Heated Balloon Deep-Drawn Into Stent Openings

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Solution Overview

Problem

Existing methods for securing implants, such as stents, to balloon catheters fail to provide a sufficient dislodgement force, leading to the risk of implant slippage during implantation due to inadequate form-locking and force-locking connections.

Innovation Solution

A process involving a heated balloon crimped with an implant having multiple through openings, where negative pressure is applied inside a sleeve and positive pressure to the balloon interior causes the balloon to be deep-drawn into the implant openings, forming a strong form-locking connection through plastic deformation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional crimping methods are used to secure the implant to the balloon, then the implant can be attached to the balloon, but the dislodgement force is insufficient leading to implant slippage risk

Engineering Contradiction:
Improveimplant fixation reliabilityVSAvoiddislodgement force
Core Design Contradiction:
ReliabilityVSForce

Solution Approach 1:

The patent applies parameter changes by heating the balloon to elevate its temperature above the glass transition temperature of the balloon material. This thermal parameter change transforms the balloon material from a rigid state to a more compliant, deformable state, enabling it to be deep-drawn into the implant openings and create enhanced form-locking connections that significantly increase dislodgement force and fixation reliability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes phase transitions by heating the balloon material through its glass transition temperature. This phase transition allows the material to change from a glassy, rigid state to a rubbery, deformable state, enabling the balloon to undergo plastic deformation and be forced into the implant openings to create secure form-locking connections

Inventive Principle:
Principle #36Phase transitions

2Strength

If the balloon material is kept at room temperature during crimping, then the crimping process is simpler, but the balloon cannot undergo sufficient plastic deformation to create strong form-locking connections

Engineering Contradiction:
Improveform-locking connection strengthVSAvoidballoon temperature
Core Design Contradiction:
StrengthVSTemperature

Solution Approach 1:

The patent deliberately changes the temperature parameter of the balloon material from room temperature to above its glass transition temperature. This parameter change enables the material to undergo plastic deformation when positive pressure is applied, allowing the balloon to be deep-drawn into the implant openings and create strong form-locking connections with significantly enhanced strength

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent utilizes thermal expansion and thermal softening effects by heating the balloon material. The elevated temperature causes the material to expand and become more compliant, enabling it to be forced into the implant openings and create enhanced form-locking connections that provide superior fixation strength

Inventive Principle:
Principle #37Thermal expansion

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 method enhances the dislodgement force of the implant, reducing the risk of slippage during implantation by creating an optimal form-locking connection between the balloon and the implant.

Implementation Method 1

the preferably heated balloon is deep-drawn into the openings of the implant, producing a form-locking connection between the balloon and the implant or the supporting structure of the implant

Methodology Applied
Scientific EffectPlastic deformation: Plasticity

Implementation Method 2

applying a negative pressure in the interior of the sleeve and applying a positive pressure to the balloon interior

Methodology Applied
Scientific EffectNegative pressure: Pressure Gradient

Implementation Method 3

applying a negative pressure in the interior of the sleeve and applying a positive pressure to the balloon interior

Methodology Applied
Scientific EffectPositive pressure: Pressure Increase

Data Source

PatentUS11185431B2Process, configuration and apparatus for fixing a stent to a balloon of a balloon catheter
Publication Date: 2021.11.30 BIOTRONIK AG
  • US11185431B2 patent drawing
  • US11185431B2 patent drawing

AI summary

A process for fixing an implant to a balloon includes providing, in an interior of a sleeve, a heated balloon having a pressurizable balloon interior and an implant crimped to the balloon. The implant has a supporting structure with a multiplicity of through openings. A negative pressure is applied in the interior of the sleeve and a positive pressure is applied to the balloon interior, so that the balloon is deep-drawn into the openings of the implant, producing a form-locking connection between the balloon and the implant. A configuration for carrying out the process and an apparatus for fixing an implant to a balloon are also provided.