Adjustable Needle Medical Device for Cervical Injection
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Solution Overview
Problem
Current devices for cervical injection of tracers for Sentinel Node Mapping in gynaecological surgery face challenges such as non-standardized needle-syringe combinations, difficulty in maintaining injection pressure, and variability in fluid delivery due to low light conditions and cervical resistance, leading to inconsistent detection of sentinel lymph nodes.
Innovation Solution
A medical device with an adjustable needle position, visual reference elements for depth indication, and a lighting system to enhance visibility, combined with a regulated injection mechanism to standardize delivery pressure and volume, allowing precise fluid delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a standardized needle-syringe combination is used for cervical injection, then injection precision and fluid delivery control are improved, but device complexity increases
Solution Approach 1:
The device is divided into distinct functional modules: a standardized needle assembly with depth markings, a syringe with volume markings, and an adjustable positioning mechanism. Each component can be independently manufactured and standardized, yet they work together as an integrated system to achieve precise injection control without excessive overall complexity
Solution Approach 2:
The standardized needle-syringe combination is designed to be universally applicable for cervical injections in Sentinel Node Mapping procedures. The device incorporates multiple functions including depth control, volume measurement, pressure regulation, and positioning adjustment within a single integrated system, reducing the need for multiple separate devices
2Productivity
If injection pressure is increased to overcome cervical resistance, then fluid delivery is improved, but needle disengagement and loss of control occur
Solution Approach 1:
The syringe incorporates visual feedback through volume markings that allow the operator to monitor fluid delivery in real-time. The standardized needle-syringe combination provides tactile feedback through consistent engagement mechanics, enabling the operator to detect and correct needle disengagement or excessive pressure conditions before loss of control occurs
Solution Approach 2:
The device incorporates an adjustable positioning mechanism that allows dynamic adjustment of needle depth and angle during the injection procedure. This dynamic adaptability enables the operator to optimize injection parameters in response to varying cervical resistance, maintaining reliable fluid delivery without excessive pressure that could cause needle disengagement
3Manufacturing precision
If needle depth is increased to ensure tracer delivery, then injection effectiveness is improved, but risk of needle disengagement and fluid leakage increases
Solution Approach 1:
The needle assembly incorporates pre-marked depth indicators that show the operator the exact penetration depth before injection begins. This preliminary visual guidance ensures the needle is inserted to the correct depth for effective tracer delivery while preventing excessive insertion that could increase disengagement risk
Solution Approach 2:
The device replaces reliance on operator skill and judgment with a standardized mechanical system featuring fixed depth markings and a regulated injection mechanism. This mechanical standardization ensures consistent, effective needle placement and fluid delivery while minimizing the risk of human error leading to needle disengagement or fluid leakage
4Measurement precision
If visual reference elements and lighting system are added, then detection accuracy is improved, but device complexity increases
Solution Approach 1:
The device incorporates visual reference elements such as colored depth markings on the needle and syringe, and potentially fluorescent or color-changing indicators that enhance visibility in the surgical field. These visual cues improve detection accuracy by providing clear, easily distinguishable reference points for depth and volume measurements without requiring complex electronic systems
Solution Approach 2:
The visual reference elements and lighting system act as intermediaries between the physical injection process and the operator's perception. They translate depth, volume, and positioning information into visually accessible formats, improving detection accuracy while adding minimal complexity through the use of passive optical elements rather than active electronic systems
Data Source
Figure 1
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AI summary
The present invention relates to a medical device (1) for the injection of a fluid into a patient's body or in a cavity thereof. Such device (1) comprises: - an injector (10), comprising a reservoir of the fluid to be injected, - a needle (12) comprising a free end (124) for the delivery of the fluid, fluidically connected to the injector (10), - a hollow tubular main body (2) extending according to a longitudinal development direction (L) and configured to house the needle (12) inside thereof, wherein said main body (2) comprises means for adjusting the position (99) of the needle (12) with respect to the main body (2) configured to engage with respective guide means (13) of the needle (12) and selectively operable to allow a sliding of the needle (12) with respect to the main body (2) according to the longitudinal development direction (L), in such a way as to increase/decrease the length of the portion of needle (12) exiting with respect to the main body (2).