Variable Stiffness Medical Device Balloon Mechanism

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Solution Overview

Problem

Transluminal devices, such as endoscopes, face challenges in maintaining optimal stiffness to navigate tortuous body channels while minimizing patient discomfort, as increased flexibility is required in some areas and increased stiffness in others to prevent kinking and enhance maneuverability.

Innovation Solution

Incorporating an inflatable balloon within the device that can be deflated to increase flexibility and inflated to increase stiffness, allowing for adjustable variable stiffness along the length of the device, with the balloon being axially movable and potentially segmented for independent inflation and deflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the endoscope is made more flexible to traverse tortuous body channels, then the ability to navigate body cavities is improved, but the maneuverability and risk of kinking worsen

Engineering Contradiction:
Improveability to traverse body channelsVSAvoidmaneuverability
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The endoscope incorporates an inflatable balloon that can dynamically change the stiffness of the shaft. By inflating the balloon, the shaft becomes stiffer for improved maneuverability; by deflating it, the shaft becomes more flexible for navigating tortuous channels. This dynamic adjustment allows the device to adapt its mechanical properties based on operational needs.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the physical parameter of shaft stiffness through balloon inflation and deflation. The balloon, when inflated, increases the rigidity of the endoscope shaft, while deflation reduces it. This parameter change enables the device to transition between flexible and stiff states to resolve the contradiction between traversability and maneuverability.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If the endoscope diameter is increased to accommodate more lumens, then the functionality is improved, but the patient discomfort increases

Engineering Contradiction:
Improvenumber of lumensVSAvoidpatient discomfort
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The endoscope design nests the inflatable balloon within the shaft, allowing the balloon to expand radially when inflated. This nested configuration enables the device to maintain a small profile during insertion (reducing patient discomfort) while providing the capability to expand functionality when needed.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The device dynamically adjusts its diameter through balloon inflation. During insertion, the balloon remains deflated to minimize diameter and patient discomfort. When functionality is needed, the balloon can be inflated to provide additional support or functionality without permanently increasing the device size.

Inventive Principle:
Principle #15Dynamics

3Stability of the object's composition

If the endoscope shaft is made stiffer to prevent kinking, then the structural integrity is improved, but the ability to follow body cavity contours worsens

Engineering Contradiction:
Improveshaft structural integrityVSAvoidability to follow body contours
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The patent uses balloon inflation to change the shaft's structural parameter (stiffness). When the balloon is inflated, it provides internal support that prevents kinking and maintains structural integrity. When deflated, it allows the shaft to become flexible enough to follow body cavity contours.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The endoscope utilizes pneumatic pressure through the inflatable balloon to adjust shaft stiffness. By introducing air or fluid pressure into the balloon, the shaft transitions from a flexible state to a stiffer state, providing on-demand structural support without permanent rigidity.

Inventive Principle:
Principle #29Pneumatics and hydraulics

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 enables the device to adapt its flexibility according to the body cavity's geometry, facilitating easier navigation and reducing the risk of kinking, while maintaining sufficient stiffness for maneuverability and therapeutic procedures.

Implementation Method 1

a flexibility of the elongate section may be configured to decrease when the balloon is inflated, and the flexibility may be configured to increase when the balloon is deflated

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS9333322B2Adjustable variable stiffness medical device and methods of use
Publication Date: 2016.05.10 BOSTON SCIENTIFIC SCIMED INC
  • US9333322B2 patent drawing
  • US9333322B2 patent drawing
  • US9333322B2 patent drawing

AI summary

A transluminal device may include an elongate section extending between a proximal end and a distal end of the device. The elongate section may be configured to be inserted into a body cavity. The device may include a balloon within the elongate section between the proximal end and the distal end.