Shape Memory Shaft for Transobturator Sling Delivery

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Solution Overview

Problem

Current sling delivery devices for treating urinary incontinence and pelvic floor disorders often risk damaging sensitive vascular and nerve tissues during the trans-obturator approach due to their fixed radius of curvature, which limits their ability to navigate around the ischiopubic ramus effectively.

Innovation Solution

A delivery device with a guide tube and an extendible/retractable shaft made of shape memory material, allowing the shaft to change its curvature from a larger radius inside the guide tube to a smaller radius when extended, enabling it to navigate around the ischiopubic ramus without penetrating sensitive tissues, and utilizing a heating/cooling element to control the shape transformation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a fixed radius of curvature delivery device is used, then the device structure is simple, but the device cannot navigate around the ischiopubic ramus effectively and risks damaging sensitive tissues

Engineering Contradiction:
Improveability to navigate around ischiopubic ramusVSAvoiddelivery device structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The delivery device employs a shape memory alloy shaft that can dynamically change its curvature radius in response to temperature changes. The shaft transitions from a first radius of curvature to a second radius of curvature, allowing the device to adapt its geometry to navigate around the ischiopubic ramus effectively while maintaining a relatively simple overall structure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention changes the physical parameter of the shaft's curvature radius by utilizing shape memory alloy properties. The shaft's radius of curvature is changed from a first radius to a second radius through temperature control, enabling the device to navigate complex anatomical paths without increasing structural complexity.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If the shaft extends with a fixed curvature, then the device structure is simple, but it cannot track closely around anatomical structures and may penetrate sensitive tissues

Engineering Contradiction:
Improverisk of injury to sensitive tissuesVSAvoidshaft structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The shaft is designed with dynamic geometry capabilities through shape memory alloy material. The shaft can change its curvature radius from a first radius to a second radius, allowing it to track closely around the ischiopubic ramus and other anatomical structures, thereby minimizing the risk of tissue penetration and injury.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The shape memory alloy shaft utilizes phase transitions between austenite and martensite phases to change its curvature radius. This phase transition mechanism allows the shaft to transform from a first radius of curvature to a second radius of curvature, enabling safe navigation around sensitive anatomical structures.

Inventive Principle:
Principle #36Phase transitions

3Reliability

If a shape memory material shaft is used, then the device can navigate around anatomical structures safely, but the device requires heating/cooling control mechanisms

Engineering Contradiction:
Improvesafety of tissue navigationVSAvoidtemperature control system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention utilizes phase transitions of shape memory alloy material to achieve curvature radius changes. The shaft transitions between austenite and martensite phases through controlled heating and cooling, enabling reliable navigation around anatomical structures. The phase transition mechanism provides inherent control without requiring complex external actuation systems.

Inventive Principle:
Principle #36Phase transitions

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

Minimizes tissue damage by allowing the shaft to track closely around anatomical structures, reducing the risk of injury to sensitive tissues during sling placement, while maintaining effective support for urinary incontinence and pelvic floor disorders treatment.

Implementation Method 1

At least the portion of the shaft extending from the guide tube is made of a shape memory material and can assume a second radius of curvature different from the first radius of curvature of the guide tube

Methodology Applied
Scientific EffectShape memory material phase transition: Phase Change

Implementation Method 2

The heating element can be energized to increase the temperature of the shape memory material above a phase transition temperature of the material

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Implementation Method 3

Alternatively or in addition, the cooling element can be energized to decrease the temperature of the shape memory material below a phase transition temperature of the material

Methodology Applied
Scientific EffectJoule heating: Joule Heating

Data Source

PatentUS8974367B2Coaxial device for delivering an implant to a patient's pelvic region
Publication Date: 2015.03.10 BOSTON SCIENTIFIC SCIMED INC
  • US8974367B2 patent drawing
  • US8974367B2 patent drawing
  • US8974367B2 patent drawing

AI summary

Systems and methods for implanting a surgical sling in a patient by a transobturator approach are disclosed. A sling delivery device couplable to a sling assembly with the surgical sling includes a guide tube and an extendible shaft section movable inside the guide tube. At least a portion of the shaft may be made of a shape memory material and can, when extended, assume a shape different from the shape of the guide tube in which the shaft is housed. This allows the extended shaft to navigate along a path that tracks close to bone structures, in particular the ischiopubic ramus, and prevents damage to surrounding tissue.