Extravascular Lead Implant Pathway for Single-Incision Defibrillation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods of implanting subcutaneous defibrillation leads require multiple incisions on the patient's torso, increasing the risk of infection, procedural complexity, and cost, while aiming to reduce surgical invasiveness.
Innovation Solution
A method and system for creating a pathway using a first and second medical device to advance through subcutaneous tissue, deflecting the distal end of the first device toward a high sternal area, and positioning a sheath to span the incision points, allowing for a single incision implantation of a defibrillation lead.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple incision points are made on the patient's torso to implant a subcutaneous defibrillation lead, then the lead can be positioned to effectively stimulate the heart, but the risk of infection, procedural complexity, and cost increase
Solution Approach 1:
The patent employs a nested device architecture where an inner medical device is inserted through the lumen of an outer medical device. The outer device serves as an introducer that guides the inner device through the subcutaneous tissue pathway, allowing both devices to work together through a single incision. This nesting approach eliminates the need for multiple separate incisions while maintaining the ability to position the defibrillation lead effectively.
Solution Approach 2:
The outer medical device acts as an intermediary tool that facilitates the insertion and positioning of the inner medical device. By using this intermediate introducer device, the patent enables complex lead positioning through a simplified single-incision approach, reducing direct tissue exposure and associated infection risks.
2Reliability
If multiple incision points are made on the patient's torso to implant a subcutaneous defibrillation lead, then the lead can be positioned to effectively stimulate the heart, but the procedural complexity increases
Solution Approach 1:
The patent employs a nested device architecture where an inner medical device is inserted through the lumen of an outer medical device. The outer device serves as an introducer that guides the inner device through the subcutaneous tissue pathway, allowing both devices to work together through a single incision. This nesting approach eliminates the need for multiple separate incisions while maintaining the ability to position the defibrillation lead effectively.
Solution Approach 2:
The patent divides the implantation procedure into distinct phases using segmented devices. The outer device handles the initial pathway creation and guidance, while the inner device performs the final lead positioning. This segmentation allows each device to be optimized for its specific function, simplifying the overall procedure despite the complexity of achieving precise lead positioning through a single incision.
3Reliability
If multiple incision points are made on the patient's torso to implant a subcutaneous defibrillation lead, then the lead can be positioned to effectively stimulate the heart, but the cost increases
Solution Approach 1:
The patent employs a nested device architecture where an inner medical device is inserted through the lumen of an outer medical device. The outer device serves as an introducer that guides the inner device through the subcutaneous tissue pathway, allowing both devices to work together through a single incision. This nesting approach eliminates the need for multiple separate incisions while maintaining the ability to position the defibrillation lead effectively.
Solution Approach 2:
The patent merges the functions of multiple incisions into a single procedural step by using the outer device as an introducer. This consolidation of access points reduces surgical time, anesthesia requirements, and postoperative care needs, thereby reducing overall procedural costs while maintaining effective lead positioning.
4Reliability
If multiple incision points are made on the patient's torso to implant a subcutaneous defibrillation lead, then the lead can be positioned to effectively stimulate the heart, but the invasiveness of the procedure increases
Solution Approach 1:
The patent employs a nested device architecture where an inner medical device is inserted through the lumen of an outer medical device. The outer device serves as an introducer that guides the inner device through the subcutaneous tissue pathway, allowing both devices to work together through a single incision. This nesting approach eliminates the need for multiple separate incisions while maintaining the ability to position the defibrillation lead effectively.
Solution Approach 2:
The outer medical device acts as an intermediary tool that facilitates the insertion and positioning of the inner medical device. By using this intermediate introducer device, the patent enables complex lead positioning through a simplified single-incision approach, reducing direct tissue exposure and associated infection risks.
Data Source
AI summary
Methods for creating a pathway for an implantable defibrillation lead within a patient, the patient having a torso with a center, left side, and a high sternal area. The method comprises creating an incision at a first location on the left side of the torso, advancing a first medical device and a second medical device through the incision and through the subcutaneous tissue toward a second location proximate the center of the torso, deflecting a distal end of the first medical device at the second location toward a third location proximate the high sternal area, advancing a distal portion of the second medical device out through the distal end of the first medical device toward the third location, and positioning a sheath within the torso, the sheath spanning a distance between the first location and the second location and a distance between the second location and the third location.