Laser Catheter Sheath for Vascular Calcification Disruption

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Solution Overview

Problem

Current medical devices struggle to effectively penetrate and disrupt calcified and fibrous vascular occlusions, particularly calcified caps, and deliver therapeutic agents without applying hydraulic force.

Innovation Solution

A catheter system with a laser catheter and a sheath featuring an attenuating member with a specific open area percentage and braid density, which uses laser-induced pressure waves to disrupt occlusions and deliver therapeutic agents by minimizing hydraulic force application.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If a balloon catheter is used to dilate a calcified and fibrous vascular occlusion, then the artery diameter can be increased, but the balloon cannot penetrate the calcified cap at the distal end of the total occlusion

Engineering Contradiction:
Improveability to penetrate calcified occlusionVSAvoiddifficulty to insert balloon into occlusion
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The patent replaces the mechanical balloon expansion system with a laser-induced shockwave system. The laser emitter delivers high-energy laser pulses that generate shockwaves through the liquid medium, which then penetrate and disrupt the calcified occlusion without requiring mechanical balloon insertion into the calcified cap.

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

Solution Approach 2:

The patent changes the physical state and energy parameters by using laser energy to create rapid pressure changes in the liquid medium. The laser pulses cause localized heating and vaporization, generating shockwaves with sufficient energy to fracture calcified tissue, thereby changing the approach from mechanical force to acoustic/pressure wave energy.

Inventive Principle:
Principle #35Parameter changes

2Strength

If electrically-induced shockwave balloon catheters are used to break calcified tissue, then the calcified occlusion can be disrupted, but hydraulic force is applied to the vascular occlusion

Engineering Contradiction:
Improveability to disrupt calcified tissueVSAvoidhydraulic force applied to occlusion
Core Design Contradiction:
StrengthVSForce

Solution Approach 1:

The patent substitutes the hydraulic force mechanism with a laser-induced shockwave mechanism. Instead of using liquid pressure to expand the balloon and apply force to the occlusion, the system uses laser energy to generate acoustic shockwaves that directly disrupt the calcified tissue through cavitation and pressure wave effects, eliminating the need for hydraulic force application.

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

3Strength

If the attenuating member has high braid density, then the structural integrity of the sheath is improved, but the laser energy transmission to the liquid medium is reduced

Engineering Contradiction:
Improvestructural integrity of sheathVSAvoidlaser energy transmission efficiency
Core Design Contradiction:
StrengthVSUse of energy by moving object

Solution Approach 1:

The patent applies local quality by creating an attenuating member with non-uniform braid density. The braid density varies along the length of the sheath, with lower density regions positioned to allow optimal laser energy transmission to the liquid medium while maintaining sufficient structural integrity in other areas. This localized variation in density enables simultaneous optimization of both structural strength and energy transmission.

Inventive Principle:
Principle #3Local quality

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

Enables efficient penetration and disruption of calcified and fibrous vascular occlusions, facilitating the delivery of therapeutic agents while minimizing damage to surrounding tissues.

Implementation Method 1

a laser emitter adapted to deliver high energy laser pulses to the liquid medium to create laser-induced pressure waves

Methodology Applied
Scientific EffectLaser-induced pressure wave: Photoacoustic Effect

Implementation Method 2

the liquid medium absorbs the light, which in turn produces laser-induced pressure waves

Methodology Applied
Scientific EffectLaser heating: Absorption (EM radiation)

Implementation Method 3

a vapor bubble. As the laser-induced pressure wave propagates away from its origin, the liquid surrounding the vapor bubble displaces inwardly, collapsing the vapor bubble and creating a cavitation event

Methodology Applied
Scientific EffectCavitation: Cavitation

Data Source

PatentEP3522812B1Laser-induced pressure wave emitting catheter sheath
Publication Date: 2021.12.01 SPECTRANETICS CORP
  • EP3522812B1 patent drawingFigure 1
  • EP3522812B1 patent drawingFigure 2A~2C
  • EP3522812B1 patent drawingFigure 2B'~2C'

AI summary

The present disclosure relates generally to the use of medical devices for the treatment of vascular conditions. In particular, the present disclosure provides devices and methods for using laser-induced pressure waves created within a sheath to disrupt intimal and medial calcium within the vasculature.