Intravascular Device Selectively Deflectable Tip Navigation

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Solution Overview

Problem

Intravascular devices face challenges in navigating tortuous vascular pathways, particularly when passing through fusiform aneurysms, due to limited control over distal tip alignment, which can lead to delayed or unsuccessful procedures.

Innovation Solution

The development of an intravascular device with a selectively deflectable tip, featuring a micro-fabricated cutting pattern in the distal section that allows for predictable deflection upon tension application, providing additional navigation control through the use of a translatable inner member within a hollow lumen.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the distal section includes a micro-fabricated cutting pattern that enables deflection, then navigation control is improved, but device complexity increases

Engineering Contradiction:
Improvenavigation controlVSAvoiddevice complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The device is divided into distinct sections: a proximal section, a distal section with micro-fabricated cutting pattern, and an inner member. The distal section is further segmented into multiple beams through the cutting pattern, allowing independent deflection control when the inner member translates, thereby improving navigation control while managing complexity through functional segmentation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The distal section transitions from a static structure to a dynamic one by incorporating a micro-fabricated cutting pattern that enables deflection. When the inner member translates within the lumen, it applies tension to the distal section, causing the beams to deflect and change the tip orientation dynamically, enhancing navigation control.

Inventive Principle:
Principle #15Dynamics

2Ease of operation

If the device provides sufficient flexibility to navigate tortuous pathways, then ease of navigation is improved, but torquability deteriorates

Engineering Contradiction:
Improveease of navigationVSAvoidtorquability
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

Different sections of the device have different structural properties: the proximal section maintains higher rigidity for torquability, while the distal section incorporates a micro-fabricated cutting pattern with multiple beams that provide localized flexibility. This allows the device to navigate tortuous pathways through the flexible distal section while the proximal section transmits torque effectively.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The device is segmented into functional zones: a proximal section for torque transmission, a distal section with cutting pattern for flexibility and deflection, and an inner member for actuation. This segmentation allows each section to optimize its properties for its specific function, balancing torquability and flexibility.

Inventive Principle:
Principle #1Segmentation

3Ease of manufacture

If the device structure is simplified for easier manufacturing, then ease of manufacture is improved, but navigation precision deteriorates

Engineering Contradiction:
Improveease of manufactureVSAvoidalignment precision
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The micro-fabricated cutting pattern in the distal section changes the structural parameters of the device by creating multiple beams with specific geometries. This pattern can be manufactured using standard micro-fabrication techniques while providing predictable deflection characteristics that improve alignment precision when the inner member translates.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The device employs a composite structure combining a hollow proximal section, a hollow distal section with micro-fabricated cutting pattern, and an inner member. This composite design integrates different functional requirements into a single device that can be manufactured using established techniques while achieving enhanced navigation precision.

Inventive Principle:
Principle #40Composite materials

4Device complexity

If traditional push/pull and rotation movements are used, then device simplicity is maintained, but navigation capability through aneurysms deteriorates

Engineering Contradiction:
Improvedevice complexityVSAvoidnavigation capability
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The device adds a dynamic deflection capability to the traditional push/pull and rotation movements. The micro-fabricated cutting pattern in the distal section allows the tip to deflect when the inner member translates, providing a new degree of freedom for navigation that enhances adaptability for passing through aneurysms and other complex vascular structures.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The invention adds a deflection dimension to the traditional one-dimensional push/pull and rotation control. By translating the inner member, the operator can now deflect the distal tip in addition to pushing/pulling and rotating, providing enhanced navigation capability through complex vascular anatomy without significantly increasing overall device complexity.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

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

Enhances navigation capabilities, enabling better alignment and passage through complex vascular anatomy, such as aneurysms, by offering an additional option beyond traditional push/pull and rotation movements, thereby improving the success rate of medical procedures.

Implementation Method 1

At least the distal section includes a micro-fabricated cutting pattern that enables deflection of the distal end in response to the application of tension to the inner member

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS11452541B2Intravascular device having a selectively deflectable tip
Publication Date: 2022.09.27 SCIENTIA VASCULAR INC
  • US11452541B2 patent drawing
  • US11452541B2 patent drawing
  • US11452541B2 patent drawing

AI summary

An intravascular device, such as s guidewire device, includes a hollow proximal section and a hollow distal section joined to the proximal section and extending distally from the proximal section to form a continuous lumen extending from a proximal end of the device to a distal end of the device. An inner member extends from the proximal end to the distal end and is joined to the distal end. The inner member is translatable within the lumen in response to applied tension. At least the distal section includes a micro-fabricated cutting pattern that enables deflection of the distal end in response to the application of tension to the inner member.