Elongate Anchoring Elements for Implantable Electrical Stimulation Leads
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Solution Overview
Problem
Implantable electrical stimulation systems face challenges in securely anchoring leads within patient tissue, leading to potential migration and instability of the leads during and after implantation.
Innovation Solution
The development of an electrical stimulation lead with elongate anchoring elements, including a lead body with anchoring lumens and extension portions that can be deployed and retracted, providing secure anchoring within tissue and facilitating easy implantation and explantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional lead anchoring methods are used, then the lead can be implanted, but the lead experiences migration and instability during and after implantation
Solution Approach 1:
The anchoring element is designed with a dynamic structure that allows it to transition between a compressed configuration (for delivery through the introducer) and an expanded configuration (for anchoring in tissue). The element can be radially expanded from a first diameter during delivery to a second, larger diameter during anchoring, providing stable fixation while maintaining deliverability through narrow access paths.
Solution Approach 2:
The anchoring element is divided into multiple segments or portions that can independently engage with the tissue. The element includes a first portion and a second portion that can be positioned at different locations, providing distributed anchoring force and improving overall lead stability through multiple contact points with the surrounding tissue.
2Reliability
If anchoring elements are deployed to prevent migration, then lead stability improves, but lead removal becomes difficult
Solution Approach 1:
The anchoring element's dynamic expandability allows it to be easily compressed for removal. During explantation, the element can be radially compressed back to its smaller first diameter, reducing its engagement with the tissue and allowing for simple withdrawal. This dynamic transformation enables the element to provide strong anchoring during use while facilitating easy removal when needed.
Solution Approach 2:
The anchoring element can be nested within itself or within the introducer during delivery and removal. The element's ability to collapse to a smaller diameter allows it to be contained within the introducer sheath during implantation and to be compressed for easy extraction during removal, providing a nested configuration that simplifies both delivery and explantation procedures.
3Ease of manufacture
If the lead body is made rigid for structural integrity, then manufacturing is simplified, but the lead cannot be delivered through narrow introducers
Solution Approach 1:
The lead body incorporates dynamic structural elements that allow it to transition between a rigid, structurally-intact configuration and a flexible, compressible configuration. The lead can maintain its structural integrity during manufacturing and implantation, then be radially compressed to a smaller profile for delivery through narrow introducers, and finally return to its rigid state for stable operation.
Solution Approach 2:
The lead body utilizes flexible materials and thin-walled structures that allow radial compression without compromising structural integrity. The lead can be compressed radially to fit through narrow introducers while maintaining its longitudinal strength and electrical conductivity, enabling delivery through minimally invasive access paths while preserving manufacturing simplicity.
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 anchoring elements effectively prevent lead migration and enhance stability during implantation, allowing for secure positioning and easy removal, thereby improving the reliability and longevity of the electrical stimulation system.
Implementation Method 1
Each of the at least one bent portion is biased to extend an extension portion of the anchoring element out of one of the at least one slot when the anchoring element is in a deployed position and can retract the extension portion into the respective anchoring lumen when the anchoring element is in a constrained position
Data Source
AI summary
An electrical stimulation lead includes a body having distal and proximal end portions, a longitudinal length, at least one anchoring lumen, and at least one open slot spaced apart from each end of the lead body. Each anchoring lumen is open at a slot and extends both distally and proximally from the slot. The lead also includes electrodes; terminals; conductors electrically coupling the terminals to the electrodes; and at least one anchoring element at least partially disposed in an anchoring lumen. Each anchoring element includes at least one bent portion biased to extend an extension portion of the anchoring element out of a slot when the anchoring element is in a deployed position and can retract the extension portion into an anchoring lumen when the anchoring element is in a constrained position. The lead further includes an attachment member attached to each anchoring element and disposed proximal to each slot.