Foldable Enclosure for Sheet-Like Repair Devices
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Solution Overview
Problem
Existing methods for delivering and positioning implantable sheet-like repair devices, such as those for soft tissue repair, often result in deformation, tearing, or adhesion issues during surgical procedures, leading to increased surgical time and larger incisions due to the fragile and flexible nature of these devices.
Innovation Solution
A foldable enclosure device with optional cutouts and securing mechanisms to protect and orient the sheet-like repair device, allowing for precise delivery and positioning without deformation or adhesion, using materials like Acetal and biocompatible polymers to ensure safety and effectiveness.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a protective delivery vehicle is used for sheet-like repair devices, then deformation and tearing are reduced, but device complexity increases
Solution Approach 1:
The patent employs a flexible, sheet-like protective delivery vehicle made from biocompatible materials that conform to the shape of the repair device while providing protection. The delivery vehicle uses flexible edges and a soft structure to prevent deformation and tearing during insertion, while maintaining simplicity through its thin-film design rather than complex mechanical structures.
Solution Approach 2:
The protective delivery vehicle acts as an intermediary between the surgical site and the fragile repair device. It provides a protective barrier that prevents direct contact between the repair device and potentially harmful surfaces or tissues during insertion and positioning, thereby reducing deformation and tearing risks without requiring complex delivery mechanisms.
2Device complexity
If the repair device is handled without protection, then device complexity is reduced, but adhesion to unwanted tissues occurs and surgical time increases
Solution Approach 1:
The protective delivery vehicle is pre-applied to the repair device before insertion into the surgical site. This preliminary protective layer prevents adhesion to unwanted tissues during handling and insertion, eliminating the need for time-consuming adjustments or replacements during the surgical procedure.
Solution Approach 2:
The protective delivery vehicle serves as an intermediary barrier between the repair device and unwanted tissues during surgical handling. This intermediate layer prevents direct adhesion while allowing for smooth insertion and positioning, thereby reducing surgical time without adding significant complexity to the delivery system.
3Length of stationary object
If the repair device is inserted through small openings, then incision size is reduced, but deformation and tearing of the fragile device occurs
Solution Approach 1:
The protective delivery vehicle is designed as a flexible, thin-film structure that can be inserted through small openings without causing deformation. Its flexible edges and soft material properties allow it to conform to the surgical site geometry while protecting the repair device during passage through narrow spaces.
Solution Approach 2:
The protective delivery vehicle provides beforehand cushioning by creating a protective barrier around the repair device before insertion. This cushioning effect prevents mechanical stress and deformation during passage through small openings, ensuring device integrity while maintaining minimal incision size.
4Strength
If aligned sheet-like repair devices are used, then strength and stress reduction are improved in specific directions, but implantation orientation precision must be maintained
Solution Approach 1:
The protective delivery vehicle incorporates asymmetric features such as directional tabs, markers, or shaped edges that indicate the correct orientation for insertion. These asymmetric elements guide the surgeon in positioning the device with the proper alignment, ensuring that the aligned fibers of the repair device are oriented correctly to provide maximum strength and stress reduction in the desired direction.
Solution Approach 2:
The protective delivery vehicle may include visual indicators such as color-coded edges, markers, or patterns that change or become visible during insertion to confirm proper orientation. These visual cues help maintain implantation orientation precision by allowing real-time verification that the aligned repair device is positioned correctly relative to the surgical site.
Data Source
AI summary
An enclosure device is disclosed for delivering an implantable sheet-like support or repair device, such as ligament, tendon or other soft tissue support or repair device, to a surgical site. The enclosure device protects the support or repair device from unwanted adhesion and deformation during delivery and facilitates its optimal positioning at the injury or repair site where the support or repair device will be implanted. The enclosure device has a planar body foldable along one or more fold lines into at least two panels configured to contain the repair device between the panels; an optional cutout in one or more panels of the planar body at the panel edge opposite the fold line configured to expose a portion of the repair device; an optional positioning tab extending out from the fold line; and an optional securing mechanism to secure the enclosure device in a folded position. Methods of using the enclosure device are described.