Mechanical Skiving for Medical Balloon Wall Thickness Control

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Solution Overview

Problem

Current methods for forming medical balloons, such as blow molding and cone grinding, result in uneven wall thickness and increased stiffness, leading to adverse bursting failure modes and reduced flexibility, which complicates navigation through tortuous vessels and increases the risk of embolization.

Innovation Solution

A mechanical skiving assembly and method using a blade holder and lathe assembly to selectively remove material from a polymer tube, allowing for the formation of a medical balloon with controlled wall thickness and flexibility by rotating a blade relative to the tube, creating a diagonal or compound angle skive that reduces the outer diameter and maintains the inner lumen integrity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If blow molding is used to form the balloon from a solid hollow polymer tube, then the balloon can be formed with a consistent longitudinal failure plane, but the wall thickness becomes uneven (thicker in cone and waist portions) leading to increased stiffness and adverse bursting failure modes

Engineering Contradiction:
Improveconsistent longitudinal failure planeVSAvoiduneven wall thickness leading to adverse bursting failure modes
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies preliminary action by performing skiving on the polymer tube before blow molding to selectively remove material from the cone and waist portions. This pre-modification of the tube geometry ensures that when the balloon is subsequently formed through blow molding, the wall thickness is more uniform throughout, preventing adverse bursting failure modes while maintaining the consistent longitudinal failure plane characteristic of blow-molded balloons.

Inventive Principle:
Principle #10Preliminary action

2Shape

If heat is applied to localize reduction of cross sectional area by stretching, then the body portion can be thinned, but the cone and waist portions become stiffer with increased molecular orientation

Engineering Contradiction:
Improvelocalized cross sectional area reductionVSAvoidincreased stiffness making balloon difficult to fold and track
Core Design Contradiction:
ShapeVSEase of operation

Solution Approach 1:

The patent applies the taking out principle by mechanically removing polymer material through skiving from the cone and waist portions of the tube before blow molding. This extraction of excess material eliminates the need for subsequent stretching operations that would increase molecular orientation and stiffness. The result is a balloon with uniform wall thickness that maintains flexibility and ease of tracking through tortuous vasculature.

Inventive Principle:
Principle #2Taking out (Extraction)

3Shape

If extreme cold temperature is applied to protect the body portion from stretching, then the body portion maintains thickness, but the cone and waist portions become stiffer with decreased flexibility

Engineering Contradiction:
Improveprotected body portion thicknessVSAvoiddecreased flexibility in cone and waist portions
Core Design Contradiction:
ShapeVSEase of operation

Solution Approach 1:

The patent replaces the thermal field approach (extreme cold temperature application) with a mechanical field approach (skiving). Instead of using temperature to control material behavior and protect certain portions, the invention uses mechanical material removal through skiving to achieve the desired wall thickness distribution. This mechanical substitution avoids the adverse effects of thermal processing on polymer molecular orientation and flexibility.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

4Shape

If cone grinding is used to remove material from cone and waist portions, then wall thickness can be reduced, but the process is limited to concentric material removal and may increase adverse failure modes

Engineering Contradiction:
Improvereduced wall thickness in cone and waist portionsVSAvoidincreased adverse failure modes with limited material removal pattern
Core Design Contradiction:
ShapeVSReliability

Solution Approach 1:

The patent employs a pneumatic or mechanical skiving system where a rotating skiving blade or cup removes material from the tube in a controlled manner. This approach differs from conventional cone grinding by enabling non-concentric, patterned material removal that can be precisely controlled to achieve uniform wall thickness throughout the balloon structure, thereby reducing adverse failure modes while maintaining reliability.

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

The skiving process effectively reduces wall thickness, enhances flexibility, and minimizes the risk of radial failure modes, improving the balloon's trackability and rewrap capabilities while maintaining a consistent longitudinal failure plane, thus enhancing the safety and efficacy of medical procedures.

Implementation Method 1

a blade holder and a tube guide wherein the blade holder retains a blade in a diagonal relationship relative to the tube guide

Methodology Applied
Scientific EffectMechanical skiving: Abrasion

Implementation Method 2

A lathe assembly includes a mandrel for extending into the lumen and fitting into the tube guide. A lathe assembly further includes a spinning mechanism that rotates the mandrel relative to the blade for skiving the exterior surface of the polymer tube

Methodology Applied
Scientific EffectRotational motion:

Data Source

PatentUS10696005B2Assembly and method of same for mechanically skiving to remove balloon parison tubing materials
Publication Date: 2020.06.30 FREUDENBERG MEDICAL LLC
  • US10696005B2 patent drawing
  • US10696005B2 patent drawing
  • US10696005B2 patent drawing

AI summary

An assembly and method for mechanically skiving a tube to later form into a medical balloon are provided. The assembly includes a blade holder and a tube guide wherein the blade holder retains the blade in a diagonal relationship relative to the tube guide. A lathe assembly includes a mandrel for extending into a lumen of the tube and fitting into the tube guide. The lathe assembly further includes a spinning mechanism that rotates the mandrel relative to the blade for skiving the exterior surface of the polymer tube. The diagonal relationship allows for precise shaping of a transition portion of the tube, which is located between a medially located un-skived portion of tube and two skived portions located at tube ends. Once the tube is skived, a molding process inflates the un-skived portion into a balloon and stretches the transition portion and the skived portions forming a medical balloon.