Epidural Sheath for Precise Spinal Lead Placement
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current implantable electrical stimulation systems face challenges in accurately positioning leads near target stimulation regions, such as dorsal root ganglia, due to anatomical complexities and the need for precise placement within the epidural space.
Innovation Solution
The use of an elongated sheath with a flexible or pre-defined bend configuration allows for the safe and precise insertion of electrical stimulation leads into the epidural space, enabling the lead to be advanced to a target location while the sheath is removed, facilitating proximity to dorsal root ganglia without causing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a lead is directly inserted into the epidural space without a sheath, then the implantation process is simpler, but the positioning accuracy and tissue protection are compromised
Solution Approach 1:
An elongated sheath is introduced as an intermediary device between the operator and the epidural space. The sheath facilitates precise lead positioning by providing a guided pathway through the epidural space to the target stimulation region, while also protecting surrounding tissues from direct manipulation damage during the implantation process.
Solution Approach 2:
The sheath is pre-positioned in the epidural space with its distal tip advanced to the target location before lead insertion. This preliminary positioning establishes an accurate trajectory and protective corridor, enabling subsequent lead placement with high precision while minimizing tissue disruption.
2Ease of operation
If the sheath is rigid to maintain structural integrity, then the sheath can be easily inserted, but tissue trauma increases
Solution Approach 1:
The sheath incorporates a flexible portion that allows dynamic adaptation to anatomical structures during insertion. This flexible section enables the sheath to conform to the epidural space geometry and navigate tissue planes smoothly, reducing mechanical trauma while maintaining overall structural integrity for easy insertion.
3Reliability
If the lead is positioned far from the target region for safety, then tissue damage is minimized, but stimulation effectiveness decreases
Solution Approach 1:
The sheath acts as a protective intermediary that enables the lead to be positioned at the optimal location for stimulation effectiveness. By providing a controlled pathway and protection during insertion, the sheath allows clinicians to place the lead closer to the target dorsal root ganglion without excessive tissue trauma, thereby improving therapeutic efficacy.
Data Source
AI summary
A method for implanting an electrical stimulation lead into a patient includes inserting an elongated sheath into a patient. The sheath includes a sheath body with a proximal end and a distal tip. The sheath defines a lumen extending from the proximal end of the sheath to the distal tip. The distal tip of the sheath is advanced to the patient's epidural space. The distal tip of the sheath is positioned at a target implantation location. A lead is advanced along the lumen of the sheath from the proximal end of the sheath body to the distal tip. The lead includes a lead body and a plurality of electrodes disposed along a distal end of the lead body. The sheath is removed from the patient while leaving the distal end of the lead at the target implantation location.