Single-Finger Catheter Manipulator for Narrow Cervical Access
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Solution Overview
Problem
Current methods for inserting an intrauterine pressure catheter (IUPC) require sufficient cervical dilation to accommodate two fingers, limiting the ability to accurately guide and position the catheter during labor, especially for women with smaller cervical diameters or medical professionals with larger fingers, which can lead to improper placement and increased risk of complications such as perforation.
Innovation Solution
A manipulator device that allows the IUPC introducer sheath to be oriented and positioned using a single finger, enabling insertion through a narrower cervix by attaching to a finger via clips, straps, or Velcro, allowing for precise guidance and placement of the catheter without requiring the traditional two-finger dilation, and facilitating easier removal of the sheath while maintaining the catheter's position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional two-finger insertion method is used, then guidance accuracy is improved, but cervical dilation requirement increases
Solution Approach 1:
The device divides the insertion function into two separate components: a introducer sheath for initial access and a separate catheter for final positioning. This segmentation allows the sheath to perform the guidance function while requiring minimal cervical dilation, and the catheter to be advanced separately for accurate placement in the amniotic cavity.
Solution Approach 2:
The introducer sheath serves as an intermediary device that facilitates catheter insertion through a narrow cervix. The sheath provides a controlled pathway and mechanical support, enabling the thinner catheter to be advanced accurately without requiring the operator's fingers to pass through the cervix first.
2Manufacturing precision
If two-finger stabilization is used, then trajectory guidance is improved, but device complexity increases
Solution Approach 1:
The introducer sheath is designed with inherent trajectory-control features such as pre-formed curves and directional tips that automatically guide the device along the correct path into the amniotic cavity. This self-guiding capability eliminates the need for complex manual manipulation techniques and reduces operator skill requirements.
3Ease of operation
If cervical dilation is increased, then catheter insertion ease is improved, but risk of complications increases
Solution Approach 1:
The catheter and introducer sheath are constructed from flexible materials that can conform to the cervical canal anatomy and bend safely around the fetal presenting part. This flexibility allows the devices to navigate tight spaces without requiring excessive force or large cervical openings, thereby reducing perforation risk while maintaining ease of insertion.
Data Source
AI summary
In various embodiments of the invention, a manipulator attaches to and allows a sheath to be positioned inside the cervix and a catheter to thereby be inserted through the sheath and be positioned in a desired location in the uterus. In various embodiments of the invention, the manipulator may be attached or permanently connected to the sheath. In various embodiments of the invention, the sheath is fenestrated to allow the catheter to be detached from the sheath. In various embodiments of the invention, the manipulator allows the sheath to be positioned through the cervix canal to allow for catheter transmitted intrauterine pressure monitoring or balloon catheter assisted ripening of the cervix.