Implantable Pulse Generator Pouch and Lead Harness for Dorsal Root Ganglia Stability
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Solution Overview
Problem
Current neuromodulation systems for treating chronic spinal pain face challenges in securely anchoring and positioning implantable pulse generators and leads during spinal procedures, particularly at dorsal root ganglia, which can lead to instability and ineffective therapy delivery.
Innovation Solution
A system comprising a pouch for encasing the implantable pulse generator with attachment members for anchoring, a lead harness for securing leads, and a lead placement tool for precise positioning of electrodes at the target site, ensuring stable placement and therapeutic proximity to dorsal root ganglia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional neuromodulation systems are used without specialized anchoring components, then the implantation procedure is simpler, but the stability and positioning accuracy of the pulse generator and leads deteriorates
Solution Approach 1:
The system divides the anchoring function into separate components: pouch with attachment members for the pulse generator, and lead harness with attachment members for the leads. This segmentation allows each component to be optimized for its specific anchoring needs while maintaining overall system stability.
Solution Approach 2:
The pouch and lead harness are prepared with attachment members before implantation, allowing the pulse generator and leads to be secured to stable anatomical structures (spinal fixation rods) during the same surgical procedure. This preliminary preparation ensures stable positioning from the outset rather than requiring subsequent adjustment procedures.
2Manufacturing precision
If leads are placed without a specialized placement tool, then the implantation procedure is faster, but the precision of electrode positioning at the dorsal root ganglia deteriorates
Solution Approach 1:
The lead placement tool acts as an intermediary device that facilitates precise lead insertion and positioning. The tool includes features such as a tapered tip for easy insertion through tissue, and a flared distal end that provides tactile feedback and visual confirmation when the lead reaches the target depth near the dorsal root ganglia, ensuring accurate electrode placement.
3Stability of the object's composition
If the pulse generator is implanted without a securing pouch, then the surgical procedure is less complex, but the positioning stability and security of the pulse generator deteriorates
Solution Approach 1:
The pouch integrates multiple functions into a single component: it encases the pulse generator for secure positioning, incorporates attachment members for anchoring to spinal fixation rods, and provides a structured interface for lead connection. This merging of functions ensures stable positioning while reducing the number of separate components needed.
Solution Approach 2:
The pouch serves multiple purposes: it acts as a protective enclosure for the pulse generator, provides attachment points for securing the device to spinal fixation rods, and offers a organized interface for lead connection. This multi-functionality reduces the need for separate components and simplifies the overall implantation procedure.
Data Source
AI summary
The present invention comprises implantable neuromodulation systems and methods comprising a protective pouch that at least partially encases an implantable pulse generator prior to implanting in a patient and is adapted to be secured within the surgical site. A lead placement tool configured to receive an electrical lead(s) along at least part of the length of the tool within an open channel or groove to assist in placing electrical leads at the desired target. The lead placement tool may have at least one, or two, angles that provide a bend or angle between first and/or second end regions relative to a straight central region and an open channel along at least one of these regions. A harness for receiving and protecting at least a portion of the length of electrical leads in operative communication with an implantable pulse generator is provided. The harness is adapted to be secured within the surgical site.