Hollow Needle Suturing Device with Internal Suture Dispensing
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Solution Overview
Problem
Current needle-based suturing methods pose a risk of accidental needle stick injuries (NSIs) to healthcare workers, which can lead to the transmission of bloodborne pathogens and result in significant human and financial costs, while also compromising the accuracy and ease of use during procedures.
Innovation Solution
A handheld suturing device with a hollow needle, internal suture dispensing mechanism, and safety shield mechanism that shields the needle during use, allowing for controlled penetration depths and minimizing user exposure to the needle point, featuring a suture management system and integral cutters for efficient suture handling.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional needle-based suturing methods are used, then suture placement can be performed, but the risk of accidental needle stick injuries (NSIs) to healthcare workers increases
Solution Approach 1:
The suture is extracted from the traditional external threading method and placed inside a hollow needle, allowing the needle to be passed through tissue first and the suture to be delivered internally through the needle lumen. This extraction of the suture delivery function from the external manipulation reduces the risk of needle stick injuries by keeping the needle point enclosed during the critical passing motion.
Solution Approach 2:
The suture is nested within the hollow needle lumen, creating a nested structure where the suture material is contained inside the needle. This nesting allows the needle to be manipulated and passed through tissue while the suture remains protected inside, eliminating external suture manipulation that could lead to accidental needle sticks.
2Object-affected harmful factors
If a safety shield mechanism is added to protect the needle, then the risk of needle stick injuries is reduced, but the device complexity increases
Solution Approach 1:
The safety shield mechanism is merged with the handle assembly, integrating the protective function into the existing device structure rather than adding a separate, independent shield component. This integration reduces overall device complexity while maintaining the safety function of shielding the needle point during manipulation.
Solution Approach 2:
The handle serves multiple functions: it provides structural support, houses the suture dispensing mechanism, and incorporates the safety shield mechanism to protect the needle point. This multi-functionality reduces the need for separate components, thereby reducing device complexity while maintaining comprehensive safety protection.
3Measurement precision
If an internal suture dispensing mechanism is implemented, then procedural accuracy is enhanced, but the device complexity increases
Solution Approach 1:
The suture dispensing mechanism is designed to be self-actuating through the natural rotational motion of the user's hand during needle manipulation. As the user rotates the handle to pass the needle through tissue, the rotational motion automatically drives the suture spool and advances the suture through the needle lumen without requiring separate manual dispensing actions. This self-service approach enhances procedural accuracy while minimizing the complexity of the dispensing mechanism.
4Reliability
If the needle is shielded during use, then user safety is improved, but the ease of operation may be compromised
Solution Approach 1:
The safety shield is designed as a dynamic component that moves with the needle during manipulation. The shield rotates along with the needle handle, maintaining its protective position over the needle point throughout the entire motion sequence. This dynamic design ensures continuous protection without requiring separate shield activation or deactivation steps, thereby maintaining ease of operation while improving safety.
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
The device significantly reduces the risk of NSIs, enhances procedural accuracy and patient trauma, is versatile for various medical applications, and is economical with minimal steps required for suture placement, while maintaining ease of use for both right- and left-handed users.
Implementation Method 1
the manipulation of the actuator by the user is translated into rotation of the suture spool and the suture material is advanced within the handle
Implementation Method 2
The suture material is fed between and is driven by rotation of the pinch rollers
Implementation Method 3
the fingers drive the suture material towards the needle, thereby advancing the suture material through the handle and needle
Data Source
AI summary
A device for suturing tissue includes a handle that has a proximal end and a distal end. The device also includes a generally hollow suturing needle including a pointed distal end, an opposite proximal end and an inner lumen having an suture exit port through which the suture exits. The device further includes a suture dispensing mechanism disposed within the handle and including an actuator which when manipulated by a user is configured to advance suture material within the handle such that the suture material is guided into the inner lumen of the hollow suturing needle and exits through the suture exit port. The device includes a safety mechanism that shields at least a portion of the needle.