Self-Expanding Lead Anchor for Spinal Cord Stimulators
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Solution Overview
Problem
Conventional lead anchors for implantable spinal cord stimulators fail to securely anchor leads, leading to lead migration, breakage, and loose connections, which can result in ineffective pain control and increased risk of infection due to variable suturing techniques.
Innovation Solution
A lead anchor design featuring a body with a lead lumen and a transverse lumen that uses a fastener to deform the lead and secure it in place, combined with a biocompatible exterior member and suture elements for anchoring to patient tissue, providing a consistent and stable fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional lead anchors use suturing technique to secure the anchor, then the anchor can be attached to tissue, but the holding force becomes highly variable depending on physician technique
Solution Approach 1:
The lead anchor system performs its own anchoring function through the self-expanding exterior member that automatically engages with surrounding tissue upon deployment, eliminating the need for physician-performed suturing operations and providing consistent holding force regardless of surgical technique
Solution Approach 2:
The exterior member transitions from a compressed delivery state to an expanded anchored state, changing its physical parameters (radius, surface area, engagement force) to achieve reliable tissue attachment without depending on variable suturing techniques
2Reliability
If conventional lead anchors are secured with increased suturing, then the anchor may hold better, but the operation time increases and infection risk increases
Solution Approach 1:
The self-expanding exterior member automatically anchors itself to tissue upon deployment through radial expansion and tissue engagement, eliminating the time-consuming suturing process while maintaining reliable anchor stability
Solution Approach 2:
The exterior member is pre-configured in a compressed state within the delivery catheter, allowing it to be deployed and automatically expand to its anchored configuration in a single motion, performing the anchoring action before the surgical procedure concludes
3Reliability
If conventional lead anchors rely on suturing, then the anchor can be attached to tissue, but the risk of infection increases
Solution Approach 1:
The self-expanding exterior member creates its own tissue attachment through radial expansion and mechanical engagement with surrounding tissue, eliminating the need for sutures that create additional infection pathways and foreign body burden
Solution Approach 2:
The suturing component is completely removed from the anchoring system, extracting the source of increased infection risk while preserving the essential function of secure tissue attachment through the exterior member's expansion mechanism
4Reliability
If conventional lead anchors do not sufficiently grip the lead, then the lead can move or migrate, but the connection becomes insecure
Solution Approach 1:
The lead anchor integrates multiple functions into a single device: the exterior member simultaneously anchors to tissue and secures the lead through friction engagement, while the fastener provides additional axial restraint, creating a unified secure connection system
Solution Approach 2:
The exterior member is formed from shape memory alloy or nitinol, combining elastic memory properties with superelastic characteristics to provide both radial expansion for tissue anchoring and longitudinal flexibility for lead engagement, achieving secure lead connection through material property integration
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 solution effectively reduces lead migration and breakage, enhances long-term pain control, and minimizes the risk of infection by providing a secure and reliable anchoring system that is less dependent on suturing technique.
Implementation Method 1
The fastener anchors the lead to the body through the transverse lumen by deforming a portion of the lead
Implementation Method 2
The exterior member is formed from shape memory alloy or nitinol
Data Source
AI summary
A lead anchor includes a body defining a lead lumen having a first opening and a second opening through which a lead can pass. The body further defines a transverse lumen that intersects the lead lumen. An exterior member is disposed around at least a portion of the body. The exterior member is formed of a biocompatible material. A fastener anchors the lead to the body through the transverse lumen by deforming a portion of the lead. The transverse lumen is configured and arranged to receive the fastener. At least one suture element is defined by the exterior member and is configured and arranged for receiving a suture to suture the lead anchor to patient tissue.