Semi-Automated Myocardial Injection Device
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Solution Overview
Problem
Current intramyocardial injection therapies for heart conditions require invasive surgery, posing risks and inefficiencies, and there is a need for less invasive methods to deliver therapeutic agents directly to the heart muscle without opening the chest cavity.
Innovation Solution
A semi-automated delivery platform using an intrusion needle guided through the chest wall, with a probing device for site localization and a secondary needle that injects therapeutic agents orthogonally into the myocardium during the cardiac cycle, controlled by a precision pump and bio-impedance measurement, allowing for on-beat injections without thoracotomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive surgery (thoracotomy) is performed to access the heart wall for injection, then reliable delivery of therapeutic agent is achieved, but device complexity and patient risk increase significantly
Solution Approach 1:
The patent employs a nested structure where the secondary needle is inserted through the intrusion needle, and the probing device is advanced through the secondary needle. This nested arrangement allows multiple functions (access, probing, injection) to be achieved through a single puncture site, eliminating the need for thoracotomy while maintaining reliable therapeutic delivery to the myocardium
Solution Approach 2:
The intrusion needle serves as an intermediary device that provides a stable access route through the chest wall and myocardium. It acts as a guide for the secondary needle and probing device, enabling minimally invasive access to the heart muscle without requiring open chest surgery, thus reducing surgical complexity while maintaining delivery reliability
2Ease of operation
If manual injection methods are used during heart beat, then procedural simplicity is maintained, but measurement precision and injection timing accuracy deteriorate
Solution Approach 1:
The system incorporates real-time feedback through the probing device that detects myocardial tissue characteristics and heart position. This feedback is transmitted to the control system, which automatically adjusts the injection timing and parameters based on the actual cardiac cycle phase, ensuring precise on-beat injection without requiring complex manual coordination
Solution Approach 2:
The control system automatically determines the optimal injection timing based on real-time cardiac cycle detection and autonomously actuates the injection mechanism. This self-service capability eliminates the need for manual timing adjustments by the operator, achieving high measurement precision while maintaining ease of operation through automated decision-making
3Manufacturing precision
If the heart is stopped for injection, then injection precision is improved, but loss of time and procedural duration increase
Solution Approach 1:
The system transitions from a static approach (stopped heart) to a dynamic approach where the injection is delivered during the natural cardiac cycle. The control system dynamically adjusts injection parameters based on real-time heart position and motion, achieving precise on-beat injection without requiring cardiac arrest, thereby eliminating time loss while maintaining injection precision
Solution Approach 2:
The injection is timed to occur during specific phases of the periodic cardiac cycle (on-beat during enlargement). By synchronizing the injection with the natural periodic rhythm of the heart, the system achieves precise placement without interrupting the cardiac cycle, avoiding the time loss associated with stopping and restarting the heart
4Ease of operation
If multiple puncture sites are created for needle access, then ease of needle positioning is improved, but object-generated harmful factors increase
Solution Approach 1:
The intrusion needle serves multiple functions: it provides initial access through the chest wall, guides the secondary needle to the target site, and can be used for both probing and injection. This multi-functionality eliminates the need for separate puncture sites for different procedures, reducing tissue damage while maintaining ease of needle positioning and access
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
This method reduces procedural risks and enhances therapeutic delivery precision, enabling minimally invasive cardiac repair with reduced recovery time and lower costs, while allowing for real-time monitoring and controlled injection timing.
Implementation Method 1
a hydrodynamic system may employ a precision pump to control injectate delivery
Implementation Method 2
the at least one probing device may be a conductive probe that measures bio-impedance of the myocardium
Implementation Method 3
the at least one probing device may be a fiber angioscope producing real time images
Data Source
AI summary
Described herein are devices and methods for performing automated and minimally invasive intramyocardial injections for cardiac repair that eliminate the need for opening the chest cavity for injections of therapeutics to the heart muscle to address heart attack, cardiomyopathy or myocardial diseases and can detect diseased tissue and deliver a specified volume of a therapeutic injectate to the region of interest.