Subcutaneous Implant Clip Anchoring for Reliable Device Positioning

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Solution Overview

Problem

Traditional implantable medical devices, such as cardiac monitors, pacemakers, and implantable cardioverter-defibrillators, require invasive surgeries for implantation and often involve complex lead placement in the heart.

Innovation Solution

A subcutaneously implantable device with a clip that anchors to muscle, bone, or tissue, and a prong that extends to contact organs, nerves, or tissues, allowing for electrical connection to an external device without the need for invasive heart lead placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional invasive surgery is used for implantation, then reliable device positioning and electrical connection can be achieved, but the risk of complications and patient discomfort increases

Engineering Contradiction:
Improvedevice positioning reliabilityVSAvoidsurgical complication risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device is divided into separate functional components: a body portion for anchoring to tissue, a lead portion for electrical contact, and a wire for external connection. This segmentation allows each component to be optimized independently while reducing overall implantation complexity and risk

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The clip acts as an intermediary element between the device body and the tissue, providing secure anchoring without requiring invasive heart lead placement. The clip mediates the connection between the subcutaneous device and the underlying muscle or bone, reducing surgical complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If complex lead placement in the heart is performed, then accurate monitoring and therapeutic intervention can be achieved, but the difficulty of the procedure increases

Engineering Contradiction:
Improvemonitoring accuracyVSAvoidlead placement complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The complex heart lead placement procedure is extracted and replaced with a simpler subcutaneous implantation approach. The lead portion extends from the subcutaneous device to contact the heart or organ surface, eliminating the need for complex internal lead placement while maintaining monitoring accuracy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The device transitions from an intracardiac placement approach to a subcutaneous external approach. Instead of placing leads inside the heart, the device is implanted under the skin with leads extending to contact the heart or organ surface from the outside, simplifying the procedure while maintaining functionality

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Ease of operation

If subcutaneous implantation is used, then the procedure becomes less invasive and safer, but the challenge of maintaining consistent device positioning arises

Engineering Contradiction:
Improveimplantation easeVSAvoiddevice positioning stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The clip is designed to perform preliminary anchoring action during implantation, securing the device to the tissue before final positioning is achieved. This preliminary fixation ensures stable device placement while maintaining the less invasive subcutaneous approach

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The mechanical anchoring system using the clip replaces complex surgical fixation mechanisms. The clip provides sufficient positioning stability through its design, eliminating the need for complex mechanical fixation systems while maintaining ease of implantation

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

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 solution enables less invasive implantation procedures, reduces the risk of complications, and maintains consistent device positioning, ensuring accurate monitoring and therapeutic interventions.

Implementation Method 1

A wire conductively connected to the first electrode is configured to be connected to an external device that is positioned outside of a patient's body to electrically connect the subcutaneously implantable device to the external device

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP4058131B1Subcutaneous device for monitoring and/or providing therapies
Publication Date: 2025.05.14 MANICKA INSTITUTE LLC
  • EP4058131B1 patent drawingFigure 1~2
  • EP4058131B1 patent drawingFigure 3A~3C
  • EP4058131B1 patent drawingFigure 3D~3E

AI summary

A subcutaneously implantable device includes a clip that is configured to anchor the subcutaneously implantable device to a muscle, a bone, and/or a first tissue, and a first prong with a proximal end attached to the clip and a distal end extending away from the clip that is configured to contact an organ, a nerve, and/or a second tissue. A first electrode on the first prong is configured to contact the organ, the nerve, and/or the second tissue. A wire conductively connected to the first electrode is configured to be connected to an external device that is positioned outside of a patient's body to electrically connect the subcutaneously implantable device to the external device.