Repositionable Implant Fastener with Swiveling Tissue Retainers
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Solution Overview
Problem
Current surgical techniques for procedures like mastopexy face challenges in achieving precise and adjustable fixation of medical devices, such as mesh, due to the need for sutures, screws, or bone anchors, which can be cumbersome and require removal and replacement for adjustments, especially in minimally invasive or restricted access procedures.
Innovation Solution
Development of repositionable fasteners with a supportive backing and swiveling tissue retainers that can be fixed in one position, removed, and repositioned without the need for sutures, screws, or bone anchors, allowing for adjustable attachment and reattachment to medical devices like surgical mesh.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional fixation methods (sutures, screws, or bone anchors) are used to attach medical devices to tissue, then reliable fixation is achieved, but the procedure becomes cumbersome and requires removal and replacement for adjustments
Solution Approach 1:
The fastener incorporates a dynamic retention mechanism where retainers can be inserted into tissue and then released to engage. This allows the fixation system to transition from an implantable state to a locked state, providing reliable fixation while maintaining the capability for adjustment through the release mechanism
Solution Approach 2:
The fastener acts as an intermediary device between the medical device and the tissue. It provides a standardized interface that simplifies attachment while the retention mechanism offers controlled engagement for reliable fixation. The fastener mediates between the need for simple attachment and the need for secure, adjustable fixation
2Manufacturing precision
If adjustments to the position of the medical device are needed after implantation, then precise positioning can be achieved, but additional time is required for removal and replacement of fixation devices
Solution Approach 1:
The fastener's dynamic retention mechanism allows for quick release and repositioning. The retainers can be easily disengaged from tissue and re-engaged at a new position, enabling precise positioning adjustments without the time-consuming process of removing and replacing traditional fixation devices
Solution Approach 2:
The fastener is pre-configured with retention mechanisms that are ready for quick engagement and disengagement. This preliminary preparation of the fixation system allows surgeons to make position adjustments rapidly without needing to perform complex removal and reattachment procedures
3Object-affected harmful factors
If minimally invasive procedures are performed with restricted access, then patient trauma is reduced, but fixation and adjustment of medical devices becomes more difficult
Solution Approach 1:
The fastener is designed as a segmented device with distinct components: the body, the retainers, and the attachment interface. This segmentation allows the fastener to be implanted through minimal access and then independently adjusted, making fixation easier in restricted access procedures while maintaining minimal patient trauma
Solution Approach 2:
The fastener serves as an intermediary that simplifies fixation in minimally invasive procedures. It provides a standardized attachment interface that can be easily manipulated through small incisions, and its retention mechanism allows for secure fixation without requiring extensive surgical exposure
Data Source
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AI summary
Implantable fasteners that can be repositioned after implantation, and implants including these repositionable implantable fasteners, have been developed. The fasteners are designed to fixate medical devices and other implantable components in the body, and can be adjusted after initial fixation in tissue to reposition the implanted medical device. The fasteners include a plurality of tissue retainers emanating from a supportive backing, wherein the tissue retainers can swivel from the plane of the supportive backing to engage tissue. The fasteners are fixated in tissue by movement in a first direction, and can be removed when pulled in a direction opposite to the first direction. The fasteners may be attached to medical devices before or after implantation. In one embodiment, the implant is a mastopexy device in the form of a mesh and the repositionable fastener.