IPG Pouch Insertion Tool for Aseptic Handling and Damage Reduction
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Solution Overview
Problem
The insertion of implantable pulse generators into protective pouches or envelopes is a delicate and challenging process, often performed manually, which can lead to contamination or damage, especially due to the slippery and thin nature of the pouch material, and there is a need for a standardized and efficient method to facilitate this process.
Innovation Solution
A dedicated insertion tool with a tubular or funneled shape, featuring a front and backside opening, an axial slot, and a latch, designed to simplify the insertion of implantable pulse generators and corresponding wiring into pouches, minimizing contact and risk of damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If manual insertion method is used, then flexibility and adaptability are maintained, but the insertion process becomes time-consuming and prone to contamination and damage
Solution Approach 1:
The patent introduces an insertion tool as an intermediary device between the operator and the pouch-device assembly. This tool includes a holding structure with fingers that grip the pouch opening, and a insertion mechanism that guides the device into the pouch. By using this intermediary tool, the direct manual handling of the thin pouch material is eliminated, reducing contamination risk while maintaining controlled insertion speed.
Solution Approach 2:
The insertion tool incorporates flexible components including a compliant holding structure with fingers that can adapt to the pouch opening shape, and a flexible insertion mechanism that can navigate the delicate pouch material without causing damage. The tool itself uses thin-walled but reinforced structures that provide guidance without excessive rigidity that could puncture or damage the pouch.
2Reliability
If direct manual handling of thin pouch material is performed, then simplicity is maintained, but contamination and damage risk increases
Solution Approach 1:
The insertion tool serves as a mediator that interacts with the pouch through its opening rather than directly handling the thin pouch walls. The tool's holding structure grasps the reinforced opening area, and the insertion mechanism guides the device through the opening into the pouch interior, eliminating direct contact with the vulnerable thin pouch material throughout the insertion process.
Solution Approach 2:
The insertion tool performs preliminary actions by first securing the pouch opening in a stable, controlled position before insertion begins. The holding structure pre-positions and stabilizes the pouch, creating a controlled entry point. This preliminary stabilization prevents accidental contact with or damage to the thin pouch walls during the subsequent insertion process.
3Manufacturing precision
If standardized insertion tool is used, then consistency and safety are improved, but adaptability to different implant sizes may be reduced
Solution Approach 1:
The insertion tool incorporates dynamic, adjustable components including movable holding fingers that can expand or contract to accommodate different pouch opening sizes, and an insertion mechanism with adjustable guidance features. These dynamic elements allow the standardized tool to adapt its geometry to match different implant-pouch combinations while maintaining consistent insertion forces and alignment, achieving both standardization and versatility.
Solution Approach 2:
The insertion tool is designed as a universal device with multiple functional elements that can accommodate various implant sizes and pouch types. The holding structure can grip different opening diameters, the insertion mechanism can guide devices of different dimensions, and the tool provides consistent sterile barriers and control for all insertion types. This multi-functionality allows a single standardized tool design to serve multiple implantation scenarios.
Data Source
AI summary
An insertion tool having a wall of tubular or funneled shape, with, on a front portion thereof, a front side opening so that an opening of an empty pouch for an implantable pulse generator, and corresponding wiring, can be shifted onto the front portion and over the front side opening, and with, on a back portion of the insertion tool, a backside opening so that an implantable pulse generator, and corresponding wiring, can be inserted through that backside opening, through a passageway opening to the front side opening and into the pouch, while manually holding the insertion tool using the back portion The wall has an axial slot between the front side opening and the backside opening.


