Medical Device Insertion System with Helical Locking Sleeve
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Solution Overview
Problem
Existing insertion systems for medical devices, such as analyte sensors, face challenges when trying to insert sensors firmly attached to larger electronics units, as they require a large opening, leading to skin bulging and difficulty penetrating the skin due to the sensor's footprint.
Innovation Solution
An insertion system comprising a medical device and an insertion device with a cap, guide sleeve, locking sleeve, and elastic member, where the cap, insertion component retractor, and locking sleeve move relative to the guide sleeve from a distal to a proximal position, allowing the separation of the insertion device from the medical device to initiate a helical movement of the locking sleeve, facilitating the retraction of the insertion component and ensuring reliable insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the sensor is firmly attached to the electronics unit with a larger footprint, then the device integration is improved, but the insertion difficulty increases due to skin bulging
Solution Approach 1:
The device is divided into two separate components: the sensor and the electronics unit. The sensor can be inserted subcutaneously first, then the electronics unit is attached separately to the skin surface. This segmentation allows the sensor to be inserted through a smaller opening without the constraint of the larger electronics unit, resolving the contradiction between integrated design and insertion ease.
Solution Approach 2:
A base plate is introduced as an intermediary component that remains on the skin surface while the sensor extends through it into the subcutaneous tissue. The base plate serves as the attachment point for the electronics unit, allowing the sensor to be inserted first and the electronics unit to be connected afterward, thus avoiding the skin bulging problem during insertion.
2Length of moving object
If a large opening is created for inserting the electronics unit, then the insertion path is cleared, but skin bulging occurs and penetration becomes difficult
Solution Approach 1:
The insertion process is segmented into two stages: first inserting the thin sensor through a small opening, then separately attaching the electronics unit to the skin surface. This eliminates the need to force a large opening for the entire integrated device, preventing skin bulging while still achieving proper device placement.
Solution Approach 2:
The sensor is inserted into the subcutaneous tissue first, establishing the insertion path and securing the sensor in place. Only after this preliminary insertion is complete is the electronics unit attached to the skin surface, avoiding the problem of trying to insert a large integrated device through bulging skin.
3Object-affected harmful factors
If the insertion component is retracted deeply into the housing, then infection risk is minimized, but the retraction mechanism complexity increases
Solution Approach 1:
The insertion component (needle) is completely extracted from the housing after insertion, rather than being merely retracted. The needle is removed from the device entirely after serving its purpose, which minimizes infection risk by eliminating any potential contamination pathway while avoiding the need for complex retraction mechanisms. The needle serves its function and is discarded.
Solution Approach 2:
The insertion needle is designed as a disposable component that is used once and then discarded. This eliminates the need for complex retraction and sterilization mechanisms, as the needle is simply removed after insertion and disposed of, minimizing infection risk through complete removal rather than complex retraction systems.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This system allows for a more reliable and user-friendly insertion of medical devices by tensioning the skin, enabling the insertion component to penetrate and insert the device effectively, even with larger electronics units, resulting in a more secure and efficient insertion process.
Implementation Method 1
an elastic member positioned between the locking sleeve and the insertion component retractor
Data Source
AI summary
An insertion system comprises a medical device and an insertion device for inserting the medical device into a body tissue of a user, the insertion device comprising:an insertion component-configured for inserting the medical device into the body tissue;an insertion component retractor;a cap;a guide sleeve and an insertion sleeve guided therein;a locking sleeve in the insertion sleeve; andan elastic member positioned between the locking sleeve and the insertion component retractor;wherein, for inserting the medical device, the cap, the insertion component retractor, the locking sleeve and the insertion sleeve are movable relative to the guide sleeve from a distal position to a proximal position, wherein the insertion device is separable from the medical device, wherein the insertion system is separation of the insertion device from the medical device releasing a movement of the locking sleeve from its proximal position to a further proximal position.