Single-Access Percutaneous Lead Insertion System
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Solution Overview
Problem
Current percutaneous insertion devices for spinal cord stimulation leads require multiple access points, increasing patient discomfort and infection risk when attempting to implant multiple leads simultaneously.
Innovation Solution
A system utilizing an insertion needle with a cannula and stylet, along with a series of dilators, allows for the expansion of a single percutaneous entry point to accommodate multiple leads, reducing the need for multiple access points and minimizing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate access points are used for implanting multiple leads, then each lead can be inserted independently, but patient discomfort and infection risk increase
Solution Approach 1:
The patent combines multiple lead insertion operations into a single access point. The insertion device includes a single puncture needle that creates one access point, and multiple leads are then inserted through this shared access point, merging what would traditionally require separate puncture sites into one unified entry point.
Solution Approach 2:
The single access point serves multiple functions: it provides passage for the puncture needle, accommodates the insertion device, and allows simultaneous or sequential passage of multiple leads. This multi-functional use of a single access point eliminates the need for multiple separate access points.
2Ease of operation
If a single access point is used for multiple leads, then patient discomfort and infection risk are reduced, but the access point must be enlarged to accommodate multiple leads
Solution Approach 1:
The access point dynamically changes size during the procedure. It starts small during the puncture phase, then expands as dilators are sequentially inserted and removed, finally reaching its largest size when multiple leads are inserted. This dynamic adaptation allows the access point to accommodate multiple leads while minimizing initial tissue disruption.
Solution Approach 2:
The access point is preliminarily created with a small puncture, then progressively enlarged through the sequential insertion and removal of dilators before final lead insertion. This preliminary, staged expansion prepares the access point to accommodate multiple leads while minimizing sudden tissue trauma.
3Loss of time
If multiple leads are inserted through a single access point, then procedural time is reduced, but the insertion device complexity increases
Solution Approach 1:
The insertion device employs a nested structure where dilators of decreasing size are inserted sequentially into the access point, with each dilator fitting within the previous one. This nesting arrangement allows multiple components to be stored and deployed in a compact manner, managing device complexity while enabling efficient multi-lead insertion.
Solution Approach 2:
The insertion process is segmented into distinct stages: puncture needle insertion, sequential dilator insertion and removal, and final lead insertion. This segmentation of the procedure into manageable steps allows complex multi-lead insertion to be performed systematically, reducing overall procedural time despite the increased device complexity.
Data Source
AI summary
Insertion devices and associated systems and methods for the percutaneous placement of patient leads are disclosed herein. A system in accordance with a particular embodiment includes a cannula having a lumen and a first dilator. The first dilator can be positioned within the lumen and the first dilator and the cannula can be used to create a percutaneous entry point. An additional dilator can be positioned over the first dilator and advanced into the percutaneous entry point to expand the percutaneous entry point. A final dilator can be inserted into the patient and two leads can be advanced into the patient through the final dilator.