Umbrella Device for Calcific Aortic Valve Resection

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Solution Overview

Problem

Current percutaneous balloon valvuloplasty for aortic stenosis is associated with high complications, limited durability, and issues such as periprosthetic leak, calcium embolization, and device migration due to irregular dilation of the calcific aortic valve during stent valve delivery.

Innovation Solution

A device and method involving an umbrella device with a shaft catheter, mechanical drill, and cauterizing mechanisms to safely resect the calcific aortic valve, preventing embolization and facilitating the delivery of stent valves by engaging and removing the valve through a combination of cauterization and mechanical grinding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If percutaneous balloon valvuloplasty is used for aortic stenosis, then the procedure can be performed minimally invasively, but complications such as periprosthetic leak, calcium embolization, and device migration occur due to irregular dilation

Engineering Contradiction:
Improveminimally invasive procedureVSAvoidcomplications including periprosthetic leak, calcium embolization, and device migration
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by performing controlled dilation of the calcific aortic valve using a balloon catheter before delivering the stent valve device. This pre-dilation step prepares the valve annulus to receive the stent valve properly, preventing irregular dilation that would cause periprosthetic leak, calcium embolization, and device migration. The balloon catheter is inflated to a controlled size to expand the calcified valve structure in a controlled manner prior to stent valve deployment.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If the calcific aortic valve is dilated prior to stent valve delivery, then the stent valve can be inserted, but irregular dilation causes periprosthetic leak, calcium embolization, and device migration

Engineering Contradiction:
Improvestent valve insertionVSAvoidirregular dilation causing periprosthetic leak, calcium embolization, and device migration
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent applies parameter changes by controlling the dilation parameters of the calcific aortic valve through a balloon catheter. The balloon is inflated to specific pressures and dimensions to achieve uniform expansion of the calcified valve annulus. This controlled parameter change ensures the valve opening becomes regular and appropriately sized for stent valve delivery, preventing irregular dilation that would lead to periprosthetic leak, calcium embolization, and device migration.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If a mechanical drill is used to resect the calcific aortic valve, then precise valve removal is achieved, but the device complexity increases

Engineering Contradiction:
Improveprecise valve removalVSAvoiddevice structure with shaft catheter, mechanical drill, and cauterizing mechanisms
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies merging by combining multiple functions into a single integrated device: a shaft catheter that delivers both a mechanical drill and cauterizing mechanisms for valve resection. The mechanical drill rotates to grind and remove calcific deposits, while the cauterizing mechanisms simultaneously seal tissue edges. This combination of drilling and cauterization in one device achieves precise valve removal while reducing the need for multiple separate instruments, thereby managing device complexity.

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

This approach reduces complications by ensuring precise valve removal and insertion of stent valves, minimizing embolization risks and improving the delivery process, thereby enhancing the safety and efficacy of percutaneous aortic valve replacement.

Implementation Method 1

a mechanism to cut and destroy a heavily calcified valve

Methodology Applied
Scientific EffectMechanical abrasion: Abrasion

Implementation Method 2

cauterizing mechanisms to safely resect the calcific aortic valve

Methodology Applied
Scientific EffectCauterization: Heating

Data Source

PatentUS10555767B2Devices, systems, and methods for valve removal
Publication Date: 2020.02.11 CVDEVICES LLC
  • US10555767B2 patent drawing
  • US10555767B2 patent drawing
  • US10555767B2 patent drawing

AI summary

Devices, systems, and methods for valve removal. In an embodiment of an umbrella device for removing a valve of the present disclosure, the umbrella device comprises an elongated shaft having a distal end, a first umbrella comprising a first mesh, the first umbrella coupled to the shaft at or near the distal end of the shaft, a second umbrella comprising a second mesh, the second umbrella coupled to the shaft proximal to the first umbrella, and a mechanical drill rotatably coupled to the shaft and positioned between the first umbrella and the second umbrella.