Subcutaneous Implant Introducer With Segmented Pocket Creator

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Solution Overview

Problem

Current medical devices face challenges in forming accurate subcutaneous pockets for implantable devices due to high insertion forces, leading to improper pocket formation, device ejection, and poor performance.

Innovation Solution

An introducer system comprising a housing with a tunneler and inserter, where the inserter has a first and second portion that cooperatively form a subcutaneous pocket, allowing for precise placement and secure positioning of the medical device within the pocket.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If high insertion forces are used to manipulate the medical device and form a pocket under the patient's skin, then the device can be implanted subcutaneously, but improper pocket formation occurs leading to device ejection and poor performance

Engineering Contradiction:
Improvedevice implantation reliabilityVSAvoidpocket formation precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The inserter is divided into a first portion and a second portion that can move relative to each other. The first portion forms the pocket while the second portion remains stationary or moves differently, allowing precise control of tissue displacement and pocket formation without excessive forces that would cause improper formation

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The inserter employs dynamic movement where the first portion can move relative to the second portion during insertion. This dynamic configuration allows the device to adapt to tissue resistance and form the pocket with controlled forces, preventing both tissue damage and inadequate pocket formation

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If the pocket is formed too large or with improper dimensions, then device placement may be easier, but the device can be ejected from the pocket during patient movement

Engineering Contradiction:
Improvedevice placement easeVSAvoiddevice retention reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The two-portion inserter design allows the first portion to create a pocket of precise dimensions while the second portion provides a reference framework. This segmentation enables formation of a pocket that is neither too large nor too small, ensuring device retention during patient movement

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent replaces brute-force mechanical insertion with a controlled mechanical system where the relative movement between portions creates the pocket through precise tissue displacement rather than forceful compression, achieving proper dimensional control

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

3Device complexity

If a simple single-portion inserter is used, then the device structure is simpler, but it cannot provide precise control over pocket formation and device positioning

Engineering Contradiction:
Improveinserter structure complexityVSAvoidpocket formation precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The inserter is segmented into two portions that can move relative to each other, providing the mechanical complexity needed for precise pocket formation. The first portion creates the pocket while the second portion provides structural support and positioning control

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The first and second portions of the inserter are configured to work together in a nested or integrated manner, where one portion moves within or relative to the other, achieving precise control without requiring completely separate devices

Inventive Principle:
Principle #7Nested doll (Nesting)

Data Source

PatentEP4029463B1Subcutaneous implant integrated instrument with pocket creator
Publication Date: 2023.12.13 CARDIAC PACEMAKERS INC
  • EP4029463B1 patent drawingFigure 1
  • EP4029463B1 patent drawingFigure 2A~2B
  • EP4029463B1 patent drawingFigure 2C

AI summary

Aspects of the present disclosure are directed toward apparatuses, methods, and systems comprising an introducer apparatus for facilitating subcutaneous implantation of a medical device. The introducer apparatus may include a housing and an inserter configured to disengage from the second portion.