Actively Deployable Fixation Clip for Implantable Leads
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Solution Overview
Problem
Existing electrical stimulation systems face challenges in maintaining the position of implantable medical leads near target tissue sites, such as occipital and trigeminal nerves, to ensure effective therapy delivery and prevent nerve damage due to lead migration.
Innovation Solution
An actively deployable fixation clip is integrated with the implantable medical device, which changes shape from an undeployed to a deployed state to engage with surrounding tissue, securely fixing the lead's position near the target site and potentially serving as an electrode for therapy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a stimulation lead is implanted to deliver electrical stimulation therapy to a target site, then electrical stimulation therapy can be delivered to treat various conditions, but the lead may migrate from the target site causing inadequate stimulation and unreliable therapy
Solution Approach 1:
The fixation clip is pre-formed in a compressed configuration that allows it to be delivered through the lead lumen along with the implantable medical device. The clip is preliminarily positioned at the target site before active deployment, ensuring proper placement before it expands to engage the tissue and secure the lead in position.
Solution Approach 2:
The fixation clip transitions from a static compressed state during delivery to an active expanded state at the target site. This dynamic transformation allows the clip to adapt its shape and size - starting compact for minimally invasive delivery through the lead lumen, then expanding to engage surrounding tissue and secure the lead position reliably.
2Stability of the object's composition
If the fixation clip is deployed to secure the lead position, then lead migration is prevented, but the clip must be delivered through a small lumen requiring a compressed configuration
Solution Approach 1:
The fixation clip is nested within the lead lumen during delivery, with the compressed clip fitting inside the lead body much like a doll within a doll. This nested configuration allows the clip to be delivered through the confined space of the lead lumen without requiring a separate delivery catheter or complex deployment mechanism.
Solution Approach 2:
The fixation clip undergoes parameter changes in its physical dimensions - specifically, it transitions from a compressed configuration with reduced cross-sectional dimensions to an expanded configuration with increased dimensions. This parameter change enables the clip to fit through the small lead lumen during delivery, then expand at the target site to engage tissue and secure the lead position.
3Adaptability or versatility
If the fixation clip is made electrically conductive to serve as an electrode, then additional stimulation capability is provided, but the material selection and design become more complex
Solution Approach 1:
The fixation clip is designed to perform multiple functions simultaneously: it provides mechanical fixation by engaging surrounding tissue to secure the lead position, and it serves as an electrical electrode for delivering stimulation therapy. This multi-functional design eliminates the need for separate fixation and electrode components, reducing overall device complexity while enhancing versatility.
Solution Approach 2:
The fixation and electrode functions are merged into a single integrated component - the fixation clip. By combining the mechanical anchoring function with the electrical stimulation function in one element, the design simplifies the overall device architecture while providing adaptability for both lead securing and electrical therapy delivery.
4Stability of the object's composition
If the fixation clip engages surrounding tissue to secure the lead, then lead migration is prevented, but there is a risk of nerve inflammation or damage
Solution Approach 1:
The fixation clip is designed with specific local qualities in its engagement features - the distal end includes engagement features that interact with surrounding tissue in a controlled manner. The clip's geometry and surface characteristics are optimized to provide adequate mechanical anchoring while minimizing tissue trauma and inflammation risk, creating different local qualities along its structure.
Solution Approach 2:
The fixation clip design incorporates preliminary anti-action by shaping the engagement features to prevent harmful effects before they occur. The clip's geometry is configured to distribute mechanical stress evenly across the engagement site, preventing concentration of forces that could cause tissue damage or nerve inflammation, thus preemptively counteracting potential harmful effects.
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 fixation clip effectively prevents lead migration, maintains optimal electrode positioning, and minimizes nerve inflammation, ensuring reliable and targeted electrical stimulation therapy.
Implementation Method 1
The fixation element is actively deployable from a first shape to a second shape
Data Source
AI summary
A system comprises an implantable medical device and an actively deployable clip attached to the implantable medical device that restricts movement of the implantable medical device once the clip is deployed within a body of a patient. In one embodiment, the implantable medical device is a lead and a clip that includes electrically conductive portion is an electrode of the lead. The implantable medical device may be implanted proximate to any suitable tissue site within the patient, and in one embodiment, the implantable medical device is implanted proximate to an occipital nerve or a trigeminal nerve of the patient.