Implantable Lead Fixation via Shape Memory Alloy Dynamics
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing implantable medical electrical leads for sacral nerve stimulation face challenges in maintaining electrode contact and stability, leading to potential migration and dislodgement, which affects the efficacy of the treatment for pelvic floor disorders like urinary incontinence.
Innovation Solution
The development of an implantable medical electrical lead with a modifiable portion that transitions from a first configuration with axial tension to a second configuration, providing increased resistance to movement within the body tissue, thereby enhancing fixation and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If a fixation mechanism is employed to prevent lead migration, then lead stability is improved, but device complexity increases
Solution Approach 1:
The lead incorporates a shape memory alloy section that can dynamically change its configuration between a compressed first configuration during implantation and an expanded second configuration for fixation. This dynamic transformation allows the lead to adapt its mechanical properties in response to environmental conditions (temperature, axial tension) rather than requiring complex active control mechanisms, thereby improving stability while managing device complexity
Solution Approach 2:
The fixation mechanism utilizes parameter changes in the shape memory alloy's physical state. When exposed to body temperature and axial tension, the alloy transitions from an austenitic phase to a martensitic phase, changing its shape and rigidity. This parameter change enables the lead to achieve stable fixation without requiring additional power sources or control systems, resolving the contradiction between stability and device complexity
2Strength
If the lead configuration is modified to increase fixation resistance, then resistance to movement is improved, but ease of operation during implantation deteriorates
Solution Approach 1:
The lead's shape memory alloy section provides dynamic mechanical properties that adapt during the implantation process. During implantation, the alloy is in a compliant first configuration that allows easy manipulation and positioning. After implantation, environmental triggers cause it to transform into a rigid second configuration that provides strong fixation resistance, thus resolving the contradiction between ease of operation and strength
Solution Approach 2:
The lead is pre-configured in a compressed first configuration that facilitates easy implantation and positioning. This preliminary state is intentionally designed to be more compliant and easier to manipulate. Once in position, the lead automatically transforms to its second configuration for fixation, eliminating the need for separate implantation and fixation procedures and maintaining ease of operation while achieving strong fixation
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 solution improves the stability and resistance of the lead within the body tissue, reducing the risk of migration and dislodgement, thus enhancing the efficacy of sacral nerve stimulation for treating pelvic floor disorders.
Implementation Method 1
the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion
Data Source
AI summary
The invention includes a 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 has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration. Kits, and systems and methods of using the lead are also included.