Percutaneous Electrode Wrapping Peripheral Nerve
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Solution Overview
Problem
Current methods for delivering therapies to peripheral nerve tissue and vascular tissue are limited in their ability to effectively manage pain and trauma-related conditions, as they often require invasive procedures and lack precise targeting and drug delivery mechanisms.
Innovation Solution
The development of a method and system for percutaneously wrapping a lead with an electrode at least 180 degrees around a peripheral nerve, using shape-memory wires and ultrasound-guided placement, to deliver electrical stimulation and drugs such as GABA agonists or anti-inflammatory agents, while minimizing tissue trauma and improving accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If percutaneous lead placement is used to wrap around peripheral nerve, then invasiveness is reduced and tissue trauma is minimized, but placement precision and control are worsened
Solution Approach 1:
The patent replaces traditional mechanical open-surgical lead placement with percutaneous insertion through the skin, using a needle-like introducer to deliver the lead directly to the nerve. This substitution of the mechanical access method reduces tissue trauma while maintaining placement precision through image guidance and controlled deployment mechanisms.
Solution Approach 2:
The patent introduces an intermediate delivery system consisting of an introducer needle and deployment mechanism that facilitates precise lead placement through percutaneous access. This intermediary system allows the lead to be delivered accurately to the target nerve while minimizing direct surgical intervention and tissue disruption.
2Reliability
If lead is wrapped at least 180 degrees around peripheral nerve, then therapeutic contact with nerve is improved, but lead complexity and deployment difficulty increase
Solution Approach 1:
The patent employs a dynamic lead design that can transition from a linear configuration during insertion to a curved or wrapped configuration around the nerve after deployment. This dynamic adaptability allows the lead to achieve the required 180-degree wrap for reliable therapeutic contact while maintaining simplicity during the insertion phase, thereby reducing deployment complexity.
Solution Approach 2:
The patent utilizes a nested delivery system where the lead is contained within an introducer needle during insertion, and then deployed in a controlled manner to wrap around the nerve. This nesting approach simplifies the insertion process by keeping the complex curved lead configuration compact during delivery, while enabling the lead to assume its functional wrapped shape at the target site.
3Adaptability or versatility
If shape-memory wire is used to form curved lead configuration, then lead flexibility and adaptability are improved, but manufacturing complexity increases
Solution Approach 1:
The patent utilizes shape-memory alloy wires that can change their physical parameters (shape, curvature) in response to temperature or other environmental stimuli. This parameter change capability allows the lead to be manufactured in a simple linear form, inserted through the percutaneous approach, and then transformed into the required curved configuration around the nerve, thereby improving flexibility while managing manufacturing complexity.
Solution Approach 2:
The patent employs composite construction combining shape-memory alloy wires with insulating and conductive materials to create a lead that integrates structural flexibility with electrical functionality. This composite approach allows the lead to achieve the desired adaptability and curved configuration while maintaining manufacturability through established composite material fabrication techniques.
4Manufacturing precision
If ultrasound guidance is used for lead placement, then placement accuracy is improved, but procedure complexity and time increase
Solution Approach 1:
The patent replaces traditional open-surgical visual and tactile guidance with ultrasound imaging guidance for lead placement. This substitution provides real-time visual feedback on lead position relative to the nerve, improving placement accuracy while reducing the need for complex surgical dissection and direct visualization, thereby managing procedure complexity.
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
This approach allows for minimally invasive, precise delivery of therapies to nerve and vascular tissues, reducing trauma and improving pain management by enabling targeted electrical stimulation and drug release, thus enhancing treatment efficacy for conditions like peripheral nerve pain.
Implementation Method 1
The lead can comprise a shape-memory material. The shape-memory material can be nitinol.
Implementation Method 2
applying electrical stimulation to the peripheral nerve via the electrode
Implementation Method 3
The lead can comprise the ability to release a drug into the mammal. The drug can be eluted from the lead over time.
Data Source
AI summary
This document relates to methods and materials involved in delivering therapies to target tissue (e.g., a peripheral nerve). For example, methods and materials for placing and subsequently using leads to deliver electrical and/or drug therapies to target tissues (e.g., nerves and/or arteries) are provided.