Gastrointestinal Bypass Sleeve with Flexible Shape Memory Alloy Support Frame

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Solution Overview

Problem

Existing gastrointestinal bypass devices for treating type-2 diabetes and obesity are invasive and cause complications such as nausea, abdominal pain, inflammation, lumen obstruction, and device migration due to inadequate anchoring in the dynamic gastrointestinal environment.

Innovation Solution

A bypass device with a support frame and sleeve configuration that includes a tubular structure with diamond-shaped and wavy-shaped annular frame members, featuring coil springs and connecting wires, designed to anchor the sleeve in the duodenum and jejunum, providing flexibility and resistance to peristalsis while minimizing tissue damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a rigid anchor structure is used to secure the sleeve in place, then the device stability is improved, but the device causes tissue damage, inflammation, and pain due to the dynamic gastrointestinal environment

Engineering Contradiction:
Improvedevice stabilityVSAvoidtissue damage and inflammation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The support frame is constructed from flexible shape memory alloy wires that can dynamically adapt to gastrointestinal peristalsis and movement. The frame members include wavy-shaped annular structures and coil springs that provide flexibility while maintaining anchoring function, allowing the device to move with the organ rather than resist it, thereby reducing tissue damage and inflammation.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The anchor structure transitions from a static rigid design to a dynamic flexible system. The shape memory alloy materials enable the frame to change its mechanical properties in response to environmental conditions, adapting to the dynamic gastrointestinal environment while maintaining stable positioning without causing harmful effects to surrounding tissues.

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If a highly compliant anchor structure is used to accommodate gastrointestinal movement, then the device flexibility is improved, but the device migration and lumen obstruction occur due to inadequate anchoring

Engineering Contradiction:
Improvedevice flexibilityVSAvoiddevice positioning reliability
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The support frame utilizes flexible shape memory alloy wires configured in wavy-shaped annular frame members and diamond-shaped patterns. This flexible structure accommodates gastrointestinal peristalsis and organ movement while maintaining reliable positioning through its ability to deform and return to its original configuration, preventing both migration and obstruction.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The device employs composite construction combining shape memory alloy materials with different mechanical properties. The frame members integrate rigid and flexible characteristics, providing sufficient anchoring strength to prevent migration while maintaining compliance to accommodate physiological movements, thus achieving both flexibility and positioning reliability.

Inventive Principle:
Principle #40Composite materials

3Stability of the object's composition

If a complex anchor structure with multiple components is used to ensure secure positioning, then the device stability is improved, but the device complexity and difficulty of navigation increase

Engineering Contradiction:
Improvedevice stabilityVSAvoidstructure complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The support frame is divided into multiple discrete frame members including wavy-shaped annular members, diamond-shaped patterns, and coil springs. These segmented components are connected through flexible joints, allowing independent movement and deformation of each segment while maintaining overall structural stability and simplifying navigation through the tortuous gastrointestinal tract.

Inventive Principle:
Principle #1Segmentation

4Stability of the object's composition

If a rigid structure is used to resist peristalsis and maintain position, then the device stability is improved, but the device causes abdominal pain and nausea due to aggressive interaction with the dynamic environment

Engineering Contradiction:
Improvedevice stabilityVSAvoidabdominal pain and nausea
Core Design Contradiction:
Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The support frame is constructed from flexible shape memory alloy wires that can dynamically adapt to gastrointestinal peristalsis and movement. The frame members include wavy-shaped annular structures and coil springs that provide flexibility while maintaining anchoring function, allowing the device to move with the organ rather than resist it, thereby reducing tissue damage and inflammation.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The anchor structure transitions from a static rigid design to a dynamic flexible system. The shape memory alloy materials enable the frame to change its mechanical properties in response to environmental conditions, adapting to the dynamic gastrointestinal environment while maintaining stable positioning without causing harmful effects to surrounding tissues.

Inventive Principle:
Principle #15Dynamics

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 effectively inhibits nutrient absorption, reduces the need for insulin therapy, and offers a non-invasive solution for type-2 diabetes and weight loss by anchoring securely in the gastrointestinal tract without causing significant adverse reactions.

Implementation Method 1

The support frame comprises a plurality of frame members configured and connected to one another so that the frame members in at least a portion of the support frame define a plurality of diamond-shaped openings arranged axially and circumferentially, a plurality of the frame members each include coil springs

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS9592144B2Bypass device, support frame for bypass device, and method
Publication Date: 2017.03.14 TERUMO KK
  • US9592144B2 patent drawing
  • US9592144B2 patent drawing
  • US9592144B2 patent drawing

AI summary

A liner support frame is configured to be positioned in a gastrointestinal tract of a human and to support a liner which inhibits nutrient absorption and anchor the liner in place in the gastrointestinal tract, the liner support frame includes a plurality of frame members connected to one another so that the liner support frame possesses a plurality of openings. The liner support frame includes a plurality of frame portions arranged axially and possessing different tapers.