Cervical Navigator With Sequential Dilators to Reduce Perforation Risk
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Solution Overview
Problem
Current cervical dilation methods using stiff dilators risk perforations and false passageway creation, leading to patient injury and procedural complications, particularly in patients with tortuous cervixes or abnormal uterine positions.
Innovation Solution
A gynecological cervical navigator system with an anchoring portion and vaginal retraction component that allows for sequential cervical dilation without re-navigating the cervical passageway, using a balloon to secure the device at the internal cervical ostia and maintain access, and a posterior vaginal wall retractor to prevent repetitive speculum insertion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If stiff dilators are used for cervical dilation, then the cervix can be dilated to the required size, but the risk of perforations and false passageway creation increases
Solution Approach 1:
The device segments the dilation process into two distinct phases: first, a flexible catheter with sequential dilators establishes the initial pathway through the cervix; second, a rigid hysteroscope is advanced through the established pathway. This segmentation allows the flexible component to navigate the tortuous cervical canal safely, then maintains the pathway for the rigid instrument without requiring re-navigation, thereby reducing perforation risk while achieving accurate dilation.
Solution Approach 2:
The device performs preliminary action by using the flexible catheter to establish and secure the cervical pathway before introducing the rigid hysteroscope. The catheter with its sequential dilators prepares the cervix in advance, creating a stable track that guides subsequent instruments. This preliminary pathway establishment eliminates the need for repeated cervical navigation attempts, reducing the cumulative risk of perforation associated with multiple dilator insertions.
2Manufacturing precision
If multiple dilators of increasing size are passed through the cervix, then the desired dilation size is achieved, but the risk of cervical injury is multiplied by each new entry attempt
Solution Approach 1:
The device divides the dilation function between two separate components: the flexible catheter handles the dangerous navigation and dilation task, while the rigid hysteroscope simply passes through the pre-established pathway. The catheter contains sequential dilators that progressively expand the cervix, and once the pathway is secured, the hysteroscope is advanced without requiring additional cervical manipulation. This segmentation maintains dilation precision while eliminating repeated navigation attempts.
Solution Approach 2:
The flexible catheter acts as an intermediary between the operator and the rigid hysteroscope during cervical navigation. It absorbs the complexity and risk of cervical canal navigation, using its flexibility and sequential dilators to safely establish the pathway. The hysteroscope, which lacks flexibility, can then be advanced through the catheter's established track without directly engaging with the cervical tissue, thereby reducing injury risk while achieving the required dilation.
3Ease of operation
If repetitive speculum insertion is performed to maintain access to the cervix, then visualization and access are maintained, but patient discomfort and procedural time increase
Solution Approach 1:
The device merges the functions of speculum retraction and cervical access maintenance into a single integrated system. The retractor component holds the vaginal walls apart, providing continuous visualization of the cervix, while the catheter with its inflation balloon maintains secure access to the internal cervical os. This combination eliminates the need for repeated speculum insertion and removal, reducing procedural time and patient discomfort while maintaining constant cervical access.
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
Reduces the risk of perforations and false passageways by maintaining a stable cervical dilation pathway, enhancing patient safety and procedural efficiency.
Implementation Method 1
inflating the inflation unit to anchor the medical device in the patient
Data Source
AI summary
A cervical navigator, including an elongate body having a rigid structure that at least partially deforms in response to contact with living tissue, and an opening disposed through a center portion of the elongate body and at least one dilator removably disposed through the opening that increases the size of an elongate body in response to insertion of at least one dilator into the opening and at least partial movement through the opening.