Scoring Catheter for Calcified Heart Valve Dilation

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Solution Overview

Problem

Current balloon valvuloplasty procedures are ineffective in treating narrowed heart valves due to limited lumen gain and high restenosis rates, and percutaneous valve implantation faces challenges with crossing, positioning, and anchoring, leading to suboptimal results and para-valvular leaks.

Innovation Solution

A scoring catheter with an expandable scoring element, capable of being deployed to a larger diameter, is used to score and reopen narrowed heart valves, facilitating better crossing and positioning of percutaneous valves, and providing improved anchoring and apposition post-deployment, potentially combined with a drug-eluting balloon for enhanced treatment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Area of stationary object

If balloon valvuloplasty is used to mechanically stretch the narrowed valve orifice, then the valve lumen is dilated, but the lumen gain is small and restenosis rates are high

Engineering Contradiction:

Improvevalve lumen areaVSAvoidrestenosis rate

Core Design Contradiction:

Area of stationary objectVSReliability

Solution Approach 1:

The scoring element is deployed before balloon dilation to score and dissect the calcified valve leaflets, creating controlled incisions that facilitate subsequent balloon expansion and prevent elastic recoil, thereby reducing restenosis

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The scoring element divides the continuous calcified valve structure into segmented sections through controlled incisions, allowing better balloon apposition and more effective dilation while maintaining structural integrity

Inventive Principle:

Principle #1Segmentation

2Adaptability or versatility

If percutaneous valve implantation is performed, then valve replacement is achieved, but the device encounters resistance while crossing the valve due to ineffective orifice from balloon dilation

Engineering Contradiction:

Improvevalve replacement capabilityVSAvoiddevice crossing difficulty

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The scoring element creates controlled incisions in the calcified valve leaflets before valve implantation, dissecting the stiffened tissue to create a more compliant pathway that facilitates easier crossing of the percutaneous valve device

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The scoring element acts as an intermediary that modifies the calcified valve structure to create a more favorable environment for percutaneous valve implantation, bridging the gap between the rigid calcified tissue and the implantable device

Inventive Principle:

Principle #24Intermediary (Mediator)

3Adaptability or versatility

If percutaneous valve implantation is performed, then valve replacement is achieved, but positioning is difficult due to bulkiness of the device and obstruction

Engineering Contradiction:

Improvevalve replacement capabilityVSAvoidpositioning precision

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The scoring element is deployed first to create controlled incisions and dissect the calcified valve structure, establishing a prepared pathway and clear anatomical landmarks that facilitate precise positioning of the subsequent percutaneous valve device

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The scoring element segments the calcified valve leaflets, creating distinct anatomical zones that serve as reference points for accurate positioning and deployment of the percutaneous valve prosthesis

Inventive Principle:

Principle #1Segmentation

4Adaptability or versatility

If percutaneous valve implantation is performed, then valve replacement is achieved, but para-valvular leaks occur due to inadequate device anchoring and apposition with the annulus

Engineering Contradiction:

Improvevalve replacement capabilityVSAvoidpara-valvular leaks

Core Design Contradiction:

Adaptability or versatilityVSObject-generated harmful factors

Solution Approach 1:

The scoring element creates controlled incisions in the calcified valve annulus and leaflets before valve implantation, allowing the percutaneous valve to achieve better apposition and anchoring by integrating into the scored tissue structure, thereby preventing para-valvular leaks

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The scoring process creates a composite structure where the dissected calcified tissue interlocks with the percutaneous valve framework, enhancing anchoring strength and sealing effectiveness to prevent para-valvular leaks

Inventive Principle:

Principle #40Composite materials

Data Source

PatentUS8398662B2Scoring catheter and method for treating diseased heart valves

Publication Date: 2013.03.19 BAVARIA MEDIZIN TECH

AI summary

The present invention provides a valvuloplasty catheter which has a scoring element at its distal part to score stenotic, calcified heart valves in radial direction and to make the single valve flaps/leaflets work again. In addition to this, the device could comprise an attached balloon to post-dilate the valve after the scoring procedure. To reduce a future recalcification, the scoring element and/or the balloon have a pharmacologic coating on their outer surface.