Steerable Epicardial Pacing Catheter for Minimally Invasive Lead Placement
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Solution Overview
Problem
Current methods for placing left ventricular leads for biventricular pacing are invasive, have high failure rates due to anatomical challenges, and require surgical intervention, limiting the procedure's accessibility and efficiency.
Innovation Solution
A steerable epicardial pacing catheter system that allows for minimally invasive placement of leads on the left ventricle and other cardiac chambers via a subxiphoid approach, using a catheter with insulated electrodes and wireless communication with a pacemaker, enabling pacing without surgical incisions and accommodating varying heart anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a lead is placed through the right atrium using a venous system and passed through the coronary sinus to reach the left ventricle, then the procedure can be performed without surgical incisions, but the procedure has high failure rates due to anatomical challenges and limited accessibility to optimal pacing locations
Solution Approach 1:
The patent introduces a steerable catheter as an intermediary device that can navigate through the coronary sinus and deliver the lead to optimal locations on the left ventricle. The catheter's steering capability allows it to overcome anatomical challenges by selectively navigating to appropriate venous pathways and target sites, thereby improving procedure success rates while maintaining minimally invasive access
Solution Approach 2:
The catheter incorporates steerable functionality that allows dynamic adjustment of its trajectory during the procedure. This dynamic steering capability enables the operator to adapt to varying anatomical configurations and reach optimal pacing locations that would be inaccessible with fixed-path approaches, thus improving both reliability and versatility
2Adaptability or versatility
If surgical intervention is performed to place left ventricular leads, then optimal placement locations can be accessed, but the procedure becomes more invasive with longer recovery time
Solution Approach 1:
The steerable catheter acts as an intermediary tool that bridges the gap between minimally invasive access and the ability to reach optimal placement locations. It enables cardiologists to access difficult-to-reach areas on the left ventricle through the coronary sinus without requiring surgical thoracotomy or sternotomy, thereby maintaining procedure simplicity while expanding access to optimal sites
Solution Approach 2:
The dynamic steering mechanism of the catheter provides the adaptability needed to reach optimal placement locations that would otherwise require surgical intervention. By allowing real-time trajectory adjustment, the catheter can navigate complex anatomical pathways and access lateral and posterior left ventricular sites without surgical incisions
3Ease of manufacture
If the lead is constrained to follow venous pathways like a railroad track, then the lead can be placed through existing anatomical structures, but the placement location becomes unpredictable and limited
Solution Approach 1:
The steerable catheter introduces dynamic control over the lead's final position, allowing the operator to direct the lead to specific target locations on the left ventricle. This overcomes the static constraint of venous pathways by enabling active steering to predetermined optimal sites, thereby achieving both anatomical guidance and location flexibility
Solution Approach 2:
The system changes the parameter of lead placement control from passive following of venous anatomy to active steering capability. By modifying the catheter's navigational parameters through steering mechanisms, the operator can adjust the final lead position to match optimal pacing locations regardless of venous pathway variations
4Adaptability or versatility
If the procedure time becomes unpredictable due to anatomical variations, then individual patient cases can be accommodated, but hospital and doctor planning becomes difficult
Solution Approach 1:
The steerable catheter provides dynamic control that accelerates the navigation process by allowing direct steering to target locations rather than relying on gradual catheter manipulation through tortuous vessels. This reduces the time needed to overcome anatomical variations and achieve optimal lead placement, making procedure duration more predictable
Data Source
AI summary
The epicardial pacing system and related method includes an epicardial catheter configured to be disposed in the middle mediastinum of the thorax of a subject for use in electrical pacing of the heart at one or more locations on the epicardial surface. The epicardial pacing catheter may include at least one electrode whereby the electrode is insulated on at least one side to allow pacing of the heart without damage to adjacent anatomical structures.