Introducer with Tissue Pocket Optimizer for Secure Implantation
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Solution Overview
Problem
The challenge lies in efficiently and minimally invasively forming a pocket under the skin for implantable medical devices, as existing methods require high insertion forces and often result in improperly sized pockets, leading to device ejection due to patient movement.
Innovation Solution
An introducer apparatus with a housing and an inserter having portions of varying widths to create asymmetric pockets, accompanied by an ejection rod for precise placement of the medical device, allowing for rotation and ejection through a distal opening, facilitating secure implantation without excessive force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high insertion forces are used to manipulate the medical device and form a pocket under the skin, then the device can be implanted, but the procedure becomes more invasive and difficult
Solution Approach 1:
The introducer device is divided into distinct functional segments: a sharp distal tip for initial tissue penetration, a mid-portion for pocket formation, and a proximal portion for device ejection. This segmentation allows each portion to be optimized for its specific function, reducing the overall insertion force required while maintaining reliable implantation
Solution Approach 2:
The introducer device performs preliminary actions in a specific sequence: first creating the pocket space, then positioning the implantable device, and finally ejecting the device. This preliminary preparation of the implantation site reduces the force needed during the actual device insertion, making the procedure less invasive
2Ease of operation
If a pocket is formed that is too large for the medical device, then device insertion is easier, but the device may be ejected due to patient movement
Solution Approach 1:
The introducer device incorporates features that allow adjustment and optimization of pocket dimensions during the implantation process. The device includes positioning features and depth indicators that enable the operator to create a pocket with precise dimensions matched to the implantable device, ensuring optimal retention while maintaining ease of insertion
Solution Approach 2:
The introducer device provides tactile and visual feedback during pocket formation and device insertion. This feedback mechanism allows the operator to sense when the pocket is properly sized and when the device is correctly positioned, preventing both over-sized pockets that lead to ejection and under-sized pockets that cause insertion difficulty
3Ease of manufacture
If the pocket dimensions are improper, then device placement is simplified, but device performance deteriorates
Solution Approach 1:
The introducer device incorporates adjustable parameters for pocket depth, width, and orientation. These parameters can be modified during the procedure to match the specific requirements of different implantable devices and patient anatomies, ensuring both ease of formation and optimal device performance
Solution Approach 2:
The introducer device is designed with dynamic capabilities that allow real-time adjustment of pocket dimensions during insertion. This dynamic adaptability enables the operator to simplify pocket formation while simultaneously optimizing the dimensions for device performance, rather than being constrained by fixed geometric parameters
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a housing having a proximal portion including a proximal opening, distal portion including a distal opening, and an intermediate portion sized to contain a medical device; and an inserter having at least a portion comprising a greater width than at least one other portion of the inserter.