Adjustable Flow Control Mechanism for Gastric Restriction Pressure Regulation

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Solution Overview

Problem

Current gastric restriction devices require regular clinician visits for adjustments, relying on power-operated pumps and invasive procedures for fluid management, which is inconvenient and inefficient.

Innovation Solution

A hydraulic restriction system with an adjustable flow control mechanism that regulates fluid flow between the restriction device and a fluid source, allowing for non-invasive, power-free adjustments of the restriction level by modifying the geometry of the flow control mechanism, such as through a flexible tube or porous membrane, to control fluid flow rates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If power-operated pumps are used to adjust fluid levels in the gastric band, then non-invasive adjustments are enabled, but patients still require regular clinician visits for operation and maintenance

Engineering Contradiction:

Improvenon-invasive adjustment capabilityVSAvoidfrequency of clinician visits

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The system uses the patient's own physiological pressure changes (from eating, swallowing, etc.) to automatically control fluid flow between the gastric band and reservoir, eliminating the need for external power sources and clinician-operated pumps. The restriction device serves itself by responding to natural physiological variations.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

A one-way flow control mechanism acts as an intermediary between the gastric band and fluid reservoir, allowing fluid to flow in only one direction based on pressure differentials. This passive mechanical intermediary eliminates the need for active power-operated pumps while maintaining adjustment capability.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If Huber needle and syringe are used for fluid injection, then direct fluid management is achieved, but invasive procedures are required for each adjustment

Engineering Contradiction:

Improvesimplicity of fluid management mechanismVSAvoidinvasiveness of adjustment procedure

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The one-way flow control mechanism serves as a permanent intermediary installed during initial implantation, eliminating the need for repeated needle punctures. Fluid management is achieved through passive pressure-driven flow rather than active injection procedures.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The flow control mechanism is pre-installed and configured during the initial surgical procedure, establishing a permanent passive fluid management system that eliminates the need for subsequent invasive injection procedures for routine adjustments.

Inventive Principle:

Principle #10Preliminary action

3Ease of operation

If the stoma opening is made large initially to accommodate gastric pouch expansion, then adequate nutrition intake is enabled, but the restriction effect is reduced

Engineering Contradiction:

Improvenutrition intake adequacyVSAvoidrestriction effect consistency

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The system dynamically adjusts the restriction level by allowing fluid to flow from the reservoir to the gastric band when the pouch expands, automatically maintaining optimal restriction pressure without manual intervention. The restriction adapts to physiological changes in real-time.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system uses pressure feedback from the gastric pouch to control fluid flow - when pouch pressure increases due to expansion or food intake, fluid flows into the band to maintain restriction, creating a self-regulating feedback loop that maintains consistent restriction effect.

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

Enables time-controlled regulation of pressure within the restriction device, providing a more constant pressure over time and reducing the need for frequent clinician visits, as temporary changes in the restriction device or patient physiology do not lead to significant fluid shifts, thus improving patient management and convenience.

Implementation Method 1

an adjustable flow control mechanism in fluid communication with the restriction device and configured to define a rate of fluid flow to and from the restriction device

Methodology Applied

Scientific EffectFluid flow control through geometry modification:

Data Source

PatentUS8034065B2Controlling pressure in adjustable restriction devices

Publication Date: 2011.10.11 ETHICON ENDO SURGERY INC

AI summary

Methods and devices are provided for regulating a hydraulic restriction system. In general, the methods and devices can allow for non-invasive pressure control using a flow control mechanism. The flow control mechanism can be disposed between an implantable restriction device and a fluid source and include an adjustable, variably-sized fluid communication member in fluid communication with the restriction device and the fluid source. The geometry of the fluid communication member can control a rate of fluid flow between the restriction device and the fluid source, thereby also regulating a rate at which a pressure of fluid within the restriction device changes. Alternatively, the fluid flow control mechanism can include a biasing mechanism that can control the rate of fluid flow between the restriction device and the fluid source.