Curved Durotomy Suture Passer for Safe Repeat Needle Passes
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Solution Overview
Problem
Existing surgical instruments for repairing dura mater tears, such as durotomies, often require removal and reinsertion for multiple suture passes, risking nerve damage and being inefficient.
Innovation Solution
A suture passing instrument with a slotted curved cannula and flexible needle allows multiple suture passes without removal from the surgical site, featuring a safety mechanism to prevent needle deployment towards nerves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing surgical instruments are used for multiple suture passes, then the instrument must be removed and reinserted, but this increases the risk of nerve damage and reduces surgical efficiency
Solution Approach 1:
The needle is nested within the cannula, allowing the needle to be advanced and retracted through the cannula multiple times without removing the instrument from the surgical site. This resolves the contradiction by enabling multiple suture passes (improving productivity) while keeping the needle contained within the protective cannula structure (improving reliability by preventing accidental nerve contact).
Solution Approach 2:
The instrument is pre-loaded with the needle and suture material before entering the surgical site. This allows multiple suture passes to be performed consecutively without removing the instrument, thereby improving surgical efficiency while maintaining safety through the protective cannula structure.
2Productivity
If the needle is deployed for multiple suture passes, then surgical speed improves, but the risk of needle misdirection towards nerves increases
Solution Approach 1:
The cannula serves as an intermediary structure that guides and constrains the needle's movement. The needle must pass through the cannula's lumen, which provides a defined pathway and prevents misdirection towards nerves. This resolves the contradiction by enabling rapid multiple suture passes (improving productivity) while the cannula acts as a safety guide (reducing harmful factors).
Solution Approach 2:
The rigid cannula structure, which might seem to limit needle flexibility, actually provides a benefit by preventing needle misdirection. The cannula converts the potential harm of needle misdirection into a benefit by providing a constrained, safe pathway for needle passage, allowing rapid firing without increasing risk.
3Ease of operation
If the instrument is removed after each suture pass, then needle control is maintained, but surgical time increases and efficiency decreases
Solution Approach 1:
The needle is nested within the cannula, allowing the surgeon to advance and retract the needle through the cannula multiple times without removing the instrument. This maintains needle control (ease of operation) while eliminating the time loss associated with repeated instrument removal and reinsertion (reducing loss of time).
Solution Approach 2:
The instrument remains continuously in place during multiple suture passes, eliminating interruptions for removal and reinsertion. The needle can be advanced, used for suturing, and retracted in a continuous sequence of actions, maintaining surgical flow and efficiency while the surgeon retains control through the handle assembly.
Data Source
AI summary
Surgical constructs, assemblies, kits and methods of tissue fixation are disclosed. A suture passing instrument includes a curved tip integral with a distal end of a shaft, a hand assembly mounted on a proximal end of the shaft, and a flexible strand attached to one or two needles and loaded through a cannulation of the shaft. The curve-shaped tip is adapted to engage dural tissue during repairs of the dura mater. The suture passing instrument can grasp and manipulate dura mater and can allow multiple suture passes through the dura mater without removal of the instrument from the durotomy site. The suture passing instrument is provided with a safety mechanism that prohibits the needle(s) to be fired into nerves, providing a safe, reliable, inexpensive, and speedy repair of a durotomy.


