Torque Lock Anchor for Spinal Cord Stimulator Leads
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Solution Overview
Problem
Conventional lead anchors for implantable spinal cord stimulators often fail to securely grip the lead, 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 and prolonged operation times.
Innovation Solution
A lead anchor design featuring a body with a lead slot and a transverse lumen that houses a fastener to deform a portion of the lead, providing secure anchorage without relying heavily on suturing, thereby reducing the risk of migration and breakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional lead anchors use suturing to secure the lead, then the lead can be anchored to tissue, but the suturing technique variability leads to insufficient grip and lead migration
Solution Approach 1:
The patent replaces the suturing mechanism with a mechanical fastening system. The lead anchor includes a body with a fastener that mechanically secures the lead through a lead slot, eliminating the need for variable suturing techniques. The fastener can be tightened to provide consistent, reliable anchorage without depending on surgeon skill or suture tension variability.
Solution Approach 2:
The patent changes the anchorage mechanism from a soft tissue-based suturing system to a rigid mechanical fastening system. The lead anchor body is made of rigid or semi-rigid material with precisely engineered slots and fasteners, transforming the anchorage parameters from dependent on suture material and technique to dependent on mechanical geometry and fastener tension, which can be more precisely controlled and standardized.
2Reliability
If conventional lead anchors rely on heavy suturing to prevent migration, then lead stability may improve, but operation time increases and infection risk increases
Solution Approach 1:
The patent replaces time-consuming suturing operations with a quick mechanical fastening system. The lead anchor can be positioned and secured using a fastener that can be tightened in seconds, dramatically reducing the time required for lead anchorage while maintaining or improving stability. This eliminates the need for multiple suture passes and knot-tying operations.
Solution Approach 2:
The lead anchor design allows for self-contained mechanical fastening without requiring additional suturing materials or complex surgical techniques. The fastener system is integrated into the anchor body itself, allowing the surgeon to simply tighten the existing mechanism rather than adding separate suturing components, thereby reducing both time and potential infection sources.
3Strength
If conventional lead anchors use multiple sutures to secure the lead, then anchorage strength may improve, but the risk of infection increases due to prolonged exposure
Solution Approach 1:
The patent replaces multiple suture passages through tissue (which create multiple potential infection pathways) with a single mechanical fastening system. The lead anchor body remains largely outside the tissue, with the fastener securing the lead at a single location, thereby minimizing the number of tissue penetrations and reducing infection risk while maintaining anchorage strength through mechanical means.
Solution Approach 2:
The patent extracts the anchorage function from the tissue suturing process and relocates it to a mechanical system that operates primarily outside the tissue. The lead anchor body and fastener system can be applied and secured with minimal tissue disruption, separating the anchorage function from the invasive suturing process and thereby reducing the window for bacterial contamination.
4Reliability
If conventional lead anchors are secured with tight sutures to prevent migration, then lead position stability improves, but lead breakage risk increases due to excessive tension
Solution Approach 1:
The lead anchor design allows for dynamic adjustment of fastener tension to achieve optimal anchorage without excessive force. The fastener can be tightened to the precise amount needed to secure the lead in position, and this tension can be monitored and adjusted during implantation. This dynamic control prevents the lead from being subjected to excessive static tension that could cause breakage, while still maintaining positional stability.
Solution Approach 2:
The patent changes the force application parameters from the all-or-nothing nature of suturing (where insufficient tension causes migration and excessive tension causes breakage) to a precisely controllable mechanical fastening system. The fastener allows for gradual tightening with feedback, enabling the surgeon to apply just the right amount of force to secure the lead without creating excessive tension that could damage the lead structure.
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 proposed lead anchor effectively secures the lead in place, reducing migration and breakage, and minimizing the risk of infection by eliminating the need for excessive suturing, thus enhancing the longevity and reliability of spinal cord stimulation systems.
Implementation Method 1
The fastener is configured and arranged for fastening the received lead to the lead anchor by deforming a portion of the lead
Data Source
Figure 1
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Figure 3A
AI summary
A lead anchor includes a body having an outer surface, a top end, a front side, a first end, and a second end opposite to the first end. The body defines a lead slot configured and arranged to receive a lead. The lead slot defines an elongated opening extending along the front side of the body from the first end to the second end. A transverse lumen extends from the top end of the body and intersects the lead slot. An exterior member is disposed around at least a portion of the body. The exterior member is formed of a biocompatible material. A fastener is disposed in the transverse lumen. The fastener is configured and arranged for fastening the received lead to the lead anchor by deforming a portion of the lead.