Implantable Lead Adapter Matrix for Stable Sacral Nerve Stimulation
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Solution Overview
Problem
Current implantable electrical stimulation systems for sacral nerve stimulation face challenges in maintaining optimal electrode placement and preventing dislodgement, leading to inconsistent nerve stimulation and potential nerve injury, especially in ambulatory patients.
Innovation Solution
An adapter matrix is introduced to operably couple a neurostimulator IPG with nonstandard implantable medical leads, providing a bridge for electrical communication and stabilizing the electrode placement through a switch matrix and power source, allowing for flexible interfacing with various lead configurations and minimizing surgical trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a temporary neurostimulation lead is implanted through the skin and connected with a temporary external pulse generator, then the lead can be easily removed and repositioned, but the lead is prone to dislodgement and requires frequent surgical intervention for repositioning
Solution Approach 1:
The patent introduces a connector assembly as an intermediary component between the lead and the pulse generator. This connector assembly includes a connector body with a receiving chamber that securely holds the lead, and a connector element that interfaces with the pulse generator. The intermediary connector provides stable mechanical coupling while allowing for controlled disconnection and reconnection, thus maintaining ease of operation while improving placement stability.
Solution Approach 2:
The connector assembly is pre-configured with alignment features, such as alignment pins and corresponding alignment holes, that guide the lead into the correct position before connection. The connector body is designed with a receiving chamber that pre-positions the lead electrode, ensuring proper alignment with the pulse generator before final connection. This preliminary action prevents misalignment and reduces the need for frequent repositioning.
2Reliability
If a permanent neurostimulation lead is implanted and connected with an implantable pulse generator, then the lead provides stable long-term stimulation, but the surgical procedure is more complex and requires larger surgical exposure
Solution Approach 1:
The patent divides the implantable system into separate modular components: the pulse generator, the connector assembly, and the lead. The connector assembly is implanted separately from both the pulse generator and the lead, creating a modular system. This segmentation allows each component to be implanted through smaller incisions and simplifies the surgical procedure while maintaining long-term stability through the secure connector design.
Solution Approach 2:
The connector assembly includes a connector body with a receiving chamber that houses the lead connector element. The lead connector is nested within the connector body, and the entire connector assembly is then connected to the pulse generator. This nested structure consolidates multiple connection points into a single implantable unit, reducing surgical complexity while ensuring stable long-term connections.
3Stability of the object's composition
If the lead is secured by suturing the lead body to subcutaneous tissue, then the lead position is stabilized, but the electrode can still be dislodged from the optimal location due to stresses on the lead
Solution Approach 1:
The connector assembly acts as an intermediary that decouples the stabilization function from the electrode position. The connector body is sutured to the tissue to provide stable anchoring, while the lead can be independently positioned and secured within the receiving chamber. This intermediary structure allows the lead body to be stabilized without directly suturing the electrode, preventing dislodgement while maintaining optimal electrode placement.
Solution Approach 2:
The connector assembly is positioned and secured to the tissue before the lead is fully connected. The receiving chamber is pre-positioned at the optimal location, and the lead is then inserted and secured within this pre-positioned chamber. This preliminary action ensures that the electrode reaches its optimal position before stabilization, preventing subsequent dislodgement while maintaining placement consistency.
Data Source
AI summary
An implantable electrical stimulation medical system is disclosed. The system includes an implantable medical device having electrical circuitry configured to perform electrical stimulation, a nonstandard implantable medical lead, and an adapter matrix. The adapter matrix electrically interfaces with the electrical circuitry and the nonstandard implantable medical lead to provide electrical stimulation from the implantable medical device to the nonstandard implantable medical lead.