Laminate Probe Biostimulator for Controlled Deep Septal Pacing
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Solution Overview
Problem
Existing pacing leads are not well suited for deep septal pacing, as they lack the ability to control penetration into the target tissue, are prone to buckling or causing tissue trauma, and often require multiple attempts for successful placement.
Innovation Solution
A biostimulator with a flexible probe having a laminated structure, comprising a conductive layer on a substrate layer, which allows for controlled penetration and compliance with tissue, reducing the risk of trauma and facilitating precise placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If existing pacing leads are used for deep septal pacing, then the leads can reach the target tissue, but they are prone to buckling or causing tissue trauma due to lack of flexibility control
Solution Approach 1:
The pacing lead incorporates a flexible body constructed from a laminate structure comprising a substrate layer and a conductive layer. This flexible construction allows the lead to bend and conform to tissue contours during insertion and positioning, reducing mechanical trauma to the septal wall while maintaining sufficient structural integrity to reach deep septal targets. The flexible body can flex without buckling, enabling smooth navigation through tissue.
Solution Approach 2:
The lead employs a composite laminate structure combining a substrate layer (提供机械强度) and a conductive layer (提供导电功能). This composite construction integrates both structural support and electrical functionality in a single flexible component, allowing the lead to be both strong enough to maintain integrity during insertion and flexible enough to comply with tissue geometry, thereby reducing trauma.
2Productivity
If existing pacing leads are used for deep septal pacing, then the leads can penetrate the septum, but they require several attempts at placement before the target region is engaged
Solution Approach 1:
The flexible body of the lead can be easily manipulated and repositioned during the procedure. Its flexibility allows for smooth adjustments without causing tissue damage, enabling operators to achieve correct positioning in fewer attempts. The lead can be advanced, retracted, and repositioned smoothly to reach the deep septal target region efficiently.
Solution Approach 2:
The lead transitions from a rigid structure to a dynamically flexible structure that can adapt its shape during insertion and positioning. This dynamic flexibility allows the lead to respond to anatomical variations and achieve proper positioning more reliably on the first attempt, reducing the need for multiple insertion attempts and minimizing procedure time.
3Ease of operation
If existing pacing leads are used for deep septal pacing, then the leads can provide electrical stimulation, but they are either too flimsy or too stiff, making them unsuitable for controlled penetration
Solution Approach 1:
The laminate structure combining substrate layer and conductive layer creates a composite material with optimized mechanical and electrical properties. The substrate provides structural support for controlled penetration, while the conductive layer ensures reliable electrical stimulation. This composite construction eliminates the need to choose between too flimsy or too stiff leads, achieving both ease of controlled insertion and placement accuracy.
Solution Approach 2:
The lead's physical parameters (flexibility, stiffness, conductivity) are optimized through the laminate construction. By adjusting the properties of the substrate and conductive layers, the lead achieves an optimal balance between flexibility for controlled manipulation and structural integrity for accurate placement. This parameter optimization enables precise control during penetration while ensuring reliable electrical function.
Data Source
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AI summary
A biostimulator (100) includes a housing (202), a fixation element (106), and a probe (108). The housing (202) includes an electronics compartment (206) containing circuitry. The fixation element (106) is coupled to the housing (202). The probe (108) is coupled to the housing (202) and electrically connected to the circuitry. The probe (108) includes a flexible body (220) extending to a tip (222). The flexible body (220) includes a conductive layer (404) laminated on a substrate layer (406). Other embodiments are also described and claimed.