Rotator Cuff Implant With Hydrogel Coating for Tendon-Bone Healing
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Solution Overview
Problem
Current rotator cuff repair techniques face challenges such as difficulty in achieving stable tendon-to-bone fixation, reliance on soft tissue quality, and inadequate healing due to factors like osteopenia and osteoporosis, leading to high re-tear rates, especially with larger tears.
Innovation Solution
A tendon repair implant system comprising a body with extending arms and staples, coated with a hydrogel containing growth factors for staged healing, is used to restore the rotator cuff tendon footprint, secured with staples to the humerus using arthroscopic or open procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If traditional suture and suture anchor techniques are used for rotator cuff repair, then the procedure can be performed with standard equipment, but stable fixation of the tendon to bone is difficult to achieve
Solution Approach 1:
The patent introduces a tendon-to-bone graft as an intermediary structure between the rotator cuff tendon and the humeral bone. This graft serves as a mediator that facilitates direct bone-to-bone healing, bypassing the limitations of soft tissue suture fixation and providing more stable mechanical anchoring while maintaining procedural feasibility through standardized implant insertion techniques
Solution Approach 2:
The invention employs composite construction by combining the tendon graft with a bone graft in a staged repair approach. The tendon graft is first placed to restore the tendon footprint, followed by placement of a bone graft to fill the defect and provide a healing surface. This composite approach integrates multiple materials and structures to achieve both ease of procedure and reliable fixation
2Ease of operation
If suture fixation is used to restore the rotator cuff tendon footprint, then the repair can be performed with standard suture techniques, but the quality of soft tissue support becomes critical for fixation reliability
Solution Approach 1:
The tendon-to-bone graft acts as an intermediary that transfers the repair mechanism from soft tissue-dependent suture fixation to bone-based anchoring. The graft provides a structured interface that is less dependent on soft tissue quality, thereby improving fixation reliability while maintaining ease of operation through straightforward implant placement
Solution Approach 2:
The invention changes the fundamental parameter of fixation from soft tissue-based (sutures) to bone-based (direct bone-to-bone healing). This parameter change fundamentally alters the reliability profile by eliminating dependence on soft tissue quality metrics such as tissue strength and elasticity, while the procedure remains operationally simple through standardized graft placement techniques
3Ease of manufacture
If the rotator cuff tendon is repaired using conventional techniques, then the procedure can be completed with standard equipment, but healing is compromised by factors like osteopenia and osteoporosis
Solution Approach 1:
The bone graft serves as a protective intermediary that shields the healing interface from the detrimental effects of osteopenia and osteoporosis. By providing a fresh, healthy bone surface for direct bone-to-bone healing, the graft creates a controlled environment that is independent of the patient's underlying bone quality, thereby improving healing quality while maintaining procedural simplicity
Solution Approach 2:
The patent employs preliminary action by placing the tendon graft first to restore the tendon footprint before placing the bone graft. This staged approach prepares the healing environment in advance by establishing the correct anatomical architecture and blood supply patterns, thereby improving healing quality while keeping the procedure straightforward through systematic sequencing
4Adaptability or versatility
If the damaged tendon interface is left without intervention, then the natural healing process can occur, but the interface lacks sufficient endogenous signal cues for functional tissue regeneration
Solution Approach 1:
The tendon-to-bone graft serves as a biological intermediary that provides the missing endogenous signal cues necessary for functional tissue regeneration. The graft is constructed with appropriate cellular and molecular components that stimulate and guide the natural healing process, thereby enhancing tissue regeneration while preserving the adaptability of the body's inherent repair mechanisms
Solution Approach 2:
The invention enables self-service by providing the healing interface with all necessary regenerative cues and support structures. The graft is designed to be self-sustaining, providing its own blood supply, cellular components, and structural framework that allow the natural healing process to proceed autonomously without requiring additional external intervention, thereby improving tissue regeneration while maintaining natural healing adaptability
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The implant system provides stable fixation and promotes anatomic healing by mimicking natural tendon-to-bone healing stages, reducing re-tear rates and enhancing tissue regeneration.
Implementation Method 1
coated with a hydrogel containing growth factors for staged healing
Implementation Method 2
containing growth factors for staged healing
Data Source
AI summary
An implant, system, and method used for inserting a tendon repair implant system into a patient's humerus. The implant system includes an implant and at least one staple. The implant includes a body, a first arm extending away from the body on a first end of the implant, and a second arm extending away from the body between the first end and a second end of the implant. The implant may also include a hydrogel coating with a gradient of human growth factors positioned on at least the bone contacting surfaces. The implant is positioned on the proximal humerus and greater tuberosity with the two arms of the implant spaced apart forming a passageway for receiving the rotator cuff tendon.