Flushable Loading Base for Prosthetic Heart Valves

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Solution Overview

Problem

Conventional crimping devices for loading prosthetic heart valves into delivery devices are cumbersome, difficult to use, and apply undue stress on the valve, making it challenging to securely engage the stent with the delivery device, especially for bioprosthetic valves with two separate cuff layers.

Innovation Solution

A loading assembly comprising a support member with a hollow body and a backing plate, including a recess with a seating surface and outlet ports, and a compression member with a frustoconical shape, which together facilitate the collapse and secure loading of the prosthetic heart valve into a minimally invasive delivery device, reducing loading forces and preventing valve damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional crimping devices are used to collapse the stented valve, then the valve can be loaded into the delivery device, but the devices are bulky and difficult to operate

Engineering Contradiction:
Improveease of operationVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The support member is divided into distinct functional components: a hollow body for structural support, a backing plate for engagement, and a recess for positioning the valve. This segmentation allows each component to be optimized independently while simplifying the overall operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention extracts the essential function of valve support and positioning from complex crimping mechanisms, isolating it into a simple support member with a recess that accommodates the valve in its collapsed state without requiring elaborate crimping apparatus.

Inventive Principle:
Principle #2Taking out (Extraction)

2Object-affected harmful factors

If conventional crimping devices are used to collapse the stented valve, then the valve can be loaded, but the devices impart undue stress on the stented valve

Engineering Contradiction:
Improvestress on valveVSAvoidloading efficiency
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The hollow body and backing plate structure provides cushioning support to the valve during the collapsing and loading process, distributing forces evenly and preventing concentrated stress that could damage the valve structure.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The support member acts as an intermediary between the valve and the delivery device, facilitating the loading process while protecting the valve from direct contact with potentially damaging forces from the delivery device or operator hands.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of time

If direct radial assemblies are used for crimping, then the valve can be collapsed, but the assemblies are bulky and time consuming to use

Engineering Contradiction:
Improvetime to load valveVSAvoidsize of crimping device
Core Design Contradiction:
Loss of timeVSVolume of moving object

Solution Approach 1:

The invention extracts only the essential support and positioning functions from complex radial crimping assemblies, eliminating bulky crimping mechanisms while retaining the core capability to hold and load the collapsed valve efficiently.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The support member with its recess is designed to automatically accommodate and position the collapsed valve without requiring complex active crimping mechanisms, allowing the valve to be loaded through simple insertion movements rather than time-consuming crimping operations.

Inventive Principle:
Principle #25Self-service

4Reliability

If conventional devices are used, then the valve can be loaded, but it is difficult to securely engage the stent with the retaining element of the delivery device

Engineering Contradiction:
Improvesecure engagementVSAvoidease of engagement
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The seating surface in the recess provides a distinct engagement interface that visually and physically indicates proper positioning of the valve, ensuring secure engagement with the retaining element through clear feedback on alignment and contact.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The invention replaces complex mechanical engagement systems with a simple geometric interface consisting of the recess and seating surface, where the shape and position of these features inherently guide and secure the valve engagement without requiring elaborate locking mechanisms.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS10722357B2Flushable loading base
Publication Date: 2020.07.28 ST JUDE MEDICAL CARDILOGY DIV INC
  • US10722357B2 patent drawing
  • US10722357B2 patent drawing
  • US10722357B2 patent drawing

AI summary

An assembly for loading a self-expanding prosthetic heart valve into a delivery device includes a support member including a body and a backing plate. The body has a longitudinal axis, a base end, a second end, and a recess extending along the longitudinal axis from the second end toward the base end. The recess has a bottom member defining a seating surface adapted to support the prosthetic heart valve. The backing plate is fixed to the body so as to define a void space between the backing plate and the body. The backing plate includes an inlet port and the recess includes a plurality of outlet ports. The inlet and outlet ports are in fluid communication with the void space. When the heart valve is received on the seating surface, each outlet port is rotationally aligned with a corresponding pocket formed between first and second cuffs of the heart valve.