Implantable Valve with External Securing Member

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Solution Overview

Problem

Current medical devices for fecal incontinence, such as artificial sphincters and valves, rely on external means for pressure regulation, leading to complications like dislocation and poor functioning due to frictional forces within the body, necessitating a solution that eliminates external regulation and ensures proper positioning.

Innovation Solution

A medical device comprising a valve member with flaps that move in response to pressure and a securing member positioned outside the bodily passageway to retain the valve member in place, utilizing elastomeric materials and designs like raised portions or grooves for secure engagement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If external means are used to regulate pressure for artificial sphincters or valves, then the flow control function is achieved, but the device complexity and risk of complications increase

Engineering Contradiction:

Improveflow control reliabilityVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The valve member is designed to automatically respond to pressure changes within the bodily passageway, causing the flaps to open or close without requiring external mechanical, electrical, or electronic control means. The device serves itself by utilizing the natural pressure differential to regulate flow.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The invention removes and eliminates the external means (mechanical, electrical, or electronic regulators) from the system, retaining only the valve member that responds autonomously to internal pressure changes, thereby simplifying the overall device structure.

Inventive Principle:

Principle #2Taking out (Extraction)

2Reliability

If external means are implanted in a patient's body for pressure regulation, then flow control is achieved, but surgical and post-surgical complications increase

Engineering Contradiction:

Improveflow control reliabilityVSAvoidsurgical complications

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The valve member operates autonomously in response to pressure changes within the bodily passageway, eliminating the need for separate external regulation devices that would require additional surgical implantation and increase complication risks.

Inventive Principle:

Principle #25Self-service

3Stability of the object's composition

If frictional force is used to support artificial sphincters or valves, then the device can be retained in place, but the possibility of dislocation increases with higher pressure

Engineering Contradiction:

Improvedevice retention stabilityVSAvoiddevice positioning reliability

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

A securing member is preliminarily positioned outside the bodily passageway to engage with the valve member before pressure changes occur, providing pre-established mechanical retention that prevents dislocation regardless of pressure variations.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The securing member acts as an intermediary element between the valve member and the bodily passageway, providing additional retention force that complements the frictional support and prevents dislocation under pressure.

Inventive Principle:

Principle #24Intermediary (Mediator)

4Ease of manufacture

If surgical placement is used for current sphincters or valves, then the device can be installed in the body, but the positioning accuracy and security are insufficient

Engineering Contradiction:

Improvesurgical implantabilityVSAvoidpositioning precision

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The securing member is positioned outside the bodily passageway in advance to engage with the valve member, ensuring accurate and secure positioning is achieved during implantation without requiring complex surgical techniques.

Inventive Principle:

Principle #10Preliminary action

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 effectively regulates bodily fluid flow without external means, reducing complications and ensuring correct positioning of the valve member, thereby improving the efficacy and reliability of the device.

Implementation Method 1

The valve member includes a plurality of flaps configured to move from a first position to a second position at a predetermined pressure or in response to being exposed to a predetermined pressure

Methodology Applied

Scientific EffectPressure response: Pressure Increase

Implementation Method 2

the artificial sphincters or valves are supported through frictional force of the bodily tissues within a patient's body

Methodology Applied

Scientific EffectFrictional force: Friction

Data Source

PatentUS9364306B2Implantable medical device and method of placement of the implantable medical device

Publication Date: 2016.06.14 BOSTON SCIENTIFIC SCIMED INC

AI summary

A medical device having a valve member and a securing member is provided. The valve member is configured to be positioned inside a bodily passageway. The valve member includes a plurality of flaps configured to move from a first position to a second position at a predetermined pressure or in response to being exposed to a predetermined pressure. The securing member is configured to be positioned outside the bodily passageway. The securing member is configured to help retain the valve member in place within the bodily passageway.