Atrial Wall Support Member for Precise Cannula Insertion

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Solution Overview

Problem

Current methods for inserting a cannula into the left atrium of the heart, such as ventricular assist devices, face challenges due to the thin and fragile nature of the atrial walls, which can lead to tissue tearing and difficulty in achieving precise placement, especially given the low pressure within the atrium and the tortuous anatomy of the heart.

Innovation Solution

A support member is used to temporarily couple to the target tissue, defining a path for a cutting device to move along and cut or dilate the tissue, allowing for precise placement of the cannula while minimizing tissue movement and deformation, thereby reducing the risk of tearing and improving precision.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If the inlet flow cannula is inserted by piercing the septum through a blind approach, then the procedure can be performed with simpler equipment, but the precision of cannula placement is poor and the risk of undesirable placement is high

Engineering Contradiction:
Improveequipment simplicityVSAvoidcannula placement precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

A support member is introduced as an intermediary device between the cutting device and the atrial wall. The support member defines a precise path for the cutting device to follow, ensuring accurate cannula placement while maintaining equipment simplicity. The support member acts as a guide that mediates between the operator and the fragile atrial tissue.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support member is deployed in advance to define the cutting path before the actual incision is made. This preliminary positioning ensures that when the cutting device is subsequently applied, it follows the pre-defined safe path, eliminating the need for complex real-time navigation systems.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If the atrial wall is dilated with a dilator or balloon catheter to accommodate the cannula, then the cannula can be inserted, but the thin and fragile tissue may tear or fracture beyond the dilator diameter

Engineering Contradiction:
Improvecannula insertion easeVSAvoidtissue integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The support member is deployed in advance to define the cutting path and provide structural support to the atrial wall before dilation occurs. This preliminary support prevents the thin and fragile tissue from tearing or fracturing during the dilation process, while still allowing the cannula to be inserted.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The support member provides beforehand cushioning to the atrial wall during the dilation process. By being in place before the dilator or balloon catheter is applied, it distributes the stress and prevents concentrated forces that would cause tissue tearing, thus protecting the fragile atrial tissue while enabling successful cannula insertion.

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

3Ease of manufacture

If the dome of the left atrium is pushed or manipulated from the outside to incise or dilate the tissue, then the incision can be made, but the low pressure inside the atrium causes the tissue to collapse into the atrium, making a clean cut difficult

Engineering Contradiction:
Improveincision capabilityVSAvoidcut cleanliness
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The support member serves as an intermediary structure that maintains the atrial wall in a stable, non-collapsed state during incision. It provides a rigid framework that prevents the tissue from folding inward due to low pressure, allowing the cutting device to make a clean incision without the tissue collapsing into the atrium.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The support member dynamically adapts to the low-pressure environment inside the atrium by providing continuous structural support. It counteracts the pressure differential that would otherwise cause the tissue to collapse, maintaining optimal geometry for precise cutting throughout the procedure.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP3076884B1Apparatus for cutting an atrial wall
Publication Date: 2020.02.05 HEARTWARE INC
  • EP3076884B1 patent drawingFigure 1
  • EP3076884B1 patent drawingFigure 2
  • EP3076884B1 patent drawingFigure 3

AI summary

A method includes coupling, at least temporarily, a support member adjacent to a target tissue. The support member is configured to support the target tissue and to define a path along which a cutting device can move. The method includes moving the cutting device along the path defined by the support member to cut and/or dilate the target tissue. In some embodiments, the method optionally includes disposing a cannula of a device within the cut defined in target tissue. The cannula is coupled to the target tissue such that a lumen defined by the cannula is in fluid communication with a volume defined at least in part by the target tissue.