Poloxamer Hydrogel Spinal Disc Prosthesis
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Solution Overview
Problem
Existing spinal disc prostheses face challenges such as uncontrolled expansion causing additional stress on the annulus, difficulty in accurate positioning, and the need for precise pre-surgical measurements and curing agents, which can lead to decomposition and mobility issues.
Innovation Solution
The development of biocompatible HA-gelatin-containing poloxamer hydrogels that transition from a liquid to a gel at body temperature, allowing for minimally invasive implantation without the need for curing agents, and can be adjusted in volume and stiffness to mimic natural spinal disc properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If a dehydrated hydrogel prosthesis is inserted and allowed to expand in situ, then the prosthesis can fill the intradiscal space, but the uncontrolled expansion creates lateral forces that stress the annulus and impede healing
Solution Approach 1:
The patent changes the physical state parameter of the hydrogel from dehydrated (solid) to hydrated (gel) through controlled water absorption. By regulating the hydration process and using pre-swollen hydrogel beads rather than completely dehydrated ones, the expansion is controlled to minimize lateral forces on the annulus while still achieving adequate volume to fill the intradiscal space.
2Ease of operation
If a dehydrated implant is used, then the implant can be inserted through a small incision, but it is difficult to accurately position the implant within the nucleus cavity
Solution Approach 1:
The patent uses pre-swollen hydrogel beads that have already been hydrated to a controlled extent before implantation. This preliminary hydration action allows the surgeon to insert the implant through a small incision while maintaining sufficient pliability for positioning, and the pre-determined swelling characteristics help predict the final volume and position within the nucleus cavity.
3Adaptability or versatility
If a flow-able curable material is used, then the implant shape can be manipulated in situ, but curing agents are required that may decompose and become mobile
Solution Approach 1:
The patent extracts and eliminates the curing agents from the system by using pre-formed hydrogel beads that have already undergone the gelation process. This removes the source of decomposition and mobility problems associated with residual curing agents, while the beads maintain their flow-able characteristics during insertion and can be manipulated in situ before settling into position.
4Manufacturing precision
If precise pre-surgical measurements are required, then the prosthesis can be customized, but the surgical process becomes more complex and time-consuming
Solution Approach 1:
The patent uses standardized pre-swollen hydrogel beads with uniform size and swelling characteristics. This homogeneity allows for predictable performance and simplifies the surgical process, as surgeons do not need to perform complex custom measurements or preparations. The standardized beads can be selected based on general anatomical categories rather than precise individual measurements.
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 hydrogels provide a biocompatible, reversible, and adjustable spinal disc prosthesis that reduces stress on the annulus, facilitates precise implantation, and eliminates the need for curing agents, promoting healing and long-term stability.
Implementation Method 1
The biocompatible compositions that consist of, or that include, HA-gelatin-containing poloxamer hydrogels are liquid at low temperatures (e.g. between about 4° C. and about room temperature) and transition to a gel/solid phase at higher temperatures, including body temperature.
Data Source
AI summary
The present invention features, inter alia, biocompatible compositions that include a poloxamer and one or more additives such as hyaluronic acid, gelatin, fibronectin, or a peptide fragment of fibronectin. The compositions are useful in tissue repair or remodeling, including repair of an injured spinal disc, in drug delivery, in cell culture, and in inhibiting the formation of adhesions.