic imaging and radiopaque markers substitute for the direct visual feedback available in open-heart surgery, enabling commissure alignment through imaging-based navigation rather than direct visual inspection.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Length of moving object

If the prosthetic valve is positioned at one end of the delivery device while the surgeon manipulates the opposite end, then the delivery device can be inserted through small access points, but rotational control and commissure alignment become significantly more difficult

Engineering Contradiction:

Improvedelivery device lengthVSAvoidrotational control

Core Design Contradiction:

Length of moving objectVSEase of operation

Solution Approach 1:

The patent incorporates dynamic rotational control mechanisms that allow the surgeon to rotate the prosthetic valve assembly along the delivery catheter. This enables active adjustment of the valve's rotational position during delivery, providing real-time control over commissure orientation despite the length and remote positioning of the device.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent utilizes fluoroscopic imaging to provide visual feedback on the rotational position of the prosthetic valve commissures relative to native valve anatomy. This feedback loop allows the surgeon to make informed rotational adjustments and verify alignment achievement, compensating for the lack of direct tactile and visual control.

Inventive Principle:

Principle #23Feedback

3Device complexity

If commissures are not properly aligned with native valve anatomy, then the implantation procedure can be completed without complex alignment mechanisms, but coronary obstruction risk increases and valve function is suboptimal

Engineering Contradiction:

Improvealignment mechanism complexityVSAvoidcoronary obstruction risk

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent incorporates pre-marked commissure indicators and alignment references on the prosthetic valve structure itself, allowing the surgeon to identify and align commissures before final deployment. This preliminary alignment action ensures proper orientation is achieved prior to the irreversible expansion and fixation of the valve.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent employs radiopaque markers and imaging guidance as intermediary tools to verify commissure alignment with native valve anatomy. These markers serve as mediators that bridge the gap between the prosthetic structure and the surgeon's ability to assess alignment, enabling reliable positioning without requiring complex mechanical alignment mechanisms.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentEP3988053B1Active alignment of commisures in prosthetic heart valve implantation

Publication Date: 2026.02.18 ST JUDE MEDICAL CARDILOGY DIV INC

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AI summary

A delivery device (1010) for a collapsible prosthetic heart valve (200) includes an inner shaft (1026), an outer shaft (1022), and a distal sheath (1024). The distal sheath forms a compartment with the inner shaft sized to receive the prosthetic heart valve in a collapsed condition. The inner shaft and the distal sheath may be movable relative to one another. The delivery device may also include a tube member (2000, 3000, 4000) and an outer sleeve (3100) overlying the tube member. The tube member may be configured to rotate or twist upon axial movement of the outer sleeve with respect to the tube member, the rotation or twisting of the tube member configured to rotate the prosthetic heart valve when the prosthetic heart valve is received within the compartment in the collapsed condition.