Segmented Loading Tool for Mitral Valve Implant Compression

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Solution Overview

Problem

Existing loading tools struggle to effectively compress and hold implants with large volumes, large diameter-to-axis ratios, and large radial support, such as self-expanding mitral valve prostheses, due to difficulties in maintaining stability and preventing distortion during the loading process.

Innovation Solution

A loading tool comprising a base, a first workpiece, and a second workpiece, where the groove, first end hole, and second end hole are coaxially arranged to allow step-by-step compression of the implant, with snap-in connections and tapered neck sections to secure and reduce the implant's size, enhancing stability and coaxiality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single compression tool is used for implants with large diameter-to-axis ratio, then the device complexity is reduced, but the manufacturing precision and stability of compression are insufficient

Engineering Contradiction:
Improvenumber of workpiecesVSAvoidcompression precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The loading tool is divided into multiple workpieces (first workpiece, second workpiece, etc.), each with progressively smaller inner cavity diameters. This segmentation allows step-by-step compression of the implant, with each workpiece providing a specific compression stage, thereby achieving high precision compression for implants with large diameter-to-axis ratio without requiring an overly complex single-component design.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The multiple workpieces are designed to be nested or sequentially assembled, with each subsequent workpiece having a smaller inner cavity than the previous one. This nested structure enables progressive compression while maintaining a relatively compact overall device complexity, as the workpieces can be stored or transported in a nested configuration.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Manufacturing precision

If the inner cavity diameter is reduced to compress large implants, then the compression ratio is improved, but the implant stability and coaxiality deteriorate

Engineering Contradiction:
Improvecompression ratioVSAvoidimplant stability
Core Design Contradiction:
Manufacturing precisionVSStability of the object's composition

Solution Approach 1:

The compression process is segmented into multiple stages, with each workpiece providing a gradual reduction in inner cavity diameter. This progressive compression approach maintains implant stability by avoiding sudden or excessive compression forces, while still achieving the required compression ratio for loading into the delivery device.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Each workpiece is designed with a specific inner cavity diameter that prepares the implant for the next stage of compression. The preliminary actions of each workpiece ensure that the implant maintains its structural integrity and coaxiality throughout the compression process, preventing distortion before the final loading stage.

Inventive Principle:
Principle #10Preliminary action

3Stability of the object's composition

If a tapered neck section is added to secure the implant, then the implant stability is improved, but the device complexity increases

Engineering Contradiction:
Improveimplant stabilityVSAvoidstructural complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The tapered neck section is added only to the specific location where the implant needs to be secured, rather than modifying the entire workpiece structure. This localized modification provides the necessary stability and grip for the implant while minimizing the overall structural complexity of the loading tool.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The tapered neck section merges the functions of implant retention and compression guidance into a single structural feature. This integration reduces the need for additional separate components, thereby limiting the increase in device complexity while achieving improved implant stability.

Inventive Principle:
Principle #5Merging (Combining)

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 tool enables secure and stable compression of implants with large diameters and radial support, reducing the risk of distortion and damage, and facilitates their loading into delivery devices for minimally invasive procedures.

Implementation Method 1

Shape memory alloy materials, such as Nitinol, can achieve self-transformation between metallic martensite and austenite at specific temperatures

Methodology Applied
Scientific EffectShape memory alloy transformation: Shape Memory Alloy

Implementation Method 2

the mitral valve prosthetic stent can be loaded into a smaller sheath at low temperature and transported to where the native mitral valve is in the heart; after release in vivo, the temperature of the mitral valve prosthetic stent gradually rises in the blood environment, which enable the stent to be self-expanding

Methodology Applied
Scientific EffectPhase transformation: Phase Change

Data Source

PatentEP4134048B1Loading tool and system for implant
Publication Date: 2024.05.08 SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
  • EP4134048B1 patent drawingFigure 1~2
  • EP4134048B1 patent drawingFigure 3~4
  • EP4134048B1 patent drawingFigure 5~6a

AI summary

A loading tool and loading system for an implant. The loading tool includes a base (100), a first workpiece (200) and a second workpiece (300). The base (100) includes a groove (101) arranged along the axial direction, and the groove (101) has an opening toward the first direction and is configured for allowing an end of an implant to be accommodated and placed therein. The first workpiece (200) includes a first inner cavity extending through the first workpiece, first inner cavity has a first end hole (201) in the first direction, and the inner diameter of the first end hole (201) is smaller than the maximum inner diameter of the groove (101). The first workpiece (200) is configured to detachably connect with the base (100). The second workpiece (300) includes a second inner cavity extending through the second workpiece, the second inner cavity has a second end hole (301) in the first direction, and the inner diameter of the second end hole (301) is smaller than that of the first end hole (201). The second workpiece (300) is configured to detachably connect with the base (100) or the first workpiece (200). The groove (101), the first end hole (201) and the second end hole (301) are coaxially arranged in sequence in the first direction after they are assembled and connected together. The implant can be compressed step by step when passing through the first end hole (201) and the second end hole (301) in sequence.