Allograft Interspinous Spacer with Deployable Retainers
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Solution Overview
Problem
Current interspinous spacers require large incisions and complex insertion methods, and their manufacturing from metallic or polymer materials faces challenges in customizing to varying bone geometries, especially in cases of bone damage or fractures where bone grafts are needed.
Innovation Solution
A deployable, bone-derived interspinous spacer system that can be laterally inserted through a single opening and deployed to maintain position between spinous processes, utilizing a core and deployable retainers to secure the spacer, which can be manufactured from allograft bone to match individual bone geometries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If current interspinous spacers are constructed from metallic or polymer materials, then manufacturing is possible, but the spacers cannot be customized to match individual bone geometries and dimensions
Solution Approach 1:
The spacer is manufactured from allograft bone material, changing the material parameter to enable natural adaptation to individual bone geometries. The bone graft material can be processed to match the specific dimensional and geometric parameters of the patient's anatomy, providing custom fit without requiring complex manufacturing processes.
Solution Approach 2:
The invention uses allograft bone as the primary material, creating a composite structure that combines the natural adaptability of bone tissue with the structural integrity needed for the spacer function. This material choice enables customization to individual bone geometries while maintaining manufacturing feasibility through established bone processing techniques.
2Ease of operation
If current interspinous spacers require insertion from opposite sides of the spine through large incisions, then the spacer can be securely positioned, but the surgical approach is complex and recovery time is extended
Solution Approach 1:
The spacer is designed with a two-part configuration: a body portion and a retainer portion that can be inserted separately through a single small incision. The body is inserted first, followed by deployment of the retainer portion, allowing secure positioning without requiring large incisions or complex multi-step insertion procedures.
Solution Approach 2:
The spacer incorporates a deployable retainer mechanism that transitions from a compact inserted state to an expanded secured state. The retainer portion is deployed after insertion to engage with the spinous processes, providing stable positioning while maintaining a simple surgical approach. The dynamic deployment mechanism ensures reliability without complicating the insertion procedure.
3Ease of operation
If current interspinous spacers use separate pieces requiring insertion from opposite sides, then the spacer can be positioned, but the procedure requires cutting thoracolumbar fascia and stripping multifidus muscles
Solution Approach 1:
The spacer is divided into a body portion and a retainer portion that can be inserted through a single small incision. This segmentation allows the spacer to be positioned without requiring large incisions, thereby reducing tissue damage to the thoracolumbar fascia and multifidus muscles while maintaining secure positioning.
Solution Approach 2:
The retainer portion is extracted as a separate deployable element that is activated after the body is inserted. This extraction approach allows the main spacer body to be positioned through minimal incision while the retainer is deployed internally to provide securing function, eliminating the need for large external incisions and reducing tissue trauma.
4Reliability
If bone grafts are used to repair damaged bone areas, then the bone can be restored, but the manufacturing of custom spacers becomes complex due to varying bone geometries
Solution Approach 1:
The allograft bone material is processed to standardize its dimensions and geometry, changing the parameter variability to a manageable level. This standardization enables the bone graft to be manufactured as a consistent spacer component while maintaining the ability to adapt to individual patient anatomies through controlled dimensional variations.
Solution Approach 2:
The allograft bone spacer is designed to serve multiple functions: it acts as both the structural spacer body and the customized fit component. The universal design allows the same basic spacer structure to be adapted to various bone geometries and patient anatomies through controlled manufacturing variations, reducing overall manufacturing complexity while maintaining repair effectiveness.
Data Source
AI summary
An allograft interspinous spacer for implantation into an interspinous space located between spinous process of adjacent vertebrae. The spacer preferably includes a body, a core and a plurality of deployable retainers. The body may be operatively associated with the plurality of deployable retainers. In use, after the body has been inserted into the interspinous space, the plurality of retainers is deployed so that they prevent migration of the spacer. The core is preferably sized and configured to be inserted and/or moved into operatively engagement with the body to deploy the plurality of retainers.


