Pre-sutured Allograft Construct with Adjustable Regions
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Solution Overview
Problem
Traditional methods for surgically repairing or replacing damaged labrums are labor-intensive and time-consuming, requiring surgeons to accurately determine and meticulously prepare allograft fascia grafts, which is complex and difficult to achieve consistently.
Innovation Solution
A pre-sutured soft-tissue matrix allograft construct with adjustable lengths and diameters, featuring a specific pattern of whip and circumferential stitches, allowing for pre-manufactured sterile grafts that can be customized during surgery, reducing the need for on-table customization and simplifying the surgical procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional manual preparation methods are used, then customization accuracy is improved, but operating time and surgical complexity increase
Solution Approach 1:
The allograft construct is pre-sutured with whip stitches and circumferential stitches before sterilization and packaging. This preliminary preparation of the suture pattern allows the graft to be ready for implantation without requiring time-consuming manual suturing during surgery, thus reducing operating time while maintaining preparation accuracy.
Solution Approach 2:
The allograft construct is divided into multiple segments with different suture densities - whip stitches in certain regions and circumferential stitches in other regions. This segmentation allows different portions of the graft to be optimized for different functions while maintaining overall preparation accuracy without requiring complete manual customization during surgery.
2Adaptability or versatility
If traditional manual preparation methods are used, then graft customization is improved, but surgical complexity and labor intensity increase
Solution Approach 1:
The suture pattern is predetermined and pre-applied to the allograft construct during manufacturing, including specific whip stitch and circumferential stitch patterns in different regions. This preliminary configuration provides customization without requiring complex manual preparation during surgery, reducing surgical complexity while maintaining adaptability.
Solution Approach 2:
The pre-sutured allograft construct with its multi-region suture pattern can be used for various labral repair configurations (segmental or circumferential) without requiring different preparation techniques. This universal design maintains graft adaptability across different surgical scenarios while eliminating the need for complex case-by-case customization procedures.
3Productivity
If pre-sutured constructs are used, then operating efficiency is improved, but manufacturing complexity increases
Solution Approach 1:
The manufacturing process divides the suture application into distinct segments - whip stitches applied in certain regions and circumferential stitches in other regions. This segmentation allows for standardized, repeatable manufacturing steps that can be automated or semi-automated, improving productivity while managing manufacturing complexity through process standardization.
Solution Approach 2:
The suture pattern is applied during the manufacturing process rather than during surgery. This preliminary action transfers the complexity from the surgical environment to the controlled manufacturing environment, where standardized procedures and equipment can efficiently handle the suture application, thereby improving surgical throughput without是不可持续的 manufacturing complexity.
Data Source
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Figure 2A
AI summary
A pre-sutured allograft construct and method of manufacture for repairing, replacing, reconstructing, or augmenting a hip or shoulder labrum may include a folded tissue portion extending from a first end to a second end and forming top, middle, and bottom folds. A stitched pattern secures the folded tissue portion into a graft roll having an overall length extending from a first adjustable region, through a central region, and through a second adjustable region. A continuous series of whip stitches extends from the first adjustable region, through the central region, and through the second adjustable region. A series of triple circumferential stitches overlays the whip stitches in the first and the second adjustable regions, while a series of circumferential stitches alternates with the whip stitches in the central region. The construct is pre-manufactured as an allograft product, but is adjustable during the surgical procedure within the body. Other embodiments are also disclosed.