Finger-Mountable Lesion Formation Device for Epicardial Access

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Solution Overview

Problem

Conventional electrosurgical devices are not well-suited for forming certain therapeutic lesions, particularly those extending from the mitral valve annulus to encircling or connecting lesions around the heart, as they cannot access the target tissue from the epicardial surface without invasive procedures.

Innovation Solution

A finger-mountable lesion formation device with electrodes and a carrier that allows for the formation of lesions on the endocardial surface without puncturing or cutting through the left atrium, using thermal insulation to protect the physician's finger and employing cooling to facilitate wider and deeper lesion creation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional electrosurgical devices are used to form lesions epicardially, then lesion formation is possible for most areas, but the target tissue becomes inaccessible for certain lesions such as those extending from the mitral valve annulus to encircling lesions

Engineering Contradiction:

Improvelesion formation capabilityVSAvoidtissue accessibility

Core Design Contradiction:

Adaptability or versatilityVSEase of operation

Solution Approach 1:

The invention inverts the conventional approach by using the physician's finger to invaginate the left atrial appendage from the inside, allowing epicardial access to endocardial structures. This inversion enables the finger-mounted electrode to reach target tissue that would otherwise be inaccessible from the external surface.

Inventive Principle:

Principle #13The other way round (Inversion)

Solution Approach 2:

The left atrial appendage serves as an intermediary structure that the physician's finger uses to access the mitral valve annulus and surrounding endocardial tissue. By invaginating the appendage, the finger creates a pathway through which the electrode can deliver energy to target structures that are normally inaccessible from the epicardial surface.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of operation

If the physician's finger is exposed to thermal energy during lesion formation, then direct tissue contact is achieved, but the finger is damaged by heat

Engineering Contradiction:

Improvedirect tissue contactVSAvoidthermal damage to finger

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

A thermal insulation layer is introduced as an intermediary between the physician's finger and the thermal energy generated during lesion formation. This insulating layer allows direct tissue contact for effective lesion creation while blocking thermal damage to the finger.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The thermal insulation layer is applied beforehand to protect the finger from thermal damage before the energy delivery process begins. This preventive measure ensures that the finger remains protected throughout the procedure while maintaining the ability to deliver thermal energy to the tissue.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Adaptability or versatility

If conventional catheters, probes, or clamps are used, then therapeutic elements can be positioned at target locations, but these devices are not well-suited for forming certain epicardial lesions without invasive procedures

Engineering Contradiction:

Improvedevice functionalityVSAvoidprocedure invasiveness

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The invention uses the physician's own finger as the delivery mechanism, eliminating the need for complex catheters, probes, or clamps. The finger-mounted electrode system is simple and direct, requiring no invasive catheter insertion or complex positioning apparatus.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Instead of using complex external devices to reach into the heart, the invention inverts the approach by using the finger to reach from the inside through the left atrial appendage. This inversion simplifies the device requirements while maintaining the ability to form complex epicardial lesions.

Inventive Principle:

Principle #13The other way round (Inversion)

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 the formation of lesions that extend from the mitral valve annulus to encircling lesions around the atrial appendage without invasive procedures, providing better control and reducing the risk of damage or complications like stroke and bleeding.

Implementation Method 1

employing cooling to facilitate wider and deeper lesion creation

Methodology Applied

Scientific EffectCooling: Cooling

Implementation Method 2

using thermal insulation to protect the physician's finger

Methodology Applied

Scientific EffectThermal insulation: Thermal Insulation

Implementation Method 3

Electromagnetic radio frequency ('RF') energy applied by the electrode heats, and eventually kills (i.e. 'ablates'), the tissue to form a lesion

Methodology Applied

Scientific EffectJoule heating: Joule Heating

Implementation Method 4

The amount of power required to coagulate tissue ranges from 5 to 150 W

Methodology Applied

Scientific EffectAblation: Ablation

Data Source

PatentUS7455669B2Finger mountable lesion formation devices and methods

Publication Date: 2008.11.25 BOSTON SCIENTIFIC SCIMED INC

AI summary

An apparatus including a lesion formation element and a carrier configured to mount the lesion formation element on a finger.