Lockable Fixation Element for Leadless Pacemaker Tissue Anchor

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Solution Overview

Problem

Existing leadless cardiac pacemakers face challenges with securely mounting tissue anchors to prevent dislodgement and loss of electrical contact with the target tissue.

Innovation Solution

A biostimulator with a lockable fixation element that includes a helix mount and a fixation element with a fastener that engages a keeper, securing the fixation element to the helix mount and preventing relative movement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If adhesives are used to secure the tissue anchor to the pacemaker body, then the tissue anchor can be mounted, but the adhesive degrades over time causing dislodgement

Engineering Contradiction:

Improvesecuring the tissue anchorVSAvoidlong-term durability of adhesive

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent replaces the chemical bonding mechanism (adhesive) with a mechanical locking system consisting of a helical channel, keeper, and fastener. This mechanical system provides reliable long-term securing without the degradation issues of adhesives, as the interlocking geometry maintains its structural integrity over time.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The securing mechanism is divided into separate functional components: the helical channel for receiving the fixation element, the keeper for receiving the fastener, and the fastener itself. This segmentation allows each component to be optimized for its specific function and enables assembly/disassembly if needed.

Inventive Principle:

Principle #1Segmentation

2Reliability

If the tissue anchor is not securely mounted, then the structure is simpler, but the tissue anchor can inadvertently rotate or disengage during tissue engagement or long-term use

Engineering Contradiction:

Improvepreventing dislodgement of fixation elementVSAvoidstructure of mounting mechanism

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The fixation element with its fastener is nested within the helical channel, and the fastener is received by the keeper. This nested arrangement provides secure mechanical locking while maintaining a compact overall structure, minimizing the space required for the mounting mechanism.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The keeper acts as an intermediary component between the helical channel and the fastener, providing a receiving structure that locks the fastener in place. This intermediary element simplifies the overall design by creating a clear mechanical interface for securing the fixation element.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20250170407A1Biostimulator having lockable fixation element

Publication Date: 2025.05.29 PACESETTER INC

AI summary

A biostimulator, such as a leadless cardiac pacemaker, including a fixation element that can be locked to a helix mount, is described. The fixation element includes a fastener that engages a keeper of the helix mount. When engaged with the keeper, the fastener locks the fixation element to the helix mount. Accordingly, the fixation element does not move relative to the helix mount when the biostimulator is delivered into a target tissue. Other embodiments are also described and claimed.