Multi-Piece Ligament Fixation for Suture Tension and Bone Sealing
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Solution Overview
Problem
Existing methods for fixing soft tissue to bone, such as ligament reconstruction, require improved anchor assemblies that maintain suture tension initially and before final fixation, and methods to seal off bone apertures to contain biologics like blood and growth factors.
Innovation Solution
A multi-piece fixation device comprising a larger collar and a smaller plug/bullet-shaped part that maintains suture tension and seals off bone apertures, using materials like PEEK or metal, with optional knotless fixation devices like Arthrex ACL TightRope®, and a three-piece device with a bone tunnel compression device, inner sleeve, and tapered screw.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single-piece anchor is used for tissue fixation, then the device structure is simple, but the ability to maintain suture tension initially and before final fixation is limited
Solution Approach 1:
The anchor device is divided into multiple pieces: a first piece (collar) that is initially impacted into the bone aperture and a second piece (plug) that is subsequently impacted into the first piece. This segmentation allows the device to maintain suture tension through the interaction between pieces while keeping each individual piece relatively simple in structure.
Solution Approach 2:
The first piece is impacted into the bone aperture in advance to establish initial fixation and maintain suture tension before the second piece is added. This preliminary action ensures that the suture tension is secured from the beginning of the procedure, allowing for subsequent tensioning and final fixation without compromising initial stability.
2Reliability
If the bone aperture is left open for tissue insertion, then the surgical procedure is simple, but biologics such as blood and growth factors are not contained
Solution Approach 1:
The fixation device is divided into a first piece that provides initial fixation and a second piece that seals the aperture. This segmentation allows the surgical procedure to proceed in stages: first inserting tissue through the open aperture, then adding the sealing second piece to contain biologics, thereby achieving both ease of operation and reliable biologic containment.
Solution Approach 2:
The first piece is inserted into the bone aperture in advance to establish a sealed environment before final tissue fixation. This preliminary sealing action contains biologics such as blood and growth factors within the aperture, creating an optimal healing environment while allowing the surgical procedure to progress systematically.
3Ease of operation
If traditional suture tying methods are used, then the fixation method is simple, but the procedure is more invasive and has higher morbidities
Solution Approach 1:
The invention extracts and eliminates the need for traditional knot-tying procedures by using a plug-based fixation system. The second piece (plug) is impacted into the first piece to secure the suture without requiring external knot tying, thereby reducing invasiveness and surgical morbidities while maintaining fixation effectiveness.
Solution Approach 2:
The anchor device performs the fixation function itself through the interaction between the first and second pieces. The plug (second piece) automatically secures the suture within the collar (first piece) through its impact insertion, eliminating the need for additional surgical steps like knot tying, thus reducing invasiveness while maintaining ease of operation.
Data Source
AI summary
Systems and methods for providing fixation of soft tissue (for example, ligament) to bone by employing a novel multi-piece device. The novel multi-piece device is a ligament fixation system consisting of a larger collar that is initially impacted into a bone aperture, and a smaller plug/bullet-shaped part that is impacted into the larger collar. During ligament repair/reconstruction, the graft is inserted into a bone tunnel with sutures from the graft extending outside the tunnel. The sutures are passed through a collar of the multi-part device and the collar is then inserted into the bone tunnel. The graft suture strands may be tensioned. Subsequently, the smaller plug/bullet-shaped part is impacted into the collar thereby maintaining the tension on the graft sutures. The plug/bullet-shaped part is tightened after the desired tension on the suture is achieved.