Leadless Biostimulator Feedthrough With Integrated Electrode Cup
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Solution Overview
Problem
Conventional pacemakers have drawbacks such as risk of lead or feedthrough pin breakage, complex connections, and risk of infection due to separate leads and pulse generator components.
Innovation Solution
The development of a leadless biostimulator with an electrical feedthrough assembly that includes a monolithic electrode body with a cup and pin integral to each other, an insulator, a flange, and a gasket, which provides a self-contained and self-sustainable pacing solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional pacemakers use separate leads and pulse generator components, then the device can provide electrical stimulation, but the risk of lead breakage and infection increases
Solution Approach 1:
The patent combines the pulse generator, electrodes, and feedthrough assembly into a single integrated leadless biostimulator device. The electronics assembly is housed within the same hermetic seal as the electrode assembly, eliminating the need for separate leads and reducing connection points that could fail. This merging of components directly addresses the reliability issue by removing lead breakage risks while simplifying the overall device structure.
2Reliability
If conventional pacemakers use separate leads and pulse generator components, then the device can provide electrical stimulation, but the risk of infection increases
Solution Approach 1:
The integration of all components within a single hermetically sealed housing eliminates multiple implantation sites and connection points, thereby reducing the risk of infection. The feedthrough assembly provides a sealed transition from internal to external components without creating vulnerable interfaces.
Solution Approach 2:
The patent converts the potential harm of having multiple components into a benefit by using a hermetic seal that protects all internal components from environmental exposure. The feedthrough assembly allows necessary external connections while maintaining the hermetic barrier, thus protecting against infection while enabling device functionality.
3Volume of moving object
If conventional feedthroughs are used in leadless biostimulators, then the device can be compact, but the feedthrough may not include features needed for therapeutic agent delivery
Solution Approach 1:
The feedthrough assembly is designed to serve multiple functions: providing electrical connections, maintaining hermetic seal, and enabling therapeutic agent delivery. The cup structure of the electrode assembly can contain filler material for drug delivery, while the same structure provides the feedthrough function. This multi-functionality allows the compact device to achieve both size reduction and enhanced versatility.
Solution Approach 2:
The patent merges the feedthrough structure with the electrode assembly, creating a unified component that performs both electrical feedthrough and therapeutic agent delivery functions. The cup-shaped electrode assembly can house filler material, combining the electrical and pharmacological functions into a single integrated structure.
Data Source
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AI summary
A leadless biostimulator including an electrical feedthrough assembly (100) mounted on a housing (110) is described. An electronics compartment (202) of the housing (102) can contain an electronics assembly (202), and the electrical feedthrough assembly (100) can include an electrode body (302, 700, 800,1302, 1402, 1502, 1602, 1802) including an electrode wall (502, 1310, 1410, 1510, 1610, 1810) extending distally from an electrode base (504, 1312, 1412, 1512, 1612, 1812) around an electrode cavity (506, 1314, 1414, 1514, 1614, 1814), an electrode tip (304, 1304, 1404, 1504, 1604, 1704, 1804) mounted on a distal end of the electrode body (302, 700, 800, 1302, 1402, 1502, 1602, 1802), a filler (416, 1316, 1416, 1516, 1616, 1816) including a therapeutic agent in the electrode cavity (506,1314,1414,1514,1614,1814) between the electrode base (504,1312,1412, 1512, 1612, 1812) and the electrode tip (304, 1304, 1404, 1504, 1604, 1704, 1804), and one or more holes (418, 1002) in at least one of the electrode body (302) or the electrode tip (304, 1304, 1404, 1504, 1604, 1704, 1804). The one or more holes (418, 1002) are configured to deliver the therapeutic agent to the target tissue when the therapeutic agent elutes from the filler (416, 1316, 1416, 1516, 1616, 1816) and passes through the one or more holes (418, 1002).