Stented Prosthesis Delivery Bumper System

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Solution Overview

Problem

Existing stented prosthetic heart valve delivery devices often cause damage to patients due to the rough outer surface of the prosthetic valves during deployment, and there is a risk of the delivery device components snagging on the prosthetic valve, leading to potential injury or improper deployment.

Innovation Solution

Incorporation of a bumper system within the delivery device, which includes a protective capsule and biasing members to smooth the transition of the prosthetic valve during loading and deployment, preventing snagging and ensuring a safe, injury-free implantation by providing a smooth surface for the capsule to advance over the prosthetic valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a protective capsule is used to cover the rough outer surface of the prosthetic valve, then patient damage is prevented, but the capsule may snag on the proximal end of the prosthetic valve during loading or recapture

Engineering Contradiction:

Improvedamage to patientVSAvoidsnagging risk

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

A bumper is introduced as an intermediary component between the capsule and the prosthetic valve. The bumper provides a smooth transition surface that allows the capsule to advance over the prosthetic valve without snagging on the rough outer surface or proximal end features, thereby maintaining both patient protection and operational reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The bumper is positioned beforehand at the proximal end of the prosthetic valve to cushion and smooth the transition zone. This pre-positioned protective element prevents the capsule from directly contacting and snagging on the rough surface features during loading and recapture operations

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Object-affected harmful factors

If the capsule is advanced over the prosthetic valve during loading, then the prosthetic valve is protected, but the rough outer surface causes snagging and potential injury

Engineering Contradiction:

Improveinjury preventionVSAvoidloading difficulty

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The bumper serves as a mediator between the capsule and the rough outer surface of the prosthetic valve, providing a smooth interface that eliminates snagging during the loading process while maintaining the protective function of the capsule

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The bumper is pre-positioned on the prosthetic valve before capsule advancement, creating a prepared smooth transition zone that facilitates easy capsule loading without requiring additional manipulation or causing operational difficulties

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If the capsule is retracted from the prosthetic valve, then deployment is enabled, but open space causes kinking in the capsule

Engineering Contradiction:

Improvedeployment capabilityVSAvoidcapsule kinking

Core Design Contradiction:

Ease of operationVSStability of the object's composition

Solution Approach 1:

A biasing member is introduced as an intermediary element that actively fills the open space created during capsule retraction. This member maintains continuous support for the capsule, preventing kinking while allowing the retraction motion necessary for deployment to proceed

Inventive Principle:

Principle #24Intermediary (Mediator)

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 bumper system effectively prevents damage to the patient and ensures proper deployment of the stented prosthetic heart valve by providing a smooth transition, reducing the risk of snagging and kinking, thereby enhancing the safety and efficacy of the minimally invasive implantation procedure.

Implementation Method 1

The bumper assembly is arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the prosthetic valve

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS11806236B2Stented prosthesis delivery system having a bumper

Publication Date: 2023.11.07 MEDTRONIC VASCULAR INC

AI summary

Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.