Non-resorbable Implantable Surgical Access Guides
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Solution Overview
Problem
Secondary surgeries, particularly in orthopedics and spine surgery, are challenging due to the removal of bony landmarks and dense adherent scar tissue, which increases surgery time and risks complications like infection and nerve damage, as existing methods fail to efficiently manage tissue formation and facilitate surgical navigation.
Innovation Solution
Nonresorbable, biocompatible, sterile surgical access devices comprising separable planar leaves and a base member with hollow projections that create a space for access, protecting delicate tissues and minimizing tissue dissection, while providing anchoring surfaces and radiographic markers for localization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional surgical methods are used for secondary surgeries, then the surgeon can perform the surgery, but the surgery time increases significantly (60 minutes or more) due to dense adherent scar tissue and removed bony landmarks
Solution Approach 1:
The patent applies preliminary action by placing an implantable guide device during the first surgery that remains in situ to facilitate the second surgery. The guide contains radiopaque markers and anatomical landmarks that are prepared in advance, allowing the surgeon to quickly locate and access the surgical site without spending time searching for landmarks or removing dense scar tissue during the revision procedure.
Solution Approach 2:
The implantable guide device serves as an intermediary between the surgeon and the surgical site. It provides radiopaque markers that can be visualized through imaging, and physical guides that direct surgical instruments to the correct location, mediating the interaction between the surgeon and the obscured anatomical landmarks.
2Reliability
If traditional surgical methods are used for secondary surgeries, then the surgery can be performed, but the risk of complications (infection, spinal cord or nerve root damage, dural tears) increases due to challenging surgical conditions
Solution Approach 1:
The guide device is implanted in advance to establish a safe pathway and mark critical anatomical structures before the revision surgery. This preliminary positioning allows the surgeon to avoid nerve roots, dura, and other delicate structures during the subsequent procedure, reducing the risk of iatrogenic injury.
Solution Approach 2:
The radiopaque markers and physical guides in the implantable guide act as intermediaries that visually and physically indicate safe zones and critical structures, allowing the surgeon to navigate around harmful areas without direct visualization, thereby reducing complication risks.
3Ease of operation
If traditional surgical methods are used for secondary surgeries, then the surgeon can access the surgical site, but dense adherent scar tissue must be carefully removed from underlying structures, increasing surgery complexity
Solution Approach 1:
The patent applies the extraction principle by removing the problematic dense adherent scar tissue that forms during the first surgery. The guide device provides a defined pathway that allows the surgeon to extract or bypass the scar tissue without having to carefully dissect and remove it layer by layer, simplifying the access to underlying structures.
Solution Approach 2:
The guide device segments the surgical approach by providing distinct radiopaque markers and physical guides that divide the complex tissue landscape into identifiable zones. This segmentation allows the surgeon to navigate through scar tissue more easily by following the segmented guidance markers rather than attempting to navigate through homogeneous dense tissue.
Data Source
AI summary
Surgical devices permitting a surgeon to access repeatedly tissue at a particular surgical site in a patient to perform multiple surgeries over time. The devices have two substantially planar and parallel leaves that are sterile, nonresorbable, and biocompatible. Each leaf forms a continuous structure and defines the entire longitudinal length of the device to accommodate the size and location of the surgical site. A base member is located in situ and adjacent the surgical site. An anchoring surface secures the device to the tissue of the patient at the surgical site. The leaves have a conjoined portion such that a manual force is required to separate the leaves, thereby expeditiously creating a pathway through which access to the tissue at the surgical site is realized with minimal tissue dissection, and the proximal ends of the leaves are not conjoined to facilitate separation of the leaves and creation of the pathway.