Intraoperative Cardiac Injection System with Vacuum Stabilization

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Solution Overview

Problem

Current minimally invasive surgical devices fail to deliver drugs or tissue-engineered materials precisely to the heart due to the heart's movement and the distortion of the pericardium caused by prior art methods, which limits accuracy and accessibility to the epicardium.

Innovation Solution

A system with a steerable catheter and end effector equipped with guide wires, vacuum ports, and sensors for precise control and suction, allowing for lateral and vertical movement, and a deflecting needle mechanism that enables accurate injection into the epicardium without creating a bleb, combined with electromagnetic tracking for real-time navigation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a minimally invasive approach is used to access the heart, then patient recovery time is reduced and infection risk is lowered, but injection accuracy into the epicardium deteriorates due to heart movement and pericardial distortion

Engineering Contradiction:
Improvepatient safety and recoveryVSAvoidinjection accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system performs preliminary actions by first establishing pericardial access and deploying a positioning device that can be secured to the pericardium before the actual injection procedure. This preliminary positioning and stabilization allows subsequent accurate needle delivery despite heart movement, as the reference frame is established in advance

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent introduces an intermediary positioning device that acts as a mediator between the external injection system and the moving heart. This device with pericardial attachment features serves as a stable reference platform that translates external control movements to the needle position while maintaining accurate positioning relative to the epicardium

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If the PerDUCER device is used to create a bleb for pericardial access, then minimally invasive access is achieved, but injection precision deteriorates due to pericardial distortion

Engineering Contradiction:
Improveminimally invasive accessVSAvoidinjection location precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The system performs preliminary pericardial access and device deployment before the actual injection, establishing a stable reference frame. The positioning device is secured to the pericardium in advance, allowing subsequent needle delivery to be precisely controlled relative to this pre-established position rather than the distorted bleb

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The injection system is segmented into distinct functional components: pericardial access device, positioning device with pericardial attachment features, and needle delivery mechanism. This segmentation allows each component to perform its specific function optimally - the positioning device handles stabilization while the needle mechanism handles precise injection delivery

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If direct visualization of the heart is not available during surgery, then minimally invasive procedure is maintained, but ability to achieve accurate injection location deteriorates

Engineering Contradiction:
Improveminimally invasive procedureVSAvoidinjection location accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system incorporates feedback mechanisms where the positioning device provides real-time information about needle position and pericardium contact. This feedback loop allows the operator to make adjustments based on sensed conditions, achieving accurate injection location without direct visual confirmation by correlating device position data with anatomical landmarks

Inventive Principle:
Principle #23Feedback

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 precise and accurate delivery of therapeutic agents to the epicardium, overcoming the limitations of prior art by allowing for controlled, precise placement and minimizing tissue distortion, thus improving the accuracy and safety of minimally invasive cardiac procedures.

Implementation Method 1

A vacuum suction is then applied to the side hole, which forces a portion of the pericardium to be pulled into the side hole and creates a bleb

Methodology Applied
Scientific EffectVacuum suction: Suction

Data Source

PatentEP2593172B1Method and apparatus for intraoperative cardiac tissue injection
Publication Date: 2021.08.25 BLUE BELT TECH INC
  • EP2593172B1 patent drawingFigure 1a~1b
  • EP2593172B1 patent drawingFigure 2a~2b
  • EP2593172B1 patent drawingFigure 3

AI summary

The apparatus provides for injecting therapeutic agents at precise locations into the bodily tissue. The apparatus comprises an end effector that is guided to a precise location by motion controllers on a handle. At a precise location, the end effector attaches via a vacuum to the cardiac tissue. A flexible needle is advanced through a deflecting tunnel in the end effector to a desired depth. A therapeutic agent is then introduced via the flexible needle into the cardiac tissue. All these manipulations can be controlled by one hand and can be viewed via imaging methods.