Adjustable Balloon Implant for Glottic Insufficiency

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Solution Overview

Problem

Conventional surgical techniques for treating dysphagia and glottic insufficiency, such as Type I Medialization Thyroplasty and Arytenoid Adduction procedures, face limitations including inability to precisely adjust implants intraoperatively and postoperatively, leading to prolonged operation times and increased risk of postoperative airway compromise due to edematous swelling.

Innovation Solution

An implant system comprising a balloon with a port connector and a band that can be inflated to pull on the thyroarytenoid muscle complex, rotating the arytenoid cartilage and tightening the vocal cord, allowing for adjustable and customizable treatment of glottic insufficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If Type I Medialization Thyroplasty procedure is performed, then glottic insufficiency is treated, but the ability to precisely adjust implants intraoperatively and postoperatively is lost

Engineering Contradiction:

Improveimplant adjustment precisionVSAvoidimplant adjustability

Core Design Contradiction:

Manufacturing precisionVSEase of operation

Solution Approach 1:

The implant system transitions from a static fixed implant to a dynamic adjustable implant. The balloon can be inflated to different volumes intraoperatively and postoperatively, allowing the arytenoid cartilage to be positioned at different locations. This dynamic adjustment capability resolves the contradiction by enabling both precise positioning and postoperative adaptability.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The implant utilizes volume parameter changes of the balloon to achieve positional adjustment. By controlling the inflation volume of the balloon, the arytenoid cartilage can be medialized to different extents, providing precise adjustment capability while maintaining ease of operation through non-invasive volume modification.

Inventive Principle:

Principle #35Parameter changes

2Manufacturing precision

If carving an implant during surgery is performed to adjust the implant, then implant fit is improved, but operation time is prolonged

Engineering Contradiction:

Improveimplant fit precisionVSAvoidoperation time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The implant is pre-formed with a standardized structure before surgery, eliminating the need for intraoperative carving and shaping. The balloon is inserted in its pre-formed state and adjusted by volume control, which significantly reduces operation time while maintaining sufficient precision through non-invasive adjustment.

Inventive Principle:

Principle #10Preliminary action

3Reliability

If Arytenoid Adduction procedure is performed to close posterior glottis, then glottic closure is improved, but postoperative airway complaints increase due to tissue edema

Engineering Contradiction:

Improveglottic closure effectivenessVSAvoidpostoperative airway compromise

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The balloon provides dynamic adjustment capability, allowing the surgeon to optimize glottic closure while monitoring airway patency. If airway compromise occurs due to edema, the balloon volume can be reduced or deflated, providing a safety mechanism that resolves the contradiction between effective closure and airway safety.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The system enables intraoperative feedback adjustment by allowing real-time modification of balloon volume based on observed glottic closure and airway status. This feedback loop allows optimization of closure effectiveness while preventing excessive edema-related complications.

Inventive Principle:

Principle #23Feedback

4Reliability

If implants or suture fixation technique is used, then glottic insufficiency is treated, but intraoperative and postoperative adjustment capability is lost

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidpostoperative adjustment capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The traditional mechanical suture fixation system is replaced with a pneumatic/hydraulic adjustment system using the balloon. This substitution maintains reliable treatment effectiveness through secure arytenoid positioning while adding the versatility of non-invasive volume-based adjustment both intraoperatively and postoperatively.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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

This solution reduces the risk of aspiration pneumonia, shortens surgical time, and enables postoperative adjustment of implants, improving glottic closure and patient acceptance of the procedure.

Implementation Method 1

The balloon has a port connector, and the band has a proximate end attached to a portion of the balloon that translates away from the port connector when the balloon is inflated through the port connector

Methodology Applied

Scientific EffectElasticity: Elasticity

Data Source

PatentUS10548720B2Methods and apparatus for treating glottic insufficiency

Publication Date: 2020.02.04 APREVENT MEDICAL INC(GB)

AI summary

An implant system for treating glottic insufficiency includes an implant, which includes a balloon with a port connector or a catheter and a band comprising a proximate end attached to a portion of the balloon that translates away from the port connector or the catheter when the balloon is inflated through the port connector or the catheter.