Fluid Diversion Device for Mitral Valve Delivery

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Solution Overview

Problem

Current hydraulic delivery systems for mitral valve replacement face challenges due to the complex, non-uniform anatomy of the mitral valve, which makes it difficult to deploy and position prosthetic valves accurately and efficiently, leading to increased procedural time and cognitive burden on clinicians.

Innovation Solution

A fluid diversion device with a cam-based mechanism that allows for selective occlusion of fluid tubes, enabling flexible deployment and recapture of prosthetic heart valves by switching between deployment and recapture configurations using a handle, reducing the need for complex arrangements of multiple stopcocks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a complex arrangement of multiple stopcocks is used to control fluid flow for deployment and recapture, then fluid flow control capability is improved, but device complexity and cognitive burden on clinicians increase

Engineering Contradiction:
Improvefluid flow control capabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent combines multiple stopcock functions into a single integrated occlusion member that can selectively occlude different tubes. The occlusion member acts as a unified component that performs the functions of multiple separate stopcocks, thereby reducing device complexity while maintaining fluid flow control capability for both deployment and recapture configurations.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The occlusion member is designed as a universal component that can occlude different subsets of tubes depending on its rotational position. This single component performs multiple functions: controlling fluid flow during deployment, controlling fluid flow during recapture, and providing a neutral position. This multi-functionality eliminates the need for multiple specialized stopcocks.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple stopcocks are used to control fluid flow, then deployment and recapture control is improved, but procedural time increases

Engineering Contradiction:
Improvedeployment and recapture controlVSAvoidprocedural time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

By merging multiple stopcock operations into a single occlusion member rotation, the patent reduces the number of discrete manual operations required. The clinician controls both deployment and recapture fluid flow by rotating one component rather than manipulating multiple stopcocks, thereby reducing procedural time while maintaining precise control capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The occlusion member is pre-configured with cam surfaces and tube positions that automatically direct fluid flow to the appropriate chamber (deployment or recapture) based on its rotational position. This preliminary arrangement of fluid pathways eliminates the need for complex real-time routing decisions, allowing faster switching between deployment and recapture modes.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If a simple occlusion mechanism is used, then device complexity is reduced, but selective occlusion capability and positioning precision are worsened

Engineering Contradiction:
Improvedevice complexityVSAvoidpositioning precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The occlusion member incorporates cam surfaces that convert rotational motion into precise linear positioning of the occlusion element within the bore. This dynamic mechanism allows the simple occlusion member to achieve high positioning precision by using the cam profile to automatically position the occlusion element at the correct location for each operational mode (deployment, recapture, neutral).

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The cam surface acts as an intermediary between the rotational actuation and the linear occlusion positioning. This intermediate mechanical element translates the simple rotational input into precise linear occlusion positioning, maintaining positioning precision while keeping the overall device structure simple.

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

Facilitates controlled and efficient deployment and recapture of prosthetic heart valves, reducing procedural time and cognitive burden on clinicians, while ensuring accurate positioning and minimizing uncontrolled movement of the valve device during deployment.

Implementation Method 1

an occlusion member disposed in the bore, wherein rotation of the occlusion member enables selective occlusion of either a first subset of tubes or a second subset of tubes disposed in the plurality of channels

Methodology Applied
Scientific EffectMechanical occlusion: Valve

Implementation Method 2

an actuator operably coupled to the occlusion member to enable selective positioning of the occlusion member in at least a first position that occludes the first subset of tubes and a second position that occludes the second subset of tubes

Methodology Applied
Scientific EffectMechanical actuation: Mechanical Force

Data Source

PatentEP4218676B1Fluid diversion devices for hydraulic delivery systems
Publication Date: 2024.11.20 TWELVE INC
  • EP4218676B1 patent drawingFigure 1~2
  • EP4218676B1 patent drawingFigure 3~4
  • EP4218676B1 patent drawingFigure 5

AI summary

A fluid diversion device configured in accordance with embodiments of the present technology can include, for example, a housing including channels configured to receive respective tubes, and a bore that extends laterally across the plurality of channels. The device can include an occlusion member disposed in the bore, where rotation of the occlusion member selectively occludes either a first subset of tubes or a second subset of tubes. The device can include an actuator that enables rotation of the occlusion member to a first position and a second position such that the first subset of tubes and the second subset of tubes are alternatively occluded in the first position or the second position for fluid communication in different directions relative to chambers of a delivery device operable to deploy and recapture the medical device.