Shape Memory Controller for Incontinence Treatment

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Solution Overview

Problem

Conventional methods for treating incontinence, such as artificial sphincters, often cause pain, tissue damage, and are cosmetically undesirable, as they rely on external fluid pressure or manual mechanisms, which can lead to ineffective and unsafe outcomes.

Innovation Solution

A shape memory apparatus comprising an elongate member and a shape memory element that changes configuration with temperature, allowing for selective opening and closing of body lumens, such as the anus and urethra, to control fluid flow, using a biocompatible material like Nitinol and a temperature control device to manage the shape memory element's transitions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional artificial sphincters use external fluid pressure to occlude body openings, then the sphincter function can be restored, but pain, skin alteration, and thrombosis occur

Engineering Contradiction:
Improvesphincter functionVSAvoidpain and tissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical fluid pressure system with a shape memory alloy element that responds to temperature changes. The SMA element directly contracts and expands in response to temperature, eliminating the need for external fluid pressure and associated mechanical components that cause tissue damage.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the control parameter from fluid pressure to temperature. The shape memory alloy element transitions between austenite and martensite phases based on temperature changes, enabling sphincter occlusion and release through thermal control rather than mechanical pressure.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If manual contraction mechanisms like pumps or pistons are used, then sphincter control is achieved, but the device becomes physiologically and cosmetically undesirable

Engineering Contradiction:
Improvesphincter controlVSAvoidmechanical components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts and eliminates complex mechanical components such as pumps, pistons, and fluid reservoirs. Only the essential shape memory alloy element and temperature control mechanism remain, significantly simplifying the device while maintaining sphincter control functionality.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The shape memory alloy element performs the contraction and expansion functions autonomously in response to temperature changes, eliminating the need for external manual operation or complex control mechanisms. The material self-regulates the sphincter opening and closing based on thermal input.

Inventive Principle:
Principle #25Self-service

3Ease of operation

If shape memory alloys are opened by applying external power, then the sphincter can be released, but tissue rupture or fluid loss may occur

Engineering Contradiction:
Improvesphincter releaseVSAvoidtissue integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent incorporates pressure sensors that provide feedback on the internal pressure within the implant. This feedback mechanism allows the system to monitor and control the opening process, preventing excessive force that could cause tissue rupture or fluid loss while still achieving effective sphincter release.

Inventive Principle:
Principle #23Feedback

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 apparatus provides a safe, easy-to-use, and effective solution for controlling fluid flow, reducing the risk of tissue damage and discomfort by using temperature-controlled shape memory alloys to manage sphincter function, thereby addressing the limitations of existing incontinence treatments.

Implementation Method 1

The shape memory element is adapted to change its configuration based on a change in temperature. This change in configuration of the shape memory element causes the apparatus to move between a first configuration and a second configuration.

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS9095406B2Shape memory controller
Publication Date: 2015.08.04 BOSTON SCIENTIFIC SCIMED INC
  • US9095406B2 patent drawing
  • US9095406B2 patent drawing
  • US9095406B2 patent drawing

AI summary

An apparatus for selectively opening and closing a body lumen within a patient's body is provided. The apparatus includes an elongate member and a shape memory element. The elongate member is configured to at least partially surround the body lumen and defines a lumen. The shape memory element is disposed of adjacent to the lumen defined by the elongate member. Further, the shape memory element is adapted to change its configuration based on a change in temperature. These changes in the configuration of the shape memory element causes the apparatus to selectively move between a first configuration and a second configuration.