Prosthetic Valve Crimping Funnel for Fast Sheath Loading Alignment

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Solution Overview

Problem

Existing crimping devices for self-expandable prosthetic valves face challenges in efficiently and quickly crimping and loading the valves into a delivery apparatus while aligning and connecting the connection features with the delivery apparatus, necessitating an improved crimping method.

Innovation Solution

A crimping device with a housing and actuator system that compresses the prosthetic valve radially through a funnel segment and pusher member, allowing axial movement and alignment of the valve for delivery, featuring a rotatable actuator and pusher member with ribs and annular grooves for precise compression and alignment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If conventional crimping devices use static conical tubes or crimping jaws, then self-expandable prosthetic valves can be crimped to a smaller diameter, but the physician cannot easily and quickly crimp and load the valve into a sheath while aligning connection features

Engineering Contradiction:

Improvecrimping and loading speedVSAvoidalignment and connection of features

Core Design Contradiction:

ProductivityVSEase of operation

Solution Approach 1:

The crimping device employs a dynamic conical surface that can change diameter, allowing the physician to easily and quickly crimp and load the prosthetic valve into a sheath while aligning connection features. The conical surface transitions from a static structure to a dynamic one that adapts during the crimping process, enabling both speed and precision in valve deployment.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The delivery apparatus integrates multiple functions including crimping, loading, and alignment capabilities into a single device. The conical surface serves both as a crimping mechanism and as an alignment guide, while the sheath simultaneously receives and secures the crimped valve, reducing the need for separate tools and steps.

Inventive Principle:

Principle #6Universality (Multi-functionality)

2Ease of manufacture

If pre-crimping is performed by the manufacturer, then the valve can be stored in compressed state, but it precludes packaging and storing valves in open diameter inside preserving solution

Engineering Contradiction:

Improvevalve packaging and storageVSAvoidcrimping time in operation room

Core Design Contradiction:

Ease of manufactureVSLoss of time

Solution Approach 1:

The device enables preliminary preparation of the valve in its open, functional state within the preserving solution, allowing the valve to be packaged and stored in a more natural configuration. The crimping action is then performed immediately before implantation in the operation room, optimizing both manufacturing ease and clinical timing.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If the crimping device is made portable for operation room use, then it can be shipped as disposable accessory, but the device complexity increases

Engineering Contradiction:

Improveportability and disposabilityVSAvoidcrimping device structure

Core Design Contradiction:

Ease of operationVSDevice complexity

Solution Approach 1:

The crimping device is divided into separable components including the conical surface element, the sheath, and the delivery apparatus. This segmentation allows the device to be manufactured as a disposable accessory that can be easily assembled and disposed of after single use, balancing portability requirements with structural functionality.

Inventive Principle:

Principle #1Segmentation

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, one-person operation for crimping and loading of prosthetic valves, ensuring precise alignment and connection features, facilitating minimally invasive procedures by providing a repeatable and predictable crimping process.

Implementation Method 1

rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment

Methodology Applied

Scientific EffectRadial compression: Compression

Implementation Method 2

Rotation of the actuator can cause the actuator to move axially over the housing

Methodology Applied

Scientific EffectMechanical advantage: Mechanical Advantage

Data Source

PatentUS11833040B2System and method for crimping a prosthetic valve

Publication Date: 2023.12.05 EDWARDS LIFESCIENCES CORP

AI summary

Embodiments of a crimping device for crimping a radially expandable and compressible prosthetic valve are disclosed. A crimping device can comprise a housing configured to receive a prosthetic valve in a radially expanded state. The housing member can include a funnel segment and an outlet in communication with the funnel segment. The crimping device can further comprise an actuator rotatably coupled to the housing, wherein rotation of the actuator relative to the housing causes the prosthetic valve to move axially through the funnel segment such that at least a portion of the prosthetic valve compresses radially by engagement with the funnel segment and exits the crimping device via the outlet.