Puncturing System With Depth Reference Element
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Solution Overview
Problem
Current puncturing systems for blood withdrawal are not suitable for frequent monitoring of blood glucose levels in diabetics, as they cause significant pain and lack reproducibility, which can lead to late-stage complications like retinopathy.
Innovation Solution
A puncturing system with a disposable puncturing unit and a puncturing drive that includes a needle element and a puncturing depth reference element, where the puncturing depth is adjustable and reproducible, minimizing pain by ensuring consistent needle penetration depth through a coupling mechanism and a stroke adaptor that adapts to the skin's surface variance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a simple spring drive with housing stops is used, then the device complexity is reduced, but the puncturing depth precision and reproducibility deteriorate
Solution Approach 1:
The puncturing system is divided into separate functional modules: a disposable puncturing unit containing the needle element and depth reference element, and a reusable puncturing instrument containing the drive mechanism. This segmentation allows the precision-critical depth reference to be factory-calibrated in the disposable unit while keeping the drive mechanism simple and replaceable.
Solution Approach 2:
A depth reference element is introduced as an intermediary component between the needle element and the housing stops. This reference element provides a precise, pre-calibrated stopping point for the needle's puncturing movement, eliminating the need for complex adjustment mechanisms in the drive while ensuring consistent puncturing depth.
2Device complexity
If manual piercing with simple lancets is used, then the device complexity is minimized, but the pain caused to the patient increases
Solution Approach 1:
The puncturing depth is pre-calibrated and fixed during manufacturing of the disposable puncturing unit. The depth reference element is pre-positioned relative to the needle element, ensuring that each puncture achieves the optimal depth automatically without requiring manual adjustment or skill, thereby minimizing pain and tissue damage.
Solution Approach 2:
The system replaces manual piercing operations with an automated spring-driven mechanism that delivers consistent, controlled puncturing force. The mechanical drive ensures uniform acceleration and deceleration of the needle, preventing the erratic motion that causes pain in manual piercing, while the depth reference element automatically limits penetration depth.
3Productivity
If frequent blood withdrawals are performed with non-reproducible puncturing depth, then the productivity for diabetes monitoring is maintained, but the reliability of the monitoring system deteriorates
Solution Approach 1:
A disposable puncturing unit is employed that contains a pre-calibrated depth reference element and a single-use needle. This ensures that every puncture, regardless of frequency or operator skill, achieves consistent depth and quality. The low cost of the disposable unit enables frequent use without compromising reliability, as each new unit guarantees optimal puncturing parameters.
Solution Approach 2:
The system fixes the puncturing depth parameter through the pre-calibrated depth reference element in the disposable unit. By making this critical parameter immutable and consistent across all units, the system ensures reliable blood withdrawal quality for frequent diabetes monitoring, eliminating variability that would otherwise compromise diagnostic accuracy.
4Device complexity
If housing stops are used to limit lancet movement, then the puncturing depth control is simplified, but the reproducibility of the reversal point position deteriorates
Solution Approach 1:
Instead of using housing stops to limit the lancet's movement from the drive side, the system inverts the approach by attaching a depth reference element to the lancet itself. The reference element's position relative to the needle tip is pre-calibrated, and the drive mechanism simply pushes the lancet forward until the reference element contacts the skin, automatically establishing the correct reversal point without complex stop mechanisms.
Data Source
AI summary
The present invention provides a puncturing system for withdrawing body fluid. The puncturing system comprises a disposable puncturing unit, which includes a needle element for piercing into skin and a puncturing depth reference element with a skin contact area. The system includes a puncturing instrument which has a puncturing drive, wherein the puncturing drive is coupled by a coupling mechanism to the puncturing unit for driving the needle element to a puncturing depth, the puncturing depth being determined by the distance in the piercing direction between the skin contact area and the position of the tip of the needle at a reversal point of the puncturing movement. The puncturing depth reference element is connected to the needle element such that the puncturing depth reference element moves with the needle element during at least part of the puncturing movement. The puncturing depth reference element has a defined longitudinal position in the piercing direction relative to the needle element at least at the reversal point of the puncturing movement.