Implantable Lead Fixation via Inflatable Modifiable Portion
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing implantable medical electrical leads for sacral nerve stimulation face challenges in maintaining electrode contact and preventing migration, as current fixation mechanisms are not sufficient to ensure consistent and effective stimulation over time.
Innovation Solution
An implantable medical electrical lead with a modifiable portion that can transition between a deflated and inflated configuration, providing increased resistance to movement within the body tissue, utilizing a fluid conduit to inflate and secure the lead in place, thereby enhancing fixation and reducing migration risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the lead body is fixed to retard migration and dislodgement of electrodes, then electrode positioning stability is improved, but the lead body movement is restricted
Solution Approach 1:
The lead incorporates a modifiable portion that can dynamically change configuration between deflated and inflated states. When deflated, the lead body can move freely for implantation and positioning. When inflated, the modifiable portion expands to provide fixation and prevent migration, thus resolving the contradiction between stability and movement by making the system adaptable to different operational phases
Solution Approach 2:
The modifiable portion changes its physical state parameter (volume) by transitioning between deflated and inflated configurations. This parameter change allows the lead to switch between a mobile state during implantation and a fixed state during operation, simultaneously satisfying the requirements for ease of operation and electrode positioning stability
2Reliability
If traditional fixation mechanisms are used to secure the lead, then migration is prevented, but surgical complexity increases
Solution Approach 1:
The lead provides its own fixation mechanism through the modifiable portion that can be inflated to secure itself within the tissue. This self-fixation capability eliminates the need for external surgical fixation techniques such as sutures or anchors, thereby improving reliability while reducing surgical complexity
Solution Approach 2:
The patent replaces traditional mechanical fixation systems (sutures, anchors, or external fixation devices) with an integrated inflatable modifiable portion. This substitution simplifies the overall system by incorporating the fixation function directly into the lead structure, reducing the number of separate components and surgical steps required
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 modifiable lead configuration ensures stable electrode positioning and effective stimulation by increasing resistance to movement, minimizing the need for surgical fixation techniques and improving the longevity of the neurostimulation therapy.
Implementation Method 1
adding fluid to the fluid conduit to transition the at least one modifiable portion from the deflated configuration to the inflated configuration
Data Source
AI summary
An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion wherein the at least one modifiable portion can exist in both a deflated configuration and an inflated configuration, and wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration. Kits, systems, and methods of using the leads are also included.