Vertebral Access Reamer-Stylet Assembly for Accurate Bone Entry
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Solution Overview
Problem
Existing systems for accessing bony anatomy, such as the vertebral body, require multiple separate instruments and steps, leading to inaccuracies and increased time under anesthesia due to potential user errors and complex workflows.
Innovation Solution
A integrated system comprising a working cannula, reamer, and guidewire or stylet, with removably coupled components that allow for a single-unit workflow, reducing the number of steps and instrumentation by integrating the reamer and stylet functions, and providing visual indicators for precise positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate instruments are used for accessing bony anatomy, then the access process can be completed with available instrumentation, but the number of steps increases and user errors may occur
Solution Approach 1:
The patent combines multiple separate instruments (access cannula, stylet, reamer) into a single integrated access system where the stylet and reamer are permanently coupled to the access cannula. This integration eliminates the need to sequentially deploy multiple separate instruments, reducing workflow steps and minimizing opportunities for user error while maintaining all necessary functions for accessing bony anatomy.
Solution Approach 2:
The integrated access system performs multiple functions through a single unified device. The access cannula with integrated stylet and reamer can simultaneously provide guidance, cutting, and access functions that previously required separate instruments, thereby simplifying the overall procedure while maintaining reliability.
2Reliability
If multiple separate instruments and workflow steps are used, then comprehensive access can be achieved, but the time under anesthesia increases
Solution Approach 1:
By merging the stylet, reamer, and access cannula into a single integrated device, the patent eliminates multiple sequential steps including inserting the access cannula, removing the trocar, directing the stylet, decoupling the stylet hub, removing the access cannula, directing the reamer, and removing the stylet shaft. This single-device approach maintains comprehensive access capability while dramatically reducing the time the patient remains under anesthesia.
3Ease of operation
If separate instruments are used sequentially, then each function can be performed by specialized tool, but the workflow becomes complex and error-prone
Solution Approach 1:
The patent integrates the stylet, reamer, and access cannula into a single device that is inserted and operated as one unit. This eliminates the complex sequential workflow of deploying multiple separate instruments, making the procedure simpler to perform and less prone to user errors such as incorrect assembly or misplacement of components.
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 integrated system simplifies the access process, reduces user errors, and minimizes the time required for access, ensuring accurate placement of the working channel for implant deployment.
Implementation Method 1
The reamer head includes cutting geometries configured to drill or ream through tissue, and in particular cortical and cancellous bone
Data Source
AI summary
Systems and methods for providing access to within a vertebral body. A stylet is removably disposed within a reamer, and the reamer is removably disposed within a working cannula. A tip of the stylet is positioned distal to a reamer head with a stylet hub being positioned proximal to a reamer hub. The reamer hub may include indicia configured to be aligned with the stylet hub to indicate a distance by which the tip is positioned beyond a distal end of the reamer. Complementary coupling features on the reamer hub and the stylet hub are configured to facilitate the workflow and provide mechanical advantage during removal of the stylet from the reamer. The system may include a spacer device configured to be positioned between the reamer hub and the stylet hub. The spacer device may be coupled to a stylet shaft of the stylet.