Therapeutic Agent Reservoir with Rate-Controlled Membrane

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Solution Overview

Problem

Implantable medical devices (IMDs) pose a risk of post-implantation infection due to their presence in the body, despite being constructed from biocompatible materials.

Innovation Solution

A therapeutic agent reservoir system is developed, comprising a polymer-based reservoir with a mixed therapeutic agent and an outer coating that includes a rate-controlling membrane, which is adhered to or implanted adjacent to the IMD to provide a controlled release of antimicrobial agents, reducing the risk of infection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an implantable medical device is constructed from biocompatible material, then the device can be safely implanted in the body, but there is still a risk of post-implantation infection

Engineering Contradiction:

ImprovebiocompatibilityVSAvoidinfection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by incorporating an antimicrobial reservoir and delivery system into the implantable medical device housing before implantation. The reservoir pre-loads antimicrobial agents that are delivered in controlled amounts to prevent infection at the implant site, addressing the infection risk before it can manifest.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent uses an antimicrobial agent as an intermediary substance between the implantable device and the patient's body. This intermediary prevents direct harmful interaction by creating a protective barrier that eliminates bacteria, thereby reducing infection risk while maintaining biocompatibility.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If a therapeutic agent reservoir is added to the implantable medical device, then infection risk is reduced, but the device complexity increases

Engineering Contradiction:

Improveinfection riskVSAvoiddevice structure

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges the antimicrobial reservoir, outer coating with rate-controlling membrane, and implantable medical device housing into a single integrated structure. The reservoir is formed within the housing itself, combining multiple functions (structural housing, drug storage, and controlled release) into one unified device, thereby reducing overall system complexity.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The implantable medical device housing serves multiple functions: it provides structural containment, houses the antimicrobial reservoir, and acts as the delivery interface through its outer coating. This multi-functionality reduces the need for separate components, simplifying the overall device architecture while maintaining infection prevention capabilities.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Duration of action of moving object

If a rate-controlling membrane is used to provide controlled release, then the therapeutic agent release rate is regulated, but the manufacturing complexity increases

Engineering Contradiction:

Improvetherapeutic agent release durationVSAvoidmanufacturing process

Core Design Contradiction:

Duration of action of moving objectVSEase of manufacture

Solution Approach 1:

The patent controls the therapeutic agent release rate by changing parameters of the outer coating membrane, specifically its porosity and thickness. By adjusting these physical parameters during manufacturing, the device achieves controlled release characteristics without requiring complex active control mechanisms, simplifying the overall manufacturing process.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent uses a thin film outer coating with rate-controlling properties as the release mechanism. This thin film approach is simpler to manufacture than bulky mechanical control systems, as it relies on the inherent properties of the membrane material and structure to regulate drug release over time.

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 system effectively reduces or eliminates the risk of post-implantation infections by providing a controlled release of antimicrobial agents, ensuring the therapeutic agent's stability and prolonged release, thereby minimizing bacterial growth and resistance.

Implementation Method 1

at least a portion of the outer coating comprises a rate-controlling membrane configured to provide a predetermined release rate of the therapeutic agent through the rate-controlling membrane

Methodology Applied

Scientific EffectDiffusion: Diffusion

Data Source

PatentUS8911427B2Therapeutic agent reservoir delivery system

Publication Date: 2014.12.16 MEDTRONIC INC

AI summary

A therapeutic agent reservoir comprises a reservoir body comprising a polymer and a therapeutic agent mixed within the polymer, and an outer coating enclosing the reservoir body, wherein at least a portion of the outer coating comprises a rate-controlling membrane configured to provide a predetermined release rate of the therapeutic agent through the rate-controlling membrane.