Dual Needle Cardiac Penetrating Device for Minimally Invasive Wall Stress Reduction

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Solution Overview

Problem

Current treatments for congestive heart failure, such as surgical interventions, often involve significant risk and are not minimally invasive, failing to effectively reduce ventricular volume and wall stress in a less traumatic manner.

Innovation Solution

A tissue penetrating device with a dual needle system, comprising an inner and outer needle, is used to penetrate the heart's external and septal walls minimally invasively, allowing for the deployment of anchors to reduce ventricular volume and alleviate wall stress by excluding scar tissue, utilizing a flexible shape-memory material for the outer needle to bend and accommodate offset insertion locations.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical interventions are used to reduce ventricular volume, then wall stress is reduced and heart function is improved, but patient risk increases and the procedure is not minimally invasive

Engineering Contradiction:
Improveheart functionVSAvoidpatient risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The surgical procedure is segmented into discrete steps: percutaneous access, needle penetration, guidewire insertion, anchor deployment, and tensioning. This segmentation allows each step to be performed minimally invasively while achieving the overall goal of ventricular volume reduction and wall stress reduction.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Guidewires and anchors serve as intermediaries that transmit force and position between the percutaneous access point and the ventricular tissue. These intermediaries enable the delivery of reconstructive forces without requiring open surgical exposure, thereby reducing patient risk while maintaining therapeutic efficacy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Shape

If traditional surgical techniques are used to exclude scar tissue, then ventricular geometry is improved, but the procedure complexity and trauma increase

Engineering Contradiction:
Improveventricular geometryVSAvoidprocedure complexity
Core Design Contradiction:
ShapeVSDevice complexity

Solution Approach 1:

Instead of approaching the ventricle from the outside through large incisions, the procedure inverts the approach by accessing the ventricular tissue percutaneously through the vascular system. Anchors are deployed from within the ventricle or through the wall, reversing the traditional external-to-internal surgical approach and simplifying the procedural trajectory.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

Traditional mechanical surgical manipulation of ventricular tissue is replaced by a tension-based system using anchors and tensioning devices. This substitution allows geometric reconstruction through controlled tension application rather than complex mechanical suturing or stapling, reducing procedure complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If ventricular volume is reduced to alleviate wall stress, then heart function improves, but the insertion locations for anchors are offset making the procedure difficult

Engineering Contradiction:
Improvewall stress reductionVSAvoidanchor insertion ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The guidewire is formed with a curved or angled configuration that matches the anatomical offset between insertion sites. This curvature allows the guidewire to navigate from the percutaneous access point to the target anchor location on the ventricular wall, facilitating easy deployment despite non-collinear insertion points.

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The device allows adjustment of insertion angles and depths to accommodate varying patient anatomies. By changing the parameters of needle orientation, guidewire curvature, and anchor placement depth, the procedure adapts to offset insertion locations while maintaining ease of operation and achieving effective wall stress reduction.

Inventive Principle:
Principle #35Parameter changes

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 device enables a minimally invasive reduction in ventricular volume, reducing wall stress and improving heart function by excluding scar tissue, thereby halting or slowing disease progression in congestive heart failure patients with reduced patient risk.

Implementation Method 1

utilizing a flexible shape-memory material for the outer needle to bend and accommodate offset insertion locations

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Data Source

PatentEP3003452B1Cardiac tissue penetrating devices
Publication Date: 2019.09.11 BIOVENTRIX INC
  • EP3003452B1 patent drawingFigure 1
  • EP3003452B1 patent drawingFigure 2
  • EP3003452B1 patent drawingFigure 3A~3C

AI summary

According to one embodiment, a tissue penetrating device includes an elongate shaft having a proximal end, a distal end, and a lumen extending there between. A first needle is disposed within the lumen of the elongate shaft and is extendable therefrom between a first configuration and a second configuration. In the first configuration, the first needle is disposed within the elongate shaft's lumen and is substantially aligned with an axis of the lumen. In the second configuration, the first needle extends distally of the elongate shaft's distal end and bends away from the lumen's axis. A second needle is disposed within a lumen of the first needle and is extendable therefrom when the first needle is positioned in the first configuration and when the first needle is positioned in the second configuration. The second needle may be extended from the first needle to penetrate tissue of a patient.