Leadless Neurostimulation Device with Integrated Electrodes
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Solution Overview
Problem
Existing implantable medical devices for neurostimulation often require separate leads, which can be invasive and less robust compared to leadless solutions.
Innovation Solution
A minimally invasive, leadless neurostimulation device with a unitary structure, featuring a housing with a secondary electrode and an attached header unit with primary electrodes, designed to provide electrical stimulation therapy without the need for separate leads.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate leads with electrodes are used for neurostimulation, then electrical stimulation therapy can be provided, but the device becomes more invasive and less robust
Solution Approach 1:
The patent merges the lead and housing into a single unitary structure where the housing itself forms the electrode assembly. The housing includes a first electrode on its distal end and a second electrode on its proximal end, eliminating the need for separate leads. This integration reduces the number of components, decreases invasiveness during implantation, and improves overall device robustness by removing the interface between lead and housing that could fail.
2Device complexity
If separate leads are used for neurostimulation, then electrical stimulation can be delivered, but the device complexity increases
Solution Approach 1:
The patent combines multiple functions into the single housing structure: the housing provides structural support, contains the battery and control electronics, and forms the electrode assembly for stimulation. The first and second electrodes are integrated directly into the housing walls, eliminating the need for separate lead wires and connections. This reduces device complexity while maintaining stimulation effectiveness through the integrated electrode-housing interface.
3Object-affected harmful factors
If lead-based neurostimulation devices are used, then electrical stimulation therapy is provided, but patient safety is compromised
Solution Approach 1:
The patent eliminates the potential safety hazards associated with separate leads by integrating the electrodes directly into the housing structure. This removes the risk of lead displacement, lead breakage, and improper lead-housing connections that could compromise patient safety. The unitary structure ensures consistent electrical contact and reduces the risk of infection at lead insertion sites, thereby improving both patient safety and stimulation therapy reliability.
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 device offers a more robust and less invasive option for neurostimulation, allowing for effective electrical stimulation therapy, such as for treating overactive bladder and pain, with improved patient safety and satisfaction.
Implementation Method 1
a dielectric mount that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode, the dielectric mount being configured to electrically insulate the at least one primary electrode from the outer housing
Implementation Method 2
the at least one primary electrode and the secondary electrode being configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a tibial nerve of a patient
Data Source
AI summary
A leadless neurostimulation device including a header unit having at least one primary electrode having a contact surface that defines an external surface on a side of the device, an outer housing that forms a side of the header unit opposite of the contact surface of the primary electrode, and a dielectric mount that receives at least a portion of the primary electrode and at least partially surrounds the primary electrode, the dielectric mount being configured to electrically insulate the primary electrode from the outer housing, the dielectric mount being received and fixed within a recessed portion of the outer housing, and a housing having a secondary electrode positioned on the same side of the leadless neurostimulation device as the primary electrode, the primary electrode and the secondary electrode being configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a tibial nerve of a patient.