Direct Soft Tissue Fixation Implant via Crimping
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing surgical fixation devices require sutures for connection between soft tissue and the device, leading to high skill requirements, potential tissue quality issues, prolonged healing times, and risks of fixation failure, such as bone fracture and suture-related complications.
Innovation Solution
A novel implantable device that secures soft tissue or tendon directly via crimping, using a device with a unicortical socket matching the tendon diameter, allowing for circumferential healing and reduced healing time, without the need for sutures, and featuring a crimping method that provides secure fixation by matching the tendon diameter to the socket.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suture connection is used between device and soft tissue, then fixation can be achieved, but surgical skill requirement increases and tissue quality issues arise
Solution Approach 1:
The patent removes the suture component from the fixation system entirely. The device directly engages the soft tissue through a crimping mechanism that secures the tissue between compression elements, eliminating the need for sutures and knots. This extraction of the suture intermediary simplifies the surgical procedure while maintaining reliable fixation.
Solution Approach 2:
The patent introduces a crimping mechanism as an intermediary between the device and soft tissue. This mechanism uses compression elements that directly contact and secure the tissue without requiring sutures. The crimping action creates a secure mechanical bond that is easier to perform surgically while maintaining fixation strength.
2Reliability
If suture connection is used between device and soft tissue, then fixation can be achieved, but healing time is prolonged
Solution Approach 1:
By removing the suture and knot-tying process entirely, the patent eliminates the prolonged protective phase that is normally required for suture-based fixations. The direct crimping mechanism allows for earlier rehabilitation initiation because there are no sutures to compromise during healing.
Solution Approach 2:
The device uses a single-use crimping mechanism that provides immediate and sufficient fixation without requiring long-term presence of sutures or other temporary fixation elements. The fixation is achieved in one action without needing prolonged protection.
3Reliability
If interference screw threads engage bone, then anchor point is created, but bone damage occurs and loosening susceptibility increases
Solution Approach 1:
The patent removes the threaded engagement mechanism entirely. Instead of using interference screws that cut threads into bone, the device uses a crimping mechanism that secures soft tissue without requiring bone thread purchase. This eliminates the harmful effect of thread engagement on bone integrity.
Solution Approach 2:
The crimping mechanism serves as an intermediary that creates the anchor point without direct threaded engagement with bone. The compression elements secure the tissue through compression rather than thread purchase, avoiding bone damage while maintaining anchor stability.
4Reliability
If unicortical socket matches tendon diameter, then circumferential healing is enabled, but device insertion complexity increases
Solution Approach 1:
The patent applies local quality by creating a socket that is precisely matched to the specific tendon diameter at the fixation site. This localized customization enables circumferential healing around the entire tendon perimeter. The crimping mechanism is then adapted to match this specific socket size, creating a coordinated system optimized for the local anatomy.
Data Source
AI summary
Disclosed herein is a device and method for securing soft tissue such as the long head of the biceps tendon (or similar) as well as free grafts or allografts directly to bone. The device is directly crimped to the preferred soft tissue. This is accomplished by the application of a crimping device to the implantable device and application of sufficient force to crimp the implantable device thereby fixing said device to the tissue in question. The complex of the device and the tissue/tendon can then be directly fixed to bone as necessary. Additionally, the same device and method can be used to connect one tendon to another as indicated.