Flexible-Tip Tissue Anchors for Cardiac Geometry Alteration

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Solution Overview

Problem

Current tissue anchors face challenges in effectively anchoring to cardiac tissue while minimizing damage and allowing for precise manipulation of cardiac tissue geometry, particularly around valves like the tricuspid and mitral valves, without causing unnecessary penetration or trauma.

Innovation Solution

An expandable tissue anchor is designed to be delivered in an unexpanded configuration, featuring a tissue-coupling portion with a higher stiffness and a tip portion with lower stiffness, allowing it to expand orthogonally against the cardiac tissue wall, with an elongate tension member for applying tensile force, and a method for deploying the anchor through the cardiac tissue wall to alter tissue geometry without penetrating the pericardial tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the tissue anchor uses a uniform stiff structure for anchoring, then anchoring strength is improved, but penetration damage to pericardial tissue increases

Engineering Contradiction:
Improveanchoring strengthVSAvoidpenetration damage to pericardial tissue
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The tissue anchor employs a non-uniform stiffness distribution along its length, with the distal tip portion having lower stiffness than the proximal shaft portion. This allows the distal tip to be more compliant and less damaging to pericardial tissue during penetration, while the proximal shaft maintains sufficient stiffness for secure anchoring to the myocardial tissue wall.

Inventive Principle:
Principle #3Local quality

2Strength

If the tissue anchor is delivered in an expanded configuration, then anchoring capability is improved, but deliverability through the cardiac tissue wall deteriorates

Engineering Contradiction:
Improveanchoring capabilityVSAvoiddeliverability through cardiac tissue wall
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The tissue anchor is designed to be dynamically configurable between a compressed delivery state and an expanded anchoring state. During delivery, the anchor is compressed to a small profile that allows passage through the delivery catheter and cardiac tissue wall. Once deployed, the anchor expands to its larger anchoring configuration, providing sufficient surface area and mechanical engagement for secure attachment to the tissue.

Inventive Principle:
Principle #15Dynamics

3Ease of manufacture

If the tissue anchor uses a single stiffness value throughout, then manufacturing simplicity is improved, but control over tissue manipulation deteriorates

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidcontrol over tissue manipulation
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The tissue anchor employs a non-uniform stiffness distribution along its length, with the distal tip portion having lower stiffness than the proximal shaft portion. This allows the distal tip to be more compliant and less damaging to pericardial tissue during penetration, while the proximal shaft maintains sufficient stiffness for secure anchoring to the myocardial tissue wall.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3432806B1Tissue anchors with flexible tips for insertion into the pericardial cavity
Publication Date: 2019.10.02 4TECH INC
  • EP3432806B1 patent drawingFigure 1
  • EP3432806B1 patent drawingFigure 2A
  • EP3432806B1 patent drawingFigure 2B

AI summary

An expandable tissue anchor (20, 120, 190, 220, 320, 420) includes an elongate tissue-coupling portion (30, 130, 192, 230, 330, 430) supported by an anchor shaft (32) at a first end (34) of the tissue-coupling portion (30, 130, 192, 230, 330, 430). The tissue-coupling portion (30, 130, 192, 230, 330, 430) is configured to be delivered in an unexpanded generally elongate configuration through a cardiac tissue wall from a first side to a second side, and to expand, on the second side of the cardiac tissue wall, to an open shape configuration, such that the tissue-coupling portion (30, 130, 192, 230, 330, 430) can be drawn tightly against the second side of the cardiac tissue wall when a tensile force is applied to the tissue-coupling portion (30, 130, 192, 230, 330, 430). The anchor (20, 120, 190, 220, 320, 420) also includes an elongate tip portion (38, 138, 238, 338, 438) supported at a second end (40, 240, 340, 440) of the tissue-coupling portion (30, 130, 192, 230, 330, 430) and configured to be delivered through the cardiac tissue wall ahead of the tissue-coupling portion (30, 130, 192, 230, 330, 430), the tip portion (38, 138, 238, 338, 438) including material having a stiffness less than a stiffness of the tissue-coupling portion (30, 130, 192, 230, 330, 430).