Adjustable Stiffness Catheter with Dynamic Mechanical Properties

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Solution Overview

Problem

Medical devices like catheters face a challenge in balancing flexibility and strength, as improving one often compromises the other, and there is a need for adjustable stiffness to accommodate individual patient requirements, especially during procedures.

Innovation Solution

The development of adjustable catheters with features such as spiral-cut hypotubes, inflatable tubes, swellable layers, stiffness-enhancing sheaths, and electro-active polymers that allow for real-time adjustment of stiffness, enabling physicians to tailor the device's flexibility and strength according to specific patient needs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If the catheter is made with increased strength, then the catheter can withstand higher forces during procedures, but the flexibility of the catheter is reduced

Engineering Contradiction:
Improvecatheter strengthVSAvoidcatheter flexibility
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The catheter incorporates an adjustable stiffness mechanism that allows the flexibility and strength properties to be dynamically changed during the procedure. A balloon or expandable structure can be inflated to increase stiffness when strength is needed, or deflated to restore flexibility when navigation is required, enabling the catheter to adapt its mechanical properties based on procedural needs rather than being fixed.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The catheter design allows for changing the physical parameters of the catheter body, specifically the stiffness parameter. This is achieved through mechanisms such as inflatable balloons, expandable frames, or adjustable support elements that can modify the catheter's mechanical properties in real-time, allowing optimization of both strength and flexibility at different stages of the procedure.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If multiple catheters with different stiffness levels are manufactured to accommodate various patient needs, then optimal performance for each patient can be achieved, but the cost and complexity of device management increases

Engineering Contradiction:
Improvepatient-specific optimizationVSAvoidcatheter variety
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The invention creates a universal catheter platform that can perform multiple functions by adjusting its stiffness property. A single catheter design incorporates the ability to modify its mechanical properties, allowing it to serve as both a flexible navigation tool and a stiff support structure depending on procedural requirements, eliminating the need for multiple specialized catheters.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The catheter transitions from a static, fixed-stiffness design to a dynamic, adjustable-stiffness design. This allows one catheter to adapt to different patient anatomies and procedural requirements by changing its stiffness in real-time, providing the versatility of multiple catheters through a single adaptable device.

Inventive Principle:
Principle #15Dynamics

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

These adjustments enable catheters to provide optimal performance by allowing for in-situ stiffness modification, enhancing procedural efficacy and safety by accommodating unique patient anatomies and requirements.

Implementation Method 1

a first spiral-cut hypotube that is disposed within the elongate polymeric shaft

Methodology Applied
Scientific EffectSpiral geometry: Helix

Implementation Method 2

Inflating the first inflatable tube causes the elongate polymeric shaft to increase in stiffness

Methodology Applied
Scientific EffectInflation: Pressurisation

Implementation Method 3

Adding an appropriate fluid to the swellable layer increases the stiffness of the adjustable catheter

Methodology Applied
Scientific EffectSwelling: Absorption (physical)

Implementation Method 4

A stiffness-enhancing sheath that is more stiff than the elongate polymeric shaft is slidably disposed over the elongate polymeric shaft

Methodology Applied
Scientific EffectSheath structure:

Implementation Method 5

Each of a number of stiffness-enhancing filaments are slidably disposed in each of the number of elongate apertures

Methodology Applied
Scientific EffectSlidable filament mechanism:

Implementation Method 6

An inner polymeric layer that includes one or more electrically actuated stiffness enhancers

Methodology Applied
Scientific EffectElectrically actuated: Electroactive Polymer

Implementation Method 7

The stiffness of the elongate polymeric shaft can be changed by applying a current to the elongate polymeric shaft

Methodology Applied
Scientific EffectElectrical current actuation: Electroactive Polymer

Data Source

PatentUS7998132B2Adjustable stiffness catheter
Publication Date: 2011.08.16 BOSTON SCIENTIFIC SCIMED INC
  • US7998132B2 patent drawing
  • US7998132B2 patent drawing
  • US7998132B2 patent drawing

AI summary

Medical devices such as catheters can include structure or provision that permit a physician or other health care professional to adjust the stiffness of at least a portion of the medical device. In some instances, the medical device may be adjusted prior to inserting the medical device into a patient. In some cases, the medical device may be adjusted while in use within the patient.