Spinal Annulotomy Sewing Device for Precise Annular Closure
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Solution Overview
Problem
There is a lack of minimally invasive technology to close the annulus fibrosus incision following the removal of the nucleus pulposus in spinal disc herniation treatment.
Innovation Solution
A device with a housing portion, actuation lever, shaft, and needles that allow for precise suturing and closure of the annulus fibrosus incision, featuring a distal end assembly with tissue bite areas and ferrule recesses for secure needle positioning and suture release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional open surgery is used to remove the nucleus pulposus, then complete removal can be achieved, but a large incision through the annulus fibrosus is required and closure is difficult
Solution Approach 1:
The device divides the closure task into multiple discrete needle positions (first needle position and second needle position) that can be sequentially engaged through the incision. Each needle can be independently positioned and secured, allowing systematic closure of the annular incision without requiring a large opening.
Solution Approach 2:
The needles are nested within the shaft structure, with the distal end assembly containing the needles in a compact configuration. This nested arrangement allows the closure device to be introduced through a small incision while maintaining the capability for complete annular closure.
2Ease of operation
If a minimally invasive device is used to close the annulus, then the incision size is reduced, but precise needle positioning and control become more difficult
Solution Approach 1:
The actuation lever provides dynamic control of the needles, allowing the operator to transition between different actuation states (first actuation lever position and second actuation lever position) to precisely control needle extension and engagement. This dynamic mechanism enables accurate positioning despite the minimally invasive approach.
Solution Approach 2:
The coupling portion acts as an intermediary mechanism between the actuation lever and the needles, translating the lever's motion into precise needle positioning. This intermediary structure ensures that even small inputs from the minimally invasive procedure result in accurate needle placement.
3Reliability
If multiple needles are used for annular closure, then complete closure can be achieved, but device complexity increases
Solution Approach 1:
Multiple needles are merged into a single integrated distal end assembly that is controlled by one actuation lever. This combination allows complete annular closure to be achieved through a unified mechanism rather than separate operations, reducing the practical complexity despite having multiple needles.
Solution Approach 2:
The actuation lever serves multiple functions: it controls the extension and retraction of multiple needles, provides selection between different needle positions, and enables coordinated closure of the annulus. This multi-functionality reduces overall device complexity by consolidating control mechanisms.
4Reliability
If the needle is extended through the tissue, then secure suturing is achieved, but tissue damage and inflammation increase
Solution Approach 1:
The needle extension is controlled to provide just enough penetration through the annular tissue to achieve secure suturing without excessive extension that would cause unnecessary tissue damage. The actuation mechanism allows precise control of the extension depth to minimize harmful effects while maintaining sufficient anchoring.
Data Source
AI summary
A device includes a selection lever pivotably coupled to a housing, a shaft coupled to the housing, and a distal end assembly coupled to the shaft. When the selection lever is in a first position and an actuation lever is pivoted from a first position to a second position, a tip of the first needle extends from a first position across a first tissue bite area to a second position in which the tip is disposed within a first ferrule recess of a receiver portion of the distal end assembly. When the selection lever is in a second position and the actuation lever is pivoted from the first position to the second position, a tip of the second needle extends from a first position across a second tissue bite area to a second position in which the tip is disposed within a second ferrule recess of the receiver portion.