Self-Expanding Biodegradable Bone Implant for CSF Leakage
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Solution Overview
Problem
Current bone implants used in transsphenoidal surgery are time-consuming to shape and arrange, and they often result in high cerebrospinal fluid (CSF) leakage rates, necessitating additional corrective surgeries due to inadequate sealing of the sella turcica hole.
Innovation Solution
A self-expanding, biodegradable implant with an intermediate open cell foam layer and adhesive coatings, comprising two portions that deploy independently to create a tight seal within the hole, promoting tissue ingrowth and reducing CSF leakage, is introduced. The implant is designed to fit within a cartridge in a compressed position and transition to a deployed position using a deployment tool.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional bone implants made of super elastic materials are used to create a tight seal, then sealing effectiveness is improved, but the time required to shape and arrange the implant increases significantly
Solution Approach 1:
The implant is pre-formed with a specific geometry that allows it to self-expand into the desired shape upon deployment. The compressed configuration is prepared in advance, eliminating the need for intraoperative shaping and arrangement of super elastic materials while maintaining the ability to create a tight seal through self-expansion
Solution Approach 2:
The implant utilizes phase transition or elastic deformation properties to change its physical state from a compressed, insertable configuration to an expanded, sealing configuration. This parameter change allows the implant to achieve tight sealing effectiveness without requiring time-consuming manual shaping during surgery
2Ease of manufacture
If traditional bone implants are used to fill the hole, then the hole can be filled, but CSF leakage rates remain high requiring additional corrective surgery
Solution Approach 1:
The implant incorporates an adhesive coating on specific surfaces that contact the bone edges surrounding the hole. This localized adhesive property enhances the sealing interface at critical areas, preventing CSF leakage without compromising the ease of overall implant insertion
Solution Approach 2:
The implant combines a biodegradable structural material with an adhesive coating layer, creating a composite structure that provides both mechanical filling capability and chemical bonding for leak prevention, thereby improving reliability without complicating the insertion process
3Reliability
If the implant structure is made complex to ensure tight sealing, then sealing reliability is improved, but the device complexity increases making it harder to use
Solution Approach 1:
The implant is divided into distinct functional portions: a structural body for filling the hole and an adhesive coating layer for sealing. This segmentation allows each portion to be optimized for its specific function while keeping the overall device simple to use during insertion
Solution Approach 2:
The implant performs the sealing function automatically through its self-expanding mechanism and adhesive coating activation upon deployment, eliminating the need for complex manual manipulation or additional sealing components. The structure serves itself to create the tight seal
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 provides a simple, safe, and effective solution for filling holes in bone tissue, reducing CSF leakage and facilitating bone ingrowth for durable fixation, with the ability to be resorbed by the body, thus minimizing the need for additional surgeries.
Implementation Method 1
A self-expanding, biodegradable implant with an intermediate open cell foam layer and adhesive coatings, comprising two portions that deploy independently to create a tight seal within the hole
Implementation Method 2
A self-expanding, biodegradable implant with an intermediate open cell foam layer and adhesive coatings
Implementation Method 3
A self-expanding, biodegradable implant with an intermediate open cell foam layer and adhesive coatings
Implementation Method 4
A self-expanding, biodegradable implant with an intermediate open cell foam layer and adhesive coatings
Data Source
AI summary
An implant to fill a hole in tissue, such as bone tissue, comprising a first portion that is insertable through the hole when in a first compressed position, wherein the first portion cannot pass through the hole when in a first deployed position; and a second portion that cannot pass through the hole when in the second deployed position. The first and second portions of the implant can be deployed independently. Therefore, in operation, it is possible to insert the first portion of the implant through the hole when in the first compressed position, deploying the first portion to transition it to the first deployed position while the second portion remains in the second compressed position, and then deploying the second portion to transition it to the second deployed position. The devices and methods may be used, for example, in transsphenoidal or other orthopedic surgeries involving bone tissue.