Self-Sealing Fill Port for Implantable Drug Delivery Refilling

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Solution Overview

Problem

Current implantable drug-delivery devices face challenges in refilling, including risk of damage and discomfort due to high pressures and multiple needle insertions, which can lead to improper drug expulsion and wear on the device.

Innovation Solution

The development of self-sealing, needle-accessible fill ports with elastomeric plugs and check valves, along with a dedicated refill instrument that allows for controlled fluid management through a single needle insertion, minimizing pressure and ensuring reliable refilling of the drug reservoir.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If manual refilling using a handheld syringe is used, then the drug reservoir can be refilled, but high pressures are generated that may damage the device and cause improper drug expulsion

Engineering Contradiction:

Improverefilling operationVSAvoiddevice integrity and drug expulsion

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

A dedicated refill instrument with a needle acts as an intermediary between the syringe and the fill port. The needle is inserted through the fill port to access the drug reservoir, allowing fluid transfer without direct connection. This intermediary structure controls pressure transmission and prevents syringe pressure from directly damaging the device components.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The system changes the pressure parameters during the refilling process. The needle and fill port design allow for pressure equalization and controlled pressure differential, preventing excessive pressure buildup that would occur with direct syringe connection. This parameter control ensures reliable drug expulsion while maintaining device integrity.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If multiple needle insertions and withdrawals are performed for refilling, then different fluids can be removed and injected, but stress is caused to the patient and unnecessary wear is created on the fill port

Engineering Contradiction:

Improvefluid exchange capabilityVSAvoidpatient stress and fill port wear

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The fill port is pre-designed with a self-sealing mechanism using an elastomeric plug that automatically seals when the needle is removed. This preliminary preparation allows for rapid fluid exchange without requiring multiple deliberate insertion and withdrawal actions, reducing patient stress and fill port wear while maintaining the ability to exchange different fluids.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The elastomeric plug in the fill port provides self-sealing functionality. When the needle is inserted, the plug moves to allow fluid passage; when the needle is removed, the plug automatically returns to seal the port. This self-service mechanism eliminates the need for manual sealing operations, reducing wear and stress while enabling efficient fluid exchange.

Inventive Principle:

Principle #25Self-service

3Ease of operation

If a fill port is located on the device surface for post-implantation access, then refilling can be performed, but the device installation within the patient's anatomy makes access uncomfortable and risks damage to the device

Engineering Contradiction:

Improvepost-implantation refilling accessVSAvoidpatient discomfort and device damage risk

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The fill port is nested within the device structure, with the elastomeric plug integrated into the port wall. The needle passes through the fill port to reach the drug reservoir, creating a nested configuration. This design allows external access while protecting internal components, reducing patient discomfort and damage risk during refilling operations.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The elastomeric plug acts as a flexible sealing element within the fill port. This flexible material allows needle penetration while maintaining a seal, and it can deform to accommodate the needle insertion and removal process. This flexibility reduces patient discomfort during access while preventing device damage through proper sealing.

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

This solution reduces the risk of damage to the device, enhances patient comfort, and ensures repeatable and reliable refilling of the drug-delivery pump, maximizing its effective lifetime.

Implementation Method 1

a fill port that includes an elastomeric plug. The plug extends at least partially through an aperture in a wall of the fill port

Methodology Applied

Scientific EffectElasticity: Elasticity

Implementation Method 2

The pump also includes a check valve, closeable over the aperture, for preventing backflow from the reservoir through the fill port

Methodology Applied

Scientific EffectCheck valve mechanism: Valve

Data Source

PatentUS9987417B2Implantable drug-delivery devices, and apparatus and methods for filling the devices

Publication Date: 2018.06.05 MINIPUMPS LLC

AI summary

In various embodiments, a tool is employed in filling a drug-delivery device. The tool may include, for example, a needle that is admitted through a fill port of the drug-delivery device.