Tapered Crimping Device for Stented Bioprosthetic Heart Valves

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Solution Overview

Problem

Existing crimping devices for stented bioprosthetic heart valves are bulky, difficult to use, time-consuming, and impart undue stress on the valve, making them unsuitable for efficient loading onto minimally invasive delivery devices.

Innovation Solution

A device with a tapered internal cavity and movable sections that enclose the valve, along with a collar and pusher mechanisms, allows for controlled crimping and loading of the valve onto a delivery system, utilizing heat-retaining gels and high heat capacity metals to facilitate the process.

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 compressed for delivery, but the devices are bulky and difficult to use

Engineering Contradiction:
Improveease of crimping operationVSAvoiddevice bulk and complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The crimping device is divided into multiple sections (first section and second section) that can move independently relative to each other. The first section includes a first crimping surface while the second section includes a second crimping surface, allowing the valve to be collapsed in stages through sequential compression actions, thereby reducing the overall device complexity and improving ease of operation

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device employs movable sections that can transition between different positions. The first section and second section are capable of moving relative to one another, enabling dynamic adjustment of the crimping surfaces to accommodate the valve collapse process, which simplifies operation compared to static conventional devices

Inventive Principle:
Principle #15Dynamics

2Productivity

If conventional crimping devices are used, then the valve can be collapsed, but the process is time consuming

Engineering Contradiction:
Improvecrimping speedVSAvoidtime required for crimping
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The device is designed with pre-configured crimping surfaces positioned to receive the valve in a predetermined orientation. The first crimping surface and second crimping surface are arranged to sequentially compress the valve in an optimized sequence, reducing the time required for crimping by eliminating unnecessary adjustment steps

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The crimping process maintains continuous compression action through the sequential engagement of the first and second crimping surfaces. As the first section compresses the valve, the second section immediately follows with additional compression, ensuring uninterrupted useful action that reduces total crimping time compared to intermittent conventional methods

Inventive Principle:
Principle #20Continuity of useful action

3Productivity

If conventional crimping devices are used, then the valve can be collapsed, but undue stress is imparted on the stented valve

Engineering Contradiction:
Improvecrimping efficiencyVSAvoidstress on valve
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The device employs specifically designed crimping surfaces with optimized local properties. The first crimping surface and second crimping surface are shaped and positioned to apply compression forces in a distributed, controlled manner across the valve structure, reducing localized stress concentrations and harmful effects while maintaining crimping efficiency

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device structure incorporates features that cushion and distribute the compression forces during the crimping process. The movable sections and crimping surfaces are designed to absorb and distribute stress evenly, preventing undue stress on the stented valve while maintaining efficient collapse

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

4Productivity

If the valve is compressed for extended periods, then it can be loaded onto the delivery device, but the integrity of the biological valve is compromised

Engineering Contradiction:
Improveloading efficiencyVSAvoidvalve integrity
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The device uses movable sections that enable rapid transition through the crimping and loading process. The first section and second section can be quickly positioned and adjusted to facilitate rapid valve collapse and loading onto the delivery device, minimizing the total time the valve remains compressed and thereby preserving biological valve integrity

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The device is designed with pre-configured mechanisms that enable rapid valve collapse and immediate loading onto the delivery device in a predetermined sequence. This preliminary arrangement of crimping surfaces and movable sections allows the valve to be compressed only for the minimum necessary time, reducing the risk to biological valve integrity

Inventive Principle:
Principle #10Preliminary action

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

The solution enables efficient, stress-reduced crimping and loading of stented bioprosthetic valves onto minimally invasive delivery devices, improving the efficiency and safety of the process.

Implementation Method 1

The first section may be manufactured from a high heat capacity metal. The second section may as well.

Methodology Applied
Scientific EffectHeat capacity:

Implementation Method 2

The first section may be filled with a heat retaining gel. Similarly, the second section may as well.

Methodology Applied
Scientific EffectHeat retaining gel: Gel

Data Source

PatentUS9168135B2Device for collapsing and loading a heart valve into a minimally invasive delivery system
Publication Date: 2015.10.27 ST JUDE MEDICAL CARDILOGY DIV INC
  • US9168135B2 patent drawing
  • US9168135B2 patent drawing
  • US9168135B2 patent drawing

AI summary

A device is provided for collapsing a stented bioprosthetic valve, including first section and second sections, each spanning between first and second ends of the device. The second section of the device is associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device. The insertion portion has a larger dimension than the exit portion. When the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved toward and through the exit portion. The valve may then be loaded on an apparatus for insertion into the body.