Dynaflex Stylet Cannula Notch Alignment for Medical Device Flexibility

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Solution Overview

Problem

Current medical devices lack the ability to dynamically adjust flexibility and rigidity, making them ineffective for navigating complex anatomical paths and transmitting force during procedures like ERCP, as they are either too rigid or too flexible, and lack tunable properties to accommodate varying anatomical challenges.

Innovation Solution

The Dynaflex technology allows for customizable notch designs and orientations between the stylet and cannula, enabling real-time adjustment of flexibility and rigidity by rotating the stylet within the cannula, creating specific flexibility profiles at predefined points along the device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional flexible materials are used to navigate contorted paths, then flexibility is improved, but pushability and tip rigidity deteriorate

Engineering Contradiction:

ImproveflexibilityVSAvoidpushability

Core Design Contradiction:

Adaptability or versatilityVSForce

Solution Approach 1:

The device is divided into multiple segments with different mechanical properties: a distal tip section with notches for flexibility, and proximal sections with solid construction for pushability. This segmentation allows each portion to perform its specific function optimally while working together as a unified device.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the device have different structural qualities - the distal tip has notches creating localized flexibility where needed for navigation, while the proximal shaft maintains solid construction for force transmission. This local differentiation resolves the contradiction between overall flexibility and localized rigidity.

Inventive Principle:

Principle #3Local quality

2Force

If stainless steel is used to improve rigidity and pushability, then force transmission is improved, but flexibility deteriorates

Engineering Contradiction:

ImprovepushabilityVSAvoidflexibility

Core Design Contradiction:

ForceVSAdaptability or versatility

Solution Approach 1:

The device separates the functions of force transmission and flexibility into different segments. The proximal stainless steel shaft provides pushability, while the distal notched section provides flexibility, allowing the device to achieve both properties simultaneously in different locations.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device combines different structural configurations within the same material (stainless steel) - solid sections for rigidity and notched sections for flexibility - creating a composite structural system that exhibits both rigid and flexible characteristics as needed.

Inventive Principle:

Principle #40Composite materials

3Adaptability or versatility

If relief notches are added to increase flexibility, then adaptability to curved paths is improved, but device complexity increases

Engineering Contradiction:

ImproveflexibilityVSAvoiddevice complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

Notches are added only in specific locations where flexibility is needed (distal tip sections), rather than throughout the entire device. This localized application of notching provides the necessary adaptability while minimizing the increase in overall device complexity.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device uses a limited number of notches in strategic locations rather than comprehensive notching throughout. This partial application of the notching feature provides sufficient flexibility for navigation while avoiding excessive complexity.

Inventive Principle:

Principle #16Partial or excessive action

4Length of moving object

If the device is made longer to reach target areas, then reachability is improved, but pushability deteriorates

Engineering Contradiction:

Improvedevice lengthVSAvoidpushability

Core Design Contradiction:

Length of moving objectVSForce

Solution Approach 1:

The long device is segmented into a flexible distal portion for navigation and a rigid proximal portion for force transmission. This segmentation allows the device to maintain length for reachability while preserving pushability through the rigid proximal sections that efficiently transmit force from the operator to the distal tip.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS7704234B2Dynaflex

Publication Date: 2010.04.27 DARR ALLAN J

AI summary

Utilizing the technology and methods disclosed, the characteristics of flexibility and rigidity for intralumenal devices, including coaxial two piece devices such as stylet and needle sets, can be adapted by the physician or device manufacturer according to the type of procedure, the patient size and unique anatomical challenges of a given procedure. Rigidity and flexibility can be actively controlled by the operator at predefined portions of a device through rotating the stylet within the cannula to bring about alignments of customized notches to impart target flexibility or rigidity profiles at specific spots on the device. The device operator may alter the relationship and orientation of specific notched and non-notched segments of either or both the stylet and cannula that are strategically located at said critical points along the length of the device.