Dissolvable Catheter Insert for Atraumatic IMD Delivery

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Solution Overview

Problem

The navigation of delivery catheters for implantable medical devices can lead to unintended perforation of tissue and difficulty in navigating through blood vessels due to contact with vessel walls, particularly when maneuvering around turns in the vasculature.

Innovation Solution

A dissolvable insert is used to enclose the delivery cup of the catheter, forming an atraumatic tip that reduces tissue perforation and facilitates navigation, dissolving over time to allow for the deployment of the implantable medical device at the target site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a non-dissolvable insert is used to enclose the delivery cup, then tissue perforation is reduced and navigation is improved, but device complexity increases and structure is complicated

Engineering Contradiction:

Improvetissue perforation riskVSAvoidcatheter structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent applies the disposable principle by using a dissolvable insert made from biocompatible, biodegradable materials that temporarily perform the protective function during delivery and then dissolve in the body. This eliminates the need for removal procedures and reduces long-term device complexity while maintaining the beneficial protective effects during the critical delivery phase.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent applies parameter changes by transitioning the insert material from a permanent, non-dissolvable state to a temporary, dissolvable state. The material properties are specifically selected to maintain structural integrity during delivery (resisting compression and maintaining shape) while being capable of dissolution in the physiological environment after deployment, thus changing the physical-chemical parameters of the material over time.

Inventive Principle:

Principle #35Parameter changes

2Device complexity

If a dissolvable insert is used to enclose the delivery cup, then device complexity is reduced and structure is simplified, but the insert must be reliably retained during navigation

Engineering Contradiction:

Improvecatheter structureVSAvoidinsert retention

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The patent applies curvature principles by designing the dissolvable insert with a rounded, atraumatic distal tip geometry. This curved configuration reduces stress concentration points and distributes mechanical loads more evenly during navigation, preventing the insert from catching on vessel walls or getting dislodged, thereby maintaining reliable retention while improving safety.

Inventive Principle:

Principle #14Spheroidality (Curvature)

3Device complexity

If the delivery catheter distal end is used directly without an insert, then device complexity is minimized, but tissue perforation risk increases and navigation capability deteriorates

Engineering Contradiction:

Improvecatheter structureVSAvoidnavigation capability

Core Design Contradiction:

Device complexityVSEase of operation

Solution Approach 1:

The patent applies the flexible shell principle by using a thin-walled, dissolvable insert that provides the necessary protective and navigational functions during delivery. The thin-film structure is flexible enough to navigate through tortuous vasculature while maintaining enough structural integrity to protect the delivery cup and reduce tissue perforation risk, achieving the desired balance without adding significant complexity.

Inventive Principle:

Principle #30Flexible shells and thin films

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 dissolvable insert simplifies the implantation process by reducing the risk of tissue perforation and improving navigation, eliminating the need for a non-dissolvable insert, and simplifying the catheter structure.

Implementation Method 1

the dissolvable insert is configured to at least partially dissolve within a body fluid of a patient to enable deployment of the IMD from within the receptacle of the delivery catheter

Methodology Applied

Scientific EffectDissolution:

Data Source

PatentUS20250380936A1Dissolvable insert for delivery catheter for implantable medical devices

Publication Date: 2025.12.18 MEDTRONIC INC

AI summary

A medical device system comprising: an implantable medical device (IMD); a delivery catheter extending from a proximal end to a distal end, wherein the distal end of the delivery catheter defines a receptacle sized to retain the IMD, the receptacle defining a distal opening; and a dissolvable insert configured to enclose the distal opening of the receptacle, wherein the dissolvable insert is configured to at least partially dissolve within a body fluid of a patient to enable deployment of the IMD from within the receptacle of the delivery catheter.