Integrated Pacemaker Lead Assembly for Pediatric Epicardial Implantation
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Solution Overview
Problem
Current epicardial pacemaker systems face high risks of lead fracture due to conductor fracture, particularly in pediatric patients, and the transition to transvenous or leadless systems is challenging due to rapid patient growth and vessel size limitations, with leadless pacemakers posing additional risks.
Innovation Solution
A pacemaker system with an integrated lead that includes a proximal pacemaker portion and a distal extension with a fixation element and electrode, allowing for epicardial implantation, reducing the risk of lead fracture and enabling versatile placement within the rib cage, suitable for pediatric patients.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If abdominal IPG placement is used in pediatric patients, then the IPG can be implanted, but the risk of lead fracture increases significantly
Solution Approach 1:
The pacemaker system is divided into two separate implantable components: a leadless pacemaker portion and a separate lead with fixation element. This segmentation allows the pacemaker to be delivered transvenously to the heart while the lead can be positioned epicardially, reducing lead fracture risk by eliminating the need for long subcutaneous leads crossing the abdomen
Solution Approach 2:
A delivery catheter serves as an intermediary tool to deliver the leadless pacemaker portion transvenously through the femoral vein to the right ventricle. This intermediary delivery system enables minimally invasive implantation without requiring abdominal incisions or long subcutaneous leads, thereby reducing lead fracture risk
2Reliability
If transvenous or leadless systems are used in pediatric patients, then lead fracture risk is reduced, but vessel size limitations prevent implantation in smaller patients
Solution Approach 1:
The system provides a dynamic solution that adapts to changing patient needs over time. The initial epicardial lead configuration can be used in infants and small children, and as the patient grows, the system can be transitioned to a transvenous or leadless configuration, making the solution adaptable across different patient size categories and developmental stages
Solution Approach 2:
The pacemaker system is designed to serve multiple functions and patient populations. It can be implanted in both infants and adults, accommodates different implantation approaches (epicardial or transvenous), and can transition from leaded to leadless configurations, providing a universal solution for pediatric pacing needs across all age groups
3Ease of operation
If leadless pacemakers are used in pediatric patients, then implantation is simplified, but the risk of vessel occlusion or tears increases
Solution Approach 1:
The system uses a partial approach by delivering only the necessary portion of the pacemaker (leadless portion) transvenously to the heart, while the lead component is positioned epicardially. This partial transvenous approach simplifies implantation compared to traditional leaded systems while avoiding the excessive transvenous delivery required for complete leadless pacemakers, thereby reducing vessel trauma risk
4Adaptability or versatility
If excessive lead slack is implanted to compensate for rapid growth, then patient growth is accommodated, but the risk of cardiac strangulation and acute bending increases
Solution Approach 1:
By segmenting the pacemaker into a leadless portion delivered to the heart and a separate epicardial lead, the system eliminates the need for excessive subcutaneous lead slack. The epicardial lead can be positioned optimally on the heart surface, accommodating growth without creating dangerous loops or slack that could cause strangulation or acute bending
Solution Approach 2:
The problematic subcutaneous lead portion is extracted from the system and replaced with an epicardial lead configuration. This removes the source of excessive slack and bending risks while maintaining the ability to accommodate patient growth through proper epicardial lead positioning and tension management
Data Source
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AI summary
A pacemaker device (400) including a pacemaker portion (402) and an integrated connector (2904). The pacemaker device (400) includes a housing assembly (3316, 4300) defining a plurality of housings (3302, 3304, 4302, 4304, 4306, 4308) for containing pacing electronics, battery material and a connector (2904, 4904). The connector (2904, 4904) is enclosed within the housing (3304, 4304, 4308) and is configured to receive a lead (3202) which is electrically connectable with the pacing electronics. The pacemaker device (400) may include a leadless pacemaker (102) inserted in the housing assembly (3316) configured to convert the leadless pacemaker (102) into a leaded configuration. The leadless pacemaker (102) may be removably attached from the pacemaker device (400) and replaced with another leadless pacemaker (102).