Controlled Delivery Catheter for Biodegradable Fallopian Tube Occlusion

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Solution Overview

Problem

Existing medical devices for occluding fallopian tubes lack consistency and control in their use, leading to potential usability issues and suboptimal medical outcomes, and there is a need for devices that can deliver occlusive materials effectively without requiring frequent repositioning or removal.

Innovation Solution

A controlled delivery device with a catheter system, including a handle, plunger, and material cartridge, allows for the localized delivery of occlusive materials to fallopian tubes, using biodegradable cyanoacrylate compositions that swell minimally and are resorbed by tissue ingrowth, maintaining occlusion and enabling non-surgical, office-based permanent contraception.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a controlled delivery device is designed to deliver occlusive material to fallopian tubes without removal or repositioning, then the reliability of occlusion is improved, but the device complexity increases

Engineering Contradiction:
Improveocclusion reliabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The delivery device is divided into distinct functional segments: an insertion tube for navigation, a catheter with end structure for precise positioning, a plunger mechanism for material delivery, and a lock mechanism for securing the device. This segmentation allows each component to perform its specific function reliably while maintaining overall device manageability

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter is nested within the insertion tube, and the material cartridge is nested within the handle assembly. The end structure is positioned at the distal end of the catheter. This nested configuration allows the device to be delivered through a single insertion point while maintaining controlled delivery capability, improving reliability without proportionally increasing external complexity

Inventive Principle:
Principle #7Nested doll (Nesting)

2Manufacturing precision

If the delivery device includes a lock mechanism to control plunger movement, then the consistency of material delivery is improved, but the ease of operation decreases

Engineering Contradiction:
Improvedelivery precisionVSAvoidease of operation
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The lock mechanism is pre-configured to engage at specific positions along the insertion tube, automatically controlling the timing and sequence of plunger movement. This preliminary setup ensures consistent material delivery without requiring complex manual coordination, as the lock mechanism guides the operator through the delivery sequence

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The lock mechanism acts as an intermediary between the operator's manual input and the plunger's material delivery action. It translates simple locking/unlocking movements into controlled, precise material discharge, maintaining delivery precision while simplifying the operator's task

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If biodegradable cyanoacrylate composition is used for occlusion, then the safety of the procedure is improved, but the duration of action decreases

Engineering Contradiction:
Improveprocedure safetyVSAvoidocclusion duration
Core Design Contradiction:
Object-affected harmful factorsVSDuration of action of stationary object

Solution Approach 1:

The patent utilizes the chemical properties of cyanoacrylate materials that allow them to undergo polymerization upon contact with moisture, forming strong adhesive bonds. The material composition and curing characteristics are specifically selected to achieve adequate occlusion strength during the healing period while ensuring complete biodegradation within 3-6 months, thus balancing safety with sufficient duration of action

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The occlusive material transitions from a liquid or gel state during delivery to a solid polymerized state after contact with tissue moisture, providing immediate occlusion. Over time, the material biodegrades and is replaced by tissue ingrowth, transitioning the occlusion mechanism from material-based to tissue-based, ensuring both safety and adequate duration

Inventive Principle:
Principle #36Phase transitions

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 device provides controlled and consistent occlusion of fallopian tubes, facilitating effective contraception and treatment of tubal disorders with minimal invasiveness and reduced need for device repositioning, enhancing user experience and medical efficacy.

Implementation Method 1

The implanted occlusive material may be permanent or may be degraded or resorbed by the body and replaced by ingrowth of tissue

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 2

The implanted occlusive material may be permanent or may be degraded or resorbed by the body and replaced by ingrowth of tissue

Methodology Applied
Scientific EffectTissue ingrowth:

Data Source

PatentEP4385529B1Devices for controlled delivery
Publication Date: 2025.07.16 FEMASYS INC
  • EP4385529B1 patent drawingFigure 1
  • EP4385529B1 patent drawingFigure 2A
  • EP4385529B1 patent drawingFigure 2B

AI summary

Disclosed herein are exemplary medical devices for controlled delivery of material compositions, particularly occlusive, therapeutic, or diagnostic compositions.