Extravascular Lead Deployment via Fluid-Assisted Tunneling
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Solution Overview
Problem
Traditional implantable cardiac defibrillator systems with transvenous leads face challenges in patients with difficult vascular access and lead revision due to fibrosis, prompting the need for extravascular ICD systems where leads are implanted outside the vascular system, such as in subcutaneous or sub-sternal locations, which requires efficient tunnel creation methods.
Innovation Solution
A system and method for deploying implantable medical electrical leads to extravascular locations using a tunneling tool with a pressure sensor assembly and fluid supply assembly, including a flow-controlled passageway and compliant chamber, to create and maintain tunnels in sub-sternal spaces, ensuring accurate pressure monitoring and fluid flow to prevent air entry and infection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If transvenous leads are used for ICD systems, then vascular access is required for lead placement, but this precludes placement in patients with difficult vascular access
Solution Approach 1:
The patent extracts the lead from the vascular system entirely, creating an extravascular ICD system where leads are placed in subcutaneous or sub-sternal spaces rather than through veins. This eliminates the vascular access requirement while maintaining ICD functionality.
2Duration of action of stationary object
If transvenous leads are implanted in the heart, then lead revision and extraction become challenging over time, but this makes long-term maintenance difficult
Solution Approach 1:
By extracting the lead from the heart and vascular system to an extravascular location, the patent eliminates fibrosis-related complications. The lead remains permanently implanted without becoming encased in fibrous tissue, making future revision or extraction significantly easier while maintaining long-term functionality.
3Adaptability or versatility
If tunnels are created in extravascular locations for lead deployment, then leads can be placed outside the vascular system, but this creates challenges in tunnel creation and maintenance
Solution Approach 1:
The patent employs a fluid supply assembly with a flow-controlled passageway that delivers fluid through the tunneling tool lumen during tunnel creation. This hydraulic approach lubricates the tunnel path, reduces friction, and prevents tissue collapse, significantly simplifying the tunnel creation process while enabling reliable extravascular lead placement.
Solution Approach 2:
The patent incorporates a pressure sensor assembly mounted in the tunneling tool handle that monitors fluid pressure in real-time during tunnel creation. This feedback mechanism allows the operator to detect tunnel formation progress, tissue resistance changes, and potential complications, enabling precise control and reducing the complexity of tunnel creation.
4Ease of operation
If fluid flow is used during tunnel creation, then tunnel formation is facilitated, but this requires complex fluid management systems
Solution Approach 1:
The patent merges the fluid supply assembly with the tunneling tool itself, integrating the flow-controlled passageway and pressure sensor assembly directly into the tool structure. This consolidation simplifies the overall system by eliminating separate fluid management components while maintaining the benefits of fluid-assisted tunnel creation.
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
The system effectively deploys implantable medical electrical leads to extravascular locations by creating stable tunnels with pressure monitoring and fluid management, reducing the risk of air entry and infection, and facilitating lead placement outside the vascular system, addressing the limitations of traditional transvenous lead systems.
Implementation Method 1
a pressure sensor assembly mounted in a handle of the tool... the operator can monitor, via a display of the pressure sensor assembly, a change in a pressure of the flow, as measured by a pressure transducer of the pressure sensor assembly
Implementation Method 2
the compliant chamber located at an elevation lower than that of the tunnel created by the tunneling tool, so that when the operator withdraws the shaft of the tunneling tool from the lumen of the introducer, after creating the tunnel within the sub-sternal space, fluid from a reserve of fluid filling the compliant chamber is drawn into the lumen of the introducer
Data Source
AI summary
A reservoir of a system for deploying an implantable lead to an extravascular location delivers a flow of fluid through a lumen of one or both of a tunneling tool and an introducer of the system. In some cases, the tunneling tool includes a pressure sensor assembly for monitoring a change in a pressure of the flow through the lumen thereof. Alternately, or in addition, a flow-controlled passageway, through which the flow of fluid from the reservoir is delivered to the lumen of the introducer, includes a compliant chamber to hold a reserve of the fluid. Fluid from the reserve may be drawn into the lumen of the introducer as the tunneling tool is withdrawn therefrom. Alternately, the introducer may include a chamber located between two seals, wherein fluid that fills the chamber is drawn distally into the lumen of the introducer, as the tunneling tool is withdrawn therefrom.