Adjustable Implant Device for In Situ Anatomical Lumen Sizing

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Solution Overview

Problem

Current surgical methods for adjusting the annular dimension of anatomical orifices, such as in cardiac and gastrointestinal surgery, face challenges in achieving precise adjustments post-implantation, leading to residual valvular insufficiency or stenosis, and require invasive procedures with risks like thrombosis and separation of valve leaflets.

Innovation Solution

An implantable device with an adjustable member that can be adjusted using a torqueable or reciprocating adjustment tool, allowing for in situ adjustment of the device's dimensions to achieve optimal valvular sufficiency and function, potentially reducing the need for open surgery and minimizing operative risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If surgical procedures are performed to adjust the annular dimension of anatomical orifices, then the size and shape of the orifice can be controlled, but the procedures require interruption of normal physiologic flow and carry risks such as thrombosis and separation of valve leaflets

Engineering Contradiction:

Improveadjustment precisionVSAvoidoperative safety

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The implantable device incorporates an adjustable member that can be dynamically adjusted after implantation to change the annular dimension. The adjustment mechanism allows the device to transition between different states (adjusted and unadjusted) without requiring surgical intervention, thereby improving operational flexibility while maintaining safety.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent replaces complex surgical mechanical procedures with a simpler adjustment mechanism that can be operated through minimal access. The adjustment member uses a torqueable or reciprocating mechanism that converts rotational or linear motion into dimensional changes, substituting invasive surgical mechanics with a more controlled and safer adjustment system.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Manufacturing precision

If the annular dimension is adjusted during surgery, then optimal valvular function can be achieved, but the adjustment cannot be fully appreciated until physiologic flow is resumed, requiring re-operation if adjustments are incorrect

Engineering Contradiction:

Improveadjustment accuracyVSAvoidoperative time

Core Design Contradiction:

Manufacturing precisionVSLoss of time

Solution Approach 1:

The device is implanted in an unadjusted state initially, allowing the patient to resume normal physiologic flow immediately. After observing the actual functional performance under real flow conditions, the adjustment member can be tuned to achieve optimal valvular function. This preliminary implantation followed by delayed adjustment eliminates the need for re-operation while ensuring accuracy.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The adjustable member enables the device to be modified after implantation based on observed performance. The dynamic adjustment capability allows surgeons to optimize valvular function post-implantation without requiring the patient to remain on bypass or undergo re-operation, thereby saving time and improving efficiency.

Inventive Principle:

Principle #15Dynamics

3Adaptability or versatility

If traditional surgical methods are used to adjust anatomical structures, then the structures can be modified, but invasive procedures with risks like thrombosis and separation of valve leaflets are required

Engineering Contradiction:

ImproveadjustabilityVSAvoidoperative risks

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces invasive surgical adjustment mechanisms with a minimally accessible adjustment system. The adjustment member can be tuned through a small access point using a torqueable or reciprocating mechanism, substituting open surgical procedures with a much less invasive process that maintains full adjustability while eliminating major operative risks.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The adjustment mechanism acts as an intermediary between the external operator and the implanted device. Through this intermediary system, adjustments can be made without direct surgical exposure of the anatomical structure, thereby maintaining adaptability while reducing harmful factors associated with invasive procedures.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS8758372B2Implantable devices for controlling the size and shape of an anatomical structure or lumen

Publication Date: 2014.06.24 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

An implantable device system for controlling the dimensions of internal anatomic passages corrects physiologic dysfunctions resulting from a structural lumen which is either too large or too small. Implantable devices are disclosed which employ various mechanisms for adjusting and maintaining the size of an orifice to which they are attached. Systems permit the implants to be implanted using minimally invasive procedures and permit final adjustments to the dimensions of the implants after the resumption of normal flow of anatomic fluids in situ.