Modular Proximal Humerus Implant for Stable Rotator Cuff Repair
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Solution Overview
Problem
Current proximal humerus defect treatments using cadaver bone grafts are expensive, have high infection risk, and result in shoulder instability and dismal functional outcomes due to long surgical times and unpredictable soft tissue ingrowth on roughened surfaces.
Innovation Solution
A modular bone repair system with a trabecular metal implant having a low profile and multiple soft tissue attachment points, featuring a neck-shaft angle of 135 degrees and a lateralized glenosphere, which includes interchangeable components to match anatomical dimensions and prevent rotational movement, thereby stabilizing the shoulder joint.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cadaver bone grafts are used for proximal humerus defects, then the native rotator cuff can be repaired to the grafted bone, but surgical time becomes extremely long and infection risk increases
Solution Approach 1:
The implant is divided into modular components including a proximal body, stem, and head portion that can be assembled separately. The proximal body includes a proximal portion and distal portion that can be independently positioned and secured, allowing for reduced surgical time while maintaining the ability to repair the native rotator cuff to the grafted bone.
Solution Approach 2:
The implant components are pre-assembled and prepared before surgery, with the proximal body, stem, and head portion pre-configured for insertion. This preliminary preparation eliminates time-consuming intraoperative assembly steps while ensuring proper positioning for cuff repair.
2Reliability
If cadaver bone grafts are used for proximal humerus defects, then bone repair can be achieved, but infection risk becomes high
Solution Approach 1:
The implant is designed as a disposable, single-use device that is sterilized and packaged individually. This eliminates the need for donor bone processing and reduces infection risk associated with allografts, while maintaining effective bone repair capability through the integrated proximal body and stem components.
Solution Approach 2:
The invention extracts the bone graft function from separate cadaveric allografts and integrates it directly into the implant structure. The proximal body and stem form an integrated bone repair system that eliminates the need for separate grafting procedures and reduces infection risk.
3Ease of manufacture
If proximal humerus replacement systems are used, then bone defect can be replaced, but shoulder instability and dismal functional outcomes occur
Solution Approach 1:
The implant incorporates a glenosphere component with specific geometric features and material properties designed to match the glenoid anatomy. The proximal body includes trabecular metal portions with optimized porosity for soft tissue ingrowth, while the stem provides secure fixation. These localized quality enhancements ensure shoulder stability and improved functional outcomes.
Solution Approach 2:
The implant uses composite construction combining metal components (proximal body, stem, head portion) with trabecular metal portions that have optimized porosity. This composite approach provides both structural integrity for bone replacement and biological integration for soft tissue attachment, preventing shoulder instability.
4Strength
If roughened surfaces are used for soft tissue attachment, then bone anchoring can be achieved, but soft tissue ingrowth becomes unpredictable and failure rate increases
Solution Approach 1:
The proximal body incorporates trabecular metal portions with optimized porosity that promote predictable soft tissue ingrowth. The porous structure provides mechanical interlocking for bone anchoring while simultaneously facilitating soft tissue penetration and integration, eliminating the unpredictability associated with roughened surfaces.
Solution Approach 2:
The implant features different surface characteristics in different regions: the proximal body includes trabecular metal portions with high porosity for soft tissue ingrowth, while the stem provides secure bone fixation. This localized quality differentiation ensures both strong bone anchoring and predictable soft tissue integration.
Data Source
AI summary
Systems, methods, and devices include a bone repair system with a modular configuration of components. A bone repair device includes a head which tapers from a circular face to a first connector stem. The bone repair device also includes a plurality of interchangeable middle portions. A middle portion includes a first receiving area at a first end and a second connector stem at a second end. The first receiving area is operable to engage the first connector stem of the head portion. The bone repair device further includes a stem portion including a second receiving area at a first end and a tapered implantation stem at a second end. The second receiving area is operable to engage the second connector stem of the middle portion. Furthermore, the stem portion, the middle portion, and the head portion are selectively coupled to form a modular arrangement.